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Ibrutinib plus rituximab amped PFS in Waldenström’s
, results of a randomized phase 3 trial show.
The results make ibrutinib plus rituximab “a new standard of care” for the disease, said investigator Meletios A. Dimopoulos, MD, with the Department of Clinical Therapeutics, National and Kapodistrian University of Athens, Greece.
“This is a combination with remarkable activity as far as progression-free survival is concerned, and well tolerated,” Dr. Dimopoulos said in a presentation of the data here at the 2018 annual meeting of the American Society of Clinical Oncology (ASCO).
Ibrutinib, a BTK inhibitor, was approved as a single agent in 2015 for the treatment of Waldenström’s macroglobulinemia.* Clinical practice guidelines from the National Comprehensive Cancer Network (NCCN) list ibrutinib as an “other” recommended regimen, noting that study data show a “lower overall and absence of major responses” reported for MYD88 wild-type patients.Rituximab alone and in combination with other agents has clinical activity in Waldenström’s. Moreover, preclinical studies have shown that rituximab and ibrutinib have synergistic activity, Dr. Dimopoulos said, presenting data from the iNNOVATE Study Group and the European Consortium for Waldenström’s Macroglobulinemia that was published concurrently in the New England Journal of Medicine.
They initiated a study of 150 symptomatic patients randomized to either ibrutinib plus rituximab or placebo plus rituximab, with a primary end point of progression-free survival.
They also assessed mutational status of MYD88 and CXCR4 in bone marrow samples, given that previous data suggest outcomes of ibrutinib treatment for this disease depend on MYD88 and CXCR4 mutational status, they said in the report.
Progression-free survival at 30 months was 82% for ibrutinib plus rituximab, compared to 28% for placebo plus rituximab (hazard ratio for progression or death, 0.20; P less than 0.001). Further, ibrutinib and rituximab had a benefit that was independent of the MYD88 or CXCR4 genotype, the investigators reported.
“Response rates with ibrutinib–rituximab were similar across different CXCR4 genotypes, but were slightly lower among patients who did not have the activating MYD88 L265P mutation, which triggers the growth of malignant cells through BTK and hematopoietic-cell kinase, both of which are targeted by ibrutinib,” they wrote.
Atrial fibrillation of grade 3 or higher occurred in 12% of the ibrutinib-rituximab and in 1% of placebo-rituximab groups. In the ibrutinib-rituximab group, the majority of these cases occurred in patients older than 75 years of age, Dr. Dimopoulos reported at ASCO.
Grade 3 or greater hypertension occurred in 13% and 4% of the ibrutinib-rituximab and placebo-rituximab groups respectively, while respiratory tract infections occurred in 4% and 0%. Conversely, the ibrutinib-rituximab arm had a lower rate of grade 3 or greater infusion reactions (1% vs. 16%), he said.
Based on this report, ibrutinib plus rituximab is “appealing, primarily in MYD88-mutated patients, which is the vast majority of Waldenström’s patients,” said Craig Hofmeister, MD, MPH, who commented on the study in a ASCO presentation discussing the results of this trial.
Dr. Hofmeister, of Winship Cancer Institute, Emory University, Atlanta, noted the numerically lower response rate in patients without the MYD88 mutation “makes me wonder whether I would want to have ibrutinib if I was MYD88 wild type.”
Atrial fibrillation and infections on the ibrutinib-rituximab regimen may require close monitoring and should be managed appropriately, he added. “Atrial fibrillation seems to be a consistent theme with ibrutinib, certainly in patients who are older and have probably more heart disease.”
The study (NCT02165397) was funded by Pharmacyclics and Janssen Research and Development. Dr. Dimopoulos reported personal fees from Amgen, Celgene, Janssen, and Takeda, outside of the submitted work. Co-authors reported disclosures related to Pharmacyclics, Bristol-Myers Squibb, Gilead, Roche, and AbbVie, among others. Dr. Hofmeister had no relevant financial disclosures.
SOURCE: Dimopoulos MA, et al. N Engl J Med. 2018 Jun 1. ASCO Abstract 8003.
*Correction, 8/27/2018: An earlier version of this story misstated the date of ibrutinib's approval as a single agent in the treatment of Waldenström’s .
, results of a randomized phase 3 trial show.
The results make ibrutinib plus rituximab “a new standard of care” for the disease, said investigator Meletios A. Dimopoulos, MD, with the Department of Clinical Therapeutics, National and Kapodistrian University of Athens, Greece.
“This is a combination with remarkable activity as far as progression-free survival is concerned, and well tolerated,” Dr. Dimopoulos said in a presentation of the data here at the 2018 annual meeting of the American Society of Clinical Oncology (ASCO).
Ibrutinib, a BTK inhibitor, was approved as a single agent in 2015 for the treatment of Waldenström’s macroglobulinemia.* Clinical practice guidelines from the National Comprehensive Cancer Network (NCCN) list ibrutinib as an “other” recommended regimen, noting that study data show a “lower overall and absence of major responses” reported for MYD88 wild-type patients.Rituximab alone and in combination with other agents has clinical activity in Waldenström’s. Moreover, preclinical studies have shown that rituximab and ibrutinib have synergistic activity, Dr. Dimopoulos said, presenting data from the iNNOVATE Study Group and the European Consortium for Waldenström’s Macroglobulinemia that was published concurrently in the New England Journal of Medicine.
They initiated a study of 150 symptomatic patients randomized to either ibrutinib plus rituximab or placebo plus rituximab, with a primary end point of progression-free survival.
They also assessed mutational status of MYD88 and CXCR4 in bone marrow samples, given that previous data suggest outcomes of ibrutinib treatment for this disease depend on MYD88 and CXCR4 mutational status, they said in the report.
Progression-free survival at 30 months was 82% for ibrutinib plus rituximab, compared to 28% for placebo plus rituximab (hazard ratio for progression or death, 0.20; P less than 0.001). Further, ibrutinib and rituximab had a benefit that was independent of the MYD88 or CXCR4 genotype, the investigators reported.
“Response rates with ibrutinib–rituximab were similar across different CXCR4 genotypes, but were slightly lower among patients who did not have the activating MYD88 L265P mutation, which triggers the growth of malignant cells through BTK and hematopoietic-cell kinase, both of which are targeted by ibrutinib,” they wrote.
Atrial fibrillation of grade 3 or higher occurred in 12% of the ibrutinib-rituximab and in 1% of placebo-rituximab groups. In the ibrutinib-rituximab group, the majority of these cases occurred in patients older than 75 years of age, Dr. Dimopoulos reported at ASCO.
Grade 3 or greater hypertension occurred in 13% and 4% of the ibrutinib-rituximab and placebo-rituximab groups respectively, while respiratory tract infections occurred in 4% and 0%. Conversely, the ibrutinib-rituximab arm had a lower rate of grade 3 or greater infusion reactions (1% vs. 16%), he said.
Based on this report, ibrutinib plus rituximab is “appealing, primarily in MYD88-mutated patients, which is the vast majority of Waldenström’s patients,” said Craig Hofmeister, MD, MPH, who commented on the study in a ASCO presentation discussing the results of this trial.
Dr. Hofmeister, of Winship Cancer Institute, Emory University, Atlanta, noted the numerically lower response rate in patients without the MYD88 mutation “makes me wonder whether I would want to have ibrutinib if I was MYD88 wild type.”
Atrial fibrillation and infections on the ibrutinib-rituximab regimen may require close monitoring and should be managed appropriately, he added. “Atrial fibrillation seems to be a consistent theme with ibrutinib, certainly in patients who are older and have probably more heart disease.”
The study (NCT02165397) was funded by Pharmacyclics and Janssen Research and Development. Dr. Dimopoulos reported personal fees from Amgen, Celgene, Janssen, and Takeda, outside of the submitted work. Co-authors reported disclosures related to Pharmacyclics, Bristol-Myers Squibb, Gilead, Roche, and AbbVie, among others. Dr. Hofmeister had no relevant financial disclosures.
SOURCE: Dimopoulos MA, et al. N Engl J Med. 2018 Jun 1. ASCO Abstract 8003.
*Correction, 8/27/2018: An earlier version of this story misstated the date of ibrutinib's approval as a single agent in the treatment of Waldenström’s .
, results of a randomized phase 3 trial show.
The results make ibrutinib plus rituximab “a new standard of care” for the disease, said investigator Meletios A. Dimopoulos, MD, with the Department of Clinical Therapeutics, National and Kapodistrian University of Athens, Greece.
“This is a combination with remarkable activity as far as progression-free survival is concerned, and well tolerated,” Dr. Dimopoulos said in a presentation of the data here at the 2018 annual meeting of the American Society of Clinical Oncology (ASCO).
Ibrutinib, a BTK inhibitor, was approved as a single agent in 2015 for the treatment of Waldenström’s macroglobulinemia.* Clinical practice guidelines from the National Comprehensive Cancer Network (NCCN) list ibrutinib as an “other” recommended regimen, noting that study data show a “lower overall and absence of major responses” reported for MYD88 wild-type patients.Rituximab alone and in combination with other agents has clinical activity in Waldenström’s. Moreover, preclinical studies have shown that rituximab and ibrutinib have synergistic activity, Dr. Dimopoulos said, presenting data from the iNNOVATE Study Group and the European Consortium for Waldenström’s Macroglobulinemia that was published concurrently in the New England Journal of Medicine.
They initiated a study of 150 symptomatic patients randomized to either ibrutinib plus rituximab or placebo plus rituximab, with a primary end point of progression-free survival.
They also assessed mutational status of MYD88 and CXCR4 in bone marrow samples, given that previous data suggest outcomes of ibrutinib treatment for this disease depend on MYD88 and CXCR4 mutational status, they said in the report.
Progression-free survival at 30 months was 82% for ibrutinib plus rituximab, compared to 28% for placebo plus rituximab (hazard ratio for progression or death, 0.20; P less than 0.001). Further, ibrutinib and rituximab had a benefit that was independent of the MYD88 or CXCR4 genotype, the investigators reported.
“Response rates with ibrutinib–rituximab were similar across different CXCR4 genotypes, but were slightly lower among patients who did not have the activating MYD88 L265P mutation, which triggers the growth of malignant cells through BTK and hematopoietic-cell kinase, both of which are targeted by ibrutinib,” they wrote.
Atrial fibrillation of grade 3 or higher occurred in 12% of the ibrutinib-rituximab and in 1% of placebo-rituximab groups. In the ibrutinib-rituximab group, the majority of these cases occurred in patients older than 75 years of age, Dr. Dimopoulos reported at ASCO.
Grade 3 or greater hypertension occurred in 13% and 4% of the ibrutinib-rituximab and placebo-rituximab groups respectively, while respiratory tract infections occurred in 4% and 0%. Conversely, the ibrutinib-rituximab arm had a lower rate of grade 3 or greater infusion reactions (1% vs. 16%), he said.
Based on this report, ibrutinib plus rituximab is “appealing, primarily in MYD88-mutated patients, which is the vast majority of Waldenström’s patients,” said Craig Hofmeister, MD, MPH, who commented on the study in a ASCO presentation discussing the results of this trial.
Dr. Hofmeister, of Winship Cancer Institute, Emory University, Atlanta, noted the numerically lower response rate in patients without the MYD88 mutation “makes me wonder whether I would want to have ibrutinib if I was MYD88 wild type.”
Atrial fibrillation and infections on the ibrutinib-rituximab regimen may require close monitoring and should be managed appropriately, he added. “Atrial fibrillation seems to be a consistent theme with ibrutinib, certainly in patients who are older and have probably more heart disease.”
The study (NCT02165397) was funded by Pharmacyclics and Janssen Research and Development. Dr. Dimopoulos reported personal fees from Amgen, Celgene, Janssen, and Takeda, outside of the submitted work. Co-authors reported disclosures related to Pharmacyclics, Bristol-Myers Squibb, Gilead, Roche, and AbbVie, among others. Dr. Hofmeister had no relevant financial disclosures.
SOURCE: Dimopoulos MA, et al. N Engl J Med. 2018 Jun 1. ASCO Abstract 8003.
*Correction, 8/27/2018: An earlier version of this story misstated the date of ibrutinib's approval as a single agent in the treatment of Waldenström’s .
REPORTING FROM ASCO 2018
Key clinical point: Adding ibrutinib to rituximab treatment improved progression-free survival in patients with Waldenström’s macroglobulinemia.
Major finding: The rate of 30-month progression-free survival was 82% for the combination of ibrutinib plus rituximab, as compared with 28% for placebo plus rituximab (hazard ratio, 0.20; P less than 0.001).
Study details: A phase 3 trial including 150 symptomatic patients with Waldenström’s macroglobulinemia who had received no previous treatment or had disease recurrence.
Disclosures: The study (NCT02165397) was funded by Pharmacyclics and Janssen Research and Development. Dr. Dimopoulos reported personal fees from Amgen, Celgene, Janssen, and Takeda, outside of the submitted work. Co-authors reported disclosures related to Pharmacyclics, Bristol-Myers Squibb, Gilead, Roche, and AbbVie, among others. Dr. Hofmeister had no relevant financial disclosures.
Source: Dimopoulos MA, et al. N Engl J Med. 2018 Jun 1. ASCO Abstract 8003.
ASCO 2018: Dr. Walter M. Stadler gives his top picks in prostate cancer research
The theme of this year’s annual meeting of the American Society of Clinical Oncology is Delivering Discoveries: Expanding the Reach of Precision Medicine. Of the more than 2,500 abstracts accepted for presentation,
• 5000, A randomized, phase 3 trial between adjuvant docetaxel and surveillance after radical radiotherapy for intermediate and high-risk prostate cancer: Results of SPCG-13 trial.
• 5002, A randomized study of finite abiraterone acetate (AA) plus leuprolide (LHRHa) versus LHRHa in biochemically recurrent nonmetastatic hormone-naïve prostate cancer (M0HNPC).
• 5004, The PROPHECY trial: Multicenter prospective trial of circulating tumor cell (CTC) AR-V7 detection in men with mCRPC receiving abiraterone (A) or enzalutamide (E).
