The Journal of Community and Supportive Oncology

Background Complete remission (CR) in acute myeloid leukemia (AML) is defined as having ≤5% leukemic blast cells in the bone marrow and return of normal hematopoiesis after the first induction cycle. There is a subset of patients, however, who achieve reduction of leukemic blast cells with a subnormal platelet count, designated as CR with incomplete platelet recovery (platelet count, ≤100,000/mcL; normal, 150,000-450,000/mcL), which is associated with inferior outcomes when compared with CR. Furthermore, there is another subset of patients with CR but superior platelet counts (≥400,000/mcL) whose prognostic significance is unclear.

Objective To establish whether CR with superior platelet counts is associated with better outcomes and can be used as a separate entity for prognostication.

Methods A retrospective chart review of 104 cases of AML was conducted. The highest platelet count during days 25-35 from initiation of induction chemotherapy (designated as day 30 platelet count) was documented. A multivariate analysis for other factors such as age, sex, risk categories, day 14+ plasma cell count (average plasma cell percentage at days 14-21), infections, allogeneic bone marrow transplant, and remission status was done.

Results Day 30 platelet count was found to be an independent predictor of survival in AML. On the multivariate analysis, the subgroup with superior platelet counts (≥400,000/mcL) was found to be associated with better outcomes.

Limitations Results need to be validated in a larger cohort.

Conclusions CR with superior platelet recovery (≥400,000/mcL) is a unique subcategory in itself and has prognostic significance. This may help better assess response to chemotherapeutic agents and aid in further decision-making regarding treatment. 

Click on the PDF icon at the top of this introduction to read the full article.

Background Complete remission (CR) in acute myeloid leukemia (AML) is defined as having ≤5% leukemic blast cells in the bone marrow and return of normal hematopoiesis after the first induction cycle. There is a subset of patients, however, who achieve reduction of leukemic blast cells with a subnormal platelet count, designated as CR with incomplete platelet recovery (platelet count, ≤100,000/mcL; normal, 150,000-450,000/mcL), which is associated with inferior outcomes when compared with CR. Furthermore, there is another subset of patients with CR but superior platelet counts (≥400,000/mcL) whose prognostic significance is unclear.

Objective To establish whether CR with superior platelet counts is associated with better outcomes and can be used as a separate entity for prognostication.

Methods A retrospective chart review of 104 cases of AML was conducted. The highest platelet count during days 25-35 from initiation of induction chemotherapy (designated as day 30 platelet count) was documented. A multivariate analysis for other factors such as age, sex, risk categories, day 14+ plasma cell count (average plasma cell percentage at days 14-21), infections, allogeneic bone marrow transplant, and remission status was done.

Results Day 30 platelet count was found to be an independent predictor of survival in AML. On the multivariate analysis, the subgroup with superior platelet counts (≥400,000/mcL) was found to be associated with better outcomes.

Limitations Results need to be validated in a larger cohort.

Conclusions CR with superior platelet recovery (≥400,000/mcL) is a unique subcategory in itself and has prognostic significance. This may help better assess response to chemotherapeutic agents and aid in further decision-making regarding treatment. 

Click on the PDF icon at the top of this introduction to read the full article.

Background Complete remission (CR) in acute myeloid leukemia (AML) is defined as having ≤5% leukemic blast cells in the bone marrow and return of normal hematopoiesis after the first induction cycle. There is a subset of patients, however, who achieve reduction of leukemic blast cells with a subnormal platelet count, designated as CR with incomplete platelet recovery (platelet count, ≤100,000/mcL; normal, 150,000-450,000/mcL), which is associated with inferior outcomes when compared with CR. Furthermore, there is another subset of patients with CR but superior platelet counts (≥400,000/mcL) whose prognostic significance is unclear.

Objective To establish whether CR with superior platelet counts is associated with better outcomes and can be used as a separate entity for prognostication.

Methods A retrospective chart review of 104 cases of AML was conducted. The highest platelet count during days 25-35 from initiation of induction chemotherapy (designated as day 30 platelet count) was documented. A multivariate analysis for other factors such as age, sex, risk categories, day 14+ plasma cell count (average plasma cell percentage at days 14-21), infections, allogeneic bone marrow transplant, and remission status was done.

Results Day 30 platelet count was found to be an independent predictor of survival in AML. On the multivariate analysis, the subgroup with superior platelet counts (≥400,000/mcL) was found to be associated with better outcomes.

Limitations Results need to be validated in a larger cohort.

Conclusions CR with superior platelet recovery (≥400,000/mcL) is a unique subcategory in itself and has prognostic significance. This may help better assess response to chemotherapeutic agents and aid in further decision-making regarding treatment. 

Click on the PDF icon at the top of this introduction to read the full article.

Background The 3 fluoroquinolone (FQ) antibiotics – ciprofoxacin, levofoxacin, and moxifoxacin – are commonly administered to oncology patients. Although these oral antibiotics are approved by the US Food and Drug Administration (FDA) for treatment of urinary tract infections, acute bacterial sinusitis, or bacterial infection in patients with chronic obstructive pulmonary disease, they are commonly prescribed off-label to neutropenic cancer patients for the prevention and treatment of infections associated with febrile neutropenia. New serious FQ-associated safety concerns have been identified through novel collaborations between FQ-treated persons who have developed long-term neuropsychiatric (NP) toxicity, pharmacovigilance experts, and basic scientists.

