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1387 Breast Implant Associated-Anaplastic Large-Cell Lymphoma (BIA-ALCL): Data Based on the Lymphoma Study Association (LYSA) Registry. Promising Results of Brentuximab Vedotin Combined with Cyclophosphamide, Doxorubicin and Prednisone (BV-CHP) As First Line Treatment for Patient Requiring Chemotherapy

Program: Oral and Poster Abstracts
Session: 624. Hodgkin Lymphomas and T/NK cell Lymphomas: Clinical and Epidemiological: Poster I
Hematology Disease Topics & Pathways:
Clinical Research, Clinically Relevant, Real World Evidence
Saturday, December 11, 2021, 5:30 PM-7:30 PM

Fabien Le Bras1*, Jean Marc Schiano De Colella2,3*, Lucie Oberic, MD4*, Emmanuel Itti, MD, PhD5*, Thua-Ha Dao, MD6*, Camille Laurent, MD, PhD7*, Luc Xerri, MD, PhD8*, Emmanuel Bachy, MD, PhD9,10*, Alexandra Traverse-Glehen, MD, PhD11*, Christophe Bonnet, MD, PhD12*, Marc André, MD13*, Luc Mathieu Fornecker, MD, PhD14,15*, Marie Bannier, MD16*, Bohrane Slama, MD17*, Youlia Kirova, MD18*, Emmanuelle Nicolas-Virelizier, MD19*, Manon Croix20*, Patrick Fogarty20*, Nadia Amara21*, Virginie Fataccioli, PhD22*, Romain Ricci23*, Hervé Tilly, MD24, Lionel Tortolano, PD25,26*, Romain Bosc, MD, PHD27*, Philippe Gaulard, MD, PhD28* and Corinne Haioun, MD29

1Lymphoid Malignancies, Henri Mondor Hospital, Créteil, France
2Institut Paoli-Calmettes, Cancer Institute, Marseille, France
3Laboratoire d'immunologie des tumeurs, Université de la Méditerranée, Marseille, France
4Department of Hematology, Institut Universitaire Cancerologie Toulouse-Oncopole, Toulouse, France
5Nuclear Medicine, Henri Mondor Hospital, Créteil, France
6Radiology, Hôpital Henri Mondor, Créteil, France
7Pathology Department, Institut Universitaire Cancerologie Toulouse-Oncopole, Toulouse, France
8Bio-Pathology Department, Institute Paoli-Calmettes, Marseille, France
9Department of Hematology, Lyon Sud Hospital, Lyon, France
10Hospices Civils De Lyon and Université Claude Bernard, Pierre-Bénite, France
11Pathology, Centre Hospitalier Lyon-Sud, Pierre-Bénite, France
12Clinical Hematology, Centre Hospitalier Universitaire, University of Liège, Liège, Belgium
13Department of Hematology, CHU UCL Namur, Yvoir, Belgium
14Department of Hematology, Strasbourg University Hospital, Strasbourg, France
15UMR-S1113 - IRFAC, INSERM, Faculté de Médecine, STRASBOURG, France
16Oncologc surgery, Institut Paoli-Calmettes, Marseille, France
17Medical oncology and Clinical hematology, Centre Hospitalier d'avignon, Avignon, France
18Radiotherapy Department, Curie Institute, Paris, France
19Service d'Hématologie, Centre Léon Bérard, Lyon, France
20Centre hospitalier Lyon sud, secteur sainte Eugénie, pavillon 6E, LYSARC, The Lymphoma Academic Research Organisation, Pierre-Bénite, France
21IUCT Toulouse Oncopole, Toulouse, France
22INSERMU955 équipe 9, Institut Mondor de Recherche Biomédicale, Créteil, France
23LYSARC, The Lymphoma Academic Research Organisation, Créteil, FRA
24INSERM U1245, Centre Henri Becquerel, UNIROUEN, University of Normandie, Rouen, France
25Pharmacy departement, Hôpital Henri Mondor, APHP, Créteil, France
26EA401 Matériaux et Santé, Université Paris-saclay, Chatenay-malabry, France
27Plastic surgery departement, Hôpital Henri Mondor, Créteil, France
28Department of Pathology, Henri Mondor Hospital, APHP, Paris Est-Créteil (UPEC) University Faculty, INSERM UMR-S 955, Créteil, France
29Lymphoid Malignancies Unit, Groupe Hospitalier Henri Mondor, Créteil Cedex, France

Background: Breast implant-associated anaplastic large-cell lymphoma (BI-ALCL) is a rare form of T-cell lymphoma arising adjacent to a breast implant, recently recognized as a provisional entity in the 2017 revised World Health Organization (WHO) lymphoma classification. The pathogenesis of this entity remains elusive even if gene alterations in epigenetic modifiers and JAK-STAT signaling are frequent. ECHELON 2 trial (Horwitz S et al. The Lancet 2019) has set BV-CHP as a new standard of treatment for CD30-positive peripheral T-cell lymphoma, mainly in systemic ALCL patients (pts) but not in BIA-ALCL. Our objective is to describe a series of pts with BIA-ALCL included in the LYSA registry focusing on the use of BV CHP as front-line chemotherapy for patient requiring chemotherapy.

Methods: since 2016, a national multidisciplinary meeting has been implemented by the French Cancer Agency to better define therapeutic strategies for newly diagnosed cases after histologic confirmation. Meanwhile, BIA-ALCL registry was funded by the LYSA to collect ambispectively, in France and more recently in Belgium, patient clinical data including reasons for breast implantation, implant manufacturer, treatment and outcome.

