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Docetaxel, Cisplatin, and Fluorouracil; Docetaxel and Cisplatin; and Epirubicin, Cisplatin, and Fluorouracil As Systemic Treatment for Advanced Gastric Carcinoma: A Randomized Phase II Trial of the Swiss Group for Clinical Cancer Research

Arnaud D. Roth, Nicola Fazio, Roger Stupp, Stephen Falk, Jürg Bernhard, Piercarlo Saletti, Dieter Köberle, Markus M. Borner, Kaspar Rufibach, Rudolf Maibach, Martin Wernli, Martin Leslie, Robert Glynne-Jones, Lukas Widmer, Matthew Seymour, Filippo de Braud

From the Oncosurgery Unit, Geneva University Hospital, Geneva; Multidisciplinary Oncology Center, University Hospital (CHUV), Lausanne; Swiss Group for Clinical Cancer Research Coordinating Center; Department of Medical Oncology, Inselspital, Bern; Oncology Institute of Southern Switzerland, Ospedale Civico, Lugano; Division of Oncology, Department of Medicine C, Kantonspital, St Gallen; Kantonspital Aarau, Aarau; Institute of Medical Oncology, Triemlispital, Zurich, Switzerland; Department of Medicine, European Institute of Oncology, Milan, Italy; Bristol Oncology Center, Bristol; St Thomas Hospital, London; Mount Vernon Hospital, Middlesex; and Cookridge Hospital, Leeds, United Kingdom

Address reprint requests to Arnaud D. Roth, MD, Department of Oncosurgery, Geneva University Hospital, 24 Micheli-Du-Crest, CH-1211 Geneva 14, Switzerland; e-mail: arnaud.roth{at}sim.hcuge.ch

Purpose This randomized phase II trial evaluated two docetaxel-based regimens to see which would be most promising according to overall response rate (ORR) for comparison in a phase III trial with epirubicin-cisplatin-fluorouracil (ECF) as first-line advanced gastric cancer therapy.

Patients and Methods Chemotherapy-naïve patients with measurable unresectable and/or metastatic gastric carcinoma, a performance status 1, and adequate hematologic, hepatic, and renal function randomly received eight 3-weekly cycles of ECF (epirubicin 50 mg/m² on day 1, cisplatin 60 mg/m² on day 1, and fluorouracil [FU] 200 mg/m²/d on days 1 to 21), TC (docetaxel initially 85 mg/m² on day 1 [later reduced to 75 mg/m² as a result of toxicity] and cisplatin 75 mg/m² on day 1), or TCF (TC plus FU 300 mg/m²/d on days 1 to 14). Study objectives included response (primary), survival, toxicity, and quality of life (QOL).

Results ORR was 25.0% (95% CI, 13% to 41%) for ECF, 18.5% (95% CI, 9% to 34%) for TC, and 36.6% (95% CI, 23% to 53%) for TCF (n = 119). Median overall survival times were 8.3, 11.0, and 10.4 months for ECF, TC, and TCF, respectively. Toxicity was acceptable, with one toxic death (TC arm). Grade 3 or 4 neutropenia occurred in more treatment cycles with docetaxel (TC, 49%; TCF, 57%; ECF, 34%). Global health status/QOL substantially improved with ECF and remained similar to baseline with both docetaxel regimens.

Conclusion Time to response and ORR favor TCF over TC for further evaluation, particularly in the neoadjuvant setting. A trend towards increased myelosuppression and infectious complications with TCF versus TC or ECF was observed.

Supported in part by Sanofi-aventis.

Presented at the 40th Annual Meeting of the American Society of Clinical Oncology, June 5-8, 2004, New Orleans, LA.

Authors’ disclosures of potential conflicts of interest and author contributions are found at the end of this article.

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