Induction chemotherapy and irradiation in advanced carcinoma of the cervix

The survival rate of patients with locally advanced cervical cancer has not changed during the past several years. The purpose of the study is to evaluate the efficacy of concomitant Mitomycin and 5-FU with irradiation. Six hundred seventy-three patients were randomized into four arms. Arm one RT alone, no maintenance chemotherapy Arm two RT alone, with maintenance chemotherapy Arm three RT concomitant chemo, no maintenance Arm four RT concomitant chemo, with maintenance Concomitant chemotherapy used Mitomycin C 10 mg/m2 day 1, 30 and oral 5-FU 300 mg/day day 1-14 and 42-56. Maintenance chemotherapy was oral using 5-FU 200 mg/day for 4 weeks with 2 weeks rest every 6 weeks for 3 courses. Six centers participated in the trial. The side effects were higher in concomitant chemotherapy arms, especially hematologic toxicity. Median follow-up time was 25 months (range 15 to 59 months). The disease-free survival data from life table analysis suggested a better disease-free survival in arms 3 and 4 (concomitant arms) and arm 2 (maintenance oral 5-FU arm) than in control (RT alone arm). The pattern of failure showed a greater difference in loco-regional recurrence in stage IIB than IIIB patients. This interim analysis shows a trend favoring the arm with concomitant chemotherapy.