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.