Karen Van Baelen, Josephine Van Cauwenberge, Marion Maetens, Gabriela Beck, Ann Camden, Megan-Claire Chase, Valerie Fraser, Siobhan Freeney, Laurie Hutcheson, Julia K Levine, Tone Lien, Rian Terveer, Claire Turner, Elzbieta Senkus, Rachel C Jankowitz, Vincent Vandecaveye, Giuseppe Floris, Patrick Neven, Hans Wildiers, Elinor Sawyer, Anne Vincent-Salomon, Patrick W B Derksen, Christine Desmedt
{"title":"临床试验中关于浸润性小叶乳腺癌的报告：系统综述。","authors":"Karen Van Baelen, Josephine Van Cauwenberge, Marion Maetens, Gabriela Beck, Ann Camden, Megan-Claire Chase, Valerie Fraser, Siobhan Freeney, Laurie Hutcheson, Julia K Levine, Tone Lien, Rian Terveer, Claire Turner, Elzbieta Senkus, Rachel C Jankowitz, Vincent Vandecaveye, Giuseppe Floris, Patrick Neven, Hans Wildiers, Elinor Sawyer, Anne Vincent-Salomon, Patrick W B Derksen, Christine Desmedt","doi":"10.1038/s41523-024-00627-5","DOIUrl":null,"url":null,"abstract":"<p><p>Invasive lobular breast cancer (ILC) differs from invasive breast cancer of no special type in many ways. Evidence on treatment efficacy for ILC is, however, lacking. We studied the degree of documentation and representation of ILC in phase III/IV clinical trials for novel breast cancer treatments. Trials were identified on Pubmed and clinicaltrials.gov. Inclusion/exclusion criteria were reviewed for requirements on histological subtype and tumor measurability. Documentation of ILC was assessed and ILC inclusion rate, central pathology and subgroup analyses were evaluated. Inclusion restrictions concerning tumor measurability were found in 39/93 manuscripts. Inclusion rates for ILC were documented in 13/93 manuscripts and varied between 2.0 and 26.0%. No central pathology for ILC was reported and 3/13 manuscripts had ILC sub-analyses. ILC is largely disregarded in most trials with poor representation and documentation. The current inclusion criteria using RECIST v1.1, fall short in recognizing the unique non-measurable metastatic infiltration of ILC.</p>","PeriodicalId":19247,"journal":{"name":"NPJ Breast Cancer","volume":"10 1","pages":"23"},"PeriodicalIF":6.5000,"publicationDate":"2024-03-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10954721/pdf/","citationCount":"0","resultStr":"{\"title\":\"Reporting on invasive lobular breast cancer in clinical trials: a systematic review.\",\"authors\":\"Karen Van Baelen, Josephine Van Cauwenberge, Marion Maetens, Gabriela Beck, Ann Camden, Megan-Claire Chase, Valerie Fraser, Siobhan Freeney, Laurie Hutcheson, Julia K Levine, Tone Lien, Rian Terveer, Claire Turner, Elzbieta Senkus, Rachel C Jankowitz, Vincent Vandecaveye, Giuseppe Floris, Patrick Neven, Hans Wildiers, Elinor Sawyer, Anne Vincent-Salomon, Patrick W B Derksen, Christine Desmedt\",\"doi\":\"10.1038/s41523-024-00627-5\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><p>Invasive lobular breast cancer (ILC) differs from invasive breast cancer of no special type in many ways. Evidence on treatment efficacy for ILC is, however, lacking. We studied the degree of documentation and representation of ILC in phase III/IV clinical trials for novel breast cancer treatments. Trials were identified on Pubmed and clinicaltrials.gov. Inclusion/exclusion criteria were reviewed for requirements on histological subtype and tumor measurability. Documentation of ILC was assessed and ILC inclusion rate, central pathology and subgroup analyses were evaluated. Inclusion restrictions concerning tumor measurability were found in 39/93 manuscripts. Inclusion rates for ILC were documented in 13/93 manuscripts and varied between 2.0 and 26.0%. No central pathology for ILC was reported and 3/13 manuscripts had ILC sub-analyses. ILC is largely disregarded in most trials with poor representation and documentation. The current inclusion criteria using RECIST v1.1, fall short in recognizing the unique non-measurable metastatic infiltration of ILC.</p>\",\"PeriodicalId\":19247,\"journal\":{\"name\":\"NPJ Breast Cancer\",\"volume\":\"10 1\",\"pages\":\"23\"},\"PeriodicalIF\":6.5000,\"publicationDate\":\"2024-03-20\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10954721/pdf/\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"NPJ Breast Cancer\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1038/s41523-024-00627-5\",\"RegionNum\":2,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q1\",\"JCRName\":\"ONCOLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"NPJ Breast Cancer","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1038/s41523-024-00627-5","RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"ONCOLOGY","Score":null,"Total":0}
Reporting on invasive lobular breast cancer in clinical trials: a systematic review.
Invasive lobular breast cancer (ILC) differs from invasive breast cancer of no special type in many ways. Evidence on treatment efficacy for ILC is, however, lacking. We studied the degree of documentation and representation of ILC in phase III/IV clinical trials for novel breast cancer treatments. Trials were identified on Pubmed and clinicaltrials.gov. Inclusion/exclusion criteria were reviewed for requirements on histological subtype and tumor measurability. Documentation of ILC was assessed and ILC inclusion rate, central pathology and subgroup analyses were evaluated. Inclusion restrictions concerning tumor measurability were found in 39/93 manuscripts. Inclusion rates for ILC were documented in 13/93 manuscripts and varied between 2.0 and 26.0%. No central pathology for ILC was reported and 3/13 manuscripts had ILC sub-analyses. ILC is largely disregarded in most trials with poor representation and documentation. The current inclusion criteria using RECIST v1.1, fall short in recognizing the unique non-measurable metastatic infiltration of ILC.
期刊介绍：
npj Breast Cancer publishes original research articles, reviews, brief correspondence, meeting reports, editorial summaries and hypothesis generating observations which could be unexplained or preliminary findings from experiments, novel ideas, or the framing of new questions that need to be solved. Featured topics of the journal include imaging, immunotherapy, molecular classification of disease, mechanism-based therapies largely targeting signal transduction pathways, carcinogenesis including hereditary susceptibility and molecular epidemiology, survivorship issues including long-term toxicities of treatment and secondary neoplasm occurrence, the biophysics of cancer, mechanisms of metastasis and their perturbation, and studies of the tumor microenvironment.
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