TY - JOUR
TI - ESMO-Magnitude of Clinical Benefit Scale version 1.1
AU - Cherny, N.I.
AU - Dafni, U.
AU - Bogaerts, J.
AU - Latino, N.J.
AU - Pentheroudakis, G.
AU - Douillard, J.-Y.
AU - Tabernero, J.
AU - Zielinski, C.
AU - Piccart, M.J.
AU - de Vries, E.G.E.
JO - Annals of Oncology
PY - 2017
VL - 28
TODO - 10
SP - 2340-2366
PB - Oxford University Press
SN - 0923-7534, 1569-8041
TODO - 10.1093/annonc/mdx310
TODO - atezolizumab;  bevacizumab;  capecitabine;  carboplatin;  ceritinib;  crizotinib;  dacarbazine;  docetaxel;  everolimus;  fluorouracil;  folinic acid;  gemcitabine;  imiquimod;  ipilimumab;  irinotecan;  lapatinib;  nivolumab;  olaparib;  osimertinib;  paclitaxel;  pembrolizumab;  pertuzumab;  placebo;  ramucirumab;  trastuzumab;  trastuzumab emtansine, Article;  basal cell carcinoma;  brain cancer;  breast cancer;  clinical assessment tool;  colorectal cancer;  duration of response;  European Society for Medical Oncology Magnitude of Clinical Benefit Scale version 1.0;  European Society for Medical Oncology Magnitude of Clinical Benefit Scale version 1.1;  head and neck cancer;  Hodgkin disease;  human;  information processing;  lung cancer;  melanoma;  outcome assessment;  ovary cancer;  overall response rate;  overall survival;  pancreas cancer;  pathological complete remission;  practice guideline;  priority journal;  progression free survival;  quality of life assessment;  remission;  treatment response;  urogenital tract tumor;  biostatistics;  clinical trial (topic);  neoplasm;  oncology;  procedures;  randomized controlled trial (topic);  standards, Biostatistics;  Clinical Trials as Topic;  Humans;  Medical Oncology;  Neoplasms;  Outcome Assessment (Health Care);  Randomized Controlled Trials as Topic
TODO - Background: The ESMO Magnitude of Clinical Benefit Scale (ESMO-MCBS) version 1.0 (v1.0) was published in May 2015 and was the first version of a validated and reproducible tool to assess the magnitude of clinical benefit from new cancer therapies. The ESMO-MCBS was designed to be a dynamic tool with planned revisions and updates based upon recognition of expanding needs and shortcomings identified since the last review. Methods: The revision process for the ESMO-MCBS incorporates a nine-step process: Careful review of critiques and suggestions, and identification of problems in the application of v1.0; Identification of shortcomings for revision in the upcoming version; Proposal and evaluation of solutions to address identified shortcomings; Field testing of solutions; Preparation of a near-final revised version for peer review for reasonableness by members of the ESMO Faculty and Guidelines Committee; Amendments based on peer review for reasonableness; Near-final review by members of the ESMO-MCBS Working Group and the ESMO Executive Board; Final amendments; Final review and approval by members of the ESMO-MCBS Working Group and the ESMO Executive Board. Results: Twelve issues for revision or amendment were proposed for consideration; proposed amendments were formulated for eight identified shortcomings. The proposed amendments are classified as either structural, technical, immunotherapy triggered or nuanced. All amendments were field tested in a wide range of studies comparing scores generated with ESMO-MCBS v1.0 and version 1.1 (v1.1). Conclusions: ESMO-MCBS v1.1 incorporates 10 revisions and will allow for scoring of single-arm studies. © The Author 2017. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved.
ER -