Mature results of a pilot study of pelvic radiotherapy with concurrent continuous infusion intra-arterial 5-FU for stage IIIB-IVA squamous cell carcinoma of the cervix

Purpose: To evaluate the long-term results of continuous infusion intra-art erial 5-fluorouracil (CI IA 5-FU) given with concurrent pelvic radiotherapy (RT) for FIGO stage IIIB-IVA carcinoma of the cervix. Methods and Materials: Between 1965 and 1974, 27 patients with extensive FI GO Stage IIIB (22 patients) or Stage IVA (5 patients) squamous cell carcino ma of the cervix were treated with CI IA 5-FU and RT, Twenty-one patients ( 78%) had bilateral pelvic wall involvement, 25 (93%) had massive tumors (gr eater than or equal to 8 cm in diameter), 7 (27%) had involvement of the lo wer one-third of the vagina, and 15 (56%) presented with hydronephrosis. Al l patients underwent routine clinical staging, transperitoneal para-aortic lymph node dissection, and bilateral hypogastric artery catheter placement. 5-FU was continuously infused at a dose rate of 10 mg/kg/day on Days 1-15 of RT, The median dose of 5-FU was 376 mg/m(2)/day (range 270-692), All pat ients received concurrent pelvic RT to a median dose of 50 Gy at 2.0 Gy per fraction. Only 4 patients received intracavitary RT. The median follow-up of surviving patients was 190 months. Results: The overall 5-year survival rate was 37%. For the 22 patients with FIGO Stage IIIB disease, the 5-year survival rate was 41%. The survival ra te for 18 patients treated with only external beam radiation and chemothera py for Stage IIIB disease was 33%. Four of 10 patients treated with only 50 Gy of external beam radiation and CI IA 5-FU were long-term survivors. Acu te complications, including hematologic toxicity and skin reactions, were s evere, with 1 death from neutropenic sepsis, Severe late complications were only observed in patients treated with greater than or equal to 60 Gy of e xternal beam radiation, Conclusions: While this series is small, the fact that 4 patients with mass ive Stage IIIB tumors survived after a total radiation dose of only 50 Gy s uggests that RT with CI IA 5-FU deserves further study. Modifications in do se, technique, and route of administration should reduce toxicity, and the addition of intracavitary RT should improve the local effectiveness of comb ined treatment, (C) 1999 Elsevier Science Inc.