AVAHO

A new safety communication from the Food and Drug Administration on the use of robotically assisted surgical devices for mastectomy and other cancer-related surgeries in women encourages physician-patient dialogue and suggests that, moving forward, data on specific oncologic outcomes – not only perioperative and short-term outcomes – are key.

The FDA is “warning patients and providers that the use of robotically assisted surgical devices for any cancer-related surgery has not been granted marketing authorization by the agency, and therefore the survival benefits to patients when compared to traditional surgery have not been established,” Terri Cornelison, MD, PhD, assistant director for the health of women in the FDA’s Center for Devices and Radiological Health, said in a statement.

The safety communication focuses on women and calls attention specifically to robotically-assisted mastectomy and hysterectomy for early cervical cancers. It says there is “limited, preliminary evidence that the use of robotically-assisted surgical devices for treatment or prevention of cancers that primarily (breast) or exclusively (cervical) affect women may be associated with diminished long-term survival.”

The FDA cited a multicenter randomized trial that found that minimally invasive radical hysterectomy in women with cervical cancer (laparoscopic and robotically assisted) was associated with a lower rate of long-term survival compared with open surgery (N Engl J Med. 2018;379:1895-1904).

The communication does not refer to any other specific studies. Regarding current evidence on robotically-assisted mastectomies, the FDA safety communication says simply that safety and effectiveness have not been established and that the agency is “aware of scientific literature and media publications describing surgeons and hospital systems that use robotically-assisted surgical devices for mastectomy.”


 

Robotically-assisted mastectomy

Walton Taylor, MD, president of the American Society of Breast Surgeons and a surgeon with Texas Health Physicians Group in Dallas, said that the FDA’s concern is valid. “I really hope that robotic surgery turns out to be good [for mastectomy]. It’s awesome technology that can be great for patients,” he said. “But we have to gather real data that shows that long-term and short-term outcomes – from a cancer standpoint – are as good as with the open procedure ... that there aren’t negative unintended consequences.”

Right now, Dr. Taylor said, robotic mastectomy “is not commonplace by any means.”

The technique for robotic nipple-sparing mastectomy (NSM) was first described by Antonio Toesca, MD, of the European Institute of Oncology in Milan (Ann Surg. 2017;266[2]:e28-e30).

In an editorial published recently in Annals of Surgical Oncology, Jesse C. Selber, MD, MPH, of the department of plastic surgery at the University of Texas MD Anderson Cancer Center in Houston, described the technique as a “natural next step in the evolution of minimally invasive breast surgery that has the potential to mitigate the challenges associated with traditional NSM” (Ann Surg Oncol. 2019;26[1]:10-11). Robotic nipple-sparing mastectomy is catching on in Europe” with very promising early results, he wrote.

At least a couple of practices promoted their performance of robotic mastectomy last year. Northwell Health, a large network of hospitals, outpatient facilities, and physicians in New York, announced in March 2018 that Neil Tanna, MD, and Alan Kadison, MD, of the divisions of plastic and reconstructive surgery and surgical oncology, respectively, had performed the first robotic nipple-sparing mastectomy and breast reconstructive surgery in the United States. Their patient carried the BRCA gene and had a preventive mastectomy at Northwell Health’s Long Island Jewish Medical Center.

In October 2018, a surgeon in Tinton Falls, N.J., Stephen Chagares, MD, announced that he had performed the first robotic nipple-sparing mastectomy with reconstruction in a patient with breast cancer at Monmouth Medical Center. His press release described a 3-cm incision “to the side of the breast, tucked neatly behind the armpit.” Both Dr. Chagares and Dr. Tanna had traveled to Milan to train with Dr. Toesca, according to the press releases.

Both of these cases – as well as a decision by Monmouth Medical Center in December 2018 to suspend the surgery pending further review – were mentioned in a letter submitted to the FDA in mid-December by Hooman Noorchashm, MD, PhD, a Philadelphia cardiothoracic surgeon-turned-patient-advocate whose wife Amy Josephine Reed, MD, PhD, died of uterine cancer in May 2017 following a laparoscopic hysterectomy performed with a power morcellator.

In his complaint, Dr. Noorchashm urged the agency to issue a warning about the “potentially dangerous/premature application” of robotic mastectomy for the treatment of breast cancer or BRCA carrier status outside the setting of randomized controlled trials with primary cancer–related outcomes metrics or an investigational device exemption from the FDA. (Receipt of the letter was acknowledged by the Allegation of Regulatory Misconduct Branch of the FDA several days later.)

In an interview, Dr. Noorchashm said he wants to see a regulatory framework that doesn’t allow 510(k) devices (devices requiring a premarket notification to the FDA) to modify an existing standard of care without having been shown to have noninferior primary outcomes. When devices are used in the diagnosis or treatment of cancerous or potentially cancerous tissue, he said, this means primary oncologic outcomes must be shown to be noninferior.

“When you have 510(k) devices able to inject themselves and affect existing standards of care without any sort of clinical trial requirement, you get the standard of care changing without any outcomes data to back it up,” he said. “That’s what happened with the power morcellator. Physicians started using it without any sort of prospective data, level 1 outcomes data, and it dramatically changed the conduct of hysterectomies.”

In its safety communication, the FDA encourages the establishment of patient registries to gather data on robotically-assisted surgical devices for all uses, including the prevention and treatment of cancer. It also says that while the agency’s evaluation of the devices has generally focused on complication rates at 30 days, the FDA “anticipates” that their use in the prevention or treatment of cancer “would be supported by specific clinical outcomes, such as local cancer recurrence, disease-free survival, or overall survival at time periods much longer than 30 days.”

The American Society of Breast Surgeons has a Nipple Sparing Mastectomy Registry that is collecting oncologic outcomes as well as aesthetic outcomes and other metrics on 2,000 patients. “In the last year or two, we’ve seen nipple-sparing mastectomy become much more commonplace,” said Dr. Taylor. Thus far, the registry does not include robotic procedures, but “if there were interest in a registry specifically for robotic nipple-sparing mastectomy, we would do it in a heartbeat.”


 

Gynecologic oncology surgery

The randomized controlled study on radical hysterectomy for cervical cancer that caught the FDA’s attention reported lower rates of disease-free survival at 4.5 years with minimally invasive surgery than with open abdominal surgery (86% versus 96.5%) and lower rates of overall survival at 3 years.

The phase 3 multicenter Laparoscopic Approach to Cervical Cancer trial recruited more than 600 women with stage IA1, IA2, or IB1 cervical cancer. Most (91.9%) had IB1 disease and either squamous-cell carcinoma, adenocarcinoma, or adenosquamous carcinoma. Differences in the outcomes remained after adjustment for age, body mass index, disease stage, lymphovascular invasion, and lymph-node involvement. The findings led to early termination of the study.

The study did not single out robotically-assisted surgery. It was a two-arm study and was “not powered to analyze laparoscopy versus robotics,” lead author Pedro T. Ramirez, MD, of the University of Texas MD Anderson Cancer Center, said in an interview. “But based on our numbers, we saw no difference [in outcomes] between the two groups.” Of the patients who underwent minimally invasive surgery, 84.4% underwent laparoscopy and 15.6% underwent robot-assisted surgery.

The study, funded by MD Anderson and Medtronic, has been criticized for potential design and conduct issues. Outside experts pointed out that the study involved extremely small numbers of patients at each of the 33 participating centers, and that cancer recurrences were clustered at 14 of these centers. It’s important to appreciate, Dr. Ramirez said in the interview, that the majority of patients were accrued in these 14 centers.

In its safety communication, the FDA noted that other researchers have reported no statistically significant difference in long-term survival when open and minimally invasive approaches to radical hysterectomy for cervical cancer have been compared.

Asked to comment on the FDA’s safety communication, Dwight D. Im, MD, who leads the National Institute of Robotic Surgery at Mercy in Baltimore, said in an e-mail that “while robotic surgery may advance into new areas, such as mastectomy and cancer prevention, more research must be done and this should be part of any conversation between gyn-surgeons who are experienced in the realm of robotic surgery, and their patients.”

Regarding the treatment of cervical cancer, “I think it is safe to say that most gynecologic oncologists now offer only open laparotomies until we have more data comparing open to minimally invasive (laparoscopic and robotic) approaches,” he said.

The FDA said in a briefing document accompanying the safety communication that it has received a “small number of medical device reports of patient injury when [robotically-assisted surgical devices] are used in cancer-related procedures.”

According to the FDA spokesperson, 5 of 32 medical device reports received between January 2016 and December 2018 describe patients who underwent hysterectomy and experienced metastases afterward. It does not appear that any of the 5 cases were a direct result of a system error or device malfunction, and the complications described in the reports are not unique to robotically-assisted surgical devices, the spokesperson said.

The safety communication “reflects the agency’s commitment to enhancing the oversight of device safety as part of our Medical Device Action Plan, as well as the agency’s ongoing commitment to advancing women’s health.”

Dr. Taylor reported that he has no current financial disclosures. Dr. Ramirez reported to the New England Journal of Medicine that he had no relevant disclosures. Dr. Im reported that he is a speaker for Intuitive Surgical, which manufacturers the da Vinci Surgical System, as well as for Conmed and Ethicon.

A new safety communication from the Food and Drug Administration on the use of robotically assisted surgical devices for mastectomy and other cancer-related surgeries in women encourages physician-patient dialogue and suggests that, moving forward, data on specific oncologic outcomes – not only perioperative and short-term outcomes – are key.

The FDA is “warning patients and providers that the use of robotically assisted surgical devices for any cancer-related surgery has not been granted marketing authorization by the agency, and therefore the survival benefits to patients when compared to traditional surgery have not been established,” Terri Cornelison, MD, PhD, assistant director for the health of women in the FDA’s Center for Devices and Radiological Health, said in a statement.

The safety communication focuses on women and calls attention specifically to robotically-assisted mastectomy and hysterectomy for early cervical cancers. It says there is “limited, preliminary evidence that the use of robotically-assisted surgical devices for treatment or prevention of cancers that primarily (breast) or exclusively (cervical) affect women may be associated with diminished long-term survival.”

The FDA cited a multicenter randomized trial that found that minimally invasive radical hysterectomy in women with cervical cancer (laparoscopic and robotically assisted) was associated with a lower rate of long-term survival compared with open surgery (N Engl J Med. 2018;379:1895-1904).

The communication does not refer to any other specific studies. Regarding current evidence on robotically-assisted mastectomies, the FDA safety communication says simply that safety and effectiveness have not been established and that the agency is “aware of scientific literature and media publications describing surgeons and hospital systems that use robotically-assisted surgical devices for mastectomy.”


 

Robotically-assisted mastectomy

Walton Taylor, MD, president of the American Society of Breast Surgeons and a surgeon with Texas Health Physicians Group in Dallas, said that the FDA’s concern is valid. “I really hope that robotic surgery turns out to be good [for mastectomy]. It’s awesome technology that can be great for patients,” he said. “But we have to gather real data that shows that long-term and short-term outcomes – from a cancer standpoint – are as good as with the open procedure ... that there aren’t negative unintended consequences.”

Right now, Dr. Taylor said, robotic mastectomy “is not commonplace by any means.”

The technique for robotic nipple-sparing mastectomy (NSM) was first described by Antonio Toesca, MD, of the European Institute of Oncology in Milan (Ann Surg. 2017;266[2]:e28-e30).

