Randomized phase II study comparing docetaxel plus cisplatin, docetaxel plus carboplatin, and paclitaxel plus carboplatin in patients with advanced or recurrent endometrial carcinoma: Japanese Gynecologic Oncology Group trial (JGOG2041)

Abstract

16526 Background: The purpose of this study is to assess the efficacy and safety of treatment with taxane plus platinum in combination therapies for advanced or recurrent endometrial carcinoma. Methods: The study planned to administer docetaxel (70 mg/m2) plus cisplatin (60 mg/m2) (DP), docetaxel (60 mg/m2) plus carboplatin (AUC 6) (DC), or paclitaxel (180 mg/m2) plus carboplatin (AUC 6) (TC) every 3 weeks until disease progression or adverse effects prohibited further therapy. Eligibility criteria of this study allowed for entry of patients with measurable disease derived from histologically confirmed stage III/IV or recurrent endometrial carcinoma and/or patients having had a treatment-free interval following cytotoxic chemotherapy, radiotherapy, or hormonal therapy of at least 6 months, 4 weeks or 2 weeks, respectively. Among these regimens the study compared the tumor response rate as the primary endpoint as well as toxicity. An independent review committee assessed the tumor response for each patient according to RECIST. Results: Ninety patients were enrolled. Of the enrolled patients, 88 were eligible and consequently 29, 29, and 30 patients were randomly assigned to DP, DC, and TC, respectively. Regarding the frequency of the main toxicities, the following were observed: grade 3 and 4 neutropenia in 83.3, 90.0, and 76.6%; febrile neutropenia in 10.0, 6.7, and 3.3%; thrombocytopenia in 6.7, 10.0, and 10.0%; diarrhea in 13.3, 3.3, and 0%, respectively; and grade 2 neurotoxicity in 13.3% of TC group. These toxicity profiles were not significantly different; however, diarrhea and neurotoxicity tended to be more frequent in DP and TC, respectively. Tumor response rates were 51.7% (0 CR, 15 PR; 95% C.I.; 32.5–70.6), 48.3% (4 CR, 10 PR; 29.4–67.5), and 60.0% (2 CR, 16 PR; 40.6–77.3) in DP, DC, and TC, respectively (P = 0.65). Conclusions: Toxicity of taxane plus platinum combination therapies was confirmed to be tolerable. The efficacy was similar in each arm and their potential efficacy will allow us to choose an experimental arm for a phase III trial to confirm a survival benefit of taxane plus platinum for endometrial carcinoma. Author Disclosure Employment or Leadership Consultant or Advisory Role Stock Ownership Honoraria Research Expert Testimony Other Remuneration Bristol-Myers Squibb, Kyowa Hakko Kogyo, Nippon Kayaku, Pfizer Japan, sanofi-aventis