A phase II trial of radiotherapy sandwiched between carboplatin and docetaxel for stage III, IV, and recurrent endometrial cancer.

Abstract

5029 Background: Management of patients with advanced endometrial cancer remains controversial and the optimal sequence of adjuvant therapy is undetermined. Feasibility and outcomes of administering pelvic radiotherapy (RT) sandwiched between docetaxel (DT) and carboplatin (C) were studied. Methods: Surgically staged IIIA (excluding positive cytology) or greater endometrial cancer, with or without measurable disease and recurrences, not previously treated with chemotherapy or pelvic radiation (RT), were eligible. The protocol included 3 cycles of DT (75 mg/m2) and C (AUC 6) followed by whole pelvic RT (45 Gy) and 3 additional cycles of DT (75 mg/m2) and C (AUC 6). Extended-field RT was given for pelvic or paraaortic lymph node involvement. Kaplan-Meier (KM) survival statistics were calculated for disease free (DFS) and overall survival (OS). Results: Forty-two patients enrolled from August 2004 to June 2009, 40 at initial diagnosis and 2 at recurrence. 6 did not complete therapy and 1 withdrew prior to therapy. Median age = 58 years (range: 21-81). 78% (32/41) = endometrioid histology. Stages = 10 IIIA, 21 IIIC, 8 IV, (recurrent = 1 IC, 1 IIA). 7 had measurable disease after surgery, 36 had lymph nodes removed. Of 227 chemotherapy cycles, 5.3% (12), 3.5% (8), and 2.6% (6), were associated with grade 3/4 neutropenia, GI toxicity, and anemia, respectively. 85% (35/41) completed all 6 prescribed chemotherapy cycles. At a median follow-up of 16.1 months (range: 1.1-50.9), 5 died. KM estimate for OS at 1 year = 94.4% (SE = 3.9%), 2 years = 90.9% (SE = 5.1%), 3 years = 79.5% (SE = 11.5%). There are an insufficient number of deaths to estimate median OS. Eight progressed or died within 3 years of study enrollment. Of recurrences, only one was in the RT field. KM estimate for PFS at 1 year is 88.4% (SE = 5.5%), 2 years= 78.2% (7.4%), 3 years=70.3% (SE = 10.0%). There are an insufficient number of progressions to estimate median PFS. Conclusions: Adjuvant combination modality therapy in a “sandwich” fashion is feasible, well-tolerated and results in excellent long-term PFS and OS. This regimen provides durable long-term disease control in advanced-stage endometrial cancer. Author Disclosure Employment or Leadership Position Consultant or Advisory Role Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration sanofi-aventis