Triple-negative breast cancer outcomes: Does AJCC 8th staging improve chemotherapy decision-making

 

Triple-negative breast cancer outcomes: Does AJCC 8th staging improve chemotherapy decision-making

by Chen-Lu Lian, Guan-Qiao Li, Ping Zhou, Jun Wang, Zhen-Yu He, San-Gang Wu 

The Breast: VOLUME 59, P117-123, OCTOBER 01, 2021

Purpose

To investigate the effect of the 8th American Joint Committee on Cancer (AJCC) pathological prognostic staging on chemotherapy decision-making for triple-negative breast cancer (TNBC) patients with T1-2N0M0 disease.

Methods

Patients diagnosed with T1-2N0M0 TNBC were retrieved from the Surveillance, Epidemiology, and End Results program. Statistical methods including Kaplan-Meier survival curve, receiver operating characteristics curve, and Cox proportional hazard model.

Results

We identified 12,156 patients, including 9371 (77.1%) patients who received chemotherapy. Overall, 57.4% of patients (n = 6975) were upstaged after being reassigned by the 8th AJCC staging. However, the 8th staging of AJCC did not have a greater prognostic value compared to the 7th staging (P = 0.064). The receipt of chemotherapy significantly improved the breast cancer-specific survival for stage T1c and T2 tumors (P < 0.001), but not for stage T1a (P = 0.188) and T1b (P = 0.376) tumors. Using AJCC 8th staging, chemotherapy benefit was only found in stage IIA patients (P = 0.002), but not for stage IA (P = 0.653) and IB (P = 0.492) patients. There were 9564 patients with stage T1c and T2 diseases and 4979 patients with 8th AJCC stage IIA disease. Therefore, approximately half of patients (47.9%, n = 4585) may be safe to omit chemotherapy using the AJCC 8th staging compared to the current chemotherapy recommendation for T1-2N0M0 TNBC.

Conclusion

The 8th AJCC staging system did not demonstrate the superior discriminatory ability of prognostic stratification than the 7th AJCC staging system in T1-2N0M0 TNBC. However, this new AJCC staging could more accurately predict the chemotherapy benefit, thereby enabling more patients to avoid unnecessary chemotherapy.

Characteristics and outcomes of COVID-19 infection in 45 patients with breast cancer: A multi-center retrospective study in Hubei, China

 

Characteristics and outcomes of COVID-19 infection in 45 patients with breast cancer: A multi-center retrospective study in Hubei, China

 

by Jielin Wei, Mengjiao Wu, Jing Liu, Xu Wang, Hua Yang, Pengfei Xia, Ling Peng, Yu Huang, Cuiwei Liu, Zihan Xia, Chuang Chen, Yanxia Zhao 

The Breast: VOLUME 59, P102-109, OCTOBER 01, 2021

 

Background

The COVID-19 pandemic is a significant worldwide health crisis. Breast cancer patients with COVID-19 are fragile and require particular clinical care. This study aimed to identify the clinical characteristics of breast cancer patients with COVID-19 and the risks associated with anti-cancer treatment.

Methods

The medical records of breast cancer patients with laboratory-confirmed COVID-19 were collected among 9559 COVID-19 patients from seven designated hospitals from 13th January to 18th March 2020 in Hubei, China. Univariate and multivariate analyses were performed to assess risk factors for COVID-19 severity.

Results

Of the 45 breast cancer patients with COVID-19, 33 (73.3%) developed non-severe COVID-19, while 12 (26.7%) developed severe COVID-19, of which 3 (6.7%) patients died. The median age was 62 years, and 3 (6.7%) patients had stage IV breast cancer. Univariate analysis showed that age over 75 and the Eastern Cooperative Oncology Group (ECOG) score were associated with COVID-19 disease severity (P < 0.05). Multivariate analysis showed that patients who received chemotherapy within 7 days had a significantly higher risk for severe COVID-19 (logistic regression model: RR = 13.886, 95% CI 1.014–190.243, P = 0.049; Cox proportional hazards model: HR = 13.909, 95% CI 1.086–178.150, P = 0.043), with more pronounced neutropenia and higher LDH, CRP and procalcitonin levels than other patients (P < 0.05).

Conclusions

In our breast cancer cohort, the severity of COVID-19 could be associated with baseline factors such as age over 75 and ECOG scores. Chemotherapy within 7 days before symptom onset could be a risk factor for severe COVID-19, reflected by neutropenia and elevated LDH, CRP and procalcitonin levels.

