SGO Issues May 24, 2018

FDA-SGO-AACR Drug Development in Gynecologic Malignancies Workshop
Roundtable determines elements of caregiver support | Lauren Hand, MD
Having More Empathy | Jolyn Taylor, MD, MPH
From the Field: Impact of Volunteer Work in Nepal

FDA-SGO-AACR Drug Development in Gynecologic Malignancies Workshop

To help spur the development of new treatments for gynecologic cancers, 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), is co-hosting a workshop on Drug Development in Gynecologic Malignancies on Thursday, June 14, from 8:00 a.m. to 5:00 p.m. at the FDA White Oak Campus in Silver Spring, MD. This workshop is a continuation of a 2015 Clinical Trial Endpoints in Ovarian Cancer Workshop hosted by FDA, SGO, AACR and the American Society of Clinical Oncology (ASCO). Interested parties can register for in-person or webcast participation.

The goals and objectives of this workshop are as follows:

• To provide a forum for open discussion between the FDA, clinicians, laboratory experts, and researchers on the way forward for diagnosis and treatment of gynecologic malignancies;
• Accelerate the development of immunotherapy in gynecologic malignancies; Facilitate open discussions among all parties in the area of gynecologic malignancies;
• Obtain input from multiple stakeholders on approaches to novel study designs to leverage rare subtypes in gynecologic malignancies; and
• Discuss the impact of biomarkers in gynecologic malignancies.

A draft agenda is available through the FDA website.

Representatives from the SGO include Rebecca Arend, MD, Assistant Professor of Obstetrics and Gynecology, University of Alabama at Birmingham; Robert L. Coleman, MD, FACOG, FACS, Professor, Department of Gynecologic Oncology and Reproductive Medicine and Executive Director, Cancer Network Research, UT MD Anderson Cancer Center; and Thomas Herzog, MD, Deputy Director and Professor of Obstetrics and Gynecology, University of Cincinnati Cancer Institute.

Dr. Arend noted the important role that clinical trials play for women with gynecologic cancers.

“Given the limited clinical benefit of immunotherapy in unselected gynecologic oncology populations, it is imperative that we develop a better understanding of which tumors are intrinsically vulnerable to immunotherapy and which tumors can be modulated to enhance the efficacy of immunotherapeutic strategies to positively affect the trajectory of our patient’s disease,” said Dr. Arend. “Impacting the survival of women with gynecologic cancer is dependent upon the number of patients and women who enroll in clinical trials.

“So far progress in immunotherapy in gynecologic oncology has been limited in comparison to other tumors due to the fact that most lack a true ‘T-cell inflamed” phenotype;” said Dr. Arend. “Therefore, it is important for us to understand how to create a microenvironment that will enable the immune system recognize and attack the tumor; it is likely such strategies will require clinical trials of strategic combinations rather than single agents.”

FDA will be live streaming the audio and slides from this workshop. FDA will also be recording the presentations and will make those recordings available for viewing on the FDA website.

Roundtable determines elements of caregiver support | Lauren Hand, MD

Last month, the University of Pittsburgh’s Women’s Cancer Research Group convened a multi-disciplinary discussion to establish the priority support services needed by caregivers of women with gynecologic cancers, during a pre-conference research roundtable at the National Ovarian Cancer Coalition’s (NOCC) 2018 Annual Conference. The roundtable was led by myself and Heidi Donovan, PhD, RN, with the support of the NOCC and Clovis Oncology.

As part of the research roundtable, a group of over 40 caregivers, survivors, health care providers, and other experts met to discuss the priority needs of caregivers and come to consensus on the “essential elements of caregiver support” that gynecologic programs should provide.

A family caregiver is anyone—a spouse, partner, family member, friend, or neighbor—who is providing unpaid assistance and support to a loved one.[1] Family caregivers are key members of gynecologic cancer survivors’ teams, often in charge of managing their loved one’s care, addressing their symptoms, and communicating between health care providers. Over the course of the illness, caregivers are expected to take on roles that were once provided by formal caregivers (medical assistants, nurses) all while coping with the emotional and financial impact that cancer has on their families.

