A phase II trial of carboplatin and docetaxel followed by radiotherapy given in a “Sandwich” method for stage III, IV, and recurrent endometrial cancer.

Abstract

Purpose: To determine feasibility and efficacy of administering docetaxel and carboplatin chemotherapy followed by pelvic radiotherapy and then consolidation chemotherapy in patients with advanced or recurrent endometrial cancer. Patients and Methods: Patients with surgically staged III-IV (excluding IIIA from positive cytology alone) endometrial cancer or biopsy confirmed recurrent disease were eligible. Treatment consisted of 3 cycles of docetaxel (75mg/m2) and carboplatin (AUC 6) on a q21 day schedule followed by involved field irradiation (45Gy) ± brachytherapy and 3 additional cycles of docetaxel and carboplatin. Kaplan-Meier (KM) methods estimated overall survival (OS) and progression free survival (PFS). Results: Forty-two patients enrolled, 7 did not complete therapy. 95% (39/41) had primary disease. Median age = 58 years (range: 21-81). 78% (32/41) = endometrioid histology. Stages=10 IIIA, 21 IIIC, 1 IVA, 7 IVB, (recurrent=1 IC, 1 IIA). There were 23 non-hematologic and 14 grade 3 and 16 grade 4 hematologic toxicities. Five patients died following treatment with a median follow-up of 16.1 months (range: 5-51). KM estimates and 95% confidence intervals for OS at 1 year were=94.4% (79.5-98.6), at 2 years 90.9% (74.2-97.0)), and at 3 years 79.6% (45.4-93.6). Of the 39 with primary disease, 9 progressed or died within 3 years of study enrollment. KM estimates and 95% confidence intervals for PFS at 1 year were 85.7% (69.0-93.8), at 2 years 75.6% (56.8-87.1), and at 3 years=68.0% (44.6-83.2). Conclusions: “Sandwiching” radiation between chemotherapy for advanced or recurrent endometrial cancer merits further development based on the reported PFS and OS.