In an editorial published recently in Annals of Surgical Oncology, Jesse C. Selber, MD, MPH, of the department of plastic surgery at the University of Texas MD Anderson Cancer Center in Houston, described the technique as a “natural next step in the evolution of minimally invasive breast surgery that has the potential to mitigate the challenges associated with traditional NSM” (Ann Surg Oncol. 2019;26[1]:10-11). Robotic nipple-sparing mastectomy is catching on in Europe” with very promising early results, he wrote.

At least a couple of practices promoted their performance of robotic mastectomy last year. Northwell Health, a large network of hospitals, outpatient facilities, and physicians in New York, announced in March 2018 that Neil Tanna, MD, and Alan Kadison, MD, of the divisions of plastic and reconstructive surgery and surgical oncology, respectively, had performed the first robotic nipple-sparing mastectomy and breast reconstructive surgery in the United States. Their patient carried the BRCA gene and had a preventive mastectomy at Northwell Health’s Long Island Jewish Medical Center.

In October 2018, a surgeon in Tinton Falls, N.J., Stephen Chagares, MD, announced that he had performed the first robotic nipple-sparing mastectomy with reconstruction in a patient with breast cancer at Monmouth Medical Center. His press release described a 3-cm incision “to the side of the breast, tucked neatly behind the armpit.” Both Dr. Chagares and Dr. Tanna had traveled to Milan to train with Dr. Toesca, according to the press releases.

Both of these cases – as well as a decision by Monmouth Medical Center in December 2018 to suspend the surgery pending further review – were mentioned in a letter submitted to the FDA in mid-December by Hooman Noorchashm, MD, PhD, a Philadelphia cardiothoracic surgeon-turned-patient-advocate whose wife Amy Josephine Reed, MD, PhD, died of uterine cancer in May 2017 following a laparoscopic hysterectomy performed with a power morcellator.

In his complaint, Dr. Noorchashm urged the agency to issue a warning about the “potentially dangerous/premature application” of robotic mastectomy for the treatment of breast cancer or BRCA carrier status outside the setting of randomized controlled trials with primary cancer–related outcomes metrics or an investigational device exemption from the FDA. (Receipt of the letter was acknowledged by the Allegation of Regulatory Misconduct Branch of the FDA several days later.)

In an interview, Dr. Noorchashm said he wants to see a regulatory framework that doesn’t allow 510(k) devices (devices requiring a premarket notification to the FDA) to modify an existing standard of care without having been shown to have noninferior primary outcomes. When devices are used in the diagnosis or treatment of cancerous or potentially cancerous tissue, he said, this means primary oncologic outcomes must be shown to be noninferior.

“When you have 510(k) devices able to inject themselves and affect existing standards of care without any sort of clinical trial requirement, you get the standard of care changing without any outcomes data to back it up,” he said. “That’s what happened with the power morcellator. Physicians started using it without any sort of prospective data, level 1 outcomes data, and it dramatically changed the conduct of hysterectomies.”

In its safety communication, the FDA encourages the establishment of patient registries to gather data on robotically-assisted surgical devices for all uses, including the prevention and treatment of cancer. It also says that while the agency’s evaluation of the devices has generally focused on complication rates at 30 days, the FDA “anticipates” that their use in the prevention or treatment of cancer “would be supported by specific clinical outcomes, such as local cancer recurrence, disease-free survival, or overall survival at time periods much longer than 30 days.”

The American Society of Breast Surgeons has a Nipple Sparing Mastectomy Registry that is collecting oncologic outcomes as well as aesthetic outcomes and other metrics on 2,000 patients. “In the last year or two, we’ve seen nipple-sparing mastectomy become much more commonplace,” said Dr. Taylor. Thus far, the registry does not include robotic procedures, but “if there were interest in a registry specifically for robotic nipple-sparing mastectomy, we would do it in a heartbeat.”


 

Gynecologic oncology surgery

The randomized controlled study on radical hysterectomy for cervical cancer that caught the FDA’s attention reported lower rates of disease-free survival at 4.5 years with minimally invasive surgery than with open abdominal surgery (86% versus 96.5%) and lower rates of overall survival at 3 years.

The phase 3 multicenter Laparoscopic Approach to Cervical Cancer trial recruited more than 600 women with stage IA1, IA2, or IB1 cervical cancer. Most (91.9%) had IB1 disease and either squamous-cell carcinoma, adenocarcinoma, or adenosquamous carcinoma. Differences in the outcomes remained after adjustment for age, body mass index, disease stage, lymphovascular invasion, and lymph-node involvement. The findings led to early termination of the study.

The study did not single out robotically-assisted surgery. It was a two-arm study and was “not powered to analyze laparoscopy versus robotics,” lead author Pedro T. Ramirez, MD, of the University of Texas MD Anderson Cancer Center, said in an interview. “But based on our numbers, we saw no difference [in outcomes] between the two groups.” Of the patients who underwent minimally invasive surgery, 84.4% underwent laparoscopy and 15.6% underwent robot-assisted surgery.

The study, funded by MD Anderson and Medtronic, has been criticized for potential design and conduct issues. Outside experts pointed out that the study involved extremely small numbers of patients at each of the 33 participating centers, and that cancer recurrences were clustered at 14 of these centers. It’s important to appreciate, Dr. Ramirez said in the interview, that the majority of patients were accrued in these 14 centers.

In its safety communication, the FDA noted that other researchers have reported no statistically significant difference in long-term survival when open and minimally invasive approaches to radical hysterectomy for cervical cancer have been compared.

Asked to comment on the FDA’s safety communication, Dwight D. Im, MD, who leads the National Institute of Robotic Surgery at Mercy in Baltimore, said in an e-mail that “while robotic surgery may advance into new areas, such as mastectomy and cancer prevention, more research must be done and this should be part of any conversation between gyn-surgeons who are experienced in the realm of robotic surgery, and their patients.”

Regarding the treatment of cervical cancer, “I think it is safe to say that most gynecologic oncologists now offer only open laparotomies until we have more data comparing open to minimally invasive (laparoscopic and robotic) approaches,” he said.

The FDA said in a briefing document accompanying the safety communication that it has received a “small number of medical device reports of patient injury when [robotically-assisted surgical devices] are used in cancer-related procedures.”

According to the FDA spokesperson, 5 of 32 medical device reports received between January 2016 and December 2018 describe patients who underwent hysterectomy and experienced metastases afterward. It does not appear that any of the 5 cases were a direct result of a system error or device malfunction, and the complications described in the reports are not unique to robotically-assisted surgical devices, the spokesperson said.

The safety communication “reflects the agency’s commitment to enhancing the oversight of device safety as part of our Medical Device Action Plan, as well as the agency’s ongoing commitment to advancing women’s health.”

Dr. Taylor reported that he has no current financial disclosures. Dr. Ramirez reported to the New England Journal of Medicine that he had no relevant disclosures. Dr. Im reported that he is a speaker for Intuitive Surgical, which manufacturers the da Vinci Surgical System, as well as for Conmed and Ethicon.

A new safety communication from the Food and Drug Administration on the use of robotically assisted surgical devices for mastectomy and other cancer-related surgeries in women encourages physician-patient dialogue and suggests that, moving forward, data on specific oncologic outcomes – not only perioperative and short-term outcomes – are key.

The FDA is “warning patients and providers that the use of robotically assisted surgical devices for any cancer-related surgery has not been granted marketing authorization by the agency, and therefore the survival benefits to patients when compared to traditional surgery have not been established,” Terri Cornelison, MD, PhD, assistant director for the health of women in the FDA’s Center for Devices and Radiological Health, said in a statement.

The safety communication focuses on women and calls attention specifically to robotically-assisted mastectomy and hysterectomy for early cervical cancers. It says there is “limited, preliminary evidence that the use of robotically-assisted surgical devices for treatment or prevention of cancers that primarily (breast) or exclusively (cervical) affect women may be associated with diminished long-term survival.”

The FDA cited a multicenter randomized trial that found that minimally invasive radical hysterectomy in women with cervical cancer (laparoscopic and robotically assisted) was associated with a lower rate of long-term survival compared with open surgery (N Engl J Med. 2018;379:1895-1904).

The communication does not refer to any other specific studies. Regarding current evidence on robotically-assisted mastectomies, the FDA safety communication says simply that safety and effectiveness have not been established and that the agency is “aware of scientific literature and media publications describing surgeons and hospital systems that use robotically-assisted surgical devices for mastectomy.”


 

Robotically-assisted mastectomy

Walton Taylor, MD, president of the American Society of Breast Surgeons and a surgeon with Texas Health Physicians Group in Dallas, said that the FDA’s concern is valid. “I really hope that robotic surgery turns out to be good [for mastectomy]. It’s awesome technology that can be great for patients,” he said. “But we have to gather real data that shows that long-term and short-term outcomes – from a cancer standpoint – are as good as with the open procedure ... that there aren’t negative unintended consequences.”

Right now, Dr. Taylor said, robotic mastectomy “is not commonplace by any means.”

The technique for robotic nipple-sparing mastectomy (NSM) was first described by Antonio Toesca, MD, of the European Institute of Oncology in Milan (Ann Surg. 2017;266[2]:e28-e30).

In an editorial published recently in Annals of Surgical Oncology, Jesse C. Selber, MD, MPH, of the department of plastic surgery at the University of Texas MD Anderson Cancer Center in Houston, described the technique as a “natural next step in the evolution of minimally invasive breast surgery that has the potential to mitigate the challenges associated with traditional NSM” (Ann Surg Oncol. 2019;26[1]:10-11). Robotic nipple-sparing mastectomy is catching on in Europe” with very promising early results, he wrote.

At least a couple of practices promoted their performance of robotic mastectomy last year. Northwell Health, a large network of hospitals, outpatient facilities, and physicians in New York, announced in March 2018 that Neil Tanna, MD, and Alan Kadison, MD, of the divisions of plastic and reconstructive surgery and surgical oncology, respectively, had performed the first robotic nipple-sparing mastectomy and breast reconstructive surgery in the United States. Their patient carried the BRCA gene and had a preventive mastectomy at Northwell Health’s Long Island Jewish Medical Center.

In October 2018, a surgeon in Tinton Falls, N.J., Stephen Chagares, MD, announced that he had performed the first robotic nipple-sparing mastectomy with reconstruction in a patient with breast cancer at Monmouth Medical Center. His press release described a 3-cm incision “to the side of the breast, tucked neatly behind the armpit.” Both Dr. Chagares and Dr. Tanna had traveled to Milan to train with Dr. Toesca, according to the press releases.

Both of these cases – as well as a decision by Monmouth Medical Center in December 2018 to suspend the surgery pending further review – were mentioned in a letter submitted to the FDA in mid-December by Hooman Noorchashm, MD, PhD, a Philadelphia cardiothoracic surgeon-turned-patient-advocate whose wife Amy Josephine Reed, MD, PhD, died of uterine cancer in May 2017 following a laparoscopic hysterectomy performed with a power morcellator.

In his complaint, Dr. Noorchashm urged the agency to issue a warning about the “potentially dangerous/premature application” of robotic mastectomy for the treatment of breast cancer or BRCA carrier status outside the setting of randomized controlled trials with primary cancer–related outcomes metrics or an investigational device exemption from the FDA. (Receipt of the letter was acknowledged by the Allegation of Regulatory Misconduct Branch of the FDA several days later.)