Results: from 2009 to 2021, 85 pts (73 in France and 12 in Belgium) gave their informed consent to participate to the registry. Median age was 57 years (range 29-82) at diagnosis. In 39 out of 85 pts (45.9%) the first implant followed a mastectomy for breast cancer. In this analysis, only implants in the breast(s) where the lymphoma occurred have been considered. Five pts (5.9%) had bilateral lymphoma and 80 pts had unilateral lymphoma (35 left side and 45 right side), 35 pts were implanted once (41.2%), 35 twice (41.2%) and 15 pts (17.6%) 3 times or more. The median period between first implant and BIA-ALCL diagnosis was 12.2 years (range 4.1-40.5), and 7 years (range 0.2-25.4) from last implant to diagnosis. The clinical presentation was seroma in 64 pts (75.3%), breast tumor mass with or without seroma in 18 pts (21.1%) and 3 pts were diagnosed without any mass or seroma (1 contiguous lymph node involvement, 2 in the context of systematic implant removal). The two main clinical presentation (i.e. seroma and tumor mass) were most often correlated with the two distinct histological subtypes (in “situ/mixed” (n=62) or “infiltrative” (n=21)). For 2 pts, histological subtype was not available. The majority of pts were Ann Arbor stage I-II (n=65, 76.5%), and 18 (21.2%) pts were stage IV. Stage was unknown in 2 pts. Considering available information, almost all patients had at least one silicone-filled (n=76) and at least one textured implant (n=85) with Biocell texturation (n=61, 71.8%). No patient had only smooth implant.

Implant removal with total capsulectomy was performed in 66 patients and 25 underwent chemotherapy based on CHOP or CHOP-like (4 to ­6 cycles) chemotherapy regimens (n=13), BV-CHP (6 cycles) (n=10) and others (n=2). Among the patients receiving chemotherapy, CR was obtained in 21 pts (84%) and in 2 pts failed to respond (8%). Among the patients treated with BV-CHP, 8 pts achieved CR (80%) and 2 pts were not yet evaluated at the time of analysis. No limiting toxicity was noted.

After a median follow-up of 28.6 months, 78 pts are alive and free of evolutive disease and 8 are lost to follow up. Seven pts died, either from lymphoma progression alone (n=2) or associated with concomitant active breast cancer (n=2), one from breast cancer alone, one from lung epidermoid cancer and one due to myocardial infarction.

Patients with an “infiltrative” histological subtype have a significantly worse outcome with a 2y-PFS of 73.8% vs 96.7% for other subtypes (“in situ/mixed subtypes”) (p=0.0039, HR=5.3) and a 2y-OS of 78.7% vs 100% (p=0.0022, HR=8.5). With a median follow-up of one year, the 10 patients treated with BV-CHP are alive and free of evolutive disease at the time of analysis.

Conclusions: We report on the basis of a limited series of patients that 6 cycles of BV-CHP provide an excellent disease control in patients with BIA-ALCL requiring chemotherapy. Confirmation of these results on a larger series of patients with a longer follow-up is needed. Such observation provides basis for a prospective trial in order to determine if treatment with BV-CHP could be installed as a standard of care for higher risk patients with BIA-ALCL, as those presenting with tumor mass and /or infiltrative subtype.

Disclosures: Le Bras: Novartis: Honoraria; Celgene BMS: Research Funding; Takeda: Honoraria, Research Funding; Kite Gilead: Honoraria. Oberic: Celgene: Honoraria; Janssen: Honoraria, Other: Support for attending meetings and/or travel; F. Hoffmann-La Roche Ltd: Membership on an entity's Board of Directors or advisory committees, Other: Support for attending meetings and/or travel; Gilead: Membership on an entity's Board of Directors or advisory committees, Other: Support for attending meetings and/or travel; AbbVie: Other: Support for attending meetings and/or travel; Incyte: Membership on an entity's Board of Directors or advisory committees. Bachy: Novartis: Honoraria; Daiishi: Research Funding; Roche: Consultancy; Takeda: Consultancy; Incyte: Consultancy; Kite, a Gilead Company: Honoraria. Bonnet: Roche: Consultancy. André: AbbVie: Other: Travel/accomodation/expenses; Roche: Other: Travel/accomodation/expenses, Research Funding; Johnson & Johnson: Research Funding; Celgene: Other: Travel/accomodation/expenses; Bristol-Myers-Squibb: Consultancy, Other: Travel/Accommodations/Expenses; Karyopharm: Consultancy; Gilead: Consultancy, Other: Travel/Accommodations/Expenses; Incyte: Consultancy; Takeda: Consultancy, Research Funding. Tilly: Janssen-Cilag: Membership on an entity's Board of Directors or advisory committees; Karyopharm: Membership on an entity's Board of Directors or advisory committees; F. Hoffmann-La Roche Ltd: Membership on an entity's Board of Directors or advisory committees, Other: Meeting attendance and travel, Research Funding; AstraZeneca: Membership on an entity's Board of Directors or advisory committees; Incyte: Membership on an entity's Board of Directors or advisory committees. Haioun: Amgen: Honoraria, Research Funding; Servier: Honoraria, Research Funding; Takeda: Honoraria, Research Funding; Janssen: Honoraria, Research Funding; Gilead: Honoraria, Research Funding; Celgene: Honoraria, Research Funding; F. Hoffmann-La Roche Ltd: Honoraria, Research Funding; Novartis: Honoraria, Research Funding; Miltenyi: Honoraria, Research Funding.

*signifies non-member of ASH