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.

Details

Serval ID
serval:BIB_20BB1386B9CA
Type
Article: article from journal or magazin.
Collection
Publications
Institution
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.
Journal
Journal of Clinical Oncology
Author(s)
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.
ISSN
1527-7755[electronic]
Publication state
Published
Issued date
2007
Volume
25
Number
22
Pages
3217-3223
Language
english
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 <or= 1, and adequate hematologic, hepatic, and renal function randomly received <or= eight 3-weekly cycles of ECF (epirubicin 50 mg/m(2) on day 1, cisplatin 60 mg/m(2) on day 1, and fluorouracil [FU] 200 mg/m(2)/d on days 1 to 21), TC (docetaxel initially 85 mg/m(2) on day 1 [later reduced to 75 mg/m(2) as a result of toxicity] and cisplatin 75 mg/m(2) on day 1), or TCF (TC plus FU 300 mg/m(2)/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.
Keywords
Adenocarcinoma/drug therapy, Adenocarcinoma/pathology, Adult, Aged, Antineoplastic Combined Chemotherapy Protocols/adverse effects, Antineoplastic Combined Chemotherapy Protocols/therapeutic use, Cisplatin/administration & dosage, Epirubicin/administration & dosage, Female, Fluorouracil/administration & dosage, Humans, Male, Middle Aged, Quality of Life, Stomach Neoplasms/drug therapy, Stomach Neoplasms/pathology, Taxoids/administration & dosage, Treatment Outcome
Pubmed
Web of science
Create date
28/01/2008 8:39
Last modification date
20/08/2019 12:57
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