In an interview, Dr. Noorchashm said he wants to see a regulatory framework that doesn’t allow 510(k) devices (devices requiring a premarket notification to the FDA) to modify an existing standard of care without having been shown to have noninferior primary outcomes. When devices are used in the diagnosis or treatment of cancerous or potentially cancerous tissue, he said, this means primary oncologic outcomes must be shown to be noninferior.

“When you have 510(k) devices able to inject themselves and affect existing standards of care without any sort of clinical trial requirement, you get the standard of care changing without any outcomes data to back it up,” he said. “That’s what happened with the power morcellator. Physicians started using it without any sort of prospective data, level 1 outcomes data, and it dramatically changed the conduct of hysterectomies.”

In its safety communication, the FDA encourages the establishment of patient registries to gather data on robotically-assisted surgical devices for all uses, including the prevention and treatment of cancer. It also says that while the agency’s evaluation of the devices has generally focused on complication rates at 30 days, the FDA “anticipates” that their use in the prevention or treatment of cancer “would be supported by specific clinical outcomes, such as local cancer recurrence, disease-free survival, or overall survival at time periods much longer than 30 days.”

The American Society of Breast Surgeons has a Nipple Sparing Mastectomy Registry that is collecting oncologic outcomes as well as aesthetic outcomes and other metrics on 2,000 patients. “In the last year or two, we’ve seen nipple-sparing mastectomy become much more commonplace,” said Dr. Taylor. Thus far, the registry does not include robotic procedures, but “if there were interest in a registry specifically for robotic nipple-sparing mastectomy, we would do it in a heartbeat.”


 

Gynecologic oncology surgery

The randomized controlled study on radical hysterectomy for cervical cancer that caught the FDA’s attention reported lower rates of disease-free survival at 4.5 years with minimally invasive surgery than with open abdominal surgery (86% versus 96.5%) and lower rates of overall survival at 3 years.

The phase 3 multicenter Laparoscopic Approach to Cervical Cancer trial recruited more than 600 women with stage IA1, IA2, or IB1 cervical cancer. Most (91.9%) had IB1 disease and either squamous-cell carcinoma, adenocarcinoma, or adenosquamous carcinoma. Differences in the outcomes remained after adjustment for age, body mass index, disease stage, lymphovascular invasion, and lymph-node involvement. The findings led to early termination of the study.

The study did not single out robotically-assisted surgery. It was a two-arm study and was “not powered to analyze laparoscopy versus robotics,” lead author Pedro T. Ramirez, MD, of the University of Texas MD Anderson Cancer Center, said in an interview. “But based on our numbers, we saw no difference [in outcomes] between the two groups.” Of the patients who underwent minimally invasive surgery, 84.4% underwent laparoscopy and 15.6% underwent robot-assisted surgery.

The study, funded by MD Anderson and Medtronic, has been criticized for potential design and conduct issues. Outside experts pointed out that the study involved extremely small numbers of patients at each of the 33 participating centers, and that cancer recurrences were clustered at 14 of these centers. It’s important to appreciate, Dr. Ramirez said in the interview, that the majority of patients were accrued in these 14 centers.

In its safety communication, the FDA noted that other researchers have reported no statistically significant difference in long-term survival when open and minimally invasive approaches to radical hysterectomy for cervical cancer have been compared.

Asked to comment on the FDA’s safety communication, Dwight D. Im, MD, who leads the National Institute of Robotic Surgery at Mercy in Baltimore, said in an e-mail that “while robotic surgery may advance into new areas, such as mastectomy and cancer prevention, more research must be done and this should be part of any conversation between gyn-surgeons who are experienced in the realm of robotic surgery, and their patients.”

Regarding the treatment of cervical cancer, “I think it is safe to say that most gynecologic oncologists now offer only open laparotomies until we have more data comparing open to minimally invasive (laparoscopic and robotic) approaches,” he said.

The FDA said in a briefing document accompanying the safety communication that it has received a “small number of medical device reports of patient injury when [robotically-assisted surgical devices] are used in cancer-related procedures.”

According to the FDA spokesperson, 5 of 32 medical device reports received between January 2016 and December 2018 describe patients who underwent hysterectomy and experienced metastases afterward. It does not appear that any of the 5 cases were a direct result of a system error or device malfunction, and the complications described in the reports are not unique to robotically-assisted surgical devices, the spokesperson said.

The safety communication “reflects the agency’s commitment to enhancing the oversight of device safety as part of our Medical Device Action Plan, as well as the agency’s ongoing commitment to advancing women’s health.”

Dr. Taylor reported that he has no current financial disclosures. Dr. Ramirez reported to the New England Journal of Medicine that he had no relevant disclosures. Dr. Im reported that he is a speaker for Intuitive Surgical, which manufacturers the da Vinci Surgical System, as well as for Conmed and Ethicon.

The American Society of Clinical Oncology has issued a new guideline on the early detection and management of colorectal cancer in people at average risk for colorectal cancer, which was written by Gilberto Lopes, MD, of the University of Miami and his associates on an ASCO expert panel.

The panel assembled by ASCO to write the guideline consisted of medical oncology, surgical oncology, surgery, gastroenterology, health technology assessment, cancer epidemiology, pathology, radiology, radiation oncology, and patient advocacy experts. Guidelines from eight different developers were examined, and recommendations from those guidelines were adapted to form the new ASCO guideline. The guideline was published in the Journal of Global Oncology.

In people who are asymptomatic, are aged 50-75 years, have no family history of colorectal cancer, are at average risk, and are in settings with high incidences of colorectal cancer, the expert panel recommends guaiac fecal occult blood test or fecal immunochemical testing every 1-2 years, flexible sigmoidoscopy every 5 years, a combination of flexible sigmoidoscopy every 10 years and annual stool-based testing, or colonoscopy every 10 years, depending on available resources. The testing strategy for those with positive stool-based testing or flxible sigmoidoscopy is colonoscopy or a double-contrast barium enema if colonoscopy is unavailable.

For patients who have polyps, polypectomy at the time of colonoscopy is recommended, with the option of referral for surgical resection if not suitable for endoscopic resection. When symptoms (iron-deficiency anemia, bleeding abdominal pain and/or change in bowel habits) are present, a colonoscopy should be performed if available. If colonoscopy is contraindicated, a double-contrast barium enema can be performed; if endoscopy is contraindicated, CT colonography can be performed.

More information, including a data supplement with additional evidence tables, a methodology supplement with information about evidence quality and strength of recommendations, slide sets, and clinical tools and resources is available at www.asco.org/resource-stratified-guidelines, the guideline noted.

Several members of the expert panel reported conflicts of interest.

Review AGA and U.S. Multi-society Task Force on Colorectal Cancer guidelines and recommendations on colorectal cancer screening, evaluation of Lynch Syndrome, colonoscopy and bowel cleansing at https://www.gastro.org/guidelines/colorectal-cancer.

lfranki@mdedge.com

SOURCE: Lopes G et al. J Glob Oncol. 2019 Feb 25. doi: 10.1200/JGO.18.00213.

The American Society of Clinical Oncology has issued a new guideline on the early detection and management of colorectal cancer in people at average risk for colorectal cancer, which was written by Gilberto Lopes, MD, of the University of Miami and his associates on an ASCO expert panel.

The panel assembled by ASCO to write the guideline consisted of medical oncology, surgical oncology, surgery, gastroenterology, health technology assessment, cancer epidemiology, pathology, radiology, radiation oncology, and patient advocacy experts. Guidelines from eight different developers were examined, and recommendations from those guidelines were adapted to form the new ASCO guideline. The guideline was published in the Journal of Global Oncology.

In people who are asymptomatic, are aged 50-75 years, have no family history of colorectal cancer, are at average risk, and are in settings with high incidences of colorectal cancer, the expert panel recommends guaiac fecal occult blood test or fecal immunochemical testing every 1-2 years, flexible sigmoidoscopy every 5 years, a combination of flexible sigmoidoscopy every 10 years and annual stool-based testing, or colonoscopy every 10 years, depending on available resources. The testing strategy for those with positive stool-based testing or flxible sigmoidoscopy is colonoscopy or a double-contrast barium enema if colonoscopy is unavailable.

For patients who have polyps, polypectomy at the time of colonoscopy is recommended, with the option of referral for surgical resection if not suitable for endoscopic resection. When symptoms (iron-deficiency anemia, bleeding abdominal pain and/or change in bowel habits) are present, a colonoscopy should be performed if available. If colonoscopy is contraindicated, a double-contrast barium enema can be performed; if endoscopy is contraindicated, CT colonography can be performed.

More information, including a data supplement with additional evidence tables, a methodology supplement with information about evidence quality and strength of recommendations, slide sets, and clinical tools and resources is available at www.asco.org/resource-stratified-guidelines, the guideline noted.

Several members of the expert panel reported conflicts of interest.

Review AGA and U.S. Multi-society Task Force on Colorectal Cancer guidelines and recommendations on colorectal cancer screening, evaluation of Lynch Syndrome, colonoscopy and bowel cleansing at https://www.gastro.org/guidelines/colorectal-cancer.

lfranki@mdedge.com

SOURCE: Lopes G et al. J Glob Oncol. 2019 Feb 25. doi: 10.1200/JGO.18.00213.

The American Society of Clinical Oncology has issued a new guideline on the early detection and management of colorectal cancer in people at average risk for colorectal cancer, which was written by Gilberto Lopes, MD, of the University of Miami and his associates on an ASCO expert panel.

The panel assembled by ASCO to write the guideline consisted of medical oncology, surgical oncology, surgery, gastroenterology, health technology assessment, cancer epidemiology, pathology, radiology, radiation oncology, and patient advocacy experts. Guidelines from eight different developers were examined, and recommendations from those guidelines were adapted to form the new ASCO guideline. The guideline was published in the Journal of Global Oncology.

In people who are asymptomatic, are aged 50-75 years, have no family history of colorectal cancer, are at average risk, and are in settings with high incidences of colorectal cancer, the expert panel recommends guaiac fecal occult blood test or fecal immunochemical testing every 1-2 years, flexible sigmoidoscopy every 5 years, a combination of flexible sigmoidoscopy every 10 years and annual stool-based testing, or colonoscopy every 10 years, depending on available resources. The testing strategy for those with positive stool-based testing or flxible sigmoidoscopy is colonoscopy or a double-contrast barium enema if colonoscopy is unavailable.

For patients who have polyps, polypectomy at the time of colonoscopy is recommended, with the option of referral for surgical resection if not suitable for endoscopic resection. When symptoms (iron-deficiency anemia, bleeding abdominal pain and/or change in bowel habits) are present, a colonoscopy should be performed if available. If colonoscopy is contraindicated, a double-contrast barium enema can be performed; if endoscopy is contraindicated, CT colonography can be performed.

More information, including a data supplement with additional evidence tables, a methodology supplement with information about evidence quality and strength of recommendations, slide sets, and clinical tools and resources is available at www.asco.org/resource-stratified-guidelines, the guideline noted.

Several members of the expert panel reported conflicts of interest.

