RT Journal Article
T1 Adjuvant nivolumab versus ipilimumab (CheckMate 238 trial): Reassessment of 4-year efficacy outcomes in patients with stage III melanoma per AJCC-8 staging criteria.
A1 Larkin, James
A1 Weber, Jeffrey
A1 Del Vecchio, Michele
A1 Gogas, Helen
A1 Arance, Ana M
A1 Dalle, Stephane
A1 Cowey, C Lance
A1 Schenker, Michael
A1 Grob, Jean-Jacques
A1 Chiarion-Sileni, Vanna
A1 Márquez-Rodas, Iván
A1 Butler, Marcus O
A1 Di Giacomo, Anna Marie
A1 Middleton, Mark R
A1 De la Cruz-Merino, Luis
A1 Arenberger, Petr
A1 Atkinson, Victoria
A1 Hill, Andrew
A1 Fecher, Leslie A
A1 Millward, Michael
A1 Khushalani, Nikhil I
A1 Queirolo, Paola
A1 Long, Georgina V
A1 Lobo, Maurice
A1 Askelson, Margarita
A1 Ascierto, Paolo A
A1 Mandalá, Mario
K1 AJCC-8 criteria
K1 Distant metastases
K1 Ipilimumab
K1 Melanoma adjuvant therapy
K1 Nivolumab
K1 Recurrence-free survival
K1 Stage 3
AB 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.
YR 2022
FD 2022-08-11
LK http://hdl.handle.net/10668/22177
UL http://hdl.handle.net/10668/22177
LA en
DS RISalud
RD Apr 10, 2025