Phase II multicenter trial of docetaxel, epirubicin, and 5-fluorouracil (DEF) in the treatment of advanced gastric cancer: a novel, safe, and active regimen.

Background: This study evaluated the efficacy and safety of docetaxel, epirubicin, and 5-fluorouracil (5-FU) [DEF] as treatment for locally advanced unresectable or metastatic gastric cancer.

Methods: Thirty-seven patients participated in the study (median age, 56 years; range, 22-73 years); Eastern Cooperative Oncology Group performance status [PS], 0-2). Docetaxel 75 mg/m2 IV (day 1), 5-FU 500 mg/m2 IV (days 1-3), and epirubicin 50 mg/m2 IV (day 1) were administered every 3 weeks for six cycles.

Results: In total, 20/37 patients (54%) completed six treatment cycles. Thirteen patients (35%; 95% confidence intervals [CI], 20% to 51%) had an objective response; 1 patient (3%) achieved a complete response and 12 patients (32%) achieved partial responses. Stable disease was observed in 7 patients (19%) and progressive disease in 5 patients (14%). Twelve patients (32%) were unevaluable. Clinical benefit (based on PS, weight gain, and analgesic consumption) was observed in 11 patients (30%). Median follow-up was 41 months (range, 26-53 months), median time to progression was 6.6 months (range, 0.5-29.2 months), median overall survival was 10.7 months (range, 7.0-14.6 months), and 1-year survival was 40%. The regimen was well tolerated. Grade 3-4 febrile neutropenia occurred in 8 patients (22%; 6% of cycles) and grade 3-4 neutropenia in 1 patient (1% of cycles). The most frequent grade 3-4 toxicities were alopecia (11% of cycles), diarrhea (4% of cycles) and vomiting (2% of cycles); grade 1-2 asthenia and fatigue occurred in 43% of cycles.

Conclusion: DEF is effective in the treatment of advanced gastric cancer, and has a good safety profile.