Docetaxel-cisplatin-5FU (TCF) versus docetaxel-cisplatin (TC) versus epirubicin-cisplatin-5FU (ECF) as systemic treatment for advanced gastric carcinoma (AGC): A randomized phase II trial of the Swiss Group for Clinical Cancer Research (SAKK)

Abstract

4020 Background: ECF is currently considered by many as a standard regimen in AGC in Europe. Based on the high efficacy reported with TC and TCF in AGC (Ann. Oncol 11; 301, 2000, ASCO Proc. 18, 245a, 1999), we launched a randomized 3-arm phase II trial to assess which of TC or TCF would be the more promising regimen to compare to ECF in a future phase III trial. Methods: Patients (pts) with AGC, without prior palliative chemotherapy, with bidimentionally measurable disease, PS≤1, normal blood counts, hepatic and renal functions, were randomized to receive up to 8 cycles q3w of TC (docetaxel 85mg/m2, ciplatine 75mg/m2), TCF (like TC + 5-FU continuous infusion (CI) 300mg/m2/d for 2w) or ECF (epirubicin 50mg/m2, cisplatin 60mg/m2, 5-FU CI 200mg/m2/d for 3w). Results: Among 121pts enrolled, 119 were treated and included in the analysis. 5 pts are still on treatment (3 ECF and 2 TCF). Preliminary results are summarized below. A total of 554 treatment cycles are documented up to now. A median of 5, 4.5 and 4 cycles of ECF, TC and TCF were given, respectively. Hematotoxicity was the main toxicity in all 3 arms with grade ≥3 granulopenia in 73%, 76% and 58% of the pts for TC, TCF and ECF, respectively. Febrile neutropenia (FN) occurence in 10 of the first 21 pts enrolled in docetaxel based regimens led to decrease docetaxel from 85 to 75mg/m2 in TC and TCF, resulting in lesser FN occurence. Grade ≥3 non-hematologic toxicity was infrequent (<10% of pts) apart from alopecia (3 arms), nausea (18% in TC and TCF pts) and diarrhea (15% in TCF pts). Conclusions: Despite an increased toxicity, docetaxel based regimens seem to be more efficacious than ECF. In terms of RR and TTP, TCF is the more promising regimen and should be chosen for formal comparison with ECF. This trial is supported in part by Aventis. Author Disclosure Employment or Leadership Consultant or Advisory Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration Aventis