Patient & Survivor Care

Objective To address gaps in previous research by prospectively examining concordance between HCPs and patients on identifying patients’ symptoms by using an identical tool for patients and HCPs at the time of the oncology clinic visit.

Methods 94 patients completed measures of symptom experience and medical comorbidities before seeing their oncology medical team. HCPs were informed of a patient’s participation in the study before seeing the patient in clinic. Immediately after the clinic visit, HCPs completed a symptom survey in which they noted the patient’s symptoms.

Results Patients reported more symptoms than the HCPs endorsed. The highest level of concordance for any symptom fell in the moderate agreement range. Kappa values reflecting concordance between patients and HCPs were not significantly different between the various patient-HCP pairs. No demographic or clinical variables for patients were found to be statistically related to the level of agreement on patients’ symptoms.

Limitations The use of a small convenience sample size drawn from 3 specialty oncology outpatient clinics may limit the generalizability of the results to other types of cancer. The distribution of cancer stage was weighted toward stages III and IV, likely contributing to the number of symptoms.

Conclusions The level of agreement between HCPs and oncology patients on patient symptoms is weak. Concordance levels were similar, regardless of the type of HCP.

Funding Siteman Cancer Center Summer Student Program. 

Objective To address gaps in previous research by prospectively examining concordance between HCPs and patients on identifying patients’ symptoms by using an identical tool for patients and HCPs at the time of the oncology clinic visit.

Methods 94 patients completed measures of symptom experience and medical comorbidities before seeing their oncology medical team. HCPs were informed of a patient’s participation in the study before seeing the patient in clinic. Immediately after the clinic visit, HCPs completed a symptom survey in which they noted the patient’s symptoms.

Results Patients reported more symptoms than the HCPs endorsed. The highest level of concordance for any symptom fell in the moderate agreement range. Kappa values reflecting concordance between patients and HCPs were not significantly different between the various patient-HCP pairs. No demographic or clinical variables for patients were found to be statistically related to the level of agreement on patients’ symptoms.

Limitations The use of a small convenience sample size drawn from 3 specialty oncology outpatient clinics may limit the generalizability of the results to other types of cancer. The distribution of cancer stage was weighted toward stages III and IV, likely contributing to the number of symptoms.

Conclusions The level of agreement between HCPs and oncology patients on patient symptoms is weak. Concordance levels were similar, regardless of the type of HCP.

Funding Siteman Cancer Center Summer Student Program. 

Objective To address gaps in previous research by prospectively examining concordance between HCPs and patients on identifying patients’ symptoms by using an identical tool for patients and HCPs at the time of the oncology clinic visit.

Methods 94 patients completed measures of symptom experience and medical comorbidities before seeing their oncology medical team. HCPs were informed of a patient’s participation in the study before seeing the patient in clinic. Immediately after the clinic visit, HCPs completed a symptom survey in which they noted the patient’s symptoms.

Results Patients reported more symptoms than the HCPs endorsed. The highest level of concordance for any symptom fell in the moderate agreement range. Kappa values reflecting concordance between patients and HCPs were not significantly different between the various patient-HCP pairs. No demographic or clinical variables for patients were found to be statistically related to the level of agreement on patients’ symptoms.

Limitations The use of a small convenience sample size drawn from 3 specialty oncology outpatient clinics may limit the generalizability of the results to other types of cancer. The distribution of cancer stage was weighted toward stages III and IV, likely contributing to the number of symptoms.

Conclusions The level of agreement between HCPs and oncology patients on patient symptoms is weak. Concordance levels were similar, regardless of the type of HCP.

Funding Siteman Cancer Center Summer Student Program. 

WASHINGTON – A coalition of cancer researchers, patient advocates, oncologists, and pharmaceutical companies has issued a 13-point call to action to create a path toward better value in cancer care.

The white paper was released at Turning the Tide Against Cancer on Oct. 9. The meeting was sponsored by the Personalized Medicine Coalition, the American Association for Cancer Research, and Feinstein Kean Healthcare, a consulting firm.

Those organizations convened an initial “Turning the Tide” meeting in 2012. At that first gathering, participants discussed how the rapid-fire scientific developments in oncology could be incorporated into clinical care without bankrupting physicians, payers, or patients.

In the 2 years since, a task force met and created the new call to action, which focuses on how to foster a shift toward patient-centeredness in research and care, and how to address cost and value in ways that align with patient-centeredness and that do not hamper innovation.

Among the recommendations:

• The government should encourage clinical trials that enable study of multiple drugs simultaneously.
• The Food and Drug Administration should modernize its regulation of personalized medicine.
• Congress should help fund the development of cancer quality and outcomes measures.
• Federal and state marketplace plans should offer broad coverage of oncology drugs and services.
• The government should do more to standardize clinical decision-making tools and make them available to the public in an easily-understood format.

“We must not only continue to support cutting-edge cancer research, but also engage patients as partners throughout the continuum of research and care because, by doing so, we can develop a better understanding of their individual needs and preferences and ensure that they receive the most effective treatment for their particular disease,” Dr. Margaret Foti, chief executive officer of the AACR, said in a statement.

The new report “demonstrates the value of shared commitment and collaboration,” John J. Castellani, president and CEO of the Pharmaceutical Research and Manufacturers of America, said at the Turning the Tide meeting.

