ESMO 2020: Impact of Rising CA-125 Levels in Treating Platinum-Sensitive Recurrent Ovarian Cancer
Posted: Friday, October 16, 2020
Treatment with regorafenib does not appear to improve progression-free survival or delay the need for subsequent chemotherapy compared with tamoxifen in women with platinum-sensitive recurrent ovarian cancer with isolated rising serum CA-125 levels but without symptoms or disease progression. In fact, the interim results of the phase II REGOVAR trial revealed a “higher rate of discontinuation of regorafenib and a low probability of reaching significant progression-free survival improvement,” prompting premature termination of study enrollment. Olivier Tredan, MD, PhD, of the Centre Léon Bérard, Lyon, France, and colleagues presented their findings at the European Society for Medical Oncology (ESMO) Virtual Congress 2020 (Abstract 829P).
The open-label study randomly assigned patients to receive tamoxifen at 40 mg by mouth daily (n = 35) or regorafenib at 120 to 160 mg by mouth daily (n = 33) during surveillance or bevacizumab maintenance. Patients' median age was 67 years, and most patients had high-grade (80%) serous histology (90%).
After 32 months of median follow-up, a final data analysis revealed that the median progression-free survival was 5.6 months with tamoxifen and 4.6 months with regorafenib (P = .7). The reason cited for permanent treatment discontinuation in the tamoxifen and regorafenib arms was disease progression in 82% and 62% and toxicities in 9% and 31%, respectively. The overall rate of response was 15% and 6% in the tamoxifen and regorafenib arms, and the median overall survival was 33.2 months versus 40.1 months, respectively.
As for safety, grade 3 and 4 toxicities were more frequent in the regorafenib arm (91% vs. 54%), including hand-foot syndrome (36%), rash (18%), and fatigue (15%). Quality of life was also reportedly poorer in the regorafenib arm compared with the tamoxifen arm.
Disclosure: For a full list of author disclosures, visit oncologypro.esmo.org.