Breast Implant-associated Anaplastic Large Cell Lymphoma Research Articles

Current Knowledge on Breast Implant-Associated Anaplastic Large Cell Lymphoma: Evidence from Italian Ministry of Health Registry Data.

Accurate estimation of Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL) incidence is crucial for assessing breast-implant-associated risk. However, the size of the implanted population worldwide is unknown, making it challenging to appropriately estimate this figure. This study aims to provide a new reliable and reproducible method to estimate the breast-implanted-population (BIP), reporting a reliable annual BIA-ALCL incidence estimate. Moreover, we discuss all activities performed over the past decade in collecting complete histories, managing, and monitoring outcomes of each Italian case. Data from the National Breast Implant Registry and from manufacturers have been used to define a new formula to estimate the BIP at risk of developing a breast-implant-related event. From the BIA-ALCL registry, complete information on Italian cases has been collected and analysed. Overall survival is estimated by the Kaplan-Meier curve. From 2010 to June 2024, 111 BIA-ALCL cases were recorded in Italy. The estimated incidence rate showed an upward trend, ranging from 2.68 to 6.35 cases per 100,000 patient-years. Thanks to newly promoted disease awareness, most patients had a complete response to treatment, resulting in a three-year overall survival rate estimate of 98.2%. The BIP formula showed to be an innovative, effective and reproducible tool to make a reliable estimation of the implanted population, confirming that BIA-ALCL is a rare disease with an incidence rate estimate varying from 2.7 to 6.3 cases/100.000 patient-years in the last five years. Eleven-year experience in this field also confirmed that this disease has a favorable prognosis if properly treated. This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .

Breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) in Romania: First case series of all documented cases

SummaryBreast implant-associated anaplastic large cell lymphoma (BIA-ALCL) is an uncommon malignancy linked to textured breast implants by moderate evidence in 2021. Documenting Romanian cases provides valuable insights into epidemiology, management, and outcomes, enhancing global understanding and informing clinical practices. Our objectives were to analyze BIA-ALCL cases in Romania, focusing on patient demographics, implant characteristics, clinical presentation, diagnostic methods, treatment, and outcomes.We conducted a retrospective review of all known BIA-ALCL cases in Romania, examining patient demographics, implant details, clinical presentation, diagnostic methods, and outcomes. Data sources included medical records, surgical reports, follow-up data, and implant characteristics like shape, texture, and manufacturer.The mean age at diagnosis was 44.4 years. All patients had textured implants and no replacements, 4 with aesthetic indication and 1 reconstruction. The mean time from implantation to diagnosis was 7.2 years. Clinical presentations were primarily late seromas, diagnosed through fine needle aspiration and immunohistochemistry. Treatments involved multidisciplinary teams, with bilateral en-bloc explantation and adjuvant therapies in two cases. One patient had immediate reconstruction with smooth implants and Acellular Dermal Matrix. No disease recurrence was observed post-treatment.The low BIA-ALCL prevalence in Romania estimated at 1:44,500 compared to the mean of 1:13,745 in Europe indicates the need for an increased awareness and tracking. Establishing mandatory national implant registries, pathology databases, and enhancing physician and patient education will help identify potential cases. All cases involved textured implants, highlighting the need for ongoing research to identify risk factors and guide surgeons consulting patients with these implants.

Neoadjuvant Immunotherapy and De-Escalation of Surgery in Locally Advanced Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL)

Breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) is a rare form of non-Hodgkin T cell lymphoma diagnosed in patients with a history of breast implants. Most patients develop a periprosthetic effusion at early stages of disease while less common presentations include a palpable mass, severe capsular contracture, lymphadenopathy, or cutaneous erythema. Due to the complex nature of this disease, a multidisciplinary approach is necessary for optimal management, particularly in locally advanced disease or inoperable patients. We present the successful use of neoadjuvant therapeutic protocols in two cases of locally advanced BIA-ALCL. The first case, a 52-year-old patient with a left breast mass-like stage III disease who underwent combined targeted immunotherapy and chemotherapy (BV-CHP). Following a complete radiological and metabolic response, the patient underwent bilateral implant removal, right total intact capsulectomy, left en bloc capsulectomy and skin resection from the left inframammary fold in continuity with the capsule. The second case, a 65-year-old patient with a right breast swelling and mass-like stage IIA disease who received targeted immunotherapy, Brentuximab vedotin (BV). Following a complete metabolic response, she underwent bilateral implant removal and en bloc capsulectomy. A literature review and the reported cases suggest the effectiveness of targeted immunotherapy as monotherapy or in combination with chemotherapy in locally advanced BIA-ALCL in disease downstaging, surgical de-escalation, reduction of significant post-operative complications and an acceptable tolerance profile. Although surgery is an essential part of treatment, timing and type of intervention should be carefully planned, especially when primary, radical resection is uncertain.

