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Title: |
Combination Therapy with Paclitaxel, Carboplatin and Megestrol Acetate for the Management of Advanced Stage or Recurrent Carcinoma of the Endometrium: A Phase II Study | |||||||||||||||||||
| Authors: | Kerri S. Bevis, M.D., Larry C. Kilgore, M.D., Ronald D. Alvarez, M.D., J. Michael Straughn, Jr., M.D., and Charles A. Leath, III, M.D. | |||||||||||||||||||
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OBJECTIVE: To determine overall survival (OS), progression-free interval (PFI), and toxicity in patients with advanced stage or recurrent endometrial cancer (EMCA) treated with combination paclitaxel, carboplatin and megestrol acetate. STUDY DESIGN: Patients with stage III/IV or recurrent EMCA were enrolled between October 2004 and April 2008 and received paclitaxel (175 mg/m2) and carboplatin (AUC 6) every 21 days for 6 cycles and megestrol acetate 40 mg orally 4 times daily for up to 5 years. Dose reductions were based on grade 3/4 hematologic toxicity. Survival was calculated from time of study enrollment. RESULTS: A total of 28 patients were evaluable: 21 (75%) patients with stage III/IV disease and 7 (25%) with recurrent disease. Three patients with recurrence received prior radiation. Mean PFI was 40.2 months (29.7–50.6). Mean OS was 50.1 months (41.5– 58.7). After a median 40.4 months (range, 5.6–68.4) of follow-up, 13 patients (46%) had no evidence of disease, 4 were alive with disease, and 10 were dead of disease. One patient died without evidence of disease. Twenty-three patients (82%) completed 6 cycles of chemotherapy. Ten patients experienced a dose reduction. Myelosuppression was common, with 22 patients (78%) experiencing grade 3/4 neutropenia and 6 patients (21%) experiencing grade 3/4 anemia. Three patients had a deep vein thrombosis. One patient experienced a pulmonary thromboembolus. CONCLUSION: Combination therapy with paclitaxel, carboplatin and megestrol acetate demonstrates activity. Myelosuppression is common but can be managed with colony-stimulating factors. The addition of hormonal therapy to cytotoxic chemotherapy may improve survival. |
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| Keywords: | carboplatin, chemotherapy, endometrial cancer, hormonal therapy, megestrol, paclitaxel, phase II trial | |||||||||||||||||||
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