Biological and clinical features of triple negative Invasive Lobular Carcinomas of the breast. Clinical outcome and actionable molecular alterations

 

Biological and clinical features of triple negative Invasive Lobular Carcinomas of the breast. Clinical outcome and actionable molecular alterations

by Fabio Conforti, Laura Pala, Eleonora Pagan, Elena Guerini Rocco, Vincenzo Bagnardi, Emilia Montagna, Giulia Peruzzotti, Tommaso De Pas, Caterina Fumagalli, Silvana Pileggi, Chiara Pesenti, Sergio Marchini, Giovanni Corso, Caterina Marchio’, Anna Sapino, Rossella Graffeo, Laetitia Collet, Philippe Aftimos, Christos Sotiriou, Martine Piccart, Richard D. Gelber, Giuseppe Viale, Marco Colleoni, Aron Goldhirsch 

The Breast:  VOLUME 59, P94-101, OCTOBER 01, 2021

Background

We report here for the first time, a comprehensive characterization of biological and clinical features of early-stage triple negative Invasive Lobular Carcinomas(TN-ILCs)

Methods

We analyzed all consecutive patients with early-stage TN-ILC operated at two reference cancer-centers between 1994 and 2012.

Primary objective was to assess the invasive disease-free survival(iDFS).

Co-primary objective was to assess biological features of TN-ILCs, including molecular intrinsic subtypes based on PAM-50 assay, expression of androgen receptor (AR) and mutational status of ERBB2-gene.

Additionally, DNA mutational status of an independent cohort of 45 TN-ILCs from three databases were analyzed, to confirm mutations in ERBB2-gene and to identify other recurrently mutated genes.

Results

Among 4152 ILCs, 74(1.8%) were TN and were analyzed.

The iDFS at 5 and 10 years of FUP were 50.4%(95%CI,38.0–61.6) and 37.2%(95%CI,25.5–48.8), respectively.

The molecular subtype was defined through PAM50-classifier for 31 out of 74 TN-ILCs: 48% were Luminal-A(15/31), 3% luminal-B(1/31), 32% HER2-enriched (10/31), and only 16% basal-like(5/31).

Luminal tumors expressed AR more frequently than non-luminal tumors (AR≥1% in 94% of luminal tumors versus 53% in non-luminal tumors; p-value = 0.001).

20% of TN-ILCs analyzed(7/35), harbored a pathogenetic and actionable mutation in the ERBB2-gene. Analysis of the independent cohort of 45 TN-ILCs from three different databases, confirmed similar percentage of pathogenetic and actionable mutations in ERBB2-gene(20%; 9/45).

Among the top 10 molecular pathways significantly enriched for recurrently mutated genes in TN-ILCs(FDR<0.05), there were ErbB-signaling and DNA-damage-response pathways.

Conclusions

TN-ILCs are rare tumors with poor prognosis. Their specific biological features require newly defined targeted therapeutic strategies

Mammographic density and prognosis in primary breast cancer patients

 

Mammographic density and prognosis in primary breast cancer patients

 

by Felix Heindl, Peter A. Fasching, Alexander Hein, Carolin C. Hack, Katharina Heusinger, Paul Gass, Patrik Pöschke, Frederik A. Stübs, Rüdiger Schulz-Wendtland, Arndt Hartmann, Ramona Erber, Matthias W. Beckmann, Julia Meyer, Lothar Häberle, Sebastian M. Jud, Julius Emons 

 

The Breast: Published: June 16, 2021

 

Purpose

Mammographic density (MD) is one of the strongest risk factors for breast cancer (BC). However, the influence of MD on the BC prognosis is unclear. The objective of this study was therefore to investigate whether percentage MD (PMD) is associated with a difference in disease-free or overall survival in primary BC patients.

Methods

A total of 2525 patients with primary, metastasis-free BC were followed up retrospectively for this analysis. For all patients, PMD was evaluated by two readers using a semi-automated method. The association between PMD and prognosis was evaluated using Cox regression models with disease-free survival (DFS) and overall survival (OS) as the outcome, and the following adjustments: age at diagnosis, year of diagnosis, body mass index, tumor stage, grading, lymph node status, hormone receptor and HER2 status.

Results

After median observation periods of 9.5 and 10.0 years, no influence of PMD on DFS (p = 0.46, likelihood ratio test (LRT)) or OS (p = 0.22, LRT), respectively, was found. In the initial unadjusted analysis higher PMD was associated with longer DFS and OS. The effect of PMD on DFS and OS disappeared after adjustment for age and was caused by the underlying age effect.

Conclusions

Although MD is one of the strongest independent risk factors for BC, in our collective PMD is not associated with disease-free and overall survival in patients with BC.

Breast Augmentation with Microtextured Anatomical Implants in 653 Women: Indications and Risk of Rotation

 

Breast Augmentation with Microtextured Anatomical Implants in 653 Women: Indications and Risk of Rotation

 by Weltz, Tim K.; Larsen, Andreas; Hemmingsen, Mathilde N.; Ørholt, Mathias; Rasmussen, Louise E.; Andersen, Peter S.; Sarmady, Faye; Elberg, Jens J.; Vester-Glowinski, Peter V.; Herly, Mikkel 

 Plastic and Reconstructive Surgery: June 2021 - Volume 147 - Issue 6 - p 940e-947e

 Background: 

Anatomical implants provide a wide range of options in terms of implant dimensions for breast augmentation. Nevertheless, many surgeons choose not to use anatomical implants due to the risk of rotation malposition and because their advantages over round implants are not clearly defined.

