The efficacy and safety of onartuzumab in patients with solid cancers: A meta-analysis of randomized trials
Bum Jun Kim1, Dalyong Kim2, Jung Han Kim1
1Department of Internal Medicine, Hallym University Medical Center, Hallym University College of Medicine, Seoul, Republic of Korea.
Background:
Onartuzumab, a humanized monovalent monoclonal antibody to the MET protein, has been tested in various cancers. We conducted a meta-analysis of randomized phase II and III clinical trials to investigate the efficacy and safety of onartuzumab in solid cancers.
Methods:
We searched PubMed, PMC, EMBASE, and the Cochrane library databases. We included randomized phase II or III trials that evaluated the additional benefits of onartuzumab in comparison with the standard treatments. Data on progression-free survival (PFS), overall survival (OS), and adverse events (AEs) were pooled and analyzed.
Results:
From nine studies, a total of 2,138 patients were included in the meta-analysis. The addition of onartuzumab to the standard treatment resulted in no improvement of PFS (hazard ratio (HR) = 1.00 [95% confidence interval (CI), 0.90-1.11], P = 0.93) and OS (HR = 1.08 [95% CI, 0.94-1.23], P = 0.29). In the subgroup analysis with patients with non-small-cell lung cancer (NSCLC), onartuzumab was not associated with a significant improvement of OS (HR = 1.12 [95% CI, 0.93-1.34], P = 0.23) and PFS (HR = 1.05 [95% CI, 0.91-1.21], P = 0.52). With respect to AEs, onartuzumab increased the incidence of hypoalbuminemia (odds ratio (OR) = 14.8 [95% CI, 3.49-62.71], P < 0.001), peripheral edema (OR = 6.52 [95% CI, 3.60-11.81], P < 0.001), neutropenia (OR = 1.36 [95% CI, 1.03-1.79], P = 0.03), thrombocytopenia (OR = 1.98 [95% CI, 1.03-3.81], P = 0.04), and venous thrombotic events (OR = 3.05 [95% CI, 1.39-6.71], P = 0.006).
Conclusion:
This meta-analysis indicates that the addition of onartuzumab to the standard treatments had no definite survival benefit with increased severe toxicities in patients with solid cancer.
Insights
Onartuzumab, an antibody targeting the MET protein, did not improve survival in solid cancer patients. The treatment also increased severe toxicities, including hypoalbuminemia and peripheral edema.
Area of Science:
- Oncology
- Clinical Pharmacology
- Biostatistics
Background:
- Onartuzumab is a monoclonal antibody targeting the MET protein, investigated for various cancers.
- Previous studies explored its potential in solid tumors, necessitating a comprehensive efficacy and safety review.
Purpose of the Study:
- To evaluate the efficacy and safety of onartuzumab in solid cancers.
- To conduct a meta-analysis of randomized phase II and III clinical trials.
Main Methods:
- Systematic search of PubMed, PMC, EMBASE, and Cochrane library databases.
- Inclusion of randomized phase II/III trials comparing onartuzumab plus standard treatment versus standard treatment alone.
- Pooled analysis of progression-free survival (PFS), overall survival (OS), and adverse events (AEs).
Main Results:
- Analysis of 9 studies with 2,138 patients showed no significant improvement in PFS (HR=1.00) or OS (HR=1.08) with onartuzumab.
- Subgroup analysis in non-small-cell lung cancer (NSCLC) also revealed no survival benefit.
- Onartuzumab significantly increased adverse events: hypoalbuminemia (OR=14.8), peripheral edema (OR=6.52), neutropenia (OR=1.36), thrombocytopenia (OR=1.98), and venous thrombotic events (OR=3.05).
Conclusions:
- Onartuzumab addition to standard treatment offers no definitive survival advantage in solid cancer patients.
- The treatment is associated with a significant increase in severe toxicities.
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