Three of the Vascular Annual Meeting’s signature events – celebrations along with distinguished lectures – occur on Saturday, VAM’s closing day. All conveniently occur in the morning, shortly before the start of the SVS Annual Business Meeting and luncheon and take place in Potomac A/B.

The John Homans Lecture, 9:30 to 10 a.m.: Jack Cronenwett, MD, Dartmouth-Hitchcock Medical Center, Lebanon, N.H., will present the lecture, “Why Should I Join the Vascular Quality Initiative?” Dr. Cronenwett spearheaded a regional quality outcomes registry, the eventual model for VQI. He later helped launch the SVS-Patient Safety Organization, which operates VQI and served as medical director until 2016. Dr. Cronenwett will discuss the VQI’s benefits for vascular practitioners and examine the VQI’s research and quality improvement opportunities. 

The Roy Greenberg Distinguished Lecture, 10:15 to 10:45 a.m.: Michael Dake, MD, professor at Stanford (Calif.) University, will present “The Vision Beyond the Vision: Same as it Ever Was, but Different.” Dr. Dake is an internationally recognized pioneer of image-guided therapies whose contributions have changed the treatment of both common and complex vascular disease issues. His groundbreaking research with CT angiography, endovascular stents and stent-grafts has forever altered the interventional landscape and his publications have dramatically influenced several fields, including vascular imaging. 

Awards Ceremony, 10 to 10:15 a.m.: Who will win two of the SVS’s top honors? Attendees will find out at the Awards Ceremony, during which the Lifetime Achievement Award AND the Medal for Innovation in Vascular Surgery will be presented. 

The Lifetime Achievement Award recognizes an individual’s outstanding and sustained contributions to the profession and SVS, and his or her exemplary professional practice and leadership. The 2018 recipient was Gregorio Sicard, MD. 

The Medal for Innovation is not an annual award; it recognizes individual whose contributions have had a transforming impact on the practice or science of vascular surgery. Past recipients include Juan Parodi, MD (2006); Timothy Chuter, MD (2008); Thomas Fogarty, MD (2010); Roy Greenberg, MD (2012); and, most recently, Edward Diethrich, MD (2013).

The identities of these two recipients are a closely guarded secret until the presentation. Be part of the unveiling and celebration.

Three of the Vascular Annual Meeting’s signature events – celebrations along with distinguished lectures – occur on Saturday, VAM’s closing day. All conveniently occur in the morning, shortly before the start of the SVS Annual Business Meeting and luncheon and take place in Potomac A/B.

The John Homans Lecture, 9:30 to 10 a.m.: Jack Cronenwett, MD, Dartmouth-Hitchcock Medical Center, Lebanon, N.H., will present the lecture, “Why Should I Join the Vascular Quality Initiative?” Dr. Cronenwett spearheaded a regional quality outcomes registry, the eventual model for VQI. He later helped launch the SVS-Patient Safety Organization, which operates VQI and served as medical director until 2016. Dr. Cronenwett will discuss the VQI’s benefits for vascular practitioners and examine the VQI’s research and quality improvement opportunities. 

The Roy Greenberg Distinguished Lecture, 10:15 to 10:45 a.m.: Michael Dake, MD, professor at Stanford (Calif.) University, will present “The Vision Beyond the Vision: Same as it Ever Was, but Different.” Dr. Dake is an internationally recognized pioneer of image-guided therapies whose contributions have changed the treatment of both common and complex vascular disease issues. His groundbreaking research with CT angiography, endovascular stents and stent-grafts has forever altered the interventional landscape and his publications have dramatically influenced several fields, including vascular imaging. 

Awards Ceremony, 10 to 10:15 a.m.: Who will win two of the SVS’s top honors? Attendees will find out at the Awards Ceremony, during which the Lifetime Achievement Award AND the Medal for Innovation in Vascular Surgery will be presented. 

The Lifetime Achievement Award recognizes an individual’s outstanding and sustained contributions to the profession and SVS, and his or her exemplary professional practice and leadership. The 2018 recipient was Gregorio Sicard, MD. 

The Medal for Innovation is not an annual award; it recognizes individual whose contributions have had a transforming impact on the practice or science of vascular surgery. Past recipients include Juan Parodi, MD (2006); Timothy Chuter, MD (2008); Thomas Fogarty, MD (2010); Roy Greenberg, MD (2012); and, most recently, Edward Diethrich, MD (2013).

The identities of these two recipients are a closely guarded secret until the presentation. Be part of the unveiling and celebration.

Three of the Vascular Annual Meeting’s signature events – celebrations along with distinguished lectures – occur on Saturday, VAM’s closing day. All conveniently occur in the morning, shortly before the start of the SVS Annual Business Meeting and luncheon and take place in Potomac A/B.

The John Homans Lecture, 9:30 to 10 a.m.: Jack Cronenwett, MD, Dartmouth-Hitchcock Medical Center, Lebanon, N.H., will present the lecture, “Why Should I Join the Vascular Quality Initiative?” Dr. Cronenwett spearheaded a regional quality outcomes registry, the eventual model for VQI. He later helped launch the SVS-Patient Safety Organization, which operates VQI and served as medical director until 2016. Dr. Cronenwett will discuss the VQI’s benefits for vascular practitioners and examine the VQI’s research and quality improvement opportunities. 

The Roy Greenberg Distinguished Lecture, 10:15 to 10:45 a.m.: Michael Dake, MD, professor at Stanford (Calif.) University, will present “The Vision Beyond the Vision: Same as it Ever Was, but Different.” Dr. Dake is an internationally recognized pioneer of image-guided therapies whose contributions have changed the treatment of both common and complex vascular disease issues. His groundbreaking research with CT angiography, endovascular stents and stent-grafts has forever altered the interventional landscape and his publications have dramatically influenced several fields, including vascular imaging. 

Awards Ceremony, 10 to 10:15 a.m.: Who will win two of the SVS’s top honors? Attendees will find out at the Awards Ceremony, during which the Lifetime Achievement Award AND the Medal for Innovation in Vascular Surgery will be presented. 

The Lifetime Achievement Award recognizes an individual’s outstanding and sustained contributions to the profession and SVS, and his or her exemplary professional practice and leadership. The 2018 recipient was Gregorio Sicard, MD. 

The Medal for Innovation is not an annual award; it recognizes individual whose contributions have had a transforming impact on the practice or science of vascular surgery. Past recipients include Juan Parodi, MD (2006); Timothy Chuter, MD (2008); Thomas Fogarty, MD (2010); Roy Greenberg, MD (2012); and, most recently, Edward Diethrich, MD (2013).

The identities of these two recipients are a closely guarded secret until the presentation. Be part of the unveiling and celebration.

CHICAGO – Adding isatuximab, an anti-CD38 monoclonal antibody, to pomalidomide and dexamethasone can prolong progression-free survival (PFS) in patients with relapsed/refractory multiple myeloma, a phase 3 trial suggests.

The median PFS was 11.53 months among patients who received isatuximab (isa) plus pomalidomide and dexamethasone (Pd), compared with 6.47 months in patients who received Pd alone (P = .001).

“[W]e now have the first randomized, phase 3 study demonstrating a significant prolonged PFS benefit of CD38 targeting combined with pomalidomide and dexamethasone in relapsed/refractory myeloma,” said Paul Richardson, MD, of the Dana-Farber Cancer Institute in Boston.

“The PFS was the longest observed in this population to date ..., and ... this PFS benefit was consistent among subgroups.”

Dr. Richardson presented these results from the ICARIA-MM trial at the annual meeting of the American Society of Clinical Oncology.

Researchers enrolled 307 patients with relapsed/refractory multiple myeloma. The patients had a median age of 67 years (range, 36-86 years) and a median time from diagnosis of 4.23 years (range, 0.5-20.5 years).

The patients had received a median of three prior therapies (range, 2-11 for the isa-Pd arm and 2-10 for the Pd arm). All patients had previously received a proteasome inhibitor and an immunomodulatory agent.

The patients received isatuximab at 10 mg/kg on days 1, 8, 15, and 22 in cycle 1, then on days 1 and 15 for subsequent cycles. Pomalidomide and dexamethasone were given at standard doses in both treatment arms.

At a median follow-up of 11.6 months, 42.2% of patients were still receiving isa-Pd, and 22.9% of patients were still on Pd alone. The most common reason for stopping either treatment was disease progression (42.9% in the isa-Pd arm and 57.5% in the Pd arm).

Efficacy

The overall response rate was 60.4% in the isa-Pd arm and 35.3% in the Pd arm (P less than .0001). The rates of complete response/stringent complete response were 4.5% and 2.0%, respectively. The rates of minimal residual disease negativity were 5.2% and 0%, respectively.

The median time to next treatment was 9.1 months in the Pd arm and was not reached in the isa-Pd arm (hazard ratio, 0.538).

The median PFS was 11.53 months in the isa-Pd arm and 6.47 months in the Pd arm (HR, 0.596; P = .001). There was a PFS benefit with isa-Pd across subgroups, including in patients with renal dysfunction, those with high-risk cytogenetics, and patients who were refractory to lenalidomide.

The median overall survival was not reached in either treatment arm. The overall survival rate was 72% in the isa-Pd arm and 63% in the Pd arm (HR, 0.687).

Safety

There were more grade 3 or higher treatment-emergent adverse events (TEAEs) with isa-Pd. However, as Dr. Richardson noted, adding isa to Pd did not increase the rates of TEAEs leading to treatment discontinuation or death.

The incidence of grade 3 or higher TEAEs was 86.8% in the isa-Pd arm and 70.5% in the Pd arm. The rate of serious TEAEs was 61.8% and 53.7%, respectively.

TEAEs leading to treatment discontinuation occurred in 7.2% of patients in the isa-Pd arm and 12.8% in the Pd arm. TEAEs leading to death occurred in 7.9% and 9.4%, respectively.

Grade 3 TEAEs (in the isa-Pd and Pd arms, respectively) included upper respiratory tract infection (3.3% and 0.7%), diarrhea (2.0% and 0.7%), bronchitis (3.3% and 0.7%), pneumonia (15.1% and 13.4%), fatigue (3.9% and 0%), back pain (2.0% and 1.3%), asthenia (3.3% and 2.7%), and dyspnea (3.9% and 1.3%).

The only grade 4 TEAE was pneumonia (1.3% in both arms).

Based on the safety and efficacy results, Dr. Richardson concluded that isa-Pd “is an important new treatment option for our patients with relapsed/refractory myeloma.”

