SGO Issues June 26, 2014
FDA disagrees with SGO position on olaparib
Allied Health Professionals Workshop seeks case studies
Allied Health Workshop addresses palliative care
Voices: At the Center of it All | Dee Sparacio
Deadline for membership upgrade July 31
On June 25 the Food and Drug Administration’s Oncologic Drugs Advisory Committee (ODAC) voted 11-2 against an indication for olaparib capsules in the treatment of ovarian cancer. G. Larry Maxwell, MD, presented SGO’s support of the new drug application at the ODAC Meeting in Silver Spring, MD.
The new drug application, submitted by AstraZeneca Pharmaceuticals LP, proposed an indication for olaparib as monotherapy for the maintenance treatment of adult patients with platinum-sensitive relapsed ovarian cancer (including fallopian tube or primary peritoneal) with germline BRCA mutation as detected by an FDA-approved test, who are in response (complete response or partial response) to platinum-based chemotherapy.
Dr. Maxwell, FACOG, COL(ret), Chair of the Department of Obstetrics and Gynecology at Inova Fairfax Hospital in Falls Church, VA, noted in his testimony that researchers are well aware of the clinical impact that PARP inhibitors have in the setting of ovarian cancer, particularly those who carry a germline mutation in one of the BRCA genes. In addition to germline mutation carriers, women whose tumors develop incompetent homologous recombination DNA repair via somatic loss/alteration of BRCA and other genes may additionally benefit from PARP inhibition.
“Before you is a large trial of unselected women with high-grade serous ovarian cancer in whom olaparib was administered following documentation of platinum-based therapeutic response,” said Dr. Maxwell. “The current trial demonstrated unprecedented levels of efficacy as measured by extension of time to progression, particularly among the subset expected to benefit to the greatest degree, namely, those whose tumors were characterized by BRCA loss.”
Dr. Maxwell added that the magnitude of effect for efficacy is impressive in this patient population, especially for those with documented BRCA mutations.
“This highly effective clinical strategy of PARP inhibition in a maintenance setting represents the first, truly individualized treatment option with unequivocal benefit, and ushers in the era of personalized medicine for recurrent ovarian cancer patients,” he said.
Study 19 demonstrated positive results in terms of an 83 percent reduction in the risk of progression or death and a seven-month median improvement in progression-free survival for patients with platinum-sensitive, gBRCAm-associated ovarian cancer in the maintenance setting.
The FDA asked ODAC to vote on whether the safety and efficacy results from Study 19 in the gBRCAm population support an accelerated approval, or whether consideration for marketing approval be delayed until the results of the SOLO-2 study are available. In rejecting the accelerated approval, the FDA noted the small sample size of study 19 and the toxicity associated with olaparib (especially nausea) as the reasoning for not granting accelerated approval. There was also a concern about the reproducibility of the treatment effect and the possibility of inducing leukemia of myelodysplastic syndrome.
“The next steps are to wait for the results of SOLO-2 and to judge the agent based on the larger SOLO-2 clinical trial,” said Bradley J. Monk, MD, FACOG, FACS, Director of the Division of Gynecologic Oncology at the University of Arizona Cancer Center-Phoenix. Dr. Monk noted that SOLO-2 is expected to complete enrollment during the first quarter of 2015.
“I think the problem here was not that the endpoint was PFS, the problem was that this is a 96 patient subset of a Phase II trial,” said Dr. Monk. “To approve a new chemical entity in the treatment of ovarian cancer based on a study which only has 96 patients just doesn’t satisfy the regulatory requirements.”
Dr. Monk, who observed the ODAC meeting via a live webcast, commended Dr. Maxwell for testifying on SGO’s behalf, and added that the testimony from ovarian cancer patients was very emotional. “There were women who got up there and cried, ‘I have ovarian cancer and I beg you to allow me to get this agent,’” he said.
For the latest information on the ODAC meeting, click here.
By Mary Callaghan, MN, RN, AOCNS, APN
SGO has tapped experts in gynecologic oncology subspecialties from across the spectrum to provide the most comprehensive education available at the 2014 Allied Health Professionals Workshop: Solutions to Practice Challenges, to be held in Chicago, Sept. 27-28, 2014.
Cancer treatment and symptom management in advanced gynecology oncology require a multidisciplinary approach to care. Allied health professionals who know how to respond to common non-clinical concerns as well as the current guidelines of common chemotherapy regimens can play a huge factor in clinical outcomes. Ultimately, this affects how each patient experiences her cancer treatment plan.
At this year’s Allied Health Workshop, a genetic counselor will help attendees better understand the current science behind BRCA and how to counsel patients and their families. SGO has also asked palliative care experts to lend insight into how to best increase quality of life for patients who are undergoing treatment for advanced disease and to help them adjust the goals of care as needed.