Objective To conduct basic science and clinical investigations of a newly identified adverse drug reaction, termed FQ-associated disability.

Methods 5 groups of C57BL/6 mice receiving the antibiotic ciprofoxacin in 10-mg increments (10 mg/kg-50 mg/kg) and 1 group of control mice were evaluated. The Southern Network on Adverse Reactions (SONAR) and a social network of FQ-treated persons with long-term NP toxicity (the Floxed Network) conducted a web-based survey. The clinical toxicity manifestations reported by 94 respondents to the web-based survey of persons who had received 1 or more doses of an FQ prescribed for any indication (generally at FDA-approved dosages) and who subsequently experienced possible adverse drug reactions were compared with adverse event information included on the product label for levofoxacin and with FQ-associated adverse events reported to the FDA’s MedWatch program.

Results Mice treated with ciprofoxacin had lower grip strengths, reduced balance, and depressive behavior compared with the controls. For the survey, 93 of 94 respondents reported FQ-associated events including anxiety, depression, insomnia, panic attacks, clouded thinking, depersonalization, suicidal thoughts, psychosis, nightmares, and impaired memory beginning within days of FQ initiation or days to months of FQ discontinuation. The FDA Adverse Event Reporting System (FAERS) included 210,705 adverse events and 2,991 fatalities for FQs. Levofoxacin and ciprofoxacin toxicities were neurologic (30% and 26%, respectively), tendon damage (8% and 6%), and psychiatric (10% and 2%). In 2013, an FDA safety review reported that FQs affect mammalian topoisomerase II, especially in mitochondria. In 2013 and 2014, SONAR fled citizen petitions requesting black box revisions identifying neuropsychiatric toxicities and mitochrondrial toxicity as serious levofoxacin-associated adverse drug reactions. In 2015, FDA advisors recommended that FQ product labels be revised to include information about this newly identified disability syndrome termed “FQ-associated disability” (FQAD).

Limitations Basic science studies evaluated NP toxicity for only 1 FQ, ciprofoxacin.

Conclusion Pharmacovigilance investigators, a social network, and basic scientists can collaborate on pharmacovigilance investigations. Revised product labels describing a new serious adverse drug reaction, levofoxacin-associated long-term disability, as recommended by an FDA advisory committee, are advised.

Funding This work was funded partly by the National Cancer Institute (1R01CA165609-01A1), the American Cancer Society (IRG-13-043-01), the South Carolina SmartState Program, and an unrestricted from Doris Levkoff Meddin to the South Carolina College of Pharmacy Center for Medication Safety and Efficacy.

Click on the PDF icon at the top of this introduction to read the full article.

Background The 3 fluoroquinolone (FQ) antibiotics – ciprofoxacin, levofoxacin, and moxifoxacin – are commonly administered to oncology patients. Although these oral antibiotics are approved by the US Food and Drug Administration (FDA) for treatment of urinary tract infections, acute bacterial sinusitis, or bacterial infection in patients with chronic obstructive pulmonary disease, they are commonly prescribed off-label to neutropenic cancer patients for the prevention and treatment of infections associated with febrile neutropenia. New serious FQ-associated safety concerns have been identified through novel collaborations between FQ-treated persons who have developed long-term neuropsychiatric (NP) toxicity, pharmacovigilance experts, and basic scientists.

Objective To conduct basic science and clinical investigations of a newly identified adverse drug reaction, termed FQ-associated disability.

Methods 5 groups of C57BL/6 mice receiving the antibiotic ciprofoxacin in 10-mg increments (10 mg/kg-50 mg/kg) and 1 group of control mice were evaluated. The Southern Network on Adverse Reactions (SONAR) and a social network of FQ-treated persons with long-term NP toxicity (the Floxed Network) conducted a web-based survey. The clinical toxicity manifestations reported by 94 respondents to the web-based survey of persons who had received 1 or more doses of an FQ prescribed for any indication (generally at FDA-approved dosages) and who subsequently experienced possible adverse drug reactions were compared with adverse event information included on the product label for levofoxacin and with FQ-associated adverse events reported to the FDA’s MedWatch program.

Results Mice treated with ciprofoxacin had lower grip strengths, reduced balance, and depressive behavior compared with the controls. For the survey, 93 of 94 respondents reported FQ-associated events including anxiety, depression, insomnia, panic attacks, clouded thinking, depersonalization, suicidal thoughts, psychosis, nightmares, and impaired memory beginning within days of FQ initiation or days to months of FQ discontinuation. The FDA Adverse Event Reporting System (FAERS) included 210,705 adverse events and 2,991 fatalities for FQs. Levofoxacin and ciprofoxacin toxicities were neurologic (30% and 26%, respectively), tendon damage (8% and 6%), and psychiatric (10% and 2%). In 2013, an FDA safety review reported that FQs affect mammalian topoisomerase II, especially in mitochondria. In 2013 and 2014, SONAR fled citizen petitions requesting black box revisions identifying neuropsychiatric toxicities and mitochrondrial toxicity as serious levofoxacin-associated adverse drug reactions. In 2015, FDA advisors recommended that FQ product labels be revised to include information about this newly identified disability syndrome termed “FQ-associated disability” (FQAD).

Limitations Basic science studies evaluated NP toxicity for only 1 FQ, ciprofoxacin.

