Feasibility of concurrent cisplatin use during primary and adjuvant chemoradiation therapy: a phase I study in Japanese patients with cancer of the uterine cervix

Abstract

Background: Although the prognostic advantages of concurrent cisplatin (CDDP) chemoradiation therapy (CCRT), for uterine cervical cancer (UCC) has been demonstrated, the feasibility of concurrent CDDP administration has not yet been evaluated. We determined the optimal CDDP dose for both weekly and monthly schedules during primary and adjuvant CCRT in patients with UCC.

Methods: The study was conducted as a phase I, dose-escalation trial. Concurrent CDDP was started at the dose of 30 mg/m(2) for the weekly schedule and at 50 mg/m(2) for the monthly schedule, and the doses were steadily escalated to the maximum tolerated dose (MTD).

Results: A total of 45 patients with UCC (25 receiving primary CCRT and 20 receiving adjuvant CCRT) were entered in the study. In both the primary and adjuvant CCRT patients, the MTD was observed to be 40 mg/m(2) for the weekly schedule and 80 mg/m(2) for the monthly schedule. Dose-limiting toxicity was observed in 10 patients (granulocytopenia in 9 patients and diarrhea in 1 patient). Disease recurrence was confirmed in 6 patients in the primary CCRT group during a mean follow-up period of 22.4 +/- 13.2 months, and in patients 3 in the adjuvant CCRT group during a mean follow-up period of 17.7 +/- 6.8 months.

Conclusion: For Japanese patients with UCC receiving primary or adjuvant CCRT therapy, the recommended CDDP dose was determined to be 30 mg/m(2) for the weekly schedule and 75 mg/m(2) for the monthly schedule.