Schramm Amelie, Friedl Thomas W P, Schochter Fabienne, Scholz Christoph, de Gregorio Nikolaus, Huober Jens, Rack Brigitte, Trapp Elisabeth, Alunni-Fabbroni Marianna, Müller Volkmar, Schneeweiss Andreas, Pantel Klaus, Meier-Stiegen Franziska, Hartkopf Andreas, Taran Florin-Andrei, Wallwiener Diethelm, Janni Wolfgang, Fehm Tanja
Gynecology and Obstetrics, University Hospital Ulm, Prittwitzstraße 43, 89075, Ulm, Germany.
Gynecology and Obstetrics, Hospital of Ludwig-Maximilians-University, Munich, Germany.
Arch Gynecol Obstet. 2016 Feb;293(2):271-81. doi: 10.1007/s00404-015-3879-7. Epub 2015 Sep 9.
The aim of the ongoing DETECT study program is to evaluate therapeutic intervention based on phenotypes of circulating tumor cells (CTC) in patients with metastatic breast cancer (MBC). Currently (as of July 2015) more than half of the projected about 2000 patients with MBC have already been screened for CTC.
Women with HER2-negative primary tumor and presence of CTC are recruited into different DETECT trials according to the HER2-phenotype of CTC. Patients with HER2-positive CTC are randomized to treatment with physicians' choice therapy (standard chemo- or endocrine therapy) with or without additional HER2-targeted therapy with lapatinib in the DETECT III trial. In DETECT IVa, postmenopausal patients with hormone-receptor positive primary cancer and HER2-negative CTC receive everolimus and standard endocrine therapy. For women with HER2-negative CTC and triple negative MBC or hormone-receptor positive tumor and indication for chemotherapy, a treatment with eribulin is offered (DETECT IVb). The clinical efficacy is investigated by CTC-Clearance and progression-free survival (PFS). The DETECT V/CHEVENDO trial extends the DETECT study program for women with HER2-positive and hormone-receptor positive MBC. The primary objective of this trial is to compare safety and quality of life (QoL) as assessed by the occurrence of adverse events in patients treated with dual (trastuzumab plus pertuzumab) HER2-targeted therapy plus either endocrine or chemotherapy. The translational research projects of the DETECT study program focus on further molecular characterization of CTC and evaluation of markers for their suitability to predict treatment response and to facilitate the development of more personalized treatment options.
正在进行的DETECT研究项目旨在评估基于转移性乳腺癌（MBC）患者循环肿瘤细胞（CTC）表型的治疗干预措施。目前（截至2015年7月），预计约2000例MBC患者中已有超过一半接受了CTC筛查。
HER2阴性原发性肿瘤且存在CTC的女性患者，根据CTC的HER2表型被纳入不同的DETECT试验。HER2阳性CTC患者在DETECT III试验中被随机分配接受医生选择的治疗（标准化疗或内分泌治疗），联合或不联合拉帕替尼进行额外的HER2靶向治疗。在DETECT IVa中，激素受体阳性原发性癌症且HER2阴性CTC的绝经后患者接受依维莫司和标准化内分泌治疗。对于HER2阴性CTC且三阴性MBC或激素受体阳性肿瘤且有化疗指征的女性患者，提供艾日布林治疗（DETECT IVb）。通过CTC清除率和无进展生存期（PFS）来研究临床疗效。DETECT V/CHEVENDO试验将DETECT研究项目扩展至HER2阳性且激素受体阳性的MBC女性患者。该试验的主要目的是比较接受双重（曲妥珠单抗加帕妥珠单抗）HER2靶向治疗联合内分泌治疗或化疗的患者中不良事件发生情况所评估的安全性和生活质量（QoL）。DETECT研究项目的转化研究项目专注于CTC的进一步分子特征分析以及评估其预测治疗反应和促进开发更个性化治疗方案的适用性标志物。
