A prospective randomised trial to study the role of levamisole and interferon alfa in an adjuvant therapy with 5-FU for stage III colon cancer
2005

Adjuvant therapy for stage III colon cancer

Sample size: 598 publication Evidence: high

Author Information

Author(s): Schippinger W, Jagoditsch M, Sorré C, Gnant M, Steger G, Hausmaninger H, Mlineritsch B, Schaberl-Moser R, Mischinger H J, Hofbauer F, Holzberger P, Mittlböck M, Jakesz R

Primary Institution: Austrian Breast and Colorectal Cancer Study Group

Hypothesis

Does the addition of levamisole or interferon alfa to 5-FU improve outcomes in stage III colon cancer?

Conclusion

The addition of levamisole to adjuvant 5-FU worsened the prognosis for patients with stage III colon cancer, while interferon alfa had no significant impact on survival.

Supporting Evidence

  • Patients treated with levamisole had a significantly higher risk of relapse.
  • Levamisole treatment was associated with a higher risk of death compared to no levamisole.
  • Interferon alfa did not show a significant impact on overall survival.

Takeaway

This study found that adding levamisole to a common cancer treatment made things worse for patients, while another drug, interferon, didn't help at all.

Methodology

Patients were randomly assigned to one of four treatment arms involving 5-FU with or without levamisole and interferon alfa.

Potential Biases

There may be risks of bias due to the multicenter design and patient selection criteria.

Limitations

The study was limited by the potential for bias in treatment adherence and the generalizability of results to broader populations.

Participant Demographics

Patients aged 18 to 80 with histologically proven stage III colon cancer.

Statistical Information

P-Value

P=0.0028 for relapse risk with levamisole; P=0.0027 for death risk with levamisole.

Confidence Interval

95% CI 1.135–1.856 for relapse; 95% CI 1.150–1.973 for death.

Statistical Significance

p<0.05

Digital Object Identifier (DOI)

10.1038/sj.bjc.6602555

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