Pilot phase II trial of radiation "sandwiched" between combination paclitaxel/platinum chemotherapy in patients with uterine papillary serous carcinoma (UPSC)

Objectives. To evaluate disease-free survival (DFS) and overall survival (OS) in patients treated with pelvic radiation "sandwiched" between six cycles of paclitaxel(T)/platinum(P) chemotherapy with optimally reduced uterine papillary serous carcinoma (UPSC). Methods. Surgically staged patients with UPSC and no visible residual disease were enrolled. Treatment involved T (175 mg/(2)) and either cisplatin (75 mg/m(2)) or carboplatin (AUC=6.0, 6.5, 7.5) every 21 days x 3 doses, followed by pelvic RT (45 Gy). Fields were extended for >2 positive pelvic or confirmed para-aortic node disease. Three additional cycles of T/P were administered after RT. Toxicity was graded by NCI CTC Version 3.0. Kaplan-Meier survival statistics were used for DFS/OS. Results. 30 women were enrolled between 1999 and 2004. Median age was 69 years (45-82 years). 60% (18/30) of patients had disease confined to the uterus (Stage I/II) and 40% (12/30) had extra-uterine disease (Stage III/IV). 29 patients completed protocol treatment. One patient was discontinued due to non-compliance and recurred at 7 months. All 30 patients are included in survival analysis. Three-year DFS and OS with Stage I/II disease was 69% and 75% and Stage III/IV disease was 54% and 52%, respectively. Of 177 chemotherapy cycles administered, grade 3 or 4 neutropenia, thrombocytopenia or anemia occurred in 42%, 1% and 3% of cycles, respectively. Six cycles were delayed I week for neutropenia. 43% of all neutropenic episodes occurred after RT. Conclusion. Radiation "sandwiched" between T/P chemotherapy is a well-tolerated and efficacious regimen for patients with completely resected UPSC. A larger multi-institutional clinical trial should be considered to confirm these pilot data. (c) 2007 Elsevier Inc. All rights reserved.