Tamoxifen is not effective in good prognosis patients with hepatocellular carcinoma

Ciro Gallo, Ermelinda De Maio, Massimo Di Maio, Giuseppe Signoriello, Bruno Daniele, Sandro Pignata, Annalisa Annunziata, Francesco Perrone

Research output: Contribution to journalArticle

13 Citations (Scopus)

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.

Original languageEnglish
Article number196
JournalBMC Cancer
Volume6
DOIs
Publication statusPublished - Jul 24 2006

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Tamoxifen
Hepatocellular Carcinoma
Survival
Therapeutics
Pharmaceutical Preparations
Randomized Controlled Trials
Databases
Liver

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

Cite this

Tamoxifen is not effective in good prognosis patients with hepatocellular carcinoma. / Gallo, Ciro; De Maio, Ermelinda; Di Maio, Massimo; Signoriello, Giuseppe; Daniele, Bruno; Pignata, Sandro; Annunziata, Annalisa; Perrone, Francesco.

In: BMC Cancer, Vol. 6, 196, 24.07.2006.

Research output: Contribution to journalArticle

Gallo, Ciro ; De Maio, Ermelinda ; Di Maio, Massimo ; Signoriello, Giuseppe ; Daniele, Bruno ; Pignata, Sandro ; Annunziata, Annalisa ; Perrone, Francesco. / Tamoxifen is not effective in good prognosis patients with hepatocellular carcinoma. In: BMC Cancer. 2006 ; Vol. 6.
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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.",
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AU - Gallo, Ciro

AU - De Maio, Ermelinda

AU - Di Maio, Massimo

AU - Signoriello, Giuseppe

AU - Daniele, Bruno

AU - Pignata, Sandro

AU - Annunziata, Annalisa

AU - Perrone, Francesco

PY - 2006/7/24

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N2 - 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.

AB - 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.

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