scholarly journals 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

Blood ◽  
2021 ◽  
Vol 138 (Supplement 1) ◽  
pp. 1387-1387
Author(s):  
Fabien Le Bras ◽  
Jean Marc Schiano De Colella ◽  
Lucie Oberic ◽  
Emmanuel Itti ◽  
Thua-Ha Dao ◽  
...  

Abstract 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. Bachy: Kite, a Gilead Company: Honoraria; Novartis: Honoraria; Daiishi: Research Funding; Roche: Consultancy; Takeda: Consultancy; Incyte: Consultancy. 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. 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.

Blood ◽  
2021 ◽  
Vol 138 (Supplement 1) ◽  
pp. 4014-4014
Author(s):  
Aia S Mehdi ◽  
Rachel O'Connell ◽  
Michael Potter ◽  
Chris Marshall ◽  
Liza Van Kerckhoven ◽  
...  

Abstract Introduction Breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) is a T-cell lymphoma associated with textured breast implants, recently recognized by the revised WHO Classification. Recommended management for BIA-ALCL involves a multidisciplinary team (MDT) approach with breast surgery, haemato-oncology, pathology, radiology and oncoplastic input. Definitive management for the 'effusion-only' subset is surgical implant and capsule removal; systemic therapy is reserved for 'mass-forming' and 'advanced-disease' cohorts. Overall prognosis is excellent with the vast majority achieving remission. Although the diagnostic and treatment paradigm is established, post treatment surveillance and follow-up guidance varies widely (globally); over-utilisation of imaging tests compromises the patient pathway, impacts limited health-care resources and is associated financial burdens on patients and providers. Recently, newly published consensus guidelines (UK MHRA and USA NCCN clarify follow-up and surveillance imaging (Table 1). The aim of this study was to review our BIA-ALCL specialist centre institutional practise; to quantify the direct economic cost (EC) of imaging surveillance and indirect EC of outpatient clinic (OPC) assessment compared EC if recent guidelines were followed. The secondary aim is to highlight and raise awareness of the latest international guidance to promote the standardisation of practise. Methods A retrospective analysis of a prospectively maintained patient database between July 2015 to October 2019 was conducted, with Institutional Review Board Approval. Data collection included patient demographics, tumour subset, treatment, clinical and imaging surveillance. Follow-up and imaging undertaken for symptomatic concerns / non-BIA-ALCL related pathology was excluded. Imaging costs were calculated using UK NHS tariffs. Results Eleven patients were treated for BIA-ALCL during the study period, with a median age of 49 at diagnosis (range 30-82years). Patients were diagnosed with: effusion-only (n=7), effusion and mass (n=2), mass-only (n=2) subtypes, at a median time of eleven years from implant insertion (IQR 8-12). All patients underwent explantation and en-bloc capsulectomy, with 1 patient required neo-adjuvant (CHOP, Brentuximab) and 1 adjuvant (CHOP) therapy (CHOP. Surveillance with imaging and OPC detected no disease recurrence to date (overall median follow-up 38 months, IQR 12-47). Post treatment episodes of surveillance imaging or follow-up related to patient symptoms were excluded. 8 patients underwent surveillance imaging at our institute (Table 2). Total cost of imaging was £10,396 ($14,396) with a median cost of £1,953 ($2,705) per patient [IQR £526-2029 ($728-2,810)]. 7 patients had completed at least 24 months follow-up since surgery during the study period (Table 3), with 3 patients having not yet completed their follow-up period of two years. Of those with completed follow-up, the median OPC follow-up per patient was 48 months (IQR 38-52), median number of OPC was 7 (IQR 6-11) and the median cost of clinic review was £982 (IQR 804-1395). The surplus cost per patient compared with recommended follow-up was £118 ($164) [IQR £0-531 ($0-738)]. Conclusions Our data shows the variable BIA-ALCL surveillance practise pattern and the associated additional direct and indirect EC of unnecessary asymptomatic surveillance imaging, with an excessive number of follow-up OPC and period of clinical follow-up after complete remission. With no recurrence detected in our patient cohort to date, this data supports the new UK and updated USA NCCN Guidelines (extrapolated from data in other NHLs, and analogous to principles of the ASH Choosing Wisely Campaign) that routine post-treatment surveillance imaging should not be performed in BIA-ALCL patients. Routine asymptomatic post-treatment surveillance imaging is clinically unnecessary and potentially leads to a 'Cascade Effect' of further tests, with increased radiation exposure, excess costs and impact on limited health-care resources. We also support open-access follow-up for patients in remission, to reduce unnecessary follow up appointments. With UK and USA guidelines now available for BIA-ALCL, we support training and education of health-care professionals, global consensus guidelines and a registry, for this rare however increasingly recognised new entity. Figure 1 Figure 1. Disclosures Iyengar: Takeda: Membership on an entity's Board of Directors or advisory committees, Other: conference support, Speakers Bureau; Gilead: Membership on an entity's Board of Directors or advisory committees, Other: conference support, Speakers Bureau; Beigene: Membership on an entity's Board of Directors or advisory committees; Abbvie: Other: conference support; Janssen: Other: conference support, Speakers Bureau. Nicholson: Pfizer: Consultancy; Kite, a Gilead Company: Other: Conference fees, Speakers Bureau; BMS/Celgene: Consultancy; Novartis: Consultancy, Other: Conference fees. El-Sharkawi: Kyowa Kirin: Other: Ad boards; Beigene: Other: Ad boards; ASTEX: Other: Ad boards; Novartis: Other: Travel Support; Takeda: Honoraria; Roche: Honoraria; Janssen: Honoraria, Other: Ad boards; AstraZeneca: Honoraria, Other: Ad boards; AbbVie: Honoraria, Other: Travel Support, Ad boards. Tasoulis: BMJ: Consultancy, Membership on an entity's Board of Directors or advisory committees. Cunningham: Roche: Research Funding; Clovis Oncology: Research Funding; Celgene: Research Funding; Eli Lilly: Research Funding; Bayer: Research Funding; OVIBIO: Membership on an entity's Board of Directors or advisory committees; 4SC: Research Funding; AstraZeneca: Research Funding; MedImmune: Research Funding.


