Van Baelen Karen, Van Cauwenberge Josephine, Maetens Marion, Beck Gabriela, Camden Ann, Chase Megan-Claire, Fraser Valerie, Freeney Siobhan, Hutcheson Laurie, Levine Julia K, Lien Tone, Terveer Rian, Turner Claire, Senkus Elzbieta, Jankowitz Rachel C, Vandecaveye Vincent, Floris Giuseppe, Neven Patrick, Wildiers Hans, Sawyer Elinor, Vincent-Salomon Anne, Derksen Patrick W B, Desmedt Christine
Laboratory for Translational Breast Cancer Research, Department of Oncology, KU Leuven, Leuven, Belgium.
Department of Gynecological Oncology, University Hospitals Leuven, Leuven, Belgium.
NPJ Breast Cancer. 2024 Mar 20;10(1):23. doi: 10.1038/s41523-024-00627-5.
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.
浸润性小叶乳腺癌(ILC)在许多方面与非特殊类型的浸润性乳腺癌不同。然而,关于ILC治疗效果的证据却很缺乏。我们研究了在新型乳腺癌治疗的III/IV期临床试验中ILC的记录程度和代表性。通过在PubMed和ClinicalTrials.gov上检索试验。对纳入/排除标准进行审查,以了解组织学亚型和肿瘤可测量性方面的要求。评估ILC的记录情况,并评估ILC的纳入率、中心病理学和亚组分析。在93篇手稿中有39篇发现了关于肿瘤可测量性的纳入限制。93篇手稿中有13篇记录了ILC的纳入率,其范围在2.0%至26.0%之间。没有报告ILC的中心病理学情况,13篇手稿中有3篇进行了ILC亚组分析。在大多数试验中,ILC在很大程度上被忽视,其代表性和记录情况较差。目前使用RECIST v1.1的纳入标准在识别ILC独特的不可测量转移浸润方面存在不足。
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