Methods: 

A retrospective review of medical records was performed on all women who underwent breast augmentation or implant exchange with microtextured anatomical implants from 2012 to 2019 in a single private clinic. The authors focused on the outcomes of a subgroup of women with glandular ptosis and nipple placement below the inframammary fold who underwent breast augmentation with anatomical implants. Furthermore, the incidence and risk factors for implant rotation were analyzed.

Results: 

In total, 653 women underwent primary breast augmentation (n = 529) or implant exchange (n = 124) with anatomical implants. The median follow-up period was 2.7 years (interquartile range, 1.6 to 3.9 years). The incidence of implant rotation was 14 (2.6 percent) in the primary augmentation group and four (3.2 percent) in the implant exchange group. Implant rotation was not associated with type of surgery (p = 0.76), implant projection (p = 0.23), or implant height (p = 0.48). The authors successfully used anatomical implants to elevate the nipple in 92.9 percent of the women with glandular ptosis without using a mastopexy.

Conclusions: 

The study results indicate that the rotation risk with microtextured implants is similar to that with macrotextured implants. Furthermore, the authors found that high-projection anatomical implants can be used as an alternative to augmentation-mastopexy in women with glandular ptosis.

CLINICAL QUESTION/LEVEL OF EVIDENCE: 

Therapeutic, III.

Safety of Routine Pedicle Division during Delayed Breast Augmentation following Free Flap Breast Reconstruction

 

Safety of Routine Pedicle Division during Delayed Breast Augmentation following Free Flap Breast Reconstruction

 

by Rose, Jessica F.; Doval, Andres F.; Zavlin, Dmitry; Ellsworth, Warren A.; Echo, Anthony; Spiegel, Aldona J

 

Plastic and Reconstructive Surgery: June 2021 - Volume 147 - Issue 6 - p 1271-1277

Background: 

Autologous free flap breast reconstruction is a common reconstructive procedure, with the ability to produce a natural breast shape and a long history of success. Despite its benefits, there are special situations in which patients lack sufficient donor-site tissue to achieve adequate breast size and projection. With this study, the authors describe their institutional experience of delayed implant augmentation after autologous breast reconstruction with a particular focus on pedicle division as a technique to improve aesthetic results.

Methods: 

A retrospective chart review of patients that underwent free flap autologous breast reconstruction with delayed implant augmentation was conducted over a 13-year period. Flaps were divided into a control group without pedicle division and a divided pedicle group. Groups were compared in terms of demographics, clinical and surgical characteristics, implant details, and postoperative implant and flap complications.

Results: 

No significant differences in terms of age, body mass index, comorbidities, radiation therapy, or surgical indications were noted. The most common reason for delayed implant augmentation after autologous breast reconstruction was change in breast size and breast asymmetry. In terms of implant and flap complications, we found no significant differences between the control and divided pedicle groups after delayed implant augmentation.

Conclusions: 

From the authors’ institutional experience, pedicle division in delayed breast augmentation with implants after free flap breast reconstruction can be safety performed in selected cases. This technique can be a powerful tool for plastic surgeons to improve the final aesthetic appearance of the reconstructed breast.

CLINICAL QUESTION/LEVEL OF EVIDENCE: 

Therapeutic, III.

Trends in endocrine therapy prescription and survival in patients with non-metastatic hormone receptor positive breast cancer treated with endocrine therapy: A population based-study

 

Trends in endocrine therapy prescription and survival in patients with non-metastatic hormone receptor positive breast cancer treated with endocrine therapy: A population based-study

Jolimoy, Patrick Roignot, Charles Coutant, Isabelle Desmoulins, Marc Maynadie, Tienhan Sandrine Dabakuyo-Yonli 

The Breast: Published: June 11, 2021

Purpose

To identify prognostic factors of invasive–disease free survival (iDFS) in women with non-metastatic hormone receptor positive (HR+) breast cancer (BC) in daily routine practice.

Methods

We performed a retrospective study using data from the Côte d’Or breast and gynecological cancer registry in France. All women diagnosed with primary invasive non-metastatic HR + BC from 1998 to 2015 and treated by endocrine therapy (ET) were included. Women with bilateral tumors or who received ET for either metastasis or relapse were excluded. We performed adjusted survival analysis and Cox regression to identify prognostic factors of iDFS.

Results

A total of 3976 women were included. Age at diagnosis, ET class, SBR grade, treatment, stage and comorbidity were independently associated with iDFS. Women who had neither surgery nor radiotherapy had the highest risk of recurrence (HR = 3.75, 95%CI [2.65–5.32], p < 0.0001). Receiving aromatase inhibitors (AI) was associated with a lower risk of recurrence (HR = 0.80, 95%CI [0.54–0.90], p = 0.055) compared to tamoxifen. Compared to women with no comorbidities, women with 1 or 2 comorbidities were more likely to receive AI (OR = 1.63, 95%CI [1.22–2.17], p = 0.0009).

Conclusions

Comorbidities, age at diagnosis and previous treatment were associated with iDFS in non-metastatic HR + BC patients. This study also showed that women who received tamoxifen for their cancer experienced worse iDFS compared to women treated with AI.