Conclusion Pharmacovigilance investigators, a social network, and basic scientists can collaborate on pharmacovigilance investigations. Revised product labels describing a new serious adverse drug reaction, levofoxacin-associated long-term disability, as recommended by an FDA advisory committee, are advised.

Funding This work was funded partly by the National Cancer Institute (1R01CA165609-01A1), the American Cancer Society (IRG-13-043-01), the South Carolina SmartState Program, and an unrestricted from Doris Levkoff Meddin to the South Carolina College of Pharmacy Center for Medication Safety and Efficacy.

Click on the PDF icon at the top of this introduction to read the full article.

Background The 3 fluoroquinolone (FQ) antibiotics – ciprofoxacin, levofoxacin, and moxifoxacin – are commonly administered to oncology patients. Although these oral antibiotics are approved by the US Food and Drug Administration (FDA) for treatment of urinary tract infections, acute bacterial sinusitis, or bacterial infection in patients with chronic obstructive pulmonary disease, they are commonly prescribed off-label to neutropenic cancer patients for the prevention and treatment of infections associated with febrile neutropenia. New serious FQ-associated safety concerns have been identified through novel collaborations between FQ-treated persons who have developed long-term neuropsychiatric (NP) toxicity, pharmacovigilance experts, and basic scientists.

Objective To conduct basic science and clinical investigations of a newly identified adverse drug reaction, termed FQ-associated disability.

Methods 5 groups of C57BL/6 mice receiving the antibiotic ciprofoxacin in 10-mg increments (10 mg/kg-50 mg/kg) and 1 group of control mice were evaluated. The Southern Network on Adverse Reactions (SONAR) and a social network of FQ-treated persons with long-term NP toxicity (the Floxed Network) conducted a web-based survey. The clinical toxicity manifestations reported by 94 respondents to the web-based survey of persons who had received 1 or more doses of an FQ prescribed for any indication (generally at FDA-approved dosages) and who subsequently experienced possible adverse drug reactions were compared with adverse event information included on the product label for levofoxacin and with FQ-associated adverse events reported to the FDA’s MedWatch program.

Results Mice treated with ciprofoxacin had lower grip strengths, reduced balance, and depressive behavior compared with the controls. For the survey, 93 of 94 respondents reported FQ-associated events including anxiety, depression, insomnia, panic attacks, clouded thinking, depersonalization, suicidal thoughts, psychosis, nightmares, and impaired memory beginning within days of FQ initiation or days to months of FQ discontinuation. The FDA Adverse Event Reporting System (FAERS) included 210,705 adverse events and 2,991 fatalities for FQs. Levofoxacin and ciprofoxacin toxicities were neurologic (30% and 26%, respectively), tendon damage (8% and 6%), and psychiatric (10% and 2%). In 2013, an FDA safety review reported that FQs affect mammalian topoisomerase II, especially in mitochondria. In 2013 and 2014, SONAR fled citizen petitions requesting black box revisions identifying neuropsychiatric toxicities and mitochrondrial toxicity as serious levofoxacin-associated adverse drug reactions. In 2015, FDA advisors recommended that FQ product labels be revised to include information about this newly identified disability syndrome termed “FQ-associated disability” (FQAD).

Limitations Basic science studies evaluated NP toxicity for only 1 FQ, ciprofoxacin.

Conclusion Pharmacovigilance investigators, a social network, and basic scientists can collaborate on pharmacovigilance investigations. Revised product labels describing a new serious adverse drug reaction, levofoxacin-associated long-term disability, as recommended by an FDA advisory committee, are advised.

Funding This work was funded partly by the National Cancer Institute (1R01CA165609-01A1), the American Cancer Society (IRG-13-043-01), the South Carolina SmartState Program, and an unrestricted from Doris Levkoff Meddin to the South Carolina College of Pharmacy Center for Medication Safety and Efficacy.

Click on the PDF icon at the top of this introduction to read the full article.

SAN FRANCISCO – Receiving adjuvant therapy for pancreatic cancer at a center that treats a high volume of patients with the disease confers a survival advantage, according to results of a retrospective cohort study reported at the symposium sponsored by ASCO, ASTRO, the American Gastroenterological Association, and the Society of Surgical Oncology.

The analysis of 245 patients found that those given adjuvant therapy at Virginia Mason Medical Center – a high-volume center seeing up to 300 patients with newly diagnosed pancreatic cancer each year and putting about a third of them in trials – had a 37% reduction in the adjusted risk of death when compared with peers referred to community clinics for this therapy, reported first author Margaret T. Mandelson, Ph.D., director of research and quality at the center’s cancer institute in Seattle.

Susan London/Frontline Medical News

“Our study does lend some support to the concept of using high-volume centers for all therapy components for pancreatic cancer that is treated with curative intent,” she commented. “Ongoing investigation of patterns of care and volume impact in medical oncology is certainly warranted.”

A variety of factors may be driving the observed survival difference, such as the regimens used, with some evidence suggesting, for example, that patients treated in the community are more likely to receive single-agent therapy, she noted.

“We know that we have a strong setting for supportive care [at the center] and that we try to maximize our patients’ tolerance to treatment,” she added. “We have a high rate of completion of treatment in this setting. And of course the impact of optimism and hope cannot be underestimated in this patient population.”

