Results from the NRG Oncology phase III clinical trial NRG GOG-0212 indicated that treating women who received complete clinical response (CCR) after first-line platinum-taxane therapy for advanced ovarian, peritoneal, or fallopian tube cancer with single-agent taxane maintenance therapy only slightly improved progression-free survival (PFS) but did not improve overall survival (OS) and lead to significant gastrointestinal and neurologic adverse events (AEs) for this population. At the fourth scheduled interim analysis, both taxane regimens reached the futility boundary for OS which led to the conclusion of the trial and the early release of study results. These outcomes were published in the Journal of Clinical Oncology.
The NRG GOG-0212 trial enrolled 1,157 women who had received CCR following first-line treatment and randomly assigned patients to receive either taxane maintenance chemotherapy with paclitaxel (P) or paclitaxel poliglumex (PP), or to a surveillance arm (S). Median follow-up on NRG-GOG 0212 was 8.1 years. At the time of median follow-up, survival durations were 58.3 months, 56.8 months, and 60.0 months for S, P and PP regimens, respectively. Grade 2 or worse gastrointestinal AEs were more frequent with the P and PP regimens (PP:20%, P:27% vs S:11%) as well as Grade 2 or worse neurological AEs (PP:46%, P:36% vs S:14%).
“Although taxane maintenance therapy was not successful for this population of women, there is an urgent need to find an effective maintenance treatment option following first-line treatment. These gynecologic cancers, especially at an advanced stage, are aggressive and lead to multiple surgical and chemotherapeutic interventions. Following complete clinical response, most women recur within 2-3 years and survival ranges vary greatly,” stated Larry J. Copeland, MD, of The Ohio State University, James Cancer Center, President of The GOG Foundation, Inc., and the lead author of the NRG-GOG 0212 manuscript.
Relative to S the hazard of death for P was 1.091 (95% confidence interval (CI): 0.911-1.31; p=0.343) and for PP was 1.033 (95% CI: 0.862-1.24; p=0.725).The median times to PFS were S:13.4, P:18.9 and PP:16.3 months. HR=0.801; 95% CI:(0.684-0.938; p=0.006) for P and HR=0.854; 95% CI:(0.729-1.00; p=0.055) for PP. 653 deaths were reported, however, none were attributed to the study treatment.