Smooth Operator: Nanotextured Breast Tissue Expanders Are Associated with Lower Rates of Capsular Contracture

Background: Continuous research on breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) has introduced a focus on surface texturizations and a shift towards smooth breast devices, yet outcomes comparing the complication profiles of differently textured tissue expanders (TEs) remain conflicting. The study aim was to compare the complication profile of a new nanotextured and MRI-compatible TE to micro- and macrotextured TEs and to identify possible predictors for complications. Methods: A retrospective analysis of women undergoing expander-based breast reconstruction after mastectomy between January 2016 and March 2022 was conducted. The primary endpoint was the development of capsular contracture. Possible predictors were analyzed in a mixed-effects model using the least absolute shrinkage and selection operator (LASSO). Moreover, a comparison of complications and an evaluation of predictors were carried out. Results: A total of 147 breasts, encompassing 82 nanotextured, 43 microtextured and 22 macrotextured TEs, were analyzed. Breasts with nanotextured TEs were less likely to develop capsular contracture overall (OR, 0.12; 95%CI 0.05–0.28, p < 0.001). Post-mastectomy radiotherapy (PMRT) was identified as a predictor for capsular contracture (OR, 4.67; 95%CI 1.86–11.71, p < 0.001). Breasts with nanotextured TEs showed a higher rate of seroma, but lower rates of malposition and pain. Predictors for developing postoperative complications included higher mastectomy weight (p = 0.008). Conclusions: Breasts with nanotextured TEs exhibited the lowest rate of capsular contracture compared to micro- and macrotextured TEs. Together with its MRI-compatibility and improved oncologic follow-up, the nanotextured TE seems to be a favorable device for expander-based breast reconstruction.

Discussion: American Association of Plastic Surgeons Consensus on Breast Implant-Associated Anaplastic Large-Cell Lymphoma.

Discussion: American Association of Plastic Surgeons Consensus on Breast Implant-Associated Anaplastic Large-Cell Lymphoma.

Discussion: American Association of Plastic Surgeons Consensus on Breast Implant-Associated Anaplastic Large-Cell Lymphoma.

Discussion: American Association of Plastic Surgeons Consensus on Breast Implant-Associated Anaplastic Large-Cell Lymphoma.

Late seroma complication in a breast augmentation patient with fibrin accumulation: a case report

Breast implant surgery is one of the most commonly performed aesthetic surgery around the world. Late seroma is a well known complication that is linked to breast implant-associated anaplastic large cell lymphoma (BIA-ALCL). However, there are some clinically confounding cases of late seroma that present with BIA-ALCL like symptoms. Here we report a case of a 30-year-old female patient who underwent bilateral breast augmentation that presented with a late seroma case with symptoms matching that of BIA-ALCL–abrupt swelling and pain–that was later diagnosed as abnormal accumulation of fibrin.

"The GalaFLEX 'Empanada' for Direct to Implant Prepectoral Breast Reconstruction".

Therapeutic, IV.

BIA-ALCL and BIA-SCC: Updates on Clinical Features and Genetic Mutations for Latest Recommendations

Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL) and Breast Implant-Associated Squamous Cell Carcinoma (BIA-SCC) are emerging neoplastic complications related to breast implants. While BIA-ALCL is often linked to macrotextured implants, current evidence does not suggest an implant-type association for BIA-SCC. Chronic inflammation and genetics have been hypothesized as key pathogenetic players, although for both conditions, the exact mechanisms and specific risks related to breast implants are yet to be established. While the genetic alterations in BIA-SCC are still unknown, JAK-STAT pathway activation has been outlined as a dominant signature of BIA-ALCL. Recent genetic investigation has uncovered various molecular players, including MEK-ERK, PI3K/AKT, CDK4-6, and PDL1. The clinical presentation of BIA-ALCL and BIA-SCC overlaps, including most commonly late seroma and breast swelling, warranting ultrasound and cytological examinations, which are the first recommended steps as part of the diagnostic work-up. While the role of mammography is still limited, MRI and CT-PET are recommended according to the clinical presentation and for disease staging. To date, the mainstay of treatment for BIA-ALCL and BIA-SCC is implant removal with en-bloc capsulectomy. Chemotherapy and radiation therapy have also been used for advanced-stage BIA-ALCL and BIA-SCC. In-depth characterization of the tumor genetics is key for the development of novel therapeutic strategies, especially for advanced stage BIA-ALCL and BIA-SCC, which show a more aggressive course and poor prognosis.

