Results from the NRG Oncology GOG-0263 phase III clinical trial testing the addition of cisplatin-based chemotherapy to adjuvant radiotherapy following radical hysterectomy and lymphadenectomy for patients with early-stage, intermediate-risk cervical carcinoma indicated that the addition of chemotherapy did not improve outcomes for patients and led to increased toxicity for patients. The outcomes of this trial support the use of the current standard of care using adjuvant radiotherapy alone following surgery. These results were presented during the Plenary Session of the Society of Gynecologic Oncology (SGO) Annual Meeting on Women's Cancer in Seattle, Washington.
"Despite the negative outcome of this study for improving recurrence-free survival in this population, there are still key takeaways we can learn from to help redirect future research." stated Sang Young Ryu, MD, of the Department of Gynecologic Oncology at the Korea Cancer Center Hospital, Korea Institute of Radiological and Medical Sciences and the lead author of the NRG-GOG 0263 abstract.
The NRG-GOG-0263 study did not meet its primary objective of improving recurrence-free survival through the addition of cisplatin chemotherapy. The trial accrued 316 eligible patients with early-stage disease and intermediate-risk factors including a combination of histopathologic factors such as capillary lymphatic space involvement, stromal invasion, and tumor size. Accrued patients had radical hysterectomy prior to enrollment onto the study. Trial participants were randomly assigned to receive either adjuvant chemo-radiotherapy (CRT) or radiotherapy alone (RT).
Ninety-two percent of patients had 28 fractions of radiation with median dosage of 50.4 Gy and duration of 39 days, and 91% of the patients in CRT arm received at least 4 cycles of weekly cisplatin. The 3-year recurrence-free survival estimates for the CRT and RT arms were 88.5% (95% CI: 82% – 93%) and 85.4% (95% CI: 79% – 90%). The recurrence-free survival hazard ratio estimate for CRT vs RT was 0.6976 (95% CI: 0.408-1.192, p = 0.0927). The estimated overall survival hazard ratio for the CRT vs RT arm was 0.586 (95% CI: 0.286 - 1.199, p = 0.0695). Grade 3 or 4 adverse events occurred in 15% and 43% of RT and CRT arms respectively (p < 0.0001).
"At this time, women with early-stage disease and intermediate-risk factors are treated with radiotherapy alone. Chemotherapy has been considered as an addition to this treatment, based on prior clinical data indicating it could potentially improve outcomes for these women. The outcomes of this trial help confirm that cisplatin chemotherapy given adjuvantly with radiotherapy is not a superior alternative. Future research needs to elaborate whether the timing of chemotherapy can improve outcomes, or if another alternative can be considered to help improve on the results of this trial while limiting toxicity," Dr. Ryu added.
This study was supported by the National Cancer Institute (NCI), part of the National Institutes of Health, and was supported by grants U10CA180822 (NRG Oncology SDMC) and U10CA180868 (NRG Oncology Operations) from the NCI.
Citation
Ryu SY, Deng W, Albuquerque K, Koh W, Mayadev JS, Heugel A, Kim B, Kim D, Cho C, Kim J, No JH, Mannel RS, Miller K, Fabian D, Small W, Rodgers W, Leath CA, Monk B. Randomized Phase III Trial of Adjuvant Radiation Versus Chemo-Radiation in Intermediate-Risk, Early-Stage Cervical Carcinoma following Radical Hysterectomy and Lymphadenectomy (Results of NRG Oncology/GOG-263). SGO (Society of Gynecologic Oncology). 3/14/2025. Plenary Session Oral Presentation.
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.
