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Record W4291012346 · doi:10.1016/j.ejca.2022.06.041

Adjuvant nivolumab versus ipilimumab (CheckMate 238 trial): Reassessment of 4-year efficacy outcomes in patients with stage III melanoma per AJCC-8 staging criteria

2022· article· en· W4291012346 on OpenAlexaff
James Larkin, Jeffrey S. Weber, Michele Del Vecchio, Helen Gogas, Ana Arance, Stéphane Dalle, C. Lance Cowey, Michael Schenker, Jean‐Jacques Grob, Vanna Chiarion‐Sileni, Iván Márquez‐Rodas, Marcus O. Butler, Anna Marie Di Giacomo, Mark R. Middleton, Luis de la Cruz‐Merino, Petr Arenberger, Victoria Atkinson, Andrew Hill, Leslie A. Fecher, Michael Millward, Nikhil I. Khushalani, Paola Queirolo, Georgina V. Long, Maurice Lobo, Margarita Askelson, Paolo A. Ascierto, Mario Mandalà

Bibliographic record

VenueEuropean Journal of Cancer · 2022
Typearticle
Languageen
FieldMedicine
TopicCancer Immunotherapy and Biomarkers
Canadian institutionsPrincess Margaret Cancer Centre
FundersSandozMerck Sharp and DohmeEMD SeronoGenentechQbioticsSun PharmaAstellas PharmaEisaiDaiichi-SankyoBeiGeneRegeneron PharmaceuticalsMylanAstraZenecaAmarin CorporationOno PharmaceuticalEli Lilly and CompanyNational Comprehensive Cancer NetworkLes Laboratories Pierre FabreArray BioPharmaAbbVieDaiichi Sankyo EuropeBayerGilead SciencesSanofiCelgeneNovartisMerckGlaxoSmithKlineAmerican Society of Clinical OncologyBristol-Myers SquibbAmgenHexal AGIncytePfizerGilead UK and Ireland Corporate ContributionsCastle BiosciencesRocheAstellas Pharma US
KeywordsMedicineIpilimumabNivolumabMelanomaCancerInternal medicineHazard ratioOncologyStage (stratigraphy)AdjuvantImmunotherapyConfidence interval

Abstract

fetched live from OpenAlex

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.

Fetched live from OpenAlex and de-inverted. Abstracts are not stored in this database: the inverted indexes are 8.6 GB of the frame’s 9.3 GB of text, and the host has 13 GB free.

How this classification was reachedexpand

Full frame distilled prediction

Teacher imitation

Not calibrated prevalence, not ground truth. Human validation pending. Learned from the 10,348 direct Codex labels and 10,348 direct Gemma labels. Candidate is the union of thresholded teacher heads; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels or direct frontier model labels.

metaresearch head score (Codex)0.001
metaresearch head score (Gemma)0.000
Version: codex-gemma-dda1882f352aValidation status: machine_predicted_unvalidated
Candidate categoriesInsufficient payload (model declined to judge)
Consensus categoriesnone
DomainCandidate signal: none · Consensus signal: none
Study designCandidate signal: Randomized trial · Consensus signal: none
GenreCandidate signal: Empirical · Consensus signal: Empirical
Teacher disagreement score0.528
Threshold uncertainty score0.998

Codex and Gemma teacher scores by category

CategoryCodexGemma
Metaresearch0.0010.000
Meta-epidemiology (narrow)0.0000.000
Meta-epidemiology (broad)0.0010.000
Bibliometrics0.0000.000
Science and technology studies0.0000.000
Scholarly communication0.0000.000
Open science0.0000.000
Research integrity0.0000.000
Insufficient payload (model declined to judge)0.0020.000

Machine scores (provisional)

The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.

Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.

Opus teacher head0.021
GPT teacher head0.311
Teacher spread0.290 · how far apart the two teachers sit on this one work
Validation statusscore_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from it

Classification

machine, unvalidated

Machine predicted; a candidate call from one teacher head, not a consensus.

Study designRandomized trial
Domainnot available
GenreEmpirical

How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".

Quick stats

Citations32
Published2022
Admission routes1
Has abstractyes

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