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
| Autor: | Rob Glynne-Jones, Rudolf Maibach, Kaspar Rufibach, Piercarlo Saletti, Martin Leslie, Stephen Falk, Arnaud Roth, Dieter Köberle, M. Wernli, Nicola Fazio, Lukas Widmer, Markus Borner, Filippo de Braud, Matthew T. Seymour, Jürg Bernhard, Roger Stupp |
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| Rok vydání: | 2007 |
| Předmět: |
Oncology
Adult Male Cancer Research medicine.medical_specialty medicine.drug_class Antineoplastic Combined Chemotherapy Protocols/adverse effects/therapeutic use Epirubicin/administration & dosage Docetaxel Adenocarcinoma Antimetabolite law.invention Randomized controlled trial law Stomach Neoplasms Internal medicine Stomach Neoplasms/drug therapy/pathology Antineoplastic Combined Chemotherapy Protocols medicine Humans Stomach cancer Aged Epirubicin ddc:616 Cisplatin business.industry Middle Aged medicine.disease Surgery Clinical trial Fluorouracil/administration & dosage Taxoids/administration & dosage Treatment Outcome Fluorouracil Quality of Life Adenocarcinoma/drug therapy/pathology Female Taxoids business Cisplatin/administration & dosage medicine.drug |
| Zdroj: | Journal of Clinical Oncology, Vol. 25, No 22 (2007) pp. 3217-23 |
| ISSN: | 1527-7755 0732-183X |
| Popis: | 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. |
| Databáze: | OpenAIRE |
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