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

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

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  • Media type: E-Article
  • Title: 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
  • Contributor: Roth, Arnaud D.; Fazio, Nicola; Stupp, Roger; Falk, Stephen; Bernhard, Jürg; Saletti, Piercarlo; Köberle, Dieter; Borner, Markus M.; Rufibach, Kaspar; Maibach, Rudolf; Wernli, Martin; Leslie, Martin; Glynne-Jones, Robert; Widmer, Lukas; Seymour, Matthew; de Braud, Filippo
  • Published: American Society of Clinical Oncology (ASCO), 2007
  • Published in: Journal of Clinical Oncology, 25 (2007) 22, Seite 3217-3223
  • Language: English
  • DOI: 10.1200/jco.2006.08.0135
  • ISSN: 0732-183X; 1527-7755
  • Origination:
  • University thesis:
  • Footnote:
  • Description: <jats:sec><jats:title>Purpose</jats:title><jats:p> 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. </jats:p></jats:sec><jats:sec><jats:title>Patients and Methods</jats:title><jats:p> 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/m<jats:sup>2</jats:sup> on day 1, cisplatin 60 mg/m<jats:sup>2</jats:sup> on day 1, and fluorouracil [FU] 200 mg/m<jats:sup>2</jats:sup>/d on days 1 to 21), TC (docetaxel initially 85 mg/m<jats:sup>2</jats:sup> on day 1 [later reduced to 75 mg/m<jats:sup>2</jats:sup> as a result of toxicity] and cisplatin 75 mg/m<jats:sup>2</jats:sup> on day 1), or TCF (TC plus FU 300 mg/m<jats:sup>2</jats:sup>/d on days 1 to 14). Study objectives included response (primary), survival, toxicity, and quality of life (QOL). </jats:p></jats:sec><jats:sec><jats:title>Results</jats:title><jats:p> 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. </jats:p></jats:sec><jats:sec><jats:title>Conclusion</jats:title><jats:p> 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. </jats:p></jats:sec>
  • Access State: Open Access