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Post Hoc Analysis Details Key Adverse Events in Patients With Advanced BCC Being Treated by Sonidegib or Vismodegib
Researchers were able to compare the main adverse events (AEs) of two medicines used in the treatment of advanced basal cell carcinoma (BCC). Results suggest that sonidegib is tolerated better by more patients vs vismodegib because of the lower overall incidence rate and a slower, less severe onset of certain AEs.
Sonidegib and vismodegib were examined using reports from two separate studies because a head-to-head trial comparing Hedgehog inhibitors has not yet been done. Data from the sonidegib phase 2 BOLT study and the expanded-access, open-label vismodegib study reported cumulative AE incidence every treatment cycle along with the time to onset and severity. Patients from each trial with histologically confirmed advanced BCC (laBCC) or metastatic BCC (mBCC) received either sonidegib 200 mg once daily or vismodegib 150 mg once daily. The authors then evaluated the cumulative occurrence of AEs, including median time to AE (30-day cycle for sonidegib vs 28 days for vismodegib), as well as graded AE severity. Only common AEs of at least 15% incidence were analyzed for this study.
Upon analysis, muscle spasm was found to be the most common AE for sonidegib and vismodegib (54.4% vs 70.6%). Other common all-grade AEs included alopecia (49.4% vs 58.0%);, dysgeusia (43.0% vs 70.6%), diarrhea (31.6% vs 25.2%), nausea (39.2% vs 19.3%), fatigue (32.9% vs 19.3%), and weight decrease (30.4% vs 16.0%). Patients treated with sonidegib had a delayed median time to onset for all AEs than compared with those who were treated with vismodegib, though fatigue and weight decrease were exceptions. Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â
The relevance of these post hoc analysis findings still needs further study to provide conclusive evidence in the absence of head-to-head comparisons. However, the data demonstrated that patients treated with sonidegib experienced less AEs overall.
Reference
Gutzmer R, Loquai C, Robert C, et al. Key Clinical adverse events in patients with advanced basal cell carcinoma treated with sonidegib or vismodegib: a post hoc analysis. Dermatol Ther (Heidelb). Published online September 6, 2021. doi:10.1007/s13555-021-00588-8