• LBA5005, Overall survival between African American (AA) and Caucasian (C) men with metastatic castration-resistant prostate cancer (mCRPC).
• 5006, Results of PROSPECT: A randomized, phase 3 trial of PROSTVAC-V/F (PRO) in men with asymptomatic or minimally symptomatic metastatic castration-resistant prostate cancer.
• 5007, KEYNOTE-199: Pembrolizumab (pembro) for docetaxel-refractory metastatic castration-resistant prostate cancer (mCRPC).
• 5020, Microsatellite instability in prostate cancer and response to immune checkpoint blockade.
• 5012, Phenotypic and genomic characterization of CTCs as a biomarker for prediction of Veliparib therapy benefit in mCRPC.
• 5022, Radium-223 retreatment in an international, open-label, phase 1/2 study in patients with castration-resistant prostate cancer and bone metastases: 2-year follow-up.
• 5032, Association of metastasis-free survival (MFS) and overall survival (OS) in nonmetastatic castration-resistant prostate cancer (nmCRPC).
• 5040, Lutetium-177 PSMA617 theranostics in metastatic castrate-resistant prostate cancer (mCRPC): Interim results of a phase 2 trial.
Dr. Walter M. Stadler, is the Fred C. Buffett Professor of Medicine and Surgery; deputy director of the University of Chicago Medicine Comprehensive Cancer Center; associate dean for clinical research; chief, section of hematology/oncology; and director, genitourinary oncology program at the University of Chicago.
The theme of this year’s annual meeting of the American Society of Clinical Oncology is Delivering Discoveries: Expanding the Reach of Precision Medicine. Of the more than 2,500 abstracts accepted for presentation,
• 5000, A randomized, phase 3 trial between adjuvant docetaxel and surveillance after radical radiotherapy for intermediate and high-risk prostate cancer: Results of SPCG-13 trial.
• 5002, A randomized study of finite abiraterone acetate (AA) plus leuprolide (LHRHa) versus LHRHa in biochemically recurrent nonmetastatic hormone-naïve prostate cancer (M0HNPC).
• 5004, The PROPHECY trial: Multicenter prospective trial of circulating tumor cell (CTC) AR-V7 detection in men with mCRPC receiving abiraterone (A) or enzalutamide (E).
• LBA5005, Overall survival between African American (AA) and Caucasian (C) men with metastatic castration-resistant prostate cancer (mCRPC).
• 5006, Results of PROSPECT: A randomized, phase 3 trial of PROSTVAC-V/F (PRO) in men with asymptomatic or minimally symptomatic metastatic castration-resistant prostate cancer.
• 5007, KEYNOTE-199: Pembrolizumab (pembro) for docetaxel-refractory metastatic castration-resistant prostate cancer (mCRPC).
• 5020, Microsatellite instability in prostate cancer and response to immune checkpoint blockade.
• 5012, Phenotypic and genomic characterization of CTCs as a biomarker for prediction of Veliparib therapy benefit in mCRPC.
• 5022, Radium-223 retreatment in an international, open-label, phase 1/2 study in patients with castration-resistant prostate cancer and bone metastases: 2-year follow-up.
• 5032, Association of metastasis-free survival (MFS) and overall survival (OS) in nonmetastatic castration-resistant prostate cancer (nmCRPC).
• 5040, Lutetium-177 PSMA617 theranostics in metastatic castrate-resistant prostate cancer (mCRPC): Interim results of a phase 2 trial.
Dr. Walter M. Stadler, is the Fred C. Buffett Professor of Medicine and Surgery; deputy director of the University of Chicago Medicine Comprehensive Cancer Center; associate dean for clinical research; chief, section of hematology/oncology; and director, genitourinary oncology program at the University of Chicago.
The theme of this year’s annual meeting of the American Society of Clinical Oncology is Delivering Discoveries: Expanding the Reach of Precision Medicine. Of the more than 2,500 abstracts accepted for presentation,
• 5000, A randomized, phase 3 trial between adjuvant docetaxel and surveillance after radical radiotherapy for intermediate and high-risk prostate cancer: Results of SPCG-13 trial.
• 5002, A randomized study of finite abiraterone acetate (AA) plus leuprolide (LHRHa) versus LHRHa in biochemically recurrent nonmetastatic hormone-naïve prostate cancer (M0HNPC).
• 5004, The PROPHECY trial: Multicenter prospective trial of circulating tumor cell (CTC) AR-V7 detection in men with mCRPC receiving abiraterone (A) or enzalutamide (E).
• LBA5005, Overall survival between African American (AA) and Caucasian (C) men with metastatic castration-resistant prostate cancer (mCRPC).
• 5006, Results of PROSPECT: A randomized, phase 3 trial of PROSTVAC-V/F (PRO) in men with asymptomatic or minimally symptomatic metastatic castration-resistant prostate cancer.
• 5007, KEYNOTE-199: Pembrolizumab (pembro) for docetaxel-refractory metastatic castration-resistant prostate cancer (mCRPC).
• 5020, Microsatellite instability in prostate cancer and response to immune checkpoint blockade.
• 5012, Phenotypic and genomic characterization of CTCs as a biomarker for prediction of Veliparib therapy benefit in mCRPC.
• 5022, Radium-223 retreatment in an international, open-label, phase 1/2 study in patients with castration-resistant prostate cancer and bone metastases: 2-year follow-up.
• 5032, Association of metastasis-free survival (MFS) and overall survival (OS) in nonmetastatic castration-resistant prostate cancer (nmCRPC).
• 5040, Lutetium-177 PSMA617 theranostics in metastatic castrate-resistant prostate cancer (mCRPC): Interim results of a phase 2 trial.
Dr. Walter M. Stadler, is the Fred C. Buffett Professor of Medicine and Surgery; deputy director of the University of Chicago Medicine Comprehensive Cancer Center; associate dean for clinical research; chief, section of hematology/oncology; and director, genitourinary oncology program at the University of Chicago.
CBT-I bests acupuncture for treating insomnia among cancer survivors
Cancer survivors who have trouble sleeping saw improvements with both cognitive-behavioral therapy designed specifically for insomnia (CBT-I) and acupuncture, according to results from the randomized, controlled CHOICE trial. But the former is more efficacious.
“Insomnia can have deleterious effects on quality of life and function, and occurs in up to 60% of cancer survivors,” lead study author Jun J. Mao, MD, chief of integrative medicine service at Memorial Sloan Kettering Cancer Center, New York, said in a press briefing held in advance of the annual meeting of the American Society of Clinical Oncology.
“CBT-I is a highly effective therapy and can be considered the gold standard of treatment,” he noted. However, this modality may be limited by poor adherence and nonresponse. Moreover, it is highly specialized and not currently available in many cancer centers or communities.
Functional imaging studies have shown that acupuncture can regulate brain regions involving cognition and emotion that are essential to sleep regulation, and clinical research has shown that it can improve pain- and hot flash–related sleep disturbances, according to Dr. Mao. About 73% of U.S. comprehensive cancer centers offer acupuncture for symptom management.
Main results of the CHOICE (Choosing Options for Insomnia in Cancer Effectively) trial showed that patients in both the CBT-I and acupuncture groups reduced their Insomnia Severity Index scores by more than one-half at the end of the 8-weeks treatment period, but the reduction was a statistically significant 2.6 points greater with CBT-I. Benefit of each treatment was still evident after 12 weeks.
Response rate was higher with CBT-I than with acupuncture only among patients having mild insomnia at baseline, and the two treatments yielded similar improvements in mental and physical quality of life.
“Among cancer patients with insomnia, we found that both acupuncture and CBT-I produced clinically meaningful and durable benefit, but overall, CBT-I is more effective in reducing insomnia severity,” Dr. Mao concluded. “Our hope is that by doing this type of research, we can help patients and clinicians pick the right kind of treatment and help them to manage their sleep. Our next step is to really examine for what type of patient treatment would be beneficial, and how to deliver this type of effective treatment to the broader community of cancer patients.”
Insomnia among cancer survivors is both prevalent and problematic, agreed ASCO President Bruce E. Johnson, MD, FASCO.
“The most common way we treat this is pharmacologically, with sleeping pills,” he noted. “This trial shows that two different methods using something other than medications can help people with sleep, and not only do they help people with sleep, but they improve their quality of life.
“We think this information will be helpful for clinicians who end up having to decide, and also, we would use this information to help decide about how the severity of the insomnia is going to influence the treatment,” maintained Dr. Johnson, who is also a professor of medicine at the Dana-Farber Cancer Institute in Boston, and a leader of the center’s lung cancer program.
Study details
The CHOICE trial did not have any restrictions on cancer type or stage; more than a half-dozen types were represented among the 160 patients enrolled, with breast cancer (31%) and prostate cancer (23%) accounting for the largest shares. The majority of patients were white (70%) and had moderate to severe insomnia (79%).
Patients were randomized to receive either acupuncture sessions (10 sessions, with points selected to treat insomnia plus comorbid symptoms such as fatigue and anxiety) or CBT-I (7 sessions), each over the course of 8 weeks.
Main results showed that at the end of treatment, the reduction in Insomnia Severity Index was 8.3 points with acupuncture and 10.9 points with CBT-I (P = .0007), Dr. Mao reported. Benefit of each treatment was sustained after 12 weeks.
In stratified analysis, the rate of response (defined as a greater than 8-point reduction) was higher with CBT-I than with acupuncture among patients with mild insomnia (Insomnia Severity Index of 8-14) (85% vs. 18%; P less than .0001), but not among patients with moderate or severe insomnia (Insomnia Severity Index of 15 or higher) (75% vs. 66%; P = .26).
The two treatments were similarly efficacious with respect to quality of life, assessed with the Patient-Reported Outcomes Measurement Information System over the entire course of the trial, for both the physical health component (P = .4) and the mental health component (P = .36).
Dr. Mao disclosed no relevant conflicts of interest. The study received funding from the Patient-Centered Outcomes Research Institute.
SOURCE: Mao JJ et al. ASCO 2018. Abstract 10001.
Cancer survivors who have trouble sleeping saw improvements with both cognitive-behavioral therapy designed specifically for insomnia (CBT-I) and acupuncture, according to results from the randomized, controlled CHOICE trial. But the former is more efficacious.
“Insomnia can have deleterious effects on quality of life and function, and occurs in up to 60% of cancer survivors,” lead study author Jun J. Mao, MD, chief of integrative medicine service at Memorial Sloan Kettering Cancer Center, New York, said in a press briefing held in advance of the annual meeting of the American Society of Clinical Oncology.
“CBT-I is a highly effective therapy and can be considered the gold standard of treatment,” he noted. However, this modality may be limited by poor adherence and nonresponse. Moreover, it is highly specialized and not currently available in many cancer centers or communities.
Functional imaging studies have shown that acupuncture can regulate brain regions involving cognition and emotion that are essential to sleep regulation, and clinical research has shown that it can improve pain- and hot flash–related sleep disturbances, according to Dr. Mao. About 73% of U.S. comprehensive cancer centers offer acupuncture for symptom management.
Main results of the CHOICE (Choosing Options for Insomnia in Cancer Effectively) trial showed that patients in both the CBT-I and acupuncture groups reduced their Insomnia Severity Index scores by more than one-half at the end of the 8-weeks treatment period, but the reduction was a statistically significant 2.6 points greater with CBT-I. Benefit of each treatment was still evident after 12 weeks.
Response rate was higher with CBT-I than with acupuncture only among patients having mild insomnia at baseline, and the two treatments yielded similar improvements in mental and physical quality of life.
“Among cancer patients with insomnia, we found that both acupuncture and CBT-I produced clinically meaningful and durable benefit, but overall, CBT-I is more effective in reducing insomnia severity,” Dr. Mao concluded. “Our hope is that by doing this type of research, we can help patients and clinicians pick the right kind of treatment and help them to manage their sleep. Our next step is to really examine for what type of patient treatment would be beneficial, and how to deliver this type of effective treatment to the broader community of cancer patients.”
Insomnia among cancer survivors is both prevalent and problematic, agreed ASCO President Bruce E. Johnson, MD, FASCO.
“The most common way we treat this is pharmacologically, with sleeping pills,” he noted. “This trial shows that two different methods using something other than medications can help people with sleep, and not only do they help people with sleep, but they improve their quality of life.
“We think this information will be helpful for clinicians who end up having to decide, and also, we would use this information to help decide about how the severity of the insomnia is going to influence the treatment,” maintained Dr. Johnson, who is also a professor of medicine at the Dana-Farber Cancer Institute in Boston, and a leader of the center’s lung cancer program.
Study details
The CHOICE trial did not have any restrictions on cancer type or stage; more than a half-dozen types were represented among the 160 patients enrolled, with breast cancer (31%) and prostate cancer (23%) accounting for the largest shares. The majority of patients were white (70%) and had moderate to severe insomnia (79%).
Patients were randomized to receive either acupuncture sessions (10 sessions, with points selected to treat insomnia plus comorbid symptoms such as fatigue and anxiety) or CBT-I (7 sessions), each over the course of 8 weeks.
Main results showed that at the end of treatment, the reduction in Insomnia Severity Index was 8.3 points with acupuncture and 10.9 points with CBT-I (P = .0007), Dr. Mao reported. Benefit of each treatment was sustained after 12 weeks.
In stratified analysis, the rate of response (defined as a greater than 8-point reduction) was higher with CBT-I than with acupuncture among patients with mild insomnia (Insomnia Severity Index of 8-14) (85% vs. 18%; P less than .0001), but not among patients with moderate or severe insomnia (Insomnia Severity Index of 15 or higher) (75% vs. 66%; P = .26).
The two treatments were similarly efficacious with respect to quality of life, assessed with the Patient-Reported Outcomes Measurement Information System over the entire course of the trial, for both the physical health component (P = .4) and the mental health component (P = .36).
Dr. Mao disclosed no relevant conflicts of interest. The study received funding from the Patient-Centered Outcomes Research Institute.
SOURCE: Mao JJ et al. ASCO 2018. Abstract 10001.