The rising – and in some cases extremely high – cost of oncology chemotherapies and personalized medicine diagnostics has attracted growing attention as these treatments gain more widespread use.

Mr. Castellani sidestepped the expense issue, but other speakers took it on directly.

“I personally am very weary of drugs and biologics being the lightning rod in this discussion,” said Patricia J. Goldsmith, CEO of CancerCare, a patient support organization. “There’s a whole host of other cost drivers and factors in the delivery of oncology care that are not really being discussed,” she said at the meeting.

“All of us in the medical community have an important role to play in restraining costs and creating value for our patients,” said Dr. Richard L. Schilsky, chief medical officer of the American Society of Clinical Oncology. The high cost of therapies and increasing copays and deductibles play a role in rising cancer care costs, but “so do the practices that doctors follow,” as well as patient expectations, he said.

Patients need to be well-informed about what can and can’t be achieved, doctors need to practice evidence-based medicine, and reimbursement needs to be overhauled to focus on spending time with patients instead of just getting paid for a service, Dr. Schilsky said at the meeting.

He suggested that value can’t be a static concept, especially when it comes to chemotherapies. A newly introduced drug might provide value initially, but less so over time as other, better therapies become available.

ASCO has spent a year developing a framework for physicians and patients to discuss value, he said. The idea is to have a user-friendly way for patients to compare the value of various treatment approaches in consultation with the doctor. That project is close to completion, said Dr. Schilsky.

Dr. Michael Kolodziej, national medical director for oncology solutions at Aetna, agreed that the patient needed to be made more of the focus of cancer care, from drug development into the physician’s office. In clinical trials, “we are not recording what’s important to patients,” he said at the meeting.

But he also took drug makers to task for developing too many me-too products. “We do not need another [tyrosine-kinase inhibitor] for chronic myelogenous leukemia,” said Dr. Kolodziej. Manufacturers should be rewarded for innovation, but “we have dissociated true innovation from reimbursement,” he added.

Ms. Goldsmith, who was recently diagnosed with cancer, said that even with her background, the conversations with her surgeons and oncologists were difficult to navigate. “We have to do better by patients,” she said.

Dr. Schilsky agreed. “Doctors, like everybody else, have varying communications skills,” he said. “But the one thing doctors don’t have is time.”

He said that physicians should be equipped and encouraged to spend that time talking with patients.

[email protected]

On Twitter @aliciaault

WASHINGTON – A coalition of cancer researchers, patient advocates, oncologists, and pharmaceutical companies has issued a 13-point call to action to create a path toward better value in cancer care.

The white paper was released at Turning the Tide Against Cancer on Oct. 9. The meeting was sponsored by the Personalized Medicine Coalition, the American Association for Cancer Research, and Feinstein Kean Healthcare, a consulting firm.

Those organizations convened an initial “Turning the Tide” meeting in 2012. At that first gathering, participants discussed how the rapid-fire scientific developments in oncology could be incorporated into clinical care without bankrupting physicians, payers, or patients.

In the 2 years since, a task force met and created the new call to action, which focuses on how to foster a shift toward patient-centeredness in research and care, and how to address cost and value in ways that align with patient-centeredness and that do not hamper innovation.

Among the recommendations:

• The government should encourage clinical trials that enable study of multiple drugs simultaneously.
• The Food and Drug Administration should modernize its regulation of personalized medicine.
• Congress should help fund the development of cancer quality and outcomes measures.
• Federal and state marketplace plans should offer broad coverage of oncology drugs and services.
• The government should do more to standardize clinical decision-making tools and make them available to the public in an easily-understood format.

“We must not only continue to support cutting-edge cancer research, but also engage patients as partners throughout the continuum of research and care because, by doing so, we can develop a better understanding of their individual needs and preferences and ensure that they receive the most effective treatment for their particular disease,” Dr. Margaret Foti, chief executive officer of the AACR, said in a statement.

The new report “demonstrates the value of shared commitment and collaboration,” John J. Castellani, president and CEO of the Pharmaceutical Research and Manufacturers of America, said at the Turning the Tide meeting.

The rising – and in some cases extremely high – cost of oncology chemotherapies and personalized medicine diagnostics has attracted growing attention as these treatments gain more widespread use.

Mr. Castellani sidestepped the expense issue, but other speakers took it on directly.

“I personally am very weary of drugs and biologics being the lightning rod in this discussion,” said Patricia J. Goldsmith, CEO of CancerCare, a patient support organization. “There’s a whole host of other cost drivers and factors in the delivery of oncology care that are not really being discussed,” she said at the meeting.

“All of us in the medical community have an important role to play in restraining costs and creating value for our patients,” said Dr. Richard L. Schilsky, chief medical officer of the American Society of Clinical Oncology. The high cost of therapies and increasing copays and deductibles play a role in rising cancer care costs, but “so do the practices that doctors follow,” as well as patient expectations, he said.

Patients need to be well-informed about what can and can’t be achieved, doctors need to practice evidence-based medicine, and reimbursement needs to be overhauled to focus on spending time with patients instead of just getting paid for a service, Dr. Schilsky said at the meeting.

He suggested that value can’t be a static concept, especially when it comes to chemotherapies. A newly introduced drug might provide value initially, but less so over time as other, better therapies become available.

