Phase II Study of Capecitabine and Oxaliplatin for Advanced Adenocarcinoma of the Small Bowel and Ampulla of Vater
| Autor: | Michael J. Overman, Rosni Adinin, Cathy Eng, James L. Abbruzzese, Gauri R. Varadhachary, Jeffrey S. Morris, Scott Kopetz, Robert A. Wolff, E. Lin |
|---|---|
| Rok vydání: | 2009 |
| Předmět: |
Adult
Male Ampulla of Vater Cancer Research medicine.medical_specialty Time Factors Organoplatinum Compounds Common Bile Duct Neoplasms Phases of clinical research Kaplan-Meier Estimate Adenocarcinoma Deoxycytidine Gastroenterology Drug Administration Schedule Capecitabine Internal medicine Antineoplastic Combined Chemotherapy Protocols Intestinal Neoplasms Intestine Small medicine Humans Prospective Studies Aged Performance status business.industry Middle Aged medicine.disease Oxaliplatin Regimen Treatment Outcome medicine.anatomical_structure Oncology Response Evaluation Criteria in Solid Tumors Female Fluorouracil business medicine.drug |
| Zdroj: | Journal of Clinical Oncology. 27:2598-2603 |
| ISSN: | 1527-7755 0732-183X |
| DOI: | 10.1200/jco.2008.19.7145 |
| Popis: | Purpose Adenocarcinomas of the small bowel and ampulla of Vater represent rare cancers that have limited data regarding first-line therapy. We conducted a phase II trial to evaluate the benefit of capecitabine in combination with oxaliplatin (CAPOX) in patients with advanced adenocarcinoma of small bowel or ampullary origin. Patients and Methods Eligible patients with metastatic or unresectable tumors and no prior systemic chemotherapy for advanced disease participated in this phase II trial. CAPOX was administered as a 21-day cycle with oxaliplatin 130 mg/m2 on day 1 and capecitabine 750 mg/m2 twice a day on days 1 through 14. The primary end point was overall response rate as assessed by Response Evaluation Criteria in Solid Tumors. Results Thirty-one patients were enrolled onto the study, and 30 patients received study treatment. The confirmed overall response rate was 50%; three patients with metastatic disease achieved complete responses. The median time to progression (TTP) was 11.3 months, and the median overall survival (OS) was 20.4 months. Subset analysis of patients with metastatic disease only (n = 25) revealed a median TTP of 9.4 months and median OS of 15.5 months. The most common grades 3 or 4 toxicities included fatigue (30%), peripheral neuropathy (10%), vomiting (10%), diarrhea (10%), and neutropenia (10%). Conclusion When administered to patients with good performance status, CAPOX is well tolerated and produces a superior response rate and longer OS compared with other regimens in the literature. CAPOX should be considered a new standard regimen for advanced small bowel and ampullary adenocarcinomas. |
| Databáze: | OpenAIRE |
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