Τίτλος:
ESMO-Magnitude of Clinical Benefit Scale version 1.1
Γλώσσες Τεκμηρίου:
Αγγλικά
Περίληψη:
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.
Συγγραφείς:
Cherny, N.I.
Dafni, U.
Bogaerts, J.
Latino, N.J.
Pentheroudakis, G.
Douillard, J.-Y.
Tabernero, J.
Zielinski, C.
Piccart, M.J.
de Vries, E.G.E.
Περιοδικό:
Annals of Oncology
Εκδότης:
Oxford University Press
Λέξεις-κλειδιά:
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
DOI:
10.1093/annonc/mdx310
