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

*Corresponding author for this work

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218 Scopus citations

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 (US)
Pages (from-to)3217-3223
Number of pages7
JournalJournal of Clinical Oncology
Volume25
Issue number22
DOIs
StatePublished - Aug 1 2007

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

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    Roth, A. D., Fazio, N., Stupp, R., Falk, S., Bernhard, J., Saletti, P., Köberle, D., Borner, M. M., Rufibach, K., Maibach, R., Wernli, M., Leslie, M., Glynne-Jones, R., Widmer, L., Seymour, M., & De Braud, F. (2007). 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. Journal of Clinical Oncology, 25(22), 3217-3223. https://doi.org/10.1200/JCO.2006.08.0135