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3.21.2018

Sylvester Researcher Dr. Brian Slomovitz Receives Award for Best Presentation at Conference

Brian M. Slomovitz, M.D., co-leader of the Gynecologic Cancers Site Disease Group at Sylvester Comprehensive Cancer Center, received the 2018 Presidential Abstract Award from the Society for Gynecologic Oncology on March 24 during the group’s Annual Meeting on Women’s Cancer in New Orleans.

The award was given to Slomovitz for his presentation, “GOG 3007, a randomized phase II (RP2) trial of everolimus and letrozole (EL) or hormonal therapy (medroxyprogesterone acetate/tamoxifen, PT) in women with advanced, persistent or recurrent endometrial carcinoma (EC): A GOG Foundation study,” which was judged the conference’s best. It was presented to him by Pamela T. Soliman, M.D., M.P.H., of MD Anderson Cancer Center, a member of the conference’s program committee who moderated the session in which Slomovitz gave his presentation.

Slomovitz, who is also professor of clinical obstetrics and gynecology and director of the Division of Gynecologic Oncology at the University of Miami Miller School of Medicine, described how he and his co-investigators in the Gynecologic Oncology Group Foundation successfully completed a randomized phase 2 trial comparing traditional hormonal therapy (tamoxifen alternating with progestins) to a novel experimental combination of everolimus, an mTOR inhibitor, and letrozole, an aromatase inhibitor. In the study, the clinically relevant endpoint was clinical benefit rate (CBR), which is the sum of the percentage of patients achieving an objective response or stable disease.

“Everolimus-letrozole is an active regimen,” Slomovitz told the conference attendees. “The response rate between the two groups was comparable, but the clinical benefit rate, progression-free survival, and overall survival favored the everolimus/letrozole arm. We observed markedly higher response rate and progression-free survival in chemotherapy- naïve patients. We observed a higher risk of thromboembolic events in the hormonal arm.”

Over a 14-month period, 74 women with advanced or recurrent endometrial cancer were enrolled. Accrual was reached four months earlier than anticipated. The CBR for everolimus/letrozole was 78 percent and compared to 69 percent in the hormonal therapy group. Similarly, the median progression-free survival for the experimental group was 6.3 months, compared to 3.8 months in the control group, and the median overall survival for the everolimus/letrozole group was not reached, compared to 16.6 months for hormonal therapy.

Of interest, Slomovitz noted, was that 40 percent of the patients had never received chemotherapy.

“Historical response rates for chemotherapy in women with endometrial cancer is approximately 50 percent,” he said. “In this study, chemo-naïve patients treated with everolimus/letrozole had a 53 percent response rate — complete or partial response — which compared to hormonal therapy at 43 percent.”

The trial confirmed that the everolimus/letrozole combination is an active regimen in patients with recurrent endometrial cancer. While the study was not designed to compare the arms statistically, the response rates in the two groups were roughly similar. The CBR was higher in the everolimus/letrozole group, and the progression-free survival and overall survival favored everolimus/letrozole. Based on this data, future investigation will include trials of oral therapy with everolimus and letrozole against traditional chemotherapy and other biologic regimens.

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