Maurie Markman, MD

Disclosures

June 01, 2016

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Hello. I am Dr Maurie Markman from Cancer Treatment Centers of America in Philadelphia. I wanted to briefly note several very interesting abstracts that are going to be presented in the oral session on gynecologic malignancies on Sunday morning at the 2016 American Society of Clinical Oncology (ASCO) meeting.

As always, a large number of interesting abstracts are being presented in the gynecologic sessions, in the poster sessions, the poster discussion sessions, and the oral sessions. In the oral session in particular this year, there are some very interesting and highly provocative studies to be presented and discussed.

Overall Survival With Olaparib in Ovarian Cancer

First I want to mention some long-awaited overall survival data, still called an interim analysis, presented by Ledermann and colleagues,[1] looking at the question of the use of olaparib as a maintenance strategy in patients who had achieved a second remission in ovarian cancer with platinum-based chemotherapy. The original study is well known and was published in the New England Journal of Medicine. It demonstrated a rather striking—in fact, almost a threefold—improvement in progression-free survival in patients who had a BRCA mutation who received olaparib versus placebo.[2]

In the overall population that included those with BRCA mutations and those without BRCA mutations, the 5-year survival was 29.2% in patients who received olaparib and 20.4% in patients who received placebo. Specifically, in the patient population that had BRCA mutations, the 5-year survival was 36.9% in patients who received olaparib versus 24.3% in patients who received placebo. This is a striking difference in overall survival and a very interesting study to follow up on.

Hormonal Maintenance Therapy After Platinum Chemotherapy in Ovarian Cancer

The next study being presented is from Gershenson and colleagues[3] from MD Anderson, which was a very long-term study with patients accrued since 1981. Individuals with low-grade ovarian cancers who, after primary platinum-based chemotherapy, either received or did not receive hormonal maintenance therapy were included in this study. This was not a randomized controlled trial, but patients were well balanced in surveillance and hormone maintenance therapy groups. This was long-term follow-up.

The primary endpoint was progression-free survival. It was notable that in those patients who had surveillance after chemotherapy (ie, did not receive hormonal therapy), the median progression-free survival was 29.9 months compared with 52.0 months in patients who received hormonal therapy. Hormonal therapy could have been a number of agents, but the most commonly used agents were letrozole and tamoxifen. This is a very provocative finding and I expect an interesting discussion to occur with this study.

An Early Trial of Pembrolizumab in Cervical Cancer

The third study that I would note is preliminary results of a phase 1b KEYNOTE-028 study.[4] This was a study that included a number of tumor types. This particular analysis looked at the use of pembrolizumab in patients previously treated with cervical cancer. In fact, in this population that included 24 patients with advanced cervical cancer, an objective response rate of 12.5% was noted with a median duration of response of 19 weeks. This is a very early-phase study with preliminary data, but it will be interesting to hear about longer follow-up with more patients.

Prolonging the Platinum-Free Interval in Ovarian Cancer

Finally, a long-awaited study will be presented: the MITO8 phase 3 randomized controlled trial, which looked at the question of artificially prolonging the platinum-free interval in patients with ovarian cancer.[5] This study looked at a population of women who had recurrence between 6 and 12 months after previous platinum-based chemotherapy. What would happen if they went right onto a platinum-based regimen versus receiving an agent like liposomal doxorubicin or topotecan or gemcitabine, to artificially prolong the platinum-free interval to then go back with a platinum-based regimen?

As many thought would happen, the outcome was that there was no advantage whatsoever for giving nonplatinum drugs before platinum-based chemotherapy. In fact, there was some suggestion, small though it was, that maybe the women who did not go right back to platinum-based chemotherapy might have had an inferior outcome. The final report and the presentation will be very interesting.

I encourage you, if your schedule permits, to listen in on the oral abstract session for gynecologic malignancies at ASCO. It is going to be very interesting. I also encourage you to view the posters as well. Thank you for your attention.

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