Giving the academic medical center perspective, Dr. James L. Abbruzzese of the Duke Cancer Institute, Duke University, Durham, N.C., speculated that volume is a proxy for processes of care: staffing, use of guidelines or treatment algorithms, staging practices, and especially a multidisciplinary approach with components such as tumor boards and use of clinical trials. And larger centers are in a better position to offer these processes.

Susan London/Frontline Medical Media

“While the primary determinant of the long-term outcome of patients requires adequate volumes, I don’t think this is the whole answer,” he summarized. “I think it relies on and relates much more to the processes and the extent to which we can bring the multidisciplinary team to the patients.”

Giving the community oncology perspective, Dr. Michael V. Seiden, chief medical officer of the US Oncology Network, contended that instead of focusing solely on outcomes, the field should be focusing on the value of care, broadly defined as outcome divided by cost.

“I don’t really think this is a discussion about should your pancreatic cancer be treated in the community or in an academic center or a large regional health center. What we have to realize is that tens of thousands of patients with pancreatic cancer who will be diagnosed in the years ahead are going to receive care across the country in a lot of different venues,” he commented. “The questions we need to answer are how do we maximize value? What should be done in the ‘mouse’ hospitals? What should be done in the gigantic centers of excellence? What should be done in the well-organized health care systems? And what should be done in the community? Because delivering maximal value requires keeping an eye not only on best outcomes, but also on patient convenience and cost.”

Giving some background to the study, Dr. Mandelson noted that a volume-outcome relationship has been established when it comes to surgery for pancreatic cancer, but not when it comes to adjuvant therapy for the disease.

She and her colleagues used registry data to identify patients who received a pancreatic cancer diagnosis during 2003-2014 and underwent primary resection at Virginia Mason Medical Center. They compared outcomes between those who stayed at the center to receive their adjuvant therapy and those who were referred to a community oncology practice to receive this therapy.

Patients were excluded if they had received neoadjuvant therapy, had synchronous cancers, died or were lost to follow-up within 3 months of surgery, or had contraindications to receiving adjuvant therapy. Also excluded were any who declined this therapy and for whom a medical oncologist could not be identified.

Results showed that the patients treated in the high-volume center and in community clinics were similar with respect to sex, insurance status, travel distance to a high-volume center, performance status, and tumor size, nodal status, and margin status, Dr. Mandelson reported. Those treated in the community were, on average, 5 years older.

At the high-volume center, 96% of patients started chemotherapy, 81% received a multiagent regimen, and 53% underwent chemoradiation. Detailed data on therapies received were not available for the community group.

The patients treated in the high-volume center had a more than one-third reduction in the adjusted risk of death relative to peers treated in the community (hazard ratio, 0.63; P less than .01). Median overall survival was 43.6 months for the former, compared with 27.9 months for the latter (P less than .01). The corresponding 5-year rates of overall survival were 38.6% and 24.8% (P less than .01).

“We know from the literature that pancreas cancer is undertreated in the community as a whole, both from the surgical perspective and the medical perspective. So it wouldn’t be surprising if some of the patients with a referral to an outside oncologist in fact never received treatment,” Dr. Mandelson commented.

“The patient population that received surgery in the community setting and then came to Virginia Mason for adjuvant therapy has not yet been analyzed, which is essentially the inverse of this study,” she noted. “That will be very powerful evidence.”

Dr. Mandelson disclosed that she had no relevant conflicts of interest. Dr. Abbruzzese disclosed that he receives honoraria from Celgene and Halozyme, and that he has a consulting or advisory role with Acerta Pharma, Bessor, Celgene, Cornerstone Pharma, Daiichi Sankyo, EMD Serono, Halozyme, Progen, Merck Sharpe & Dohme, Sun BioPharma, and Viba Therapeutics. Dr. Seiden disclosed that he is an employee of McKesson Specialty Health and Texas Oncology; that he is chief medical officer of US Oncology; and that he owns stock in and receives travel expenses from McKesson Specialty Health.

tor@frontlinemedcom.com

SAN FRANCISCO – Receiving adjuvant therapy for pancreatic cancer at a center that treats a high volume of patients with the disease confers a survival advantage, according to results of a retrospective cohort study reported at the symposium sponsored by ASCO, ASTRO, the American Gastroenterological Association, and the Society of Surgical Oncology.

The analysis of 245 patients found that those given adjuvant therapy at Virginia Mason Medical Center – a high-volume center seeing up to 300 patients with newly diagnosed pancreatic cancer each year and putting about a third of them in trials – had a 37% reduction in the adjusted risk of death when compared with peers referred to community clinics for this therapy, reported first author Margaret T. Mandelson, Ph.D., director of research and quality at the center’s cancer institute in Seattle.

Susan London/Frontline Medical News

“Our study does lend some support to the concept of using high-volume centers for all therapy components for pancreatic cancer that is treated with curative intent,” she commented. “Ongoing investigation of patterns of care and volume impact in medical oncology is certainly warranted.”

A variety of factors may be driving the observed survival difference, such as the regimens used, with some evidence suggesting, for example, that patients treated in the community are more likely to receive single-agent therapy, she noted.

“We know that we have a strong setting for supportive care [at the center] and that we try to maximize our patients’ tolerance to treatment,” she added. “We have a high rate of completion of treatment in this setting. And of course the impact of optimism and hope cannot be underestimated in this patient population.”

