PROSPECTIVE PHASE I II STUDIES OF DEFINITIVE IRRADIATION AND CHEMOTHERAPY FOR ADVANCED GYNECOLOGIC MALIGNANCIES/

Purpose: This is a prospective study to evaluate toxicity and efficacy of concurrent irradiation and three cycles of chemotherapy bolus cisp latin and infusion 5-fluorouracil (5FU) in patients with advanced gyne cologic malignancies. Materials and Methods: Patients received cisplat in, 50 mg/m(2) I.V. rapid infusion, and 5-day continuous infusion of 5 FU (750 mg/m(2) per day (schedule A); or cisplatin 75 mg/m(2) i.v. rap id infusion, and 4-day continuous infusion of 5FU 1,000 mg/ m(2) per d ay (schedule B). Schedule A was given to 25 patients in the first 36 m onths of the study and was changed to schedule B in an additional 42 p atients. All patients received irradiation, which usually consisted of 20 Gy whole pelvis, 30-40 Gy split field, and two intracavitary inser tions for a total of 80-90 Gy to point A. Primary cervical cancer occu rred in 40 patients with 3 having stage IB bulky, 2 with stage IIA, 5 with stage IIB, 2 with stage IIIA, 23 with stage IIIB, 4 with stage IV , and 1 with stage IVB. Recurrent cervical carcinoma after radical hys terectomy occurred in 18 patients. The remainder of the patients consi sted of two each with stages III and IV endometrial carcinoma, two wit h stage III vaginal carcinoma, two with stage III vulvar carcinoma, an d one with recurrent vulvar carcinoma. Patients were treated from 1985 through 1992. Results: The 5-year overall survivals for patients with stages IB (bulky)-IIB cervical cancer was 70%, 25% for stages IIIA-IV A, and 39% for patients with recurrent cervical carcinoma. All four pa tients with endometrial carcinoma have recurred and died. Two patients with vulvar carcinoma are alive and free of disease, and one is dead of intercurrent disease. One patient with stage III vaginal carcinoma is alive and free of disease, while the other recurred and died. No si gnificant differences were observed in the toxicity of the two chemoth erapy schedules. There were 9/39 (23%) grade 4 and one fatal complicat ion in those with primary cervical carcinoma. The overall fistulae rat e was 11% (4/39) with three patients developing rectovaginal fistulae and one having vesicovaginal fistula. Conclusion: Concurrent chemother apy and irradiation for advanced gynecologic malignancies as administe red in this study is highly toxic and fails to demonstrate an obvious survival improvement.