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Adverse events risk associated with regorafenib in the treatment of advanced solid tumors: meta-analysis of
Xiaonan Yin1, Yuan Yin1, Chaoyong Shen1
1Department of Gastrointestinal Surgery, West China Hospital, Sichuan University, Chengdu 610041, Sichuan, China, hxwcwk@126.com.
Background:
Regorafenib is a novel multikinase inhibitor (MKI) approved for use in the treatment of metastatic colorectal cancer (CRC), treatment-refractory gastrointestinal stromal tumors, and other solid tumor malignancies. However, the adverse events (AEs) associated with regorafenib have not been systematically investigated. Hence, we performed a meta-analysis to identify AEs associated with regorafenib in patients with advanced solid tumors.
Methods:
The databases of PubMed, MEDLINE, and Embase and abstracts presented in American Society of Clinical Oncology annual meetings were searched for relevant publications from January 2004 to September 2017. Eligible studies were limited to prospective randomized controlled trials (RCTs) that evaluate the use of regorafenib in patients with advanced solid tumors. Incidence, relative risk (RR), and 95% CIs were calculated using a random or fixed effects model on the basis of the heterogeneity of the included studies.
Results:
A total of 2,065 patients from six RCTs were included, and 1,340 of them received regorafenib and 725 received a placebo. Sixteen all-grade AEs and 15 high-grade AEs were investigated for their association with regorafenib. Results showed that hand-foot skin reaction (HFSR; 54%), diarrhea (33%), fatigue (32%), hypertension (31%), oral mucositis (28%), and anorexia (23%) were the most frequent clinical AEs. The most common high-grade (grade, ≥3) AEs were HFSR (16%), hypertension (13%), fatigue (6%), increased aspartate aminotransferase (AST; 6%), and hypophosphatemia (6%). Pooled RR showed that the use of regorafenib was associated with an increased risk of developing AEs. Subgroup analysis based on the prior MKI treatment showed that prior MKI treatment was associated with an increased incidence of all-grade anorexia (P=0.03) and a reduced incidence of high-grade increased AST (P=0.04). However, subgroup analysis based on the tumor type showed that no significant differences were found when comparing the RR of all-grade and high-grade AEs in patients with CRC or non-CRC.
Conclusion:
The meta-analysis systematically investigated regorafenib-associated AEs. Knowledge of these AEs is essential for minimizing treatment-related toxicities and improving clinical outcomes.
Insights
Regorafenib, a multikinase inhibitor, is linked to frequent adverse events like hand-foot skin reaction and diarrhea in advanced cancer patients. Understanding these side effects is key to managing toxicity and improving patient outcomes.
Area of Science:
- Oncology
- Pharmacology
- Clinical Trials
Background:
- Regorafenib is an approved multikinase inhibitor (MKI) for metastatic colorectal cancer (CRC) and other advanced solid tumors.
- Systematic investigation of regorafenib's adverse events (AEs) is lacking.
- This meta-analysis identifies AEs associated with regorafenib in advanced cancer patients.
Purpose of the Study:
- To systematically identify and quantify adverse events associated with regorafenib treatment.
- To assess the relative risk of specific AEs in patients receiving regorafenib compared to placebo.
- To explore potential differences in AE incidence based on prior MKI treatment or tumor type.
Main Methods:
- Meta-analysis of prospective randomized controlled trials (RCTs) published from 2004 to 2017.
- Inclusion of studies evaluating regorafenib in patients with advanced solid tumors.
- Calculation of incidence, relative risk (RR), and 95% confidence intervals (CIs) using random or fixed effects models.
Main Results:
- Six RCTs with 2,065 patients (1,340 regorafenib, 725 placebo) were analyzed.
- Frequent all-grade AEs included hand-foot skin reaction (HFSR; 54%), diarrhea (33%), and fatigue (32%).
- Common high-grade (≥3) AEs were HFSR (16%) and hypertension (13%). Regorafenib use significantly increased AE risk (RR).
Conclusions:
- This meta-analysis systematically characterizes regorafenib-associated AEs.
- Awareness of these AEs is crucial for mitigating treatment toxicity.
- Improved AE management can lead to better clinical outcomes for patients receiving regorafenib.
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