[Phase II clinical trial of docetaxel, platinum and S-1 for advanced gastric cancer]

To evaluate the efficacy and safety profile and to explore the role of docetaxel, S-1 plus cisplatin (DCS) or oxaliplatin (DOS) in the treatment of advanced gastric cancer.

A total of 45 patients with advanced gastric cancer were recruited. They received DCS or DOS at the discretion of investigators. Docetaxel was given intravenously at the dose of 60 mg/m² at d1, S-1 60 mg×m⁻²×d⁻¹ or 80 - 120 mg/d according to individual patient's area of body surface orally from d1 to d14 and cisplatin 30 mg/m² at d1, d2 or oxaliplatin 111 - 127 (median: 117) mg/m ²at d2. Each cycle was for 21 days.

Forty-three patients received ≥ 1 complete cycle of DCS/DOS with a median cycle number of 5(range: 1 - 8). Among 42 patients evaluated for efficacy, the outcomes were partial response (n = 28), stable disease (n = 9) and progression (n = 5). The response rate was 66.7%. Progression-free survival (PFS) of 32 patients on chemotherapy alone was 7.1 months and the median overall survival (OS) was not reached. The most common grade 3/4 adverse effects included neutropenia (46.5%), thrombocytopenia (9.3%), vomiting (9.3%), nausea (7.0%) and diarrhea (4.7%). Ten of fourteen patients with advanced unresectable gastric cancer without clinically detectable distant metastases underwent surgical resection after a median of 4 (2-6) cycles of DCS or DOS and 9 (64.3%) had R0 resection.

DCS/DOS is effective for advanced gastric cancer and in the setting of neoadjuvant chemotherapy. And the toxicities of DCS/DOS are manageable.