Wu S, Chen JJ, Kudelka A, Lu J, Zhu XIncidence and risk of hypertension with sorafenib in patients with cancer: A systematic review and meta-analysis. Lancet Oncol 9: 117-123

Division of Medical Oncology, Department of Medicine, State University of New York, Stony Brook, NY 11794-9447, USA.
The Lancet Oncology (Impact Factor: 24.69). 03/2008; 9(2):117-23. DOI: 10.1016/S1470-2045(08)70003-2
Source: PubMed


Sorafenib is used in patients with advanced renal-cell carcinoma (RCC) or hepatocellular cancer, and its application in other types of cancers is also undergoing extensive clinical assessment. Hypertension is one of the major side-effects of this drug, and reported incidences vary substantially between clinical trials. We did a systematic review and meta-analysis of published clinical trials to establish the incidence of hypertension associated with sorafenib. The aim of this study is to gain a better understanding of the overall risk of hypertension in patients with cancer who receive sorafenib.
Databases, including Medline (July, 1966, to July, 2007), and Web of Science, and abstracts presented at the American Society of Clinical Oncology annual meetings from 2004 to 2007 were searched to identify relevant studies. Eligible studies were prospective clinical trials of patients with cancer assigned single-drug sorafenib at 400 mg twice daily with data on hypertension available. Incidence and relative risk (RR) of hypertension were calculated using a random-effects or fixed-effects model, depending on the heterogeneity of the included studies.
Nine studies published between January, 2006, and July, 2007, which included a total of 4599 patients with RCC or other solid tumours, were selected from 223 articles screened for analysis. For patients assigned sorafenib, the overall incidence of all-grade and high-grade (ie, grade 3 or 4) hypertension were 23.4% (95% CI 16.0-32.9%) and 5.7% (2.5-12.6%), respectively. No significant difference was noted between patients with RCC or a non-RCC malignancy (all grade: RR 1.03 [95% CI 0.73-1.45], p=0.89; high-grade: RR 1.23 [0.76-1.99], p=0.40) who were assigned sorafenib. Sorafenib was associated with a significantly increased risk of all-grade hypertension in patients with cancer with an RR of 6.11 (2.44-15.32], p<0.001) compared with controls.
Patients with cancer assigned sorafenib have a significant risk of developing hypertension. Appropriate monitoring and treatment is strongly recommended to prevent cardiovascular complications.

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    • "Furthermore, clinical efficacy was also found for sorafenib in phase II clinical trials for other malignant diseases such as advanced melanoma, breast cancer, nonsmall cell lung cancer, urothelial cancer, prostate cancer, carcinoma of the head and neck, gastrointestinal stromal tumours and thyroid cancer. With the wider usage in clinical practice, side-effects of sorafenib began to be recognized and some of which may be potentially life threatening, such as congestive heart failure (CHF), arterial thrombosis, wound dehiscence, haemorrhage, hypertension, and renal dysfunction (Chu et al., 2008; Wu et al., 2008; Chu et al., 2009; Je et al., 2009; Kerkela et al., 2009; Choueiri et al., 2010; Ewer et al., 2010; Hutson et al., 2010). Fatal adverse events (FAEs) are deaths that related to use of the pharmaceutical agent. "
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