Bolus mitomycin C and 5-FU with sequential radiation for poor-prognosis locally advanced cervical cancer

Forty patients with locally advanced cervical carcinoma were entered into a protocol utilizing the bolus administration of both mitomycin C (10 or 15 mg) on Day 1 and 5-fluorouracil (400 mg) on Day 1-5 followed by sequential pelvic irradiation on Day 6 between September 1980 and October 1985. All patients had poor-prognosis FIGO stage IB, IIB, IIIB, or IVA disease. Only patients with poor prognosis factors such as bulky tumor masses of 5 cm or greater noted on the initial physical exam (37 patients) or poorly differentiated histology (3 patients) were eligible for this study. There were three severe side effects seen in the 24 patients receiving 15 mg mitomycin C. One patient developed thrombocytopenia, one patient developed acute radiation enteritis, and the third patient developed radiation proctitis requiring laser therapy. Only 1 of 16 patients receiving 10 mg mitomycin C developed a complication (thrombocytopenia). Neutropenia was mild in all patients. No infections were seen. Thrombocytopenia never warranted platelet transfusion. No patients developed therapy-related bowel obstruction or fistulae. Median follow-up was 11.3 years with a range of 6.2-14.2 years. A complete response rate of 63%, a local control rate of 58%, and a 5-year survival rate of 44% were obtained. This does not appear to offer any benefit over radiation alone. This present study supports the superiority of higher dose concurrent infusional chemotherapy and radiation over low-dose sequential bolus chemotherapy and radiation.