ASCO has spent a year developing a framework for physicians and patients to discuss value, he said. The idea is to have a user-friendly way for patients to compare the value of various treatment approaches in consultation with the doctor. That project is close to completion, said Dr. Schilsky.

Dr. Michael Kolodziej, national medical director for oncology solutions at Aetna, agreed that the patient needed to be made more of the focus of cancer care, from drug development into the physician’s office. In clinical trials, “we are not recording what’s important to patients,” he said at the meeting.

But he also took drug makers to task for developing too many me-too products. “We do not need another [tyrosine-kinase inhibitor] for chronic myelogenous leukemia,” said Dr. Kolodziej. Manufacturers should be rewarded for innovation, but “we have dissociated true innovation from reimbursement,” he added.

Ms. Goldsmith, who was recently diagnosed with cancer, said that even with her background, the conversations with her surgeons and oncologists were difficult to navigate. “We have to do better by patients,” she said.

Dr. Schilsky agreed. “Doctors, like everybody else, have varying communications skills,” he said. “But the one thing doctors don’t have is time.”

He said that physicians should be equipped and encouraged to spend that time talking with patients.

[email protected]

On Twitter @aliciaault

WASHINGTON – A coalition of cancer researchers, patient advocates, oncologists, and pharmaceutical companies has issued a 13-point call to action to create a path toward better value in cancer care.

The white paper was released at Turning the Tide Against Cancer on Oct. 9. The meeting was sponsored by the Personalized Medicine Coalition, the American Association for Cancer Research, and Feinstein Kean Healthcare, a consulting firm.

Those organizations convened an initial “Turning the Tide” meeting in 2012. At that first gathering, participants discussed how the rapid-fire scientific developments in oncology could be incorporated into clinical care without bankrupting physicians, payers, or patients.

In the 2 years since, a task force met and created the new call to action, which focuses on how to foster a shift toward patient-centeredness in research and care, and how to address cost and value in ways that align with patient-centeredness and that do not hamper innovation.

Among the recommendations:

• The government should encourage clinical trials that enable study of multiple drugs simultaneously.
• The Food and Drug Administration should modernize its regulation of personalized medicine.
• Congress should help fund the development of cancer quality and outcomes measures.
• Federal and state marketplace plans should offer broad coverage of oncology drugs and services.
• The government should do more to standardize clinical decision-making tools and make them available to the public in an easily-understood format.

“We must not only continue to support cutting-edge cancer research, but also engage patients as partners throughout the continuum of research and care because, by doing so, we can develop a better understanding of their individual needs and preferences and ensure that they receive the most effective treatment for their particular disease,” Dr. Margaret Foti, chief executive officer of the AACR, said in a statement.

The new report “demonstrates the value of shared commitment and collaboration,” John J. Castellani, president and CEO of the Pharmaceutical Research and Manufacturers of America, said at the Turning the Tide meeting.

The rising – and in some cases extremely high – cost of oncology chemotherapies and personalized medicine diagnostics has attracted growing attention as these treatments gain more widespread use.

Mr. Castellani sidestepped the expense issue, but other speakers took it on directly.

“I personally am very weary of drugs and biologics being the lightning rod in this discussion,” said Patricia J. Goldsmith, CEO of CancerCare, a patient support organization. “There’s a whole host of other cost drivers and factors in the delivery of oncology care that are not really being discussed,” she said at the meeting.

“All of us in the medical community have an important role to play in restraining costs and creating value for our patients,” said Dr. Richard L. Schilsky, chief medical officer of the American Society of Clinical Oncology. The high cost of therapies and increasing copays and deductibles play a role in rising cancer care costs, but “so do the practices that doctors follow,” as well as patient expectations, he said.

Patients need to be well-informed about what can and can’t be achieved, doctors need to practice evidence-based medicine, and reimbursement needs to be overhauled to focus on spending time with patients instead of just getting paid for a service, Dr. Schilsky said at the meeting.

He suggested that value can’t be a static concept, especially when it comes to chemotherapies. A newly introduced drug might provide value initially, but less so over time as other, better therapies become available.

ASCO has spent a year developing a framework for physicians and patients to discuss value, he said. The idea is to have a user-friendly way for patients to compare the value of various treatment approaches in consultation with the doctor. That project is close to completion, said Dr. Schilsky.

Dr. Michael Kolodziej, national medical director for oncology solutions at Aetna, agreed that the patient needed to be made more of the focus of cancer care, from drug development into the physician’s office. In clinical trials, “we are not recording what’s important to patients,” he said at the meeting.

But he also took drug makers to task for developing too many me-too products. “We do not need another [tyrosine-kinase inhibitor] for chronic myelogenous leukemia,” said Dr. Kolodziej. Manufacturers should be rewarded for innovation, but “we have dissociated true innovation from reimbursement,” he added.

Ms. Goldsmith, who was recently diagnosed with cancer, said that even with her background, the conversations with her surgeons and oncologists were difficult to navigate. “We have to do better by patients,” she said.

Dr. Schilsky agreed. “Doctors, like everybody else, have varying communications skills,” he said. “But the one thing doctors don’t have is time.”

He said that physicians should be equipped and encouraged to spend that time talking with patients.

