ESMO-Magnitude of Clinical Benefit Scale version 1.1

被引：480

作者：

Cherny, N. I. ^{[1
]}

Dafni, U. ^{[2
,3
]}

Bogaerts, J. ^{[4
]}

Latino, N. J. ^{[5
]}

Pentheroudakis, G. ^{[6
]}

Douillard, J. -Y. ^{[5
]}

Tabernero, J. ^{[7
]}

Zielinski, C. ^{[8
]}

Piccart, M. J. ^{[9
]}

de Vries, E. G. E. ^{[10
]}

机构：

[1] Shaare Zedek Med Ctr, Dept Med Oncol, Canc Pain & Palliat Med Serv, Jerusalem, Israel

[2] Natl & Kapodistrian Univ Athens, Sch Hlth Sci, Lab Biostat, Athens, Greece

[3] Frontier Sci Fdn Hellas, Athens, Greece

[4] EORTC Headquarters, Methodol Direct, Brussels, Belgium

[5] ESMO Head Off, Lugano, Switzerland

[6] Ioannina Univ Hosp, Med Oncol Dept, Ioannina, Greece

[7] Vall Hebron Univ Hosp, Med Oncol Dept, Barcelona, Spain

[8] Med Univ Vienna, Div Oncol, Vienna, Austria

[9] Univ Libre Bruxelles, Jules Bordet Inst, Brussels, Belgium

[10] Univ Groningen, Univ Med Ctr Groningen, Dept Med Oncol, Groningen, Netherlands

来源：

ANNALS OF ONCOLOGY | 2017年 / 28卷 / 10期

关键词：

magnitude of clinical benefit scale; biostatistics; single arm studies; European Society for Medical Oncology; OLAPARIB MAINTENANCE THERAPY; CELL LUNG-CANCER; QUALITY-OF-LIFE; IPILIMUMAB PLUS DACARBAZINE; OPEN-LABEL; PHASE-III; NEOADJUVANT PERTUZUMAB; TRASTUZUMAB EMTANSINE; 1ST-LINE THERAPY; OVARIAN-CANCER;

D O I：

10.1093/annonc/mdx310

中图分类号：

R73 [肿瘤学];

学科分类号：

100214 ;

摘要：

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. Scoring remains very stable; revisions in v1.1 alter the scores of only 12 out of 118 comparative studies and facilitate scoring for single-arm studies.

引用

页码：2340 / 2366

页数：27

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