Internal mammary node irradiation in node-positive breast cancer treated with mastectomy and taxane-based chemotherapy

 

Internal mammary node irradiation in node-positive breast cancer treated with mastectomy and taxane-based chemotherapy

 

by Won Kyung Cho, Jee Suk Chang, Seung Gyu Park, Nalee Kim, Doo Ho Choi, Haeyoung Kim, Yong Bae Kim, Won Park, Chang Ok Suh 

 

The Breast: VOLUME 59, P37-43, OCTOBER 01, 2021

 

Background

It is important to continually reevaluate the risk/benefit calculus of internal mammary node irradiation (IMNI) in the era of modern systemic therapy. We aimed to investigate the effect of IMNI on survival in node-positive breast cancer treated with mastectomy and anthracycline plus taxane-based chemotherapy.

Methods

We analyzed 348 patients who underwent mastectomy and anthracycline plus taxane-based chemotherapy for node-positive breast cancer between January 2006 and December 2011. All patients received postoperative radiation therapy (RT) with IMNI (n = 105, 30.2%) or without IMNI (n = 243, 69.8%). The benefit of IMNI for disease-free survival (DFS) and overall survival (OS) was evaluated using multivariate analysis and inverse probability of treatment weighting (IPTW) to adjust for unbalanced covariates between the groups.

Results

After a median follow-up of 95 months, the 10-year locoregional recurrence-free survival rate, DFS, and OS in all patients were 94.8%, 77.4%, and 86.2%, respectively. The IPTW-adjusted hazard ratio (HR) for the association of IMNI (vs. no IMNI) with DFS and OS was 0.208 (95% confidence intervals (CI) 0.045–0.966) and 0.460 (95% CI, 0.220–0.962), respectively. In multivariate analysis, IMNI was a favorable factor for DFS (HR, 0.458; P = 0.021) and OS (HR 0.233, P = 0.018).

Conclusions

IMNI was associated with improved DFS and OS in node-positive patients treated with mastectomy, post-mastectomy RT, and taxane-based chemotherapy, although the rate of locoregional recurrence was low.

“To Pre or Not to Pre”: Introduction of a Prepectoral Breast Reconstruction Assessment Score to Help Surgeons Solving the Decision-Making Dilemma. Retrospective Results of a Multicenter Experience

 

“To Pre or Not to Pre”: Introduction of a Prepectoral Breast Reconstruction Assessment Score to Help Surgeons Solving the Decision-Making Dilemma. Retrospective Results of a Multicenter Experience

 

by Casella, Donato; Kaciulyte, Juste; Lo Torto, Federico; Mori, Francesco L. R.; Barellini, Leonardo; Fausto, Alfonso; Fanelli, Benedetta; Greco, Manfredi; Ribuffo, Diego; Marcasciano, Marco 

 

Plastic and Reconstructive Surgery: June 2021 - Volume 147 - Issue 6 - p 1278-1286

 

Background: Implant-based reconstruction is the most performed breast reconstruction, and both subpectoral and prepectoral approaches can lead to excellent results. Choosing the best procedure requires a thorough understanding of every single technique, and proper patient selection is critical to achieve surgical success, in particular when dealing with prepectoral breast reconstruction.

Methods: Between January of 2014 and December of 2018, patients undergoing mastectomy and eligible for immediate prepectoral breast reconstruction with tissue expander or definitive implant, were selected. The Prepectoral Breast Reconstruction Assessment score was applied to evaluate patient-related preoperative and intraoperative risk factors that could influence the success of prepectoral breast reconstruction. All patients were scored retrospectively, and the results obtained through this assessment tool were compared to the records of the surgical procedures actually performed.

Results: Three hundred fifty-two patients were included; 112 of them underwent direct-to-implant immediate reconstruction, and 240 underwent the two-stage procedure with temporary tissue expander. According to the Prepectoral Breast Reconstruction Assessment score, direct-to-implant reconstruction should have been performed 6.2 percent times less, leading to an increase of 1.4 percent in two-stage reconstruction and 4.8 percent in submuscular implant placement.

Conclusions: To date, there is no validated system to guide surgeons in identifying the ideal patient for subcutaneous or retropectoral breast reconstruction and eventually whether she is a good candidate for direct-to-implant or two-stage reconstruction. The authors processed a simple risk-assessment score to objectively evaluate the patient’s risk factors, to standardize the decision-making process, and to identify the safest and most reliable breast reconstructive procedure. CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, IV.

BIA-ALCL and Textured Breast Implants: A Systematic Review of Evidence Supporting Surgical Risk Management Strategies

 

BIA-ALCL and Textured Breast Implants: A Systematic Review of Evidence Supporting Surgical Risk Management Strategies

 by Nelson, Jonas A.; McCarthy, Colleen; Dabic, Stefan; Polanco, Thais; Chilov, Marina; Mehrara, Babak J.; Disa, Joseph J

 Plastic and Reconstructive Surgery: May 2021 - Volume 147 - Issue 5S - p 7S-13S

 Background:  Breast implant–associated anaplastic large cell lymphoma (BIA-ALCL) is a significant public health concern for women with breast implants. The increase in incidence rates underscores the need for improved methods for risk reduction and risk management. The purpose of this study was to perform a systematic review to assess surgical risk reduction techniques and analyze communication/informed consent practices in patients with textured implants.

