Bi-weekly docetaxel and 5-fluorouracil: an effective and feasible treatment for advanced gastric cancer with poor performance status

Background: The survival benefits from cytotoxic chemotherapy have been demonstrated in advanced gastric cancer (AGC). A large proportion of AGC patients initially present poor performance status (PS); however, most of the clinical evidence comes from trials on patients with good PS. A better-designed regimen is greatly needed for AGC patients with poor PS. Objective: To evaluate the efficacy and safety of a modified combination regimen with docetaxel plus 5-fluorouracil (5-FU) every two weeks as first-line treatment in AGC patients with poor PS. Methods: From September 2011 to December 2013, 12 patients diagnosed with AGC with Eastern Cooperative Oncology Group (ECOG) PS scores of 3 or 4 were included in this study. All the patients received docetaxel 60 mg/m(2) on Day 1, 5-FU 400 mg/m(2) intravenous (i.v.) bolus on Day 1, and a 46-hour continuous i.v. infusion of 5-FU 2400 mg/m(2) every two weeks, until disease progressed or patients experienced unacceptable toxicity or declined treatment. Detailed clinical, pathologic and survival data were all recorded. Results: Eleven out of 12 patients were assessable for responses, whereas nine cases (75%) achieved partial response, one (8.3%) achieved stabilized disease, and one (8.3%) had progressive disease. The median progression-free survival was 6.5 months (95% CI: 4.8–8.2). The median overall survival was 12.0 months (95% CI: 9.0–15.0). The most common Grade 3/4 toxicities were anemia in seven patients (58.3%). No patient experienced febrile neutropenia. Conclusion: The novel modification of bi-weekly docetaxel and 5-FU is a promising treatment option for AGC with poor PS, showing great efficacy and acceptable toxicity.