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Adjuvant nivolumab versus ipilimumab (CheckMate 238 trial): Reassessment of 4-year efficacy outcomes in patients with stage III melanoma per AJCC-8 staging criteria
J. Larkin, J. Weber, M. Del Vecchio, H. Gogas, AM. Arance, S. Dalle, CL. Cowey, M. Schenker, JJ. Grob, V. Chiarion-Sileni, I. Márquez-Rodas, MO. Butler, AM. Di Giacomo, MR. Middleton, L. De la Cruz-Merino, P. Arenberger, V. Atkinson, A. Hill, LA....
Jazyk angličtina Země Anglie, Velká Británie
Typ dokumentu časopisecké články, randomizované kontrolované studie
- MeSH
- adjuvancia imunologická škodlivé účinky MeSH
- ipilimumab škodlivé účinky MeSH
- lidé MeSH
- melanom * farmakoterapie chirurgie MeSH
- nádory kůže * farmakoterapie chirurgie MeSH
- nivolumab škodlivé účinky MeSH
- staging nádorů MeSH
- Check Tag
- lidé MeSH
- Publikační typ
- časopisecké články MeSH
- randomizované kontrolované studie MeSH
PURPOSE: Nivolumab was approved as adjuvant therapy for melanoma based on data from CheckMate 238, which enrolled patients per American Joint Committee on Cancer version 7 (AJCC-7) criteria. Here, we analyse long-term outcomes per AJCC-8 staging criteria compared with AJCC-7 results to inform clinical decisions for patients diagnosed per AJCC-8. PATIENTS AND METHODS: In a double-blind, phase 3 trial (NCT02388906), patients aged ≥15 years with resected, histologically confirmed AJCC-7 stage IIIB, IIIC, or IV melanoma were randomised to receive nivolumab 3 mg/kg every 2 weeks or ipilimumab 10 mg/kg every 3 weeks for 4 doses and then every 12 weeks, both intravenously ≤1 year. Recurrence-free survival (RFS) and distant metastasis-free survival (DMFS) were assessed in patients with stage III disease, per AJCC-7 and AJCC-8. RESULTS: Per AJCC-7 staging, 42.4% and 57.3% of patients were in substage IIIB and IIIC, respectively; per AJCC-8, 1.1%, 30.4%, 62.8%, and 5.0% were in IIIA, IIIB, IIIC, and IIID. After 4 years' minimum follow-up, the AJCC-7 superior efficacy of nivolumab over ipilimumab in patients with resected stage III melanoma was preserved per AJCC-8 analysis. No statistically significant difference in RFS between stage III substage hazard ratios was observed per AJCC-7 or -8 staging criteria (interaction test: AJCC-7, P = 0.8115; AJCC-8, P = 0.1051; P = 0.8392 ((AJCC-7) and P = 0.8678 (AJCC-8) for DMFS). CONCLUSIONS: CheckMate 238 4-year RFS and DMFS outcomes are consistent per AJCC-7 and AJCC-8 staging criteria. Outcome benefits can therefore be translated for patients diagnosed per AJCC-8.
Center for Immuno Oncology University Hospital of Siena Siena Italy
Department of Clinical Oncology Hospital University Virgen Macarena Seville Spain
Department of Cutaneous Oncology H Lee Moffitt Cancer Center Tampa FL USA
Department of Dermatology Aix Marseille University Hôpital de La Timone Marseille France
Department of Dermatology Hospices Civils de Lyon Pierre Bénite France
Department of Internal Medicine National and Kapodistrian University of Athens Athens Greece
Department of Internal Medicine University of Michigan Rogel Cancer Center Ann Arbor MI USA
Department of Medical Oncology and Hematology Princess Margaret Cancer Centre Toronto ON Canada
Department of Medical Oncology Hospital Clínic de Barcelona IDIBAPS Barcelona Spain
Department of Medical Oncology Oncology Center Sf Nectarie Craiova Romania
Department of Medical Oncology Tasman Health Care Southport QLD Australia
Department of Medical Oncology Texas Oncology Baylor Charles A Sammons Cancer Center Dallas TX USA
Department of Medical Oncology The Royal Marsden NHS Foundation Trust London UK
Department of Oncology Churchill Hospital Oxford UK
Melanoma Oncology Unit Veneto Institute of Oncology IOV IRCCS Padua Italy
Oncology Clinical Development Bristol Myers Squibb Princeton NJ USA
Citace poskytuje Crossref.org
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- $a Larkin, James $u Department of Medical Oncology, The Royal Marsden NHS Foundation Trust, London, UK. Electronic address: James.Larkin@rmh.nhs.uk
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- $a Adjuvant nivolumab versus ipilimumab (CheckMate 238 trial): Reassessment of 4-year efficacy outcomes in patients with stage III melanoma per AJCC-8 staging criteria / $c J. Larkin, J. Weber, M. Del Vecchio, H. Gogas, AM. Arance, S. Dalle, CL. Cowey, M. Schenker, JJ. Grob, V. Chiarion-Sileni, I. Márquez-Rodas, MO. Butler, AM. Di Giacomo, MR. Middleton, L. De la Cruz-Merino, P. Arenberger, V. Atkinson, A. Hill, LA. Fecher, M. Millward, NI. Khushalani, P. Queirolo, GV. Long, M. Lobo, M. Askelson, PA. Ascierto, M. Mandalá
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- $a PURPOSE: Nivolumab was approved as adjuvant therapy for melanoma based on data from CheckMate 238, which enrolled patients per American Joint Committee on Cancer version 7 (AJCC-7) criteria. Here, we analyse long-term outcomes per AJCC-8 staging criteria compared with AJCC-7 results to inform clinical decisions for patients diagnosed per AJCC-8. PATIENTS AND METHODS: In a double-blind, phase 3 trial (NCT02388906), patients aged ≥15 years with resected, histologically confirmed AJCC-7 stage IIIB, IIIC, or IV melanoma were randomised to receive nivolumab 3 mg/kg every 2 weeks or ipilimumab 10 mg/kg every 3 weeks for 4 doses and then every 12 weeks, both intravenously ≤1 year. Recurrence-free survival (RFS) and distant metastasis-free survival (DMFS) were assessed in patients with stage III disease, per AJCC-7 and AJCC-8. RESULTS: Per AJCC-7 staging, 42.4% and 57.3% of patients were in substage IIIB and IIIC, respectively; per AJCC-8, 1.1%, 30.4%, 62.8%, and 5.0% were in IIIA, IIIB, IIIC, and IIID. After 4 years' minimum follow-up, the AJCC-7 superior efficacy of nivolumab over ipilimumab in patients with resected stage III melanoma was preserved per AJCC-8 analysis. No statistically significant difference in RFS between stage III substage hazard ratios was observed per AJCC-7 or -8 staging criteria (interaction test: AJCC-7, P = 0.8115; AJCC-8, P = 0.1051; P = 0.8392 ((AJCC-7) and P = 0.8678 (AJCC-8) for DMFS). CONCLUSIONS: CheckMate 238 4-year RFS and DMFS outcomes are consistent per AJCC-7 and AJCC-8 staging criteria. Outcome benefits can therefore be translated for patients diagnosed per AJCC-8.
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