A phase II study of capecitabine plus docetaxel in gemcitabine-pretreated metastatic pancreatic cancer patients: CapTere
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- 作者：Heloisa P. Soares (1)
Soley Bayraktar (1)
Marcelo Blaya (2)
Gilberto Lopes (3)
Jaime Merchan (1)
Jessica Macintyre (1)
Carlos Mayo (1)
Mark R. Green (1)
Orlando Silva (1)
Joe Levi (1)
Gail Walker (1)
Caio M. Rocha-Lima (1) - 关键词：Pancreatic cancer ; Gemcitabine pretreated ; Second ; line chemotherapy ; Capecitabine ; Docetaxel
- 刊名：Cancer Chemotherapy and Pharmacology
- 出版年：2014
- 出版时间：April 2014
- 年：2014
- 卷：73
- 期：4
- 页码：839-845
- 全文大小：452 KB
- 参考文献：1. http://www.cancer.org/research/cancerfactsfigures/cancerfactsfigures/cancer-facts-figures-20132013. Accessed 4 Sept 2013
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Soley Bayraktar (1)
Marcelo Blaya (2)
Gilberto Lopes (3)
Jaime Merchan (1)
Jessica Macintyre (1)
Carlos Mayo (1)
Mark R. Green (1)
Orlando Silva (1)
Joe Levi (1)
Gail Walker (1)
Caio M. Rocha-Lima (1)
1. Division of Hematology/Oncology, Sylvester Comprehensive Cancer Center, University of Miami, 1475 NW 12th Ave St 3300, Miami, FL, 33136, USA
2. Tulane University, New Orleans, LA, USA
3. Johns Hopkins Singapore International Medical Center, Singapore, Republic of Singapore - ISSN：1432-0843
文摘
Purpose Docetaxel and capecitabine combination is synergistic in preclinical models. We investigated the efficacy and toxicity of this combination as second-line chemotherapy in patients with metastatic pancreatic adenocarcinoma (mPC), pretreated with gemcitabine-based chemotherapy. Methods Eligible patients were treated with capecitabine 800?mg/m2 orally PO bid on days 1-4 in combination with intravenous docetaxel 30?mg/m2 on days 1 and 8 of each 21-day cycle. The primary end point was overall response rate. Using a three-stage sequential design, two interim analyses for early stopping due to lack of efficacy were planned and conducted after 13 and 26 patients were accrued. Secondary end points included time to treatment failure, progression-free survival (PFS), overall survival (OS) and 50?% drop in CA19-9 levels. Results Forty-three patients were evaluable for toxicity and 42 evaluable for response, at a median age of 64?years. The majority of patients (74?%) had ECOG PS 0-1. Six patients (14?%) achieved a partial tumor response, and stable disease for ? cycles was observed in 59?% of patients (n?=?25). Thirty-five percent (n?=?11/31) of patients had a ?0?% decrease in CA19-9 levels. The median PFS was 3.7?months (95?% CI 2.1-.3?months), and the median OS was 5.3?months (95?% CI 4.3-.6?months). Treatment was generally well tolerated. Grade 3 toxicity and grade 4 toxicity were seen in 45 and 5?% of patients, respectively. One patient had a potential treatment-related mortality. Conclusions The combination of capecitabine and docetaxel is active and well tolerated in mPC patients pretreated with gemcitabine-based therapy.