This study was funded by Sanofi. Dr. Richardson reported financial relationships with Celgene, Janssen, and Takeda. His coinvestigators reported relationships with a range of companies.

jensmith@mdedge.com

SOURCE: Richardson P et al. ASCO 2019, Abstract 8004.

CHICAGO – Adding isatuximab, an anti-CD38 monoclonal antibody, to pomalidomide and dexamethasone can prolong progression-free survival (PFS) in patients with relapsed/refractory multiple myeloma, a phase 3 trial suggests.

The median PFS was 11.53 months among patients who received isatuximab (isa) plus pomalidomide and dexamethasone (Pd), compared with 6.47 months in patients who received Pd alone (P = .001).

“[W]e now have the first randomized, phase 3 study demonstrating a significant prolonged PFS benefit of CD38 targeting combined with pomalidomide and dexamethasone in relapsed/refractory myeloma,” said Paul Richardson, MD, of the Dana-Farber Cancer Institute in Boston.

“The PFS was the longest observed in this population to date ..., and ... this PFS benefit was consistent among subgroups.”

Dr. Richardson presented these results from the ICARIA-MM trial at the annual meeting of the American Society of Clinical Oncology.

Researchers enrolled 307 patients with relapsed/refractory multiple myeloma. The patients had a median age of 67 years (range, 36-86 years) and a median time from diagnosis of 4.23 years (range, 0.5-20.5 years).

The patients had received a median of three prior therapies (range, 2-11 for the isa-Pd arm and 2-10 for the Pd arm). All patients had previously received a proteasome inhibitor and an immunomodulatory agent.

The patients received isatuximab at 10 mg/kg on days 1, 8, 15, and 22 in cycle 1, then on days 1 and 15 for subsequent cycles. Pomalidomide and dexamethasone were given at standard doses in both treatment arms.

At a median follow-up of 11.6 months, 42.2% of patients were still receiving isa-Pd, and 22.9% of patients were still on Pd alone. The most common reason for stopping either treatment was disease progression (42.9% in the isa-Pd arm and 57.5% in the Pd arm).

Efficacy

The overall response rate was 60.4% in the isa-Pd arm and 35.3% in the Pd arm (P less than .0001). The rates of complete response/stringent complete response were 4.5% and 2.0%, respectively. The rates of minimal residual disease negativity were 5.2% and 0%, respectively.

The median time to next treatment was 9.1 months in the Pd arm and was not reached in the isa-Pd arm (hazard ratio, 0.538).

The median PFS was 11.53 months in the isa-Pd arm and 6.47 months in the Pd arm (HR, 0.596; P = .001). There was a PFS benefit with isa-Pd across subgroups, including in patients with renal dysfunction, those with high-risk cytogenetics, and patients who were refractory to lenalidomide.

The median overall survival was not reached in either treatment arm. The overall survival rate was 72% in the isa-Pd arm and 63% in the Pd arm (HR, 0.687).

Safety

There were more grade 3 or higher treatment-emergent adverse events (TEAEs) with isa-Pd. However, as Dr. Richardson noted, adding isa to Pd did not increase the rates of TEAEs leading to treatment discontinuation or death.

The incidence of grade 3 or higher TEAEs was 86.8% in the isa-Pd arm and 70.5% in the Pd arm. The rate of serious TEAEs was 61.8% and 53.7%, respectively.

TEAEs leading to treatment discontinuation occurred in 7.2% of patients in the isa-Pd arm and 12.8% in the Pd arm. TEAEs leading to death occurred in 7.9% and 9.4%, respectively.

Grade 3 TEAEs (in the isa-Pd and Pd arms, respectively) included upper respiratory tract infection (3.3% and 0.7%), diarrhea (2.0% and 0.7%), bronchitis (3.3% and 0.7%), pneumonia (15.1% and 13.4%), fatigue (3.9% and 0%), back pain (2.0% and 1.3%), asthenia (3.3% and 2.7%), and dyspnea (3.9% and 1.3%).

The only grade 4 TEAE was pneumonia (1.3% in both arms).

Based on the safety and efficacy results, Dr. Richardson concluded that isa-Pd “is an important new treatment option for our patients with relapsed/refractory myeloma.”

This study was funded by Sanofi. Dr. Richardson reported financial relationships with Celgene, Janssen, and Takeda. His coinvestigators reported relationships with a range of companies.

jensmith@mdedge.com

SOURCE: Richardson P et al. ASCO 2019, Abstract 8004.

CHICAGO – Adding isatuximab, an anti-CD38 monoclonal antibody, to pomalidomide and dexamethasone can prolong progression-free survival (PFS) in patients with relapsed/refractory multiple myeloma, a phase 3 trial suggests.

The median PFS was 11.53 months among patients who received isatuximab (isa) plus pomalidomide and dexamethasone (Pd), compared with 6.47 months in patients who received Pd alone (P = .001).

“[W]e now have the first randomized, phase 3 study demonstrating a significant prolonged PFS benefit of CD38 targeting combined with pomalidomide and dexamethasone in relapsed/refractory myeloma,” said Paul Richardson, MD, of the Dana-Farber Cancer Institute in Boston.

“The PFS was the longest observed in this population to date ..., and ... this PFS benefit was consistent among subgroups.”

Dr. Richardson presented these results from the ICARIA-MM trial at the annual meeting of the American Society of Clinical Oncology.

Researchers enrolled 307 patients with relapsed/refractory multiple myeloma. The patients had a median age of 67 years (range, 36-86 years) and a median time from diagnosis of 4.23 years (range, 0.5-20.5 years).

The patients had received a median of three prior therapies (range, 2-11 for the isa-Pd arm and 2-10 for the Pd arm). All patients had previously received a proteasome inhibitor and an immunomodulatory agent.

The patients received isatuximab at 10 mg/kg on days 1, 8, 15, and 22 in cycle 1, then on days 1 and 15 for subsequent cycles. Pomalidomide and dexamethasone were given at standard doses in both treatment arms.

At a median follow-up of 11.6 months, 42.2% of patients were still receiving isa-Pd, and 22.9% of patients were still on Pd alone. The most common reason for stopping either treatment was disease progression (42.9% in the isa-Pd arm and 57.5% in the Pd arm).

Efficacy

The overall response rate was 60.4% in the isa-Pd arm and 35.3% in the Pd arm (P less than .0001). The rates of complete response/stringent complete response were 4.5% and 2.0%, respectively. The rates of minimal residual disease negativity were 5.2% and 0%, respectively.

The median time to next treatment was 9.1 months in the Pd arm and was not reached in the isa-Pd arm (hazard ratio, 0.538).

The median PFS was 11.53 months in the isa-Pd arm and 6.47 months in the Pd arm (HR, 0.596; P = .001). There was a PFS benefit with isa-Pd across subgroups, including in patients with renal dysfunction, those with high-risk cytogenetics, and patients who were refractory to lenalidomide.

The median overall survival was not reached in either treatment arm. The overall survival rate was 72% in the isa-Pd arm and 63% in the Pd arm (HR, 0.687).

Safety

There were more grade 3 or higher treatment-emergent adverse events (TEAEs) with isa-Pd. However, as Dr. Richardson noted, adding isa to Pd did not increase the rates of TEAEs leading to treatment discontinuation or death.

The incidence of grade 3 or higher TEAEs was 86.8% in the isa-Pd arm and 70.5% in the Pd arm. The rate of serious TEAEs was 61.8% and 53.7%, respectively.

TEAEs leading to treatment discontinuation occurred in 7.2% of patients in the isa-Pd arm and 12.8% in the Pd arm. TEAEs leading to death occurred in 7.9% and 9.4%, respectively.

Grade 3 TEAEs (in the isa-Pd and Pd arms, respectively) included upper respiratory tract infection (3.3% and 0.7%), diarrhea (2.0% and 0.7%), bronchitis (3.3% and 0.7%), pneumonia (15.1% and 13.4%), fatigue (3.9% and 0%), back pain (2.0% and 1.3%), asthenia (3.3% and 2.7%), and dyspnea (3.9% and 1.3%).

The only grade 4 TEAE was pneumonia (1.3% in both arms).

Based on the safety and efficacy results, Dr. Richardson concluded that isa-Pd “is an important new treatment option for our patients with relapsed/refractory myeloma.”

This study was funded by Sanofi. Dr. Richardson reported financial relationships with Celgene, Janssen, and Takeda. His coinvestigators reported relationships with a range of companies.

jensmith@mdedge.com

SOURCE: Richardson P et al. ASCO 2019, Abstract 8004.

CHICAGO – Targeted neoadjuvant therapy with trastuzumab emtansine (T-DM1) had similar efficacy with less toxicity, compared with a standard chemotherapy–based regimen for patients with HER2- and hormone receptor–positive breast cancers in the phase 2 Swedish PREDIX HER2 trial.

Sharon Worcester/MDedge News

The pathologic complete response (pCR) rate was 45% among 98 participants who were randomized to received T-DM1, and 47% in those randomized to receive docetaxel, trastuzumab, and pertuzumab (DTP), Jonas C.S. Bergh, MD, PhD, reported at the annual meeting of the American Society of Clinical Oncology.

The pCR rate in hormone receptor(HR) –positive tumors was 36% in both groups, and the rates in HR-negative tumors were 59% and 67% in the T-DM1 and DTP arms, respectively; any differences in pCR rates between the groups were not statistically significant, said Dr. Bergh of the Karolinska Institute and University Hospital, Stockholm.

Patients were adults with HER2-positive breast cancer and tumor size greater than 20 mm or verified lymph node metastases at enrollment, and 62.6% of tumors were HR positive. Both treatment arms received their assigned therapy every 3 weeks for a planned total of six courses, but the protocol allowed a switch to the competing treatment upon progression, lack of response, or drug-related severe toxicity. All received postoperative epirubicin+cyclophosphamide every 3 weeks, with the T-DM1 arm receiving 4 courses and the DTP arm receiving 2 courses, and both arms also received adjuvant trastuzumab for 11 courses.

Age (median of 52 years), menopausal status, and histological type and grade were well balanced between the treatment groups.


Grade 3/4 adverse events occurred on 63 occasions in the DTP arm, compared with 10 in the T-DM1 arm; febrile neutropenia accounted for 26 and 3 of the events in the groups, respectively. All events, with the exception of liver toxicity, occurred more frequently in the DTP arm, Dr. Bergh said.

