Prospective phase I/II study of irradiation and concurrent chemotherapy for recurrent cervical cancer after radical hysterectomy.

The purpose of the present study was to evaluate the long-term toxicity and efficacy of irradiation and concurrent chemotherapy for patients with a pelvic recurrence of cervical cancer after a hysterectomy. This prospective phase I / II study was designed to administer irradiation and three cycles of concurrent chemotherapy with cisplatin and 5-FU to patients with recurrent cervical cancer confined to the pelvis. Initial therapy was a hysterectomy and none received prior pelvic irradiation. A total of 22 patients were entered into the study. Patients received irradiation and three cycles of concurrent cisplatin and 5-FU. The acute toxicity from chemotherapy and irradiation was grade 3 in 18% and grade 4 in 9%. No patient died from a treatment-related complication. Follow-up times ranged from 7.2 to 17.6 years. At last follow-up, 14 patients died of metastatic cervical cancer and eight were alive. The 10- and 15-year overall survivals were 35%. Long-term complications included leg edema, vesico-vaginal, and recto-vaginal fistulae. Pelvic abscesses developed in three of the four patients with a fistula. By logistic regression, the only significant factor for survival was total irradiation dose (P = 0.04). In conclusion, long-term survival with this treatment regimen is possible but is accompanied by significant late toxicity.