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Open Access Research article

Tamoxifen is not effective in good prognosis patients with hepatocellular carcinoma

Ciro Gallo1*, Ermelinda De Maio2, Massimo Di Maio2, Giuseppe Signoriello1, Bruno Daniele3, Sandro Pignata4, Annalisa Annunziata1, Francesco Perrone2 and the CLIP (Cancer of the Liver Italian Programme) Investigators

Author Affiliations

1 Department of Medicine and Public Health, Second University, Naples, Italy

2 Clinical Trials Unit, National Cancer Institute, Naples, Italy

3 G. Rummo Hospital, Benevento, Italy

4 Medical Oncology B, National Cancer Institute, Naples, Italy

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BMC Cancer 2006, 6:196  doi:10.1186/1471-2407-6-196

Published: 24 July 2006

Abstract

Background

Large randomised clinical trials and systematic reviews substantiate that tamoxifen is ineffective in improving survival of patients with hepatocellular carcinoma (HCC). However, a recent report suggested that the drug might prolong survival among patients with well preserved liver function. The aim of this paper is to validate this hypothesis.

Methods

We used the updated database of the phase 3 randomised CLIP-1 trial that compared tamoxifen with supportive therapy. Primary endpoint was overall survival. Treatment arms were compared within strata defined according to the Okuda stage and the CLIP-score. Survival differences were tested by the Log-rank test.

Results

Tamoxifen was not effective in prolonging survival in Okuda I-II subgroup (p = 0.501). Median survival times were equal to 16.8 (95%CI 12.7–18.5) months for tamoxifen and 16.8 (95%CI 13.5–22.4) months for the control arms; 1-year survival probabilities were equal to 58.8% (95%CI 51.7–65.8) and 59.4 (95%CI 52.5–66.2), respectively. Similar results were observed in the better CLIP subgroup (score 0/1), without evidence of difference between the two treatment arms (p = 0.734). Median survival times were equal to 29.2 (95%CI 20.1–36.4) months with tamoxifen and 29.0 (95%CI 23.3–35.2) months without; 1-year survival probabilities were equal to 80.9% (95%CI 72.5–89.3) with tamoxifen and 77.1% (95%CI 68.6–85.7) for the control arm.

Conclusion

The recent suggestion that tamoxifen might be effective in the subgroup of patients with better prognosis is not supported by a reanalysis of the CLIP-1 trial. Tamoxifen should no longer be considered for the treatment of HCC patients and future trials of medical treatment should concentrate on different drugs.