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While the therapeutic landscape of breast cancer has been expanding, we lack knowledge about the potential differential efficacy of most drugs according to the body mass index (BMI). Here, we conducted a systematic review on recent clinical drug trials to document the dosing regimen of recent drugs, the reporting of BMI and the possible exclusion of patients according to BMI, other adiposity measurements and\/or diabetes (leading comorbidity of obesity). We further explored whether treatment efficacy was evaluated according to BMI.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>A search of Pubmed and ClinicalTrials.gov was performed to identify phase I-IV trials investigating novel systemic breast cancer treatments. Dosing regimens and exclusion based on BMI, adiposity measurements or diabetes, documentation of BMI and subgroup analyses according to BMI were assessed.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>495 trials evaluating 26 different drugs were included. Most of the drugs (21\/26, 81%)\u00a0were given in a fixed dose independent of patient weight. BMI was an exclusion criterion in 3 out of 495 trials. Patients with diabetes, the leading comorbidity of obesity, were excluded in 67\/495 trials (13.5%). Distribution of patients according to BMI was mentioned in 8% of the manuscripts, subgroup analysis was performed in 2 trials. No other measures of adiposity\/body composition were mentioned in any of the trials. Retrospective analyses on the impact of BMI were performed in 6 trials.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>Patient adiposity is hardly considered as most novel drug treatments are given in a fixed dose. BMI is generally not reported in recent trials and few secondary analyses are performed. Given the prevalence of patients with obesity and the impact obesity can have on pharmacokinetics and cancer biology, more attention should be given by investigators and study sponsors to reporting patient\u2019s BMI and evaluating its impact on treatment efficacy and toxicity.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1186\/s13058-024-01832-7","type":"journal-article","created":{"date-parts":[[2024,5,22]],"date-time":"2024-05-22T09:02:11Z","timestamp":1716368531000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":15,"title":["Reporting on patient\u2019s body mass index (BMI) in recent clinical trials for patients with breast cancer: a systematic review"],"prefix":"10.1186","volume":"26","author":[{"given":"Josephine","family":"Van Cauwenberge","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Karen","family":"Van Baelen","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Marion","family":"Maetens","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tatjana","family":"Geukens","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ha Linh","family":"Nguyen","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ines","family":"Nevelsteen","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ann","family":"Smeets","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Anne","family":"Deblander","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Patrick","family":"Neven","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Stijn","family":"Koolen","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hans","family":"Wildiers","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kevin","family":"Punie","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5223-5579","authenticated-orcid":false,"given":"Christine","family":"Desmedt","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2024,5,22]]},"reference":[{"key":"1832_CR1","unstructured":"World health statistics 2022: monitoring health for the SDGs, sustainable development goals. 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KP: research grants paid to institution: MSD and Sanofi, speaker fees and honoraria for consultancy and advisory board functions: Astra Zeneca, Eli Lilly, Exact Sciences, Focus Patient, Gilead, MSD, Novartis, Pfizer, Roche, Seagen, speaker fees and honoraria for consultancy and advisory board functions paid to institution: Astra Zeneca, Eli Lilly, Exact Sciences, Gilead, MSD, Novartis, Pfizer, Roche, Seagen, stock options: Need Inc, travel grants: Astra Zeneca, Novartis, Pfizer, PharmaMar, Roche. HW: his institution received financial compensation on his behalf for advisory boards, lecture fees and\/or consultancy fees from Immutep Pty, MSD, Astrazenca, Daiichi, AbbVie, Lilly, Roche, EISAI, Pfizer, Sirtex, Gilead. He received travel support from Pfizer and Roche.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests"}}],"article-number":"81"}}