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Risk of hypertension and renal dysfunction with an angiogenesis inhibitor sunitinib: systematic review and
Xiaolei Zhu1, Kathleen Stergiopoulos, Shenhong Wu
1Kidney Specialists of Long Island, Port Jefferson Station, NY, USA.
Background:
Sunitinib is a multitargeted tyrosine kinase inhibitor used in the treatment of metastatic renal cell carcinoma (RCC) and gastrointestinal stromal tumor (GIST), and undergoing evaluation for other malignancy. Hypertension is one of its major side effects with a substantial variation in the reported incidences among clinical studies. We here performed a systematic review and meta-analysis of published clinical trials to determine its overall risk.
Methods:
Relevant studies were searched and identified in MEDLINE (OVID 1966 to July, 2007), Web of Science, and abstracts presented at the American Society of Clinical Oncology annual meetings from 2004 through 2007. Eligible studies were prospective clinical trials that had described events of hypertension for patients who received single agent sunitinib. The incidence of hypertension and relative risk (RR) were calculated using the random-effects or the fixed-effects model.
Results:
A total of 4,999 patients with RCC and other malignancies from 13 clinical trials were included for analysis. Among patients receiving sunitinib, the incidence of all-grade and high-grade hypertensions were 21.6% (95% CI: 18.7-24.8%) and 6.8% (95% CI: 5.3-8.8%) respectively. The risk may vary with tumor type and the dosing schedule of sunitinib. Sunitinib was associated with a significantly increased risk of high-grade hypertension (RR=22.72, 95% CI: 4.48 to 115.29, p<0.001) and renal dysfunction (RR: 1.36, 95% CI: 1.20 to 1.54, p<0.001) in comparison with controls.
Conclusions:
There is a significant risk of developing hypertension and renal dysfunction among patients receiving sunitinib. Adequate monitoring and treatment of hypertension is recommended.
Insights
Sunitinib treatment significantly increases the risk of hypertension and renal dysfunction in cancer patients. Close monitoring and management of blood pressure are crucial for those undergoing sunitinib therapy.
Area of Science:
- Oncology
- Pharmacology
- Clinical Trials
Background:
- Sunitinib is a tyrosine kinase inhibitor used for metastatic renal cell carcinoma (RCC) and gastrointestinal stromal tumor (GIST).
- Hypertension is a known side effect of sunitinib, with variable reported incidences.
- This study aimed to determine the overall risk of hypertension associated with sunitinib.
Purpose of the Study:
- To conduct a systematic review and meta-analysis of clinical trials on sunitinib.
- To quantify the incidence and relative risk of hypertension in patients treated with sunitinib.
- To assess the risk of renal dysfunction associated with sunitinib therapy.
Main Methods:
- Systematic search of MEDLINE, Web of Science, and ASCO abstracts (2004-2007).
- Inclusion of prospective clinical trials of single-agent sunitinib with reported hypertension events.
- Calculation of incidence and relative risk using random-effects or fixed-effects models.
Main Results:
- Analysis included 4,999 patients from 13 clinical trials.
- Overall incidence of all-grade and high-grade hypertension were 21.6% and 6.8%, respectively.
- Sunitinib significantly increased the risk of high-grade hypertension (RR=22.72) and renal dysfunction (RR=1.36).
Conclusions:
- Sunitinib therapy poses a significant risk for developing hypertension and renal dysfunction.
- Close monitoring of blood pressure is recommended for patients on sunitinib.
- Management strategies for sunitinib-induced hypertension should be implemented.
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