Front-line Bevacizumab in combination with Oxaliplatin, Leucovorin and 5-Fluorouracil (FOLFOX) in patients with metastatic colorectal cancer: a multicenter phase II study
2007

Bevacizumab with FOLFOX for Metastatic Colorectal Cancer

Sample size: 53 publication 10 minutes Evidence: moderate

Author Information

Author(s): Emmanouilides Christos, Sfakiotaki Georgia, Androulakis Nikolaos, Kalbakis Kostas, Christophylakis Charalambos, Kalykaki Antonia, Vamvakas Lambros, Kotsakis Athanasios, Agelaki Sofia, Diamandidou Eleni, Touroutoglou Nikolaos, Chatzidakis Adam, Georgoulias Vassilis, Mavroudis Dimitris, Souglakos John

Hypothesis

To evaluate the efficacy and the toxicity of front line FOLFOX4 combined with bevacizumab in patients with metastatic colorectal cancer.

Conclusion

The combination of FOLFOX4/bevacizumab appears to be highly effective, well tolerated and merits further evaluation in patients with metastatic colorectal cancer.

Supporting Evidence

  • Fifty-three patients were enrolled in the study.
  • The overall response rate was 67.9%.
  • The median time to tumor progression was 11 months.
  • The probability of 1-, 2-, and 3-year survival was 79.8%, 63.8%, and 58.3%, respectively.
  • Grade 3–4 neutropenia occurred in 15.1% of patients.

Takeaway

This study tested a new treatment for patients with advanced colon cancer and found it works well and is safe.

Methodology

Chemotherapy-naïve patients with metastatic colorectal cancer received a combination of bevacizumab, oxaliplatin, leucovorin, and 5-fluorouracil every two weeks.

Potential Biases

Potential selection bias due to the non-randomized nature of the study.

Limitations

The study is a phase II trial, which may limit the generalizability of the results.

Participant Demographics

Median age of participants was 65 years, with 56.6% being male.

Statistical Information

P-Value

0.0023

Confidence Interval

95% C.I.: 53.8%–92%

Statistical Significance

p<0.05

Digital Object Identifier (DOI)

10.1186/1471-2407-7-91

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