Ultimately, 9 patients switched from T-DM1 to DTP – 7 for progression or lack of response and 2 because of toxicity, and 18 switched from DTP to T-DM1 because of either progression or lack of response, and 14 because of toxicity. One patient in each group achieved pCR after switching, he noted.

“There was clearly better quality of life [during the study] for the T-DM1 group,” he added, noting that the quality of life data were reported separately at the meeting.

Additionally, an exploratory analysis demonstrated an early steep decrease of F-FDG uptake, suggesting that PET/CT may be a useful tool for predicting pCR.

Although neoadjuvant therapy produces high pCR rates and is the standard of care in HER2 positive breast cancer, the optimal treatment regimen remains to be established; but the current findings, along with prior data showing efficacy with T-DM1 in patients who fail to respond to two or more lines of anti-HER2 therapies, suggest it is a potential new standard for neoadjuvant therapy, particularly for patients with HER2- and HR-positive disease, he concluded.

Dr. Bergh reported a financial relationship with UpToDate, and research funding to his institution from Amgen, AstraZeneca, Bayer, Merck, Pfizer, Roche, and Sanofi.

SOURCE: Bergh J et al. ASCO 2019, Abstract 501.

CHICAGO – Targeted neoadjuvant therapy with trastuzumab emtansine (T-DM1) had similar efficacy with less toxicity, compared with a standard chemotherapy–based regimen for patients with HER2- and hormone receptor–positive breast cancers in the phase 2 Swedish PREDIX HER2 trial.

Sharon Worcester/MDedge News

The pathologic complete response (pCR) rate was 45% among 98 participants who were randomized to received T-DM1, and 47% in those randomized to receive docetaxel, trastuzumab, and pertuzumab (DTP), Jonas C.S. Bergh, MD, PhD, reported at the annual meeting of the American Society of Clinical Oncology.

The pCR rate in hormone receptor(HR) –positive tumors was 36% in both groups, and the rates in HR-negative tumors were 59% and 67% in the T-DM1 and DTP arms, respectively; any differences in pCR rates between the groups were not statistically significant, said Dr. Bergh of the Karolinska Institute and University Hospital, Stockholm.

Patients were adults with HER2-positive breast cancer and tumor size greater than 20 mm or verified lymph node metastases at enrollment, and 62.6% of tumors were HR positive. Both treatment arms received their assigned therapy every 3 weeks for a planned total of six courses, but the protocol allowed a switch to the competing treatment upon progression, lack of response, or drug-related severe toxicity. All received postoperative epirubicin+cyclophosphamide every 3 weeks, with the T-DM1 arm receiving 4 courses and the DTP arm receiving 2 courses, and both arms also received adjuvant trastuzumab for 11 courses.

Age (median of 52 years), menopausal status, and histological type and grade were well balanced between the treatment groups.


Grade 3/4 adverse events occurred on 63 occasions in the DTP arm, compared with 10 in the T-DM1 arm; febrile neutropenia accounted for 26 and 3 of the events in the groups, respectively. All events, with the exception of liver toxicity, occurred more frequently in the DTP arm, Dr. Bergh said.

Ultimately, 9 patients switched from T-DM1 to DTP – 7 for progression or lack of response and 2 because of toxicity, and 18 switched from DTP to T-DM1 because of either progression or lack of response, and 14 because of toxicity. One patient in each group achieved pCR after switching, he noted.

“There was clearly better quality of life [during the study] for the T-DM1 group,” he added, noting that the quality of life data were reported separately at the meeting.

Additionally, an exploratory analysis demonstrated an early steep decrease of F-FDG uptake, suggesting that PET/CT may be a useful tool for predicting pCR.

Although neoadjuvant therapy produces high pCR rates and is the standard of care in HER2 positive breast cancer, the optimal treatment regimen remains to be established; but the current findings, along with prior data showing efficacy with T-DM1 in patients who fail to respond to two or more lines of anti-HER2 therapies, suggest it is a potential new standard for neoadjuvant therapy, particularly for patients with HER2- and HR-positive disease, he concluded.

Dr. Bergh reported a financial relationship with UpToDate, and research funding to his institution from Amgen, AstraZeneca, Bayer, Merck, Pfizer, Roche, and Sanofi.

SOURCE: Bergh J et al. ASCO 2019, Abstract 501.

CHICAGO – Targeted neoadjuvant therapy with trastuzumab emtansine (T-DM1) had similar efficacy with less toxicity, compared with a standard chemotherapy–based regimen for patients with HER2- and hormone receptor–positive breast cancers in the phase 2 Swedish PREDIX HER2 trial.

Sharon Worcester/MDedge News

The pathologic complete response (pCR) rate was 45% among 98 participants who were randomized to received T-DM1, and 47% in those randomized to receive docetaxel, trastuzumab, and pertuzumab (DTP), Jonas C.S. Bergh, MD, PhD, reported at the annual meeting of the American Society of Clinical Oncology.

The pCR rate in hormone receptor(HR) –positive tumors was 36% in both groups, and the rates in HR-negative tumors were 59% and 67% in the T-DM1 and DTP arms, respectively; any differences in pCR rates between the groups were not statistically significant, said Dr. Bergh of the Karolinska Institute and University Hospital, Stockholm.

Patients were adults with HER2-positive breast cancer and tumor size greater than 20 mm or verified lymph node metastases at enrollment, and 62.6% of tumors were HR positive. Both treatment arms received their assigned therapy every 3 weeks for a planned total of six courses, but the protocol allowed a switch to the competing treatment upon progression, lack of response, or drug-related severe toxicity. All received postoperative epirubicin+cyclophosphamide every 3 weeks, with the T-DM1 arm receiving 4 courses and the DTP arm receiving 2 courses, and both arms also received adjuvant trastuzumab for 11 courses.

Age (median of 52 years), menopausal status, and histological type and grade were well balanced between the treatment groups.


Grade 3/4 adverse events occurred on 63 occasions in the DTP arm, compared with 10 in the T-DM1 arm; febrile neutropenia accounted for 26 and 3 of the events in the groups, respectively. All events, with the exception of liver toxicity, occurred more frequently in the DTP arm, Dr. Bergh said.

Ultimately, 9 patients switched from T-DM1 to DTP – 7 for progression or lack of response and 2 because of toxicity, and 18 switched from DTP to T-DM1 because of either progression or lack of response, and 14 because of toxicity. One patient in each group achieved pCR after switching, he noted.

“There was clearly better quality of life [during the study] for the T-DM1 group,” he added, noting that the quality of life data were reported separately at the meeting.

Additionally, an exploratory analysis demonstrated an early steep decrease of F-FDG uptake, suggesting that PET/CT may be a useful tool for predicting pCR.

Although neoadjuvant therapy produces high pCR rates and is the standard of care in HER2 positive breast cancer, the optimal treatment regimen remains to be established; but the current findings, along with prior data showing efficacy with T-DM1 in patients who fail to respond to two or more lines of anti-HER2 therapies, suggest it is a potential new standard for neoadjuvant therapy, particularly for patients with HER2- and HR-positive disease, he concluded.

Dr. Bergh reported a financial relationship with UpToDate, and research funding to his institution from Amgen, AstraZeneca, Bayer, Merck, Pfizer, Roche, and Sanofi.

SOURCE: Bergh J et al. ASCO 2019, Abstract 501.

The Food and Drug Administration has invited submission of pathogen samples for its Database for Reference Grade Microbial Sequences (FDA-ARGOS), which seeks to support research and regulatory decisions regarding DNA testing for pathogens with quality-controlled and curated genomic sequence data. Such testing and devices could be used as medical countermeasures against biothreats such as Ebola and Zika.

Infectious disease next-generation sequencing could use DNA analysis to help identify pathogens – from viruses to parasites – faster and more efficiently by, in theory, accomplishing with one test what was only possible before with many, according to the FDA. In order to not only further development of such tests and devices but also aid regulatory and scientific review of them, the FDA has collaborated with the Department of Defense, the National Center for Biotechnology Information, and Institute for Genome Sciences at the University of Maryland, Baltimore, to create FDA-ARGOS.

However, the FDA and its collaborators need samples of pathogens to continue developing the database, so they’ve invited health care professionals to submit samples for that purpose. More information, including preferred organism list and submission guidelines, can be found on the FDA-ARGOS website.

cpalmer@mdedge.com

The Food and Drug Administration has invited submission of pathogen samples for its Database for Reference Grade Microbial Sequences (FDA-ARGOS), which seeks to support research and regulatory decisions regarding DNA testing for pathogens with quality-controlled and curated genomic sequence data. Such testing and devices could be used as medical countermeasures against biothreats such as Ebola and Zika.

Infectious disease next-generation sequencing could use DNA analysis to help identify pathogens – from viruses to parasites – faster and more efficiently by, in theory, accomplishing with one test what was only possible before with many, according to the FDA. In order to not only further development of such tests and devices but also aid regulatory and scientific review of them, the FDA has collaborated with the Department of Defense, the National Center for Biotechnology Information, and Institute for Genome Sciences at the University of Maryland, Baltimore, to create FDA-ARGOS.

However, the FDA and its collaborators need samples of pathogens to continue developing the database, so they’ve invited health care professionals to submit samples for that purpose. More information, including preferred organism list and submission guidelines, can be found on the FDA-ARGOS website.

cpalmer@mdedge.com

The Food and Drug Administration has invited submission of pathogen samples for its Database for Reference Grade Microbial Sequences (FDA-ARGOS), which seeks to support research and regulatory decisions regarding DNA testing for pathogens with quality-controlled and curated genomic sequence data. Such testing and devices could be used as medical countermeasures against biothreats such as Ebola and Zika.

Infectious disease next-generation sequencing could use DNA analysis to help identify pathogens – from viruses to parasites – faster and more efficiently by, in theory, accomplishing with one test what was only possible before with many, according to the FDA. In order to not only further development of such tests and devices but also aid regulatory and scientific review of them, the FDA has collaborated with the Department of Defense, the National Center for Biotechnology Information, and Institute for Genome Sciences at the University of Maryland, Baltimore, to create FDA-ARGOS.

However, the FDA and its collaborators need samples of pathogens to continue developing the database, so they’ve invited health care professionals to submit samples for that purpose. More information, including preferred organism list and submission guidelines, can be found on the FDA-ARGOS website.

cpalmer@mdedge.com

Results from a prospective study appear to confirm the utility of the Haemophilia Early Arthropathy Detection by UltraSound (HEAD‐US) scoring system to evaluate joint bleeding rates in patients with hemophilia A who are treated exclusively with secondary or tertiary prophylaxis.