Many caregivers of women with gynecologic cancer experience a wide range of unmet needs (e.g., obtaining information, social support, coping skills) and experience high levels of distress. Caregivers can suffer from anxiety and depression and neglect their physical health, resulting in their own health problems.[2,3] The intense feeling of needing to provide care 24/7 combined with the guilt and burden of this role has been echoed by many caregivers.

Using the modified Delphi method, a validated survey technique designed to elicit a reliable consensus from a group of experts, attendees brainstormed and prioritized support strategies to meet a list of literature-derived caregiver needs. At the conclusion of the event, 15 essential elements of caregiver support were identified. Essential elements ranged from those that should be currently within reach (e.g., information for the caregiver on managing the patient’s symptoms) to those that are more aspirational (e.g., integrative services focused on the health and well-being of the caregiver.) The final list of essential elements will be published as a white paper and policy priorities to proactively care for caregivers.

As our health care system changes, we as health care providers need to address the gaps in the system. We not only need to partner with patients and their caregivers as we formulate treatment plans but also address the impact of these treatment plans on the health and outcomes of the caregiver. Providers also must recognize the economic, financial, emotional, and physical impact of cancer and caregiving on the entire family unit.

References
1. Schulz R, Eden J. Families Caring for an Aging America. Board Heal Care Serv Heal [Internet]. [cited 2018 May 11]; Available from: http://www.nap.edu/23606
2. Petricone-Westwood D, Lebel S. Being a caregiver to patients with ovarian cancer: A scoping review of the literature. Gynecol Oncol [Internet]. 2016;143(1):184–92. Available from: http://dx.doi.org/10.1016/j.ygyno.2016.07.007
3. Stafford L, Judd F. Partners of long-term gynaecologic cancer survivors: Psychiatric morbidity, psychosexual outcomes and supportive care needs. Gynecol Oncol. 2010;118(3):268–73.

Lauren Hand, MD, is a Gynecologic Oncology fellow at Magee-Womens Hospital of The University of Pittsburgh Medical Center. Heidi Donovan, PhD, RN, is a Professor and Vice Chair of Research at The University of Pittsburgh School of Nursing and is the Principal Investigator of WRITE Symptoms (GOG-259): Nurse-delivered WRITE Symptoms vs. Self-directed WRITE Symptoms vs. Care as Usual for optimal symptom management for women with recurrent ovarian, fallopian tube, or primary peritoneal cancer.

Having More Empathy | Jolyn Taylor, MD, MPH

I woke up early, rounded and then reviewed the other inpatients I was responsible for that weekend. Made my “To Do” list and started checking off boxes. Made a new list, made new boxes, made new checkmarks. This was the start of my first call as a clinical fellow on a busy service. I felt the pressure. I couldn’t miss anything, I had to do a good job. I had warned my family that I would see them in a week when my call ended.

Then my husband called after rounds. He had brought my father to the ER with chest pain. I tucked in the service then strolled over to the ER to see my father. He was entertaining the staff around him with stories and jokes as usual. My husband and I waited for the discharge paperwork and I checked my phone every few seconds for patient updates. Then three ER staff members came and rushed Dad to the other part of the ER, the “sick” part. The ER physician explained that he had an ascending aortic dissection. Dad was scared and confused while I was in shock. A cardiothoracic surgeon was driving in and he would take Dad to surgery soon. He went to surgery and we all waited. Finally, the surgeon came out and we knew Dad had survived the surgery. He went to the ICU and we all took a breath.