In preparation for this workshop, SGO is requesting case studies that relate to mid-level practice challenges and topics such as survivorship, obesity and general wellness education submitted by both SGO Allied members and non-members. These submissions will be evaluated for possible presentation at the workshop, promoting an even broader education grounded in the day-to-day experience of the women’s cancer treatment team.
To ensure a truly customized education experience for all attendees to the 2014 Allied Health Professionals Workshop: Solutions to Practice Challenges, SGO welcomes suggestions for questions, practice challenges, and topics to be addressed. Suggestions may be sent to firstname.lastname@example.org.
Mary Callaghan, MN, RN, AOCNS, APN is a practicing Gynecological Oncology Advance Practice Nurse at Northwestern Memorial Hospital in Chicago and is a presenter and course director for the 2014 Allied Health Professionals Workshop.
By Carolyn Lefkowits, MD
As palliative care is such an important part of comprehensive cancer care, I am excited that we have the opportunity to present and discuss several practice and clinical aspects of this topic at the 2014 Allied Health Professionals Workshop: Solutions to Practice Challenges.
Palliative care assesses and addresses the physical, psychological, social and spiritual needs of both patients and families. It provides assistance with decision making for patients, families and medical teams. Palliative care is not synonymous with end-of-life care. Rather, it can be appropriate at any point in the disease course and can be offered concurrently with disease-modifying therapies, including when the goal is cure.
The demonstrated benefits of palliative care include improved symptom management, improved quality of life and more efficient utilization of healthcare resources. As Laura Havrilesky, MD, highlighted in her January 2014 Gynecologic Oncology editorial earlier this year, palliative care services “enhance the quality and value of gynecologic cancer care.”
Practitioners of all levels can benefit from discussions on palliative care at the 2014 Allied Health Professionals Workshop. Attendees will have an opportunity to gain a more complete understanding of the benefits of and evidence behind early implementation palliative care, as well as what distinguishes palliative care from hospice, and how those differences impact the patient.
I am also excited to discuss ideas for more effective ways both to explain palliative care to patients and colleagues and to integrate palliative care into standard oncology care throughout the disease course in order to provide truly comprehensive care to our patients.
Carolyn Lefkowits, MD, is a gynecologic oncology fellow at University of Pittsburgh/Magee Women’s Hospital and will be a presenter at the 2014 Allied Health Professionals Workshop.
Over the past nine years I have seen an increase in the number of non-profit organizations whose mission is to raise awareness of gynecologic cancers and funds for research. There are national organizations and many local gynecologic cancer organizations that consistently raise awareness about the risks and symptoms of gynecologic cancers via TV, radio, print, Twitter and Facebook. Other non-profits fund research host dinners, walks and runs, teas, and auctions. This private funding has been so important the past few years as government funding of cancer research has been reduced.
Along with these organizations there are individual women, some newly diagnosed, others in treatment and others years out of treatment who share their journey with gynecologic cancer through memoirs, blogs and news articles. Women with gynecologic cancers are taking more control of their own treatment plans. Women are speaking up about side effects and their personal needs. Others are openly discussing their cognitive issues and their need for psychosocial support. They are doing this in support groups, online groups, and social media. Women are having conversations about these issues with their gynecologic oncologists, nurses and social workers. Our needs as survivors are moving to the center of our health care discussions.
Another place where patients and survivors are coming together is at the center of research. I recently had the privilege of being a patient reviewer for the Patient-Centered Outcomes Institute (PCORI). PCORI was authorized by Congress to fund and provide patients with results from comparative effectiveness research (CER). In CER research, studies are designed to help provide patients and their health care providers with ways to make informed decisions regarding the effectiveness, benefits, and harms of different prevention, treatment and care options.
PCORI has multiple funding cycles through the year and various categories in which researchers can apply for funding. One of the major criteria for funding a PCORI research project is that the studies are required to have patients take part in all aspects of the study. Patients are engaged in the study design including its outcomes, they are also active participants in the study itself and they aid in disseminating the results of the study.
The type of research that PCORI funds answers many of the questions that patients have been asking for years about their treatments and follow-up care. I know that during my recurrence I wish I had more information about what would work best for me–surgery first and then chemotherapy or chemotherapy first and then surgery. Patients want to know the risks and benefits of different treatments. They want to compare the side effects of each treatment choice in order to make an educated decision about how much they want that side effect to impact their quality of life. They also want to be sure that the outcomes they see are important to them. And they want strong science to support the decisions they make.
I came home from the PCORI review happy to see patients working with researchers and stakeholders to make a difference in the lives of others. And I look forward to seeing the growth of more patient-centered research in the coming years just as I have seen the growth in patient-driven organizations.
Applications are due July 31 for SGO members who are eligible to upgrade to the next level of membership. Click here to download the appropriate membership application. Contact email@example.com with any questions.