FOLFOXIRI (folinic acid, 5-fluorouracil, oxaliplatin and irinotecan) vs FOLFIRI (folinic acid, 5-fluorouracil and irinotecan) as first-line treatment in metastatic colorectal cancer (MCC): a multicentre randomised phase III trial from the Hellenic Oncology Research Group (HORG)
2006

Comparing Two Treatments for Metastatic Colorectal Cancer

Sample size: 283 publication 10 minutes Evidence: moderate

Author Information

Author(s): Souglakos J, Androulakis N, Syrigos K, Polyzos A, Ziras N, Athanasiadis A, Kakolyris S, Tsousis S, Kouroussis Ch, Vamvakas L, Kalykaki A, Samonis G, Mavroudis D, Georgoulias V

Primary Institution: University General Hospital of Heraklion

Hypothesis

To compare the efficacy and toxicity of FOLFOXIRI vs FOLFIRI as first-line treatment in metastatic colorectal cancer.

Conclusion

The study found no significant survival advantage of FOLFOXIRI over FOLFIRI, despite FOLFOXIRI showing a longer median overall survival.

Supporting Evidence

  • Patients treated with FOLFOXIRI had a higher incidence of alopecia, diarrhoea, and neurosensory toxicity.
  • The median overall survival was 19.5 months for FOLFIRI and 21.5 months for FOLFOXIRI.
  • 85% of patients had disease progression and 62% had died by the end of the study.

Takeaway

Doctors wanted to see if a new combination of drugs worked better than an older one for treating cancer, but they found out that both worked about the same.

Methodology

A multicentre randomised phase III trial comparing FOLFOXIRI and FOLFIRI in 283 chemotherapy-naïve patients with metastatic colorectal cancer.

Limitations

The study did not demonstrate a significant difference in overall survival between the two treatment regimens.

Participant Demographics

Patients were mostly older adults, with nearly half being 65 years or older.

Statistical Information

P-Value

0.337

Confidence Interval

95% CI: 1.701–3.703

Statistical Significance

p=0.337

Digital Object Identifier (DOI)

10.1038/sj.bjc.6603011

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