Docetaxel (Taxotere (R))-cisplatin (TC): An effective drug combination in gastric carcinoma

Purpose: A multi-centric trial was performed to explore the clinical activi ty, in terms of response and toxicity (primary objectives), duration of res ponse and survival (secondary objectives), of docetaxel with cisplatin in a dvanced gastric cancer (AGC). Patients and methods: Patients with measurable unresectable and/or metastat ic gastric carcinoma, performance status less than or equal to 1, normal he matological, hepatic and renal functions and not pretreated for advanced di sease by chemotherapy received up to eight cycles of TC (docetaxel 85 mg/m( 2) d1, cisplatin 75 mg/m(2) d1) q3w. Dose escalation to 100 mg/m(2) was per formed in five patients and was discontinued for excessive toxicity. Results: Forty-eight patients were accrued. A median of 5 cycles/patient wa s given. We observed 2 complete and 25 partial responses for an overall int ent to treat response rate of 56% (95% CI: 41%-71%). Twelve patients had st able disease for greater than or equal to 9 weeks (3 cycles). The median ti me to progression and overall survival were 6.6 and 9 months, respectively. Grade greater than or equal to 3 toxicities were neutropenia 81%, anemia 3 2%, thrombocytopenia 4%, alopecia 36%, fatigue 9%, mucositis 9%, diarrhea 6 %, nausea/vomiting 4%, neurologic 2%, and one anaphylaxis precluding treatm ent administration. We recorded nine episodes of non-fatal febrile neutrope nia in eight patients, two of them with docetaxel at 100 mg/m(2). There wer e no direct treatment-related deaths. Conclusions: TC is active in AGC with a high response rate in a multicentri c trial. Despite its hematotoxicity, this regimen is well tolerated and can be recycled as originally planned in 78% of the cases. These results may s erve as basis for further developments of docetaxel containing regimens in this disease.