[email protected]

On Twitter @aliciaault

The Food and Drug Administration has approved an oral combination of two drugs for the prevention of nausea and vomiting in patients undergoing cancer chemotherapy.

The combination of palonosetron, approved in 2008, and a new drug, netupitant, prevent nausea and vomiting during both the acute phase and delayed phase (from 25 to 120 hours) after the start of chemotherapy, according to an FDA press statement. The effectiveness of the combination drug, marketed as Akynzeo by Eisai, was established in two clinical trials of 1,720 participants receiving cancer chemotherapy. Participants were randomly assigned to receive Akynzeo or oral palonosetron, the FDA statement said.

In the first trial, 98.5%, 90.4%, and 89.6% of Akynzeo-treated participants did not experience any vomiting or require rescue medication for nausea during the acute, delayed, and overall phases, respectively, compared with 89.7%, 80.1%, and 76.5% of participants treated with oral palonosetron.

The second trial showed similar results.Common side effects of Akynzeo in the clinical trials were headache, asthenia, fatigue, dyspepsia, and constipation, the FDA noted in the statement.

The Food and Drug Administration has approved an oral combination of two drugs for the prevention of nausea and vomiting in patients undergoing cancer chemotherapy.

The combination of palonosetron, approved in 2008, and a new drug, netupitant, prevent nausea and vomiting during both the acute phase and delayed phase (from 25 to 120 hours) after the start of chemotherapy, according to an FDA press statement. The effectiveness of the combination drug, marketed as Akynzeo by Eisai, was established in two clinical trials of 1,720 participants receiving cancer chemotherapy. Participants were randomly assigned to receive Akynzeo or oral palonosetron, the FDA statement said.

In the first trial, 98.5%, 90.4%, and 89.6% of Akynzeo-treated participants did not experience any vomiting or require rescue medication for nausea during the acute, delayed, and overall phases, respectively, compared with 89.7%, 80.1%, and 76.5% of participants treated with oral palonosetron.

The second trial showed similar results.Common side effects of Akynzeo in the clinical trials were headache, asthenia, fatigue, dyspepsia, and constipation, the FDA noted in the statement.

The Food and Drug Administration has approved an oral combination of two drugs for the prevention of nausea and vomiting in patients undergoing cancer chemotherapy.

The combination of palonosetron, approved in 2008, and a new drug, netupitant, prevent nausea and vomiting during both the acute phase and delayed phase (from 25 to 120 hours) after the start of chemotherapy, according to an FDA press statement. The effectiveness of the combination drug, marketed as Akynzeo by Eisai, was established in two clinical trials of 1,720 participants receiving cancer chemotherapy. Participants were randomly assigned to receive Akynzeo or oral palonosetron, the FDA statement said.

In the first trial, 98.5%, 90.4%, and 89.6% of Akynzeo-treated participants did not experience any vomiting or require rescue medication for nausea during the acute, delayed, and overall phases, respectively, compared with 89.7%, 80.1%, and 76.5% of participants treated with oral palonosetron.

The second trial showed similar results.Common side effects of Akynzeo in the clinical trials were headache, asthenia, fatigue, dyspepsia, and constipation, the FDA noted in the statement.

MADRID – The investigational neurokinin-1 receptor antagonist rolapitant met all of its endpoints in the prevention of chemotherapy-induced nausea and vomiting in a phase III trial.

Among 532 patients receiving cisplatin chemotherapy, 72.7% randomized to oral rolapitant versus 58.4% on placebo achieved the primary endpoint of complete response, defined as no emesis or use of rescue medication, in the delayed phase of more than 24 hours to 120 hours following chemotherapy (P less than .001).

Complete responses also were higher with rolapitant in the acute phase (0-24 hours) post chemotherapy (83.7% vs. 73.7%; P = .005) and the overall phase (0-120 hours) post chemotherapy (70.1% vs. 56.5%; P = .001), according to a late-breaking abstract reported at the European Society for Medical Oncology Congress.

Rolapitant works by blocking activation of neurokinin (NK)-1 receptors concentrated in the brain, which play a central role in nausea and vomiting.

Rolapitant is unique in that it has an extremely long half-life of 180 hours and NK-1 receptor occupancy of more than 90% for up to 5 days, study coauthor Dr. Bernardo Rapoport of the Medical Oncology Centre of Rosebank, Johannesburg, South Africa, explained during a press briefing on the study.

Kaplan-Meier analysis suggests that the effect of rolapitant begins in the acute phase, with separation of the curves beginning at about 12 hours.

More than 85% of cancer patients not treated appropriately can be affected by chemotherapy-induced nausea and vomiting, Dr. Rapoport said, adding that active management of this “most feared” side effect can improve quality of life and compliance with cancer treatment.

There was a slight improvement in quality of life in the rolapitant arm versus controls, as measured by the Functional Living Index-Emesis questionnaire (mean total score 112.5 vs. 108.4; P = .032).

Patients in the study were evenly randomized on the day of chemotherapy to oral rolapitant 200 mg or placebo, plus intravenous granisetron and oral dexamethasone.

Treatment-related adverse events were consistent across both arms, with most considered related to chemotherapy or the underlying cancer, Dr. Rapoport said.

Rolapitant is being developed by Tesaro in oral and intravenous formulations. A new drug application was filed in September 2014 with the U.S. Food and Drug Administration for oral rolapitant based on results from four controlled trials.