 Methods: A systematic review of the literature was conducted in PubMed (legacy), Embase (Embase.com), and Scopus with four search strategies including key terms centered around breast reconstruction and BIA-ALCL.

Results: A total of 571 articles were identified, of which 276 were included in the final review after duplicates were removed. After review, no articles were determined to fit the inclusion criteria of demonstrating data-driven evidence of BIA-ALCL risk reduction through surgical measures, demonstrating a significant lack of data on risk reduction for BIA-ALCL.

Conclusions: Risk management for BIA-ALCL is an evolving area requiring additional investigation. Although removal of textured devices in asymptomatic patients is not currently recommended by the Food and Drug Administration, variability in estimates of risk has led many patients to electively replace these implants in an effort to decrease their risk of developing BIA-ALCL. To date, however, there is no evidence supporting the concept that replacing textured implants with smooth implants reduces risk for this disease. This information should be used to aid in the informed consent process for patients presenting to discuss management of textured breast implants.

Chemotherapy de-escalation using an 18F-FDG-PET-based pathological response-adapted strategy in patients with HER2-positive early breast cancer (PHERGain): a multicentre, randomised, open-label, non-comparative, phase 2 trial

 

Chemotherapy de-escalation using an 18F-FDG-PET-based pathological response-adapted strategy in patients with HER2-positive early breast cancer (PHERGain): a multicentre, randomised, open-label, non-comparative, phase 2 trial

 

by José Manuel Pérez-García, Geraldine Gebhart, Manuel Ruiz Borrego, Agostina Stradella, Begoña Bermejo, Peter Schmid, Frederik Marmé, Santiago Escrivá-de-Romani, Lourdes Calvo, Nuria Ribelles, Noelia Martinez, Cinta Albacar, Aleix Prat, Florence Dalenc, Khaldoun Kerrou, Marco Colleoni, Noemia Afonso, Serena Di Cosimo, Miguel Sampayo-Cordero, Andrea Malfettone, Javier Cortés, Antonio Llombart-Cussac, PHERGain steering committee and trial investigators 

 

The Lancet Oncology: VOLUME 22, ISSUE 6, P858-871, JUNE 01, 2021

 

18F-FDG-PET identified patients with HER2-positive, early-stage breast cancer who were likely to benefit from chemotherapy-free dual HER2 blockade with trastuzumab and pertuzumab, and a reduced impact on global health status. Depending on the forthcoming results for the 3-year invasive disease-free survival endpoint, this strategy might be a valid approach to select patients not requiring chemotherapy.

The role of CDK4/6 inhibitors in early breast cancer

 

The role of CDK4/6 inhibitors in early breast cancer

 

by Miguel Gil-Gil, Emilio Alba, Joaquín Gavilá, Juan de la Haba-Rodríguez, Eva Ciruelos, Pablo Tolosa, Daniele Candini, Antonio Llombart-Cussac 

 

The Breast: VOLUME 58, P160-169, AUGUST  01, 2021

 

The use of cyclin-dependent kinase 4/6 inhibitors (CDK4/6i) has proven to be a successful strategy in the treatment of advanced hormone receptor-positive (HR+) and human epidermal growth factor receptor 2-negative (HER2 -) breast cancer (BC), leading to a strong interest in their possible role in the treatment of early luminal BC. In this review we collect the most relevant and recent information on the use of CDK4/6i for the treatment of early BC in the neoadjuvant and adjuvant settings. Specifically, we evaluate the results of the large phase 3 adjuvant trials recently released, which have yielded apparently divergent results.

Revision Breast Reconstruction with Prepectoral Pocket Conversion of Submuscular Breast Implants

 

Revision Breast Reconstruction with Prepectoral Pocket Conversion of Submuscular Breast Implants

 

by Kraenzlin, Franca; Chopra, Karan; Kokosis, George; Venturi, Mark L.; Mesbahi, Ali; Nahabedian, Maurice Y.

 

Plastic and Reconstructive Surgery: May 2021 - Volume 147 - Issue 5 - p 743e-748e

 

Background:

Prepectoral reconstruction using prosthetic devices has demonstrated a notable increase in popularity and confers a number of advantages over subpectoral placement, including minimal animation, no pain secondary to muscle spasm, and less device displacement or malposition. As such, more women with implants in the dual-plane position are seeking a remedy for animation deformities, chronic pain caused by muscle spasm, and implant malposition. The purpose of this study was to review outcomes following the conversion from subpectoral to prepectoral implant placement.

 Methods:

This was a retrospective review of 63 patients who underwent breast implant conversion from the subpectoral plane to the prepectoral plane from 2009 to 2019.