Cancer survivors who have trouble sleeping saw improvements with both cognitive-behavioral therapy designed specifically for insomnia (CBT-I) and acupuncture, according to results from the randomized, controlled CHOICE trial. But the former is more efficacious.
“Insomnia can have deleterious effects on quality of life and function, and occurs in up to 60% of cancer survivors,” lead study author Jun J. Mao, MD, chief of integrative medicine service at Memorial Sloan Kettering Cancer Center, New York, said in a press briefing held in advance of the annual meeting of the American Society of Clinical Oncology.
“CBT-I is a highly effective therapy and can be considered the gold standard of treatment,” he noted. However, this modality may be limited by poor adherence and nonresponse. Moreover, it is highly specialized and not currently available in many cancer centers or communities.
Functional imaging studies have shown that acupuncture can regulate brain regions involving cognition and emotion that are essential to sleep regulation, and clinical research has shown that it can improve pain- and hot flash–related sleep disturbances, according to Dr. Mao. About 73% of U.S. comprehensive cancer centers offer acupuncture for symptom management.
Main results of the CHOICE (Choosing Options for Insomnia in Cancer Effectively) trial showed that patients in both the CBT-I and acupuncture groups reduced their Insomnia Severity Index scores by more than one-half at the end of the 8-weeks treatment period, but the reduction was a statistically significant 2.6 points greater with CBT-I. Benefit of each treatment was still evident after 12 weeks.
Response rate was higher with CBT-I than with acupuncture only among patients having mild insomnia at baseline, and the two treatments yielded similar improvements in mental and physical quality of life.
“Among cancer patients with insomnia, we found that both acupuncture and CBT-I produced clinically meaningful and durable benefit, but overall, CBT-I is more effective in reducing insomnia severity,” Dr. Mao concluded. “Our hope is that by doing this type of research, we can help patients and clinicians pick the right kind of treatment and help them to manage their sleep. Our next step is to really examine for what type of patient treatment would be beneficial, and how to deliver this type of effective treatment to the broader community of cancer patients.”
Insomnia among cancer survivors is both prevalent and problematic, agreed ASCO President Bruce E. Johnson, MD, FASCO.
“The most common way we treat this is pharmacologically, with sleeping pills,” he noted. “This trial shows that two different methods using something other than medications can help people with sleep, and not only do they help people with sleep, but they improve their quality of life.
“We think this information will be helpful for clinicians who end up having to decide, and also, we would use this information to help decide about how the severity of the insomnia is going to influence the treatment,” maintained Dr. Johnson, who is also a professor of medicine at the Dana-Farber Cancer Institute in Boston, and a leader of the center’s lung cancer program.
Study details
The CHOICE trial did not have any restrictions on cancer type or stage; more than a half-dozen types were represented among the 160 patients enrolled, with breast cancer (31%) and prostate cancer (23%) accounting for the largest shares. The majority of patients were white (70%) and had moderate to severe insomnia (79%).
Patients were randomized to receive either acupuncture sessions (10 sessions, with points selected to treat insomnia plus comorbid symptoms such as fatigue and anxiety) or CBT-I (7 sessions), each over the course of 8 weeks.
Main results showed that at the end of treatment, the reduction in Insomnia Severity Index was 8.3 points with acupuncture and 10.9 points with CBT-I (P = .0007), Dr. Mao reported. Benefit of each treatment was sustained after 12 weeks.
In stratified analysis, the rate of response (defined as a greater than 8-point reduction) was higher with CBT-I than with acupuncture among patients with mild insomnia (Insomnia Severity Index of 8-14) (85% vs. 18%; P less than .0001), but not among patients with moderate or severe insomnia (Insomnia Severity Index of 15 or higher) (75% vs. 66%; P = .26).
The two treatments were similarly efficacious with respect to quality of life, assessed with the Patient-Reported Outcomes Measurement Information System over the entire course of the trial, for both the physical health component (P = .4) and the mental health component (P = .36).
Dr. Mao disclosed no relevant conflicts of interest. The study received funding from the Patient-Centered Outcomes Research Institute.
SOURCE: Mao JJ et al. ASCO 2018. Abstract 10001.
REPORTING FROM ASCO 2018
Key clinical point:
Major finding: After 8 weeks of treatment, the reduction in Insomnia Severity Index was 8.3 points with acupuncture and 10.9 points with CBT-I (P = .0007).
Study details: A randomized, controlled trial among 160 survivors of diverse cancers having any degree of insomnia.
Disclosures: Dr. Mao disclosed no relevant conflicts of interest. The study received funding from the Patient-Centered Outcomes Research Institute.
Source: Mao JJ et al. ASCO 2018. Abstract 10001.
Uptake of lung cancer screening is exceedingly low
Most heavy smokers in the United States who are eligible for low-dose CT screening for lung cancer do not receive it, according to a cross-sectional study reported in a press briefing held before the annual meeting of the American Society of Clinical Oncology.
Results of the National Lung Screening Trial reported in 2011 showed a 20% reduction in lung cancer mortality with targeted low-dose CT (LDCT) screening, noted lead study author Danh C. Pham, MD, of the James Graham Brown Cancer Center at the University of Louisville (Ky.).
Since 2013, the U.S. Preventive Services Task Force has recommended this screening for people aged 55-80 years who are current or former heavy smokers, defined as having smoked at least 30 pack-years, he added. “More importantly, in 2015, the Centers for Medicare and Medicaid Services expanded Medicare coverage for LDCT for lung cancer screening,” he said.
However, results of the new study showed that nationally, only 1.9% of more than 7.6 million eligible current and former smokers underwent LDCT screening in 2016. By region, the South had one of the lowest rates, despite having the most accredited screening sites and the greatest number of eligible patients.
The findings are stark when juxtaposed with rates of screening for some other cancers, Dr. Pham maintained. For example, 65% of women aged 40 years or older underwent mammography for breast cancer screening in 2015.
“This ultimately begs the question as to the root of the disparity,” he said. “Are physicians not referring enough? Or perhaps, are eligible patients not wanting screening, even if they know a test is available? Unfortunately, controversy still exists among providers about costs and benefits of screening, while patients at risk for lung cancer also perhaps lack adequate awareness of the benefits of screening.”
It is also possible that the stigma attached to smoking, a modifiable risk factor, and thus to lung cancer screening may be a deterrent, Dr. Pham speculated. Specifically, patients may perceive screening-detected lung cancer as confirmation of a poor lifestyle choice.
“Regardless of the reason, this ultimately is a call to action on everyone’s part to increase this much-needed screening, whether that’s through creating awareness or conducting additional research, to urgently increase screening for the No. 1 cancer killer in America, as it has been now documented that effective screening can prevent nearly 12,000 premature lung cancer deaths per year,” he concluded.
Oncologists in the lung cancer field “would certainly like to be put out of business by an effective screening program,” commented ASCO President Bruce E. Johnson, MD, FASCO.
These new findings should be considered in light of the fact that the study period came only about a year after the change in reimbursement for LDCT, he noted. “So this is not a measure of the steady-state situation, but rather when this was first implemented.”
Nonetheless, it is “very disappointing” how little LDCT screening is being used, added Dr. Johnson, who is also a professor of medicine at the Dana-Farber Cancer Institute in Boston, and a leader of the center’s lung cancer program. “It should be saving 12,000 lives a year, and with this number, it’s about 250 lives. As correctly stated, there is a certain stigma whereby people who smoke feel as if they deserve it or that it’s sort of a self-punishment.”
He agreed that the findings represent a call to action. “We hope that the message will get out there, that people who fall into this risk pattern, folks who have smoked a pack of cigarettes daily for 30 years or longer, will get in and get themselves screened for lung cancer.”
What will it take?
Policy change would likely help increase uptake of LDCT lung cancer screening, according to Dr. Pham. “I think the most radical thing we could suggest based on our study so far would potentially be making lung cancer screening a national quality health measure, just the way that CMS made [mammograms for] breast cancer and colonoscopies [for colorectal cancer] national areas of improvement in 2008,” he elaborated.
“I agree that that could be an effective strategy, particularly since physicians are increasingly being required [to follow] our quality measures to optimize the reimbursement,” commented Richard L. Schilsky, MD, FACP, FASCO, chief medical officer of ASCO and press briefing moderator.
“Keep in mind that, generally speaking, screening of healthy or high-risk individuals for cancer is typically performed by primary care physicians, not by oncologists,” he further noted. “So one of the things that we also need to do is to be sure that primary care physicians are well aware of the screening data and the importance of referring the appropriate patients for screening, and are aware of screening centers available in their communities.”
Dr. Johnson said that the society has been active in that area. “ASCO is working with the American College of Physicians and some of the other primary care groups to try to get the message out about the screening,” as well as to educate them about the large potential impact of screening and treatment. “There are 15 million cancer survivors in the United States, and for the people who fit those criteria for smoking, [we need] to make certain they are getting screened.”
Study details
For the study, Dr. Pham and his colleagues used data from the American College of Radiology’s Lung Cancer Screening Registry, collecting total number of LDCTs performed in 2016 from all 1,796 accredited radiographic screening sites. They also used data from the 2015 National Health Interview Survey to estimate eligible smokers who could be screened based on the USPSTF recommendations.
Overall, 1.9% of 7,612,975 eligible current and former heavy smokers underwent LDCT, he reported. By census region, the rate was highest in the Northeast (3.5%) and lowest in the West (1.0%).
Notably, only 1.6% of eligible heavy smokers in the South underwent LDCT, even though that region had, by far, the most accredited screening sites (663) and the most eligible patients (3,072,095). The rate was highest in the Northeast, at 3.5%, even though that region had the second-lowest number of accredited screening sites (404) and the fewest eligible patients (1,152,141).
Dr. Pham disclosed no relevant conflicts of interest. The study received grant funding from the Bristol-Myers Squibb Foundation.
SOURCE: Pham DC et al. ASCO 2018. Abstract 6504.
Most heavy smokers in the United States who are eligible for low-dose CT screening for lung cancer do not receive it, according to a cross-sectional study reported in a press briefing held before the annual meeting of the American Society of Clinical Oncology.
Results of the National Lung Screening Trial reported in 2011 showed a 20% reduction in lung cancer mortality with targeted low-dose CT (LDCT) screening, noted lead study author Danh C. Pham, MD, of the James Graham Brown Cancer Center at the University of Louisville (Ky.).
Since 2013, the U.S. Preventive Services Task Force has recommended this screening for people aged 55-80 years who are current or former heavy smokers, defined as having smoked at least 30 pack-years, he added. “More importantly, in 2015, the Centers for Medicare and Medicaid Services expanded Medicare coverage for LDCT for lung cancer screening,” he said.
However, results of the new study showed that nationally, only 1.9% of more than 7.6 million eligible current and former smokers underwent LDCT screening in 2016. By region, the South had one of the lowest rates, despite having the most accredited screening sites and the greatest number of eligible patients.
The findings are stark when juxtaposed with rates of screening for some other cancers, Dr. Pham maintained. For example, 65% of women aged 40 years or older underwent mammography for breast cancer screening in 2015.
“This ultimately begs the question as to the root of the disparity,” he said. “Are physicians not referring enough? Or perhaps, are eligible patients not wanting screening, even if they know a test is available? Unfortunately, controversy still exists among providers about costs and benefits of screening, while patients at risk for lung cancer also perhaps lack adequate awareness of the benefits of screening.”
It is also possible that the stigma attached to smoking, a modifiable risk factor, and thus to lung cancer screening may be a deterrent, Dr. Pham speculated. Specifically, patients may perceive screening-detected lung cancer as confirmation of a poor lifestyle choice.
“Regardless of the reason, this ultimately is a call to action on everyone’s part to increase this much-needed screening, whether that’s through creating awareness or conducting additional research, to urgently increase screening for the No. 1 cancer killer in America, as it has been now documented that effective screening can prevent nearly 12,000 premature lung cancer deaths per year,” he concluded.
Oncologists in the lung cancer field “would certainly like to be put out of business by an effective screening program,” commented ASCO President Bruce E. Johnson, MD, FASCO.
These new findings should be considered in light of the fact that the study period came only about a year after the change in reimbursement for LDCT, he noted. “So this is not a measure of the steady-state situation, but rather when this was first implemented.”
Nonetheless, it is “very disappointing” how little LDCT screening is being used, added Dr. Johnson, who is also a professor of medicine at the Dana-Farber Cancer Institute in Boston, and a leader of the center’s lung cancer program. “It should be saving 12,000 lives a year, and with this number, it’s about 250 lives. As correctly stated, there is a certain stigma whereby people who smoke feel as if they deserve it or that it’s sort of a self-punishment.”
He agreed that the findings represent a call to action. “We hope that the message will get out there, that people who fall into this risk pattern, folks who have smoked a pack of cigarettes daily for 30 years or longer, will get in and get themselves screened for lung cancer.”
What will it take?
Policy change would likely help increase uptake of LDCT lung cancer screening, according to Dr. Pham. “I think the most radical thing we could suggest based on our study so far would potentially be making lung cancer screening a national quality health measure, just the way that CMS made [mammograms for] breast cancer and colonoscopies [for colorectal cancer] national areas of improvement in 2008,” he elaborated.
“I agree that that could be an effective strategy, particularly since physicians are increasingly being required [to follow] our quality measures to optimize the reimbursement,” commented Richard L. Schilsky, MD, FACP, FASCO, chief medical officer of ASCO and press briefing moderator.
“Keep in mind that, generally speaking, screening of healthy or high-risk individuals for cancer is typically performed by primary care physicians, not by oncologists,” he further noted. “So one of the things that we also need to do is to be sure that primary care physicians are well aware of the screening data and the importance of referring the appropriate patients for screening, and are aware of screening centers available in their communities.”
Dr. Johnson said that the society has been active in that area. “ASCO is working with the American College of Physicians and some of the other primary care groups to try to get the message out about the screening,” as well as to educate them about the large potential impact of screening and treatment. “There are 15 million cancer survivors in the United States, and for the people who fit those criteria for smoking, [we need] to make certain they are getting screened.”
