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Real‐World nivolumab dosing patterns and safety outcomes in patients receiving adjuvant therapy for melanoma

BACKGROUND: Nivolumab at a dose of 480 mg every 4 weeks (Q4W) is approved for the adjuvant treatment of melanoma. However, real‐world data on this regimen are limited in this setting. METHODS: This retrospective observational study utilized data from the US Oncology Network iKnowMed electronic healt...

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Autores principales: Samlowski, Wolfram, Robert, Nicholas J., Chen, Liwei, Schenkel, Brad, Davis, Catherine, Moshyk, Andriy, Kotapati, Srividya, Poretta, Tayla, Weber, Jeffrey S.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: John Wiley and Sons Inc. 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9939122/
https://www.ncbi.nlm.nih.gov/pubmed/35880244
http://dx.doi.org/10.1002/cam4.5061
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author Samlowski, Wolfram
Robert, Nicholas J.
Chen, Liwei
Schenkel, Brad
Davis, Catherine
Moshyk, Andriy
Kotapati, Srividya
Poretta, Tayla
Weber, Jeffrey S.
author_facet Samlowski, Wolfram
Robert, Nicholas J.
Chen, Liwei
Schenkel, Brad
Davis, Catherine
Moshyk, Andriy
Kotapati, Srividya
Poretta, Tayla
Weber, Jeffrey S.
author_sort Samlowski, Wolfram
collection PubMed
description BACKGROUND: Nivolumab at a dose of 480 mg every 4 weeks (Q4W) is approved for the adjuvant treatment of melanoma. However, real‐world data on this regimen are limited in this setting. METHODS: This retrospective observational study utilized data from the US Oncology Network iKnowMed electronic health record database and patient medical charts. Eligible patients were diagnosed with melanoma and received adjuvant nivolumab monotherapy from March to August 2018. Patients were grouped by dosing regimen: cohort 1 (C1), de novo nivolumab 480 mg Q4W; cohort 2 (C2), switched to nivolumab 480 mg Q4W after nivolumab 240 mg or 3 mg/kg every 2 weeks (Q2W); cohort 3 (C3), de novo nivolumab 3 mg/kg Q2W; or cohort 4 (C4), de novo nivolumab 240 mg Q2W. Patients were followed for up to 12 months. Duration of therapy and safety/tolerability were assessed. RESULTS: One hundred ninety‐one patients were included (C1, n = 40; C2, n = 74; C3, n = 22; C4, n = 55). Duration of therapy was relatively consistent across cohorts (median, 10.3 months; range, 8.3–10.7). Likewise, proportions of patients experiencing treatment‐related adverse events (TRAEs) were similar (range, 54.5%–60.1%), as were the most common events (fatigue, rash, diarrhea, hypothyroidism, nausea, and pruritus). However, proportions experiencing ‘significant’ TRAEs varied between cohorts. Proportions discontinuing treatment were relatively consistent across cohorts. Propensity score matching and sensitivity analyses generally supported the unadjusted findings. CONCLUSIONS: Real‐world safety profiles of nivolumab 240 mg Q2W and 480 mg Q4W were similar, and both were comparable to the well‐documented safety of weight‐based dosing (3 mg/kg Q2W), further supporting their approval and use in the adjuvant setting for melanoma.
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spelling pubmed-99391222023-02-20 Real‐World nivolumab dosing patterns and safety outcomes in patients receiving adjuvant therapy for melanoma Samlowski, Wolfram Robert, Nicholas J. Chen, Liwei Schenkel, Brad Davis, Catherine Moshyk, Andriy Kotapati, Srividya Poretta, Tayla Weber, Jeffrey S. Cancer Med RESEARCH ARTICLES BACKGROUND: Nivolumab at a dose of 480 mg every 4 weeks (Q4W) is approved for the adjuvant treatment of melanoma. However, real‐world data on this regimen are limited in this setting. METHODS: This retrospective observational study utilized data from the US Oncology Network iKnowMed electronic health record database and patient medical charts. Eligible patients were diagnosed with melanoma and received adjuvant nivolumab monotherapy from March to August 2018. Patients were grouped by dosing regimen: cohort 1 (C1), de novo nivolumab 480 mg Q4W; cohort 2 (C2), switched to nivolumab 480 mg Q4W after nivolumab 240 mg or 3 mg/kg every 2 weeks (Q2W); cohort 3 (C3), de novo nivolumab 3 mg/kg Q2W; or cohort 4 (C4), de novo nivolumab 240 mg Q2W. Patients were followed for up to 12 months. Duration of therapy and safety/tolerability were assessed. RESULTS: One hundred ninety‐one patients were included (C1, n = 40; C2, n = 74; C3, n = 22; C4, n = 55). Duration of therapy was relatively consistent across cohorts (median, 10.3 months; range, 8.3–10.7). Likewise, proportions of patients experiencing treatment‐related adverse events (TRAEs) were similar (range, 54.5%–60.1%), as were the most common events (fatigue, rash, diarrhea, hypothyroidism, nausea, and pruritus). However, proportions experiencing ‘significant’ TRAEs varied between cohorts. Proportions discontinuing treatment were relatively consistent across cohorts. Propensity score matching and sensitivity analyses generally supported the unadjusted findings. CONCLUSIONS: Real‐world safety profiles of nivolumab 240 mg Q2W and 480 mg Q4W were similar, and both were comparable to the well‐documented safety of weight‐based dosing (3 mg/kg Q2W), further supporting their approval and use in the adjuvant setting for melanoma. John Wiley and Sons Inc. 2022-07-25 /pmc/articles/PMC9939122/ /pubmed/35880244 http://dx.doi.org/10.1002/cam4.5061 Text en © 2022 The Authors. Cancer Medicine published by John Wiley & Sons Ltd. https://creativecommons.org/licenses/by/4.0/This is an open access article under the terms of the http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited.
spellingShingle RESEARCH ARTICLES
Samlowski, Wolfram
Robert, Nicholas J.
Chen, Liwei
Schenkel, Brad
Davis, Catherine
Moshyk, Andriy
Kotapati, Srividya
Poretta, Tayla
Weber, Jeffrey S.
Real‐World nivolumab dosing patterns and safety outcomes in patients receiving adjuvant therapy for melanoma
title Real‐World nivolumab dosing patterns and safety outcomes in patients receiving adjuvant therapy for melanoma
title_full Real‐World nivolumab dosing patterns and safety outcomes in patients receiving adjuvant therapy for melanoma
title_fullStr Real‐World nivolumab dosing patterns and safety outcomes in patients receiving adjuvant therapy for melanoma
title_full_unstemmed Real‐World nivolumab dosing patterns and safety outcomes in patients receiving adjuvant therapy for melanoma
title_short Real‐World nivolumab dosing patterns and safety outcomes in patients receiving adjuvant therapy for melanoma
title_sort real‐world nivolumab dosing patterns and safety outcomes in patients receiving adjuvant therapy for melanoma
topic RESEARCH ARTICLES
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9939122/
https://www.ncbi.nlm.nih.gov/pubmed/35880244
http://dx.doi.org/10.1002/cam4.5061
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