Results:

 A total of 73 implant pocket conversions from subpectoral to prepectoral were performed on 41 women who met inclusion criteria for this study. The mean time interval from the initial subpectoral operation to the prepectoral conversion was 1608.4 days. The reasons cited for prepectoral conversion was animation deformity (87.8 percent), significant levels of pain related to the implant (34.1 percent), capsular contracture (26.8 percent), or asymmetries and implant displacements (9.8 percent); 7.8 percent of individuals continued to experience their presenting symptom after plane conversion. Rippling and wrinkling were noted in 19.5 percent of individuals and edge visibility was documented in 4.9 percent. Complication rates were low, and no patients experienced necrosis of the mastectomy flap or nipple-areola complex.

Conclusions:

The use of prepectoral conversion for revision implant-based breast reconstruction successfully resolves animation deformity. This technique can be reliably and safely performed in a variety of patient demographics. CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, IV.

Management of Symptomatic Patients with Textured Implants

 

Management of Symptomatic Patients with Textured Implants

 

by Asaad, Malke; Offodile, Anaeze C.; Santanelli Di Pompeo, Fabio; Bevers, Therese B.; Stelly, Sharon; Carew, Lori A.; Barnea, Yoav; Miranda, Roberto N.; Butler, Charles E.; Clemens, Mark W.

 

Plastic and Reconstructive Surgery: May 2021 - Volume 147 - Issue 5S - p 58S-68S

 

Summary:

 Proper management of symptomatic textured implant patients is critical to identify and treat associated oncologic disease. Textured surface breast implants were first introduced more than 50 years ago in an effort to decrease high rates of capsular contracture and implant malposition observed with first-generation smooth surface breast implants. Textured implants were dominant over smooth devices in the United States in the late 1990s, but they fell out of favor for newer-generation smooth implants, while texture remained the dominant selling implants worldwide until recently. A class I device recall by the US Food and Drug Administration in 2019 precipitated a removal of the highest selling implant worldwide, Allergan Biocell, due to a disproportionately increased risk of breast implant–associated anaplastic large cell lymphoma (BIA-ALCL). Operative strategies, such as bacterial control at the time of textured implant insertion, have not been credibly shown to affect or prevent the future development of BIA-ALCL. BIA-ALCL patients require complete surgical excision of their disease, whereas textured implant patients who are otherwise asymptomatic do not require surgical removal. For suspicious cases, diagnostic testing with CD30 immunohistochemistry should be performed before any surgical intervention. Capsules are evaluated with 12 strategic regional biopsies in a standardized approach. If surgeons are revising or exchanging textured implants, they may reasonably consider a total capsulectomy, though this is not advocated by the Food and Drug Administration or national societies, and has not been shown to mitigate future risk of BIA-ALCL. The purpose of this article is to review data on and outcomes for textured surface implants, disease-associated risk, and the management strategy for revisionary surgery and device surveillance.

Trastuzumab emtansine for HER2-positive metastatic breast cancer: Outcomes from a whole-of-population Australian cohort

 

Trastuzumab emtansine for HER2-positive metastatic breast cancer: Outcomes from a whole-of-population Australian cohort

by Benjamin Daniels, Belinda E. Kiely, Monica Tang, Nehmat Houssami, Sarah J. Lord, Sallie-Anne Pearson 

The Breast: Published: May 07, 2021

Highlights

•Real-world T-DM1 recipients are older than trial participants.

•Real-world T-DM1 recipients have more prior pertuzumab exposure than trial participants.

•Median overall survival was 10 months shorter than that reported from the trial.

Purpose

We aim to describe the treatment patterns and overall survival (OS) outcomes in patients receiving trastuzumab emtansine (T-DM1) for HER2-positive metastatic breast cancer (HER2+MBC) in routine clinical care.

Methods

Retrospective, whole-of-population cohort study of people initiating T-DM1 for HER2+MBC between October 2015 and May 2019 in Australia. We used dispensing claims to estimate time-to-T-DM1 initiation, duration of treatment, and treatments administered prior to and following T-DM1 therapy. We estimated OS from T-DM1 initiation and stratified results based on whether patients received first- or second-line T-DM1 treatment. We benchmarked outcomes to those reported in the pivotal, EMILIA trial.

Results

345 patients initiated T-DM1: 309 as second-line therapy for HER2+MBC and 36 as first-line therapy. 51% of patients had received endocrine therapy and 98% of second-line patients received pertuzumab prior to starting T-DM1. The median age was 57 years (53 in EMILIA); median time-to-T-DM1 initiation from start of HER2-targeted therapy for HER2+MBC was 11.6 months (IQR: 7.9–16.6); median duration of T-DM1 treatment was 6.5 months (3.1–13.5; 7.6 months in EMILIA), and median OS was 19.3 months (7.9–29.5; 29.9 months in EMILIA).

Conclusions

Our findings highlight differences in patient characteristics (older, more previous pertuzumab therapy) and outcomes (shorter OS) from the T-DM1 pivotal trial and provide real-world estimates that can inform patient, clinician and policy, decisions around the use of HER2-targeted therapies in routine clinical care.