Giving the academic medical center perspective, Dr. James L. Abbruzzese of the Duke Cancer Institute, Duke University, Durham, N.C., speculated that volume is a proxy for processes of care: staffing, use of guidelines or treatment algorithms, staging practices, and especially a multidisciplinary approach with components such as tumor boards and use of clinical trials. And larger centers are in a better position to offer these processes.

Susan London/Frontline Medical Media

“While the primary determinant of the long-term outcome of patients requires adequate volumes, I don’t think this is the whole answer,” he summarized. “I think it relies on and relates much more to the processes and the extent to which we can bring the multidisciplinary team to the patients.”

Giving the community oncology perspective, Dr. Michael V. Seiden, chief medical officer of the US Oncology Network, contended that instead of focusing solely on outcomes, the field should be focusing on the value of care, broadly defined as outcome divided by cost.

“I don’t really think this is a discussion about should your pancreatic cancer be treated in the community or in an academic center or a large regional health center. What we have to realize is that tens of thousands of patients with pancreatic cancer who will be diagnosed in the years ahead are going to receive care across the country in a lot of different venues,” he commented. “The questions we need to answer are how do we maximize value? What should be done in the ‘mouse’ hospitals? What should be done in the gigantic centers of excellence? What should be done in the well-organized health care systems? And what should be done in the community? Because delivering maximal value requires keeping an eye not only on best outcomes, but also on patient convenience and cost.”

Giving some background to the study, Dr. Mandelson noted that a volume-outcome relationship has been established when it comes to surgery for pancreatic cancer, but not when it comes to adjuvant therapy for the disease.

She and her colleagues used registry data to identify patients who received a pancreatic cancer diagnosis during 2003-2014 and underwent primary resection at Virginia Mason Medical Center. They compared outcomes between those who stayed at the center to receive their adjuvant therapy and those who were referred to a community oncology practice to receive this therapy.

Patients were excluded if they had received neoadjuvant therapy, had synchronous cancers, died or were lost to follow-up within 3 months of surgery, or had contraindications to receiving adjuvant therapy. Also excluded were any who declined this therapy and for whom a medical oncologist could not be identified.

Results showed that the patients treated in the high-volume center and in community clinics were similar with respect to sex, insurance status, travel distance to a high-volume center, performance status, and tumor size, nodal status, and margin status, Dr. Mandelson reported. Those treated in the community were, on average, 5 years older.

At the high-volume center, 96% of patients started chemotherapy, 81% received a multiagent regimen, and 53% underwent chemoradiation. Detailed data on therapies received were not available for the community group.

The patients treated in the high-volume center had a more than one-third reduction in the adjusted risk of death relative to peers treated in the community (hazard ratio, 0.63; P less than .01). Median overall survival was 43.6 months for the former, compared with 27.9 months for the latter (P less than .01). The corresponding 5-year rates of overall survival were 38.6% and 24.8% (P less than .01).

“We know from the literature that pancreas cancer is undertreated in the community as a whole, both from the surgical perspective and the medical perspective. So it wouldn’t be surprising if some of the patients with a referral to an outside oncologist in fact never received treatment,” Dr. Mandelson commented.

“The patient population that received surgery in the community setting and then came to Virginia Mason for adjuvant therapy has not yet been analyzed, which is essentially the inverse of this study,” she noted. “That will be very powerful evidence.”

Dr. Mandelson disclosed that she had no relevant conflicts of interest. Dr. Abbruzzese disclosed that he receives honoraria from Celgene and Halozyme, and that he has a consulting or advisory role with Acerta Pharma, Bessor, Celgene, Cornerstone Pharma, Daiichi Sankyo, EMD Serono, Halozyme, Progen, Merck Sharpe & Dohme, Sun BioPharma, and Viba Therapeutics. Dr. Seiden disclosed that he is an employee of McKesson Specialty Health and Texas Oncology; that he is chief medical officer of US Oncology; and that he owns stock in and receives travel expenses from McKesson Specialty Health.

tor@frontlinemedcom.com

SAN FRANCISCO – Receiving adjuvant therapy for pancreatic cancer at a center that treats a high volume of patients with the disease confers a survival advantage, according to results of a retrospective cohort study reported at the symposium sponsored by ASCO, ASTRO, the American Gastroenterological Association, and the Society of Surgical Oncology.

The analysis of 245 patients found that those given adjuvant therapy at Virginia Mason Medical Center – a high-volume center seeing up to 300 patients with newly diagnosed pancreatic cancer each year and putting about a third of them in trials – had a 37% reduction in the adjusted risk of death when compared with peers referred to community clinics for this therapy, reported first author Margaret T. Mandelson, Ph.D., director of research and quality at the center’s cancer institute in Seattle.

Susan London/Frontline Medical News

“Our study does lend some support to the concept of using high-volume centers for all therapy components for pancreatic cancer that is treated with curative intent,” she commented. “Ongoing investigation of patterns of care and volume impact in medical oncology is certainly warranted.”

A variety of factors may be driving the observed survival difference, such as the regimens used, with some evidence suggesting, for example, that patients treated in the community are more likely to receive single-agent therapy, she noted.

“We know that we have a strong setting for supportive care [at the center] and that we try to maximize our patients’ tolerance to treatment,” she added. “We have a high rate of completion of treatment in this setting. And of course the impact of optimism and hope cannot be underestimated in this patient population.”