Study details
For the study, Dr. Pham and his colleagues used data from the American College of Radiology’s Lung Cancer Screening Registry, collecting total number of LDCTs performed in 2016 from all 1,796 accredited radiographic screening sites. They also used data from the 2015 National Health Interview Survey to estimate eligible smokers who could be screened based on the USPSTF recommendations.
Overall, 1.9% of 7,612,975 eligible current and former heavy smokers underwent LDCT, he reported. By census region, the rate was highest in the Northeast (3.5%) and lowest in the West (1.0%).
Notably, only 1.6% of eligible heavy smokers in the South underwent LDCT, even though that region had, by far, the most accredited screening sites (663) and the most eligible patients (3,072,095). The rate was highest in the Northeast, at 3.5%, even though that region had the second-lowest number of accredited screening sites (404) and the fewest eligible patients (1,152,141).
Dr. Pham disclosed no relevant conflicts of interest. The study received grant funding from the Bristol-Myers Squibb Foundation.
SOURCE: Pham DC et al. ASCO 2018. Abstract 6504.
Most heavy smokers in the United States who are eligible for low-dose CT screening for lung cancer do not receive it, according to a cross-sectional study reported in a press briefing held before the annual meeting of the American Society of Clinical Oncology.
Results of the National Lung Screening Trial reported in 2011 showed a 20% reduction in lung cancer mortality with targeted low-dose CT (LDCT) screening, noted lead study author Danh C. Pham, MD, of the James Graham Brown Cancer Center at the University of Louisville (Ky.).
Since 2013, the U.S. Preventive Services Task Force has recommended this screening for people aged 55-80 years who are current or former heavy smokers, defined as having smoked at least 30 pack-years, he added. “More importantly, in 2015, the Centers for Medicare and Medicaid Services expanded Medicare coverage for LDCT for lung cancer screening,” he said.
However, results of the new study showed that nationally, only 1.9% of more than 7.6 million eligible current and former smokers underwent LDCT screening in 2016. By region, the South had one of the lowest rates, despite having the most accredited screening sites and the greatest number of eligible patients.
The findings are stark when juxtaposed with rates of screening for some other cancers, Dr. Pham maintained. For example, 65% of women aged 40 years or older underwent mammography for breast cancer screening in 2015.
“This ultimately begs the question as to the root of the disparity,” he said. “Are physicians not referring enough? Or perhaps, are eligible patients not wanting screening, even if they know a test is available? Unfortunately, controversy still exists among providers about costs and benefits of screening, while patients at risk for lung cancer also perhaps lack adequate awareness of the benefits of screening.”
It is also possible that the stigma attached to smoking, a modifiable risk factor, and thus to lung cancer screening may be a deterrent, Dr. Pham speculated. Specifically, patients may perceive screening-detected lung cancer as confirmation of a poor lifestyle choice.
“Regardless of the reason, this ultimately is a call to action on everyone’s part to increase this much-needed screening, whether that’s through creating awareness or conducting additional research, to urgently increase screening for the No. 1 cancer killer in America, as it has been now documented that effective screening can prevent nearly 12,000 premature lung cancer deaths per year,” he concluded.
Oncologists in the lung cancer field “would certainly like to be put out of business by an effective screening program,” commented ASCO President Bruce E. Johnson, MD, FASCO.
These new findings should be considered in light of the fact that the study period came only about a year after the change in reimbursement for LDCT, he noted. “So this is not a measure of the steady-state situation, but rather when this was first implemented.”
Nonetheless, it is “very disappointing” how little LDCT screening is being used, added Dr. Johnson, who is also a professor of medicine at the Dana-Farber Cancer Institute in Boston, and a leader of the center’s lung cancer program. “It should be saving 12,000 lives a year, and with this number, it’s about 250 lives. As correctly stated, there is a certain stigma whereby people who smoke feel as if they deserve it or that it’s sort of a self-punishment.”
He agreed that the findings represent a call to action. “We hope that the message will get out there, that people who fall into this risk pattern, folks who have smoked a pack of cigarettes daily for 30 years or longer, will get in and get themselves screened for lung cancer.”
What will it take?
Policy change would likely help increase uptake of LDCT lung cancer screening, according to Dr. Pham. “I think the most radical thing we could suggest based on our study so far would potentially be making lung cancer screening a national quality health measure, just the way that CMS made [mammograms for] breast cancer and colonoscopies [for colorectal cancer] national areas of improvement in 2008,” he elaborated.
“I agree that that could be an effective strategy, particularly since physicians are increasingly being required [to follow] our quality measures to optimize the reimbursement,” commented Richard L. Schilsky, MD, FACP, FASCO, chief medical officer of ASCO and press briefing moderator.
“Keep in mind that, generally speaking, screening of healthy or high-risk individuals for cancer is typically performed by primary care physicians, not by oncologists,” he further noted. “So one of the things that we also need to do is to be sure that primary care physicians are well aware of the screening data and the importance of referring the appropriate patients for screening, and are aware of screening centers available in their communities.”
Dr. Johnson said that the society has been active in that area. “ASCO is working with the American College of Physicians and some of the other primary care groups to try to get the message out about the screening,” as well as to educate them about the large potential impact of screening and treatment. “There are 15 million cancer survivors in the United States, and for the people who fit those criteria for smoking, [we need] to make certain they are getting screened.”
Study details
For the study, Dr. Pham and his colleagues used data from the American College of Radiology’s Lung Cancer Screening Registry, collecting total number of LDCTs performed in 2016 from all 1,796 accredited radiographic screening sites. They also used data from the 2015 National Health Interview Survey to estimate eligible smokers who could be screened based on the USPSTF recommendations.
Overall, 1.9% of 7,612,975 eligible current and former heavy smokers underwent LDCT, he reported. By census region, the rate was highest in the Northeast (3.5%) and lowest in the West (1.0%).
Notably, only 1.6% of eligible heavy smokers in the South underwent LDCT, even though that region had, by far, the most accredited screening sites (663) and the most eligible patients (3,072,095). The rate was highest in the Northeast, at 3.5%, even though that region had the second-lowest number of accredited screening sites (404) and the fewest eligible patients (1,152,141).
Dr. Pham disclosed no relevant conflicts of interest. The study received grant funding from the Bristol-Myers Squibb Foundation.
SOURCE: Pham DC et al. ASCO 2018. Abstract 6504.
REPORTING FROM ASCO 2018
Key clinical point: The rate of lung cancer screening among eligible patients is overall very low.
Major finding: Just 1.9% of estimated, eligible current and former heavy smokers in the United States underwent low-dose CT screening for lung cancer in 2016.
Study details: Nationwide, cross-sectional cohort study of screening among an estimated 7,612,975 eligible smokers.
Disclosures: Dr. Pham disclosed no relevant conflicts of interest. The study received grant funding from the Bristol-Myers Squibb Foundation.
Source: Pham DC et al. ASCO 2018. Abstract 6504.
New remote monitoring system lessens symptoms in head and neck cancer
A new system for remotely assessing and transmitting selected vitals and self-reported measures reduces symptom severity among patients with head and neck cancer receiving radiation therapy, in a randomized trial reported at a press briefing held before the annual meeting of the American Society of Clinical Oncology.
“Head and neck cancer patients who receive radiation treatment have a high symptom burden and also are at increased risk for dehydration during treatment,” said lead study author Susan K. Peterson, PhD, a professor in the department of behavioral science at the University of Texas MD Anderson Cancer Center, Houston. “Previously, we have shown that it was feasible to use mobile and sensor technology to identify treatment-related symptoms and early dehydration risk in patients receiving radiation treatment as part of their outpatient care.”
In the new trial, the investigators tested the CYCORE system (Cyberinfrastructure for Comparative Effectiveness Research), which consists of a Bluetooth-enabled weight scale and blood pressure cuff, and a mobile tablet with a symptom-tracking app that sends information directly to the physician each weekday. A network hub/router was set up in patients’ homes to transmit their sensor readouts, and the mobile app transmitted their symptom data to secure firewall-protected computers. “CYCORE also included a software infrastructure that enabled the analysis and viewing of data in near-real time and was compliant with safety and security and confidentiality standards,” Dr. Peterson noted.
Main trial results showed that compared with peers receiving only usual care (weekly visits with the radiation oncologist), patients receiving usual care augmented with the CYCORE system had lower mean scores on a 10-point scale for general symptoms (0.5-point difference) and for symptoms specific to head and neck cancer (0.6-point difference). In addition, daily remote tracking of patient well-being allowed clinicians to more rapidly detect and respond to symptoms.
“This is important because symptoms can affects patients’ ability to tolerate treatment and can also impact their quality of life during treatment,” Dr. Peterson said.
The mean age of the patients was 60 years; the oldest was 86 years old. “This supports the notion that the use of technology-based interventions can be feasible in older patients,” she maintained. In addition, patients in the CYCORE group showed at least 80% adherence to the daily monitoring tasks.
“We believe that good patient adherence plus the fact that this imposed minimal burden on clinicians for the monitoring supports the use of systems like CYCORE during intensive treatment periods in cancer care, and that using sensor and mobile technology to monitor patients during critical periods of outpatient care can provide a timely source of information for clinical decision making and may ultimately improve quality of life and health outcomes,” Dr. Peterson concluded. “Our next steps would be to explore ways to implement this as part of clinical care, including in community cancer centers, where most patients receive their care.”
“This is yet another application of technology-enabled sharing of information generated at home,” said ASCO President Bruce E. Johnson, MD, FASCO, noting that a similar study last year showed better patient-reported experience and overall survival.
Such technology will likely be increasingly used to obtain timely information that ultimately leads to a reduction in complications, he speculated.
“This information in head and neck cancer is particularly important because patients commonly get a lot of side effects when attempting to swallow enough fluids, such that some centers end up putting a feeding tube into the stomach because it’s so difficult to swallow,” added Dr. Johnson, who is also a professor of medicine at the Dana-Farber Cancer Institute and a leader of the Dana-Farber/Harvard Cancer Center Lung Cancer Program, Boston. “So this is a particularly important clinical application in cancer.”
Study details
The trial population consisted of 357 patients undergoing radiation therapy for head and neck cancer. “We believe that this is the first and largest study of its kind in head and neck cancer,” Dr. Peterson said.
The severity of symptoms and their interference with daily activities were assessed at serial time points with the MD Anderson Symptom Inventory.
In the CYCORE group, 87% of patients measured their blood pressure daily, 86% measured their weight daily, and 80% used the symptom-tracking app daily.
At the end of radiation therapy, the CYCORE patients had lower (i.e., better) mean scores for general symptoms (e.g., pain, nausea, fatigue) relative to usual care counterparts (2.9 vs. 3.4), with a difference still evident 6-8 weeks later (1.6 vs. 1.9) (P = .007).
In addition, the CYCORE patients had lower mean scores for symptoms specific to head and neck cancer (e.g., dysphagia, pain, rash) at the end of radiation therapy (4.2 vs. 4.8), with a difference still evident 6-8 weeks later (1.7 vs. 2.1) (P = .009).
The groups fared essentially the same with respect to scores assessing interference of symptoms with activities of daily living.
Dr. Peterson disclosed that she had no relevant conflicts of interest. The study received funding from the National Institutes of Health.
SOURCE: Peterson et al. ASCO 2018, Abstract 6063.
A new system for remotely assessing and transmitting selected vitals and self-reported measures reduces symptom severity among patients with head and neck cancer receiving radiation therapy, in a randomized trial reported at a press briefing held before the annual meeting of the American Society of Clinical Oncology.
“Head and neck cancer patients who receive radiation treatment have a high symptom burden and also are at increased risk for dehydration during treatment,” said lead study author Susan K. Peterson, PhD, a professor in the department of behavioral science at the University of Texas MD Anderson Cancer Center, Houston. “Previously, we have shown that it was feasible to use mobile and sensor technology to identify treatment-related symptoms and early dehydration risk in patients receiving radiation treatment as part of their outpatient care.”
In the new trial, the investigators tested the CYCORE system (Cyberinfrastructure for Comparative Effectiveness Research), which consists of a Bluetooth-enabled weight scale and blood pressure cuff, and a mobile tablet with a symptom-tracking app that sends information directly to the physician each weekday. A network hub/router was set up in patients’ homes to transmit their sensor readouts, and the mobile app transmitted their symptom data to secure firewall-protected computers. “CYCORE also included a software infrastructure that enabled the analysis and viewing of data in near-real time and was compliant with safety and security and confidentiality standards,” Dr. Peterson noted.
Main trial results showed that compared with peers receiving only usual care (weekly visits with the radiation oncologist), patients receiving usual care augmented with the CYCORE system had lower mean scores on a 10-point scale for general symptoms (0.5-point difference) and for symptoms specific to head and neck cancer (0.6-point difference). In addition, daily remote tracking of patient well-being allowed clinicians to more rapidly detect and respond to symptoms.
“This is important because symptoms can affects patients’ ability to tolerate treatment and can also impact their quality of life during treatment,” Dr. Peterson said.
The mean age of the patients was 60 years; the oldest was 86 years old. “This supports the notion that the use of technology-based interventions can be feasible in older patients,” she maintained. In addition, patients in the CYCORE group showed at least 80% adherence to the daily monitoring tasks.
“We believe that good patient adherence plus the fact that this imposed minimal burden on clinicians for the monitoring supports the use of systems like CYCORE during intensive treatment periods in cancer care, and that using sensor and mobile technology to monitor patients during critical periods of outpatient care can provide a timely source of information for clinical decision making and may ultimately improve quality of life and health outcomes,” Dr. Peterson concluded. “Our next steps would be to explore ways to implement this as part of clinical care, including in community cancer centers, where most patients receive their care.”
“This is yet another application of technology-enabled sharing of information generated at home,” said ASCO President Bruce E. Johnson, MD, FASCO, noting that a similar study last year showed better patient-reported experience and overall survival.
Such technology will likely be increasingly used to obtain timely information that ultimately leads to a reduction in complications, he speculated.