HEAD-US showed a strong correlation with the joint bleeding rate over a 3 year period for ankles and knees, but not for elbows.

“Primary prophylaxis is considered the most effective regimen in preventing arthropathy formation. However, due to social and economic reasons, a considerable number of children and young adults with haemophilia worldwide are currently treated by secondary or tertiary prophylaxis,” Atanas Banchev, MD, of University Hospital Tsaritsa Giovanna – ISUL, Bulgaria, and colleagues, wrote in a letter to the editor in Haemophilia. “Due to its wide availability and low cost, the sonographic score Haemophilia Early Arthropathy Detection by UltraSound (HEAD‐US) has recently become an attractive tool for assessment of joint status.”

The researchers conducted a prospective study of 42 patients with moderate to severe hemophilia A. The patients were treated with secondary or tertiary prophylaxis for a minimum of 5 years and had no history of inhibitors or factor VIII inhibitor antibodies.

The team collected data on patient demographics, disease characteristics, and prophylactic therapy. Patients were assessed at regular intervals at various treatment facilities throughout Bulgaria.

The scoring was based on three markers: synovitis (score 0‐2), cartilage (score 0‐4) and subchondral bone (score of 0‐2) with a maximum score of eight points per joint, according to the researchers.

A total of 250 joints were evaluated via the HEAD‐US scoring system. Dr. Banchev and colleagues reported that articular damage was present in 34% (n = 85) of joints evaluated with the tool. No defects were detected in the remaining joints (n = 165).

Mean HEAD‐US scores for each specific joint were 2.2 (range 0‐8) for ankles, 0.96 (range 0‐8) for knees, and 0.73 (range 0‐6) for elbows.

The researchers reported a strong correlation between the assessed joint bleeding rates for 3 years and the corresponding HEAD-US scores in ankles and knees. For ankles, the Spearman’s correlation coefficient was 0.545 (P less than .001) and for knees it was 0.692 (P less than .001).

They found no statistically significant correlation between the HEAD-US score and the assessed joint bleeding rates for 3 years in elbows (coefficient 0.161, P = .143).

One key limitation of the study was the nonconsideration of therapeutic compliance in the outcome assessment.

No funding sources were reported. The authors reported having no conflicts of interest.

SOURCE: Banchev A et al. Haemophilia. 2019 May 27. doi: 10.1111/hae.13771.

Results from a prospective study appear to confirm the utility of the Haemophilia Early Arthropathy Detection by UltraSound (HEAD‐US) scoring system to evaluate joint bleeding rates in patients with hemophilia A who are treated exclusively with secondary or tertiary prophylaxis.

HEAD-US showed a strong correlation with the joint bleeding rate over a 3 year period for ankles and knees, but not for elbows.

“Primary prophylaxis is considered the most effective regimen in preventing arthropathy formation. However, due to social and economic reasons, a considerable number of children and young adults with haemophilia worldwide are currently treated by secondary or tertiary prophylaxis,” Atanas Banchev, MD, of University Hospital Tsaritsa Giovanna – ISUL, Bulgaria, and colleagues, wrote in a letter to the editor in Haemophilia. “Due to its wide availability and low cost, the sonographic score Haemophilia Early Arthropathy Detection by UltraSound (HEAD‐US) has recently become an attractive tool for assessment of joint status.”

The researchers conducted a prospective study of 42 patients with moderate to severe hemophilia A. The patients were treated with secondary or tertiary prophylaxis for a minimum of 5 years and had no history of inhibitors or factor VIII inhibitor antibodies.

The team collected data on patient demographics, disease characteristics, and prophylactic therapy. Patients were assessed at regular intervals at various treatment facilities throughout Bulgaria.

The scoring was based on three markers: synovitis (score 0‐2), cartilage (score 0‐4) and subchondral bone (score of 0‐2) with a maximum score of eight points per joint, according to the researchers.

A total of 250 joints were evaluated via the HEAD‐US scoring system. Dr. Banchev and colleagues reported that articular damage was present in 34% (n = 85) of joints evaluated with the tool. No defects were detected in the remaining joints (n = 165).

Mean HEAD‐US scores for each specific joint were 2.2 (range 0‐8) for ankles, 0.96 (range 0‐8) for knees, and 0.73 (range 0‐6) for elbows.

The researchers reported a strong correlation between the assessed joint bleeding rates for 3 years and the corresponding HEAD-US scores in ankles and knees. For ankles, the Spearman’s correlation coefficient was 0.545 (P less than .001) and for knees it was 0.692 (P less than .001).

They found no statistically significant correlation between the HEAD-US score and the assessed joint bleeding rates for 3 years in elbows (coefficient 0.161, P = .143).

One key limitation of the study was the nonconsideration of therapeutic compliance in the outcome assessment.

No funding sources were reported. The authors reported having no conflicts of interest.

SOURCE: Banchev A et al. Haemophilia. 2019 May 27. doi: 10.1111/hae.13771.

Results from a prospective study appear to confirm the utility of the Haemophilia Early Arthropathy Detection by UltraSound (HEAD‐US) scoring system to evaluate joint bleeding rates in patients with hemophilia A who are treated exclusively with secondary or tertiary prophylaxis.

HEAD-US showed a strong correlation with the joint bleeding rate over a 3 year period for ankles and knees, but not for elbows.

“Primary prophylaxis is considered the most effective regimen in preventing arthropathy formation. However, due to social and economic reasons, a considerable number of children and young adults with haemophilia worldwide are currently treated by secondary or tertiary prophylaxis,” Atanas Banchev, MD, of University Hospital Tsaritsa Giovanna – ISUL, Bulgaria, and colleagues, wrote in a letter to the editor in Haemophilia. “Due to its wide availability and low cost, the sonographic score Haemophilia Early Arthropathy Detection by UltraSound (HEAD‐US) has recently become an attractive tool for assessment of joint status.”

The researchers conducted a prospective study of 42 patients with moderate to severe hemophilia A. The patients were treated with secondary or tertiary prophylaxis for a minimum of 5 years and had no history of inhibitors or factor VIII inhibitor antibodies.

The team collected data on patient demographics, disease characteristics, and prophylactic therapy. Patients were assessed at regular intervals at various treatment facilities throughout Bulgaria.

The scoring was based on three markers: synovitis (score 0‐2), cartilage (score 0‐4) and subchondral bone (score of 0‐2) with a maximum score of eight points per joint, according to the researchers.

A total of 250 joints were evaluated via the HEAD‐US scoring system. Dr. Banchev and colleagues reported that articular damage was present in 34% (n = 85) of joints evaluated with the tool. No defects were detected in the remaining joints (n = 165).

Mean HEAD‐US scores for each specific joint were 2.2 (range 0‐8) for ankles, 0.96 (range 0‐8) for knees, and 0.73 (range 0‐6) for elbows.

The researchers reported a strong correlation between the assessed joint bleeding rates for 3 years and the corresponding HEAD-US scores in ankles and knees. For ankles, the Spearman’s correlation coefficient was 0.545 (P less than .001) and for knees it was 0.692 (P less than .001).

They found no statistically significant correlation between the HEAD-US score and the assessed joint bleeding rates for 3 years in elbows (coefficient 0.161, P = .143).

One key limitation of the study was the nonconsideration of therapeutic compliance in the outcome assessment.

No funding sources were reported. The authors reported having no conflicts of interest.

SOURCE: Banchev A et al. Haemophilia. 2019 May 27. doi: 10.1111/hae.13771.

SAN FRANCISCO – Significant and rapid weight loss, fueled by a low-calorie diet, seemed to boost long-term diabetes prevention in patients who were prediabetic, a new study finds. And to the surprise of researchers, the results were the same regardless of dietary and exercise interventions more than 3 years after the initial weight loss.

There’s a big limitation, though: About half of the participants who initially lost weight dropped out during the 3-year study, and data about them are not yet available. Still, only 4% of those who completed the study converted to diabetes, compared with expected rates of as much as 16%.

This is a “fantastic success,” co-lead investigator and physiologist, Ian Macdonald, PhD, of the University of Nottingham (England), said in a presentation of the PREVIEW study at the annual scientific sessions of the American Diabetes Association.

The randomized, controlled, multicenter trial recruited 2,223 participants with prediabetes in several European countries and Australia and New Zealand. The participants, of whom about two-thirds were women, were aged 25-70 years (average, 52 years) and had an average body mass index of 35 kg/m².

They were assigned to a 2-month, rapid weight-loss program in which they were limited to no more than 800 calories per day. “The participants were fully briefed on the risks to health associated with prediabetes and on the problems of diabetes itself, and they were highly motivated to take part in the study,” Dr. Macdonald said in an interview after the presentation.

A total of 1,857 participants achieved the required weight loss of at least 8% and were then assigned to one of four interventions: a high-protein, low-glycemic diet (either with moderate- or high-intensity physical activity) or a moderate-protein, moderate-glycemic diet (either with moderate- or high-intensity physical activity).

A total of 962 participants remained in the study for another 34 months until completion, with roughly the same number (235-244) in each of the four intervention groups.

The researchers expected that 16% of those in the moderate-diet group would convert to type 2 diabetes, as would 11% of those in the high-protein, low-glycemic group, Dr. Macdonald said in the presentation.

The researchers, who offered limited statistical detail about the study, did not disclose how many participants in each group actually developed diabetes by 36 months (January 2019). Dr. Macdonald said in the interview that those numbers would not be available until the study has been accepted for publication. He noted, however, that the numbers in the two groups were nearly identical, and the researchers disclosed that the overall number was just 4% (n = 62).

That number is “substantially less than would be predicted,” Dr. Macdonald noted in the presentation, adding that “there is no difference” between the interventions.

He said protein consumption in the high-protein diet was not sustained, probably because of lack of adherence. In contrast, the physical activity in the groups increased significantly at the beginning of the study, he said, and “it did not fall off too badly.”

According to Dr. Macdonald, the prevention of progression to diabetes “was almost certainly because of this large, initial weight loss, which was at least partially and impressively sustained. A high-protein, low-glycemic diet was not superior to a moderate-protein, moderate-glycemic diet in relation to prevention of type 2 diabetes.”

The study was funded by the European Union and various other sources, including national funds, in the participating countries. Dr. Macdonald reported advisory board service with Nestlé Research, European Juice Manufacturers, and Mars.

