SGO Issues June 21, 2018
Drug Development Workshop: Progress made, education important
SGO Survivorship Toolkit updated for patients
Saving the oncologist one step at a time: My wellness strategy | Nathalie McKenzie, MD, MSPH
CDC hosts webinar on becoming an HPV vaccine champion
On June 14, the U.S. Food and Drug Administration (FDA), in conjunction with the Society of Gynecologic Oncology (SGO) and the American Association for Cancer Research (AACR), hosted a workshop on Drug Development in Gynecologic Malignancies to help spur the development of new treatments for gynecologic cancers. The SGO member presenters noted that while funding challenges exist, the stakeholders had a productive dialogue and progress is being made in immunotherapy treatments and combination therapies.
“We had a very productive dialogue between Society leadership, FDA personnel, patient advocates, and industry representatives that will hopefully continue to spur thoughtful and robust drug development in the gynecologic space,” said Thomas Herzog, MD, from the University of Cincinnati Cancer Institute. “Moving forward, we hope to develop a summary white paper that details the nuanced discussions on clinical trial designs whereby we best identify novel compounds and drug combinations that will benefit our patients.”
Robert Coleman, MD, from The University of Texas MD Anderson Cancer Center in Houston added, “The forum provided a unique blend of input from all stakeholders, providing insight, context and merit to strategies addressing the complex environment of bringing new assets to the clinic. Laying the framework for efficient and unambiguous drug development is a key step in this process.”
Citing the latest drug approvals for pembrolizumab for cervical cancer, Rebecca Arend, MD, from The University of Alabama at Birmingham, noted that there are no less than 50 on-going combination trials. “I think everyone agreed that combinations will likely be more effective [especially for ovarian cancer] than single agent,” she said.
“It was exciting to see Dr. Robert Coleman discuss innovative adaptive trial design for immunotherapies,” said Annie Ellis, research advocate with the Ovarian Cancer Research Fund Alliance. “Could adaptive designs be utilized with rare cancers? Patients see the success of immunotherapy in other cancers and the commercials on TV and hope more progress in our own cancers will be seen soon.
“Many patients do not realize that the response rate is not 100 percent for currently approved immunotherapies. Even with the low response rates of ovarian cancer immunotherapy trials, participants enroll hoping that they’ll be one of the few to have a dramatic and durable response,” she said.
David Gershenson, MD, from the University of Texas MD Anderson Cancer Center in Houston added that patient advocates are critical in moving the field forward in terms of rare tumors.
“Ideally, it would be great to have a cadre of five or so advocates to assist in each of the rare subtypes—clear cell, low-grade serous, mucinous, small cell hypercalcemic, etc.—to advise investigators in the design of trials and to lobby the Cancer Therapy Evaluation Program [CTEP], pharmaceutical companies, and Congress,” he said. “Although we did query a few advocates in our run-up to developing the front-line low-grade serous carcinoma (LGSC) trial, such a subgroup would have been invaluable in advising us.”
Dr. Gershenson said that another issue with which advocates could play a major role is assisting researchers in establishing “a new normal” in terms of the operational issues regarding international rare tumor trials.
“Changing traditional methods has been challenging, and we need a task force of advocates and committed investigators to help determine the way forward,” he said.
In addition to immunotherapy and rare cancers, Alan D’Andrea, MD of Dana-Farber Cancer Institute in Boston provided an overview of mechanisms of resistance to PARP inhibitors and development of organoids to rapidly identify PARPi resistant tumors. Gordon Mills MD, from The University of Texas MD Anderson Cancer Center in Houston reviewed rational combinations to overcome PARP inhibitor resistance and development of a platform for real time selection of drug combinations based on adaptive response.
“Until a ‘home run’ emerges, more trials are opening in first line when immune systems are stronger. As patient advocate Mary Scroggins discussed at the workshop, the number of trials and multiple combinations is daunting,” said Ellis. “Patient education is important.”
The SGO Survivorship Toolkit, originally launched in 2013, has been updated and is ready for distribution on the SGO and FWC websites. The Toolkit documents were revised to allow for easy adaptability to Electronic Medical Records, and reformatted to specifically meet the needs of the patients.