“This information in head and neck cancer is particularly important because patients commonly get a lot of side effects when attempting to swallow enough fluids, such that some centers end up putting a feeding tube into the stomach because it’s so difficult to swallow,” added Dr. Johnson, who is also a professor of medicine at the Dana-Farber Cancer Institute and a leader of the Dana-Farber/Harvard Cancer Center Lung Cancer Program, Boston. “So this is a particularly important clinical application in cancer.”
Study details
The trial population consisted of 357 patients undergoing radiation therapy for head and neck cancer. “We believe that this is the first and largest study of its kind in head and neck cancer,” Dr. Peterson said.
The severity of symptoms and their interference with daily activities were assessed at serial time points with the MD Anderson Symptom Inventory.
In the CYCORE group, 87% of patients measured their blood pressure daily, 86% measured their weight daily, and 80% used the symptom-tracking app daily.
At the end of radiation therapy, the CYCORE patients had lower (i.e., better) mean scores for general symptoms (e.g., pain, nausea, fatigue) relative to usual care counterparts (2.9 vs. 3.4), with a difference still evident 6-8 weeks later (1.6 vs. 1.9) (P = .007).
In addition, the CYCORE patients had lower mean scores for symptoms specific to head and neck cancer (e.g., dysphagia, pain, rash) at the end of radiation therapy (4.2 vs. 4.8), with a difference still evident 6-8 weeks later (1.7 vs. 2.1) (P = .009).
The groups fared essentially the same with respect to scores assessing interference of symptoms with activities of daily living.
Dr. Peterson disclosed that she had no relevant conflicts of interest. The study received funding from the National Institutes of Health.
SOURCE: Peterson et al. ASCO 2018, Abstract 6063.
A new system for remotely assessing and transmitting selected vitals and self-reported measures reduces symptom severity among patients with head and neck cancer receiving radiation therapy, in a randomized trial reported at a press briefing held before the annual meeting of the American Society of Clinical Oncology.
“Head and neck cancer patients who receive radiation treatment have a high symptom burden and also are at increased risk for dehydration during treatment,” said lead study author Susan K. Peterson, PhD, a professor in the department of behavioral science at the University of Texas MD Anderson Cancer Center, Houston. “Previously, we have shown that it was feasible to use mobile and sensor technology to identify treatment-related symptoms and early dehydration risk in patients receiving radiation treatment as part of their outpatient care.”
In the new trial, the investigators tested the CYCORE system (Cyberinfrastructure for Comparative Effectiveness Research), which consists of a Bluetooth-enabled weight scale and blood pressure cuff, and a mobile tablet with a symptom-tracking app that sends information directly to the physician each weekday. A network hub/router was set up in patients’ homes to transmit their sensor readouts, and the mobile app transmitted their symptom data to secure firewall-protected computers. “CYCORE also included a software infrastructure that enabled the analysis and viewing of data in near-real time and was compliant with safety and security and confidentiality standards,” Dr. Peterson noted.
Main trial results showed that compared with peers receiving only usual care (weekly visits with the radiation oncologist), patients receiving usual care augmented with the CYCORE system had lower mean scores on a 10-point scale for general symptoms (0.5-point difference) and for symptoms specific to head and neck cancer (0.6-point difference). In addition, daily remote tracking of patient well-being allowed clinicians to more rapidly detect and respond to symptoms.
“This is important because symptoms can affects patients’ ability to tolerate treatment and can also impact their quality of life during treatment,” Dr. Peterson said.
The mean age of the patients was 60 years; the oldest was 86 years old. “This supports the notion that the use of technology-based interventions can be feasible in older patients,” she maintained. In addition, patients in the CYCORE group showed at least 80% adherence to the daily monitoring tasks.
“We believe that good patient adherence plus the fact that this imposed minimal burden on clinicians for the monitoring supports the use of systems like CYCORE during intensive treatment periods in cancer care, and that using sensor and mobile technology to monitor patients during critical periods of outpatient care can provide a timely source of information for clinical decision making and may ultimately improve quality of life and health outcomes,” Dr. Peterson concluded. “Our next steps would be to explore ways to implement this as part of clinical care, including in community cancer centers, where most patients receive their care.”
“This is yet another application of technology-enabled sharing of information generated at home,” said ASCO President Bruce E. Johnson, MD, FASCO, noting that a similar study last year showed better patient-reported experience and overall survival.
Such technology will likely be increasingly used to obtain timely information that ultimately leads to a reduction in complications, he speculated.
“This information in head and neck cancer is particularly important because patients commonly get a lot of side effects when attempting to swallow enough fluids, such that some centers end up putting a feeding tube into the stomach because it’s so difficult to swallow,” added Dr. Johnson, who is also a professor of medicine at the Dana-Farber Cancer Institute and a leader of the Dana-Farber/Harvard Cancer Center Lung Cancer Program, Boston. “So this is a particularly important clinical application in cancer.”
Study details
The trial population consisted of 357 patients undergoing radiation therapy for head and neck cancer. “We believe that this is the first and largest study of its kind in head and neck cancer,” Dr. Peterson said.
The severity of symptoms and their interference with daily activities were assessed at serial time points with the MD Anderson Symptom Inventory.
In the CYCORE group, 87% of patients measured their blood pressure daily, 86% measured their weight daily, and 80% used the symptom-tracking app daily.
At the end of radiation therapy, the CYCORE patients had lower (i.e., better) mean scores for general symptoms (e.g., pain, nausea, fatigue) relative to usual care counterparts (2.9 vs. 3.4), with a difference still evident 6-8 weeks later (1.6 vs. 1.9) (P = .007).
In addition, the CYCORE patients had lower mean scores for symptoms specific to head and neck cancer (e.g., dysphagia, pain, rash) at the end of radiation therapy (4.2 vs. 4.8), with a difference still evident 6-8 weeks later (1.7 vs. 2.1) (P = .009).
The groups fared essentially the same with respect to scores assessing interference of symptoms with activities of daily living.
Dr. Peterson disclosed that she had no relevant conflicts of interest. The study received funding from the National Institutes of Health.
SOURCE: Peterson et al. ASCO 2018, Abstract 6063.
REPORTING FROM ASCO 2018
Key clinical point: .
Major finding: Compared with usual care, the system for tracking and transmitting vitals and self-reported measures through sensor and mobile devices was associated with milder general symptoms (0.5-point difference) and head and neck cancer symptoms (0.6-point difference).
Study details: A randomized controlled trial among 357 patients with head and neck cancer undergoing radiation therapy.
Disclosures: Dr. Peterson disclosed that she had no conflicts of interest. The study received funding from the National Institutes of Health.
Source: Peterson et al. ASCO 2018, Abstract 6063.
Adjuvant trastuzumab for breast cancer: 6 months may suffice
Shortening the duration of adjuvant trastuzumab (Herceptin) therapy for early-stage HER2+ breast cancer from the current standard of 12 months to 6 months yields similar efficacy but halves the incidence of cardiac toxicity, the PERSEPHONE trial found.
“In 2005, trastuzumab was licensed with a standard of three weekly injections for 12 months, and this was the duration used empirically in pivotal registration studies,” lead study author Helena Earl, MD, professor of clinical cancer medicine at the University of Cambridge, England, said in a press briefing leading up to the annual meeting of the American Society of Clinical Oncology.
However, cardiac toxicity has been particularly problematic with this regimen. Furthermore, the Fin-HER trial, while small, suggested that only 9 weeks of adjuvant trastuzumab was possibly as efficacious (N Engl J Med. 2006 Feb;354[8]:809-20).
Dr. Earl and her coinvestigators enrolled in their phase 3 noninferiority, randomized, controlled trial 4,089 women with early-stage HER2+ breast cancer, randomizing them to either 6 months or 12 months of trastuzumab, mapped onto standard U.K. real-world practice.
The main findings showed that the 4-year rate of disease-free survival, the trial’s primary endpoint, was nearly 90% in both groups, with the absolute difference of just 0.4% falling well within the predefined 3% margin for noninferiority.
Moreover, the rate of stopping trastuzumab because of cardiotoxicity was half as high with the shorter-duration therapy; patients in that arm had more rapid recovery of cardiac function, too.
“The PERSEPHONE trial’s first results demonstrate that 6 months of adjuvant trastuzumab is noninferior to 12 months; 6 months, compared with 12 months, of treatment reduces cardiac and other toxicities and costs both to patients and health care systems,” Dr. Earl summarized. “We are confident [these results] will mark the first steps towards reduction of treatment duration for many women with HER2+ breast cancer.”
The investigators are still analyzing quality of life, patient-reported outcomes, and health economic data, she said. In addition, they are performing translational studies to look for biomarkers that may identify subgroups who fare better with one or the other duration of trastuzumab.
Will the standard change?
At present, the PERSEPHONE findings are not sufficient to change the existing standard of care of 12 months of adjuvant trastuzumab, according to Dr. Earl. “We need to be very careful and cautious about coming out at this point and saying, ‘Yes, 6 months is enough,’ ” she maintained. “At the moment, I do think we need to wait for longer follow-up and we need to take a real close look at the data. Changing from an established treatment that works is always going to be a very complex and very challenging thing to do.”
“Personally, I find the results quite compelling, and I think that it is likely that they will signal a shift even in the U.S. oncology community toward shorter duration of Herceptin adjuvant therapy,” commented Richard L. Schilsky, MD, FACP, FASCO, chief medical officer of ASCO and press briefing moderator. However, “we don’t have data yet on overall survival. Survival in this study is still relatively short for a breast cancer population, although patients with HER2+ disease oftentimes have a somewhat more aggressive course,” he noted. In addition, the ongoing translational studies will be critical to any decisions about changing the standard of care because some subgroups of patients will probably not fare as well with the shorter-duration therapy.
U.S. payers are unlikely to start covering only 6 months of trastuzumab unless the drug’s label is changed based on new data or clinical practice guidelines begin to endorse that shorter duration, according to Dr. Schilsky. “Until one of those things occurs, there is not really a rationale for a payer to mandate that a physician undertake a course of treatment that they may not think is in the patient’s best interest,” he elaborated.
As roughly 12% to 15% of women with early breast cancer have HER2+ disease, the PERSEPHONE findings could have considerable implications for treatment costs, noted Bruce E. Johnson, MD, FASCO, president of ASCO.
However, longer follow-up will be needed before any change to the standard is made, he agreed. “One has to be circumspect about how long you wait and how much more data one has before making a definitive statement. With 8% deaths and 12% recurrences, it may be a bit early to make a definite change in practice.”
While important, the more favorable safety of the 6-month therapy is not sufficient, according to Dr. Johnson, who is also a professor of medicine at the Dana-Farber Cancer Institute and a leader of the Dana-Farber/Harvard Cancer Center Lung Cancer Program, both in Boston. “In my opinion, the efficacy drives most of the therapeutic decision making. We are encouraged by this, and 5-year follow-up is certainly a reasonable initial step. But to be sure of the efficacy, you probably need a bit more time and a few more events,” he explained.
Study details
Patients enrolled in PERSEPHONE had stage Ia to IIIa breast cancer. They were randomized evenly to either 6 months (9 cycles) or 12 months (18 cycles) of adjuvant trastuzumab, given with or after completion of chemotherapy.
Main results showed that the 4-year rate of disease-free survival was 89.8% with 12 months of trastuzumab and 89.4% with 6 months of trastuzumab (hazard ratio, 1.07; P for noninferiority = .01), Dr. Earl reported.
Cardiotoxicity data for the trial population, previously reported (Br J Cancer. 2016 Dec 6;115[12]:1462-70), showed that the rate of stopping trastuzumab because of this adverse effect was 8% with the standard-duration therapy and 4% with the shorter-duration therapy (P less than .0001). Patients saw recovery of cardiac function after stopping the drug (P less than .0001), with more rapid recovery in the shorter-duration group (P = .02).
The group given 6 months of trastuzumab also had lower rates of grade 3 or 4 cough, fatigue, pain, chills, and palpitations, problems which patients reported were having an impact on their lives, Dr. Earl noted. “Perhaps more importantly, patients given 6 months of treatment will be able to return more quickly to their normal lives once their treatment is completed.”
Dr. Earl disclosed that she has a consulting or advisory role with Celgene, Pfizer, Roche, and AstraZeneca; receives travel, accommodations, or expenses, and receives honoraria from Pfizer, Daiichi Sankyo, Amgen, and AstraZeneca; and receives research funding from Roche and Sanofi Pasteur. The study was funded by the National Institute for Health Research in the United Kingdom.
SOURCE: Earl H et al. ASCO 2018, Abstract 506.
Shortening the duration of adjuvant trastuzumab (Herceptin) therapy for early-stage HER2+ breast cancer from the current standard of 12 months to 6 months yields similar efficacy but halves the incidence of cardiac toxicity, the PERSEPHONE trial found.
“In 2005, trastuzumab was licensed with a standard of three weekly injections for 12 months, and this was the duration used empirically in pivotal registration studies,” lead study author Helena Earl, MD, professor of clinical cancer medicine at the University of Cambridge, England, said in a press briefing leading up to the annual meeting of the American Society of Clinical Oncology.
However, cardiac toxicity has been particularly problematic with this regimen. Furthermore, the Fin-HER trial, while small, suggested that only 9 weeks of adjuvant trastuzumab was possibly as efficacious (N Engl J Med. 2006 Feb;354[8]:809-20).
Dr. Earl and her coinvestigators enrolled in their phase 3 noninferiority, randomized, controlled trial 4,089 women with early-stage HER2+ breast cancer, randomizing them to either 6 months or 12 months of trastuzumab, mapped onto standard U.K. real-world practice.
The main findings showed that the 4-year rate of disease-free survival, the trial’s primary endpoint, was nearly 90% in both groups, with the absolute difference of just 0.4% falling well within the predefined 3% margin for noninferiority.
Moreover, the rate of stopping trastuzumab because of cardiotoxicity was half as high with the shorter-duration therapy; patients in that arm had more rapid recovery of cardiac function, too.
“The PERSEPHONE trial’s first results demonstrate that 6 months of adjuvant trastuzumab is noninferior to 12 months; 6 months, compared with 12 months, of treatment reduces cardiac and other toxicities and costs both to patients and health care systems,” Dr. Earl summarized. “We are confident [these results] will mark the first steps towards reduction of treatment duration for many women with HER2+ breast cancer.”
