BACKGROUND: A Phase I-II trial of cisplatin and radical radiation therapy was initiated for advanced, recurrent, and poor prognosis carcinoma of the uterine cervix. METHODS: From September 1983 to October 1991, 55 patients were entered on the protocol. Forty patients had advanced cervical carcinoma International Federation of Gynecology and Obstetrics (FIGO) Stages IIB-IVB, 4 patients were treated for recurrent disease, and 11 patients had FIGO Stage I disease with poor prognostic factors. Cisplatin was administered weekly on an outpatient basis at a dose of 1 mg/kg (maximum, 60 mg) during teletherapy. The radiation fields included the pelvis only in 20 patients, the pelvis and paraaortic fields in 33 patients, and the paraaortic fields alone in 2 patients. The total number of cycles of cisplatin received ranged from 3-6 (mean 5.2). There were no interruptions in the planned radiation therapy. RESULTS: Neutropenia occurred in 18 of 55 patients (32.7%) with only 1 (1.8%) having Grade IV toxicity. Mild thrombocytopenia occurred in only one patient. No significant gastrointestinal, neurologic, or renal toxicity was observed. Of the 48 patients with measurable or evaluable disease, all had a complete response within the radiation field. The follow-up has ranged from 1-85+ months. Currently, there have been 19 (34.5%) recurrences, only 2 (3.7%) of which have occurred in the radiation field. CONCLUSIONS: The weekly cisplatin chemotherapy administered during radiation therapy was well tolerated in this high-risk group of patients and did not diminish the ability to give standard doses of radiation.
BACKGROUND: A Phase I-II trial of cisplatin and radical radiation therapy was initiated for advanced, recurrent, and poor prognosis carcinoma of the uterine cervix. METHODS: From September 1983 to October 1991, 55 patients were entered on the protocol. Forty patients had advanced cervical carcinoma International Federation of Gynecology and Obstetrics (FIGO) Stages IIB-IVB, 4 patients were treated for recurrent disease, and 11 patients had FIGO Stage I disease with poor prognostic factors. Cisplatin was administered weekly on an outpatient basis at a dose of 1 mg/kg (maximum, 60 mg) during teletherapy. The radiation fields included the pelvis only in 20 patients, the pelvis and paraaortic fields in 33 patients, and the paraaortic fields alone in 2 patients. The total number of cycles of cisplatin received ranged from 3-6 (mean 5.2). There were no interruptions in the planned radiation therapy. RESULTS:Neutropenia occurred in 18 of 55 patients (32.7%) with only 1 (1.8%) having Grade IV toxicity. Mild thrombocytopenia occurred in only one patient. No significant gastrointestinal, neurologic, or renal toxicity was observed. Of the 48 patients with measurable or evaluable disease, all had a complete response within the radiation field. The follow-up has ranged from 1-85+ months. Currently, there have been 19 (34.5%) recurrences, only 2 (3.7%) of which have occurred in the radiation field. CONCLUSIONS: The weekly cisplatin chemotherapy administered during radiation therapy was well tolerated in this high-risk group of patients and did not diminish the ability to give standard doses of radiation.