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Phase III Trial Comparing Radical Radiotherapy With and Without Cisplatin Chemotherapy in Patients With Advanced Squamous Cell Cancer of the Cervix

From the Department of Oncology, University of Alberta, Edmonton, and Department of Oncology, University of Calgary, Calgary, Alberta; National Cancer Institute of Canada Clinical Trials Group, Queen’s University, and Kingston General Hospital, Kingston, Ontario; Department of Gynecology Oncology, University of Montreal, and Department of Oncology, McGill University, Montreal; and Hamilton Regional Cancer Centre, Hamilton, Ontario, Canada.

Address reprint requests to R.G. Pearcey, MD, Cross Cancer Institute, 11560 University Ave, Edmonton, Alberta, Canada, T6G 1Z2; email: robertpe{at}cancerboard.ab.ca

PURPOSE: To test the hypothesis that cisplatin (CDDP) administered concurrently with standard radiotherapy (RT) would improve pelvic control and survival in patients with advanced squamous cell cancer of the cervix.

PATIENTS AND METHODS: A total of 259 patients with International Federation of Gynecology and Obstetrics stage IB to IVA squamous cell cervical cancer with central disease 5 cm or histologically confirmed pelvic lymph node involvement were randomized to receive RT (external-beam RT plus brachytherapy) plus weekly CDDP chemotherapy (40 mg/m²) (arm 1) or the same RT without chemotherapy (arm 2).

RESULTS: A total of 253 patients were available for analysis. Median follow-up was 82 months. No significant difference was found in progression-free survival (P = .33). No significant difference in 3- and 5-year survival rates was found (69% v 66% and 62% v 58%, respectively; P = .42). The hazard ratio for survival (arm 2 to arm 1) was 1.10 (95% confidence interval, 0.75 to 1.62).

CONCLUSION: This study did not show a benefit to either pelvic control or survival by adding concurrent weekly CDDP chemotherapy in a dose of 40 mg/m² to radical RT as given in this trial. Careful attention to RT details is important for achieving optimum outcome for patients with this disease.

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