Adjuvant Chemotherapy with Docetaxel, Cisplatin, and Continuous-Infusion 5-Fluorouracil for Gastric Cancer: A Phase II Study.

Objective: This study evaluated the efficacy and safety of adjuvant chemotherapy with the docetaxel plus cisplatin and 5-fluorouracil (5-FU) (DCF) regimen in patients with gastric cancer.

Methods: Thirty-two patients with gastric or gastroesophageal junction cancer were enrolled in this study after undergoing radical resection. The patients received the following chemotherapy: docetaxel (60 mg/m(2)) on day 1, cisplatin (12 mg/m(2) per day) on days 1 to 5, and 5-FU (2500 mg/m(2)) continuous infusion for 120 hours, repeated every 3 weeks for six cycles. The primary end point was disease-free survival (DFS).

Results: The median DFS was 17.0 months. The 1-year DFS was 72%, and the 2-year DFS was 37.5%. The median overall survival was 28.0 months. Using univariate analysis, the technique of lymph node dissection was a predictor for postoperative relapse. The median DFS was 15.0 months in the D1 group and 18.0 months in the D2 group (P = .043). The most frequent grade 3/4 adverse events were neutropenia (56.25%), diarrhea (9.38%), nausea (6.25%), and vomiting (6.25%); 12.5% of patients developed febrile neutropenia. There were no chemotherapy-related deaths.

Conclusions: The modified DCF regimen is an effective adjuvant chemotherapy in gastric cancer. Hematologic toxicity was frequent but manageable. This regimen merits further investigation.