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Lessons learnt from scoring adjuvant colon cancer trials and meta-analyses using the ESMO-Magnitude of Clinical Benefit Scale V.1.1.

التفاصيل البيبلوغرافية
العنوان: Lessons learnt from scoring adjuvant colon cancer trials and meta-analyses using the ESMO-Magnitude of Clinical Benefit Scale V.1.1.
المؤلفون: Knapen DG; Medical Oncology, University Medical Centre Groningen, Groningen, Groningen, Netherlands., Cherny NI; Medical Oncology, Shaare Zedek Medical Center, Jerusalem, Jerusalem, Israel., Zygoura P; Statistics, Frontier Science Foundation-Hellas, Statistics, Athens, Zografou, Greece., Latino NJ; ESMO-MCBS Working Group, European Society for Medical Oncology, Viganello, Switzerland., Douillard JY; ESMO-MCBS Working Group, European Society for Medical Oncology, Viganello, Switzerland., Dafni U; Nursing, National and Kapodistrian University of Athens, Goudi-Athens, Greece; University of Athens, Athens, Greece., de Vries EGE; Medical Oncology, University Medical Centre Groningen, Groningen, Groningen, Netherlands., de Groot DJ; Medical Oncology, University Medical Centre Groningen, Groningen, Groningen, Netherlands. Electronic address: d.j.a.de.groot@umcg.nl.
المصدر: ESMO open [ESMO Open] 2020 Sep; Vol. 5 (5), pp. e000681.
نوع المنشور: Journal Article; Meta-Analysis
اللغة: English
بيانات الدورية: Publisher: Elsevier Country of Publication: England NLM ID: 101690685 Publication Model: Print Cited Medium: Internet ISSN: 2059-7029 (Electronic) Linking ISSN: 20597029 NLM ISO Abbreviation: ESMO Open Subsets: MEDLINE
أسماء مطبوعة: Publication: 2021 : [London] : Elsevier
Original Publication: London : BMJ, [2016]-
مواضيع طبية MeSH: Colonic Neoplasms*/drug therapy , Medical Oncology*, Fluorouracil/therapeutic use ; Humans ; Oxaliplatin ; United States ; United States Food and Drug Administration
مستخلص: Click here to listen to the Podcast BACKGROUND: Form 1 of the European Society for Medical Oncology-Magnitude of Clinical Benefit Scale (ESMO-MCBS) serves to grade therapies with curative intent. Hitherto only few trials with curative intent have been field tested using form 1. We aimed to evaluate the applicability of the scale and to assess the reasonableness of the generated scores in early colon cancer, in order to identify shortcomings that may be rectified in future amendments.
Methods: Adjuvant studies were identified in PubMed, Food and Drug Administration and European Medicines Agency registration sites, as well as ESMO and National Comprehensive Cancer Network guidelines. Studies meeting inclusion criteria were graded using form 1 of the ESMO-MCBS V.1.1 and field tested by ESMO Colorectal Cancer Faculty. Shortcomings of the scale were identified and evaluated.
Results: Eighteen of 57 trials and 7 out of 14 meta-analyses identified met criteria for ESMO-MCBS V.1.1 grading. In stage III colon cancer, randomised clinical trials and meta-analyses of modulated 5-fluorouracil (5-FU) based chemotherapy versus surgery scored ESMO-MCBS grade A and randomised controlled trials (RCTs) and meta-analyses comprising oxaliplatin added to this 5-FU backbone showed a more modest additional overall survival benefit (grade A and B). For stage II colon cancer, the findings are less consistent. The fluoropyrimidine trials in stage II were graded 'no evaluable benefit' but the most recent meta-analysis demonstrated a 5.4% survival advantage after 8 years follow-up (grade A). RCTs and a meta-analysis adding oxaliplatin demonstrated no added benefit. Exploratory toxicity evaluation and annotation was problematic given inconsistent toxicity reporting and limited results of late toxicity. Field testers (n=37) reviewed the scores, 25 confirmed their reasonableness, 12 found them mostly reasonable. Moreover, they identified the inability of crediting improved convenience in non-inferiority trials as a shortcoming.
Conclusion: Form 1 of the ESMO-MCBS V.1.1 provided very reasonable grading for adjuvant colon cancer studies.
Competing Interests: Competing interests: EGEdV reports Institutional Financial Support for her advisory role from Daiichi Sankyo, Merck, NSABP, Pfizer, Sanofi, Synthon and Institutional Financial Support for clinical trials or contracted research from Amgen, AstraZeneca, Bayer, Chugai Pharma, CytomX Therapeutics, G1 Therapeutics, Genentech, Nordic Nanovector, Radius Health, Regeneron, Roche, Synthon, all outside the submitted work.
(© Author (s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. Published by BMJ on behalf of the European Society for Medical Oncology.)
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فهرسة مساهمة: Keywords: ESMO-MCBS; adjuvant chemotherapy; early colon cancer; quality of life; toxicity
المشرفين على المادة: 04ZR38536J (Oxaliplatin)
U3P01618RT (Fluorouracil)
تواريخ الأحداث: Date Created: 20200907 Date Completed: 20210818 Latest Revision: 20240329
رمز التحديث: 20240329
مُعرف محوري في PubMed: PMC7476457
DOI: 10.1136/esmoopen-2020-000681
PMID: 32893188
قاعدة البيانات: MEDLINE
الوصف
تدمد:2059-7029
DOI:10.1136/esmoopen-2020-000681