Marina Frimer, MD, Gynecologic Oncologist from Northwell Health/Long Island Jewish Medical Center in New York, and Mary Callaghan, APN, from the Northwestern Memorial Hospital in Chicago, headed up the Clinical Practice Committee subcommittee to update the Survivorship Toolkit, which includes the following highlights for a patient audience:
- Individual Treatment Summary: Summarizes treatment, lists possible side effects and includes a follow-up care plan
- Wellness and Preventive Health: Provides resources for maintaining a healthy lifestyle
- Survivorship Calendar: Tracks appointments and care team contact information
“This toolkit allows patients to have an understanding of the side effects of treatment – short term and long term, a centralized location of their treatment plans and have a record to show their primary care physicians,” said Dr. Frimer.
I am a 14-year cancer survivor, the daughter of a cancer survivor and a mid-career gynecologic oncologist. I am therefore ever conscious of the fragility of human life. Yet, I have no fear. With grounded confidence all of us can adapt and persevere.
Ambition, drive, intelligence, and social IQ cannot change certain unfortunate circumstances, but how we proceed—-how we adapt and persevere—could make all the difference. Take, for example, the increasing rates of physician burn out in our society . How can we adapt and persevere in the current physician employment landscape—one that some claim is associated with poor health for our physicians?
Here are some examples of what my husband (an entrepreneur turned life coach) and I do to protect ourselves and our young children from outside pressures. Our strategy is to arm ourselves with some key defense tactics such as enhanced nutrition, physical and mental fitness training, stress reduction and goal setting.
Let’s start with meals. Dodging the plethora of unhealthy drinks and meals offered at work cafeterias, hotels and restaurants was crucial and may have had the single greatest impact on our health as a family. The goal was to eliminate processed foods, fried foods, sugary drinks and those with artificial sweeteners . We soon realized that we had to develop some “On the go” options such as raw vegetables, mixed nuts, fresh fruits, and good fats . Water is our go-to drink.
We then developed a mental fitness strategy incorporating meditation, mindfulness and positive affirmations to stay focused on our goals and reduce stress [3,4]. We immediately saw the positive effects in every aspect of our lives including parenting, marriage, and career. Just 15 minutes to decompress at critical times in the day will have a big impact.
We also started waking up earlier in the morning, before the kids rose, to do a 15- to 30-minute High-Intensity Interval Training (HIT) routine [5.6]. We even have a workout for the beach, hotel room, stairwell at the hospital—no excuses! We have a version for pretty much ANYWHERE.
Finally, adequate sleep . In order to get adequate sleep, however, we had to free up some time. This is where staying focused and efficient comes in. Upon closer examination, I found that many commitments made over time were not getting me any closer to my two-, five-, or 10-year goals. Constantly forcing myself to stay on track and focused now allows me to objectively triage offers and responsibilities and only commit to those that position me on the path to achieving my personal short- and long-term goals.
Although my strategy is just one example of many, I hope that it will serve as a catalyst for some of our readers. I encourage my fellow health care providers to put the same thought, research, and hard work towards optimizing your own overall health and survival as you have done for your patients and while building your careers.
Nathalie Dauphin McKenzie, MD, MSPH, is a gynecologic oncologist at Florida Hospital Medical Group in Orlando, FL.
- Medscape National Physician Burnout & Depression Report 2018, online January 17, 2018.
- Food: What the Heck Should I Eat? Mark Hyman, MD, 2018
- Understanding Stress and Mental Fitness: Techniques for Building Resilience, Jaymie Meyer, corporatewellnessmagazine.com
- Yoga, Meditation and Mind-Body Health: Increased BDNF, Cortisol Awakening Response, and Altered Inflammatory Marker Expression after a 3-Month Yoga and Meditation Retreat. Frontiers in Human Neuroscience, 2017; 11. Cahn et al.
- Where Does HIT Fit? An Examination of the Affective Response to High-Intensity Intervals in Comparison to Continuous Moderate- and Continuous Vigorous-Intensity Exercise in the Exercise Intensity-Affect Continuum, M. Jung PLOS Dec 2014
- Science Shows Only This Workout Can Actually Make You Younger. Jill Brown, Huffingtonpost.com, May 2017
- Why We Sleep: The New Science of Sleep and Dreams, Mathew Walker, PhD, October 2017
The Centers for Disease Control and Prevention (CDC) is hosting a webinar, “Back-to-School Showcase: Resources to Help You Become an HPV Champion,” on Wednesday, June 27, at 10:00 a.m. – 11:00 a.m. PT / 1:00 p.m. – 2:00 p.m. ET to help promote HPV vaccination during the summer and back-to-school vaccination season as well as National Immunization Awareness Month (NIAM) in the month of August. Registration is available online.