Giving the academic medical center perspective, Dr. James L. Abbruzzese of the Duke Cancer Institute, Duke University, Durham, N.C., speculated that volume is a proxy for processes of care: staffing, use of guidelines or treatment algorithms, staging practices, and especially a multidisciplinary approach with components such as tumor boards and use of clinical trials. And larger centers are in a better position to offer these processes.

Susan London/Frontline Medical Media

“While the primary determinant of the long-term outcome of patients requires adequate volumes, I don’t think this is the whole answer,” he summarized. “I think it relies on and relates much more to the processes and the extent to which we can bring the multidisciplinary team to the patients.”

Giving the community oncology perspective, Dr. Michael V. Seiden, chief medical officer of the US Oncology Network, contended that instead of focusing solely on outcomes, the field should be focusing on the value of care, broadly defined as outcome divided by cost.

“I don’t really think this is a discussion about should your pancreatic cancer be treated in the community or in an academic center or a large regional health center. What we have to realize is that tens of thousands of patients with pancreatic cancer who will be diagnosed in the years ahead are going to receive care across the country in a lot of different venues,” he commented. “The questions we need to answer are how do we maximize value? What should be done in the ‘mouse’ hospitals? What should be done in the gigantic centers of excellence? What should be done in the well-organized health care systems? And what should be done in the community? Because delivering maximal value requires keeping an eye not only on best outcomes, but also on patient convenience and cost.”

Giving some background to the study, Dr. Mandelson noted that a volume-outcome relationship has been established when it comes to surgery for pancreatic cancer, but not when it comes to adjuvant therapy for the disease.

She and her colleagues used registry data to identify patients who received a pancreatic cancer diagnosis during 2003-2014 and underwent primary resection at Virginia Mason Medical Center. They compared outcomes between those who stayed at the center to receive their adjuvant therapy and those who were referred to a community oncology practice to receive this therapy.

Patients were excluded if they had received neoadjuvant therapy, had synchronous cancers, died or were lost to follow-up within 3 months of surgery, or had contraindications to receiving adjuvant therapy. Also excluded were any who declined this therapy and for whom a medical oncologist could not be identified.

Results showed that the patients treated in the high-volume center and in community clinics were similar with respect to sex, insurance status, travel distance to a high-volume center, performance status, and tumor size, nodal status, and margin status, Dr. Mandelson reported. Those treated in the community were, on average, 5 years older.

At the high-volume center, 96% of patients started chemotherapy, 81% received a multiagent regimen, and 53% underwent chemoradiation. Detailed data on therapies received were not available for the community group.

The patients treated in the high-volume center had a more than one-third reduction in the adjusted risk of death relative to peers treated in the community (hazard ratio, 0.63; P less than .01). Median overall survival was 43.6 months for the former, compared with 27.9 months for the latter (P less than .01). The corresponding 5-year rates of overall survival were 38.6% and 24.8% (P less than .01).

“We know from the literature that pancreas cancer is undertreated in the community as a whole, both from the surgical perspective and the medical perspective. So it wouldn’t be surprising if some of the patients with a referral to an outside oncologist in fact never received treatment,” Dr. Mandelson commented.

“The patient population that received surgery in the community setting and then came to Virginia Mason for adjuvant therapy has not yet been analyzed, which is essentially the inverse of this study,” she noted. “That will be very powerful evidence.”

Dr. Mandelson disclosed that she had no relevant conflicts of interest. Dr. Abbruzzese disclosed that he receives honoraria from Celgene and Halozyme, and that he has a consulting or advisory role with Acerta Pharma, Bessor, Celgene, Cornerstone Pharma, Daiichi Sankyo, EMD Serono, Halozyme, Progen, Merck Sharpe & Dohme, Sun BioPharma, and Viba Therapeutics. Dr. Seiden disclosed that he is an employee of McKesson Specialty Health and Texas Oncology; that he is chief medical officer of US Oncology; and that he owns stock in and receives travel expenses from McKesson Specialty Health.

tor@frontlinemedcom.com

Background Effective palliation in patients with locally advanced head and neck cancer is important. Cyclical hypofractionated radiotherapy (Quad Shot) is a short-course palliative regimen with good patient compliance, low rates of acute toxicity, and delayed late fibrosis.

Objective To review use of the Quad Shot technique at our institution in order to quantify the palliative response in locally advanced head and neck cancer.

Methods The medical records of 70 patients with head and neck squamous cell carcinoma who had been treated with the Quad Shot technique were analyzed retrospectively (36 had been treated with intensity-modulated radiation therapy and 34 with 3-D conformal radiotherapy). They had received cyclical hypofractionated radiotherapy administrated as 14.8 Gy in 4 fractions over 2 days, twice daily, repeated every 3 weeks for a total of 3 cycles. The total prescribed dose was 44.4 Gy. Primary endpoints were improvement in pain using a verbal numeric pain rating scale (range 1-10, 10 being severe pain) and dysphagia using the Food Intake Level Scale, and the secondary endpoints included overall survival (OS), local regional recurrence-free survival (LRRFS), progression-free survival (PFS) and time to progression.

