Phase II trial of adjuvant pelvic radiation “sandwiched” between combination paclitaxel and carboplatin in women with uterine papillary serous carcinoma

AbstractObjectiveTo evaluate the safety and survival in women treated with adjuvant pelvic radiation “sandwiched” between six cycles of paclitaxel and carboplatin chemotherapy with completely resected UPSC.MethodsSurgically staged women with UPSC (FIGO stage 1–4) and no visible residual disease were enrolled. Treatment involved paclitaxel (175mg/m2) and carboplatin (AUC=6.0–7.5) every 21days for 3 doses, followed by radiation therapy (RT), followed by an additional 3cycles of paclitaxel and carboplatin (AUC=5–6). Survival analysis, using Kaplan–Meier methods, was performed on patients who completed at least 3cycles of chemotherapy and RT.ResultsA total of 81 patients were enrolled, of which 72 patients completed the first 3cycles of chemotherapy followed by prescribed RT. Median age was 67years (range: 43–82years). 59/72 (82%) had disease confined to the uterus and 13/72 (18%) had completely resected extra-uterine disease (stage 3 and 4). 65 (83%) completed the protocol. Overall PFS and OS for combined stage 1 and 2 patients was 65.5±3.6months and 76.5±4.3months, respectively. PFS and OS for combined stage 3 and 4 patients was 25.8±3.0 and 35.9±5.3months, respectively. Three-year % survival probability for stage 1 and 2 patients was 84% and for stage 3 and 4 patients was 50%. Of the 435 chemotherapy cycles administered, there were 11(2.5%) G3/G4 non-hematologic toxicities. 26(6.0%) cycles had dose reductions and 37(8.5%) had dose delays.ConclusionsCompared to prior studies of single modality adjuvant therapy, RT “sandwiched” between paclitaxel and carboplatin chemotherapy is well-tolerated and highly efficacious in women with completely resected UPSC