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).
The results showed that 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% and 85.4%.
Therefore the researchers concluded that 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.
Ref: Ryu SY, Deng W et al. 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.
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