June 27 2022
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.
Support for this study was provided by the National Cancer Institute:U10CA180822 (NRG Oncology SDMC), U10CA180868 (NRG Oncology Operations and UG1CA189867 (NCORP) as well as Cell Therapeutics Inc (see Acknowledgment section, p.13). No honoraria were paid to any of the authors. The analysis, interpretation and content of this manuscript are the responsibility of the authors (ClinicalTrials.gov number, NCT00108745.)
Citation
Copeland LJ, Brady MF, Burger RA, Rodgers WH, Huang HQ, Cella D, O'Malley DM, Street DG, Tewari KS, Bender DP, Morris RT, Lowery WJ, Miller DS, Dewdney SB, Spirtos NM, Lele SB, Guntupalli S, Ueland FR, Glaser GE, Mannel RS, DiSaia PJ. Phase III Randomized Trial of Maintenance Taxanes Versus Surveillance in Women With Advanced Ovarian/Tubal/Peritoneal Cancer: A Gynecologic Oncology Group 0212:NRG Oncology Study. J Clin Oncol. 2022 Jun 27:JCO2200146. doi: 10.1200/JCO.22.00146. Epub ahead of print. PMID: 35759733.
About NRG Oncology (www.nrgoncology.org)
NRG Oncology conducts practice-changing, multi-institutional clinical and translational research to improve the lives of patients with cancer. Founded in 2012, NRG Oncology is a Pennsylvania-based nonprofit corporation that integrates the research of the legacy National Surgical Adjuvant Breast and Bowel Project (NSABP), Radiation Therapy Oncology Group (RTOG), and legacy Gynecologic Oncology Group, now The GOG Foundation, Inc. (GOG) programs. The research network seeks to carry out clinical trials with emphases on gender-specific malignancies, including gynecologic, breast, and prostate cancers, and on localized or locally advanced cancers of all types. NRG Oncology’s extensive research organization comprises multidisciplinary investigators, including medical oncologists, radiation oncologists, surgeons, physicists, pathologists, and statisticians, and encompasses more than 1,300 research sites located world-wide with predominance in the United States and Canada. NRG Oncology is supported primarily through grants from the National Cancer Institute (NCI) and is one of five research groups in the NCI’s National Clinical Trials Network.
About The GOG Foundation, Inc. (www.gog.org)
The GOG Foundation, Inc. is a not-for-profit organization with the purpose of promoting excellence in the quality and integrity of clinical and translational scientific research in the field of gynecologic malignancies. The GOG Foundation is committed to maintaining the highest standards in clinical trials development, execution, analysis, and distribution of results.The GOG Foundation is the only clinical trialist group in the United States that focuses its research on patients with pelvic malignancies, such as cancer of the ovary (including surface peritoneal malignancies), uterus (including endometrium, soft tissue sarcoma, and gestational trophoblastic neoplasia), cervix, and vulva. The GOG Foundation is multi-disciplinary in its approach to clinical trials, and includes gynecologic oncologists, medical oncologists, pathologists, radiation oncologists, oncology nurses, biostatisticians (including those with expertise in bioinformatics), basic scientists, quality of life experts, data managers, and administrative personnel.