A phase II study of biweekly oxaliplatin plus infusional 5-fluorouracil and folinic acid (FOLFOX-4) as first-line treatment of advanced gastric cancer patients
2005

FOLFOX-4 Treatment for Advanced Gastric Cancer

Sample size: 61 publication Evidence: moderate

Author Information

Author(s): De Vita F, Orditura M, Matano E, Bianco R, Carlomagno C, Infusino S, Damiano V, Simeone E, Diadema M R, Lieto E, Castellano P, Pepe S, De Placido S, Galizia G, Di Martino N, Ciardiello F, Catalano G, Bianco A R

Primary Institution: Second University of Naples School of Medicine

Hypothesis

The study aims to assess the toxicity and clinical activity of biweekly oxaliplatin in combination with infusional 5-fluorouracil and folinic acid in patients with advanced gastric cancer.

Conclusion

FOLFOX-4 is an active and well-tolerated chemotherapy regimen for advanced gastric cancer, showing a response rate of 38% and a median overall survival of 11.2 months.

Supporting Evidence

  • Four complete responses and 19 partial responses were observed, leading to an overall response rate of 38%.
  • Stable disease was observed in 36% of patients.
  • The median time to progression was 7.1 months.
  • The median overall survival was 11.2 months.
  • Grade 3 and 4 hematologic toxicities were observed in 36% and 10% of patients, respectively.

Takeaway

Doctors tested a new medicine combination to help people with a serious stomach cancer, and it worked pretty well for many of them.

Methodology

Patients received oxaliplatin, folinic acid, and 5-fluorouracil every two weeks, and their responses and toxicities were assessed.

Limitations

The study was limited to previously untreated patients and may not represent all advanced gastric cancer cases.

Participant Demographics

{"median_age":64,"sex_distribution":{"male":62,"female":38},"performance_status":{"0":15,"1":64,"2":21},"metastatic_disease":92}

Statistical Information

P-Value

0.0026

Confidence Interval

{"overall_response_rate":"95% CI, 25.8–50.2","median_time_to_progression":"95% CI, 5.6–8.7","median_overall_survival":"95% CI, 9.66–14.39"}

Statistical Significance

p<0.05

Digital Object Identifier (DOI)

10.1038/sj.bjc.6602573

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