Tumor grade and progesterone receptor status predict 21-gene recurrence score in early stage invasive breast carcinoma |
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Authors: | Jing Li Huang Scott Kizy Schelomo Marmor Ariella Altman Anne Blaes Heather Beckwith Todd M. Tuttle Jane Yuet Ching Hui |
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Affiliation: | 1.Sint Augustinus-University of Antwerp,Antwerp,Belgium;2.Semmelweis University,Budapest,Hungary;3.CHU Sart Tilman Liege and Liege University,Liege,Belgium;4.University Cancer & Blood Center, LLC,Athens,USA;5.Sarah Cannon Research Institute,London,UK;6.University College London Cancer Institute,London,UK;7.University of Alabama,Birmingham,USA;8.Center for Cancer and Blood Disorders,Bethesda,USA;9.University of Miami Miller School of Medicine,Miami,USA;10.Cooper Hospital University Medical Center,Camden,USA;11.Nemocnice Horovice, Onkologicke Oddelení,Horovice,Czech Republic;12.The John Hopkins University School of Medicine,Baltimore,USA;13.Michigan State University,East Lansing,USA;14.Greenville Hospital System,Greenville,USA;15.Metairie Oncologist LLC,Metairie,USA;16.Merck KGaA,Darmstadt,Germany;17.EMD Serono,Billerica,USA;18.Sarah Cannon Research Institute,Nashville,USA |
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Abstract: | PurposeAgents targeting programmed death receptor 1 (PD-1) or its ligand (PD-L1) have shown antitumor activity in the treatment of metastatic breast cancer (MBC). The aim of this study was to assess the activity of avelumab, a PD-L1 inhibitor, in patients with MBC.MethodsIn a phase 1 trial (JAVELIN Solid Tumor; NCT01772004), patients with MBC refractory to or progressing after standard-of-care therapy received avelumab intravenously 10 mg/kg every 2 weeks. Tumors were assessed every 6 weeks by RECIST v1.1. Adverse events (AEs) were graded by NCI-CTCAE v4.0. Membrane PD-L1 expression was assessed by immunohistochemistry (Dako PD-L1 IHC 73-10 pharmDx).ResultsA total of 168 patients with MBC, including 58 patients with triple-negative breast cancer (TNBC), were treated with avelumab for 2–50 weeks and followed for 6–15 months. Patients were heavily pretreated with a median of three prior therapies for metastatic or locally advanced disease. Grade ≥ 3 treatment-related AEs occurred in 13.7% of patients, including two treatment-related deaths. The confirmed objective response rate (ORR) was 3.0% overall (one complete response and four partial responses) and 5.2% in patients with TNBC. A trend toward a higher ORR was seen in patients with PD-L1+ versus PD-L1? tumor-associated immune cells in the overall population (16.7% vs. 1.6%) and in the TNBC subgroup (22.2% vs. 2.6%).ConclusionAvelumab showed an acceptable safety profile and clinical activity in a subset of patients with MBC. PD-L1 expression in tumor-associated immune cells may be associated with a higher probability of clinical response to avelumab in MBC. |
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