After undergoing gastrectomy, patients began postoperative
chemotherapy. The regimen consisted of docetaxel (60 mg/m2) on day 1, cisplatin (12 mg/m2 per day) on days 1 to 5, and 5-FU (2500 mg/m2) continuous infusion for 120 hours. Chemotherapy was repeated every 3 weeks for a total of six cycles. Dose reductions or interruptions were allowed to manage potentially serious or life-threatening adverse events. Full doses of antineoplastic agents were given for the first cycle. If an episode of grade 2 neutropenia, thrombocytopenia, or nonhematologic toxicity was recorded, the treatment was delayed until the toxicity resolved to baseline or grade 1. If grade 3 or 4 adverse events occurred, subsequent doses of cytotoxic drugs were reduced to 75% of the planned dose until the toxicity resolved Nutlin-3 purchase to baseline or GSK-3 phosphorylation grade 1. After dose reduction, if grade 3 or 4 toxicities still occurred, patients were removed from the study. Postoperatively, all of the patients underwent a systematic baseline assessment. Chest and abdominal computed tomography scan and whole-body bone scan were required to exclude patients with postoperative recurrence and/or distant metastasis. During and after adjuvant chemotherapy, follow-up visits were required at 3-month intervals for 2 years, then at 6-month intervals for 3 years, and yearly thereafter. Follow-up consisted of a physical examination,
a complete blood count, liver function testing, and chest/abdominal Epothilone B (EPO906, Patupilone) computed tomography scan as clinically indicated. If signs or symptoms indicated a possible recurrence, further tests were then conducted to verify whether the patient was disease free. The same assessment paradigm was used for each patient. The primary end point of the
study was disease-free survival (DFS). Secondary end points were overall survival (OS) and toxicity. DFS was defined as the time from enrollment to recurrence, second cancer, or death from any cause, whichever came first. OS was defined as the time from enrollment to death from any cause or to the last follow-up visit. Patients who were still alive were censored on the date of the last follow-up visit for the purposes of statistical analysis. Adverse events were graded according to the National Cancer Institute’s Common Terminology Criteria for Adverse Events (version 3.0) (Bethesda, MD). Adverse events were recorded during chemotherapy and for 4 weeks after the last dose of study medication. Statistical analyses were performed using SPSS version 17.0 (SPSS Inc., Chicago, IL). Estimates of values were calculated using 95% confidence intervals (CIs). DFS and OS were analyzed using the Kaplan-Meier method. A P value of less than .05 was considered to be statistically significant. From November 2006 to June 2011, 32 patients with gastric cancer were enrolled in this study. The median age was 50 years (range = 24-68).