Prospective clinical study phase IIa open-label and not randomized of efficacy and toxicity of weekly paclitaxel chemotherapy in patients with advanced esophagogastric adenocarcinoma

Abstract

Introduction: Weekly paclitaxel is widely used in Japan as second-line chemotherapy in esophagogastric adenocarcinoma. There are no studies in the Mexican population. The aim of this study is to determine efficacy and toxicity of weekly paclitaxel for patients with advanced esophagogastric adenocarcinoma. Methods: Prospective clinical study single center phase IIa, which included patients over 18 years with advanced esophagogastric adenocarcinoma who attended the National Cancer Institute in Mexico City between May 2015 and April 2016 to start second-line chemotherapy, were excluded patients with central nervous system disease. Progression-free survival (PFS) was estimated using the Kaplan-Meier method. Results: 27 patients were included, most were men and the median age was 57 years. By RECIST 1.1, 40.74% had stable disease. The median PFS was 2.7 months (range 1 to 9 months). The main toxicities were peripheral neuropathy in 44.4%, 33.3% nausea, anemia 22.2%, neutropenia 22.2% and no grade 4 toxicities. Conclusion: Esophagogastric adenocarcinoma cancer patients treated at Mexico with weekly paclitaxel had a tumor response and a disease-free survival equivalent to patients in clinical trials but different toxicity profile than Asian patients.