Review AGA and U.S. Multi-society Task Force on Colorectal Cancer guidelines and recommendations on colorectal cancer screening, evaluation of Lynch Syndrome, colonoscopy and bowel cleansing at https://www.gastro.org/guidelines/colorectal-cancer.

lfranki@mdedge.com

SOURCE: Lopes G et al. J Glob Oncol. 2019 Feb 25. doi: 10.1200/JGO.18.00213.

The American Society of Clinical Oncology has issued a new guideline on the early detection and management of colorectal cancer in people at average risk for colorectal cancer, which was written by Gilberto Lopes, MD, of the University of Miami and his associates on an ASCO expert panel.

The panel assembled by ASCO to write the guideline consisted of medical oncology, surgical oncology, surgery, gastroenterology, health technology assessment, cancer epidemiology, pathology, radiology, radiation oncology, and patient advocacy experts. Guidelines from eight different developers were examined, and recommendations from those guidelines were adapted to form the new ASCO guideline. The guideline was published in the Journal of Global Oncology.

In people who are asymptomatic, are aged 50-75 years, have no family history of colorectal cancer, are at average risk, and are in settings with high incidences of colorectal cancer, the expert panel recommends guaiac fecal occult blood test or fecal immunochemical testing every 1-2 years, flexible sigmoidoscopy every 5 years, a combination of flexible sigmoidoscopy every 10 years and annual stool-based testing, or colonoscopy every 10 years, depending on available resources. The testing strategy for those with positive stool-based testing or flexible sigmoidoscopy is colonoscopy or a double-contrast barium enema if colonoscopy is unavailable.

For patients who have polyps, polypectomy at the time of colonoscopy is recommended, with the option of referral for surgical resection if not suitable for endoscopic resection. When symptoms (iron-deficiency anemia, bleeding, abdominal pain, and/or change in bowel habits) are present, a colonoscopy should be performed if available. If colonoscopy is contraindicated, a double-contrast barium enema can be performed; if endoscopy is contraindicated, CT colonography can be performed.

More information, including a data supplement with additional evidence tables, a methodology supplement with information about evidence quality and strength of recommendations, slide sets, and clinical tools and resources is available at www.asco.org/resource-stratified-guidelines, the guideline noted.

Several members of the expert panel reported conflicts of interest.

lfranki@mdedge.com

SOURCE: Lopes G et al. J Glob Oncol. 2019 Feb 25. doi: 10.1200/JGO.18.00213.

This story was updated on March 4, 2019.

The American Society of Clinical Oncology has issued a new guideline on the early detection and management of colorectal cancer in people at average risk for colorectal cancer, which was written by Gilberto Lopes, MD, of the University of Miami and his associates on an ASCO expert panel.

The panel assembled by ASCO to write the guideline consisted of medical oncology, surgical oncology, surgery, gastroenterology, health technology assessment, cancer epidemiology, pathology, radiology, radiation oncology, and patient advocacy experts. Guidelines from eight different developers were examined, and recommendations from those guidelines were adapted to form the new ASCO guideline. The guideline was published in the Journal of Global Oncology.

In people who are asymptomatic, are aged 50-75 years, have no family history of colorectal cancer, are at average risk, and are in settings with high incidences of colorectal cancer, the expert panel recommends guaiac fecal occult blood test or fecal immunochemical testing every 1-2 years, flexible sigmoidoscopy every 5 years, a combination of flexible sigmoidoscopy every 10 years and annual stool-based testing, or colonoscopy every 10 years, depending on available resources. The testing strategy for those with positive stool-based testing or flexible sigmoidoscopy is colonoscopy or a double-contrast barium enema if colonoscopy is unavailable.

For patients who have polyps, polypectomy at the time of colonoscopy is recommended, with the option of referral for surgical resection if not suitable for endoscopic resection. When symptoms (iron-deficiency anemia, bleeding, abdominal pain, and/or change in bowel habits) are present, a colonoscopy should be performed if available. If colonoscopy is contraindicated, a double-contrast barium enema can be performed; if endoscopy is contraindicated, CT colonography can be performed.

More information, including a data supplement with additional evidence tables, a methodology supplement with information about evidence quality and strength of recommendations, slide sets, and clinical tools and resources is available at www.asco.org/resource-stratified-guidelines, the guideline noted.

Several members of the expert panel reported conflicts of interest.

lfranki@mdedge.com

SOURCE: Lopes G et al. J Glob Oncol. 2019 Feb 25. doi: 10.1200/JGO.18.00213.

This story was updated on March 4, 2019.

The American Society of Clinical Oncology has issued a new guideline on the early detection and management of colorectal cancer in people at average risk for colorectal cancer, which was written by Gilberto Lopes, MD, of the University of Miami and his associates on an ASCO expert panel.

The panel assembled by ASCO to write the guideline consisted of medical oncology, surgical oncology, surgery, gastroenterology, health technology assessment, cancer epidemiology, pathology, radiology, radiation oncology, and patient advocacy experts. Guidelines from eight different developers were examined, and recommendations from those guidelines were adapted to form the new ASCO guideline. The guideline was published in the Journal of Global Oncology.

In people who are asymptomatic, are aged 50-75 years, have no family history of colorectal cancer, are at average risk, and are in settings with high incidences of colorectal cancer, the expert panel recommends guaiac fecal occult blood test or fecal immunochemical testing every 1-2 years, flexible sigmoidoscopy every 5 years, a combination of flexible sigmoidoscopy every 10 years and annual stool-based testing, or colonoscopy every 10 years, depending on available resources. The testing strategy for those with positive stool-based testing or flexible sigmoidoscopy is colonoscopy or a double-contrast barium enema if colonoscopy is unavailable.

For patients who have polyps, polypectomy at the time of colonoscopy is recommended, with the option of referral for surgical resection if not suitable for endoscopic resection. When symptoms (iron-deficiency anemia, bleeding, abdominal pain, and/or change in bowel habits) are present, a colonoscopy should be performed if available. If colonoscopy is contraindicated, a double-contrast barium enema can be performed; if endoscopy is contraindicated, CT colonography can be performed.

More information, including a data supplement with additional evidence tables, a methodology supplement with information about evidence quality and strength of recommendations, slide sets, and clinical tools and resources is available at www.asco.org/resource-stratified-guidelines, the guideline noted.

Several members of the expert panel reported conflicts of interest.

lfranki@mdedge.com

SOURCE: Lopes G et al. J Glob Oncol. 2019 Feb 25. doi: 10.1200/JGO.18.00213.

This story was updated on March 4, 2019.

SAN FRANCISCO – The immune checkpoint inhibitor pembrolizumab (Keytruda) was associated in a small case series with remarkable overall and progression-free survival of patients with pulmonary sarcomatoid carcinoma (PSC), a rare variant of non–small cell lung cancer (NSCLC) with a grim prognosis.

Among five patients with PSC, three of whom were treatment naive, none experienced disease progression on pembrolizumab after a median follow-up of 13 months – although one died from a fungal infection unrelated to therapy – with the longest overall survival to date out to 33 months.

In contrast, patients with PSC treated before the advent of immunotherapy had a median progression-free survival of just 2 months and median overall survival a brief 4-6 months, reported Vineeth Sukrithan, MD, and his colleagues at the Albert Einstein College of Medicine, New York.

“It’s a uniquely enriched population of patients with lung cancer that have the best prognosis in terms of benefits from checkpoint inhibitors,” he said in an interview at the ASCO-SITC Clinical Immuno-Oncology Symposium.

PSC, a poorly differentiated subtype of NSCLC, accounts for about 0.3%-1.3% of all cases of lung cancer. It is closely associated with a history of heavy cigarette smoking and is rapidly fatal, with a poor response to conventional chemotherapy, although approximately 20% of patients with PSC have MET exon 14–skipping mutations that are “exquisitely” sensitive to crizotinib (Xalkori), Dr. Sukrithan explained.

PSC tumors are also unique in that they have extraordinarily high levels of programmed death-ligand 1 (PD-L1), the target of immune checkpoint inhibitors, with tumor proportion scores exceeding 90% in some cases.

Additionally, up to 43% of PSC tumors have been found to have a high mutational burden, with more than 10 mutations per megabase, suggesting that these tumors may be especially attractive targets for checkpoint inhibitor therapy, he said.

The investigators retrospectively studied surgical pathology and treatment records for all patients with advanced PSC diagnosed at their center from June 2015 to June 2018 who received pembrolizumab. They performed immunohistochemistry testing on tissue samples from the patients to quantify PD-L1 expression.

They compared the results with a cohort of patients with advanced PSC diagnosed from June 2012 to June 2015, prior to the clinical availability of anti-PD-1/PD-L1 checkpoint inhibitors.

The PD-L1-treated cohort included two men and three women, ranging from 48 to 67 years, with smoking pack-years ranging from 24 to 50. Two of the patients had received prior chemotherapy followed by pembrolizumab, and the remaining three received pembrolizumab monotherapy.

Tumor proportion scores ranged from more than 75% of tumor cells examined in one patient to 100% of cells in another.

The objective response rate to pembrolizumab was 80% consisting of one complete response and three partial responses. The fifth patient continued to have stable disease out to more than 17 months.

“This highly treatment-refractory disease now should be carefully assessed for immuno-oncologic and molecularly targeted options, which are associated with significant improvement in outcomes,” the investigators wrote in a poster presentation.

The study was internally funded. Dr. Sukrithan reported having no disclosures.

SOURCE: Sukrithan V et al. ASCO-SITC, Abstract 115.

SAN FRANCISCO – The immune checkpoint inhibitor pembrolizumab (Keytruda) was associated in a small case series with remarkable overall and progression-free survival of patients with pulmonary sarcomatoid carcinoma (PSC), a rare variant of non–small cell lung cancer (NSCLC) with a grim prognosis.

Among five patients with PSC, three of whom were treatment naive, none experienced disease progression on pembrolizumab after a median follow-up of 13 months – although one died from a fungal infection unrelated to therapy – with the longest overall survival to date out to 33 months.

In contrast, patients with PSC treated before the advent of immunotherapy had a median progression-free survival of just 2 months and median overall survival a brief 4-6 months, reported Vineeth Sukrithan, MD, and his colleagues at the Albert Einstein College of Medicine, New York.

“It’s a uniquely enriched population of patients with lung cancer that have the best prognosis in terms of benefits from checkpoint inhibitors,” he said in an interview at the ASCO-SITC Clinical Immuno-Oncology Symposium.

PSC, a poorly differentiated subtype of NSCLC, accounts for about 0.3%-1.3% of all cases of lung cancer. It is closely associated with a history of heavy cigarette smoking and is rapidly fatal, with a poor response to conventional chemotherapy, although approximately 20% of patients with PSC have MET exon 14–skipping mutations that are “exquisitely” sensitive to crizotinib (Xalkori), Dr. Sukrithan explained.

PSC tumors are also unique in that they have extraordinarily high levels of programmed death-ligand 1 (PD-L1), the target of immune checkpoint inhibitors, with tumor proportion scores exceeding 90% in some cases.

Additionally, up to 43% of PSC tumors have been found to have a high mutational burden, with more than 10 mutations per megabase, suggesting that these tumors may be especially attractive targets for checkpoint inhibitor therapy, he said.

The investigators retrospectively studied surgical pathology and treatment records for all patients with advanced PSC diagnosed at their center from June 2015 to June 2018 who received pembrolizumab. They performed immunohistochemistry testing on tissue samples from the patients to quantify PD-L1 expression.