Blood ◽  
2011 ◽  
Vol 118 (21) ◽  
pp. 3689-3689
Author(s):  
Maja Ølholm Vase ◽  
Søren Friis ◽  
Andrea Bautz ◽  
Henrik Toft Sørensen ◽  
Francesco d'Amore

Abstract Abstract 3689 Introduction: An increased risk of alk-negative T- cell anaplastic large cell lymphoma (T-ALCL) in women with silicone breast implants has recently been suggested. Several small series and case-reports have been published, but, so far, only one analytical epidemiological population-based study has specifically addressed this hypothesis (de Jong et al, JAMA, 2008). Methods: We identified a nationwide cohort of Danish women, who underwent breast implant surgery for any reason (cosmetic or reconstruction) at public hospitals or in private clinics. Data including civil registry number and date of surgery were obtained from the Danish National Hospital Register (1977–2009) and from The Danish Registry for Plastic Surgery of the Breast (1999–2009) and eight private clinics of plastic surgery (1973–1995). The civil registry number, assigned to all Danish citizens by the Central Population Registry (CPR), encodes gender and date of birth, and secures valid linkage to population-based registries in Denmark. Identification of lymphoma cases was performed by combined linkages to the Danish Cancer Registry and the Danish Lymphoma Group (LYFO). This combined strategy was applied in order to maximize catchment of incident lymphoma cases (capture-recapture analysis). Results: We identified a cohort of 18,356 women, who underwent breast implant surgery between 1973–2009. The vast majority of breast implants were silicone gel-filled implants. Among study-subjects, 11,380 underwent surgery for strictly cosmetic reasons, while 6,976 received breast implants as part of a breast reconstruction secondary to breast cancer. The number of non-Hodgkin lymphoma (NHL) and T-ALCL cases expected in the general female population of Denmark was 350/year and 10/year in the study period. The total person-years for the study-cohort (162699,5 years)were multiplied by the estimated incidence rates for T-ALCL in the breast (3/100.000.000 person-years)to ascertain the expected number (0,005) of ALCL in the breast among cohort members. The total number of NHL cases observed was 60. There were no cases of ALCL in the study-cohort and none had an implant-near localization. Conclusion: This is a comprehensive epidemiologic study addressing the specific issue of the possible association between T-ALCL and breast implants. Our large nationwide cohort study does not support a major association between T-ALCL lymphomas and breast implants either implanted for cosmetic reasons in otherwise healthy recipients or for reconstructive purposes in women previously treated for breast cancer. Due to the rarity of this condition, additional population-based analyses are needed to further evaluate potential biological procedure-related or implant-specific associations. An extended analysis of pooled data from different Nordic countries is ongoing. Disclosures: No relevant conflicts of interest to declare.


