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Journal of Clinical Oncology, Vol 24, No 31 (November 1), 2006: pp. 4991-4997
© 2006 American Society of Clinical Oncology.
DOI: 10.1200/JCO.2006.06.8429
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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

Eric Van Cutsem, Vladimir M. Moiseyenko, Sergei Tjulandin, Alejandro Majlis, Manuel Constenla, Corrado Boni, Adriano Rodrigues, Miguel Fodor, Yee Chao, Edouard Voznyi, Marie-Laure Risse, Jaffer A. Ajani

From the University Hospital Gasthuisberg, Leuven, Belgium; N.N. Petrov Research Institute of Oncology, St Petersburg; N.N. Blokhin Cancer Research Center; Russian Scientific Centre of Radiology, Moscow, Russia; Fundación Arturo López Pérez; Hospital Clinico Universidad de Chile, Santiago, Chile; C.H. de Pontevedra, Pontevedra, Spain; Arcispedale Santa Maria Nuova, Reggio Emilia, Italy; Hospitais da Universidade de Coimbra, Coimbra, Portugal; Taipei Veterans General Hospital, Taipei, Taiwan; sanofi aventis, Antony, France; and The University of Texas M.D. Anderson Cancer Center, Houston, TX

Address reprint requests to Jaffer A. Ajani, MD, Department of Gastrointestinal Medical Oncology, University of Texas M.D. Anderson Cancer Center, Mail Stop 4261, 1515 Holcombe Blvd, Houston, TX 77030; e-mail: jajani{at}mdanderson.org

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/m2 and cisplatin 75 mg/m2 (day 1) plus fluorouracil 750 mg/m2/d (days 1 to 5) every 3 weeks or cisplatin 100 mg/m2 (day 1) plus fluorouracil 1,000 mg/m2/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.

Authors' disclosures of potential conflicts of interest and author contributions are found at the end of this article.


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