Rolapitant will face stiff competition in the market from Merck’s long-standing NK1 receptor antagonist, aprepitant (Emend), which is approved for prevention of chemotherapy-induced nausea and vomiting in combination with a corticosteroid and a 5-HT₃ antagonist. Rolapitant failed to meet a key secondary endpoint in a phase III trial last year, sending Tesaro stocks tumbling.

[email protected]

MADRID – The investigational neurokinin-1 receptor antagonist rolapitant met all of its endpoints in the prevention of chemotherapy-induced nausea and vomiting in a phase III trial.

Among 532 patients receiving cisplatin chemotherapy, 72.7% randomized to oral rolapitant versus 58.4% on placebo achieved the primary endpoint of complete response, defined as no emesis or use of rescue medication, in the delayed phase of more than 24 hours to 120 hours following chemotherapy (P less than .001).

Complete responses also were higher with rolapitant in the acute phase (0-24 hours) post chemotherapy (83.7% vs. 73.7%; P = .005) and the overall phase (0-120 hours) post chemotherapy (70.1% vs. 56.5%; P = .001), according to a late-breaking abstract reported at the European Society for Medical Oncology Congress.

Rolapitant works by blocking activation of neurokinin (NK)-1 receptors concentrated in the brain, which play a central role in nausea and vomiting.

Rolapitant is unique in that it has an extremely long half-life of 180 hours and NK-1 receptor occupancy of more than 90% for up to 5 days, study coauthor Dr. Bernardo Rapoport of the Medical Oncology Centre of Rosebank, Johannesburg, South Africa, explained during a press briefing on the study.

Kaplan-Meier analysis suggests that the effect of rolapitant begins in the acute phase, with separation of the curves beginning at about 12 hours.

More than 85% of cancer patients not treated appropriately can be affected by chemotherapy-induced nausea and vomiting, Dr. Rapoport said, adding that active management of this “most feared” side effect can improve quality of life and compliance with cancer treatment.

There was a slight improvement in quality of life in the rolapitant arm versus controls, as measured by the Functional Living Index-Emesis questionnaire (mean total score 112.5 vs. 108.4; P = .032).

Patients in the study were evenly randomized on the day of chemotherapy to oral rolapitant 200 mg or placebo, plus intravenous granisetron and oral dexamethasone.

Treatment-related adverse events were consistent across both arms, with most considered related to chemotherapy or the underlying cancer, Dr. Rapoport said.

Rolapitant is being developed by Tesaro in oral and intravenous formulations. A new drug application was filed in September 2014 with the U.S. Food and Drug Administration for oral rolapitant based on results from four controlled trials.

Rolapitant will face stiff competition in the market from Merck’s long-standing NK1 receptor antagonist, aprepitant (Emend), which is approved for prevention of chemotherapy-induced nausea and vomiting in combination with a corticosteroid and a 5-HT₃ antagonist. Rolapitant failed to meet a key secondary endpoint in a phase III trial last year, sending Tesaro stocks tumbling.

[email protected]

MADRID – The investigational neurokinin-1 receptor antagonist rolapitant met all of its endpoints in the prevention of chemotherapy-induced nausea and vomiting in a phase III trial.

Among 532 patients receiving cisplatin chemotherapy, 72.7% randomized to oral rolapitant versus 58.4% on placebo achieved the primary endpoint of complete response, defined as no emesis or use of rescue medication, in the delayed phase of more than 24 hours to 120 hours following chemotherapy (P less than .001).

Complete responses also were higher with rolapitant in the acute phase (0-24 hours) post chemotherapy (83.7% vs. 73.7%; P = .005) and the overall phase (0-120 hours) post chemotherapy (70.1% vs. 56.5%; P = .001), according to a late-breaking abstract reported at the European Society for Medical Oncology Congress.

Rolapitant works by blocking activation of neurokinin (NK)-1 receptors concentrated in the brain, which play a central role in nausea and vomiting.

Rolapitant is unique in that it has an extremely long half-life of 180 hours and NK-1 receptor occupancy of more than 90% for up to 5 days, study coauthor Dr. Bernardo Rapoport of the Medical Oncology Centre of Rosebank, Johannesburg, South Africa, explained during a press briefing on the study.

Kaplan-Meier analysis suggests that the effect of rolapitant begins in the acute phase, with separation of the curves beginning at about 12 hours.

More than 85% of cancer patients not treated appropriately can be affected by chemotherapy-induced nausea and vomiting, Dr. Rapoport said, adding that active management of this “most feared” side effect can improve quality of life and compliance with cancer treatment.

There was a slight improvement in quality of life in the rolapitant arm versus controls, as measured by the Functional Living Index-Emesis questionnaire (mean total score 112.5 vs. 108.4; P = .032).

Patients in the study were evenly randomized on the day of chemotherapy to oral rolapitant 200 mg or placebo, plus intravenous granisetron and oral dexamethasone.

Treatment-related adverse events were consistent across both arms, with most considered related to chemotherapy or the underlying cancer, Dr. Rapoport said.

Rolapitant is being developed by Tesaro in oral and intravenous formulations. A new drug application was filed in September 2014 with the U.S. Food and Drug Administration for oral rolapitant based on results from four controlled trials.