The investigators are still analyzing quality of life, patient-reported outcomes, and health economic data, she said. In addition, they are performing translational studies to look for biomarkers that may identify subgroups who fare better with one or the other duration of trastuzumab.
Will the standard change?
At present, the PERSEPHONE findings are not sufficient to change the existing standard of care of 12 months of adjuvant trastuzumab, according to Dr. Earl. “We need to be very careful and cautious about coming out at this point and saying, ‘Yes, 6 months is enough,’ ” she maintained. “At the moment, I do think we need to wait for longer follow-up and we need to take a real close look at the data. Changing from an established treatment that works is always going to be a very complex and very challenging thing to do.”
“Personally, I find the results quite compelling, and I think that it is likely that they will signal a shift even in the U.S. oncology community toward shorter duration of Herceptin adjuvant therapy,” commented Richard L. Schilsky, MD, FACP, FASCO, chief medical officer of ASCO and press briefing moderator. However, “we don’t have data yet on overall survival. Survival in this study is still relatively short for a breast cancer population, although patients with HER2+ disease oftentimes have a somewhat more aggressive course,” he noted. In addition, the ongoing translational studies will be critical to any decisions about changing the standard of care because some subgroups of patients will probably not fare as well with the shorter-duration therapy.
U.S. payers are unlikely to start covering only 6 months of trastuzumab unless the drug’s label is changed based on new data or clinical practice guidelines begin to endorse that shorter duration, according to Dr. Schilsky. “Until one of those things occurs, there is not really a rationale for a payer to mandate that a physician undertake a course of treatment that they may not think is in the patient’s best interest,” he elaborated.
As roughly 12% to 15% of women with early breast cancer have HER2+ disease, the PERSEPHONE findings could have considerable implications for treatment costs, noted Bruce E. Johnson, MD, FASCO, president of ASCO.
However, longer follow-up will be needed before any change to the standard is made, he agreed. “One has to be circumspect about how long you wait and how much more data one has before making a definitive statement. With 8% deaths and 12% recurrences, it may be a bit early to make a definite change in practice.”
While important, the more favorable safety of the 6-month therapy is not sufficient, according to Dr. Johnson, who is also a professor of medicine at the Dana-Farber Cancer Institute and a leader of the Dana-Farber/Harvard Cancer Center Lung Cancer Program, both in Boston. “In my opinion, the efficacy drives most of the therapeutic decision making. We are encouraged by this, and 5-year follow-up is certainly a reasonable initial step. But to be sure of the efficacy, you probably need a bit more time and a few more events,” he explained.
Study details
Patients enrolled in PERSEPHONE had stage Ia to IIIa breast cancer. They were randomized evenly to either 6 months (9 cycles) or 12 months (18 cycles) of adjuvant trastuzumab, given with or after completion of chemotherapy.
Main results showed that the 4-year rate of disease-free survival was 89.8% with 12 months of trastuzumab and 89.4% with 6 months of trastuzumab (hazard ratio, 1.07; P for noninferiority = .01), Dr. Earl reported.
Cardiotoxicity data for the trial population, previously reported (Br J Cancer. 2016 Dec 6;115[12]:1462-70), showed that the rate of stopping trastuzumab because of this adverse effect was 8% with the standard-duration therapy and 4% with the shorter-duration therapy (P less than .0001). Patients saw recovery of cardiac function after stopping the drug (P less than .0001), with more rapid recovery in the shorter-duration group (P = .02).
The group given 6 months of trastuzumab also had lower rates of grade 3 or 4 cough, fatigue, pain, chills, and palpitations, problems which patients reported were having an impact on their lives, Dr. Earl noted. “Perhaps more importantly, patients given 6 months of treatment will be able to return more quickly to their normal lives once their treatment is completed.”
Dr. Earl disclosed that she has a consulting or advisory role with Celgene, Pfizer, Roche, and AstraZeneca; receives travel, accommodations, or expenses, and receives honoraria from Pfizer, Daiichi Sankyo, Amgen, and AstraZeneca; and receives research funding from Roche and Sanofi Pasteur. The study was funded by the National Institute for Health Research in the United Kingdom.
SOURCE: Earl H et al. ASCO 2018, Abstract 506.
Shortening the duration of adjuvant trastuzumab (Herceptin) therapy for early-stage HER2+ breast cancer from the current standard of 12 months to 6 months yields similar efficacy but halves the incidence of cardiac toxicity, the PERSEPHONE trial found.
“In 2005, trastuzumab was licensed with a standard of three weekly injections for 12 months, and this was the duration used empirically in pivotal registration studies,” lead study author Helena Earl, MD, professor of clinical cancer medicine at the University of Cambridge, England, said in a press briefing leading up to the annual meeting of the American Society of Clinical Oncology.
However, cardiac toxicity has been particularly problematic with this regimen. Furthermore, the Fin-HER trial, while small, suggested that only 9 weeks of adjuvant trastuzumab was possibly as efficacious (N Engl J Med. 2006 Feb;354[8]:809-20).
Dr. Earl and her coinvestigators enrolled in their phase 3 noninferiority, randomized, controlled trial 4,089 women with early-stage HER2+ breast cancer, randomizing them to either 6 months or 12 months of trastuzumab, mapped onto standard U.K. real-world practice.
The main findings showed that the 4-year rate of disease-free survival, the trial’s primary endpoint, was nearly 90% in both groups, with the absolute difference of just 0.4% falling well within the predefined 3% margin for noninferiority.
Moreover, the rate of stopping trastuzumab because of cardiotoxicity was half as high with the shorter-duration therapy; patients in that arm had more rapid recovery of cardiac function, too.
“The PERSEPHONE trial’s first results demonstrate that 6 months of adjuvant trastuzumab is noninferior to 12 months; 6 months, compared with 12 months, of treatment reduces cardiac and other toxicities and costs both to patients and health care systems,” Dr. Earl summarized. “We are confident [these results] will mark the first steps towards reduction of treatment duration for many women with HER2+ breast cancer.”
The investigators are still analyzing quality of life, patient-reported outcomes, and health economic data, she said. In addition, they are performing translational studies to look for biomarkers that may identify subgroups who fare better with one or the other duration of trastuzumab.
Will the standard change?
At present, the PERSEPHONE findings are not sufficient to change the existing standard of care of 12 months of adjuvant trastuzumab, according to Dr. Earl. “We need to be very careful and cautious about coming out at this point and saying, ‘Yes, 6 months is enough,’ ” she maintained. “At the moment, I do think we need to wait for longer follow-up and we need to take a real close look at the data. Changing from an established treatment that works is always going to be a very complex and very challenging thing to do.”
“Personally, I find the results quite compelling, and I think that it is likely that they will signal a shift even in the U.S. oncology community toward shorter duration of Herceptin adjuvant therapy,” commented Richard L. Schilsky, MD, FACP, FASCO, chief medical officer of ASCO and press briefing moderator. However, “we don’t have data yet on overall survival. Survival in this study is still relatively short for a breast cancer population, although patients with HER2+ disease oftentimes have a somewhat more aggressive course,” he noted. In addition, the ongoing translational studies will be critical to any decisions about changing the standard of care because some subgroups of patients will probably not fare as well with the shorter-duration therapy.
U.S. payers are unlikely to start covering only 6 months of trastuzumab unless the drug’s label is changed based on new data or clinical practice guidelines begin to endorse that shorter duration, according to Dr. Schilsky. “Until one of those things occurs, there is not really a rationale for a payer to mandate that a physician undertake a course of treatment that they may not think is in the patient’s best interest,” he elaborated.
As roughly 12% to 15% of women with early breast cancer have HER2+ disease, the PERSEPHONE findings could have considerable implications for treatment costs, noted Bruce E. Johnson, MD, FASCO, president of ASCO.
However, longer follow-up will be needed before any change to the standard is made, he agreed. “One has to be circumspect about how long you wait and how much more data one has before making a definitive statement. With 8% deaths and 12% recurrences, it may be a bit early to make a definite change in practice.”
While important, the more favorable safety of the 6-month therapy is not sufficient, according to Dr. Johnson, who is also a professor of medicine at the Dana-Farber Cancer Institute and a leader of the Dana-Farber/Harvard Cancer Center Lung Cancer Program, both in Boston. “In my opinion, the efficacy drives most of the therapeutic decision making. We are encouraged by this, and 5-year follow-up is certainly a reasonable initial step. But to be sure of the efficacy, you probably need a bit more time and a few more events,” he explained.
Study details
Patients enrolled in PERSEPHONE had stage Ia to IIIa breast cancer. They were randomized evenly to either 6 months (9 cycles) or 12 months (18 cycles) of adjuvant trastuzumab, given with or after completion of chemotherapy.
Main results showed that the 4-year rate of disease-free survival was 89.8% with 12 months of trastuzumab and 89.4% with 6 months of trastuzumab (hazard ratio, 1.07; P for noninferiority = .01), Dr. Earl reported.
Cardiotoxicity data for the trial population, previously reported (Br J Cancer. 2016 Dec 6;115[12]:1462-70), showed that the rate of stopping trastuzumab because of this adverse effect was 8% with the standard-duration therapy and 4% with the shorter-duration therapy (P less than .0001). Patients saw recovery of cardiac function after stopping the drug (P less than .0001), with more rapid recovery in the shorter-duration group (P = .02).
The group given 6 months of trastuzumab also had lower rates of grade 3 or 4 cough, fatigue, pain, chills, and palpitations, problems which patients reported were having an impact on their lives, Dr. Earl noted. “Perhaps more importantly, patients given 6 months of treatment will be able to return more quickly to their normal lives once their treatment is completed.”
Dr. Earl disclosed that she has a consulting or advisory role with Celgene, Pfizer, Roche, and AstraZeneca; receives travel, accommodations, or expenses, and receives honoraria from Pfizer, Daiichi Sankyo, Amgen, and AstraZeneca; and receives research funding from Roche and Sanofi Pasteur. The study was funded by the National Institute for Health Research in the United Kingdom.
SOURCE: Earl H et al. ASCO 2018, Abstract 506.
REPORTING FROM ASCO 2018
Key clinical point:
Major finding: The 4-year rate of disease-free survival was 89.8% with 12 months of trastuzumab and 89.4% with 6 months of trastuzumab (P for noninferiority = .01)
Study details: Phase 3 noninferiority, randomized, controlled trial among 4,089 women with early HER2+ breast cancer (PERSEPHONE trial).
Disclosures: Dr. Earl disclosed that she has a consulting or advisory role with Celgene, Pfizer, Roche, and AstraZeneca; receives travel, accommodations, or expenses, and honoraria from Pfizer, Daiichi Sankyo, Amgen, and AstraZeneca; and receives research funding from Roche and Sanofi Pasteur. The study was funded by the National Institute for Health Research in the United Kingdom.
Source: Earl H et al. ASCO 2018, Abstract 506.
New regimens for youth with T-cell malignancies yield best outcomes yet
A set of novel chemotherapy regimens yield excellent outcomes—the best yet—among pediatric and young adult patients with T-cell malignancies, finds a phase 3 randomized controlled trial conducted by the Children’s Oncology Group (ALL0434).
“Despite very intense and complex chemotherapy, 20% of children and adolescents enrolled in Children’s Oncology Group T-cell leukemia trials between 2000 and 2005 did not survive. New drugs were needed to improve survival rates for T-cell malignancies,” lead study author Kimberly P. Dunsmore, MD, a professor at Virginia Tech, Roanoke, said in a press briefing leading up to the annual meeting of the American Society of Clinical Oncology.
The ALL0434 trial tested the addition of methotrexate (Trexall) and/or nelarabine (Arranon), a T cell–specific drug known to be efficacious in relapsed disease, to standard chemotherapy, with tailoring of the regimen to recurrence risk. Analyses were based on 1,545 patients with T-cell acute lymphoblastic leukemia (T-ALL) or T-cell lymphoblastic lymphoma (T-LL).
Results for all patients with T-ALL showed that, with addition of either or both drugs, more than 90% were alive at 4 years and more than 80% were leukemia free. Adding nelarabine to standard chemotherapy improved disease-free survival among the subset having intermediate- or high-risk disease, and the best outcomes were seen with addition of both nelarabine and an escalating dose of methotrexate.
Although patients with T-LL did not see benefit from addition of nelarabine, they still had an 85% rate of overall survival at 4 years.
“ALL0434 is the largest trial for children and young adults with T-cell malignancy ever conducted. It has the best-ever survival data,” Dr. Dunsmore commented.
“Our next steps will be to examine what implications and benefits may accrue when using nelarabine in protocols without cranial irradiation. This is to decrease long-term neurologic side effects, and we think it may be possible since nelarabine also reduces CNS relapses,” she said.
“This trial highlights how effective our pediatric and young adult oncologists are at accruing: This is a rare disease, and they were able to put more than 1,500 patients on trial with this rare disease over the course of time,” commented ASCO President Bruce E. Johnson, MD, FASCO.
The new combination regimens are noteworthy in that they improved survival by an absolute 10% without minimal increase in toxicity, he maintained.
“This is part of the paradigm where nelarabine had been approved [by the FDA] for relapsed or recurrent disease, and in this particular setting, it has been moved upfront, closer to the initial treatment, improving the outcomes for those patients,” elaborated Dr. Johnson, who is also a professor of medicine at the Dana-Farber Cancer Institute and a leader of the Dana-Farber/Harvard Cancer Center Lung Cancer Program, both in Boston.
Study details
The ALL0434 trial enrolled patients aged 1-30 years with newly diagnosed T-ALL or T-LL. After induction chemotherapy, all patients received standard chemotherapy, the Children’s Oncology Group augmented Berlin-Frankfurt-Munster regimen (N Engl J Med. 1998;338:1663-71), and depending on recurrence risk, cranial irradiation.
In addition to that regimen, they were randomly assigned to four arms, according to methotrexate dosing (high dose with leucovorin rescue in the inpatient setting vs. escalating dose in the outpatient setting) and nelarabine therapy (receipt vs. nonreceipt).
