Dana-Farber Cancer Institute, Brigham and Women’s Hospital and Harvard Medical School, Boston, MA, USA.
J Clin Oncol. 2011 Sep 1;29(25):3450-6. doi: 10.1200/JCO.2010.34.4309. Epub 2011 Aug 1.
Sunitinib is a multitargeted receptor tyrosine kinase inhibitor approved for treatment of renal cell carcinoma (RCC) and GI stromal tumor. Congestive heart failure (CHF) is an important adverse effect that has been reported with sunitinib, but overall incidence and relative risk (RR) remain undefined. We performed an up-to-date meta-analysis to determine the risk of developing CHF in patients with both RCC and non-RCC tumors treated with sunitinib.
Medline databases were searched for articles published between January 1966 and February 2011. Eligible studies were limited to phase II and III trials of sunitinib with adequate safety reporting in patients with cancer of any tumor type. Summary incidence, RR, and 95% CIs were calculated using random- or fixed-effects models based on the heterogeneity of included studies.
A total of 6,935 patients were included. Overall incidence for all- and high-grade CHF in sunitinib-treated patients was 4.1% (95% CI, 1.5% to 10.6%) and 1.5% (95% CI, 0.8% to 3.0%), respectively. RR of all- and high-grade CHF in sunitinib-treated patients compared with placebo-treated patients was 1.81 (95% CI, 1.30 to 2.50; P < .001) and 3.30 (95% CI, 1.29 to 8.45; P = .01), respectively. On subgroup analysis, there was no difference observed in CHF incidence for patients with RCC versus non-RCC or in trials with or without cardiac monitoring. No evidence of publication bias was observed.
Sunitinib use is associated with increased risk of CHF in patients with cancer.
舒尼替尼是一种多靶点受体酪氨酸激酶抑制剂，适用于治疗肾细胞癌（RCC）和胃肠道间质瘤（GIST）。充血性心力衰竭（CHF）是舒尼替尼的一种重要不良反应，但总的发生率和相对风险（RR）仍不明确。我们进行了一项最新的荟萃分析，以确定接受舒尼替尼治疗的 RCC 和非 RCC 肿瘤患者发生 CHF 的风险。
检索了 1966 年 1 月至 2011 年 2 月期间发表的 Medline 数据库文章。合格研究仅限于舒尼替尼的 II 期和 III 期试验，这些试验在任何肿瘤类型的癌症患者中具有充分的安全性报告。使用随机或固定效应模型根据纳入研究的异质性计算汇总发生率、RR 和 95%置信区间（CI）。
共纳入 6935 例患者。舒尼替尼治疗患者的所有和高级别 CHF 的总发生率分别为 4.1%（95%CI，1.5%至 10.6%）和 1.5%（95%CI，0.8%至 3.0%）。与安慰剂治疗患者相比，舒尼替尼治疗患者的所有和高级别 CHF 的 RR 分别为 1.81（95%CI，1.30 至 2.50；P<0.001）和 3.30（95%CI，1.29 至 8.45；P=0.01）。亚组分析显示，在 RCC 与非 RCC 患者或有或无心脏监测的试验中，CHF 发生率无差异。未观察到发表偏倚的证据。
舒尼替尼的使用与癌症患者发生 CHF 的风险增加相关。
