{"title":"The Growth Modulation Index (GMI) as an Efficacy Outcome in Cancer Clinical Trials: A Scoping Review with Suggested Reporting Guidelines.","authors":"Kilian Trin, Cynthia Dalleau, Simone Mathoulin-Pelissier, Christophe Le Tourneau, Derek Dinart, Carine Bellera","doi":"10.1007/s11912-025-01667-1","DOIUrl":null,"url":null,"abstract":"<p><strong>Purpose of review: </strong>The growth modulation index (GMI) is defined as the ratio between the time to progression of a new line of treatment and the previous line. This ratio can be used to determine whether the new line of treatment brings a clinical benefit. It has been proposed as an outcome in trials evaluating non-cytotoxic drugs. Its interest lies in the intra-patient comparison. The terminology employed to refer to the GMI, as well as its definitions, are highly variable in the literature. Some uses of the GMI are arbitrary and not based on any scientific rationale. Our aim is to describe how the GMI is reported in the scientific literature.</p><p><strong>Recent findings: </strong>We carried out a scoping review using PubMed, Scopus, Web of Science and BASE (Bielefeld Academic Search Engine). The algorithm was composed of the terms \"growth modulation index\", \"time to progression ratio\" and \"progression-free survival ratio\". Documents in English, with full-text available, published up to 2023, were included. Among 227 included documents, 166 of which discussed GMI specifically. On these 166 documents, 76 reported on observational studies, 62 on interventional studies and 17 on methodological or statistical developments pertaining to the GMI. All were about oncology. Our review highlights significant variability in the reporting and use of the GMI. To address this, we propose standardized reporting guidelines. Additionally, we emphasize the need for methodological and statistical developments to improve the use of the GMI and to develop novel GMI-based trial designs.</p>","PeriodicalId":10861,"journal":{"name":"Current Oncology Reports","volume":" ","pages":""},"PeriodicalIF":4.7000,"publicationDate":"2025-03-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Current Oncology Reports","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1007/s11912-025-01667-1","RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"ONCOLOGY","Score":null,"Total":0}
引用次数: 0
Abstract
Purpose of review: The growth modulation index (GMI) is defined as the ratio between the time to progression of a new line of treatment and the previous line. This ratio can be used to determine whether the new line of treatment brings a clinical benefit. It has been proposed as an outcome in trials evaluating non-cytotoxic drugs. Its interest lies in the intra-patient comparison. The terminology employed to refer to the GMI, as well as its definitions, are highly variable in the literature. Some uses of the GMI are arbitrary and not based on any scientific rationale. Our aim is to describe how the GMI is reported in the scientific literature.
Recent findings: We carried out a scoping review using PubMed, Scopus, Web of Science and BASE (Bielefeld Academic Search Engine). The algorithm was composed of the terms "growth modulation index", "time to progression ratio" and "progression-free survival ratio". Documents in English, with full-text available, published up to 2023, were included. Among 227 included documents, 166 of which discussed GMI specifically. On these 166 documents, 76 reported on observational studies, 62 on interventional studies and 17 on methodological or statistical developments pertaining to the GMI. All were about oncology. Our review highlights significant variability in the reporting and use of the GMI. To address this, we propose standardized reporting guidelines. Additionally, we emphasize the need for methodological and statistical developments to improve the use of the GMI and to develop novel GMI-based trial designs.
期刊介绍:
This journal aims to review the most important, recently published clinical findings in the field of oncology. By providing clear, insightful, balanced contributions by international experts, the journal intends to serve all those involved in the care of those affected by cancer.
We accomplish this aim by appointing international authorities to serve as Section Editors in key subject areas, such as cancer prevention, leukemia, melanoma, neuro-oncology, and palliative medicine. Section Editors, in turn, select topics for which leading experts contribute comprehensive review articles that emphasize new developments and recently published papers of major importance, highlighted by annotated reference lists. An international Editorial Board reviews the annual table of contents, suggests articles of special interest to their country/region, and ensures that topics are current and include emerging research. Commentaries from well-known figures in the field are also provided.