Rolapitant will face stiff competition in the market from Merck’s long-standing NK1 receptor antagonist, aprepitant (Emend), which is approved for prevention of chemotherapy-induced nausea and vomiting in combination with a corticosteroid and a 5-HT₃ antagonist. Rolapitant failed to meet a key secondary endpoint in a phase III trial last year, sending Tesaro stocks tumbling.

[email protected]

EDINBURGH – When your patient says he or she wants to die, what do you do?

There’s no single answer, but asking the right questions can help patients find peace as well as perspective, according to Dr. Ilora Finlay, who spoke at the 15th World Congress on Cancers of the Skin about the types of conversations and seemingly small actions that can make a big difference for patients coping with advanced cancer.

In an interview at the meeting, Dr. Finlay shared some of her expertise from decades of clinical experience in palliative care.

The congress was sponsored by the Skin Cancer Foundation.

[email protected]

EDINBURGH – When your patient says he or she wants to die, what do you do?

There’s no single answer, but asking the right questions can help patients find peace as well as perspective, according to Dr. Ilora Finlay, who spoke at the 15th World Congress on Cancers of the Skin about the types of conversations and seemingly small actions that can make a big difference for patients coping with advanced cancer.

In an interview at the meeting, Dr. Finlay shared some of her expertise from decades of clinical experience in palliative care.

The congress was sponsored by the Skin Cancer Foundation.

[email protected]

EDINBURGH – When your patient says he or she wants to die, what do you do?

There’s no single answer, but asking the right questions can help patients find peace as well as perspective, according to Dr. Ilora Finlay, who spoke at the 15th World Congress on Cancers of the Skin about the types of conversations and seemingly small actions that can make a big difference for patients coping with advanced cancer.

In an interview at the meeting, Dr. Finlay shared some of her expertise from decades of clinical experience in palliative care.

The congress was sponsored by the Skin Cancer Foundation.

[email protected]

EDINBURGH – U.S. military personnel deployed overseas during the past decade have increased risk factors for skin cancer, a new survey suggests.

Researchers reported that 77% of veterans were exposed to 4 or more hours of bright sun during a typical day, but only 27% had ready access to sunscreen while working. Another 32% had no access to sunscreen.

A full 62% of veterans reported getting sunburned while deployed, with 42% having two or more sunburns, 16% four or more sunburns, and 15% at least one blistering sunburn.

Twenty-nine percent of veterans noticed changes in size, shape, or color of moles since deployment, but only 4% reported receiving a skin exam by a physician since returning home.

“This study demonstrates room for improvement for skin cancer prevention in veterans’ populations,” dermatologist Jennifer Powers of Vanderbilt University, Nashville, Tenn., reported at the 15th World Congress on Cancers of the Skin.

The 30-question survey was given to U.S. military workers engaged in Operation Enduring Freedom, Operation Iraqi Freedom, or Operation New Dawn presenting at the Nashville postdeployment clinic, Tennessee Valley Healthcare System, U.S. Department of Veterans. The combat missions occurred at a more equatorial latitude than the mean center of the United States population, increasing the potential for ultraviolet exposure and the development of skin cancer, Dr. Powers noted.

Of the 197 respondents, 64% identified as white, 22% as African American, and 8% as Hispanic. Almost half (48%) were fair-skinned.

Only 22% of veterans reported being made very aware of the risks of skin cancer, compared with 41% who reported not being made aware at all.

Dr. Powers highlighted a prior retrospective review of tumor registries showing that the melanoma incidence increased from 1990-1994 to 2000-2004 among white active-duty military personnel and that rates were significantly higher among those 45 years or older (Cancer Epidemiol. Biomarkers Prev. 2011;20:318-23).

The congress was sponsored by the Skin Cancer Foundation.

[email protected]

EDINBURGH – U.S. military personnel deployed overseas during the past decade have increased risk factors for skin cancer, a new survey suggests.

Researchers reported that 77% of veterans were exposed to 4 or more hours of bright sun during a typical day, but only 27% had ready access to sunscreen while working. Another 32% had no access to sunscreen.

A full 62% of veterans reported getting sunburned while deployed, with 42% having two or more sunburns, 16% four or more sunburns, and 15% at least one blistering sunburn.

Twenty-nine percent of veterans noticed changes in size, shape, or color of moles since deployment, but only 4% reported receiving a skin exam by a physician since returning home.

“This study demonstrates room for improvement for skin cancer prevention in veterans’ populations,” dermatologist Jennifer Powers of Vanderbilt University, Nashville, Tenn., reported at the 15th World Congress on Cancers of the Skin.

The 30-question survey was given to U.S. military workers engaged in Operation Enduring Freedom, Operation Iraqi Freedom, or Operation New Dawn presenting at the Nashville postdeployment clinic, Tennessee Valley Healthcare System, U.S. Department of Veterans. The combat missions occurred at a more equatorial latitude than the mean center of the United States population, increasing the potential for ultraviolet exposure and the development of skin cancer, Dr. Powers noted.

Of the 197 respondents, 64% identified as white, 22% as African American, and 8% as Hispanic. Almost half (48%) were fair-skinned.

Only 22% of veterans reported being made very aware of the risks of skin cancer, compared with 41% who reported not being made aware at all.