Locoregional therapy in de novo metastatic breast cancer. The unanswered question

 

Locoregional therapy in de novo metastatic breast cancer. The unanswered question

by Maria-Joao Cardoso, Kefah Mokbel 

The Breast: Published: May 07, 2021

Breast cancer has now overtaken lung cancer as the world's mostly commonly-diagnosed cancer, according to statistics released by the International Agency for Research on Cancer (IARC) in December 2020. Five to eight percent of newly diagnosed breast cancer cases are metastatic at diagnosis. Intriguingly this number has not changed over the last decade even with the widespread use of more sensitive systemic staging modalities like PET-CT.

[Articles] Intraoperative irradiation for early breast cancer (ELIOT): long-term recurrence and survival outcomes from a single-centre, randomised, phase 3 equivalence trial

 

[Articles] Intraoperative irradiation for early breast cancer (ELIOT): long-term recurrence and survival outcomes from a single-centre, randomised, phase 3 equivalence trial

by Roberto Orecchia, Umberto Veronesi, Patrick Maisonneuve, Viviana Enrica Galimberti, Roberta Lazzari, Paolo Veronesi, Barbara Alicja Jereczek-Fossa, Federica Cattani, Claudia Sangalli, Alberto Luini, Pietro Caldarella, Marco Venturino, Daniele Sances, Stefano Zurrida, Giuseppe Viale, Maria Cristina Leonardi, Mattia Intra 

The Lancet Oncology : VOLUME 22, ISSUE 5, P597-608, MAY 01, 2021

Background

In the randomised, phase 3 equivalence trial on electron intraoperative radiotherapy (ELIOT), accelerated partial breast irradiation (APBI) with the use of intraoperative radiotherapy was associated with a higher rate of ipsilateral breast tumour recurrence (IBTR) than whole-breast irradiation (WBI) in patients with early-stage breast cancer. Here, we aimed to examine the planned long-term recurrence and survival outcomes from the ELIOT trial.

Methods

This single-centre, randomised, phase 3 equivalence trial was done at the European Institute of Oncology (Milan, Italy). Eligible women, aged 48–75 years with a clinical diagnosis of a unicentric breast carcinoma with an ultrasound diameter not exceeding 25 mm, clinically negative axillary lymph nodes, and who were suitable for breast-conserving surgery, were randomly assigned (1:1) via a web-based system, with a random permuted block design (block size of 16) and stratified by clinical tumour size, to receive post-operative WBI with conventional fractionation (50 Gy given as 25 fractions of 2 Gy, plus a 10 Gy boost), or 21 Gy intraoperative radiotherapy with electrons (ELIOT) in a single dose to the tumour bed during surgery. The trial was open label and no-one was masked to treatment group assignment. The primary endpoint was the occurrence of IBTR. The trial was designed assuming a 5-year IBTR rate of 3% in the WBI group and equivalence of the two groups, if the 5-year IBTR rate in the ELIOT group did not exceed a 2·5 times excess, corresponding to 7·5%. Overall survival was the secondary endpoint. The main analysis was done by intention to treat. The cumulative incidence of IBTR events and overall survival were assessed at 5, 10, and 15 years of follow-up. This trial is registered with ClinicalTrials.gov, NCT01849133.

Findings

Between Nov 20, 2000, and Dec 27, 2007, 1305 women were enrolled and randomly assigned: 654 to the WBI group and 651 to the ELIOT group. After a median follow-up of 12·4 years (IQR 9·7–14·7), 86 (7%) patients developed IBTR, with 70 (11%) cases in the ELIOT group and 16 (2%) in the WBI group, corresponding to an absolute excess of 54 IBTRs in the ELIOT group (HR 4·62, 95% CI 2·68–7·95, p<0·0001). In the ELIOT group, the 5-year IBTR rate was 4·2% (95% CI 2·8–5·9), the 10-year rate was 8·1% (6·1–10·3), and the 15-year rate was 12·6% (9·8–15·9). In the WBI group, the 5-year IBTR rate was 0·5% (95% CI 0·1–1·3), the 10-year rate was 1·1% (0·5–2·2), and the 15-year rate was 2·4% (1·4–4·0). At final follow-up on March 11, 2019, 193 (15%) women had died from any cause, with no difference between the two groups (98 deaths in the ELIOT group vs 95 in the WBI group; HR 1·03, 95% CI 0·77–1·36, p=0·85). In the ELIOT group, the overall survival rate was 96·8% (95% CI 95·1–97·9) at 5 years, 90·7% (88·2–92·7) at 10 years, and 83·4% (79·7–86·4) at 15 years; and in the WBI group, the overall survival rate was 96·8% (95·1–97·9) at 5 years, 92·7% (90·4–94·4) at 10 years, and 82·4% (78·5–85·6) at 15 years. We did not collect long-term data on adverse events.

Interpretation

The long-term results of this trial confirmed the higher rate of IBTR in the ELIOT group than in the WBI group, without any differences in overall survival. ELIOT should be offered to selected patients at low-risk of IBTR.