Abstract PO2-20-12: Breast Implant-associated Squamous Cell Carcinoma

Abstract A 54-year-old female with a history of bilateral breast implants presented with intermittent left breast pain for 6 months. She first had bilateral breast implants placed in 1996 and had no reported issues until 2010, when she had bacteremia and seeding infection with subsequent removal of both implants. She then had a second set of silicone-based implants placed in 2012 with no issues for 10 years. Family history was negative for breast cancer or any other malignancy. She had no prior smoking history. Vital signs and laboratory values were unremarkable. On exam, the left breast appeared larger than the right, dense, thickened, and slightly edematous. No lymphadenopathy was palpated. Both mammogram and ultrasound of bilateral breasts, done at the onset of her pain, were normal. Given the patient’s symptoms, an MRI of the breasts was done, with findings concerning an infection or lymphoma. It revealed an irregular fluid collection in the left breast. The fluid collection was rim-enhancing with frond-like areas of enhancing tissue, extending through the inferior aspect of the capsule into the subcutaneous tissue of the lower outer quadrant of the left breast. Enhancement and edema extended off of the superior and posterior aspect of the prosthesis into the pectoralis muscle. It was particularly prominent along the medial aspect of the prosthesis where it extended in the chest wall between the sternum and the costal cartilage. There were 3 mildly enlarged left intramammary lymph nodes measuring up to 7 mm in short axis, with diffuse edema seen within the breast. No axillary adenopathy was seen in the MRI. She was referred to surgery and had both right and left breast implants removed, and a left breast JP drain was placed. The pathology from the left breast capsule excision revealed squamous cell carcinoma, well-differentiated and invasive, associated with a scar and extending to the surgical margin. She was diagnosed with a rare case of breast implant-associated squamous cell carcinoma (BIA-SCC). Subsequent staging imaging showed postsurgical inflammatory changes with no nodal metastatic disease. She continued to follow up outpatient with plans of multidisciplinary meeting to discuss long-term treatment options. Most patients undergoing breast augmentation experience no serious complications. Previously, rare incidences of breast-implant-associated anaplastic large cell lymphoma (BIA-ALCL) had been reported, with 1234 cases as of 2022. More recently, cases of BIA-SCC have been seen. Primary SCC of the breast is extremely rare in both augmented and non-augmented women. 19 cases of BIA-SCC are reported in the literature as of 2022, all seen in females, typically arising from capsular tissue around the breast implant. It is a rare and potentially aggressive malignancy, with unclear etiology and undefined therapy regimen due to a paucity of data. Suggested treatments include resection with a negative margin, although this could require an extensive and complex reconstruction, including plastic surgery soft tissue coverage of the resection defect. Definitive radiation to obtain local control can be considered in an organ-sparing approach. Consideration can also be given to either chemosensitization with agents such as cisplatin or combining radiation with immunotherapy. Citation Format: Farhan Azad, Ajay Siva, Prutha Patel, Clive Miranda, Matthew Gravina. Breast Implant-associated Squamous Cell Carcinoma [abstract]. In: Proceedings of the 2023 San Antonio Breast Cancer Symposium; 2023 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2024;84(9 Suppl):Abstract nr PO2-20-12.

Abstract PO1-20-08: Primary breast implant-associated squamous cell carcinoma with subsequent TEMPUS testing and failure of immunotherapy

