The taxol, cisplatin, and S1 combination has shown promising results in patients with stomach cancer, but we do not know the exact efficacy and toxicity profiles of this three-drug regimen in elderly patients with gastric cancer.Methods
In this non-randomized phase 2 trial, we administered taxol (80 mg/m2 intravenously on days 1 and 8), cisplatin (30 mg/m2 intravenously on days 1 and 8), and S1 (35 mg/m2 orally twice a day on days 1–14) in a 3-week cycle to patients older than 65 years with recurrent or metastatic gastric cancer.Findings
From September 2007 to April 2011, 28 patients (22 men, median age 69 years) were enrolled. The common sites of metastatic lesions were abdominal lymph nodes (57.1%), liver (21.4%), peritoneum (17.9%), and lungs (7.1%). The median number of cycles was 3.5 (range 1–8). 50.0% of patients had a response: one (3.6%) had a complete response and 13 (46.4%) a partial response. Median overall survival (OS) was 7.6 months (1.46). All 28 patients were assessed for safety, performance status, and body mass index (BMI), and had laboratory blood tests. This treatment was moderately tolerated with grade 3/4 neutropenia in 67.9% of cycles, grade 3 anaemia in 21.4%, and thrombocytopenia in 3.6%. Non-haematological toxic effects were grade 3 general weakness in 25.0% of patients, grade 4 diarrhoea 3.6%, and grade 2 pneumonia in 10.7%. Compared with younger patients, more grade 3/4 neutropenia, anaemia, and general weakness were noted. Treatment-related mortality was 3.6%. Only BMI was correlated with OS by the use of Cox regression analysis (relative risk (RR) 0.865, 95% CI 0.751–0.995, P = 0.043).Interpretation
The combination of taxol, cisplatin, and S1 in elderly patients with gastric cancer resulted in a fairly high disease response rate and survival duration that were similar to those in younger patients, but the more frequent neutropenia, anaemia, and general weakness were seen as barriers to treatment in elderly patients. The chemotherapy regimen must be used with caution, especially in elderly patients with low BMI.