A phase II Brown University Oncology Group study of docetaxel, oxaliplatin, and capecitabine (DOC) for metastatic esophagogastric cancer

Abstract

e15541^ Background: We previously reported results of a phase I study of oxaliplatin, docetaxel, and capecitabine for advanced esophagogastric cancer (Evans et al, Am J C Onc 2007). In this phase II component we describe response rates, toxicity, and survival data. Methods: Patients with histologically confirmed metastatic esophagogastric squamous or adenocarcinoma were eligible. Patients received oxaliplatin 50mg/m2 and docetaxel 35mg/m2 on days 1 and 8 as well as capecitabine 750 mg/m2 twice daily on days 1–10 in each 21 day cycle. Results: 21 patients were enrolled and were evaluable. Median age was 65, range 46–83. All had adenocarcinoma histology. Three patients received prior adjuvant or neoadjuvant therapy. A total of 91 cycles were delivered, median of 4, range of 1–11. Median follow-up was 2 years; all patients have been followed for at least 1 year. Median overall survival was 11 months. The overall response rate was 43%. Three patients achieved a complete response. Two of these patients remain without evidence of disease at 38 and 12 months. Three patients experienced confirmed pulmonary emboli, and one patient expired at home with possible pulmonary embolism (exact cause unknown).Other Grade 3/4 toxicities were: nausea (3/21), fatigue (2/21), diarrhea (4/21), hand/foot (1/21), dehydration (3/21), esophagitis (2/21), infection (1/21), Electrolyte (3/21), neutropenic fever (2/21), neutropenia (4/21), anemia (1/21). Conclusions: DOC is an active and easily administered regimen for metastatic esophagogastric cancer. Consideration should be given for prophylactic anticoagulation for patients with metastatic esophagogastric cancer. [Table: see text] ASCO Conflict of Interest Policy and Exceptions In compliance with the guidelines established by the ASCO Conflict of Interest Policy (J Clin Oncol. 2006 Jan 20;24[3]:519–521) and the Accreditation Council for Continuing Medical Education (ACCME), ASCO strives to promote balance, independence, objectivity, and scientific rigor through disclosure of financial and other interests, and identification and management of potential conflicts. According to the ASCO Conflict of Interest Policy, the following financial and other relationships must be disclosed: employment or leadership position, consultant or advisory role, stock ownership, honoraria, research funding, expert testimony, and other remuneration (J Clin Oncol. 2006 Jan 20;24[3]:520). The ASCO Conflict of Interest Policy disclosure requirements apply to all authors who submit abstracts to the Annual Meeting. For clinical trials that began accrual on or after April 29, 2004, ASCO's Policy places some restrictions on the financial relationships of principal investigators (J Clin Oncol. 2006 Jan 20;24[3]:521). If a principal investigator holds any restricted relationships, his or her abstract will be ineligible for placement in the 2009 Annual Meeting unless the ASCO Ethics Committee grants an exception. Among the circumstances that might justify an exception are that the principal investigator (1) is a widely acknowledged expert in a particular therapeutic area; (2) is the inventor of a unique technology or treatment being evaluated in the clinical trial; or (3) is involved in international clinical oncology research and has acted consistently with recognized international standards of ethics in the conduct of clinical research. NIH-sponsored trials are exempt from the Policy restrictions. Abstracts for which authors requested and have been granted an exception in accordance with ASCO's Policy are designated with a caret symbol (^) in the Annual Meeting Proceedings. For more information about the ASCO Conflict of Interest Policy and the exceptions process, please visit www.asco.org/conflictofinterest .