Phase II trial evaluating capecitabine and irinotecan in patients (pts) with esophago-gastric (E-G) carcinoma having progressed or relapsed within 3 months of platinum-based chemotherapy

Abstract

4170 Background: To assess the efficacy and toxicity of a 3-weekly regimen containing capecitabine combined with irinotecan (CapeIri) in refractory or relapsed E-G carcinomas. Primary endpoints were response rate (RR) and disease free survival (DFS) with secondary endpoints of overall survival (OS) and toxicity. Methods: 29 pts with locally advanced or metastatic E-G carcinoma (27 adenocarcinoma, 2 squamous carcinoma) with documented progression during or within 3 months of completion of chemotherapy were recruited between January 2003 and November 2004. Capecitabine (2000mg/m2/day Day 1–14) and Irinotecan (250mg/m2 Day 1) (CapeIri) was given every 3 weeks. CT response was assessed at 12 and 24 weeks. Results: Four pts were ineligible due to no measurable disease (number, n=3) and progression > 3 months since platinum therapy (n=1). Median age of the 25 eligible pts was 59 years and 21 pts (84%) had metastatic disease. All pts had previously received platinum although one pt had capecitabine alone immediately prior to study entry. 19/25 (76%) received a 3-drug ECF-like regimen. At present, with a median follow up of 4.3 months, 21 pts are assessable for response. 3 pts responded, RR 14.3% (95% CI 3.1–36.3%) and 3 pts (14.3%) had stable disease. Improvement in the following tumor-related symptoms occurred: dysphagia 43% (3/7 pts), reflux 50% (5/10), anorexia 44% (4/9), weight loss 43% (3/7), vomiting 60% (3/5) and pain 29% (4/14). 8 pts (32%) had grade 3/4 neutropenia and 1 pt (4%) had febrile neutropenia. There were no toxic deaths. Median DFS was 2.8 months and median survival was 6.3 months. Conclusions: Second-line chemotherapy with CapeIri in primary refractory and relapsed esophago-gastric carcinoma is effective, tolerable palliative treatment and warrants further investigation. Author Disclosure Employment or Leadership Consultant or Advisory Role Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration Roche, sanofi-aventis Roche, sanofi-aventis Roche-educational grant and free drug. Money to research fund, sanofi-aventis towards drug costs, to research fund not myself.