Breast Cancer ◽  
2020 ◽  
Vol 27 (3) ◽  
pp. 499-504
Author(s):  
Yoko Ohishi ◽  
Aki Mitsuda ◽  
Kozue Ejima ◽  
Hidetomo Morizono ◽  
Tomoyuki Yano ◽  
...  

Blood ◽  
2014 ◽  
Vol 124 (21) ◽  
pp. 3095-3095 ◽  
Author(s):  
Barbara Pro ◽  
Ranjana Advani ◽  
Pauline Brice ◽  
Nancy L. Bartlett ◽  
Joseph D. Rosenblatt ◽  
...  

Abstract Background: Systemic anaplastic large cell lymphoma (sALCL) is a CD30-positive aggressive subtype of mature T-cell lymphoma. Approximately 50% of patients (pts) with sALCL develop recurrent disease after frontline treatment (Savage, 2008). Outcomes have historically been poor for pts with relapsed T-cell lymphomas, including sALCL, with a median overall survival (OS) and progression-free survival (PFS) of 5.5 months (mos) and 3.1 mos, respectively (Mak, 2013). A phase 2 study evaluated the efficacy and safety of brentuximab vedotin, a CD30-directed antibody-drug conjugate, in pts with relapsed or refractory sALCL (ClinicalTrials.gov #NCT00866047). Four-year follow-up data from this ongoing trial are presented. Methods: Pts received 1.8 mg/kg brentuximab vedotin every 3 weeks as a 30-minute outpatient IV infusion for up to 16 cycles. Response was assessed according to the Revised Response Criteria for Malignant Lymphoma (Cheson 2007). Assessments of response and durability of response per an independent review facility (IRF) have been previously reported. Following a protocol amendment that removed the requirement for routine CT scanning during the follow-up period, response is now being assessed per the investigator. Survival and disease status are being assessed every 3 mos for 2 years, every 6 mos during years 3 to 5, and annually thereafter. CT scans are required if progression is suspected clinically. Results: The enrolled population of 58 pts was heavily pretreated with poor prognosis. As previously reported, 72% of patients had ALK-negative disease, 62% had primary refractory disease (defined as no complete remission [CR] or relapse within 3 months of frontline therapy), and 26% had failed a prior autologous stem cell transplant (SCT). Pts had received a median of 2 prior systemic chemotherapy regimens (range, 1 to 6). Per investigator, the objective response rate (ORR) with brentuximab vedotin was 83% (48 pts) and the CR rate was 62% (36 pts), which were similar to the previously reported ORR (86%) and CR (59%) rates per IRF. At the time of this analysis (data cut June 2014), all pts had discontinued treatment and the median observation time from first dose was 46.3 mos (range, 0.8 to 57.7). Sixty-two percent (36 of 58) of pts were alive at last follow-up and the estimated 4-year survival rate by Kaplan-Meier analysis was 64% (95% CI: 51%, 76%). Median OS by best clinical response was CR (n=36): median not reached; partial remission (n=12): 11.6 mos; stable disease (n=4): 6.9 mos; and progressive disease (n=2): 4.2 mos. Median PFS was 20.0 mos (95% CI: 9.4, – [range, 0.8 to 54.9+]) for all pts and was not reached in pts with CR. Median PFS for pts with ALK-positive (25.5 mos) and ALK-negative (20.0 mos) disease were similar. Median PFS for pts with PET-negative disease at Cycle 4 (n=28) was not reached, whereas median PFS for pts with PET-positive disease at Cycle 4 (n=20) was 6.7 mos. After discontinuing treatment, 18 pts received a hematopoietic SCT (9 allogeneic, 9 autologous). The median PFS for the pts who achieved a CR and did not receive a post-treatment SCT (n=21) was 37.7 mos (95% CI: 14.1, - [range, 2.8 to 51.1+]) and the median PFS was not reached for the pts who achieved a CR and received a subsequent SCT (n=15) (95% CI: 9.5, - [range, 8.0 to 54.4+]). Of the 36 pts who achieved CR per the investigator, 17 (47%) remain in follow-up free of progression: 10 pts received a consolidative SCT following treatment with brentuximab vedotin and 7 pts received no further therapy after completing brentuximab vedotin treatment. As previously reported, adverse events (AEs) in ≥20% of pts were peripheral sensory neuropathy, nausea, fatigue, pyrexia, diarrhea, rash, constipation, and neutropenia. AEs ≥ Grade 3 that occurred in ≥5% of pts were neutropenia, thrombocytopenia, peripheral sensory neuropathy, anemia, recurrent ALCL, and fatigue. Conclusions: After a median observation time of approximately 4 years from first dose of brentuximab vedotin, the 4-year survival rate was 64%. Forty-seven percent of patients with CR remain in follow-up with no evidence of progression, suggesting that brentuximab vedotin treatment may be curative for some patients. A randomized phase 3 study is being conducted to evaluate brentuximab vedotin in combination with cyclophosphamide, doxorubicin, and prednisone for frontline treatment of CD30-positive mature T-cell lymphomas, including sALCL (ClinicalTrials.gov #NCT01777152). Figure 1 Figure 1. Disclosures Pro: Seattle Genetics, Inc.: Consultancy, Research Funding, Travel expenses Other. Advani:Takeda Pharmaceuticals International Co.: Research Funding; Celgene: Research Funding; Pharmacyclics: Research Funding; Janssen Pharmaceuticals: Research Funding; Genentech: Research Funding; Seattle Genetics, Inc.: Other, Research Funding. Brice:Seattle Genetics, Inc.: Research Funding; Takeda Pharmaceuticals International Co.: Honoraria, Research Funding; Roche: Honoraria. Bartlett:Genentech: Research Funding; ImaginAb: Research Funding; Celgene: Research Funding; MedImmune: Research Funding; Novartis: Research Funding; Pharmacyclics: Research Funding; Pfizer: Research Funding; Takeda Pharmaceuticals International Co.: Research Funding; Seattle Genetics, Inc.: Other, Research Funding; Janssen: Research Funding; AstraZeneca: Research Funding. Rosenblatt:Seattle Genetics, Inc.: Research Funding; University of Miami: Employment. Illidge:Seattle Genetics, Inc.: Consultancy, Research Funding; Takeda Pharmaceuticals International Co.: Consultancy, Honoraria. Matous:Seattle Genetics, Inc.: Research Funding, Speakers Bureau; Celgene: Consultancy, Speakers Bureau; Onyx: Speakers Bureau; Takeda Pharmaceuticals International Co.: Speakers Bureau. Ramchandern:Seattle Genetics, Inc.: Research Funding, Speakers Bureau. Fanale:Seattle Genetics, Inc.: Consultancy, Honoraria, Other, Research Funding. Connors:Seattle Genetics, Inc.: Research Funding; Roche: Research Funding. Wang:Seattle Genetics, Inc.: Employment, Equity Ownership. Huebner:Takeda Pharmaceuticals International Co.: Employment, Equity Ownership. Kennedy:Seattle Genetics, Inc.: Employment, Equity Ownership. Shustov:Seattle Genetics, Inc.: Research Funding.