Among patients with T-ALL, those with low-risk disease were ineligible for nelarabine and did not receive cranial irradiation, whereas those with intermediate- and high-risk disease were randomized to all four arms, Dr. Dunsmore explained. In addition, those who did not achieve remission on induction chemotherapy were nonrandomly assigned to the high-dose methotrexate plus nelarabine arm.
Patients with T-LL were ineligible for high-dose methotrexate and were randomized to escalating-dose methotrexate with or without nelarabine.
Among all patients with T-ALL, the 4-year rate of overall survival was 90.2%, and the 4-year rate of disease-free survival was 84.1%, Dr. Dunsmore reported.
Disease-free survival was better with escalating-dose methotrexate than with high-dose methotrexate (89.8% vs. 78%).
Addition of nelarabine for patients with T-ALL having intermediate- or high-risk disease improved disease-free survival, from 83% without the drug to 88% with the drug (P = .0450), and reduced the rate of CNS relapse. Disease-free survival was highest, at 91%, among those who received both escalating-dose methotrexate and nelarabine.
Among the patients who did not achieve remission from induction chemotherapy, the 4-year rate of overall survival was 54%. “This is important because it’s more than double the past survival rates,” Dr. Dunsmore noted.
Patients with T-LL fared similarly well whether they received nelarabine or not; fully 85% overall were still alive at 4 years.
In terms of adverse effects of nelarabine therapy, the rate of peripheral neuropathy (motor or sensory), one of the more problematic adverse effects of the drug, was 8% in the trial population overall and did not exceed 9% in any treatment arm, she reported.
Dr. Dunsmore disclosed that an immediate family member is an employee of and has a leadership role with TypeZero Technologies; that she receives travel, accommodations, and/or expenses from Novo Nordisk; and that an immediate family member receives travel, accommodations, and/or expenses from Tandem Diabetes Care. The study received funding from the Cancer Therapy Evaluation Program within the National Cancer Institute/National Institutes of Health and received support from the St. Baldrick’s Foundation.
SOURCE: Dunsmore KP et al. ASCO 2018, Abstract 10500.
A set of novel chemotherapy regimens yield excellent outcomes—the best yet—among pediatric and young adult patients with T-cell malignancies, finds a phase 3 randomized controlled trial conducted by the Children’s Oncology Group (ALL0434).
“Despite very intense and complex chemotherapy, 20% of children and adolescents enrolled in Children’s Oncology Group T-cell leukemia trials between 2000 and 2005 did not survive. New drugs were needed to improve survival rates for T-cell malignancies,” lead study author Kimberly P. Dunsmore, MD, a professor at Virginia Tech, Roanoke, said in a press briefing leading up to the annual meeting of the American Society of Clinical Oncology.
The ALL0434 trial tested the addition of methotrexate (Trexall) and/or nelarabine (Arranon), a T cell–specific drug known to be efficacious in relapsed disease, to standard chemotherapy, with tailoring of the regimen to recurrence risk. Analyses were based on 1,545 patients with T-cell acute lymphoblastic leukemia (T-ALL) or T-cell lymphoblastic lymphoma (T-LL).
Results for all patients with T-ALL showed that, with addition of either or both drugs, more than 90% were alive at 4 years and more than 80% were leukemia free. Adding nelarabine to standard chemotherapy improved disease-free survival among the subset having intermediate- or high-risk disease, and the best outcomes were seen with addition of both nelarabine and an escalating dose of methotrexate.
Although patients with T-LL did not see benefit from addition of nelarabine, they still had an 85% rate of overall survival at 4 years.
“ALL0434 is the largest trial for children and young adults with T-cell malignancy ever conducted. It has the best-ever survival data,” Dr. Dunsmore commented.
“Our next steps will be to examine what implications and benefits may accrue when using nelarabine in protocols without cranial irradiation. This is to decrease long-term neurologic side effects, and we think it may be possible since nelarabine also reduces CNS relapses,” she said.
“This trial highlights how effective our pediatric and young adult oncologists are at accruing: This is a rare disease, and they were able to put more than 1,500 patients on trial with this rare disease over the course of time,” commented ASCO President Bruce E. Johnson, MD, FASCO.
The new combination regimens are noteworthy in that they improved survival by an absolute 10% without minimal increase in toxicity, he maintained.
“This is part of the paradigm where nelarabine had been approved [by the FDA] for relapsed or recurrent disease, and in this particular setting, it has been moved upfront, closer to the initial treatment, improving the outcomes for those patients,” elaborated Dr. Johnson, who is also a professor of medicine at the Dana-Farber Cancer Institute and a leader of the Dana-Farber/Harvard Cancer Center Lung Cancer Program, both in Boston.
Study details
The ALL0434 trial enrolled patients aged 1-30 years with newly diagnosed T-ALL or T-LL. After induction chemotherapy, all patients received standard chemotherapy, the Children’s Oncology Group augmented Berlin-Frankfurt-Munster regimen (N Engl J Med. 1998;338:1663-71), and depending on recurrence risk, cranial irradiation.
In addition to that regimen, they were randomly assigned to four arms, according to methotrexate dosing (high dose with leucovorin rescue in the inpatient setting vs. escalating dose in the outpatient setting) and nelarabine therapy (receipt vs. nonreceipt).
Among patients with T-ALL, those with low-risk disease were ineligible for nelarabine and did not receive cranial irradiation, whereas those with intermediate- and high-risk disease were randomized to all four arms, Dr. Dunsmore explained. In addition, those who did not achieve remission on induction chemotherapy were nonrandomly assigned to the high-dose methotrexate plus nelarabine arm.
Patients with T-LL were ineligible for high-dose methotrexate and were randomized to escalating-dose methotrexate with or without nelarabine.
Among all patients with T-ALL, the 4-year rate of overall survival was 90.2%, and the 4-year rate of disease-free survival was 84.1%, Dr. Dunsmore reported.
Disease-free survival was better with escalating-dose methotrexate than with high-dose methotrexate (89.8% vs. 78%).
Addition of nelarabine for patients with T-ALL having intermediate- or high-risk disease improved disease-free survival, from 83% without the drug to 88% with the drug (P = .0450), and reduced the rate of CNS relapse. Disease-free survival was highest, at 91%, among those who received both escalating-dose methotrexate and nelarabine.
Among the patients who did not achieve remission from induction chemotherapy, the 4-year rate of overall survival was 54%. “This is important because it’s more than double the past survival rates,” Dr. Dunsmore noted.
Patients with T-LL fared similarly well whether they received nelarabine or not; fully 85% overall were still alive at 4 years.
In terms of adverse effects of nelarabine therapy, the rate of peripheral neuropathy (motor or sensory), one of the more problematic adverse effects of the drug, was 8% in the trial population overall and did not exceed 9% in any treatment arm, she reported.
Dr. Dunsmore disclosed that an immediate family member is an employee of and has a leadership role with TypeZero Technologies; that she receives travel, accommodations, and/or expenses from Novo Nordisk; and that an immediate family member receives travel, accommodations, and/or expenses from Tandem Diabetes Care. The study received funding from the Cancer Therapy Evaluation Program within the National Cancer Institute/National Institutes of Health and received support from the St. Baldrick’s Foundation.
SOURCE: Dunsmore KP et al. ASCO 2018, Abstract 10500.
A set of novel chemotherapy regimens yield excellent outcomes—the best yet—among pediatric and young adult patients with T-cell malignancies, finds a phase 3 randomized controlled trial conducted by the Children’s Oncology Group (ALL0434).
“Despite very intense and complex chemotherapy, 20% of children and adolescents enrolled in Children’s Oncology Group T-cell leukemia trials between 2000 and 2005 did not survive. New drugs were needed to improve survival rates for T-cell malignancies,” lead study author Kimberly P. Dunsmore, MD, a professor at Virginia Tech, Roanoke, said in a press briefing leading up to the annual meeting of the American Society of Clinical Oncology.
The ALL0434 trial tested the addition of methotrexate (Trexall) and/or nelarabine (Arranon), a T cell–specific drug known to be efficacious in relapsed disease, to standard chemotherapy, with tailoring of the regimen to recurrence risk. Analyses were based on 1,545 patients with T-cell acute lymphoblastic leukemia (T-ALL) or T-cell lymphoblastic lymphoma (T-LL).
Results for all patients with T-ALL showed that, with addition of either or both drugs, more than 90% were alive at 4 years and more than 80% were leukemia free. Adding nelarabine to standard chemotherapy improved disease-free survival among the subset having intermediate- or high-risk disease, and the best outcomes were seen with addition of both nelarabine and an escalating dose of methotrexate.
Although patients with T-LL did not see benefit from addition of nelarabine, they still had an 85% rate of overall survival at 4 years.
“ALL0434 is the largest trial for children and young adults with T-cell malignancy ever conducted. It has the best-ever survival data,” Dr. Dunsmore commented.
“Our next steps will be to examine what implications and benefits may accrue when using nelarabine in protocols without cranial irradiation. This is to decrease long-term neurologic side effects, and we think it may be possible since nelarabine also reduces CNS relapses,” she said.
“This trial highlights how effective our pediatric and young adult oncologists are at accruing: This is a rare disease, and they were able to put more than 1,500 patients on trial with this rare disease over the course of time,” commented ASCO President Bruce E. Johnson, MD, FASCO.
The new combination regimens are noteworthy in that they improved survival by an absolute 10% without minimal increase in toxicity, he maintained.
“This is part of the paradigm where nelarabine had been approved [by the FDA] for relapsed or recurrent disease, and in this particular setting, it has been moved upfront, closer to the initial treatment, improving the outcomes for those patients,” elaborated Dr. Johnson, who is also a professor of medicine at the Dana-Farber Cancer Institute and a leader of the Dana-Farber/Harvard Cancer Center Lung Cancer Program, both in Boston.
Study details
The ALL0434 trial enrolled patients aged 1-30 years with newly diagnosed T-ALL or T-LL. After induction chemotherapy, all patients received standard chemotherapy, the Children’s Oncology Group augmented Berlin-Frankfurt-Munster regimen (N Engl J Med. 1998;338:1663-71), and depending on recurrence risk, cranial irradiation.
In addition to that regimen, they were randomly assigned to four arms, according to methotrexate dosing (high dose with leucovorin rescue in the inpatient setting vs. escalating dose in the outpatient setting) and nelarabine therapy (receipt vs. nonreceipt).
Among patients with T-ALL, those with low-risk disease were ineligible for nelarabine and did not receive cranial irradiation, whereas those with intermediate- and high-risk disease were randomized to all four arms, Dr. Dunsmore explained. In addition, those who did not achieve remission on induction chemotherapy were nonrandomly assigned to the high-dose methotrexate plus nelarabine arm.
Patients with T-LL were ineligible for high-dose methotrexate and were randomized to escalating-dose methotrexate with or without nelarabine.
Among all patients with T-ALL, the 4-year rate of overall survival was 90.2%, and the 4-year rate of disease-free survival was 84.1%, Dr. Dunsmore reported.
Disease-free survival was better with escalating-dose methotrexate than with high-dose methotrexate (89.8% vs. 78%).
Addition of nelarabine for patients with T-ALL having intermediate- or high-risk disease improved disease-free survival, from 83% without the drug to 88% with the drug (P = .0450), and reduced the rate of CNS relapse. Disease-free survival was highest, at 91%, among those who received both escalating-dose methotrexate and nelarabine.
Among the patients who did not achieve remission from induction chemotherapy, the 4-year rate of overall survival was 54%. “This is important because it’s more than double the past survival rates,” Dr. Dunsmore noted.
Patients with T-LL fared similarly well whether they received nelarabine or not; fully 85% overall were still alive at 4 years.
In terms of adverse effects of nelarabine therapy, the rate of peripheral neuropathy (motor or sensory), one of the more problematic adverse effects of the drug, was 8% in the trial population overall and did not exceed 9% in any treatment arm, she reported.
Dr. Dunsmore disclosed that an immediate family member is an employee of and has a leadership role with TypeZero Technologies; that she receives travel, accommodations, and/or expenses from Novo Nordisk; and that an immediate family member receives travel, accommodations, and/or expenses from Tandem Diabetes Care. The study received funding from the Cancer Therapy Evaluation Program within the National Cancer Institute/National Institutes of Health and received support from the St. Baldrick’s Foundation.
SOURCE: Dunsmore KP et al. ASCO 2018, Abstract 10500.
REPORTING FROM ASCO 2018
Key clinical point:
Major finding: Patients with T-ALL had a 4-year rate of overall survival of 90.2% and disease-free survival of 84.1%; patients with T-LL had a 4-year rate of overall survival of 85%.
Study details: Phase 3 randomized controlled trial among 1,545 youth with T-ALL or T-LL testing various regimens of methotrexate and/or nelarabine with standard chemotherapy (ALL0434).
Disclosures: Dr. Dunsmore disclosed that an immediate family member is an employee of and has a leadership role with TypeZero; that she receives travel, accommodations, and/or expenses from Novo Nordisk; and that an immediate family member receives travel, accommodations, and/or expenses from Tandem Diabetes Care. The study received funding from the Cancer Therapy Evaluation Program within the National Cancer Institute/National Institutes of Health and received support from the St. Baldrick’s Foundation.
Source: Dunsmore KP et al. ASCO 2018, Abstract 10500.
Upfront NGS testing of metastatic NSCLC saves money, time
Comprehensive testing of newly diagnosed metastatic non–small cell lung cancer (NSCLC) with next-generation sequencing (NGS) for known lung cancer–related genomic alterations is cost-saving relative to single-gene testing strategies and often faster, a new study finds.
“We know now that genomic testing for all patients with advanced NSCLC is the standard of care to help detect oncogenic drivers, to inform treatment decisions,” lead study author Nathan A. Pennell, MD, PhD, codirector of the Cleveland Clinic lung cancer program, said in a press briefing leading up to the ASCO annual meeting. But the optimal strategy for this testing is unclear.
