Sequential chemotherapy and irradiation in advanced stage endometrial cancer: A Gynecologic Oncology Group phase I trial of doxorubicin–cisplatin followed by whole abdomen irradiation

The optimal treatment regimen for advanced stage endometrial carcinoma (EC) is yet to be established. The objective of this study was to evaluate the feasibility and toxicity of delivering sequential doxorubicin-cisplatin (AC) followed by whole abdomen irradiation (WAI).Patients with stage III/IV EC with <2 cm residual disease were eligible. The treatment regimen included 3 cycles of AC (50 mg/m(2) each) followed by WAI plus para-aortic and/or true pelvic boost. Outcome objectives were feasibility of the regimen, acute toxicity and chronic irradiation toxicity monitored for at least one year after completing treatment.Thirty-one patients were entered onto the study. Twenty-nine were evaluable for feasibility of the regimen, and 22 patients were evaluable for chronic radiation toxicity with a median follow-up of 21 months. Three patients (14%) experienced severe chronic toxicity including one treatment-related death. The five-year progression-free survival (PFS) and overall survival (OS) was 52.5% and 60.1% respectively.The results from the first stage of this study found this regimen of sequential AC followed by WAI eligible for further study. Although toxicity was not excessive at the time of completion of the first stage, there was insufficient interest by the Gynecologic Oncology Group to continue study of this regimen; therefore, a conclusion regarding feasibility and chronic toxicity in an expanded cohort as initially intended is not possible. The risk of recurrence in advanced EC is sufficiently high that may warrant further investigation of sequential chemotherapy and WAI.