NRG Oncology Study on Treatment for Advanced Endometrial Cancer Chosen as ‘Editor’s Choice’ in Journal of Clinical Oncology

October 28 2020

The paper “Carboplatin and Paclitaxel for Advanced Endometrial Cancer: Final Overall Survival and Adverse Event Analysis of a Phase 3 Trial (NRG Oncology/GOG 0209)” to be published in the Journal of Clinical Oncology has been chosen as that issue’s “Editor’s Choice” based on the study’s findings that carboplatin and paclitaxel should be considered the first-line therapy for advanced or recurrent endometrial cancer.

This randomized phase III trial compared how well two different combination chemotherapy regimens work in treating patients with newly diagnosed FIGO stage III-IV or recurrent endometrial cancer that is stage III-IV. The study compared paclitaxel, doxorubicin, cisplatin, an active control known as the TAP regimen, to paclitaxel and carboplatin, known as the TC regimen. The trial sought to determine if doxorubicin could be omitted and carboplatin substituted for cisplatin in the front-line therapy for advanced endometrial cancer. The study found that TC is not inferior to TAP in terms of overall survival and progression-free survival and that the toxicity and quality-of-life profile favors TC over TAP.

“Given its more favorable toxicity profile, and the small but potentially meaningful differences in health-related quality of life favoring TC, TC should be considered the first-line therapy for advanced or recurrent endometrial cancer,” said the study’s lead author David Scott Miller, MD, the Amy and Vernon E. Faulconer Distinguished Chair in Medical Science, Director and Dallas Foundation Chair in Gynecologic Oncology, and Professor of Obstetrics & Gynecology at the University of Texas Southwestern Medical Center. “The tolerability of the TC regimen further notes that it serves as a suitable backbone for combination with targeted therapies in future trials.” Following public dissemination of these data at the opening plenary session of the Annual Meeting on Women’s Cancer of the Society of Gynecologic Oncology by Dr. David Miller, the TC regimen was adopted throughout the world as the chemotherapy standard for this indication. Furthermore, the TC regimen now serves as the chemotherapy backbone for several ongoing innovative trials evaluating novel therapeutics and emerging molecules from the NCI’s drug discovery pipeline.

Between August 25, 2003 and April 20, 2009, 1,381 patients were enrolled in the study by 266 participating Gynecologic Oncology Group clinical sites. With a median age at enrollment of 61 years, most had measurable or recurrent disease (61%), were non-Hispanic (86%), white (78%), or had good performance status (64%). More than 50% had endometrioid tumors and 77% had no prior pelvic radiation treatment.

Chemotherapy was ultimately initiated in 1,282 eligible patients. The patients were treated with doxorubicin 45 mg/m2 and cisplatin 50 mg/m2 (d1), followed by paclitaxel 160 mg/m2 (d2) with GCSF, or paclitaxel 175 mg/m2 and carboplatin AUC 6 (d1) q21d for 7 cycles. The primary endpoint was overall survival (OS).Progression-free survival (PFS), health-related quality of life (HRQoL), and toxicity were secondary endpoints. Non-inferiority of TC to TAP was concluded for OS [median 37 vs. 41 months, respectively; hazard ratio (HR) 1.002; 90% confidence interval (CI), 0.9-1.12], and PFS (median 13 vs. 14 mo.; HR 1.032; 90% CI, 0.93-1.15). Neutropenic fever was reported in 7% of patients receiving TAP and 6% of those on TC.Grade >2 sensory neuropathy was recorded in 26% on TAP and 20% on TC (p =0.40). More grade >3 thrombocytopenia (23% vs. 12%), vomiting (7% vs. 4%), diarrhea (6% vs. 2%), and metabolic (14% vs. 8%) toxicities were reported with TAP. Neutropenia (52% vs. 80%) was more common with TC. Small HRQoL differences favored TC.

NRG Oncology/GOG 0209 was supported by grants from the National Cancer Institute, part of the National Institutes of Health, to the Gynecologic Oncology Group (GOG) Administrative Office (CA 27469), the Gynecologic Oncology Group Statistical Office (CA 37517), NRG Oncology SDMC (U10 CA180822), NRG Operations (U10CA180868), and NCORP (UG1CA189867).

Citation

Miller DS, Filiaci VL, Mannel RS, Cohn DE, Matsumoto T, Tewari KS, DiSilvestro P, Pearl ML, Argenta PA, Powell MA, Zweizig SL, Warshal DP, Hanjani P, Carney ME, Huang H, Cella D, Zaino R, Fleming GF. Carboplatin and Paclitaxel for Advanced Endometrial Cancer: Final Overall Survival and Adverse Event Analysis of a Phase III Trial (NRG Oncology/GOG0209). J Clin Oncol. 2020 Sep 29:JCO2001076. doi: 10.1200/JCO.20.01076. Epub ahead of print. PMID: 33078978.

About NRG Oncology
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 Gynecologic Oncology Group (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.

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