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Risk of treatment-related mortality with sorafenib in cancer patients: a meta-analysis of 20 randomly controlled trials

Risk of sorafenib-associated death

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International Journal of Clinical Pharmacy Aims and scope Submit manuscript

Abstract

Background Sorafenib is a relatively new multi-kinase inhibitor used to treat a wide range of cancers. As fatal adverse events from sorafenib therapy are rare, their investigation requires a meta-analysis. Aim of the review To provide a meta-analysis of sorafenib-associated fatal adverse events with the most expansive and current data. Method We searched Medline, EMBASE, Web of Science and Cochrane Library databases. We also searched abstracts from a number of conferences. Twenty trials of sorafenib were found in 9434 cancer patients, tested against placebos and against other drugs. We calculated relative risks and incidences for sorafenib-associated mortality. Results Overall incidence of sorafenib-associated mortality was 3.3 %. Patients with renal cell carcinoma (RCC) and thyroid cancer had treatment-related mortality ≥5 %. Patients treated with sorafenib had a significantly greater risk of mortality than those in placebo/control groups, with an RR of 1.75. Subgroup analyses also showed significant differences in sorafenib versus placebo (RR 1.87, 95 % CI 1.23–2.86; I 2 = 0.0 %, P = 0.865); and sorafenib + platinum-based chemotherapy (RR 2.03, 95 % CI 1.15–3.59; I 2 = 0.0 %, P = 0.654). However, sorafenib had lower risk than other multi-targeted antiangiogenic tyrosine kinase inhibitors. Patients with RCC and non-small-cell lung carcinoma were significantly more vulnerable. Conclusion Sorafenib presents a significant risk of fatal adverse events (FAEs) in patients with cancer, especially for RCC or non-small-cell lung carcinoma, and in patients treated with sorafenib + platinum-based chemotherapy. However, compared with other multi-targeted antiangiogenic tyrosine kinase inhibitors, sorafenib has a lower risk of FAEs.

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Acknowledgments

We thank Edanz for its linguistic assistance during the preparation of this manuscript.

Funding

No special funding was received for this review.

Conflicts of interest

The authors have no conflict of interest.

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Authors and Affiliations

  1. Medical College of Nanchang University, No. 461 Bayi Road, Nanchang, China

    Xiongwen Yang & Xiong Pan

  2. The Second Affiliated Hospital of Nanchang University, No. 1 Minde Road, Nanchang, China

    Xiaoshu Cheng & Yingzhang Cheng

  3. Thoracic Surgery of Jiangxi Province Tumor Hospital, No. 519 Beijing East Road, Nanchang, China

    Yukang Kuang

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  1. Xiongwen Yang
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Correspondence to Yingzhang Cheng or Yukang Kuang.

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Xiongwen Yang and Xiong Pan are common first authors.

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Yang, X., Pan, X., Cheng, X. et al. Risk of treatment-related mortality with sorafenib in cancer patients: a meta-analysis of 20 randomly controlled trials. Int J Clin Pharm 37, 1047–1056 (2015). https://doi.org/10.1007/s11096-015-0151-y

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  • DOI: https://doi.org/10.1007/s11096-015-0151-y

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