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Treatment-related toxicities of apatinib in solid tumors: a meta-analysis
Ling Peng1, Xianghua Ye2, Yun Hong3
1Department of Thoracic Oncology, The First Affiliated Hospital, School of Medicine, Zhejiang University, Hangzhou, Zhejiang Province, China.
Background:
Apatinib is a novel small molecular drug targeting vascular endothelial growth factor receptor-2 (VEGFR-2), which is being studied in multiple tumor types. We performed a meta-analysis to quantify the overall incidence and risk of hypertension, proteinuria, and hand-foot-syndrome (HFS) in cancer patients receiving apatinib.
Results:
Altogether, 820 cancer patients from 7 prospective trials were included for the meta-analysis. The incidences of all-grade and high-grade hypertension were 45.4% and 9.7%. The incidences of all-grade and high-grade proteinuria were 45.1% and 3.7%. The incidences of all-grade and high-grade HFS were 35.9% and 8.6%. The RRs of all-grade hypertension, proteinuria and HFS of apatinib compared to placebo were increased (hypertension, RR = 6.53; proteinuria, RR = 2.62, and HFS, RR = 11.45). The RRs of developing high-grade hypertension and HFS were substantially higher than that of placebo (hypertension, RR = 7.73; HFS, RR = 7.23), but not for proteinuria (RR = 2.56, 95% CI: 0.57-11.52).
Materials And Methods:
Prospective phase II and III clinical trials of cancer patients receiving apatinib were searched and included. Summary incidences, relative risk (RR), and 95% confidence intervals (CI) were calculated by using either fixed or random effects models according to the heterogeneity of the studies.
Conclusions:
Apatinib is generally well tolerated, and associated with increased risks of all-grade hypertension, proteinuria and HFS, and high-grade hypertension and HFS, but not high-grade proteinuria.
Insights
Apatinib treatment in cancer patients increases risks for hypertension, proteinuria, and hand-foot-syndrome (HFS). High-grade hypertension and HFS risks were significantly elevated, but high-grade proteinuria risk was not.
Area of Science:
- Oncology
- Pharmacology
- Clinical Trials
Background:
- Apatinib is a novel small molecule drug targeting vascular endothelial growth factor receptor-2 (VEGFR-2).
- It is under investigation for efficacy across various cancer types.
- This meta-analysis focuses on adverse events associated with apatinib therapy.
Purpose of the Study:
- To quantify the incidence and risk of hypertension, proteinuria, and hand-foot-syndrome (HFS) in cancer patients treated with apatinib.
- To compare the risks of these adverse events against placebo in clinical trials.
- To evaluate the safety profile of apatinib concerning specific adverse events.
Main Methods:
- A meta-analysis was conducted on data from 7 prospective clinical trials (Phase II and III).
- Included patients (n=820) received apatinib for various cancers.
- Incidences and relative risks (RR) with 95% confidence intervals (CI) were calculated using fixed or random effects models.
Main Results:
- The incidences of all-grade hypertension, proteinuria, and HFS were 45.4%, 45.1%, and 35.9%, respectively.
- High-grade incidences were 9.7% for hypertension, 3.7% for proteinuria, and 8.6% for HFS.
- Apatinib significantly increased the risk of all-grade and high-grade hypertension (RR=6.53, RR=7.73) and HFS (RR=11.45, RR=7.23) compared to placebo. The risk for high-grade proteinuria was not significantly increased (RR=2.56).
Conclusions:
- Apatinib is associated with increased risks of all-grade and high-grade hypertension and hand-foot-syndrome (HFS).
- The risk for high-grade proteinuria was not significantly elevated compared to placebo.
- Overall, apatinib is considered generally well-tolerated despite these associated risks.
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