title: Incidence and risk of sorafenib-induced hypertension: a systematic review and meta-analysis.
abstract: Hypertension is one of the major side effects of sorafenib, and reported incidences vary substantially among clinical trials. A systematic review was conducted using Medline, PubMed, Embase, and the Cochrane Library for all longitudinal studies to investigate the incidence and risk of hypertension events in cancer patients treated with sorafenib. A total of 14 randomized controlled trials and 39 prospective single-arm trials involving 13,555 patients were selected for the meta-analysis. The relative risk of all-grade and high-grade hypertension associated with sorafenib were 3.07 (95% confidence interval [CI], 2.05–4.60; P<.01) and 3.31 (95% CI, 2.21–4.95; P<.01), respectively. The overall incidence of sorafenib-induced all-grade and high-grade hypertension were 19.1% (95% CI, 15.8%–22.4%) and 4.3% (95% CI, 3.0%–5.5%), respectively. A significantly higher incidence of hypertension was noted in patients with renal cell carcinoma (RCC) compared with those with non-RCC malignancies (all-grade: 24.9% [95% CI, 19.7%–30.1%] vs 15.7%[95% CI, 12.1%–19.3%]; P<.05; high-grade:8.6% [95% CI, 6.0%–11.2%] vs 1.8% [95% CI, 0.9%–2.6%]; P<.05). The trials with median progression-free survival (PFS) longer than 5.3 months (mean PFS) demonstrated a significantly higher incidence of high-grade hypertension than trials with shorter PFS (6.3% [95% CI, 4.1%–8.5%] vs 2.6% [95% CI, 1.4%– 3.8%]; P<.05). Findings of the meta-analysis indicated a significantly high risk of sorafenib-induced hypertension. Patients with RCC have a significantly higher incidence of hypertension and the occurrence of hypertension may be associated with improved prognosis.
authors.forename: Yan
authors.initials: Y
authors.lastname: Li
authors.forename: Shun
authors.initials: S
authors.lastname: Li
authors.forename: Yaofeng
authors.initials: Y
authors.lastname: Zhu
authors.forename: Xinyue
authors.initials: X
authors.lastname: Liang
authors.forename: Hui
authors.initials: H
authors.lastname: Meng
authors.forename: Jun
authors.initials: J
authors.lastname: Chen
authors.forename: Dongqing
authors.initials: D
authors.lastname: Zhang
authors.forename: Hu
authors.initials: H
authors.lastname: Guo
authors.forename: Benkang
authors.initials: B
authors.lastname: Shi
mesh_terms: D000368:Aged; D000970:Antineoplastic Agents / Q000009:adverse effects* / Q000627:therapeutic use*; D002292:Carcinoma, Renal Cell / Q000188:drug therapy; D004358:Drug Therapy; D006801:Humans; D006973:Hypertension / Q000139:chemically induced* / Q000453:epidemiology*; D015994:Incidence; D007680:Kidney Neoplasms / Q000188:drug therapy; D008875:Middle Aged; D009369:Neoplasms / Q000188:drug therapy*; D009536:Niacinamide / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D010671:Phenylurea Compounds / Q000009:adverse effects* / Q000627:therapeutic use*; D011379:Prognosis; D012307:Risk Factors; D000077157:Sorafenib; D016896:Treatment Outcome
chemical_list: D000970:Antineoplastic Agents; D010671:Phenylurea Compounds; D009536:Niacinamide; D000077157:Sorafenib