SAN FRANCISCO – Significant and rapid weight loss, fueled by a low-calorie diet, seemed to boost long-term diabetes prevention in patients who were prediabetic, a new study finds. And to the surprise of researchers, the results were the same regardless of dietary and exercise interventions more than 3 years after the initial weight loss.

There’s a big limitation, though: About half of the participants who initially lost weight dropped out during the 3-year study, and data about them are not yet available. Still, only 4% of those who completed the study converted to diabetes, compared with expected rates of as much as 16%.

This is a “fantastic success,” co-lead investigator and physiologist, Ian Macdonald, PhD, of the University of Nottingham (England), said in a presentation of the PREVIEW study at the annual scientific sessions of the American Diabetes Association.

The randomized, controlled, multicenter trial recruited 2,223 participants with prediabetes in several European countries and Australia and New Zealand. The participants, of whom about two-thirds were women, were aged 25-70 years (average, 52 years) and had an average body mass index of 35 kg/m².

They were assigned to a 2-month, rapid weight-loss program in which they were limited to no more than 800 calories per day. “The participants were fully briefed on the risks to health associated with prediabetes and on the problems of diabetes itself, and they were highly motivated to take part in the study,” Dr. Macdonald said in an interview after the presentation.

A total of 1,857 participants achieved the required weight loss of at least 8% and were then assigned to one of four interventions: a high-protein, low-glycemic diet (either with moderate- or high-intensity physical activity) or a moderate-protein, moderate-glycemic diet (either with moderate- or high-intensity physical activity).

A total of 962 participants remained in the study for another 34 months until completion, with roughly the same number (235-244) in each of the four intervention groups.

The researchers expected that 16% of those in the moderate-diet group would convert to type 2 diabetes, as would 11% of those in the high-protein, low-glycemic group, Dr. Macdonald said in the presentation.

The researchers, who offered limited statistical detail about the study, did not disclose how many participants in each group actually developed diabetes by 36 months (January 2019). Dr. Macdonald said in the interview that those numbers would not be available until the study has been accepted for publication. He noted, however, that the numbers in the two groups were nearly identical, and the researchers disclosed that the overall number was just 4% (n = 62).

That number is “substantially less than would be predicted,” Dr. Macdonald noted in the presentation, adding that “there is no difference” between the interventions.

He said protein consumption in the high-protein diet was not sustained, probably because of lack of adherence. In contrast, the physical activity in the groups increased significantly at the beginning of the study, he said, and “it did not fall off too badly.”

According to Dr. Macdonald, the prevention of progression to diabetes “was almost certainly because of this large, initial weight loss, which was at least partially and impressively sustained. A high-protein, low-glycemic diet was not superior to a moderate-protein, moderate-glycemic diet in relation to prevention of type 2 diabetes.”

The study was funded by the European Union and various other sources, including national funds, in the participating countries. Dr. Macdonald reported advisory board service with Nestlé Research, European Juice Manufacturers, and Mars.

SAN FRANCISCO – Significant and rapid weight loss, fueled by a low-calorie diet, seemed to boost long-term diabetes prevention in patients who were prediabetic, a new study finds. And to the surprise of researchers, the results were the same regardless of dietary and exercise interventions more than 3 years after the initial weight loss.

There’s a big limitation, though: About half of the participants who initially lost weight dropped out during the 3-year study, and data about them are not yet available. Still, only 4% of those who completed the study converted to diabetes, compared with expected rates of as much as 16%.

This is a “fantastic success,” co-lead investigator and physiologist, Ian Macdonald, PhD, of the University of Nottingham (England), said in a presentation of the PREVIEW study at the annual scientific sessions of the American Diabetes Association.

The randomized, controlled, multicenter trial recruited 2,223 participants with prediabetes in several European countries and Australia and New Zealand. The participants, of whom about two-thirds were women, were aged 25-70 years (average, 52 years) and had an average body mass index of 35 kg/m².

They were assigned to a 2-month, rapid weight-loss program in which they were limited to no more than 800 calories per day. “The participants were fully briefed on the risks to health associated with prediabetes and on the problems of diabetes itself, and they were highly motivated to take part in the study,” Dr. Macdonald said in an interview after the presentation.

A total of 1,857 participants achieved the required weight loss of at least 8% and were then assigned to one of four interventions: a high-protein, low-glycemic diet (either with moderate- or high-intensity physical activity) or a moderate-protein, moderate-glycemic diet (either with moderate- or high-intensity physical activity).

A total of 962 participants remained in the study for another 34 months until completion, with roughly the same number (235-244) in each of the four intervention groups.

The researchers expected that 16% of those in the moderate-diet group would convert to type 2 diabetes, as would 11% of those in the high-protein, low-glycemic group, Dr. Macdonald said in the presentation.

The researchers, who offered limited statistical detail about the study, did not disclose how many participants in each group actually developed diabetes by 36 months (January 2019). Dr. Macdonald said in the interview that those numbers would not be available until the study has been accepted for publication. He noted, however, that the numbers in the two groups were nearly identical, and the researchers disclosed that the overall number was just 4% (n = 62).

That number is “substantially less than would be predicted,” Dr. Macdonald noted in the presentation, adding that “there is no difference” between the interventions.

He said protein consumption in the high-protein diet was not sustained, probably because of lack of adherence. In contrast, the physical activity in the groups increased significantly at the beginning of the study, he said, and “it did not fall off too badly.”

According to Dr. Macdonald, the prevention of progression to diabetes “was almost certainly because of this large, initial weight loss, which was at least partially and impressively sustained. A high-protein, low-glycemic diet was not superior to a moderate-protein, moderate-glycemic diet in relation to prevention of type 2 diabetes.”

The study was funded by the European Union and various other sources, including national funds, in the participating countries. Dr. Macdonald reported advisory board service with Nestlé Research, European Juice Manufacturers, and Mars.

Forks out for science

pictore/E+

True scientists should have no limits to what they’ll do for their research. Charles Darwin proved that greatly during his life – he spent years discovering and cataloging new species.

But did you know he also chowed down on nearly every animal he found?

His taste for unusual fare began at Cambridge as a member of the “Glutton Club.” He and his fellow gluttons were dedicated to sampling “birds and beasts which were before unknown to human palate,” as reported in an article on NPR. His eating adventures only grew while on the famed Beagle voyage, where he tried puma, iguanas, armadillos, giant tortoises, and even a 20-pound rodent that he declared “the very best meat I ever tasted.”

The noble tradition of tasting your test subjects continues today. The author of the article referenced above asked scientists on social media for stories of eating what they are supposed to be studying, and the answers came pouring in.

From tasting tadpoles to nibbling on 30,000-year-old bison meat, scientists all over the world have found they can’t resist the call to just have a tiny taste.
 

The umbrella’s just not cutting it

grafxart8888/iStock/Getty Images Plus

Bad news for everyone who hates melanoma but also hates sunscreen: That Tommy Bahama beach umbrella isn’t doing much to shield your skin.

A team lead by researcher Hao Ou-Yang conducted a study comparing the effects of harmful UV rays on subjects who used sunscreen with subjects who only used the shade of an umbrella.

In the battle of Sun vs. Umbrella, the humble parasol had no chance. While neither sun protection method completely prevented sunburn, 78% of the umbrella-only group experienced sunburn, compared with 25% of the sunscreen wearers.

The researchers determined that umbrella shade alone is not sufficient to protect against sunburn during extended exposure to the sun (in the case of this experiment, exposure was 3.5 hours). Sunscreen, despite being smelly and sticky and gloopy, is definitely needed to protect skin from those UV rays. So, suck it up and pile on that Coppertone this summer.
 

Oh no, there goes Tokyo (again)

CSA Images/Vetta

Godzilla. The king of the monsters. For 65 years, the big green guy has been the scourge (mostly) of Japan and the entire world. He arrives, he destroys, and there is very nearly nothing we can do about him.

If you’re an astute fan of the Godzilla series (and we love a good Godzilla movie at MDedge headquarters), you’ll have noticed that Godzilla is a lot bigger than he used to be. In the first movie, he stood at a relatively meager 50 meters. Nowadays, he’s scraping 120 meters, more than double his original size.

What’s going on?

In an actual study published in Science, a team at Dartmouth College in Hanover, N.H., determined that Godzilla is evolving 30 times faster than any other organism on Earth. It’s enough to make even the influenza virus jealous.

So, what is going on? Why is Godzilla evolving so quickly? The scientists assumed that Godzilla is a ceratosaurid dinosaur and ran through the usual suspects. No other dinosaur of that family got so big. Genetic drift and natural selection can’t explain it either.

The truth may be more unsettling: Our own anxiety is fueling his growth. Godzilla was born because of nuclear testing and the fear stemming from it. And the Dartmouth team even found a correlation between Godzilla’s size and American military spending from 1954 to 2019, a neat barometer of the world’s collective anxiety.

Or, you know, people just want to see a 400-foot-tall lizard destroying things. But that’s hardly worthy of a study in an elite research journal.
 

Hole lotta trypophobia goin’ on

jeanro/iStock/Getty Images Plus

We didn’t know this was even a thing, but Twitter doesn’t like pictures of woodpeckers … digging little holes in tree trunks … and then stuffing the holes with acorns.

A recent tweet of such a photo caused a minor pandemic of virality when users reacted with revulsion and panic caused by trypophobia, which is a fear of irregular patterns of small holes or bumps. You won’t find trypophobia in the DSM-5 – the term was first used in an Internet forum in 2005 – but it is a source of some debate among academics, according to Live Science.

One group says the patterns look like some poisonous animals, and that people are programmed by evolution to fear such creatures. Others suggest that the reaction is not fear but disgust, because the patterns of holes look like the lesions and pustules caused by infectious diseases such as smallpox.

We’re not scientists, so we’ll stay out of the debate on causality. But we do think we’ve uncovered the first documented case, and it goes back to the 1960s TV series “Batman.” The hero’s trusted sidekick, Robin (coincidentally, another type of bird), must have been the first person with trypophobia:

“Holy tintinnabulation!”

“Holy uncanny photographic mental processes!”

“Holy priceless collection of Etruscan snoods!”

Holy patterns of woodpecker acorns! There can be no diagnostic doubt: For Robin, it was all about the holes.

imnews@mdedge.com

Forks out for science

pictore/E+

True scientists should have no limits to what they’ll do for their research. Charles Darwin proved that greatly during his life – he spent years discovering and cataloging new species.

But did you know he also chowed down on nearly every animal he found?

