Randomized phase III trial of conventional paclitaxel and carboplatin (c-TC) versus dose dense weekly paclitaxel and carboplatin (dd-TC) in women with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer: Japanese Gynecologic Oncology

Abstract

5506 Background: Tri-weekly administration with paclitaxel and carboplatin (c-TC) is considered the standard of care for treatment of ovarian carcinoma. We compared the c-TC with dose dense weekly administration with TC (dd-TC) as first-line chemotherapy for stage II-IV epithelial ovarian, fallopian tube or primary peritoneal cancer. Methods: We randomly assigned patients to receive carboplatin to an area under the plasma concentration-time curve of 6 with either paclitaxel at 180 mg/m2 on day 1 or paclitaxel at 80 mg/m2 on days 1, 8, and 15. The treatments were repeated every 3 weeks for six cycles; in responding patients, additional three cycles were administered. Primary endpoint was progression-free survival (PFS) to be compared by log-rank test. Assuming 300 eligible patients in each arm, the study had 0.8 power to detect 5 months increase in median PFS at 0.05 two-sided alpha. Results: Of 637 patients who underwent randomization, 631 were eligible. After median follow-up of 29 months, median duration of PFS in the c-TC group and dd-TC group was 17.1 and 27.9 months, respectively (P=0.0014 by the log-rank test), and overall survival at 2 years was 77.7% and 83.6%, respectively (P=0.05). Among 282 patients with measurable disease, objective response rates were 53.3% and 55.8% in the c-TC and dd-TC groups respectively (P=0.91). Grade 3 and 4 anemia was reported more frequently in the dd-TC group, and other toxicities were similar in both groups. Conclusions: The dd-TC improves PFS as compared with c-TC in patients with advanced epithelial ovarian cancer. Author Disclosure Employment or Leadership Consultant or Advisory Role Stock Ownership Honoraria Research Expert Testimony Other Remuneration Aska, Bristol-Myers Squibb, Chugai, Daiichi Sankyo, Kyowa Hakko Kogyo, Mochida, Nippon Kayaku, Pfizer Oncology, sanofi-aventis, Yakult Bristol-Myers Squibb, Yakult