Real‐World nivolumab dosing patterns and safety outcomes in patients receiving adjuvant therapy for melanoma
Abstract 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 electroni...
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| Format: | Article |
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Wiley
2023-02-01
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| Series: | Cancer Medicine |
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| Online Access: | https://doi.org/10.1002/cam4.5061 |
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| author | Wolfram Samlowski Nicholas J. Robert Liwei Chen Brad Schenkel Catherine Davis Andriy Moshyk Srividya Kotapati Tayla Poretta Jeffrey S. Weber |
| author_facet | Wolfram Samlowski Nicholas J. Robert Liwei Chen Brad Schenkel Catherine Davis Andriy Moshyk Srividya Kotapati Tayla Poretta Jeffrey S. Weber |
| author_sort | Wolfram Samlowski |
| collection | DOAJ |
| description | Abstract 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. |
| format | Article |
| id | doaj-art-af40e545f9924238b22b08dd911e1b09 |
| institution | OA Journals |
| issn | 2045-7634 |
| language | English |
| publishDate | 2023-02-01 |
| publisher | Wiley |
| record_format | Article |
| series | Cancer Medicine |
| spelling | doaj-art-af40e545f9924238b22b08dd911e1b092025-08-20T02:23:32ZengWileyCancer Medicine2045-76342023-02-011232378238810.1002/cam4.5061Real‐World nivolumab dosing patterns and safety outcomes in patients receiving adjuvant therapy for melanomaWolfram Samlowski0Nicholas J. Robert1Liwei Chen2Brad Schenkel3Catherine Davis4Andriy Moshyk5Srividya Kotapati6Tayla Poretta7Jeffrey S. Weber8Comprehensive Cancer Centers of Nevada and University of Nevada Las Vegas Kirkorian School of Medicine Las Vegas Nevada USAMcKesson Life Sciences The Woodlands Texas USAMcKesson Life Sciences The Woodlands Texas USABristol Myers Squibb Princeton New Jersey USABristol Myers Squibb Princeton New Jersey USABristol Myers Squibb Princeton New Jersey USABristol Myers Squibb Princeton New Jersey USABristol Myers Squibb Princeton New Jersey USAPerlmutter Cancer Center NYU School of Medicine New York New York USAAbstract 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.https://doi.org/10.1002/cam4.5061adjuvant therapydosing intervalflat dosingmelanomanivolumabreal‐world |
| spellingShingle | Wolfram Samlowski Nicholas J. Robert Liwei Chen Brad Schenkel Catherine Davis Andriy Moshyk Srividya Kotapati Tayla Poretta Jeffrey S. Weber Real‐World nivolumab dosing patterns and safety outcomes in patients receiving adjuvant therapy for melanoma Cancer Medicine adjuvant therapy dosing interval flat dosing melanoma nivolumab real‐world |
| 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 | adjuvant therapy dosing interval flat dosing melanoma nivolumab real‐world |
| url | https://doi.org/10.1002/cam4.5061 |
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