His taste for unusual fare began at Cambridge as a member of the “Glutton Club.” He and his fellow gluttons were dedicated to sampling “birds and beasts which were before unknown to human palate,” as reported in an article on NPR. His eating adventures only grew while on the famed Beagle voyage, where he tried puma, iguanas, armadillos, giant tortoises, and even a 20-pound rodent that he declared “the very best meat I ever tasted.”

The noble tradition of tasting your test subjects continues today. The author of the article referenced above asked scientists on social media for stories of eating what they are supposed to be studying, and the answers came pouring in.

From tasting tadpoles to nibbling on 30,000-year-old bison meat, scientists all over the world have found they can’t resist the call to just have a tiny taste.
 

The umbrella’s just not cutting it

grafxart8888/iStock/Getty Images Plus

Bad news for everyone who hates melanoma but also hates sunscreen: That Tommy Bahama beach umbrella isn’t doing much to shield your skin.

A team lead by researcher Hao Ou-Yang conducted a study comparing the effects of harmful UV rays on subjects who used sunscreen with subjects who only used the shade of an umbrella.

In the battle of Sun vs. Umbrella, the humble parasol had no chance. While neither sun protection method completely prevented sunburn, 78% of the umbrella-only group experienced sunburn, compared with 25% of the sunscreen wearers.

The researchers determined that umbrella shade alone is not sufficient to protect against sunburn during extended exposure to the sun (in the case of this experiment, exposure was 3.5 hours). Sunscreen, despite being smelly and sticky and gloopy, is definitely needed to protect skin from those UV rays. So, suck it up and pile on that Coppertone this summer.
 

Oh no, there goes Tokyo (again)

CSA Images/Vetta

Godzilla. The king of the monsters. For 65 years, the big green guy has been the scourge (mostly) of Japan and the entire world. He arrives, he destroys, and there is very nearly nothing we can do about him.

If you’re an astute fan of the Godzilla series (and we love a good Godzilla movie at MDedge headquarters), you’ll have noticed that Godzilla is a lot bigger than he used to be. In the first movie, he stood at a relatively meager 50 meters. Nowadays, he’s scraping 120 meters, more than double his original size.

What’s going on?

In an actual study published in Science, a team at Dartmouth College in Hanover, N.H., determined that Godzilla is evolving 30 times faster than any other organism on Earth. It’s enough to make even the influenza virus jealous.

So, what is going on? Why is Godzilla evolving so quickly? The scientists assumed that Godzilla is a ceratosaurid dinosaur and ran through the usual suspects. No other dinosaur of that family got so big. Genetic drift and natural selection can’t explain it either.

The truth may be more unsettling: Our own anxiety is fueling his growth. Godzilla was born because of nuclear testing and the fear stemming from it. And the Dartmouth team even found a correlation between Godzilla’s size and American military spending from 1954 to 2019, a neat barometer of the world’s collective anxiety.

Or, you know, people just want to see a 400-foot-tall lizard destroying things. But that’s hardly worthy of a study in an elite research journal.
 

Hole lotta trypophobia goin’ on

jeanro/iStock/Getty Images Plus

We didn’t know this was even a thing, but Twitter doesn’t like pictures of woodpeckers … digging little holes in tree trunks … and then stuffing the holes with acorns.

A recent tweet of such a photo caused a minor pandemic of virality when users reacted with revulsion and panic caused by trypophobia, which is a fear of irregular patterns of small holes or bumps. You won’t find trypophobia in the DSM-5 – the term was first used in an Internet forum in 2005 – but it is a source of some debate among academics, according to Live Science.

One group says the patterns look like some poisonous animals, and that people are programmed by evolution to fear such creatures. Others suggest that the reaction is not fear but disgust, because the patterns of holes look like the lesions and pustules caused by infectious diseases such as smallpox.

We’re not scientists, so we’ll stay out of the debate on causality. But we do think we’ve uncovered the first documented case, and it goes back to the 1960s TV series “Batman.” The hero’s trusted sidekick, Robin (coincidentally, another type of bird), must have been the first person with trypophobia:

“Holy tintinnabulation!”

“Holy uncanny photographic mental processes!”

“Holy priceless collection of Etruscan snoods!”

Holy patterns of woodpecker acorns! There can be no diagnostic doubt: For Robin, it was all about the holes.

imnews@mdedge.com

Forks out for science

pictore/E+

True scientists should have no limits to what they’ll do for their research. Charles Darwin proved that greatly during his life – he spent years discovering and cataloging new species.

But did you know he also chowed down on nearly every animal he found?

His taste for unusual fare began at Cambridge as a member of the “Glutton Club.” He and his fellow gluttons were dedicated to sampling “birds and beasts which were before unknown to human palate,” as reported in an article on NPR. His eating adventures only grew while on the famed Beagle voyage, where he tried puma, iguanas, armadillos, giant tortoises, and even a 20-pound rodent that he declared “the very best meat I ever tasted.”

The noble tradition of tasting your test subjects continues today. The author of the article referenced above asked scientists on social media for stories of eating what they are supposed to be studying, and the answers came pouring in.

From tasting tadpoles to nibbling on 30,000-year-old bison meat, scientists all over the world have found they can’t resist the call to just have a tiny taste.
 

The umbrella’s just not cutting it

grafxart8888/iStock/Getty Images Plus

Bad news for everyone who hates melanoma but also hates sunscreen: That Tommy Bahama beach umbrella isn’t doing much to shield your skin.

A team lead by researcher Hao Ou-Yang conducted a study comparing the effects of harmful UV rays on subjects who used sunscreen with subjects who only used the shade of an umbrella.

In the battle of Sun vs. Umbrella, the humble parasol had no chance. While neither sun protection method completely prevented sunburn, 78% of the umbrella-only group experienced sunburn, compared with 25% of the sunscreen wearers.

The researchers determined that umbrella shade alone is not sufficient to protect against sunburn during extended exposure to the sun (in the case of this experiment, exposure was 3.5 hours). Sunscreen, despite being smelly and sticky and gloopy, is definitely needed to protect skin from those UV rays. So, suck it up and pile on that Coppertone this summer.
 

Oh no, there goes Tokyo (again)

CSA Images/Vetta

Godzilla. The king of the monsters. For 65 years, the big green guy has been the scourge (mostly) of Japan and the entire world. He arrives, he destroys, and there is very nearly nothing we can do about him.

If you’re an astute fan of the Godzilla series (and we love a good Godzilla movie at MDedge headquarters), you’ll have noticed that Godzilla is a lot bigger than he used to be. In the first movie, he stood at a relatively meager 50 meters. Nowadays, he’s scraping 120 meters, more than double his original size.

What’s going on?

In an actual study published in Science, a team at Dartmouth College in Hanover, N.H., determined that Godzilla is evolving 30 times faster than any other organism on Earth. It’s enough to make even the influenza virus jealous.

So, what is going on? Why is Godzilla evolving so quickly? The scientists assumed that Godzilla is a ceratosaurid dinosaur and ran through the usual suspects. No other dinosaur of that family got so big. Genetic drift and natural selection can’t explain it either.

The truth may be more unsettling: Our own anxiety is fueling his growth. Godzilla was born because of nuclear testing and the fear stemming from it. And the Dartmouth team even found a correlation between Godzilla’s size and American military spending from 1954 to 2019, a neat barometer of the world’s collective anxiety.

Or, you know, people just want to see a 400-foot-tall lizard destroying things. But that’s hardly worthy of a study in an elite research journal.
 

Hole lotta trypophobia goin’ on

jeanro/iStock/Getty Images Plus

We didn’t know this was even a thing, but Twitter doesn’t like pictures of woodpeckers … digging little holes in tree trunks … and then stuffing the holes with acorns.

A recent tweet of such a photo caused a minor pandemic of virality when users reacted with revulsion and panic caused by trypophobia, which is a fear of irregular patterns of small holes or bumps. You won’t find trypophobia in the DSM-5 – the term was first used in an Internet forum in 2005 – but it is a source of some debate among academics, according to Live Science.

One group says the patterns look like some poisonous animals, and that people are programmed by evolution to fear such creatures. Others suggest that the reaction is not fear but disgust, because the patterns of holes look like the lesions and pustules caused by infectious diseases such as smallpox.

We’re not scientists, so we’ll stay out of the debate on causality. But we do think we’ve uncovered the first documented case, and it goes back to the 1960s TV series “Batman.” The hero’s trusted sidekick, Robin (coincidentally, another type of bird), must have been the first person with trypophobia:

“Holy tintinnabulation!”

“Holy uncanny photographic mental processes!”

“Holy priceless collection of Etruscan snoods!”

Holy patterns of woodpecker acorns! There can be no diagnostic doubt: For Robin, it was all about the holes.

imnews@mdedge.com

SAN FRANCISCO – Climate change is having a negative impact on patients, and “psychiatrists see themselves as one of the remedies,” Lise Van Susteren, MD, said at the annual meeting of the American Psychiatric Association.

Vidyard Video

“We can find reasons to hope even in dark times,” Dr. Van Susteren said. “We understand science. We have all the tools ... this is what we do for a living. We warn about behaviors that are going hurt us now and are going to be even worse down the road.”


In a video discussion, Dr. Van Susteren spoke with David A. Pollack, MD, about the accomplishments of the Climate Psychiatry Alliance, an organization they helped launch more than 2 years ago that warns the medical profession and the public about risks of climate change and the impact of climate disruption on mental health. One victory, for example, was getting the APA to vote to divest from fossil fuels.

Dr. Van Susteren and Dr. Pollack also discuss steps psychiatrists can take as individuals to provide care for patients suffering from the effects of climate change – such as prescribing “park therapy.” In their offices, physicians can look toward emerging solutions such as My Green Doctor and Health Care Without Harm, Dr. Pollack said.


Dr. Van Susteren has a private psychiatry private practice in Washington and has no disclosures. Dr. Pollack is affiliated with Oregon Health & Science University in Portland. He has no disclosures.

ghenderson@mdedge.com

SAN FRANCISCO – Climate change is having a negative impact on patients, and “psychiatrists see themselves as one of the remedies,” Lise Van Susteren, MD, said at the annual meeting of the American Psychiatric Association.

Vidyard Video

“We can find reasons to hope even in dark times,” Dr. Van Susteren said. “We understand science. We have all the tools ... this is what we do for a living. We warn about behaviors that are going hurt us now and are going to be even worse down the road.”


