Trial reportEuropean journal of cancer (Oxford, England : 1990)2019
Prognostic and predictive value of AJCC-8 staging in the phase III EORTC1325/KEYNOTE-054 trial of pembrolizumab vs placebo in resected high-risk stage III melanoma.
Trial report in European journal of cancer (Oxford, England : 1990), 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 29 papers, 2 of them syntheses that pooled it.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
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Who cites it
29 citing papers in PubMed, 2 syntheses or guidelines pooled it, 84 citations in OpenAlex.
- Immune checkpoint inhibitors in adjuvant setting after radical resection of melanoma: a meta-analysis of the pivotal trials.Human vaccines & immunotherapeutics · 2022Pooled it
- Pooled it
- Longer Follow-Up Confirms Recurrence-Free Survival Benefit of Adjuvant Pembrolizumab in High-Risk Stage III Melanoma: Updated Results From the EORTC 1325-MG/KEYNOTE-054 Trial.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2020Trial
- Adjuvant Approaches in Fully Resected Stage III and IV Cutaneous Melanoma: Where Are We Now?Cancers · 2026Review
- Preoperative ultrasound before sentinel lymph node biopsy in melanoma in the era of neoadjuvant treatment: a systematic review and meta-analysis of diagnostic performance and cost analysis.EClinicalMedicine · 2026Article
- Anti-PD-1 matches interferon as adjuvant therapy for acral melanoma: a retrospective study.Therapeutic advances in medical oncology · 2026Article
- Adjuvant Use of Pembrolizumab for Stage III Melanoma in a Real-World Setting in Europe.Cancers · 2024Article
- Review
- Adjuvant Therapy for High-Risk Stage II Melanoma: Current Paradigms in Management and Future Directions.Cancers · 2024Review
- Molecular and Clinicopathological Biomarkers in the Neoadjuvant Treatment of Patients with Advanced Resectable Melanoma.Biomedicines · 2024Review
- Pembrolizumab Versus High-Dose Interferon-α2b as Adjuvant Therapy for Pediatric Melanoma: A Retrospective Study.Dermatology practical & conceptual · 2024Article
- Adjuvant Nivolumab versus Ipilimumab in Resected Stage III/IV Melanoma: 5-Year Efficacy and Biomarker Results from CheckMate 238.Clinical cancer research : an official journal of the American Association for Cancer Research · 2023Article
- Survival of patients with stage IIIC and IIID melanomas with nodal metastases in the light of new therapies.Postepy dermatologii i alergologii · 2022Article
- Prognostic nomograms for lung neuroendocrine carcinomas based on lymph node ratio: a SEER database analysis.The Journal of international medical research · 2022Article
- Neoadjuvant immune checkpoint inhibitors in high-risk stage III melanoma.Human vaccines & immunotherapeutics · 2022Review
- Clinical Significance of Distant Metastasis-Free Survival (DMFS) in Melanoma: A Narrative Review from Adjuvant Clinical Trials.Journal of clinical medicine · 2021Review
- Pembrolizumab in the adjuvant treatment of melanoma: efficacy and safety.Expert review of anticancer therapy · 2021Article
- Factors Influencing the Adjuvant Therapy Decision: Results of a Real-World Multicenter Data Analysis of 904 Melanoma Patients.Cancers · 2021Article
- Pathological response and survival with neoadjuvant therapy in melanoma: a pooled analysis from the International Neoadjuvant Melanoma Consortium (INMC).Nature medicine · 2021Article
- Reply to E. Hindié.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2020Article
Corrections and comments
- Commented on by
- Commented on byIs AJCC 82020
Authors and funding
32 authors at 20 institutions in 12 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundThe American Joint Committee on Cancer-8 (AJCC) classification of melanoma was implemented in January 2018. It was based on data gathered when checkpoint inhibitors were not used as adjuvant therapy in stage III melanoma. The European Organization for Research and Treatment of Cancer (EORTC) 1325/KEYNOTE-054 double-blind phase III trial evaluated pembrolizumab vs placebo in AJCC-7 stage IIIA (excluding lymph node metastasis ≤1 mm), IIIB or IIIC (without in-transit metastasis) patients after complete lymphadenectomy. PATIENTS, METHODS AND
resultsPatients (n = 1019) were randomised 1:1 to pembrolizumab 200 mg or placebo every 3 weeks (total of 18 doses, ∼1 year). At 1.25-year median follow-up, pembrolizumab prolonged relapse-free survival (RFS) in the total population (1-year RFS rate: 75.4% vs 61.0%; hazard ratio [HR] 0.57; logrank P < 0.0001) and consistently in the AJCC-7 subgroups. Prognostic and predictive values of AJCC-8 for RFS were evaluated in this study. Patient distribution according to the AJCC-8 stage subgroups was 8% (IIIA), 34.7% (IIIB), 49.7% (IIIC), 3.7% (IIID) and 3.8% (unknown). AJCC-8 classification was strongly associated with RFS (HRs for stage IIIB, IIIC and IIID vs IIIA were 4.0, 5.7 and 12.2, respectively) but showed no predictive importance for the treatment comparison regarding RFS (test for interaction: P = 0.68). The 1-year RFS rate for pembrolizumab vs placebo and the HRs (99% confidence interval) within each AJCC-8 subgroup were as follows: stage IIIA (92.7% vs 92.5%; 0.76 [0.11-5.43]), IIIB (79.0% vs 65.5%; 0.59 [0.35-0.99]), IIIC (73.6% vs 53.9%; 0.48 [0.33-0.70]) and IIID (50.0% vs 33.3%; 0.69 [0.24-2.00]).
conclusionsAJCC-8 staging had a strong prognostic importance for RFS but no predictive importance: the RFS benefit of pembrolizumab was observed across AJCC-8 subgroups in resected high-risk stage III melanoma patients.
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.