Several studies on recurrent epithelial ovarian cancer, undifferentiated endometrial adenocarcinoma, and BRCA mutations were presented at the 2019 Society of Gynecologic Oncology (SGO) 50th Annual Meeting on Women’s Cancer, held March 16-19 in Honolulu, HI.
Doximity spoke with an SGO expert, Bobbie J. Rimel, MD, a gynecologic cancer researcher and the associate director for Gynecologic Oncology clinical trials at Cedars-Sinai Medical Center, about these topics she covered in her presentations (below) and more at SGO 2019.
Presentations (all abstracts can be searched for here):
- Phase II trial of pembrolizumab with cisplatin and gemcitabine in women with recurrent platinum-resistant ovarian cancer
- Undifferentiated endometrial adenocarcinoma: Treatment and characteristics of a rare disease
- Breast cancer surveillance following ovarian cancer in BRCA mutation carriers
Doximity: What were some of the key takeaways from your presentation on the phase II trial of pembrolizumab with cisplatin and gemcitabine in women with recurrent platinum-resistant ovarian cancer?
Bobby J. Rimel, MD: That presentation was led by the study’s first author, Christine Walsh, MD, who was my partner. The trial concept was to use combination chemotherapy and add pembrolizumab (anti-PD-1 antibody MK-3475) as an adjunct to increase the response rate in recurrent, platinum-resistant ovarian cancer — which is a group of patients that is really difficult to treat. We had enrolled 21 patients so far and had 17 evaluable patients at the time of the presentation.
We’ve had some modest responses with one exceptional responder: a patient that has a clear cell carcinoma of the ovary after receiving an initial six treatments of the cisplatin and gemcitabine and then starting on pembrolizumab on the second cycle. She has had a remarkable response with complete resolution of her disease and really durable response of about a year on the pembrolizumab, which is really exciting.
We have two other patients who have responded for greater than six months and are continuing to respond 12 months out. Overall, the trial has overwhelming durability, which is really what we were going for so it’s a very exciting time.
Dox: What are the next steps?
BR: The next steps for the trial are to see if there is a biomarker that can predict response. We heard from other studies at this meeting look at PD-1 and PD-L1 scoring as a way of evaluating who is going to respond and who isn’t — which in a trial of this size having so few patients, the biomarker analysis may help us understand the reason for having one responder.
That’s the next steps for the study: do the translational work that’s required in order to understand more about the people that responded versus the people that didn’t. If it turns out that our translational work proves our hypothesis, that PD-L1 positive patients do much better, then we’ll consider a second study looking at PD-L1 positive tumors to try to better define who should get those kinds of regimens.
Dox: What are the main takeaways and clinical applications from your presentation on undifferentiated endometrial adenocarcinoma?
BR: Undifferentiated endometrial adenocarcinoma is a really rare disease. However, we were able to query our database and find some patients. Our examination is one of the largest series in the literature. We didn’t find any earth-shattering information, but we found that a few patients did have a very aggressive tumor type. That sort of confirmed what we had expected about undifferentiated tumors being aggressive and the prognosis is poor.
The novel thing about our presentation is the way we found these patients using Deep 6 AI, which is a tool that helps us to identify cohorts as well as individual patients for clinical trials. The tool is really powerful — it does a search within medical records that allowed us to find the cohort much quicker than usual.
For the patients that had early-stage disease that we could remove with surgery, they actually did pretty well. I think that’s interesting — that surgery is still a mainstage treatment for early-stage disease.
Dox: What are the main takeaways and clinical applications from your presentation on breast cancer surveillance following ovarian cancer in BRCA mutation carriers?
BR: Breast cancer surveillance is still a really important part for BRCA positive women if they haven’t had a prophetic vasectomy. Basically, the study was looking at the feasibility of how often it was done and making sure it was done. In our group, we were able to demonstrate that this was commonly performed, although some patients might not be getting the proper amounts of screening as they expect. We confirmed our hypothesis on the expected number of screened positive patients, which is good too.
Dox: What are some major themes that emerged at the conference that matter to you?
Rimel: I think that financial toxicity was one of the major key takeaways. This is probably some of the best data that I’ve seen presented on the effects of drug costs on patients. The presenter [had said] that bankruptcy is as much of a killer as cancer itself — that these [financial] toxicities can actually have [adverse] health-related outcomes.
I recognize in my own patients with extreme amounts of financial toxicity and distress, they seem to have a more difficult time [compared to other patients] because they are unable to have the financial means to be comfortable. Also, many might choose hospice where they otherwise wouldn’t, but that’s just sort of personal opinion. Being able to see that data was very, very striking. It confirmed for me that financial toxicity has to be evaluated as we evaluate novel therapies.
[Another presentation focused on data from] the TWiST analysis for niraparib, which is a PARP inhibitor used in a maintenance setting in recurrent ovarian cancer. That study basically targets patients who have improved health-related quality of life. The drug costs $800 a month — but what isn’t included in the TWiST analysis is the financial toxicity since they didn’t screen for that.
They didn’t have data to present on it, but it would be fascinating to have that data, if we screened for financial toxicity. Everybody in the TWiST analysis got the drugs for free because they were on a clinical trial. That’s not true for most patients. In real life, we need to understand if the quality of life is truly better when they are on an incredibly expensive drug.
Financial toxicity blew me away because they followed each other [at SGO]: the health-related outcomes of the TWiST analysis was followed by the financial toxicity session. It was like a slap in the face — I was shocked.
I was also inspired by the invited presidential speaker Dr. Agnes Binagwaho. It’s just incredible what the leadership of Rwanda has chosen to do and the power given to the country. To be able to turn from having widespread infectious communal diseases — which used to be the perception of Africa held by outsiders — to not be the major health care issue. It’s a lesson for all of us: they have better vaccination rates in Rwanda than they do in LA county.
Interviewed by assistant editor Sri Ravipati
Illustration by April Brust