Phase III study of docetaxel and cisplatin plus fluorouracil compared with cisplatin and fluorouracil as first-line therapy for advanced gastric cancer: A report of the V325 study group
Author | dc.contributor.author | Van Cutsem, Eric | |
Author | dc.contributor.author | Moiseyenko, Vladimir M. | es_CL |
Author | dc.contributor.author | Tjulandin, Sergei | es_CL |
Author | dc.contributor.author | Majlis, Alejandro | es_CL |
Author | dc.contributor.author | Constenla, Manuel | es_CL |
Author | dc.contributor.author | Boni, Corrado | es_CL |
Author | dc.contributor.author | Rodrigues, Adriano | es_CL |
Author | dc.contributor.author | Fodor, Miguel | es_CL |
Author | dc.contributor.author | Chao, Yee | es_CL |
Author | dc.contributor.author | Voznyi, Edouard | es_CL |
Author | dc.contributor.author | Risse, Marie-Laure | es_CL |
Author | dc.contributor.author | Ajani, Jaffer A. | es_CL |
Admission date | dc.date.accessioned | 2009-06-23T17:55:16Z | |
Available date | dc.date.available | 2009-06-23T17:55:16Z | |
Publication date | dc.date.issued | 2006-11-01 | |
Cita de ítem | dc.identifier.citation | JOURNAL OF CLINICAL ONCOLOGY Volume: 24 Issue: 31 Pages: 4991-4997 Published: NOV 1 2006 | en |
Identifier | dc.identifier.issn | 0732-183X | |
Identifier | dc.identifier.uri | https://repositorio.uchile.cl/handle/2250/128011 | |
Abstract | dc.description.abstract | Purpose In the randomized, multinational phase II/III trial (V325) of untreated advanced gastric cancer patients, the phase II part selected docetaxel, cisplatin, and fluorouracil (DCF) over docetaxel and cisplatin for comparison against cisplatin and fluorouracil (CF; reference regimen) in the phase III part. Patients and Methods Advanced gastric cancer patients were randomly assigned to docetaxel 75 mg/m(2) and cisplatin 75 mg/m(2) (day 1) plus fluorouracil 750 mg/m(2)/ d ( days 1 to 5) every 3 weeks or cisplatin 100 mg/m(2) ( day 1) plus fluorouracil 1,000 mg/m(2)/ d (days 1 to 5) every 4 weeks. The primary end point was time-to-progression (TTP). Results In 445 randomly assigned and treated patients ( DCF = 221; CF = 224), TTP was longer with DCF versus CF (32% risk reduction; log-rank P <.001). Overall survival was longer with DCF versus CF (23% risk reduction; log-rank P =.02). Two-year survival rate was 18% with DCF and 9% with CF. Overall response rate was higher with DCF (chi(2) P =.01). Grade 3 to 4 treatment-related adverse events occurred in 69% ( DCF) v 59% ( CF) of patients. Frequent grade 3 to 4 toxicities for DCF v CF were: neutropenia (82% v 57%), stomatitis (21% v 27%), diarrhea (19% v 8%), lethargy ( 19% v 14%). Complicated neutropenia was more frequent with DCF than CF (29% v 12%). Conclusion Adding docetaxel to CF significantly improved TTP, survival, and response rate in gastric cancer patients, but resulted in some increase in toxicity. Incorporation of docetaxel, as in DCF or with other active drug(s), is a new therapy option for patients with untreated advanced gastric cancer. | en |
Lenguage | dc.language.iso | en | en |
Publisher | dc.publisher | AMER SOC CLINICAL ONCOLOGY | en |
Keywords | dc.subject | Neoplasmas del esófago--Terapia con drogas | en |
Título | dc.title | Phase III study of docetaxel and cisplatin plus fluorouracil compared with cisplatin and fluorouracil as first-line therapy for advanced gastric cancer: A report of the V325 study group | en |
Document type | dc.type | Artículo de revista |
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