Document Detail

Clinical benefit with docetaxel plus fluorouracil and cisplatin compared with cisplatin and fluorouracil in a phase III trial of advanced gastric or gastroesophageal cancer adenocarcinoma: the V-325 Study Group.
MedLine Citation:
PMID:  17664467     Owner:  NLM     Status:  MEDLINE    
PURPOSE: For patients with advanced gastric or gastroesophageal cancer (AGGEC) providing clinical benefit with improved palliation is highly desirable. However, a prospective evaluation of clinical benefit in AGGEC patients has never before been reported in a phase III setting.
PATIENTS AND METHODS: In a multinational trial (V325), 445 patients were randomly assigned and treated with either docetaxel plus cisplatin and fluorouracil (DCF) or cisplatin and fluorouracil (CF). Clinical benefit was prospectively evaluated in this trial as a secondary end point. The primary measure for clinical benefit analysis was time to definitive worsening by one or more categories of Karnofsky performance status (KPS). Secondary clinical benefit end points included time to 5% definitive weight loss, time to definitive worsening of appetite by one grade, pain-free survival (defined as time to first appearance of pain), and time to first cancer pain-related opioid intake. Clinical benefit assessments were recorded at each clinic visit.
RESULTS: Clinical benefit assessments were performed in more than 75% of patients throughout V325. DCF significantly prolonged time to definitive worsening of KPS compared with CF (median, 6.1 v 4.8 months; hazard ratio, 1.38; 95% CI, 1.08 to 1.76; log-rank P = .009). Although time to definitive weight loss and time to definitive worsening of appetite favored DCF, the results were not statistically significant. Pain-free survival and time to first cancer pain-related opioid intake were comparable.
CONCLUSION: To our knowledge, V325 is the first phase III trial to report clinical benefit in AGGEC patients. Clinical benefit was assessed beyond protocol-specific chemotherapy. The addition of D to CF not only significantly improved clinical benefit but also improved quality of life, time to progression, and overall survival compared with CF.
Jaffer A Ajani; Vladimir M Moiseyenko; Sergei Tjulandin; Alejandro Majlis; Manuel Constenla; Corrado Boni; Adriano Rodrigues; Miguel Fodor; Yee Chao; Edouard Voznyi; Cindy Marabotti; Eric Van Cutsem;
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Publication Detail:
Type:  Clinical Trial, Phase III; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  Journal of clinical oncology : official journal of the American Society of Clinical Oncology     Volume:  25     ISSN:  1527-7755     ISO Abbreviation:  J. Clin. Oncol.     Publication Date:  2007 Aug 
Date Detail:
Created Date:  2007-07-31     Completed Date:  2007-09-13     Revised Date:  2013-05-28    
Medline Journal Info:
Nlm Unique ID:  8309333     Medline TA:  J Clin Oncol     Country:  United States    
Other Details:
Languages:  eng     Pagination:  3205-9     Citation Subset:  IM    
Department of Gastrointestinal Medical Oncology, The University of Texas M.D. Anderson Cancer Center, Houston, TX 77030, USA.
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MeSH Terms
Adenocarcinoma / drug therapy*,  pathology
Antineoplastic Combined Chemotherapy Protocols / adverse effects,  therapeutic use*
Chi-Square Distribution
Cisplatin / administration & dosage
Drug Administration Schedule
Esophageal Neoplasms / drug therapy*,  pathology
Fluorouracil / administration & dosage
Middle Aged
Neoplasm Metastasis
Proportional Hazards Models
Prospective Studies
Quality of Life
Stomach Neoplasms / drug therapy*,  pathology
Survival Rate
Taxoids / administration & dosage
Treatment Outcome
Reg. No./Substance:
0/Taxoids; 15663-27-1/Cisplatin; 15H5577CQD/docetaxel; 51-21-8/Fluorouracil
Comment In:
J Clin Oncol. 2007 Aug 1;25(22):3188-90   [PMID:  17664464 ]
J Clin Oncol. 2007 Dec 1;25(34):5528-9; author reply 5529-30   [PMID:  18048833 ]
Nat Clin Pract Oncol. 2008 Mar;5(3):132-3   [PMID:  18253105 ]

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