The next two weeks in the hospital were fraught with complications and setbacks. There was pneumonia, a small stroke, atrial fibrillation, wound seroma and repeated aspiration from a nerve injury. We finally brought him home and did all we could to help him recover, but over the next six months it appeared that we would lose him. I watched as he slipped away. Then, after months of decline, my family had the fortune that most of our patients do not: he got better. It has been a year and a half and he has made a remarkable recovery.

I tell my story because it taught me a lot about wellness. In our SGO Fellows Wellness Curriculum we discussed many topics, but two especially resonated because of this experience. The first was to make time for what matters. As trainees, we have limited control over our schedule, but I learned that even so, I could make time in my life for what I decided was most important. We decided what was important to do as a family and prioritized things that brought us joy and meaning. I didn’t believe it was possible before because there were so many check boxes to go through and so much to worry about, but I learned I had had the wrong perspective on “possible.”

The other topic that resonated was how empathy can combat burnout. During this time, when my father was getting worse, I understood the anxious looks from families, the complaints and the questions in new ways. I remembered what it was like to be on the other side of patient care. This understanding and empathy brought deeper meaning and satisfaction to my work and has helped to carry me through when I’m tired after a long week.

It is important that we are discussing burnout. Seeing others who truly believe in wellness and want to make a difference is powerful. I knew I had people around me who cared during the worst days of my father’s illness. Hopefully, working together and supporting each other, we can create a true culture of wellness in medicine.

Jolyn Taylor, MD, MPH, is a Gynecologic Oncology Fellow at the University of Texas MD Anderson Cancer Center in Houston, TX.

From the Field: Impact of Volunteer Work in Nepal | Katie McMullen

In January 2018, Judith Wolf, MD, embarked upon her third trip to Nepal as a volunteer with Health Volunteers Overseas (HVO). HVO is a nonprofit organization dedicated to improving global health by bringing teaching, training and professional opportunity to health workers in resource-scarce countries. Volunteers like Dr. Wolf travel to project sites to work with their colleagues and those-in-training, collaborating to improve care.

“The main priority for HVO volunteers at this site is to provide surgical training–including our knowledge of anatomy or pelvic dissection planes and surgical skills– all while using the equipment and facilities that are available at the site,” noted Dr. Wolf, who spent a week working with staff at Bhaktapur Cancer Hospital (BCH). “Women presenting with gynecologic cancers [in Nepal] need the opportunity to have the appropriate surgeries for their cancer.”

On this third assignment at BCH, located in Bhaktapur—a city located just 8 miles from the Nepalese capital of Kathmandu—Dr. Wolf sought to expand upon training from her previous trips.

“I saw improvement in surgical skills and definite improvement in the hospital. An additional operating room was added, allowing for more surgical procedures to be done for the patients and more opportunity for the surgeons to learn when volunteers are there,” said Dr. Wolf.

She also noted that BCH staff had put to use techniques that she had shared during her previous assignments.

“The surgeons had told me that they had used the Churney incision for radical hysterectomies several times and called many of my shared surgical techniques the ‘Wolf technique’,” Dr. Wolf added.

In addition to the work she does to improve gynecologic care for patients at BCH by empowering local staff with new skills and knowledge, Dr. Wolf noted that her volunteer experience has expanded her own knowledge and skills.“I learn something every time I go, because I’m always put in situations that I haven’t faced before. You learn to think on your feet,” noted Dr. Wolf following her 2017 assignment in Nepal.

“The volunteer work that I do puts a completely different perspective on the importance of caring for patients and the best way possible with the tools that we have,” she shared after her most recent assignment. “Personally, it’s the most gratifying work that I’ve done in my entire career.”

Her positive experience leads her to urge others to get involved. “Do it!” she encouraged. “It will be more gratifying than just about anything else that you can do with your skills.”

SGO is a sponsor of HVO’s oncology program. They seek volunteers for short-term (one- to four-week) assignments in Bhutan, Honduras and Nepal. Interested volunteers should visit the HVO website to learn more.

Katie McMullen is the Communications Manager for Health Volunteers Overseas.