Paclitaxel and Carboplatin in Patients With Completely or Optimally Resected Carcinosarcoma of the Uterus: A Phase II Trial by the Japanese Uterine Sarcoma Group and the Tohoku Gynecologic Cancer Unit

Abstract

ObjectiveThis study aimed to evaluate the efficacy of paclitaxel and carboplatin in patients with completely or optimally resected uterine carcinosarcoma.Materials and MethodsWe conducted a single-arm multicenter prospective phase II trial at 20 Japanese medical facilities. Eligible patients had histologically confirmed uterine carcinosarcoma without prior chemotherapy or radiotherapy. Patients received 6 courses of 175 mg/m2 paclitaxel over 3 hours, followed by a 30-minute intravenous administration of carboplatin at an area under the serum concentration-time curve of 6.ResultsA total of 51 patients were enrolled in this study, 48 of whom underwent complete resection and 3 of whom underwent optimal resection. At 2 years, the progression-free survival and overall survival rates were 78.2% (95% confidence interval [CI], 64.1%–87.3%) and 87.9% (95% CI, 75.1%–94.4%), respectively. At 4 years, these rates were 67.9% (95% CI, 53.0%–79.0%) and 76.0% (95% CI, 60.5%–86.1%), respectively. Although 15 patients showed disease recurrence during the follow-up period (median, 47.8 months; range, 2.1–72.8 months), a total of 40 (78.4%) patients completed the 6 courses of treatment that had been planned.ConclusionsThe combination of paclitaxel and carboplatin was a feasible and effective postoperative adjuvant therapy for patients with completely or optimally resected uterine carcinosarcoma.