TY - JOUR
TI - A standardised, generic, validated approach to stratify the magnitude of clinical benefit that can be anticipated from anti-cancer therapies: The European Society for Medical Oncology Magnitude of Clinical Benefit Scale (ESMO-MCBS)
AU - Cherny, N.I.
AU - Sullivan, R.
AU - Dafni, U.
AU - Kerst, J.M.
AU - Sobrero, A.
AU - Zielinski, C.
AU - de Vries, E.G.E.
AU - Piccart, M.J.
JO - Annals of Oncology
PY - 2015
VL - 26
TODO - 8
SP - 1547-1573
PB - Oxford University Press
SN - 0923-7534, 1569-8041
TODO - 10.1093/annonc/mdv249
TODO - abiraterone;  afatinib;  bevacizumab;  cabazitaxel;  capecitabine;  carboplatin;  cetuximab;  cisplatin;  crizotinib;  docetaxel;  doxorubicin;  enzalutamide;  eribulin;  erlotinib;  everolimus;  exemestane;  gefitinib;  gemcitabine;  lapatinib;  mitoxantrone;  paclitaxel;  pemetrexed;  pertuzumab;  placebo;  platinum derivative;  prednisone;  regorafenib;  tipiracil plus trifluridine;  trastuzumab;  unindexed drug, anemia;  Article;  breast cancer;  cancer research;  cancer therapy;  clinical assessment tool;  clinical decision making;  clinical trial (topic);  colorectal cancer;  cost benefit analysis;  cost effectiveness analysis;  drug fatality;  esophagus cancer;  European Society for Medical Oncology Magnitude of Clinical Benefit Scale;  health care delivery;  health care organization;  health care policy;  human;  kidney carcinoma;  long term survival;  lung cancer;  neutropenia;  ovary cancer;  overall survival;  pancreas cancer;  phase 2 clinical trial (topic);  phase 3 clinical trial (topic);  practice guideline;  priority journal;  progression free survival;  prostate cancer;  quality of life;  randomized controlled trial (topic);  reproducibility;  sarcoma;  standardization;  stomach cancer;  thrombocytopenia;  treatment response;  unspecified side effect;  validation study;  advisory committee;  cost benefit analysis;  Europe;  medical society;  Neoplasms;  outcome assessment;  procedures;  treatment outcome, Advisory Committees;  Cost-Benefit Analysis;  Europe;  Humans;  Neoplasms;  Outcome Assessment (Health Care);  Societies, Medical;  Treatment Outcome
TODO - The value of any new therapeutic strategy or treatment is determined by the magnitude of its clinical benefit balanced against its cost. Evidence for clinical benefit from new treatment options is derived from clinical research, in particular phase III randomised trials, which generate unbiased data regarding the efficacy, benefit and safety of new therapeutic approaches. To date, there is no standard tool for grading the magnitude of clinical benefit of cancer therapies, which may range from trivial (median progression-free survival advantage of only a few weeks) to substantial (improved longterm survival). Indeed, in the absence of a standardised approach for grading the magnitude of clinical benefit, conclusions and recommendations derived from studies are often hotly disputed and very modest incremental advances have often been presented, discussed and promoted as major advances or 'breakthroughs'. Recognising the importance of presenting clear and unbiased statements regarding the magnitude of the clinical benefit from new therapeutic approaches derived from high-quality clinical trials, the European Society for Medical Oncology (ESMO) has developed a validated and reproducible tool to assess the magnitude of clinical benefit for cancer medicines, the ESMO Magnitude of Clinical Benefit Scale (ESMO-MCBS). This tool uses a rational, structured and consistent approach to derive a relative ranking of the magnitude of clinically meaningful benefit that can be expected from a new anti-cancer treatment. The ESMO-MCBS is an important first step to the critical public policy issue of value in cancer care, helping to frame the appropriate use of limited public and personal resources to deliver cost-effective and affordable cancer care. The ESMO-MCBS will be a dynamic tool and its criteria will be revised on a regular basis. © The Author 2015. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved.
ER -