%0 Journal Article
%A Larkin, James
%A Weber, Jeffrey
%A Del Vecchio, Michele
%A Gogas, Helen
%A Arance, Ana M
%A Dalle, Stephane
%A Cowey, C Lance
%A Schenker, Michael
%A Grob, Jean-Jacques
%A Chiarion-Sileni, Vanna
%A Márquez-Rodas, Iván
%A Butler, Marcus O
%A Di Giacomo, Anna Marie
%A Middleton, Mark R
%A De la Cruz-Merino, Luis
%A Arenberger, Petr
%A Atkinson, Victoria
%A Hill, Andrew
%A Fecher, Leslie A
%A Millward, Michael
%A Khushalani, Nikhil I
%A Queirolo, Paola
%A Long, Georgina V
%A Lobo, Maurice
%A Askelson, Margarita
%A Ascierto, Paolo A
%A Mandalá, Mario
%T Adjuvant nivolumab versus ipilimumab (CheckMate 238 trial): Reassessment of 4-year efficacy outcomes in patients with stage III melanoma per AJCC-8 staging criteria.
%D 2022
%U http://hdl.handle.net/10668/22177
%X 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. 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. 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). 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.
%K AJCC-8 criteria
%K Distant metastases
%K Ipilimumab
%K Melanoma adjuvant therapy
%K Nivolumab
%K Recurrence-free survival
%K Stage 3
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