Results Pain response occurred in 61% of the patients. The mean pain scores decreased significantly from pre to post treatment (5.81 to 2.55, P = .009). The mean initial dysphagia score improved from 2.20 to 4.77 55 (P = .045). 26% of patients developed mucositis (≤ grade 2), with 9% developing grade 3-level mucositis. 12 patients had tumor recurrence. The estimated 1-year PFS was 20.7%. The median survival was 3.85 months with an estimated 1-year OS of 22.6%. Pain response (hazard ratio [HR], 2.69; 95% confidence index [CI], I.552-1.77) and completion of all 3 cycles (HR, 1.71; 95% CI, 1.003-2.907) were predictive for improved OS.

Limitations This study is a retrospective analysis.

Conclusion Quad Shot is an appropriate palliative regimen for locally advanced head and neck cancer.

Click on the PDF icon at the top of this introduction to read the full article.

Background Effective palliation in patients with locally advanced head and neck cancer is important. Cyclical hypofractionated radiotherapy (Quad Shot) is a short-course palliative regimen with good patient compliance, low rates of acute toxicity, and delayed late fibrosis.

Objective To review use of the Quad Shot technique at our institution in order to quantify the palliative response in locally advanced head and neck cancer.

Methods The medical records of 70 patients with head and neck squamous cell carcinoma who had been treated with the Quad Shot technique were analyzed retrospectively (36 had been treated with intensity-modulated radiation therapy and 34 with 3-D conformal radiotherapy). They had received cyclical hypofractionated radiotherapy administrated as 14.8 Gy in 4 fractions over 2 days, twice daily, repeated every 3 weeks for a total of 3 cycles. The total prescribed dose was 44.4 Gy. Primary endpoints were improvement in pain using a verbal numeric pain rating scale (range 1-10, 10 being severe pain) and dysphagia using the Food Intake Level Scale, and the secondary endpoints included overall survival (OS), local regional recurrence-free survival (LRRFS), progression-free survival (PFS) and time to progression.

Results Pain response occurred in 61% of the patients. The mean pain scores decreased significantly from pre to post treatment (5.81 to 2.55, P = .009). The mean initial dysphagia score improved from 2.20 to 4.77 55 (P = .045). 26% of patients developed mucositis (≤ grade 2), with 9% developing grade 3-level mucositis. 12 patients had tumor recurrence. The estimated 1-year PFS was 20.7%. The median survival was 3.85 months with an estimated 1-year OS of 22.6%. Pain response (hazard ratio [HR], 2.69; 95% confidence index [CI], I.552-1.77) and completion of all 3 cycles (HR, 1.71; 95% CI, 1.003-2.907) were predictive for improved OS.

Limitations This study is a retrospective analysis.

Conclusion Quad Shot is an appropriate palliative regimen for locally advanced head and neck cancer.

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Background Effective palliation in patients with locally advanced head and neck cancer is important. Cyclical hypofractionated radiotherapy (Quad Shot) is a short-course palliative regimen with good patient compliance, low rates of acute toxicity, and delayed late fibrosis.

Objective To review use of the Quad Shot technique at our institution in order to quantify the palliative response in locally advanced head and neck cancer.

Methods The medical records of 70 patients with head and neck squamous cell carcinoma who had been treated with the Quad Shot technique were analyzed retrospectively (36 had been treated with intensity-modulated radiation therapy and 34 with 3-D conformal radiotherapy). They had received cyclical hypofractionated radiotherapy administrated as 14.8 Gy in 4 fractions over 2 days, twice daily, repeated every 3 weeks for a total of 3 cycles. The total prescribed dose was 44.4 Gy. Primary endpoints were improvement in pain using a verbal numeric pain rating scale (range 1-10, 10 being severe pain) and dysphagia using the Food Intake Level Scale, and the secondary endpoints included overall survival (OS), local regional recurrence-free survival (LRRFS), progression-free survival (PFS) and time to progression.

Results Pain response occurred in 61% of the patients. The mean pain scores decreased significantly from pre to post treatment (5.81 to 2.55, P = .009). The mean initial dysphagia score improved from 2.20 to 4.77 55 (P = .045). 26% of patients developed mucositis (≤ grade 2), with 9% developing grade 3-level mucositis. 12 patients had tumor recurrence. The estimated 1-year PFS was 20.7%. The median survival was 3.85 months with an estimated 1-year OS of 22.6%. Pain response (hazard ratio [HR], 2.69; 95% confidence index [CI], I.552-1.77) and completion of all 3 cycles (HR, 1.71; 95% CI, 1.003-2.907) were predictive for improved OS.

Limitations This study is a retrospective analysis.

Conclusion Quad Shot is an appropriate palliative regimen for locally advanced head and neck cancer.

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In his January podcast for The Journal of Community and Supportive Oncology, Editor-in-Chief Dr David Henry discusses a Commentary by Dr Thomas Strouse on the use on cannabinoids in the cancer treatment setting and a Community Translations article on the recent approval of idarucizumab as the first specific oral anticoagulant reversal agent. Also included in the line-up are two Review articles, one on new therapies for antiemetic prophylaxis for chemotherapy-induced nausea and vomiting and another on the management of epidermal growth factor receptor inhibitor-associated rash; and Original Reports on cyclical hypofractionated radiotherapy for palliative treatment in locally advanced head and neck cancer and on the impact of surgery for early-stage non-small-cell lung cancer on patient quality of life.

Listen to the podcast below.

