Randomized phase III trial of adjuvant radiation versus chemoradiation in intermediate-risk, early-stage cervical cancer following radical hysterectomy and lymphadenectomy: results from NRG Oncology/GOG-263/KGOG 1008

BACKGROUND: To determine whether adjuvant chemoradiation (CRT) with weekly cisplatin improves recurrence-free survival (RFS) compared with radiation (RT) in pathologically proven intermediate risk early-stage cervical cancer following radical hysterectomy and lymphadenectomy. METHODS: were administered during RT. RFS was the primary endpoint in randomized and eligible patients. Secondary endpoints included overall survival (OS), quality of life (QoL), and adverse events (AEs). RESULTS: and squamous cell carcinoma histology. Out of 316 patients, 292 (92.4%) received 28 fractions of RT with a median dose of 50.4 Gy and a median treatment duration of 39 days. Three-year RFS was 88.5% in the CRT arm and 85.4% in the RT arm. Both RFS [hazard ratio (HR) 0.698, 95% confidence interval (CI) 0.408-1.192, P = 0.09], as well as OS [HR 0.586, 95% CI 0.286-1.199, P = 0.07] favored CRT compared with RT alone. Grade 3 or 4 AEs occurred in 43% and 15% in the CRT and RT arms, respectively (P < 0.01). A transient decline in QoL occurred in the CRT arm compared with RT after starting treatments and recovered to pre-treatment level by 36 weeks. CONCLUSION: Although RFS and OS favored CRT, the addition of cisplatin during RT did not statistically improve RFS or OS in cervical cancer patients with intermediate pathological risk factors following radical hysterectomy and lymphadenectomy. CRT increased grade 3 and 4 AEs with a transient decline in QoL.