2019 ◽  
Vol 1 (1) ◽  
Author(s):  
Nigel S G Mercer

Abstract Breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) is a rare disease known to be associated with textured breast implants. The most up-to-date incidence in the United Kingdom is 1:24,000 and 45 confirmed cases have been reported since the first UK case was reported in 2012 and there has been one confirmed death as a result of BIA-ALCL. How the regulatory framework in the United Kingdom works and shapes the information, which must be given by surgeons to patients contemplating breast augmentation, for any reason, is discussed. In addition, the approach to informing patients with breast implants in situ is discussed. It is surgeons’ duty to inform all prospective patients that there is a risk of BIA-ALCL. Not to do so in the United Kingdom would be likely to leave surgeons open to legal action by patients who develop the disease.


2020 ◽  
Vol 2 (4) ◽  
pp. 398-407 ◽  
Author(s):  
Maria A Mitry ◽  
Julie Sogani ◽  
Elizabeth J Sutton ◽  
Priyadarshini Kumar ◽  
Steven Horwitz ◽  
...  

Abstract Breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) is a rare but increasingly important diagnosis as the incidence of breast implant placement, both elective and reconstructive, continues to rise. When detected and treated early, this indolent disease carries an excellent prognosis. However, because the clinical presentation is often nonspecific, it is crucial for radiologists to accurately identify the imaging findings associated with BIA-ALCL to facilitate a timely diagnosis. This article will provide radiologists with an overview of the diagnosis, imaging findings, and management of BIA-ALCL.


2017 ◽  
Vol 2017 ◽  
pp. 1-6 ◽  
Author(s):  
Daniel E. Ezekwudo ◽  
Tolulope Ifabiyi ◽  
Bolanle Gbadamosi ◽  
Kristle Haberichter ◽  
Zhou Yu ◽  
...  