Dr. Powers highlighted a prior retrospective review of tumor registries showing that the melanoma incidence increased from 1990-1994 to 2000-2004 among white active-duty military personnel and that rates were significantly higher among those 45 years or older (Cancer Epidemiol. Biomarkers Prev. 2011;20:318-23).

The congress was sponsored by the Skin Cancer Foundation.

[email protected]

EDINBURGH – U.S. military personnel deployed overseas during the past decade have increased risk factors for skin cancer, a new survey suggests.

Researchers reported that 77% of veterans were exposed to 4 or more hours of bright sun during a typical day, but only 27% had ready access to sunscreen while working. Another 32% had no access to sunscreen.

A full 62% of veterans reported getting sunburned while deployed, with 42% having two or more sunburns, 16% four or more sunburns, and 15% at least one blistering sunburn.

Twenty-nine percent of veterans noticed changes in size, shape, or color of moles since deployment, but only 4% reported receiving a skin exam by a physician since returning home.

“This study demonstrates room for improvement for skin cancer prevention in veterans’ populations,” dermatologist Jennifer Powers of Vanderbilt University, Nashville, Tenn., reported at the 15th World Congress on Cancers of the Skin.

The 30-question survey was given to U.S. military workers engaged in Operation Enduring Freedom, Operation Iraqi Freedom, or Operation New Dawn presenting at the Nashville postdeployment clinic, Tennessee Valley Healthcare System, U.S. Department of Veterans. The combat missions occurred at a more equatorial latitude than the mean center of the United States population, increasing the potential for ultraviolet exposure and the development of skin cancer, Dr. Powers noted.

Of the 197 respondents, 64% identified as white, 22% as African American, and 8% as Hispanic. Almost half (48%) were fair-skinned.

Only 22% of veterans reported being made very aware of the risks of skin cancer, compared with 41% who reported not being made aware at all.

Dr. Powers highlighted a prior retrospective review of tumor registries showing that the melanoma incidence increased from 1990-1994 to 2000-2004 among white active-duty military personnel and that rates were significantly higher among those 45 years or older (Cancer Epidemiol. Biomarkers Prev. 2011;20:318-23).

The congress was sponsored by the Skin Cancer Foundation.

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Physicians should ready themselves now for the new set of rules expected when hydrocodone-containing products become subject to tighter regulation on Oct. 6, according to various physician groups.

After a years-long process, the Drug Enforcement Administration announced in late August that it would be moving hydrocodone-containing products from schedule III to schedule II.

That rule takes effect on Oct. 6.

After that date, physicians who want to prescribe HCPs will have to use tamper-proof prescription forms, or use e-prescribing programs. They can call in a 72-hour supply, but must follow that up by mailing the prescription to the pharmacy. Refills by fax or phone are otherwise prohibited.

Patients who are on long term HCP therapy can get up to a 90-day supply through three separate, no-refill prescriptions.

The American Medical Association, which campaigned against the rescheduling of HCPs, is now urging its members to be prepared for the changes in prescribing and work flow that will come with the new landscape.

In a fact sheet, the AMA says that physicians should try to refill prescriptions before Oct. 6, noting that these prescriptions will essentially be grandfathered in under the old rules until Apr. 2015.

The American Society of Clinical Oncology in early September also notified its members of the coming changes, and said that it, too, had opposed rescheduling of HCPs.

Many physician groups have said that moving HCPs to schedule II will not stop abuse or diversion and may hurt patients who have a legitimate need. Dr. Reid Blackwelder, president of the American Academy of Family Physicians, said that “it’s hard to say,” whether upscheduling will make a dent in inappropriate or unnecessary prescribing.

He said in an interview that his practice already requires patients on long-term opioid therapy to come in at least every 3 months for refills and an evaluation. Although physicians may have to change their practice schedules to accommodate refill visits, those visits are good opportunities for education and follow-up, said Dr. Blackwelder.

Requiring face-to-face visits “creates more opportunities to review a treatment plan and make sure it still makes sense,” he said, noting that for many patients, short-acting opioids are the wrong medication.

Dr. Andrew Kolodny, for one, is applauding the rescheduling of HCPs, saying that the explosion in prescriptions for HCPs such as Vicodin (hydrocodone/acetaminophen) has been the single biggest contributor to the rise in opioid addiction.

“I think this is going to have an enormous impact on bringing the epidemic to an end,” Dr. Kolodny, chief medical officer at the Phoenix House Foundation and director of Physicians for Responsible Opioid Prescribing, said in an interview.

He noted that many opioid addicts get their start with HCPs, in part because they are ubiquitous.

The schedule change will bring “a sharp reduction in prescribing of hydrocodone-containing products,” because “it will communicate to prescribers that this drug is every bit as addictive as the other opioids, and needs to be prescribed cautiously,” said Dr. Kolodny.

Dr. Kolodny disclosed that Physicians for Responsible Opioid Prescribing does not accept any industry funding. It is a financed as a Phoenix House program.

[email protected]

On Twitter @aliciaault

Physicians should ready themselves now for the new set of rules expected when hydrocodone-containing products become subject to tighter regulation on Oct. 6, according to various physician groups.

After a years-long process, the Drug Enforcement Administration announced in late August that it would be moving hydrocodone-containing products from schedule III to schedule II.

That rule takes effect on Oct. 6.