He and his colleagues conducted a decision analytic modeling study among hypothetical insurance plans having 1 million enrollees. Outcomes were compared between NGS testing and three single-gene testing strategies.
Data indicated that compared with exclusionary, sequential, or hot-spot panel testing approaches, NGS testing simultaneously for eight genomic alterations having Food and Drug Administration–approved or investigational targeted therapies could save up to $2.1 million among Medicare beneficiaries and up to $250,842 among patients covered by commercial insurance. The costs to payers decreased as the percentage of patients receiving NGS testing increased. Moreover, the wait time for results was similar or roughly half as long with NGS.
“Our results showed that there were substantial cost savings associated with upfront NGS testing compared to all other strategies,” Dr. Pennell said. “In addition, NGS had a faster turnaround time than either sequential or exclusionary testing, which is critically important for sick lung cancer patients, to make sure they get their treatment as quickly as possible. Waiting a month or longer is simply no longer viable for patients because they get sick very quickly and these treatments work very well.”
Of note, the model indicated that some patients undergoing initial single-gene testing strategies never had their genomic alterations detected because tissue for testing ran out and they were too sick to undergo another biopsy.
“The bottom line is, ultimately, using the best single test upfront results in the fastest turnaround time, the highest percentage of patients with targetable alterations identified, and overall the lowest cost to payers,” he summarized.
A major challenge in this population is going back and retesting for known or new genomic alterations, agreed ASCO President Bruce E. Johnson, MD, FASCO. “At our upcoming meeting, we are going to hear about RET, which may end up as a target and may therefore need to be tested for.”
Recently, oncologists have a new attractive option of billing for NGS panels rather than for single gene tests, he noted.
“This study really shows that by doing all the testing at the same time, you can both get results back more quickly as well as get information,” said Dr. Johnson, professor of medicine at the Dana-Farber Cancer Institute and a leader of the Dana-Farber/Harvard Cancer Center Lung Cancer Program, Boston. “This study looked at an NGS panel of eight genes, but most of the NGS panels contain somewhere between 50 and 400 genes, so you get a lot more information with this at a cost that’s competitive or less. So this will be welcome news to people who are ordering these gene panels.”
Study details
For NSCLC, there are currently approved treatments that target alterations in EGFR, ALK, ROS1, and BRAF, and investigational treatments in clinical trials that target alterations in MET, HER2, RET, and NTRK1.
In the model Dr. Pennell and his colleagues developed, patients with newly diagnosed metastatic NSCLC received testing for programmed death ligand 1 (PD-L1) plus testing for the above known lung cancer–related genes using one of four strategies:
- NGS testing (testing of all eight genes plus KRAS simultaneously).
- Sequential testing (testing one gene at a time starting with EGFR).
- Exclusionary testing (testing for KRAS mutation, the most common genomic alteration, followed by sequential testing for changes in other genes only if KRAS was not mutated).
- Hot-spot panel testing (combined testing for EGFR, ALK, ROS1, and BRAF), followed by either single-gene or NGS testing for alterations in other genes.
Model results indicated that among 1 million hypothetical plan enrollees, 2,066 patients covered by the Centers for Medicare & Medicaid Services and 156 covered by U.S. commercial insurers would have newly diagnosed metastatic NSCLC and therefore be eligible for testing.
Estimated time to receive test results was 2 weeks for NGS testing and for panel testing, compared with 4.7 weeks for exclusionary testing and 4.8 weeks for sequential testing.
In the CMS population, NGS testing would save about $1.4 million compared with exclusionary testing, more than $1.5 million compared with sequential testing, and about $2.1 million compared with panel testing. In the commercial health plan cohort, NGS would save $3,809 compared with exclusionary testing, $127,402 compared with sequential testing, and $250,842 compared with panel testing.
Dr. Pennell disclosed that he has a consulting or advisory role with AstraZeneca, Lilly, and Regeneron, and that his institution receives research funding from Genentech, NewLink Genetics, Clovis Oncology, Astex Pharmaceuticals, Celgene, AstraZeneca, Pfizer, and Merck. The study received funding from Novartis.
SOURCE: Pennell et al., ASCO Annual Meeting Abstract 9031.
Comprehensive testing of newly diagnosed metastatic non–small cell lung cancer (NSCLC) with next-generation sequencing (NGS) for known lung cancer–related genomic alterations is cost-saving relative to single-gene testing strategies and often faster, a new study finds.
“We know now that genomic testing for all patients with advanced NSCLC is the standard of care to help detect oncogenic drivers, to inform treatment decisions,” lead study author Nathan A. Pennell, MD, PhD, codirector of the Cleveland Clinic lung cancer program, said in a press briefing leading up to the ASCO annual meeting. But the optimal strategy for this testing is unclear.
He and his colleagues conducted a decision analytic modeling study among hypothetical insurance plans having 1 million enrollees. Outcomes were compared between NGS testing and three single-gene testing strategies.
Data indicated that compared with exclusionary, sequential, or hot-spot panel testing approaches, NGS testing simultaneously for eight genomic alterations having Food and Drug Administration–approved or investigational targeted therapies could save up to $2.1 million among Medicare beneficiaries and up to $250,842 among patients covered by commercial insurance. The costs to payers decreased as the percentage of patients receiving NGS testing increased. Moreover, the wait time for results was similar or roughly half as long with NGS.
“Our results showed that there were substantial cost savings associated with upfront NGS testing compared to all other strategies,” Dr. Pennell said. “In addition, NGS had a faster turnaround time than either sequential or exclusionary testing, which is critically important for sick lung cancer patients, to make sure they get their treatment as quickly as possible. Waiting a month or longer is simply no longer viable for patients because they get sick very quickly and these treatments work very well.”
Of note, the model indicated that some patients undergoing initial single-gene testing strategies never had their genomic alterations detected because tissue for testing ran out and they were too sick to undergo another biopsy.
“The bottom line is, ultimately, using the best single test upfront results in the fastest turnaround time, the highest percentage of patients with targetable alterations identified, and overall the lowest cost to payers,” he summarized.
A major challenge in this population is going back and retesting for known or new genomic alterations, agreed ASCO President Bruce E. Johnson, MD, FASCO. “At our upcoming meeting, we are going to hear about RET, which may end up as a target and may therefore need to be tested for.”
Recently, oncologists have a new attractive option of billing for NGS panels rather than for single gene tests, he noted.
“This study really shows that by doing all the testing at the same time, you can both get results back more quickly as well as get information,” said Dr. Johnson, professor of medicine at the Dana-Farber Cancer Institute and a leader of the Dana-Farber/Harvard Cancer Center Lung Cancer Program, Boston. “This study looked at an NGS panel of eight genes, but most of the NGS panels contain somewhere between 50 and 400 genes, so you get a lot more information with this at a cost that’s competitive or less. So this will be welcome news to people who are ordering these gene panels.”
Study details
For NSCLC, there are currently approved treatments that target alterations in EGFR, ALK, ROS1, and BRAF, and investigational treatments in clinical trials that target alterations in MET, HER2, RET, and NTRK1.
In the model Dr. Pennell and his colleagues developed, patients with newly diagnosed metastatic NSCLC received testing for programmed death ligand 1 (PD-L1) plus testing for the above known lung cancer–related genes using one of four strategies:
- NGS testing (testing of all eight genes plus KRAS simultaneously).
- Sequential testing (testing one gene at a time starting with EGFR).
- Exclusionary testing (testing for KRAS mutation, the most common genomic alteration, followed by sequential testing for changes in other genes only if KRAS was not mutated).
- Hot-spot panel testing (combined testing for EGFR, ALK, ROS1, and BRAF), followed by either single-gene or NGS testing for alterations in other genes.
Model results indicated that among 1 million hypothetical plan enrollees, 2,066 patients covered by the Centers for Medicare & Medicaid Services and 156 covered by U.S. commercial insurers would have newly diagnosed metastatic NSCLC and therefore be eligible for testing.
Estimated time to receive test results was 2 weeks for NGS testing and for panel testing, compared with 4.7 weeks for exclusionary testing and 4.8 weeks for sequential testing.
In the CMS population, NGS testing would save about $1.4 million compared with exclusionary testing, more than $1.5 million compared with sequential testing, and about $2.1 million compared with panel testing. In the commercial health plan cohort, NGS would save $3,809 compared with exclusionary testing, $127,402 compared with sequential testing, and $250,842 compared with panel testing.
Dr. Pennell disclosed that he has a consulting or advisory role with AstraZeneca, Lilly, and Regeneron, and that his institution receives research funding from Genentech, NewLink Genetics, Clovis Oncology, Astex Pharmaceuticals, Celgene, AstraZeneca, Pfizer, and Merck. The study received funding from Novartis.
SOURCE: Pennell et al., ASCO Annual Meeting Abstract 9031.
Comprehensive testing of newly diagnosed metastatic non–small cell lung cancer (NSCLC) with next-generation sequencing (NGS) for known lung cancer–related genomic alterations is cost-saving relative to single-gene testing strategies and often faster, a new study finds.
“We know now that genomic testing for all patients with advanced NSCLC is the standard of care to help detect oncogenic drivers, to inform treatment decisions,” lead study author Nathan A. Pennell, MD, PhD, codirector of the Cleveland Clinic lung cancer program, said in a press briefing leading up to the ASCO annual meeting. But the optimal strategy for this testing is unclear.
He and his colleagues conducted a decision analytic modeling study among hypothetical insurance plans having 1 million enrollees. Outcomes were compared between NGS testing and three single-gene testing strategies.
Data indicated that compared with exclusionary, sequential, or hot-spot panel testing approaches, NGS testing simultaneously for eight genomic alterations having Food and Drug Administration–approved or investigational targeted therapies could save up to $2.1 million among Medicare beneficiaries and up to $250,842 among patients covered by commercial insurance. The costs to payers decreased as the percentage of patients receiving NGS testing increased. Moreover, the wait time for results was similar or roughly half as long with NGS.
“Our results showed that there were substantial cost savings associated with upfront NGS testing compared to all other strategies,” Dr. Pennell said. “In addition, NGS had a faster turnaround time than either sequential or exclusionary testing, which is critically important for sick lung cancer patients, to make sure they get their treatment as quickly as possible. Waiting a month or longer is simply no longer viable for patients because they get sick very quickly and these treatments work very well.”
Of note, the model indicated that some patients undergoing initial single-gene testing strategies never had their genomic alterations detected because tissue for testing ran out and they were too sick to undergo another biopsy.
“The bottom line is, ultimately, using the best single test upfront results in the fastest turnaround time, the highest percentage of patients with targetable alterations identified, and overall the lowest cost to payers,” he summarized.
A major challenge in this population is going back and retesting for known or new genomic alterations, agreed ASCO President Bruce E. Johnson, MD, FASCO. “At our upcoming meeting, we are going to hear about RET, which may end up as a target and may therefore need to be tested for.”
Recently, oncologists have a new attractive option of billing for NGS panels rather than for single gene tests, he noted.
“This study really shows that by doing all the testing at the same time, you can both get results back more quickly as well as get information,” said Dr. Johnson, professor of medicine at the Dana-Farber Cancer Institute and a leader of the Dana-Farber/Harvard Cancer Center Lung Cancer Program, Boston. “This study looked at an NGS panel of eight genes, but most of the NGS panels contain somewhere between 50 and 400 genes, so you get a lot more information with this at a cost that’s competitive or less. So this will be welcome news to people who are ordering these gene panels.”
Study details
For NSCLC, there are currently approved treatments that target alterations in EGFR, ALK, ROS1, and BRAF, and investigational treatments in clinical trials that target alterations in MET, HER2, RET, and NTRK1.
In the model Dr. Pennell and his colleagues developed, patients with newly diagnosed metastatic NSCLC received testing for programmed death ligand 1 (PD-L1) plus testing for the above known lung cancer–related genes using one of four strategies:
- NGS testing (testing of all eight genes plus KRAS simultaneously).
- Sequential testing (testing one gene at a time starting with EGFR).
- Exclusionary testing (testing for KRAS mutation, the most common genomic alteration, followed by sequential testing for changes in other genes only if KRAS was not mutated).
- Hot-spot panel testing (combined testing for EGFR, ALK, ROS1, and BRAF), followed by either single-gene or NGS testing for alterations in other genes.
Model results indicated that among 1 million hypothetical plan enrollees, 2,066 patients covered by the Centers for Medicare & Medicaid Services and 156 covered by U.S. commercial insurers would have newly diagnosed metastatic NSCLC and therefore be eligible for testing.
Estimated time to receive test results was 2 weeks for NGS testing and for panel testing, compared with 4.7 weeks for exclusionary testing and 4.8 weeks for sequential testing.
In the CMS population, NGS testing would save about $1.4 million compared with exclusionary testing, more than $1.5 million compared with sequential testing, and about $2.1 million compared with panel testing. In the commercial health plan cohort, NGS would save $3,809 compared with exclusionary testing, $127,402 compared with sequential testing, and $250,842 compared with panel testing.
Dr. Pennell disclosed that he has a consulting or advisory role with AstraZeneca, Lilly, and Regeneron, and that his institution receives research funding from Genentech, NewLink Genetics, Clovis Oncology, Astex Pharmaceuticals, Celgene, AstraZeneca, Pfizer, and Merck. The study received funding from Novartis.
SOURCE: Pennell et al., ASCO Annual Meeting Abstract 9031.
REPORTING FROM THE ASCO ANNUAL MEETING
Key clinical point:
Major finding: Relative to exclusionary, sequential, or panel testing, NGS testing could save up to $2.1 million among CMS beneficiaries and up to $250,842 among patients covered by commercial insurance.
Study details: A decision analytic modeling study in hypothetical cohorts of 1 million insurance plan enrollees.
Disclosures: Dr. Pennell disclosed that he has a consulting or advisory role with AstraZeneca, Lilly, and Regeneron, and that his institution receives research funding from Genentech, NewLink Genetics, Clovis Oncology, Astex Pharmaceuticals, Celgene, AstraZeneca, Pfizer, and Merck. The study received funding from Novartis.
Source: Pennell et al. ASCO Annual Meeting, Abstract 9031.