They compared the results with a cohort of patients with advanced PSC diagnosed from June 2012 to June 2015, prior to the clinical availability of anti-PD-1/PD-L1 checkpoint inhibitors.

The PD-L1-treated cohort included two men and three women, ranging from 48 to 67 years, with smoking pack-years ranging from 24 to 50. Two of the patients had received prior chemotherapy followed by pembrolizumab, and the remaining three received pembrolizumab monotherapy.

Tumor proportion scores ranged from more than 75% of tumor cells examined in one patient to 100% of cells in another.

The objective response rate to pembrolizumab was 80% consisting of one complete response and three partial responses. The fifth patient continued to have stable disease out to more than 17 months.

“This highly treatment-refractory disease now should be carefully assessed for immuno-oncologic and molecularly targeted options, which are associated with significant improvement in outcomes,” the investigators wrote in a poster presentation.

The study was internally funded. Dr. Sukrithan reported having no disclosures.

SOURCE: Sukrithan V et al. ASCO-SITC, Abstract 115.

SAN FRANCISCO – The immune checkpoint inhibitor pembrolizumab (Keytruda) was associated in a small case series with remarkable overall and progression-free survival of patients with pulmonary sarcomatoid carcinoma (PSC), a rare variant of non–small cell lung cancer (NSCLC) with a grim prognosis.

Among five patients with PSC, three of whom were treatment naive, none experienced disease progression on pembrolizumab after a median follow-up of 13 months – although one died from a fungal infection unrelated to therapy – with the longest overall survival to date out to 33 months.

In contrast, patients with PSC treated before the advent of immunotherapy had a median progression-free survival of just 2 months and median overall survival a brief 4-6 months, reported Vineeth Sukrithan, MD, and his colleagues at the Albert Einstein College of Medicine, New York.

“It’s a uniquely enriched population of patients with lung cancer that have the best prognosis in terms of benefits from checkpoint inhibitors,” he said in an interview at the ASCO-SITC Clinical Immuno-Oncology Symposium.

PSC, a poorly differentiated subtype of NSCLC, accounts for about 0.3%-1.3% of all cases of lung cancer. It is closely associated with a history of heavy cigarette smoking and is rapidly fatal, with a poor response to conventional chemotherapy, although approximately 20% of patients with PSC have MET exon 14–skipping mutations that are “exquisitely” sensitive to crizotinib (Xalkori), Dr. Sukrithan explained.

PSC tumors are also unique in that they have extraordinarily high levels of programmed death-ligand 1 (PD-L1), the target of immune checkpoint inhibitors, with tumor proportion scores exceeding 90% in some cases.

Additionally, up to 43% of PSC tumors have been found to have a high mutational burden, with more than 10 mutations per megabase, suggesting that these tumors may be especially attractive targets for checkpoint inhibitor therapy, he said.

The investigators retrospectively studied surgical pathology and treatment records for all patients with advanced PSC diagnosed at their center from June 2015 to June 2018 who received pembrolizumab. They performed immunohistochemistry testing on tissue samples from the patients to quantify PD-L1 expression.

They compared the results with a cohort of patients with advanced PSC diagnosed from June 2012 to June 2015, prior to the clinical availability of anti-PD-1/PD-L1 checkpoint inhibitors.

The PD-L1-treated cohort included two men and three women, ranging from 48 to 67 years, with smoking pack-years ranging from 24 to 50. Two of the patients had received prior chemotherapy followed by pembrolizumab, and the remaining three received pembrolizumab monotherapy.

Tumor proportion scores ranged from more than 75% of tumor cells examined in one patient to 100% of cells in another.

The objective response rate to pembrolizumab was 80% consisting of one complete response and three partial responses. The fifth patient continued to have stable disease out to more than 17 months.

“This highly treatment-refractory disease now should be carefully assessed for immuno-oncologic and molecularly targeted options, which are associated with significant improvement in outcomes,” the investigators wrote in a poster presentation.

The study was internally funded. Dr. Sukrithan reported having no disclosures.

SOURCE: Sukrithan V et al. ASCO-SITC, Abstract 115.

WASHINGTON – Proteasome inhibitors are essential components of therapeutic regimens for multiple myeloma, but at least one member of this class of life-extending agents, carfilzomib (Kyprolis), is also associated with a significant increase in risk of heart failure, cautioned a specialist in plasma cell disorders.

Neil Osterweil/MDedge News

In addition, immunomodulating agents such as lenalidomide (Revlimid) and pomalidomide (Pomalyst) are associated with increased risk for thromboembolic events, said R. Frank Cornell, MD, clinical director of plasma cell disorders at Vanderbilt University Medical Center in Nashville, Tenn.

In an ongoing, prospective study comparing rates of cardiac adverse events in patients receiving carfilzomib or another proteasome inhibitor, bortezomib (Velcade), Dr. Cornell and his colleagues found that while there were no significant differences in progression-free survival (PFS) or overall survival (OS) between the treatments, “patients who experienced a cardiovascular event had significantly worse progression-free and overall survival compared to those that did not have a cardiovascular event,” he said at the American College of Cardiology’s Advancing the Cardiovascular Care of the Oncology Patient meeting.

The Prospective Observation of Cardiac Safety With Proteasome Inhibition (PROTECT) trial, scheduled for completion in August 2019, enrolled 95 patients with relapsed multiple myeloma and randomly assigned them on a 2:1 basis to receive carfilzomib or bortezomib.

The investigators found that cardiovascular adverse events occurred in 33 of the 65 patients (51%) randomized to carfilzomib, compared with 5 of 30 patients (17%) assigned to bortezomib.

The events included grade 1 or 2 heart failure (HF) in 12 patients on carfilzomib vs. 2 on bortezomib, and grade 3 or 4 HF in 11 vs. 1, respectively. Hypertension was significantly more frequent among patients on carfilzomib, and one patient on carfilzomib died from the acute coronary syndrome 24 hours after receiving carfilzomib in the second week of treatment.

The investigators found that both B-type natriuretic peptide (BNP) and N-terminal pro b-type natriuretic peptide (NT-proBNP) were highly predictive of cardiovascular adverse events. Patients on carfilzomib who had levels of the markers above normal at baseline had an odds ratio (OR) for cardiovascular events of 7.39 (P less than .0001), and those with BNP or NT-proBNP increases at week 2 or 3 during cycle 1 had an OR for a cardiovascular adverse event of 63.5 (P less than .001).

In multivariate analysis, the risk for cardiovascular events for patients treated with carfilzomib was significantly lower for patients with one or no traditional cardiovascular risk factors, compared with patients with two or more.

“Prospective monitoring with natriuretic peptides should be considered, particularly early in treatment,” Dr. Cornell said.
 

IMiDs and thromboembolism

In early clinical trials of immunomodulators (IMiDs) for multiple myeloma, investigators saw that the incidence of thromboembolic events was lower among patients who received thromboprophylaxis than among those who did not, Dr. Cornell noted.

“From this, certain guidelines have been developed such that all patients considered to be at risk should at least receive an aspirin, 81-325 mg, and patients at higher risk for thromboembolism should receive low-molecular-weight heparin or therapeutic-dose warfarin,” he said.

There is little guidance, however, about the use of direct oral anticoagulants in this population, he added, a fact that prompted him and his colleagues in oncology and cardiology to perform a pilot study of apixaban (Eliquis) for primary prevention of venous thromboembolism (VTE) in patients with multiple myeloma who were receiving immunodulatory drugs.

Results of the pilot study, reported in a poster session at the 2018 annual meeting of the American Society of Hematology, showed that among 50 patients who received apixaban 2.5 mg twice daily for 6 months during IMiD therapy, there were no VTEs, stroke, or myocardial infarction, and no episodes of major bleeding. There were just three nonmajor bleeding events, and one early withdrawal from apixaban due to an allergic reaction manifesting as generalized edema.

“Further study is needed to validate this as a potential primary prophylaxis in patients receiving IMiDs for multiple myeloma,” Dr. Cornell said.

He reported having no financial disclosures. Millennium Pharmaceuticals is a sponsor of the PROTECT trial.

WASHINGTON – Proteasome inhibitors are essential components of therapeutic regimens for multiple myeloma, but at least one member of this class of life-extending agents, carfilzomib (Kyprolis), is also associated with a significant increase in risk of heart failure, cautioned a specialist in plasma cell disorders.

Neil Osterweil/MDedge News

In addition, immunomodulating agents such as lenalidomide (Revlimid) and pomalidomide (Pomalyst) are associated with increased risk for thromboembolic events, said R. Frank Cornell, MD, clinical director of plasma cell disorders at Vanderbilt University Medical Center in Nashville, Tenn.

In an ongoing, prospective study comparing rates of cardiac adverse events in patients receiving carfilzomib or another proteasome inhibitor, bortezomib (Velcade), Dr. Cornell and his colleagues found that while there were no significant differences in progression-free survival (PFS) or overall survival (OS) between the treatments, “patients who experienced a cardiovascular event had significantly worse progression-free and overall survival compared to those that did not have a cardiovascular event,” he said at the American College of Cardiology’s Advancing the Cardiovascular Care of the Oncology Patient meeting.

The Prospective Observation of Cardiac Safety With Proteasome Inhibition (PROTECT) trial, scheduled for completion in August 2019, enrolled 95 patients with relapsed multiple myeloma and randomly assigned them on a 2:1 basis to receive carfilzomib or bortezomib.

The investigators found that cardiovascular adverse events occurred in 33 of the 65 patients (51%) randomized to carfilzomib, compared with 5 of 30 patients (17%) assigned to bortezomib.

The events included grade 1 or 2 heart failure (HF) in 12 patients on carfilzomib vs. 2 on bortezomib, and grade 3 or 4 HF in 11 vs. 1, respectively. Hypertension was significantly more frequent among patients on carfilzomib, and one patient on carfilzomib died from the acute coronary syndrome 24 hours after receiving carfilzomib in the second week of treatment.

The investigators found that both B-type natriuretic peptide (BNP) and N-terminal pro b-type natriuretic peptide (NT-proBNP) were highly predictive of cardiovascular adverse events. Patients on carfilzomib who had levels of the markers above normal at baseline had an odds ratio (OR) for cardiovascular events of 7.39 (P less than .0001), and those with BNP or NT-proBNP increases at week 2 or 3 during cycle 1 had an OR for a cardiovascular adverse event of 63.5 (P less than .001).

In multivariate analysis, the risk for cardiovascular events for patients treated with carfilzomib was significantly lower for patients with one or no traditional cardiovascular risk factors, compared with patients with two or more.

“Prospective monitoring with natriuretic peptides should be considered, particularly early in treatment,” Dr. Cornell said.
 

IMiDs and thromboembolism

In early clinical trials of immunomodulators (IMiDs) for multiple myeloma, investigators saw that the incidence of thromboembolic events was lower among patients who received thromboprophylaxis than among those who did not, Dr. Cornell noted.

“From this, certain guidelines have been developed such that all patients considered to be at risk should at least receive an aspirin, 81-325 mg, and patients at higher risk for thromboembolism should receive low-molecular-weight heparin or therapeutic-dose warfarin,” he said.