Abstract Primary squamous cell carcinoma of the breast is a rare entity, and there are a limited number of cases in the literature describing squamous cell carcinoma arising from breast implants. It has been hypothesized that these implant-associated cancers may arise from epithelialization of the implant capsule followed by chronic inflammation. None of the cases in the literature were treated with immunotherapy. We present a case of an aggressive, primary sarcomatoid squamous cell carcinoma of the breast arising from a breast implant that was treated unsuccessfully with simultaneous chemotherapy and immunotherapy following TEMPUS testing. Introduction: Breast augmentation is the most common plastic surgery procedure performed worldwide, with more than 300,000 done in the United States every year. While breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) is extensively discussed in recent literature, other breast implant-associated cancers are rarer and less studied. Breast implant-associated squamous cell carcinoma (BIA-SCC) specifically is an extremely rare complication of breast augmentation and no guidelines for treatment exist. The American Society of Plastic Surgeons (ASPS) released a statement on BIA-SCC on 9/2022 following a safety communication from the FDA, and it is recommended health care providers submit case reports of BIA-SCC to a patient registry. Case study: We present the case of a female patient who underwent bilateral breast augmentation in 2006 with Mcghan textured, pre-pectoral, areolar saline implants. In 2022, she presented with swelling and a lump in her breast and underwent bilateral breast implant removal with capsulectomy. Pathology showed triple negative sarcomatoid squamous cell carcinoma of the right breast capsule. TEMPUS testing on the breast biopsy revealed a PIK3CA mutation and PD-L1 negative status. Her case was discussed with a multi-disciplinary team including plastic surgery, multiple oncologists, and radiation oncology and her clinical picture was determined to be most consistent with BIA-SCC. Based on the KEYNOTE-522 study, she was determined to be a candidate for neoadjuvant therapy with pembrolizumab and chemotherapy as she was newly diagnosed, previously untreated, nonmetastatic, and had a triple negative tumor. She received two cycles of carboplatin, paclitaxel, and pembrolizumab but unfortunately rapidly progressed with chest wall extension, multiple new pulmonary nodules, worsening lymphadenopathy, right ventricular tumor thrombus, and new malignant pleural effusion and was transitioned to hospice. Discussion: Seven cases of BIA-SCC, one case of squamous cell carcinoma (SCC) after liquid silicone injection augmentation, one case of squamous metaplasia on the breast implant capsule, and one case of epithelization of the breast implant capsule have been previously described in the literature (Table 1). None of the available cases of BIA-SCC report TEMPUS testing, and none of the patients were treated with immunotherapy. The origin of BIA-SCC is unclear, but several theories have been described including chronic inflammation leading to conversion of epithelial tissue on the capsule to SCC. It is unknown how the breast implant capsule might become epithelialized to begin with – introduction of epithelium intraoperatively during augmentation, rupture of epidermal cysts, existence of epithelium in the area from a childhood injury or from birth, or epithelization from chronic shear forces from the augmentation or leakage of the implant are all possibilities. With the ongoing data gathering through the FDA patient registry, we will continue to learn more about these rare cancers and potentially get further insight into their origins. Table 1 An overview of cases of BIA-SCC in the literature Citation Format: Emily Podany, Katherine Clifton. Primary breast implant-associated squamous cell carcinoma with subsequent TEMPUS testing and failure of immunotherapy [abstract]. In: Proceedings of the 2023 San Antonio Breast Cancer Symposium; 2023 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2024;84(9 Suppl):Abstract nr PO1-20-08.

AB141. SOH24AB_151. Breast implant associated anaplastic large cell lymphoma (BIA-ALCL): a case study

AB141. SOH24AB_151. Breast implant associated anaplastic large cell lymphoma (BIA-ALCL): a case study

D9. Updated Epidemiology Of Breast Implant-associated Anaplastic Large Cell Lymphoma (BIA-ALCL) in the United States

D9. Updated Epidemiology Of Breast Implant-associated Anaplastic Large Cell Lymphoma (BIA-ALCL) in the United States

Long-Term Implications of Implant-Based Breast Reconstruction: What You Should Know About Breast Implant Illness and Breast Implant-Associated ALCL

Long-Term Implications of Implant-Based Breast Reconstruction: What You Should Know About Breast Implant Illness and Breast Implant-Associated ALCL

282 (PB-098) Poster - Breast implant–associated anaplastic large cell lymphoma (BIA-ALCL): A mass but no fluid

282 (PB-098) Poster - Breast implant–associated anaplastic large cell lymphoma (BIA-ALCL): A mass but no fluid

American Association of Plastic Surgeons Consensus on Breast Implant-Associated Anaplastic Large-Cell Lymphoma.

