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 Charles University 3rd Faculty of Medicine and University Hospital Kralovske Vinohrady Prague Czech Republic

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 Internal Medicine University of Western Australia and Sir Charles Gairdner Hospital Nedlands WA Australia

Department of Medical Oncology and Hematology Princess Margaret Cancer Centre Toronto ON Canada

Department of Medical Oncology General University Hospital Gregorio Marañón and CIBERONC Madrid Spain

Department of Medical Oncology Hospital Clínic de Barcelona IDIBAPS Barcelona Spain

Department of Medical Oncology Laura and Isaac Perlmutter Cancer Center NYU Langone Health New York NY USA

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

Division of Cancer Services Gallipoli Medical Research Foundation University of Queensland Brisbane QLD Australia

Medical Oncology of Melanoma Sarcoma and Rare Tumors IEO European Institute of Oncology IRCCS Milan Italy

Melanoma Cancer Immunotherapy and Development Therapeutics Unit Istituto Nazionale Tumori IRCCS Fondazione Pascale Naples Italy

Melanoma Institute Australia The University of Sydney and Royal North Shore and Mater Hospitals Sydney NSW Australia

Melanoma Oncology Unit Veneto Institute of Oncology IOV IRCCS Padua Italy

Oncology Clinical Development Bristol Myers Squibb Princeton NJ USA

Oncology Unit University of Perugia Perugia Italy

Unit of Melanoma Medical Oncology Department of Medical Oncology and Hematology Fondazione IRCCS Istituto Nazionale dei Tumori Milan Italy

Citace poskytuje Crossref.org

Adjuvant Nivolumab versus Ipilimumab in Resected Stage III/IV Melanoma: 5-Year Efficacy and Biomarker Results from CheckMate 238

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ClinicalTrials.gov
NCT02388906