Breast implant–associated anaplastic large T-cell lymphoma has recently been recognized as an entity, with few reports describing the two common subtypes: in situ (indolent) and infiltrative. Recently, the infiltrative subtypes have been shown to be more aggressive requiring adjuvant chemotherapy. We report a rare case of breast implant–associated anaplastic large cell lymphoma (BIA-ALCL) in a 65-year-old Caucasian female following silicone breast implantation and multiple capsulectomies. We discuss the rare presentation of this disease, histopathologic features of the indolent and infiltrative subtypes of ALCL, and their clinical significance. We also review the literature for up-to-date information on the diagnosis and clinical management. Treatment modalities including targeted therapy are also discussed. Although BIA-ALCL is rare, it should always be considered as part of the differential diagnosis especially in women with breast implants. Given the increasing rate of breast reconstruction and cosmetic surgeries, we anticipate a continuous rise in incidence rates of this rare disease; thus, caution must be taken to avoid misdiagnosis.


Blood ◽  
2019 ◽  
Vol 134 (Supplement_1) ◽  
pp. 5283-5283
Author(s):  
Anna Vanazzi ◽  
Safaa Ramadan ◽  
Francesca De Lorenzi ◽  
Paola Arena ◽  
Enrico Derenzini ◽  
...  

INTRODUCTION AND BACKGROUND: Breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) is a rare form of T-cell non-Hodgkin lymphoma, recently recognized by the World Health Organization classification of lymphoid neoplasms. Clinical and histologic findings suggest a distinct entity from systemic ALCL. Except in advanced cases, BIA-ALCL usually has an indolent course. The prognosis is often favorable and complete surgical excision for localized disease is generally the only treatment. The disease often presents with a delayed seroma around the breast implant - almost exclusively with a textured surface - breast pain, swelling and asymmetry, capsular contracture, but it can also present with a breast mass and lymph node involvement. Tumor nodules, axillary node involvement, bilateral breast involvement and infiltrative pattern on capsule histology are associated with more aggressive behavior. Systemic involvement has also been less commonly reported. In accordance with the FDA recommendation, all cases of histologically confirmed BIA-ALCL should be reported to the BIA-ALCL PROFILE Registry. In Italy, the Ministry of Health sensitizes to notify each BIA-ALCL diagnosis through the compilation of a specific online form. Since 2015 all the notified cases were collected in the Italian Ministry of Health's database, named Dispovigilance. So far, 47 cases have been reported, as of the last updated survey. METHODS: We report our single center experience at European Institute of Oncology (IEO) in Milan, Italy. A total of 27.588 breast implants has been placed in our Institute between 01/2001 and 12/2018.The first case of BI-ALCL was diagnosed in july 2015 and a total of 7 cases have been diagnosed to date. In 4 cases implants were placed at EIO. Median age at diagnosis was 52 (32-71). All patients presented with monolateral and localized disease, with stage IA (TNM classification). In 6 patients periprosthetic seroma preceded diagnosis and fine needle aspirate of the periprosthetic effusion documented BIA-ALCL, while breast pain and tumor nodule were present in one patient. In 5 out of 7 patients breast implantation was performed for reconstruction after breast cancer surgery, in 2 patients for cosmetic purposes. Textured devices had been implanted in all of them. All but one patients with previous hIstory of breast cancer had 2 surgery for reconstruction. Overall, interval between first implant and ALCL diagnosis ranged between 5 and 22 years (median: 11 ys). Interval between second implant and ALCL diagnosis was of 4-11 years (median: 6 ys). Presurgery PET/CT scan and MRI were performed in most patients. Treatment included total capsulectomy in all patient, bilateral surgery in case of bilateral implants. One patient received RT after surgery for higly suggestive residual disease. Immediate reconstruction was performed in 1 patient. With a median follow up of 16 months (range 1-49), all patients are alive with no relapse observed to date. CONCLUSIONS: This report represents the largest single centre experience in Italy. Given the peculiarity of this new recently recognized malignancy, a multidisciplinary approach is essential for the diagnosis and management of these patients. Management requires experts in diagnostic imaging, pathology, hematology/oncology, plastic surgery and surgical oncology and radiation oncology. It is critical that physicians are educated about the clinical presentation, diagnostic criteria, and treatment modalities. This comprehensive approach allows a quite favorable outcome in this rare and challenging complication of breast reconstruction. Disclosures Derenzini: TG-THERAPEUTICS: Research Funding.


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