There is little guidance, however, about the use of direct oral anticoagulants in this population, he added, a fact that prompted him and his colleagues in oncology and cardiology to perform a pilot study of apixaban (Eliquis) for primary prevention of venous thromboembolism (VTE) in patients with multiple myeloma who were receiving immunodulatory drugs.

Results of the pilot study, reported in a poster session at the 2018 annual meeting of the American Society of Hematology, showed that among 50 patients who received apixaban 2.5 mg twice daily for 6 months during IMiD therapy, there were no VTEs, stroke, or myocardial infarction, and no episodes of major bleeding. There were just three nonmajor bleeding events, and one early withdrawal from apixaban due to an allergic reaction manifesting as generalized edema.

“Further study is needed to validate this as a potential primary prophylaxis in patients receiving IMiDs for multiple myeloma,” Dr. Cornell said.

He reported having no financial disclosures. Millennium Pharmaceuticals is a sponsor of the PROTECT trial.

WASHINGTON – Proteasome inhibitors are essential components of therapeutic regimens for multiple myeloma, but at least one member of this class of life-extending agents, carfilzomib (Kyprolis), is also associated with a significant increase in risk of heart failure, cautioned a specialist in plasma cell disorders.

Neil Osterweil/MDedge News

In addition, immunomodulating agents such as lenalidomide (Revlimid) and pomalidomide (Pomalyst) are associated with increased risk for thromboembolic events, said R. Frank Cornell, MD, clinical director of plasma cell disorders at Vanderbilt University Medical Center in Nashville, Tenn.

In an ongoing, prospective study comparing rates of cardiac adverse events in patients receiving carfilzomib or another proteasome inhibitor, bortezomib (Velcade), Dr. Cornell and his colleagues found that while there were no significant differences in progression-free survival (PFS) or overall survival (OS) between the treatments, “patients who experienced a cardiovascular event had significantly worse progression-free and overall survival compared to those that did not have a cardiovascular event,” he said at the American College of Cardiology’s Advancing the Cardiovascular Care of the Oncology Patient meeting.

The Prospective Observation of Cardiac Safety With Proteasome Inhibition (PROTECT) trial, scheduled for completion in August 2019, enrolled 95 patients with relapsed multiple myeloma and randomly assigned them on a 2:1 basis to receive carfilzomib or bortezomib.

The investigators found that cardiovascular adverse events occurred in 33 of the 65 patients (51%) randomized to carfilzomib, compared with 5 of 30 patients (17%) assigned to bortezomib.

The events included grade 1 or 2 heart failure (HF) in 12 patients on carfilzomib vs. 2 on bortezomib, and grade 3 or 4 HF in 11 vs. 1, respectively. Hypertension was significantly more frequent among patients on carfilzomib, and one patient on carfilzomib died from the acute coronary syndrome 24 hours after receiving carfilzomib in the second week of treatment.

The investigators found that both B-type natriuretic peptide (BNP) and N-terminal pro b-type natriuretic peptide (NT-proBNP) were highly predictive of cardiovascular adverse events. Patients on carfilzomib who had levels of the markers above normal at baseline had an odds ratio (OR) for cardiovascular events of 7.39 (P less than .0001), and those with BNP or NT-proBNP increases at week 2 or 3 during cycle 1 had an OR for a cardiovascular adverse event of 63.5 (P less than .001).

In multivariate analysis, the risk for cardiovascular events for patients treated with carfilzomib was significantly lower for patients with one or no traditional cardiovascular risk factors, compared with patients with two or more.

“Prospective monitoring with natriuretic peptides should be considered, particularly early in treatment,” Dr. Cornell said.
 

IMiDs and thromboembolism

In early clinical trials of immunomodulators (IMiDs) for multiple myeloma, investigators saw that the incidence of thromboembolic events was lower among patients who received thromboprophylaxis than among those who did not, Dr. Cornell noted.

“From this, certain guidelines have been developed such that all patients considered to be at risk should at least receive an aspirin, 81-325 mg, and patients at higher risk for thromboembolism should receive low-molecular-weight heparin or therapeutic-dose warfarin,” he said.

There is little guidance, however, about the use of direct oral anticoagulants in this population, he added, a fact that prompted him and his colleagues in oncology and cardiology to perform a pilot study of apixaban (Eliquis) for primary prevention of venous thromboembolism (VTE) in patients with multiple myeloma who were receiving immunodulatory drugs.

Results of the pilot study, reported in a poster session at the 2018 annual meeting of the American Society of Hematology, showed that among 50 patients who received apixaban 2.5 mg twice daily for 6 months during IMiD therapy, there were no VTEs, stroke, or myocardial infarction, and no episodes of major bleeding. There were just three nonmajor bleeding events, and one early withdrawal from apixaban due to an allergic reaction manifesting as generalized edema.

“Further study is needed to validate this as a potential primary prophylaxis in patients receiving IMiDs for multiple myeloma,” Dr. Cornell said.

He reported having no financial disclosures. Millennium Pharmaceuticals is a sponsor of the PROTECT trial.

Adjuvant treatments appear to have no significant detrimental long-term effects on sperm count in men being treated for clinical stage I testicular cancer, results of a recent investigation suggest.

Sperm number and concentration were largely stable over time in patients who received a round of chemotherapy or radiation to lymph nodes following orchiectomy, according to results of the 182-patient study.

Investigators said they still offer sperm banking before orchiectomy, since some patients will have low sperm counts prior to orchiectomy that persist after the procedure.
Moreover, the type of testicular cancer and the potential need for other postorchiectomy treatments are often “unknown factors” that underscore the importance of sperm banking, said the researchers, led by Kristina Weibring, MD, of Karolinska University Hospital, Stockholm.

“Assisted reproductive measures may be necessary for these patients regardless of any treatment given,” the researchers noted. The report is in Annals of Oncology.

The lack of effect on sperm counts in this study stands in contrast to previous studies, which clearly show the detrimental effects of multiple chemotherapy cycles on sperm recovery, the investigators said.

Their study comprised 182 patients 18-50 years of age with clinical stage I testicular cancer who underwent unilateral orchiectomy. Depending on tumor characteristics, the patients then received one cycle of adjuvant carboplatin, one cycle of a bleomycin, etoposide, and cisplatin (BEP) regimen, surveillance, or adjuvant radiotherapy to the infradiaphragmal para-aortic and ipsilateral iliac lymph nodes. Sperm samples were obtained at 6, 12, 24, 36, and 60 months after the completion of treatment.

While there was a transient drop in the radiation-treated patients at the 6-month evaluation, mean total sperm number otherwise increased over time in all groups, according to the investigators’ report.

Similarly, mean sperm concentration significantly increased from baseline to 12 months post treatment in the surveillance, BEP, and carboplatin groups, with a nonsignificant decrease in the radiotherapy group, they said in the report.

There were generally no significant differences in sperm count or concentration for the treatments, compared with surveillance, beyond a significant decrease in mean sperm count for radiation versus surveillance, they added.

There were likewise no significant changes in sperm measures for seminoma and nonseminoma patients at any point over the 5 years of evaluation, reported data show.

“With the results of this study, we can now inform our patients that adjuvant chemotherapy does not seem to affect the testicular function,” Dr. Weibring and her colleagues concluded.

The authors reported that they had no conflicts of interest related to the study, which was supported by the Swedish Cancer Society, among other sources.

SOURCE: Weibring K et al. Ann Oncol. 2019 Feb 25. doi: 10.1093/annonc/mdz017/5348526.

Adjuvant treatments appear to have no significant detrimental long-term effects on sperm count in men being treated for clinical stage I testicular cancer, results of a recent investigation suggest.

Sperm number and concentration were largely stable over time in patients who received a round of chemotherapy or radiation to lymph nodes following orchiectomy, according to results of the 182-patient study.

Investigators said they still offer sperm banking before orchiectomy, since some patients will have low sperm counts prior to orchiectomy that persist after the procedure.
Moreover, the type of testicular cancer and the potential need for other postorchiectomy treatments are often “unknown factors” that underscore the importance of sperm banking, said the researchers, led by Kristina Weibring, MD, of Karolinska University Hospital, Stockholm.

“Assisted reproductive measures may be necessary for these patients regardless of any treatment given,” the researchers noted. The report is in Annals of Oncology.

The lack of effect on sperm counts in this study stands in contrast to previous studies, which clearly show the detrimental effects of multiple chemotherapy cycles on sperm recovery, the investigators said.

Their study comprised 182 patients 18-50 years of age with clinical stage I testicular cancer who underwent unilateral orchiectomy. Depending on tumor characteristics, the patients then received one cycle of adjuvant carboplatin, one cycle of a bleomycin, etoposide, and cisplatin (BEP) regimen, surveillance, or adjuvant radiotherapy to the infradiaphragmal para-aortic and ipsilateral iliac lymph nodes. Sperm samples were obtained at 6, 12, 24, 36, and 60 months after the completion of treatment.

While there was a transient drop in the radiation-treated patients at the 6-month evaluation, mean total sperm number otherwise increased over time in all groups, according to the investigators’ report.

Similarly, mean sperm concentration significantly increased from baseline to 12 months post treatment in the surveillance, BEP, and carboplatin groups, with a nonsignificant decrease in the radiotherapy group, they said in the report.

There were generally no significant differences in sperm count or concentration for the treatments, compared with surveillance, beyond a significant decrease in mean sperm count for radiation versus surveillance, they added.

There were likewise no significant changes in sperm measures for seminoma and nonseminoma patients at any point over the 5 years of evaluation, reported data show.

“With the results of this study, we can now inform our patients that adjuvant chemotherapy does not seem to affect the testicular function,” Dr. Weibring and her colleagues concluded.

The authors reported that they had no conflicts of interest related to the study, which was supported by the Swedish Cancer Society, among other sources.

SOURCE: Weibring K et al. Ann Oncol. 2019 Feb 25. doi: 10.1093/annonc/mdz017/5348526.

Adjuvant treatments appear to have no significant detrimental long-term effects on sperm count in men being treated for clinical stage I testicular cancer, results of a recent investigation suggest.

Sperm number and concentration were largely stable over time in patients who received a round of chemotherapy or radiation to lymph nodes following orchiectomy, according to results of the 182-patient study.

Investigators said they still offer sperm banking before orchiectomy, since some patients will have low sperm counts prior to orchiectomy that persist after the procedure.
Moreover, the type of testicular cancer and the potential need for other postorchiectomy treatments are often “unknown factors” that underscore the importance of sperm banking, said the researchers, led by Kristina Weibring, MD, of Karolinska University Hospital, Stockholm.

“Assisted reproductive measures may be necessary for these patients regardless of any treatment given,” the researchers noted. The report is in Annals of Oncology.

The lack of effect on sperm counts in this study stands in contrast to previous studies, which clearly show the detrimental effects of multiple chemotherapy cycles on sperm recovery, the investigators said.

Their study comprised 182 patients 18-50 years of age with clinical stage I testicular cancer who underwent unilateral orchiectomy. Depending on tumor characteristics, the patients then received one cycle of adjuvant carboplatin, one cycle of a bleomycin, etoposide, and cisplatin (BEP) regimen, surveillance, or adjuvant radiotherapy to the infradiaphragmal para-aortic and ipsilateral iliac lymph nodes. Sperm samples were obtained at 6, 12, 24, 36, and 60 months after the completion of treatment.

