In an Indian single-center phase III trial reported in the Journal of Clinical Oncology, Gupta et al found that cisplatin-based chemoradiotherapy improved disease-free survival vs neoadjuvant chemotherapy and radical surgery in women with locally advanced squamous cervical cancer.
In the open-label trial, 633 eligible patients with stage IB2, IIA, or IIB disease at Tata Memorial Centre were randomized between September 2003 and February 2015 to receive neoadjuvant chemotherapy plus surgery (n = 316) or standard concomitant chemoradiation (n = 317). The neoadjuvant chemotherapy plus surgery group received three cycles of paclitaxel and carboplatin once every 3 weeks followed by radical hysterectomy; if indicated, patients in this group also received postoperative adjuvant radiation or concomitant chemotherapy and radiotherapy. Patients in the chemoradiation group received standard radiotherapy with concomitant cisplatin once every week for 5 weeks.
Randomization was stratified by disease stage. The primary endpoint was disease-free survival.
Median follow-up was 58.5 months. Five-year disease-free survival was 69.3% in the neoadjuvant chemotherapy plus surgery group vs 76.7% in the concomitant chemoradiation group (hazard ratio [HR] = 1.38, P = .038). No difference in 5-year overall survival was observed (75.4% vs 74.7%, HR = 1.025, P = .87).
In subgroup analysis, a significant disease-free survival benefit of chemoradiation appeared to be restricted to patients with stage IIB disease, with 5-year rates of 67.2% vs 79.3% (unadjusted HR = 1.90, P = .003). A significant interaction between treatment effect and stages IIA and IIB disease was observed (P = .04).
Delayed toxicities at ≥ 24 months after treatment completion in the neoadjuvant chemotherapy plus surgery group vs concomitant chemoradiation group included rectal toxicity in 2.2% vs 3.5%, bladder toxicity in 1.6% vs 3.5%, and vaginal toxicity in 12.0% vs 25.6%, respectively.
The investigators concluded, “Cisplatin-based concomitant chemoradiation resulted in superior [disease-free survival] compared with neoadjuvant chemotherapy followed by radical surgery in locally advanced cervical cancer.”
The study was supported by an intramural research grant from the Tata Memorial Centre, Government of India.
Sudeep Gupta, MD, of the Department of Medical Oncology, Tata Memorial Centre, Mumbai, is the corresponding author for the Journal of Clinical Oncology article.
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