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Impact of baseline characteristics on outcomes of advanced HCC patients treated with sorafenib: a secondary analysis of a phase III study

Abstract

Background

The current study aims to investigate the impact of baseline characteristics on the outcomes of sorafenib-treated advanced Hepatocellular carcinoma (HCC) patients in the setting of a clinical trial.

Methods

This is a secondary analysis of the comparator arm (sorafenib arm) of the NCT00699374 study which is a phase III multicenter study conducted between 2008 and 2010. The univariate probability of overall and progression-free survival was assessed among different patient subsets through Kaplan–Meier analysis and log-rank testing. Multivariate analysis of factors affecting overall and progression-free survival was then conducted through Cox regression analysis.

Results

All patients within the comparator (sorafenib) arm were included in the analysis (N = 544 patients). In multivariate analysis, prior hepatectomy (P = 0.028), prior locoregional treatment (P = 0.048), grade 1 ALBI score (P < 0.001), ECOG performance score of 0 (P < 0.001), BMI ≥ 25 (P = 0.026), AFP < 200 (P = 0.001), and no extra-hepatic spread (P = 0.007) were associated with better overall survival. Likewise, in multivariate analysis, non-Asian race (P = 0.004), grade 1 ALBI score (P = 0.001), ECOG performance score of 0 (P = 0.006), and no extra-hepatic spread (P = 0.005) were associated with better progression-free survival. Moreover, development of high-grade hand–foot skin reaction was associated with a statistically significant improvement in overall survival (P = 0.003), which was further confirmed in a multivariate analysis adjusted for other relevant baseline factors (P = 0.002).

Conclusion

Within a cohort of highly selected advanced HCC patients, baseline patient-, liver-, and disease-centered variables play an important role in predicting patient outcomes. This information is important in terms of therapeutic decision-making and patient counseling.

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Acknowledgements

This publication is based on research using information obtained from http://www.projectdatasphere.org, which is maintained by Project Data Sphere, LLC. Neither Project Data Sphere, LLC, nor the owner(s) of any information from the web site have contributed to, approved or are in any way responsible for the contents of this publication.

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Correspondence to Omar Abdel-Rahman.

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The authors declare that they have no competing interests.

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This article does not contain any studies with human participants or animals performed by the author. The current study is fully compliant with all applicable ethical and legal standards. It complies fully with the Declaration of Helsinki.

Informed consent

As this study is based on a publicly available data set without identifying patient information, informed consent was not needed.

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Abdel-Rahman, O. Impact of baseline characteristics on outcomes of advanced HCC patients treated with sorafenib: a secondary analysis of a phase III study. J Cancer Res Clin Oncol 144, 901–908 (2018). https://doi.org/10.1007/s00432-018-2610-z

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  • DOI: https://doi.org/10.1007/s00432-018-2610-z

Keywords

  • Sorafenib
  • HCC
  • BMI
  • ALBI
  • Prognosis