In the absence of high-quality evidence, there is a need for guidelines and multidisciplinary consensus recommendations on breast implant-associated anaplastic large-cell lymphoma (BIA-ALCL). The purpose of this expert consensus conference was to evaluate the existing evidence regarding the diagnosis and management of BIA-ALCL caused by textured implants. This article aims to provide evidence-based recommendations regarding the management and prevention of BIA-ALCL. A comprehensive search was conducted in the MEDLINE, Cochrane Library, and Embase databases, and supplemented by manual searches of relevant English-language articles and "related articles" sections. Studies focusing on breast surgery and lymphoma associated with breast implants were included for analysis. Meta-analyses were performed and reviewed by experts selected by the American Association of Plastic Surgeons using a Delphi consensus method. A total of 840 articles published between January of 2011 and January of 2023 were initially identified and screened. The full text of 188 articles was assessed. An additional 43 articles were excluded for focus, and 145 articles were included in the synthesis of results, with 105 of them being case reports or case series. The analysis encompassed a comprehensive examination of the selected articles to determine the incidence, risk factors, clinical presentation, diagnostic approaches, and treatment modalities related to BIA-ALCL. Plastic surgeons should be aware of the elevated risks by implant surface type, implement appropriate patient surveillance, and follow the recommendations outlined in this statement to ensure patient safety and optimize outcomes. Ongoing research on the pathogenesis, genetic drivers, and preventative and prophylactic measures for BIA-ALCL is crucial for improving patient care. Risk, V.

Our Experience in Diagnosing and Treating Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL).

Breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) is an uncommon T-cell lymphoma detected in association with textured implants. It presents as a fluid accumulation around the implant, usually years after the implantation. We present our experience in diagnosing and treating four patients with BIA-ALCL, each widely differing from the other. Data on patients' surgical history, relevant medical information, and findings on pathological slides were retrieved from their medical charts and retrospectively reviewed. Each of the four patients was diagnosed with BIA-ALCL, one after breast augmentation, one after breast reconstruction with an implant, one after breast reconstruction with a latissimus dorsi flap and implant, and the fourth after the removal of breast implants. The cases were presented to a multidisciplinary team and subsequently underwent surgery. All four are currently free of tumors, as established by a negative follow-up via positron emission tomography-computed tomography. Although the incidence of BIA-ALCL is rare, these cases emphasize the need to rule out the diagnosis of BIA-ALCL in patients with textured implants or a history of implanted textured devices who present with symptoms such as late seroma or peri-implant mass. This pathology is typically indolent and slow-growing and heightened awareness for an early diagnosis could lead to quicker intervention and enhanced patient management.

Prepectoral and Retropectoral Breast-implant-Associated Anaplastic Large-cell Lymphoma.

Breast-implant-associated anaplastic large cell lymphoma (BIA-ALCL) is a non-Hodgkin lymphoma that arises in the space between the surface of a breast implant and the fibrous capsule that grows around the implant. Since its first description 20 years ago, almost 1000 cases of BIA-ALCL have been diagnosed worldwide. Nowadays, guidelines describe the diagnosis, staging, and treatment of this disease. We present the first two cases diagnosed and treated in Peru, demonstrating a wide range of aggressiveness of BIA-ALCL.

Incidental Bystander or Essential Culprit: A Systematic Review of Bacterial Significance in the Pathogenesis of Breast Implant-Associated Anaplastic Large Cell Lymphoma.

Breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) is a distinct subtype of T-cell non-Hodgkin lymphoma that arises in the context of prolonged exposure to textured breast implants. The intent of this manuscript is to explore whether the bacterial presence in biofilms on these implants is a mere incidental finding or plays a pivotal role in the pathogenesis of BIA-ALCL. Our goal is to delineate the extent of bacterial involvement, offering insights into potential underlying mechanisms, and establishing future research priorities aimed at resolving the remaining uncertainties surrounding this complex association. A comprehensive systematic review of several databases was performed. The search strategy was designed and conducted by an experienced librarian using controlled vocabulary with keywords. The electronic search identified 442 publications. After evaluation, six studies from 2015 to 2021 were included, encompassing 201 female patients aged 23 to 75. The diagnosis span post-implantation ranged from 53 to 135.6 months. Studies consistently found bacteria near breast implants in both BIA-ALCL cases and controls, with varied microbial findings. Both BIA-ALCL cases and controls exhibited the presence of specific bacteria, including Pseudomonas aeruginosa, Klebsiella oxytoca, Staphylococcus aureus, and Ralstonia spp., without any statistically significant differences between groups. The use of antiseptic and antimicrobial agents during implant insertion did not demonstrate any impact on reducing or altering the risk of developing BIA-ALCL. Our systematic review reveals that the current evidence is inadequate to link bacterial etiology as a central factor in the development of BIA-ALCL. The limitations in the existing data prevent a complete dismissal of the role of biofilms in its pathogenesis. The observed gap in knowledge underscores the need for more focused and comprehensive research, which should be structured in a multi-faceted approach. Initially, this involves the utilization of sophisticated genomic and proteomic methods. Following this, it is crucial to delve into the study of immunological reactions specifically induced by biofilms. Finally, this research should incorporate extended observational studies, meticulously tracking the evolution of biofilm development and its correlation with the emergence of BIA-ALCL. In light of the inconclusive nature of current findings, further investigation is not only justified but urgently needed to clarify these unresolved issues.

