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
- Study type
- Clinical trial
- Study name
- V325
- Phase
- Phase 2/3
- Design
- Multinational randomised phase 2/3 trial (in the phase 2 part, the DCF regimen was preferred over docetaxel plus cisplatin for comparison with CF in the phase 3 part)
- Sample size
- 445 patients randomised and treated (DCF: 221; CF: 224)
- Source
- JCO · 2006
In plain words
In this study, patients with advanced stomach cancer who had not yet had any treatment received either a three-drug combination of docetaxel, cisplatin and fluorouracil or a two-drug combination of cisplatin and fluorouracil. Adding docetaxel slowed the growth of the disease, helped patients live longer and made the treatment work in more patients. On the other hand, side effects (especially a severe drop in white blood cells and diarrhoea) were more common with the three-drug combination, so the choice of this treatment should be made with the doctor, taking each patient's situation into account.
Key results
Treatment arms and regimens
Docetaxel 75 mg/m² and cisplatin 75 mg/m² (day 1) plus fluorouracil 750 mg/m² per day (days 1 to 5), every 3 weeks.
Cisplatin 100 mg/m² (day 1) plus fluorouracil 1000 mg/m² per day (days 1 to 5), every 4 weeks.
Source of the regimen details: Abstract of the paper
Doses are given for the information of specialists, as in this study’s protocol, and are not a prescription. Every drug must be prescribed by the treating physician for the individual patient.
Study population
Patients with previously untreated advanced gastric cancer.
Endpoints
Primary endpoint: time to progression (TTP). The abstract also reports overall survival, 2-year survival rate, overall response rate and adverse events.
Safety and side effects
Treatment-related grade 3 to 4 adverse events occurred in 69% of patients with DCF versus 59% with CF. Common grade 3 to 4 toxicities (DCF versus CF): neutropenia 82% versus 57%, stomatitis 21% versus 27%, diarrhoea 19% versus 8%, lethargy 19% versus 14%. Complicated neutropenia was more frequent with DCF (29% versus 12%).
Clinical significance and place in guidelines
Based on the abstract, adding docetaxel to the CF regimen improved time to progression, survival and response rate in advanced gastric cancer, and the authors considered it a new option for first-line treatment, although with increased toxicity. The exact place of this regimen in current guidelines and the status of drug approvals should be checked separately.
Limitations
The abstract does not address the study's limitations. Increased toxicity (especially neutropenia and complicated neutropenia) was reported with DCF. Exact TTP and overall survival values (such as medians and hazard ratios) are not given in the abstract and are in the full text.
This summary was prepared by the editorial team from the published paper; the original paper is the final reference. Read the original abstract on PubMed.