While there was a transient drop in the radiation-treated patients at the 6-month evaluation, mean total sperm number otherwise increased over time in all groups, according to the investigators’ report.

Similarly, mean sperm concentration significantly increased from baseline to 12 months post treatment in the surveillance, BEP, and carboplatin groups, with a nonsignificant decrease in the radiotherapy group, they said in the report.

There were generally no significant differences in sperm count or concentration for the treatments, compared with surveillance, beyond a significant decrease in mean sperm count for radiation versus surveillance, they added.

There were likewise no significant changes in sperm measures for seminoma and nonseminoma patients at any point over the 5 years of evaluation, reported data show.

“With the results of this study, we can now inform our patients that adjuvant chemotherapy does not seem to affect the testicular function,” Dr. Weibring and her colleagues concluded.

The authors reported that they had no conflicts of interest related to the study, which was supported by the Swedish Cancer Society, among other sources.

SOURCE: Weibring K et al. Ann Oncol. 2019 Feb 25. doi: 10.1093/annonc/mdz017/5348526.

Diet plays an important role in patient response to anti-programmed death-1 (PD-1) cancer immunotherapy, preliminary findings from a gut microbiome study involving 146 melanoma patients suggest.

Specifically, a high-fiber diet was associated with a more diverse gut microbiome and with improved response to anti-PD-1 therapy, whereas a diet high in sugar and processed meat was associated with fewer of the gut bacteria known to be associated with improved response, Christine Spencer, PhD, reported during a press conference highlighting data to be presented at the upcoming American Association for Cancer Research (AACR) annual meeting in Atlanta.

“We found that patients who reported eating high-fiber diets were about five times as likely to respond to anti-PD-1 checkpoint blockade immunotherapy (odds ratio vs. low-fiber diet, 5.3),” said Dr. Spencer, a research scientist at the Parker Institute for Cancer Immunotherapy.

Notably, more than 40% of patients reported taking probiotics, and those, surprisingly, were also associated with reduced gut microbiome diversity, she said.

For this study, Dr. Spencer and her colleagues at the University of Texas MD Anderson Cancer Center, Houston, analyzed prospectively collected fecal samples from 146 melanoma patients, and collected baseline diet information via the National Cancer Institute dietary screener questionnaire, as well as information about probiotic and antibiotic use, in a subset of 113 who were initiating therapy at MD Anderson. Those patients were then followed to assess therapy response.

“Our early data suggest that different foods and supplements may impact response to cancer immunotherapy in patients, and we think this is likely mediated by the gut microbiome,” she said.

Since only 20%-30% of cancer patients respond to immunotherapy, the findings hint at potential approaches for improving gut microbiome diversity, and thus response to anti-PD-1 cancer immunotherapy.

“Eat your high-fiber foods: fruits, vegetables, and whole grains – lots of different kinds and lots of them,” she said. “High-fiber diets have been linked to health benefits in several other contexts, and this study, although preliminary, shows fiber is linked to more favorable gut microbiome in patients, and better response to cancer immunotherapy.”

Conversations about the use of probiotic supplements also are important, she said.

“A lot of people have the perception that probiotics will provide health benefits, but that might not be the case in cancer patients. We’re not saying all of them are bad, but the message is that these factors have never before been studied in patients on immunotherapy, and our data suggest for the first time that they could matter,” she said, noting that future directions include validation of the findings in larger cohorts.

SOURCE: Spencer C et al. AACR 2019, Abstract preview.

Diet plays an important role in patient response to anti-programmed death-1 (PD-1) cancer immunotherapy, preliminary findings from a gut microbiome study involving 146 melanoma patients suggest.

Specifically, a high-fiber diet was associated with a more diverse gut microbiome and with improved response to anti-PD-1 therapy, whereas a diet high in sugar and processed meat was associated with fewer of the gut bacteria known to be associated with improved response, Christine Spencer, PhD, reported during a press conference highlighting data to be presented at the upcoming American Association for Cancer Research (AACR) annual meeting in Atlanta.

“We found that patients who reported eating high-fiber diets were about five times as likely to respond to anti-PD-1 checkpoint blockade immunotherapy (odds ratio vs. low-fiber diet, 5.3),” said Dr. Spencer, a research scientist at the Parker Institute for Cancer Immunotherapy.

Notably, more than 40% of patients reported taking probiotics, and those, surprisingly, were also associated with reduced gut microbiome diversity, she said.

For this study, Dr. Spencer and her colleagues at the University of Texas MD Anderson Cancer Center, Houston, analyzed prospectively collected fecal samples from 146 melanoma patients, and collected baseline diet information via the National Cancer Institute dietary screener questionnaire, as well as information about probiotic and antibiotic use, in a subset of 113 who were initiating therapy at MD Anderson. Those patients were then followed to assess therapy response.

“Our early data suggest that different foods and supplements may impact response to cancer immunotherapy in patients, and we think this is likely mediated by the gut microbiome,” she said.

Since only 20%-30% of cancer patients respond to immunotherapy, the findings hint at potential approaches for improving gut microbiome diversity, and thus response to anti-PD-1 cancer immunotherapy.

“Eat your high-fiber foods: fruits, vegetables, and whole grains – lots of different kinds and lots of them,” she said. “High-fiber diets have been linked to health benefits in several other contexts, and this study, although preliminary, shows fiber is linked to more favorable gut microbiome in patients, and better response to cancer immunotherapy.”

Conversations about the use of probiotic supplements also are important, she said.

“A lot of people have the perception that probiotics will provide health benefits, but that might not be the case in cancer patients. We’re not saying all of them are bad, but the message is that these factors have never before been studied in patients on immunotherapy, and our data suggest for the first time that they could matter,” she said, noting that future directions include validation of the findings in larger cohorts.

SOURCE: Spencer C et al. AACR 2019, Abstract preview.

Diet plays an important role in patient response to anti-programmed death-1 (PD-1) cancer immunotherapy, preliminary findings from a gut microbiome study involving 146 melanoma patients suggest.

Specifically, a high-fiber diet was associated with a more diverse gut microbiome and with improved response to anti-PD-1 therapy, whereas a diet high in sugar and processed meat was associated with fewer of the gut bacteria known to be associated with improved response, Christine Spencer, PhD, reported during a press conference highlighting data to be presented at the upcoming American Association for Cancer Research (AACR) annual meeting in Atlanta.

“We found that patients who reported eating high-fiber diets were about five times as likely to respond to anti-PD-1 checkpoint blockade immunotherapy (odds ratio vs. low-fiber diet, 5.3),” said Dr. Spencer, a research scientist at the Parker Institute for Cancer Immunotherapy.

Notably, more than 40% of patients reported taking probiotics, and those, surprisingly, were also associated with reduced gut microbiome diversity, she said.

For this study, Dr. Spencer and her colleagues at the University of Texas MD Anderson Cancer Center, Houston, analyzed prospectively collected fecal samples from 146 melanoma patients, and collected baseline diet information via the National Cancer Institute dietary screener questionnaire, as well as information about probiotic and antibiotic use, in a subset of 113 who were initiating therapy at MD Anderson. Those patients were then followed to assess therapy response.

“Our early data suggest that different foods and supplements may impact response to cancer immunotherapy in patients, and we think this is likely mediated by the gut microbiome,” she said.

Since only 20%-30% of cancer patients respond to immunotherapy, the findings hint at potential approaches for improving gut microbiome diversity, and thus response to anti-PD-1 cancer immunotherapy.

“Eat your high-fiber foods: fruits, vegetables, and whole grains – lots of different kinds and lots of them,” she said. “High-fiber diets have been linked to health benefits in several other contexts, and this study, although preliminary, shows fiber is linked to more favorable gut microbiome in patients, and better response to cancer immunotherapy.”

Conversations about the use of probiotic supplements also are important, she said.

“A lot of people have the perception that probiotics will provide health benefits, but that might not be the case in cancer patients. We’re not saying all of them are bad, but the message is that these factors have never before been studied in patients on immunotherapy, and our data suggest for the first time that they could matter,” she said, noting that future directions include validation of the findings in larger cohorts.

SOURCE: Spencer C et al. AACR 2019, Abstract preview.

In this episode, Charles E. Geyer, MD, of Virginia Commonweath University joins guest host Jame Abraham, MD, of the Cleveland Clinic to discuss the KATHERINE trial and its impact on the treatment of HER2-positive breast cancer.

And Ilana Yurkiewicz, MD, talks about whether it’s better for physicians to be vague about prognosis. Dr. Yurkiewicz is a fellow in hematology and oncology at Stanford (Calif.) University and is also a columnist for Hematology News. More from Dr. Yurkiewicz here.

Subscribe to Blood & Cancer here:

Apple PodcastsGoogle Podcasts

In this episode, Charles E. Geyer, MD, of Virginia Commonweath University joins guest host Jame Abraham, MD, of the Cleveland Clinic to discuss the KATHERINE trial and its impact on the treatment of HER2-positive breast cancer.

And Ilana Yurkiewicz, MD, talks about whether it’s better for physicians to be vague about prognosis. Dr. Yurkiewicz is a fellow in hematology and oncology at Stanford (Calif.) University and is also a columnist for Hematology News. More from Dr. Yurkiewicz here.

Subscribe to Blood & Cancer here:

Apple PodcastsGoogle Podcasts

In this episode, Charles E. Geyer, MD, of Virginia Commonweath University joins guest host Jame Abraham, MD, of the Cleveland Clinic to discuss the KATHERINE trial and its impact on the treatment of HER2-positive breast cancer.

And Ilana Yurkiewicz, MD, talks about whether it’s better for physicians to be vague about prognosis. Dr. Yurkiewicz is a fellow in hematology and oncology at Stanford (Calif.) University and is also a columnist for Hematology News. More from Dr. Yurkiewicz here.

Subscribe to Blood & Cancer here:

Apple PodcastsGoogle Podcasts

Karyopharm Therapeutics must finish a randomized phase 3 trial of selinexor plus dexamethasone before the Food and Drug Administration will proceed with a safety and tolerability assessment for the first-in-class multiple myeloma drug.

By an 8-5 vote, the FDA Oncologic Drugs Advisory Committee said that data from STORM 2, Karyopharm’s single-arm phase 2b trial, didn’t sufficiently show that selinexor exerted any significant benefit over dexamethasone alone, used because the company claims it potentiates selinexor’s action.

Committee members also expressed concerns about the drug’s challenging adverse event profile. In STORM Part 2, 60% of patients experienced serious treatment-emergent adverse events and 10 died from them.

“This trial design is not adequate to assess tolerability and efficacy,” and move the drug along, said Christian S. Hinrichs, MD, of the National Cancer Institute. For that to happen, “we’d be looking for several things. We’d be looking for a subset of patients who benefited profoundly, which could be somewhat compelling despite a lower overall response rate. Next we might be looking for durable response, and here we see 4-month responses. And finally, what we look for in a single-arm trial is a really favorable side effect profile, like we see in checkpoint inhibitors. That is clearly not the case with this drug. So, on the basis of both the trial design and the results, I find it hard to conclude that these data allow for an adequate assessment that safety and efficacy are proven.”

The decision came despite the pleas of 15 patients and one patient advocate who said the drug improved clinical status and quality of life, and even extended life beyond what anyone expected. However, several committee members noted that Karyopharm paid for speakers’ travel and that patients who had negative experiences would probably be too sick to attend.