Impact of Brentuximab Vedotin in Patients with Breast Implant-Associated Anaplastic Large Cell Lymphoma with Capsule Infiltration Requiring Chemotherapy

Background: Breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) is an uncommon peripheral T-cell lymphoma most frequently arising around a textured surface breast implant. It has been shown that capsule infiltration (T2, T3 and T4 of the TNM staging system) was an adverse prognostic factor. In this context, chemotherapy (with or without brentuximab vedotin [BV]) may be proposed, considering other factors such as metastatic disease or incomplete resection. Furthermore, the need for adjuvant chemotherapy in patients with stage IIA (T4N0M0) and complete en-bloc excision without residual disease is debated. Aim: To assess the management of BIA-ALCL with capsule infiltration, in particular: 1) To assess the impact of BV in those patients; 2) To evaluate the need for adjuvant chemotherapy in patients with stage IIA and complete en-bloc excision without residual disease. Methods: Since 2016, a national multidisciplinary meeting has been implemented by the French National Cancer Institute (NCI) to optimize management of patients with BIA-ALCL, particularly those with advanced disease. Meanwhile, a national registry has been set up by the LYSA, in collaboration with health authorities. Central pathological review has been carried out within the French NCI-labeled Lymphopath network. Results: From 2009 to 2023, 125 patients with BIA-ALCL were recorded, of which 111 (94 from France and 17 from Belgium) had complete data and were included in the present analysis. Overall, median age at diagnosis of BIA-ALCL was 58 years (24-82 years). Reasons for initial implantation were breast cancer reconstruction (n=54; 49%), cosmetic (n=45; 41%) or other (n=12; 10%). The median interval from first implantation to diagnosis of BIA-ALCL was 12.3 years (4-40 years). The median number of implants in the breast involved by BIA-ALCL was 2 (1-8), including at least one silicone implant in 95 (86%) patients, and at least one textured implant in all informative cases (n=102; Most often Allergan Biocell implants). At diagnosis of BIA-ALCL, 78/110 (71%) patients presented with periprosthetic effusion only, 20 (18%) had effusion and a breast mass, 6 (5.5%) had a breast mass only, and 6 (5.5%) had neither. At pathological examination of the capsule, T-stage was T1 (confined to effusion or a layer on luminal side of capsule) in 73/111 (66%) cases, T2-T3 (capsule infiltration) in 5 (4.5%) cases, T4 (lymphoma infiltrates beyond the capsule) in 32 (29%) cases, and unclassifiable in 1 case. Moreover, 18/111 (16%) patients had at least one non-breast extranodal involvement. Among the 36 patients with capsule infiltration (5 T2-T3 and 31 T4), 13 (including 11 T4) were treated with BV-CH(E)P regimen, 12 (all T4) with a CHOP/CHOP-like regimen, and 11 (including 8 T4) did not receive any chemotherapy. The main reasons for receiving chemotherapy were metastatic disease, incomplete resection, or no surgery. Patients who did not receive chemotherapy had a localized disease (3 stage IB/IC and 8 stage IIA) with complete en-bloc excision and no residual disease. Patients treated with BV-CH(E)P regimen and CHOP/CHOP-like regimen had similar characteristics without significant differences regarding age, clinical presentation, stage and surgery. After a median follow-up of 47 months from BIA-ALCL diagnosis, for BV-CH(E)P and CHOP/CHOP-like groups, the respective 4-year PFS rates were 100% and 57% (p=0.01), and the respective 4-year OS rates were 100% and 73% (p=0.07). Regarding the 11 patients who did not receive chemotherapy, 4-year PFS and OS were both 75%, which corresponds to a single event being a death without progression occurring more than 3 years after the diagnosis of lymphoma (4-year lymphoma-specific survival was 100%). Conclusions: 1) In patients with capsule infiltration requiring chemotherapy, BV-CH(E)P regimen was associated with improved PFS and OS compared with CHOP/CHOP-like regimen; 2) Patients with stage IIA and complete en-bloc excision without residual disease had favorable outcome without the need for adjuvant chemotherapy. These results should be confirmed prospectively.