In a video discussion, Dr. Van Susteren spoke with David A. Pollack, MD, about the accomplishments of the Climate Psychiatry Alliance, an organization they helped launch more than 2 years ago that warns the medical profession and the public about risks of climate change and the impact of climate disruption on mental health. One victory, for example, was getting the APA to vote to divest from fossil fuels.

Dr. Van Susteren and Dr. Pollack also discuss steps psychiatrists can take as individuals to provide care for patients suffering from the effects of climate change – such as prescribing “park therapy.” In their offices, physicians can look toward emerging solutions such as My Green Doctor and Health Care Without Harm, Dr. Pollack said.


Dr. Van Susteren has a private psychiatry private practice in Washington and has no disclosures. Dr. Pollack is affiliated with Oregon Health & Science University in Portland. He has no disclosures.

ghenderson@mdedge.com

SAN FRANCISCO – Climate change is having a negative impact on patients, and “psychiatrists see themselves as one of the remedies,” Lise Van Susteren, MD, said at the annual meeting of the American Psychiatric Association.

Vidyard Video

“We can find reasons to hope even in dark times,” Dr. Van Susteren said. “We understand science. We have all the tools ... this is what we do for a living. We warn about behaviors that are going hurt us now and are going to be even worse down the road.”


In a video discussion, Dr. Van Susteren spoke with David A. Pollack, MD, about the accomplishments of the Climate Psychiatry Alliance, an organization they helped launch more than 2 years ago that warns the medical profession and the public about risks of climate change and the impact of climate disruption on mental health. One victory, for example, was getting the APA to vote to divest from fossil fuels.

Dr. Van Susteren and Dr. Pollack also discuss steps psychiatrists can take as individuals to provide care for patients suffering from the effects of climate change – such as prescribing “park therapy.” In their offices, physicians can look toward emerging solutions such as My Green Doctor and Health Care Without Harm, Dr. Pollack said.


Dr. Van Susteren has a private psychiatry private practice in Washington and has no disclosures. Dr. Pollack is affiliated with Oregon Health & Science University in Portland. He has no disclosures.

ghenderson@mdedge.com

Combined aerobic and resistance exercise training was found to be the most effective training technique to reduce proinflammatory markers in overweight patients with moderate hemophilia A.

“Combined training has been established as the most effective type of exercise in terms of modification of cardiovascular disease risk factors,” wrote Behrouz Parhampour, of Iran University of Medical Sciences in Tehran, and colleagues. The findings of the study were published in Haemophilia.

The researchers conducted a randomized clinical study of 48 patients with moderate hemophilia A. Study patients had a body mass index of 25-30 kg/m² and were aged 35-55 years.

Study participants were randomly allocated to aerobic training (n = 12), resistance training (n = 12), combined training (n = 12), and control (n = 12) arms. The training regimens consisted of 45‐minute sessions three times per week for a total of 6 weeks.

Interleukin‐10, adiponectin, tumor necrosis factor–alpha, IL‐6, and high-sensitive C‐reactive protein were measured before and after training. Weight-related measures, including waist‐to‐hip ratio and waist circumference, were also evaluated.

The researchers found there was a significant reduction in weight, waist‐to‐hip ratio, waist circumference, and body mass index in the combined, resistance, and aerobic training arms, compared with the control arm.

Additionally, they reported a significant reduction in high-sensitive C‐reactive protein, IL‐6, and tumor necrosis factor–alpha levels in the combined training group versus the control group (P equal to or less than .02 for all three).

There were no episodes of bleeding among patients in any of the intervention groups.

“The possible mechanism for the effect of exercise training on weight loss is to increase metabolic consumption which may subsequently reduce the low‐grade inflammation commonly noted among overweight patients,” the researchers wrote.

The authors acknowledged that two key limitations of the study were the short duration of training and small sample size.

“Combined training can be used as an effective nonpharmacological strategy to improve joint function and prevent disorders associated with sedentary lifestyle like cardiovascular complications in [hemophilia patients],” they concluded.

The study was funded by the Iran University of Medical Sciences. The authors reported having no conflicts of interest.

SOURCE: Parhampour B et al. Haemophilia. 2019 May 26. doi: 10.1111/hae.13764.

Combined aerobic and resistance exercise training was found to be the most effective training technique to reduce proinflammatory markers in overweight patients with moderate hemophilia A.

“Combined training has been established as the most effective type of exercise in terms of modification of cardiovascular disease risk factors,” wrote Behrouz Parhampour, of Iran University of Medical Sciences in Tehran, and colleagues. The findings of the study were published in Haemophilia.

The researchers conducted a randomized clinical study of 48 patients with moderate hemophilia A. Study patients had a body mass index of 25-30 kg/m² and were aged 35-55 years.

Study participants were randomly allocated to aerobic training (n = 12), resistance training (n = 12), combined training (n = 12), and control (n = 12) arms. The training regimens consisted of 45‐minute sessions three times per week for a total of 6 weeks.

Interleukin‐10, adiponectin, tumor necrosis factor–alpha, IL‐6, and high-sensitive C‐reactive protein were measured before and after training. Weight-related measures, including waist‐to‐hip ratio and waist circumference, were also evaluated.

The researchers found there was a significant reduction in weight, waist‐to‐hip ratio, waist circumference, and body mass index in the combined, resistance, and aerobic training arms, compared with the control arm.

Additionally, they reported a significant reduction in high-sensitive C‐reactive protein, IL‐6, and tumor necrosis factor–alpha levels in the combined training group versus the control group (P equal to or less than .02 for all three).

There were no episodes of bleeding among patients in any of the intervention groups.

“The possible mechanism for the effect of exercise training on weight loss is to increase metabolic consumption which may subsequently reduce the low‐grade inflammation commonly noted among overweight patients,” the researchers wrote.

The authors acknowledged that two key limitations of the study were the short duration of training and small sample size.

“Combined training can be used as an effective nonpharmacological strategy to improve joint function and prevent disorders associated with sedentary lifestyle like cardiovascular complications in [hemophilia patients],” they concluded.

The study was funded by the Iran University of Medical Sciences. The authors reported having no conflicts of interest.

SOURCE: Parhampour B et al. Haemophilia. 2019 May 26. doi: 10.1111/hae.13764.

Combined aerobic and resistance exercise training was found to be the most effective training technique to reduce proinflammatory markers in overweight patients with moderate hemophilia A.

“Combined training has been established as the most effective type of exercise in terms of modification of cardiovascular disease risk factors,” wrote Behrouz Parhampour, of Iran University of Medical Sciences in Tehran, and colleagues. The findings of the study were published in Haemophilia.

The researchers conducted a randomized clinical study of 48 patients with moderate hemophilia A. Study patients had a body mass index of 25-30 kg/m² and were aged 35-55 years.

Study participants were randomly allocated to aerobic training (n = 12), resistance training (n = 12), combined training (n = 12), and control (n = 12) arms. The training regimens consisted of 45‐minute sessions three times per week for a total of 6 weeks.

Interleukin‐10, adiponectin, tumor necrosis factor–alpha, IL‐6, and high-sensitive C‐reactive protein were measured before and after training. Weight-related measures, including waist‐to‐hip ratio and waist circumference, were also evaluated.

The researchers found there was a significant reduction in weight, waist‐to‐hip ratio, waist circumference, and body mass index in the combined, resistance, and aerobic training arms, compared with the control arm.

Additionally, they reported a significant reduction in high-sensitive C‐reactive protein, IL‐6, and tumor necrosis factor–alpha levels in the combined training group versus the control group (P equal to or less than .02 for all three).

There were no episodes of bleeding among patients in any of the intervention groups.

“The possible mechanism for the effect of exercise training on weight loss is to increase metabolic consumption which may subsequently reduce the low‐grade inflammation commonly noted among overweight patients,” the researchers wrote.

The authors acknowledged that two key limitations of the study were the short duration of training and small sample size.

“Combined training can be used as an effective nonpharmacological strategy to improve joint function and prevent disorders associated with sedentary lifestyle like cardiovascular complications in [hemophilia patients],” they concluded.

The study was funded by the Iran University of Medical Sciences. The authors reported having no conflicts of interest.

SOURCE: Parhampour B et al. Haemophilia. 2019 May 26. doi: 10.1111/hae.13764.

CHICAGO – Daratumumab plus bortezomib, thalidomide, and dexamethasone (D-VTd) provided a “robust clinical benefit” over bortezomib, thalidomide, and dexamethasone alone (VTd) in a phase 3 trial of patients with newly diagnosed multiple myeloma, according to the trial’s principal investigator.

Courtesy Wikimedia Commons/KGH/Creative Commons License

D-VTd produced significantly higher rates of stringent complete response (sCR) and progression-free survival (PFS) than did VTd, said Philippe Moreau, MD, of the University Hospital of Nantes (France).

Dr. Moreau presented these results, from the CASSIOPEIA trial, at the annual meeting of the American Society of Clinical Oncology. The findings were simultaneously published in the Lancet (2019 Jun 3. doi: 10.1016/S0140-6736[19]31240-1).

CASSIOPEIA enrolled 1,085 patients with newly diagnosed multiple myeloma who were eligible for high-dose chemotherapy and hematopoietic stem cell transplant (HSCT). This is a two-part trial, and Dr. Moreau presented final results from part 1.

In part 1, patients were randomized to induction with D-VTd or VTd, followed by autologous HSCT and consolidation with D-VTd or VTd. In part 2, which is ongoing, patients who achieve a partial response or better are randomized to observation or maintenance with daratumumab for up to 2 years.

Baseline characteristics were well balanced between the D-VTd and VTd arms. The median age was 59 years (range, 22-65) and 58 years (range, 26-65), respectively. Most patients had an Eastern Cooperative Oncology Group performance status of 0 or 1, and most had an International Staging System stage of I or II.

The median follow-up was 18.8 months. Most patients completed induction – 85% in the D-VTd arm and 81% in the VTd arm – and went on to HSCT – 90% and 89%, respectively. The most common reasons for treatment discontinuation in both arms were adverse events and progression.
 

Response and survival

The primary endpoint for part 1 was the rate of sCR at 100 days after HSCT. The sCR rate was significantly higher in the D-VTd arm than it was in the VTd arm – 29% and 20%, respectively (odds ratio, 1.60; P less than .0010).

The overall response rate was significantly higher in the D-VTd arm than in the VTd arm – 93% and 90%, respectively (P less than .0001) – as was the rate of minimal residual disease (MRD) negativity – 64% and 44%, respectively (P less than .0001).