In his January podcast for The Journal of Community and Supportive Oncology, Editor-in-Chief Dr David Henry discusses a Commentary by Dr Thomas Strouse on the use on cannabinoids in the cancer treatment setting and a Community Translations article on the recent approval of idarucizumab as the first specific oral anticoagulant reversal agent. Also included in the line-up are two Review articles, one on new therapies for antiemetic prophylaxis for chemotherapy-induced nausea and vomiting and another on the management of epidermal growth factor receptor inhibitor-associated rash; and Original Reports on cyclical hypofractionated radiotherapy for palliative treatment in locally advanced head and neck cancer and on the impact of surgery for early-stage non-small-cell lung cancer on patient quality of life.

Listen to the podcast below.

In his January podcast for The Journal of Community and Supportive Oncology, Editor-in-Chief Dr David Henry discusses a Commentary by Dr Thomas Strouse on the use on cannabinoids in the cancer treatment setting and a Community Translations article on the recent approval of idarucizumab as the first specific oral anticoagulant reversal agent. Also included in the line-up are two Review articles, one on new therapies for antiemetic prophylaxis for chemotherapy-induced nausea and vomiting and another on the management of epidermal growth factor receptor inhibitor-associated rash; and Original Reports on cyclical hypofractionated radiotherapy for palliative treatment in locally advanced head and neck cancer and on the impact of surgery for early-stage non-small-cell lung cancer on patient quality of life.

Listen to the podcast below.

Background There is a paucity of literature comparing quality of life (QoL) before and after surgery in stage IA lung cancer, where surgical resection is the recommended curative treatment.

Objective To assess the impact of surgery on physical and mental health-related QoL in patients with stage IA lung cancer treated with surgical resection.

Methods Participants in the I-ELCAP cohort who were diagnosed with their first primary pathologic stage IA non-small-cell lung cancer, underwent surgery, and provided follow-up information on QoL 1 year later were included in the present analysis (N = 107). QoL information was collected using the SF-12 (12-item Short Form Health Survey), which generates 2 component scores related to mental health and physical health.

Results Statistical analyses indicated that physical health QoL was significantly worsened from before surgery to after surgery, whereas mental health QoL marginally improved from before to after surgery. Physical health QoL worsened for women from baseline to follow-up, but not for men. Only lobectomy (not limited resection) had an impact on QoL from before to after surgery.

Limitations Results are considered preliminary given the small sample size and multiple comparisons.

Conclusions The current study findings have implications for lung cancer health care professionals in regard to how they can most effectively present the possible impact of surgery on quality of life to this subset of patients in which disease has not yet significantly progressed.

Funding/sponsorship Gift from Sonia Lasry Gardner, in memory of her father, Moise Lasry. 

Click on the PDF icon at the top of this introduction to read the full article.

Background There is a paucity of literature comparing quality of life (QoL) before and after surgery in stage IA lung cancer, where surgical resection is the recommended curative treatment.

Objective To assess the impact of surgery on physical and mental health-related QoL in patients with stage IA lung cancer treated with surgical resection.

Methods Participants in the I-ELCAP cohort who were diagnosed with their first primary pathologic stage IA non-small-cell lung cancer, underwent surgery, and provided follow-up information on QoL 1 year later were included in the present analysis (N = 107). QoL information was collected using the SF-12 (12-item Short Form Health Survey), which generates 2 component scores related to mental health and physical health.

Results Statistical analyses indicated that physical health QoL was significantly worsened from before surgery to after surgery, whereas mental health QoL marginally improved from before to after surgery. Physical health QoL worsened for women from baseline to follow-up, but not for men. Only lobectomy (not limited resection) had an impact on QoL from before to after surgery.

Limitations Results are considered preliminary given the small sample size and multiple comparisons.

Conclusions The current study findings have implications for lung cancer health care professionals in regard to how they can most effectively present the possible impact of surgery on quality of life to this subset of patients in which disease has not yet significantly progressed.

Funding/sponsorship Gift from Sonia Lasry Gardner, in memory of her father, Moise Lasry. 

Click on the PDF icon at the top of this introduction to read the full article.

Background There is a paucity of literature comparing quality of life (QoL) before and after surgery in stage IA lung cancer, where surgical resection is the recommended curative treatment.

Objective To assess the impact of surgery on physical and mental health-related QoL in patients with stage IA lung cancer treated with surgical resection.

Methods Participants in the I-ELCAP cohort who were diagnosed with their first primary pathologic stage IA non-small-cell lung cancer, underwent surgery, and provided follow-up information on QoL 1 year later were included in the present analysis (N = 107). QoL information was collected using the SF-12 (12-item Short Form Health Survey), which generates 2 component scores related to mental health and physical health.

Results Statistical analyses indicated that physical health QoL was significantly worsened from before surgery to after surgery, whereas mental health QoL marginally improved from before to after surgery. Physical health QoL worsened for women from baseline to follow-up, but not for men. Only lobectomy (not limited resection) had an impact on QoL from before to after surgery.

Limitations Results are considered preliminary given the small sample size and multiple comparisons.

Conclusions The current study findings have implications for lung cancer health care professionals in regard to how they can most effectively present the possible impact of surgery on quality of life to this subset of patients in which disease has not yet significantly progressed.

Funding/sponsorship Gift from Sonia Lasry Gardner, in memory of her father, Moise Lasry. 

Click on the PDF icon at the top of this introduction to read the full article.