Women & Infant's Hospital, Brown University
Gynecologic Oncology
Dr. Paul DiSilvestro is the Director of the Program in Women’s Oncology at Women and Infants Hospital and Professor and Division Director of Gynecologic Oncology in the Department of Obstetrics and Gynecology at The Alpert School of Medicine at Brown University. He currently serves as the Vice Chair of the Gynecologic Oncology Committee of NRG Oncology. His primary research interest is in the development, implementation and oversight of gynecologic cancer clinical trials. In addition to his leadership role in NRG Oncology, Dr. DiSilvestro is a Board Examiner with the American Board of Obstetrics and Gynecology and a member of the Board of Directors of NRG Oncology and the GOG Foundation.
Presenter of 2 Presentations
Panel Discussion
Session Type
Plenary Session
Date
09/30/2022
Session Time
02:45 PM - 03:55 PM
Room
Hall 501
Session Icon
Presenter
- Robert L Coleman (United States of America)
- Paul A. DiSilvestro (United States of America)
- Antonio Gonzalez-Martin (Spain)
- Thomas J. Herzog (United States of America)
- Mansoor R. Mirza (Denmark)
- Bradley J. Monk (United States of America)
- Kathleen N. Moore (United States of America)
- Amit Oza (Canada)
- Isabelle L. Ray-Coquard (France)
- Brian M. Slomovitz (United States of America)
- Jonathan A. Ledermann (United Kingdom)
Lecture Time
03:13 PM - 03:51 PM
SEMINAL ABSTRACT PRESENTATION: OVERALL SURVIVAL (OS) AT 7-YEAR (Y) FOLLOW-UP (F/U) IN PATIENTS (PTS) WITH NEWLY DIAGNOSED ADVANCED OVARIAN CANCER (OC) AND A BRCA MUTATION (BRCAM) WHO RECEIVED MAINTENANCE OLAPARIB IN THE SOLO1/GOG-3004 TRIAL
Session Type
Plenary Session
Date
09/30/2022
Session Time
02:45 PM - 03:55 PM
Room
Hall 501
Session Icon
Lecture Time
02:58 PM - 03:03 PM
Abstract
Objectives
In the Phase III SOLO1/GOG-3004 trial (NCT01844986), maintenance olaparib provided sustained benefit beyond the end of treatment in pts with newly diagnosed advanced OC and a BRCAm. At 5-y f/u, median progression-free survival was 56.0 months [m] with olaparib vs 13.8m with placebo (pbo) (HR 0.33; 95% CI 0.25–0.43); 48% vs 21% of pts, respectively, were progression-free (KM estimates) (Banerjee et al. Lancet Oncol 2021). Given that most OC deaths occur 5‒10y after diagnosis, we report OS in SOLO1 at 7-y f/u, a clinically relevant timepoint.Methods
Pts who were in response to first-line platinum-based chemotherapy received maintenance olaparib tablets 300 mg bid or pbo for up to 2y or until progression. A descriptive analysis of OS, a secondary endpoint, was performed 7y after the last pt was randomized; prespecified final analysis of OS is planned at 60% data maturity.
Results
260 pts were randomized to olaparib and 131 to pbo (median treatment duration 24.6 vs 13.9m, respectively). At OS data maturity of 38.1% (data cut-off 7 Mar 2022), median OS was not reached in olaparib pts vs 75.2m in pbo pts, with an OS HR of 0.55 (95% CI 0.40–0.76; unadjusted for crossover; 44.3% of pbo pts received a PARP inhibitor in a subsequent line of therapy) (Table). At 7y, 45.3% of olaparib pts vs 20.6% of pbo pts were alive and had still not received a first subsequent treatment (KM estimates). The incidence of MDS/AML remained low and new primary malignancies remained balanced between arms (Table).
Conclusions
2y of maintenance olaparib provided a clinically meaningful improvement in OS over pbo in pts with newly diagnosed advanced OC and a BRCAm. At 7y, 67.0% of olaparib pts vs 46.5% of pbo pts were alive; no new safety signals were detected. These data provide the longest f/u for any PARP inhibitor in this setting and support use of maintenance olaparib to achieve long-term remission and enhance the potential for cure.Permission statement: Previously presented at the European Society for Medical Oncology (ESMO) 2022, FPN (Final Publication Number): 517O, Paul DiSilvestro et al. Reused with permission.