Dr. Moreau noted that sCR and MRD negativity rates were superior with D-VTd across all subgroups except among patients with high-risk cytogenetics and International Staging System stage III disease.

“Dara-VTd resulted in a robust clinical benefit with a higher rate of response, including stringent CR, including MRD negativity,” Dr. Moreau said. “And this translated into a better progression-free survival, with a 53% reduction in the risk of progression or death.”

The 18-month PFS was 93% in the D-VTd arm and 85% in the VTd arm (hazard ratio, 0.47; P less than .0001). D-VTd reduced the risk of progression or death across all subgroups.

The median overall survival (OS) was not reached in either treatment arm. The 18-month OS rate was 98% in the D-VTd arm and 95% in the VTd arm. The 24-month OS rate was 97% and 93%, respectively.

“These results are the best ever reported in the setting of stem cell transplantation,” Dr. Moreau said.
 

Safety

The most common grade 3/4 treatment-emergent adverse events (in the D-VTd and VTd arms, respectively) were neutropenia (28% and 15%), lymphopenia (17% and 10%), stomatitis (13% and 16%), and thrombocytopenia (11% and 7%).

The rate of infusion-related reactions was 35% in the D-VTd arm and 0% in the VTd arm. The rate of infections was 66% and 57%, respectively. The most common serious infection was pneumonia, which occurred in 4% and 2% of patients, respectively. The rate of second primary malignancies was 2% in both arms.

Based on the safety and efficacy results, Dr. Moreau concluded that D-VTd “should be considered a valid treatment option” for newly diagnosed multiple myeloma patients who are eligible for HSCT.

Dr. Moreau reported relationships with Amgen, Celgene, Janssen-Cilag, Novartis, and Takeda. The study is sponsored by the French Intergroupe Francophone du Myelome in collaboration with the Dutch-Belgian Cooperative Trial Group for Hematology Oncology and Janssen Research & Development.

jensmith@mdedge.com

SOURCE: Moreau P et al. ASCO 2019, Abstract 8003.

CHICAGO – Daratumumab plus bortezomib, thalidomide, and dexamethasone (D-VTd) provided a “robust clinical benefit” over bortezomib, thalidomide, and dexamethasone alone (VTd) in a phase 3 trial of patients with newly diagnosed multiple myeloma, according to the trial’s principal investigator.

Courtesy Wikimedia Commons/KGH/Creative Commons License

D-VTd produced significantly higher rates of stringent complete response (sCR) and progression-free survival (PFS) than did VTd, said Philippe Moreau, MD, of the University Hospital of Nantes (France).

Dr. Moreau presented these results, from the CASSIOPEIA trial, at the annual meeting of the American Society of Clinical Oncology. The findings were simultaneously published in the Lancet (2019 Jun 3. doi: 10.1016/S0140-6736[19]31240-1).

CASSIOPEIA enrolled 1,085 patients with newly diagnosed multiple myeloma who were eligible for high-dose chemotherapy and hematopoietic stem cell transplant (HSCT). This is a two-part trial, and Dr. Moreau presented final results from part 1.

In part 1, patients were randomized to induction with D-VTd or VTd, followed by autologous HSCT and consolidation with D-VTd or VTd. In part 2, which is ongoing, patients who achieve a partial response or better are randomized to observation or maintenance with daratumumab for up to 2 years.

Baseline characteristics were well balanced between the D-VTd and VTd arms. The median age was 59 years (range, 22-65) and 58 years (range, 26-65), respectively. Most patients had an Eastern Cooperative Oncology Group performance status of 0 or 1, and most had an International Staging System stage of I or II.

The median follow-up was 18.8 months. Most patients completed induction – 85% in the D-VTd arm and 81% in the VTd arm – and went on to HSCT – 90% and 89%, respectively. The most common reasons for treatment discontinuation in both arms were adverse events and progression.
 

Response and survival

The primary endpoint for part 1 was the rate of sCR at 100 days after HSCT. The sCR rate was significantly higher in the D-VTd arm than it was in the VTd arm – 29% and 20%, respectively (odds ratio, 1.60; P less than .0010).

The overall response rate was significantly higher in the D-VTd arm than in the VTd arm – 93% and 90%, respectively (P less than .0001) – as was the rate of minimal residual disease (MRD) negativity – 64% and 44%, respectively (P less than .0001).

Dr. Moreau noted that sCR and MRD negativity rates were superior with D-VTd across all subgroups except among patients with high-risk cytogenetics and International Staging System stage III disease.

“Dara-VTd resulted in a robust clinical benefit with a higher rate of response, including stringent CR, including MRD negativity,” Dr. Moreau said. “And this translated into a better progression-free survival, with a 53% reduction in the risk of progression or death.”

The 18-month PFS was 93% in the D-VTd arm and 85% in the VTd arm (hazard ratio, 0.47; P less than .0001). D-VTd reduced the risk of progression or death across all subgroups.

The median overall survival (OS) was not reached in either treatment arm. The 18-month OS rate was 98% in the D-VTd arm and 95% in the VTd arm. The 24-month OS rate was 97% and 93%, respectively.

“These results are the best ever reported in the setting of stem cell transplantation,” Dr. Moreau said.
 

Safety

The most common grade 3/4 treatment-emergent adverse events (in the D-VTd and VTd arms, respectively) were neutropenia (28% and 15%), lymphopenia (17% and 10%), stomatitis (13% and 16%), and thrombocytopenia (11% and 7%).

The rate of infusion-related reactions was 35% in the D-VTd arm and 0% in the VTd arm. The rate of infections was 66% and 57%, respectively. The most common serious infection was pneumonia, which occurred in 4% and 2% of patients, respectively. The rate of second primary malignancies was 2% in both arms.

Based on the safety and efficacy results, Dr. Moreau concluded that D-VTd “should be considered a valid treatment option” for newly diagnosed multiple myeloma patients who are eligible for HSCT.

Dr. Moreau reported relationships with Amgen, Celgene, Janssen-Cilag, Novartis, and Takeda. The study is sponsored by the French Intergroupe Francophone du Myelome in collaboration with the Dutch-Belgian Cooperative Trial Group for Hematology Oncology and Janssen Research & Development.

jensmith@mdedge.com

SOURCE: Moreau P et al. ASCO 2019, Abstract 8003.

CHICAGO – Daratumumab plus bortezomib, thalidomide, and dexamethasone (D-VTd) provided a “robust clinical benefit” over bortezomib, thalidomide, and dexamethasone alone (VTd) in a phase 3 trial of patients with newly diagnosed multiple myeloma, according to the trial’s principal investigator.

Courtesy Wikimedia Commons/KGH/Creative Commons License

D-VTd produced significantly higher rates of stringent complete response (sCR) and progression-free survival (PFS) than did VTd, said Philippe Moreau, MD, of the University Hospital of Nantes (France).

Dr. Moreau presented these results, from the CASSIOPEIA trial, at the annual meeting of the American Society of Clinical Oncology. The findings were simultaneously published in the Lancet (2019 Jun 3. doi: 10.1016/S0140-6736[19]31240-1).

CASSIOPEIA enrolled 1,085 patients with newly diagnosed multiple myeloma who were eligible for high-dose chemotherapy and hematopoietic stem cell transplant (HSCT). This is a two-part trial, and Dr. Moreau presented final results from part 1.

In part 1, patients were randomized to induction with D-VTd or VTd, followed by autologous HSCT and consolidation with D-VTd or VTd. In part 2, which is ongoing, patients who achieve a partial response or better are randomized to observation or maintenance with daratumumab for up to 2 years.

Baseline characteristics were well balanced between the D-VTd and VTd arms. The median age was 59 years (range, 22-65) and 58 years (range, 26-65), respectively. Most patients had an Eastern Cooperative Oncology Group performance status of 0 or 1, and most had an International Staging System stage of I or II.

The median follow-up was 18.8 months. Most patients completed induction – 85% in the D-VTd arm and 81% in the VTd arm – and went on to HSCT – 90% and 89%, respectively. The most common reasons for treatment discontinuation in both arms were adverse events and progression.
 

Response and survival

The primary endpoint for part 1 was the rate of sCR at 100 days after HSCT. The sCR rate was significantly higher in the D-VTd arm than it was in the VTd arm – 29% and 20%, respectively (odds ratio, 1.60; P less than .0010).

The overall response rate was significantly higher in the D-VTd arm than in the VTd arm – 93% and 90%, respectively (P less than .0001) – as was the rate of minimal residual disease (MRD) negativity – 64% and 44%, respectively (P less than .0001).

Dr. Moreau noted that sCR and MRD negativity rates were superior with D-VTd across all subgroups except among patients with high-risk cytogenetics and International Staging System stage III disease.

“Dara-VTd resulted in a robust clinical benefit with a higher rate of response, including stringent CR, including MRD negativity,” Dr. Moreau said. “And this translated into a better progression-free survival, with a 53% reduction in the risk of progression or death.”

The 18-month PFS was 93% in the D-VTd arm and 85% in the VTd arm (hazard ratio, 0.47; P less than .0001). D-VTd reduced the risk of progression or death across all subgroups.

The median overall survival (OS) was not reached in either treatment arm. The 18-month OS rate was 98% in the D-VTd arm and 95% in the VTd arm. The 24-month OS rate was 97% and 93%, respectively.

“These results are the best ever reported in the setting of stem cell transplantation,” Dr. Moreau said.
 

Safety

The most common grade 3/4 treatment-emergent adverse events (in the D-VTd and VTd arms, respectively) were neutropenia (28% and 15%), lymphopenia (17% and 10%), stomatitis (13% and 16%), and thrombocytopenia (11% and 7%).

The rate of infusion-related reactions was 35% in the D-VTd arm and 0% in the VTd arm. The rate of infections was 66% and 57%, respectively. The most common serious infection was pneumonia, which occurred in 4% and 2% of patients, respectively. The rate of second primary malignancies was 2% in both arms.

Based on the safety and efficacy results, Dr. Moreau concluded that D-VTd “should be considered a valid treatment option” for newly diagnosed multiple myeloma patients who are eligible for HSCT.

Dr. Moreau reported relationships with Amgen, Celgene, Janssen-Cilag, Novartis, and Takeda. The study is sponsored by the French Intergroupe Francophone du Myelome in collaboration with the Dutch-Belgian Cooperative Trial Group for Hematology Oncology and Janssen Research & Development.

jensmith@mdedge.com

SOURCE: Moreau P et al. ASCO 2019, Abstract 8003.