LAUSR

5584 Background: We studied the effectiveness and safety of dose-dense paclitaxel plus carboplatin in advanced or recurrent uterine corpus cancer. Methods: The patient eligibility criteria were women aged 20–75 years with histologically confirmed uterine corpus ; FIGO stage III who had residual tumors, FIGO stage IV, and recurrence after first-line radical treatment, or second-line chemotherapy or radiotherapy. They received paclitaxel (80 mg/m2, days 1, 8, 15) + carboplatin (area under the curve 5, day 1 every 3 weeks). The primary endpoint was the response rate (RR). The secondary endpoints were feasibility, progression-free survival, overall survival, and adverse effects. The threshold RR was set to 40%. The expected RR of this treatment was set to 60%; the number of necessary cases calculated with a type I error of 5% and power of 80% was 44. Considering the existence of dropped cases, we set the target number of cases in this study to 48. Results: Forty-eight patients were registered, and 45 were eligible to receive the treatment. The median age of the patients was 61 years (43–76). Twenty-two patients had recurrence; the others had primary advanced corpus cancer. On histology, there were 10 cases of serous carcinoma, 3 cases of endometrioid carcinoma G3, 2 cases of carcinosarcoma, and 2 cases of clear cell carcinoma. Twenty-eight patients (62%) could receive 6 or more cycles of chemotherapy. The RR (complete, 13 cases; partial, 20 cases) was 73.3% (60.7–86.0 95% confidence interval). Conclusions: Dose-dense paclitaxel plus carboplatin was safe and effective for advanced or recurrent uterine corpus cancer. Clinical trial information: R000019874 UMIN000017138.