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

Research output: Contribution to journalArticlepeer-review

Abstract

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/m 2 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.

Original languageEnglish
Pages (from-to)3217-3223
Number of pages7
JournalJournal of Clinical Oncology
Volume25
Issue number22
DOIs
Publication statusPublished - Aug 1 2007

ASJC Scopus subject areas

  • Cancer Research
  • Oncology

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