Phase Ii Study Of Biweekly Docetaxel And Cisplatin Combination Chemotherapy In First-Line Advanced Gastric Cancer

15601 Background: Docetaxel and cisplatin, as single agents, have demonstrated activity in patients with advanced gastric cancer. Docetaxel and cisplatin have shown a different toxicity profile; consequently the combination of these drugs could be a safe and effective treatment. Therefore, we conducted a phase II study to assess efficacy and toxicity of a biweekly regimen of docetaxel plus cisplatin in patients with advanced gastric cancer who have never been treated with palliative chemotherapy. Methods: Fifty-two patients with advanced gastric cancer were enrolled, histologically confirmed of gastric adenocarcinoma, at least one measurable lesion, ECOG PS ≤2, no prior palliative chemotherapy and adequate bone marrow, renal and hepatic function. Docetaxel 50 mg/m2 and cisplatin 50 mg/m2 were administered every two weeks until progression disease, unbearable toxicity or a maximum of 12 cycles. The objective response was evaluated according to RECIST criteria and toxicity was assessed according to the NCI-CTC 2.0. Results: In total, 392 cycles were administered (median 8, range 1–12 cycles), with a median dose intensity of 91% for docetaxel and cisplatin. The median age was 66 years (range 37–84), 71% were male, 6.5% had ECOG 0 and 78.3% ECOG 1. The objective response rate was 37.0% (95% CI, 23.0–50.9) with one complete response and 16 partial responses, over 46 evaluable patients. Sixteen patients had stable disease. Median time to progression was 5.5 months (95% CI, 4.0–7.0) and median overall survival 8.9 months (95% CI: 6.0–11.9). The most common grade 3–4 toxicities per cycle were neutropenia (5.9%), anaemia (1.8%), asthenia (1.8%), vomiting (1.0%), nausea (0.8%) and thrombocytopenia (0.8%). Conclusions: Biweekly administration of docetaxel and cisplatin in advanced gastric cancer has a manageable toxicity profile and shows a promising antitumor activity as a first-line therapy. No significant financial relationships to disclose.