After that date, physicians who want to prescribe HCPs will have to use tamper-proof prescription forms, or use e-prescribing programs. They can call in a 72-hour supply, but must follow that up by mailing the prescription to the pharmacy. Refills by fax or phone are otherwise prohibited.

Patients who are on long term HCP therapy can get up to a 90-day supply through three separate, no-refill prescriptions.

The American Medical Association, which campaigned against the rescheduling of HCPs, is now urging its members to be prepared for the changes in prescribing and work flow that will come with the new landscape.

In a fact sheet, the AMA says that physicians should try to refill prescriptions before Oct. 6, noting that these prescriptions will essentially be grandfathered in under the old rules until Apr. 2015.

The American Society of Clinical Oncology in early September also notified its members of the coming changes, and said that it, too, had opposed rescheduling of HCPs.

Many physician groups have said that moving HCPs to schedule II will not stop abuse or diversion and may hurt patients who have a legitimate need. Dr. Reid Blackwelder, president of the American Academy of Family Physicians, said that “it’s hard to say,” whether upscheduling will make a dent in inappropriate or unnecessary prescribing.

He said in an interview that his practice already requires patients on long-term opioid therapy to come in at least every 3 months for refills and an evaluation. Although physicians may have to change their practice schedules to accommodate refill visits, those visits are good opportunities for education and follow-up, said Dr. Blackwelder.

Requiring face-to-face visits “creates more opportunities to review a treatment plan and make sure it still makes sense,” he said, noting that for many patients, short-acting opioids are the wrong medication.

Dr. Andrew Kolodny, for one, is applauding the rescheduling of HCPs, saying that the explosion in prescriptions for HCPs such as Vicodin (hydrocodone/acetaminophen) has been the single biggest contributor to the rise in opioid addiction.

“I think this is going to have an enormous impact on bringing the epidemic to an end,” Dr. Kolodny, chief medical officer at the Phoenix House Foundation and director of Physicians for Responsible Opioid Prescribing, said in an interview.

He noted that many opioid addicts get their start with HCPs, in part because they are ubiquitous.

The schedule change will bring “a sharp reduction in prescribing of hydrocodone-containing products,” because “it will communicate to prescribers that this drug is every bit as addictive as the other opioids, and needs to be prescribed cautiously,” said Dr. Kolodny.

Dr. Kolodny disclosed that Physicians for Responsible Opioid Prescribing does not accept any industry funding. It is a financed as a Phoenix House program.

[email protected]

On Twitter @aliciaault

Physicians should ready themselves now for the new set of rules expected when hydrocodone-containing products become subject to tighter regulation on Oct. 6, according to various physician groups.

After a years-long process, the Drug Enforcement Administration announced in late August that it would be moving hydrocodone-containing products from schedule III to schedule II.

That rule takes effect on Oct. 6.

After that date, physicians who want to prescribe HCPs will have to use tamper-proof prescription forms, or use e-prescribing programs. They can call in a 72-hour supply, but must follow that up by mailing the prescription to the pharmacy. Refills by fax or phone are otherwise prohibited.

Patients who are on long term HCP therapy can get up to a 90-day supply through three separate, no-refill prescriptions.

The American Medical Association, which campaigned against the rescheduling of HCPs, is now urging its members to be prepared for the changes in prescribing and work flow that will come with the new landscape.

In a fact sheet, the AMA says that physicians should try to refill prescriptions before Oct. 6, noting that these prescriptions will essentially be grandfathered in under the old rules until Apr. 2015.

The American Society of Clinical Oncology in early September also notified its members of the coming changes, and said that it, too, had opposed rescheduling of HCPs.

Many physician groups have said that moving HCPs to schedule II will not stop abuse or diversion and may hurt patients who have a legitimate need. Dr. Reid Blackwelder, president of the American Academy of Family Physicians, said that “it’s hard to say,” whether upscheduling will make a dent in inappropriate or unnecessary prescribing.

He said in an interview that his practice already requires patients on long-term opioid therapy to come in at least every 3 months for refills and an evaluation. Although physicians may have to change their practice schedules to accommodate refill visits, those visits are good opportunities for education and follow-up, said Dr. Blackwelder.

Requiring face-to-face visits “creates more opportunities to review a treatment plan and make sure it still makes sense,” he said, noting that for many patients, short-acting opioids are the wrong medication.

Dr. Andrew Kolodny, for one, is applauding the rescheduling of HCPs, saying that the explosion in prescriptions for HCPs such as Vicodin (hydrocodone/acetaminophen) has been the single biggest contributor to the rise in opioid addiction.

“I think this is going to have an enormous impact on bringing the epidemic to an end,” Dr. Kolodny, chief medical officer at the Phoenix House Foundation and director of Physicians for Responsible Opioid Prescribing, said in an interview.

He noted that many opioid addicts get their start with HCPs, in part because they are ubiquitous.

The schedule change will bring “a sharp reduction in prescribing of hydrocodone-containing products,” because “it will communicate to prescribers that this drug is every bit as addictive as the other opioids, and needs to be prescribed cautiously,” said Dr. Kolodny.

Dr. Kolodny disclosed that Physicians for Responsible Opioid Prescribing does not accept any industry funding. It is a financed as a Phoenix House program.

[email protected]

On Twitter @aliciaault