| Autor: |
Alberto Hernando-Calvo, Abdulazeez Salawu, Rachel Y. Chen, Daniel V. Araujo, Marc Oliva, Zhihui Amy Liu, Lillian L. Siu |
| Rok vydání: |
2022 |
| Předmět: |
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| Zdroj: |
European journal of cancer (Oxford, England : 1990). 175 |
| ISSN: |
1879-0852 |
| Popis: |
Despite the increased number of novel immunotherapy (IO) agents under current development, their toxicity profile remains to be fully elucidated.An IO risk stratification model was developed based on 5 different variables: treatment-related deaths; rate of grade ≥3 treatment-related adverse events or treatment-emergent adverse events; grade ≥2 encephalopathy or central nervous system toxicity; grade ≥2 cytokine release syndrome; and the number and type of dose-limiting toxicity. Phase 1 IO trials published from January 2014 to December 2020 were reviewed and categorised based on our risk stratification model into three categories: low-, intermediate- and high-risk. Clinical trial variables were associated with the high-risk category. To review the quality of reporting across phase 1 IO trials, a subset of studies was further examined by the use of the ASCO/SITC Trial Reporting in Immuno-Oncology (TRIO) standards.Different IO compounds demonstrated diverse risk profiles. In multivariable analysis, combination versus IO single agent treatment, and testing IO agents different from anti-programmed death-1/programmed death ligand-1 (anti-PD1/L1), anti-cytotoxic t-lymphocyte antigen-4 (anti-CTLA4) antibodies and anti-cancer vaccines were associated with a higher toxicity risk. None of the studies examined in our dataset reported all the items included in the TRIO standards.Our results have important implications for future clinical trial design. Additionally, standards for reporting are urgently needed. |
| Databáze: |
OpenAIRE |
| Externí odkaz: |
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