Selinexor is a completely new therapeutic option for relapsed multiple myeloma patients. It is a twice-weekly, oral tablet that inhibits nuclear export protein Exportin 1 (XPO1), which regulates the localization of tumor suppressor proteins and is associated with poor prognosis. Aberrant XPO1 expression causes tumor suppressors to locate away from their targets, allowing tumors to grow. Inhibiting it with selinexor blocks signal transduction pathways, interrupting tumor cell proliferation and inducing apoptosis while sparing normal cells.

msullivan@mdege.com

Karyopharm Therapeutics must finish a randomized phase 3 trial of selinexor plus dexamethasone before the Food and Drug Administration will proceed with a safety and tolerability assessment for the first-in-class multiple myeloma drug.

By an 8-5 vote, the FDA Oncologic Drugs Advisory Committee said that data from STORM 2, Karyopharm’s single-arm phase 2b trial, didn’t sufficiently show that selinexor exerted any significant benefit over dexamethasone alone, used because the company claims it potentiates selinexor’s action.

Committee members also expressed concerns about the drug’s challenging adverse event profile. In STORM Part 2, 60% of patients experienced serious treatment-emergent adverse events and 10 died from them.

“This trial design is not adequate to assess tolerability and efficacy,” and move the drug along, said Christian S. Hinrichs, MD, of the National Cancer Institute. For that to happen, “we’d be looking for several things. We’d be looking for a subset of patients who benefited profoundly, which could be somewhat compelling despite a lower overall response rate. Next we might be looking for durable response, and here we see 4-month responses. And finally, what we look for in a single-arm trial is a really favorable side effect profile, like we see in checkpoint inhibitors. That is clearly not the case with this drug. So, on the basis of both the trial design and the results, I find it hard to conclude that these data allow for an adequate assessment that safety and efficacy are proven.”

The decision came despite the pleas of 15 patients and one patient advocate who said the drug improved clinical status and quality of life, and even extended life beyond what anyone expected. However, several committee members noted that Karyopharm paid for speakers’ travel and that patients who had negative experiences would probably be too sick to attend.

Selinexor is a completely new therapeutic option for relapsed multiple myeloma patients. It is a twice-weekly, oral tablet that inhibits nuclear export protein Exportin 1 (XPO1), which regulates the localization of tumor suppressor proteins and is associated with poor prognosis. Aberrant XPO1 expression causes tumor suppressors to locate away from their targets, allowing tumors to grow. Inhibiting it with selinexor blocks signal transduction pathways, interrupting tumor cell proliferation and inducing apoptosis while sparing normal cells.

msullivan@mdege.com

Karyopharm Therapeutics must finish a randomized phase 3 trial of selinexor plus dexamethasone before the Food and Drug Administration will proceed with a safety and tolerability assessment for the first-in-class multiple myeloma drug.

By an 8-5 vote, the FDA Oncologic Drugs Advisory Committee said that data from STORM 2, Karyopharm’s single-arm phase 2b trial, didn’t sufficiently show that selinexor exerted any significant benefit over dexamethasone alone, used because the company claims it potentiates selinexor’s action.

Committee members also expressed concerns about the drug’s challenging adverse event profile. In STORM Part 2, 60% of patients experienced serious treatment-emergent adverse events and 10 died from them.

“This trial design is not adequate to assess tolerability and efficacy,” and move the drug along, said Christian S. Hinrichs, MD, of the National Cancer Institute. For that to happen, “we’d be looking for several things. We’d be looking for a subset of patients who benefited profoundly, which could be somewhat compelling despite a lower overall response rate. Next we might be looking for durable response, and here we see 4-month responses. And finally, what we look for in a single-arm trial is a really favorable side effect profile, like we see in checkpoint inhibitors. That is clearly not the case with this drug. So, on the basis of both the trial design and the results, I find it hard to conclude that these data allow for an adequate assessment that safety and efficacy are proven.”

The decision came despite the pleas of 15 patients and one patient advocate who said the drug improved clinical status and quality of life, and even extended life beyond what anyone expected. However, several committee members noted that Karyopharm paid for speakers’ travel and that patients who had negative experiences would probably be too sick to attend.

Selinexor is a completely new therapeutic option for relapsed multiple myeloma patients. It is a twice-weekly, oral tablet that inhibits nuclear export protein Exportin 1 (XPO1), which regulates the localization of tumor suppressor proteins and is associated with poor prognosis. Aberrant XPO1 expression causes tumor suppressors to locate away from their targets, allowing tumors to grow. Inhibiting it with selinexor blocks signal transduction pathways, interrupting tumor cell proliferation and inducing apoptosis while sparing normal cells.

msullivan@mdege.com

The Royal Swedish Academy of Sciences has awarded the 2019 Sjöberg Prize to Dennis J. Slamon, MD, PhD, and Brian J. Druker, MD.

Milo Mitchell, UCLA Milo Mitchell, UCLA

The pair received the prize, which is worth $1 million, “for their groundbreaking contributions to the clinical development of targeted therapy directed against genetic aberrations in cancer.”

Dr. Slamon, a professor at the University of California, Los Angeles, conducted research that led to the development of trastuzumab as a treatment for HER2-positive breast cancer.

Dr. Druker, a professor at Oregon Health and Science University in Portland, found that imatinib could treat chronic myeloid leukemia by inhibiting BCR-ABL.

Kristyna Wentz-Graff, OHSU

Dr. Druker and Dr. Slamon both plan to use the prize money to identify new targets for cancer therapies.

In other news, Steven A. Rosenberg, MD, PhD, of the National Cancer Institute in Bethesda, Md., won the 2019 Szent-Györgyi Prize for Progress in Cancer Research.

Dr. Rosenberg won the $25,000 prize for his “pioneering role in the development of adoptive immunotherapy to treat cancer.”

National Institutes of Health National Institutes of Health

Dr. Rosenberg is credited with conducting trials of interleukin-2 that led to its U.S. approval, identifying tumor-infiltrating lymphocytes in metastatic melanoma, showing that adoptive cell transfer can prompt tumor regression in advanced melanoma and breast cancer, and being the first person to use chimeric antigen receptor (CAR) T cells to treat aggressive lymphomas.

With his current work, Dr. Rosenberg is exploring the use of adoptive cell transfer in epithelial cancers.

Dr. Rosenberg also received the 2019 Dr. Nathan Davis Award for Outstanding Government Service. He is one of eight individuals who won the award this year.

The award is named after the founding father of the American Medical Association and is given to “elected and career officials in federal, state, or municipal service whose outstanding contributions have promoted the art and science of medicine and the betterment of public health.”
 

Movers in Medicine highlights career moves and personal achievements by hematologists and oncologists. Did you switch jobs, take on a new role, climb a mountain? Tell us all about it at hematologynews@mdedge.com, and you could be featured in Movers in Medicine.

jensmith@mdedge.com

The Royal Swedish Academy of Sciences has awarded the 2019 Sjöberg Prize to Dennis J. Slamon, MD, PhD, and Brian J. Druker, MD.

Milo Mitchell, UCLA Milo Mitchell, UCLA

The pair received the prize, which is worth $1 million, “for their groundbreaking contributions to the clinical development of targeted therapy directed against genetic aberrations in cancer.”

Dr. Slamon, a professor at the University of California, Los Angeles, conducted research that led to the development of trastuzumab as a treatment for HER2-positive breast cancer.

Dr. Druker, a professor at Oregon Health and Science University in Portland, found that imatinib could treat chronic myeloid leukemia by inhibiting BCR-ABL.

Kristyna Wentz-Graff, OHSU

Dr. Druker and Dr. Slamon both plan to use the prize money to identify new targets for cancer therapies.

In other news, Steven A. Rosenberg, MD, PhD, of the National Cancer Institute in Bethesda, Md., won the 2019 Szent-Györgyi Prize for Progress in Cancer Research.

Dr. Rosenberg won the $25,000 prize for his “pioneering role in the development of adoptive immunotherapy to treat cancer.”

National Institutes of Health National Institutes of Health

Dr. Rosenberg is credited with conducting trials of interleukin-2 that led to its U.S. approval, identifying tumor-infiltrating lymphocytes in metastatic melanoma, showing that adoptive cell transfer can prompt tumor regression in advanced melanoma and breast cancer, and being the first person to use chimeric antigen receptor (CAR) T cells to treat aggressive lymphomas.

With his current work, Dr. Rosenberg is exploring the use of adoptive cell transfer in epithelial cancers.

Dr. Rosenberg also received the 2019 Dr. Nathan Davis Award for Outstanding Government Service. He is one of eight individuals who won the award this year.

The award is named after the founding father of the American Medical Association and is given to “elected and career officials in federal, state, or municipal service whose outstanding contributions have promoted the art and science of medicine and the betterment of public health.”
 

Movers in Medicine highlights career moves and personal achievements by hematologists and oncologists. Did you switch jobs, take on a new role, climb a mountain? Tell us all about it at hematologynews@mdedge.com, and you could be featured in Movers in Medicine.

jensmith@mdedge.com

The Royal Swedish Academy of Sciences has awarded the 2019 Sjöberg Prize to Dennis J. Slamon, MD, PhD, and Brian J. Druker, MD.

Milo Mitchell, UCLA Milo Mitchell, UCLA

The pair received the prize, which is worth $1 million, “for their groundbreaking contributions to the clinical development of targeted therapy directed against genetic aberrations in cancer.”

Dr. Slamon, a professor at the University of California, Los Angeles, conducted research that led to the development of trastuzumab as a treatment for HER2-positive breast cancer.

Dr. Druker, a professor at Oregon Health and Science University in Portland, found that imatinib could treat chronic myeloid leukemia by inhibiting BCR-ABL.

Kristyna Wentz-Graff, OHSU

Dr. Druker and Dr. Slamon both plan to use the prize money to identify new targets for cancer therapies.

In other news, Steven A. Rosenberg, MD, PhD, of the National Cancer Institute in Bethesda, Md., won the 2019 Szent-Györgyi Prize for Progress in Cancer Research.

Dr. Rosenberg won the $25,000 prize for his “pioneering role in the development of adoptive immunotherapy to treat cancer.”

National Institutes of Health National Institutes of Health

Dr. Rosenberg is credited with conducting trials of interleukin-2 that led to its U.S. approval, identifying tumor-infiltrating lymphocytes in metastatic melanoma, showing that adoptive cell transfer can prompt tumor regression in advanced melanoma and breast cancer, and being the first person to use chimeric antigen receptor (CAR) T cells to treat aggressive lymphomas.

With his current work, Dr. Rosenberg is exploring the use of adoptive cell transfer in epithelial cancers.

Dr. Rosenberg also received the 2019 Dr. Nathan Davis Award for Outstanding Government Service. He is one of eight individuals who won the award this year.

The award is named after the founding father of the American Medical Association and is given to “elected and career officials in federal, state, or municipal service whose outstanding contributions have promoted the art and science of medicine and the betterment of public health.”
 

Movers in Medicine highlights career moves and personal achievements by hematologists and oncologists. Did you switch jobs, take on a new role, climb a mountain? Tell us all about it at hematologynews@mdedge.com, and you could be featured in Movers in Medicine.

jensmith@mdedge.com