dc.contributor.author | Larkin, J | |
dc.contributor.author | Weber, J | |
dc.contributor.author | Del Vecchio, M | |
dc.contributor.author | Gogas, H | |
dc.contributor.author | Arance, AM | |
dc.contributor.author | Dalle, S | |
dc.contributor.author | Cowey, CL | |
dc.contributor.author | Schenker, M | |
dc.contributor.author | Grob, J-J | |
dc.contributor.author | Chiarion-Sileni, V | |
dc.contributor.author | Márquez-Rodas, I | |
dc.contributor.author | Butler, MO | |
dc.contributor.author | Di Giacomo, AM | |
dc.contributor.author | Middleton, MR | |
dc.contributor.author | De la Cruz-Merino, L | |
dc.contributor.author | Arenberger, P | |
dc.contributor.author | Atkinson, V | |
dc.contributor.author | Hill, A | |
dc.contributor.author | Fecher, LA | |
dc.contributor.author | Millward, M | |
dc.contributor.author | Khushalani, NI | |
dc.contributor.author | Queirolo, P | |
dc.contributor.author | Long, GV | |
dc.contributor.author | Lobo, M | |
dc.contributor.author | Askelson, M | |
dc.contributor.author | Ascierto, PA | |
dc.contributor.author | Mandalá, M | |
dc.coverage.spatial | England | |
dc.date.accessioned | 2022-08-19T10:20:35Z | |
dc.date.available | 2022-08-19T10:20:35Z | |
dc.date.issued | 2022-08-11 | |
dc.identifier | S0959-8049(22)00392-6 | |
dc.identifier.citation | European Journal of Cancer, 2022, 173 pp. 285 - 296 | en_US |
dc.identifier.issn | 0959-8049 | |
dc.identifier.uri | https://repository.icr.ac.uk/handle/internal/5280 | |
dc.identifier.eissn | 1879-0852 | |
dc.identifier.eissn | 1879-0852 | |
dc.identifier.doi | 10.1016/j.ejca.2022.06.041 | |
dc.description.abstract | 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. | |
dc.format | Print-Electronic | |
dc.format.extent | 285 - 296 | |
dc.language | eng | |
dc.language.iso | eng | en_US |
dc.publisher | Elsevier BV | en_US |
dc.relation.ispartof | European Journal of Cancer | |
dc.rights.uri | http://creativecommons.org/licenses/by/4.0/ | en_US |
dc.subject | AJCC-8 criteria | |
dc.subject | Distant metastases | |
dc.subject | Ipilimumab | |
dc.subject | Melanoma adjuvant therapy | |
dc.subject | Nivolumab | |
dc.subject | Recurrence-free survival | |
dc.subject | Stage 3 | |
dc.title | Adjuvant nivolumab versus ipilimumab (CheckMate 238 trial): Reassessment of 4-year efficacy outcomes in patients with stage III melanoma per AJCC-8 staging criteria. | en_US |
dc.type | Journal Article | |
dcterms.dateAccepted | 2022-06-21 | |
dc.date.updated | 2022-08-19T10:19:25Z | |
rioxxterms.version | VoR | en_US |
rioxxterms.versionofrecord | 10.1016/j.ejca.2022.06.041 | en_US |
rioxxterms.licenseref.startdate | 2022-08-11 | |
rioxxterms.type | Journal Article/Review | en_US |
pubs.author-url | https://www.ncbi.nlm.nih.gov/pubmed/35964471 | |
pubs.organisational-group | /ICR | |
pubs.organisational-group | /ICR/Primary Group | |
pubs.organisational-group | /ICR/Primary Group/ICR Divisions | |
pubs.organisational-group | /ICR/Primary Group/ICR Divisions/Clinical Studies | |
pubs.organisational-group | /ICR/Primary Group/ICR Divisions/Clinical Studies/Melanoma and Kidney Cancer | |
pubs.organisational-group | /ICR/Primary Group/Royal Marsden Clinical Units | |
pubs.organisational-group | /ICR/Primary Group/ICR Divisions/Clinical Studies/Melanoma and Kidney Cancer/Melanoma and Kidney Cancer (hon.) | |
pubs.publication-status | Published online | |
pubs.volume | 173 | |
dc.contributor.icrauthor | Larkin, James | |
icr.provenance | Deposited by Mr Arek Surman (impersonating Prof James Larkin) on 2022-08-19. Deposit type is initial. No. of files: 1. Files: 1-s2.0-S0959804922003926-main.pdf | |