PMID- 35912002
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20220808
IS  - 1745-1981 (Print)
IS  - 1740-4398 (Electronic)
IS  - 1740-4398 (Linking)
VI  - 11
DP  - 2022
TI  - Benefit-risk assessment of sonidegib and vismodegib in the treatment of locally 
      advanced basal cell carcinoma.
LID - 10.7573/dic.2022-1-2 [doi]
LID - 2022-1-2
AB  - BACKGROUND: Sonidegib and vismodegib are Hedgehog pathway inhibitors (HhIs) that 
      play a relevant role in the management of locally advanced basal cell carcinoma 
      (laBCC). This study compared the efficacy and safety of both HhIs based on their 
      available data using effect size measures such as number needed to treat (NNT), 
      number needed to harm (NNH), and likelihood to be helped or harmed (LHH). 
      METHODS: We reviewed data from pivotal trials of sonidegib (BOLT) and vismodegib 
      (ERIVANCE). The NNT for sonidegib and vismodegib was calculated from objective 
      response rate (ORR) values. The NNH was calculated from data relating to 
      treatment discontinuation due to adverse events (AEs) and incidence of AEs. The 
      LHH was calculated as the ratio between the corresponding NNH and NNT. RESULTS: 
      For sonidegib (200 mg), the NNT for ORR at 18 months was 1.65 (95% CI 1.35-2.01) 
      whilst that for vismodegib (150 mg) at 21 months was 2.10 (95% CI 1.65-2.82). The 
      NNH related to treatment discontinuation due to AEs was 1.9 (95% CI 1.6-2.5) for 
      sonidegib and 1.8 (95% CI 1.4-2.2) for vismodegib. The LHH for sonidegib and 
      vismodegib related to treatment discontinuation due to AEs was 1.14 and 0.84, 
      respectively, whilst the LHH according to AEs of grade >/=3 was 1.41 for sonidegib 
      and 0.85 for vismodegib. CONCLUSIONS: Sonidegib showed a better benefit-risk 
      ratio compared to vismodegib, being more likely to achieve therapeutic response 
      than to AEs leading to discontinuation. These results should be confirmed in 
      clinical practice and/or in a direct comparison study.
CI  - Copyright (c) 2022 Garcia Ruiz AJ, Garcia-Agua Soler N, Herrera Acosta E, Zalaudek 
      I, Malvehy J.
FAU - Garcia Ruiz, Antonio J
AU  - Garcia Ruiz AJ
AD  - Pharmacology Department, University of Malaga, Institute of Biomedical Research 
      in Malaga (IBIMA), Malaga, Spain.
FAU - Garcia-Agua Soler, Nuria
AU  - Garcia-Agua Soler N
AD  - Pharmacology Department, University of Malaga, Institute of Biomedical Research 
      in Malaga (IBIMA), Malaga, Spain.
FAU - Herrera Acosta, Enrique
AU  - Herrera Acosta E
AD  - Dermatology Department, Hospital Virgen de la Victoria, Malaga, Spain.
FAU - Zalaudek, Iris
AU  - Zalaudek I
AD  - Dermatology Department, University of Trieste, Trieste, Italy.
FAU - Malvehy, Josep
AU  - Malvehy J
AD  - Dermatology Department, Hospital Clinic of Barcelona, Institut d'Investigacions 
      Biomediques August Pi I Sunyer (IDIBAPS), University of Barcelona, Barcelona, 
      Spain.
AD  - Centro de Investigacion Biomedica en Red (CIBER) on Rare Disease, Instituto de 
      Salud Carlos III, Madrid, Spain.
LA  - eng
PT  - Journal Article
DEP - 20220707
PL  - England
TA  - Drugs Context
JT  - Drugs in context
JID - 101262187
PMC - PMC9281973
OTO - NOTNLM
OT  - locally advanced basal cell carcinoma
OT  - sonidegib
OT  - vismodegib
COIS- Disclosure and potential conflicts of interest: IZ is Advisory Board and has 
      received speakers fees from Sun Pharma, Novartis, Roche, MSD, Sanofi Genzyme, 
      Philogen. JM has research and educational grants by Sun Pharma, Roche, MSD, 
      Novartis and BMS. The International Committee of Medical Journal Editors (ICMJE) 
      Potential Conflicts of Interests form for the authors is available for download 
      at: 
      https://www.drugsincontext.com/wp-content/uploads/2022/06/dic.2022-1-2-COI.pdf
EDAT- 2022/08/02 06:00
MHDA- 2022/08/02 06:01
PMCR- 2022/07/07
CRDT- 2022/08/01 03:54
PHST- 2022/01/21 00:00 [received]
PHST- 2022/05/27 00:00 [accepted]
PHST- 2022/08/02 06:00 [pubmed]
PHST- 2022/08/02 06:01 [medline]
PHST- 2022/08/01 03:54 [entrez]
PHST- 2022/07/07 00:00 [pmc-release]
AID - dic-2022-1-2 [pii]
AID - 10.7573/dic.2022-1-2 [doi]
PST - epublish
SO  - Drugs Context. 2022 Jul 7;11:2022-1-2. doi: 10.7573/dic.2022-1-2. eCollection 
      2022.