Preoperative non-palpable breast lesion localization, innovative techniques and clinical outcomes in surgical practice: a systematic review and meta-analysis

 

Preoperative non-palpable breast lesion localization, innovative techniques and clinical outcomes in surgical practice: a systematic review and meta-analysis

 

by Francesco Garzotto, Rosanna Irene Comoretto, Silvia Michieletto, Gianpaolo Franzoso, Marcello Lo Mele, Dario Gregori, Maria Giuseppina Bonavina, Fernando Bozza, Francesca Caumo, Tania Saibene 

The Breast: VOLUME 58, P93-105, AUGUST 01, 2021

Highlights

•Positioning and localization of reflectors' is nearly of the 100% rate of success. Overall, positive margins rates were 12% (8–17%).

•The re-excision and clear margins rates were 12% (95% CI, 8–17%) and 87% (80–92%), respectively.

•Comparing NWNI and WGL techniques, positive margin rate is lower for the first one and re-excision rate is slightly higher using the latter.

•This technology overcomes the limitations related to other techniques: migrations, the coordination between radiology and surgery, the use of radioactive substances.

•The procedure is comfortable for the radiologist while allow surgeon at resecting the non-palpable lesions ensuring clear margins, avoiding the re-excisions.

•The cosmetic outcome can be obtained minimizing the resection of healthy-tissue.

Abstract

Pre-operative localization of non-palpable breast lesions with non-wired non-ionizing (NWNI) techniques may improve clinical outcomes as reoperation rate, cosmetic outcome and contribute to organizational aspects improvement in breast-conserving surgery (BCS). However only limited literature is available and clinical studies involving these forefront devices are often small and non-randomized. Furthermore, there is a lack of consensus on free margins and cosmetic outcomes definitions. The objective of the present meta-analysis was to determine the crude clinical outcomes reported for the NWNI techniques on BCS. A literature search was performed of PubMed, Embase and Scopus databases up to February 2021 in order to select all prospective or retrospective clinical trials on pre-operative breast lesion localization done with NWNI devices. All studies were assessed following the PRISMA recommendations. Continuous outcomes were described in averages corrected for sample size, while binomial outcomes were described using the weighted average proportion.

Twenty-seven studies with a total of 2103 procedures were identified. The technique is consolidated, showing for both reflectors’ positioning and localization nearly the 100% rate of success. The re-excision and clear margins rates were 14% (95% CI, 11–17%) and 87% (80–92%), respectively. Overall, positive margins rates were 12% (8–17%). In studies that compared NWNI and wire localization techniques, positive margin rate is lower for the first techniques (12%, 6–22% vs 17%, 12–23%) and re-excision rate is slightly higher using the latter (13%, 9–19% vs 16%, 13–18%).

Pre-operative NWNI techniques are effective in the localization of non-palpable breast lesions and are promising in obtaining clear (or negative) margins minimizing the need for re-excision and improving the cosmetic outcomes. Randomized trials are needed to confirm these findings.

Prediction of severe neutropenia and diarrhoea in breast cancer patients treated with abemaciclib

 

Prediction of severe neutropenia and diarrhoea in breast cancer patients treated with abemaciclib

 

by Natansh D. Modi, Ahmad Y. Abuhelwa, Sarah Badaoui, Emily Shaw, Kiran Shankaran, Ross A. McKinnon, Andrew Rowland, Michael J. Sorich, Ashley M. Hopkins

 

The Breast:  VOLUME 58, P57-62, AUGUST 01, 2021

 

Introduction

Neutropenia and diarrhoea are common and potentially serious adverse events associated with abemaciclib in advanced breast cancer (ABC), and the risk factors have been minimally explored. The study aimed to develop clinical prediction tools that allow personalized predictions of neutropenia and diarrhoea following abemaciclib initiation.

Materials and methods

Data was pooled from MONARCH 1, 2 and 3 trials investigating abemaciclib. Cox proportional hazard analysis was used to assess the association between pre-treatment clinicopathological data and grade ≥3 diarrhoea and neutropenia occurring within the first 365 days of abemaciclib use.

Results

Older age was associated with increased risk of grade ≥3 diarrhoea [HR [95%CI] for age > 70: 1.72 [1.14–2.58]; P = 0.009]. A clinical prediction tool for abemaciclib induced grade ≥3 neutropenia was optimally defined by race, ECOGPS and white blood cell count. Large discrimination between subgroups was observed; the highest risk subgroup had a 64% probability of grade ≥3 neutropenia within the first 365 days of abemaciclib (150 mg twice daily) + fulvestrant/NSAI, compared to 5% for the lowest risk subgroup.

Conclusion

The study identified advanced age as significantly associated with an increased risk of abemaciclib induced grade ≥ 3 diarrhoea. A clinical prediction tool, defined by race, ECOGPS and pre-treatment white blood cell count, was able to discriminate subgroups with significantly different risks of grade ≥3 neutropenia following abemaciclib initiation. The tool may enable improved interpretation of personalized risks and the risk-benefit ratio of abemaciclib.

Not All Breast Explants Are Equal: Contemporary Strategies in Breast Explantation Surgery

 

Not All Breast Explants Are Equal: Contemporary Strategies in Breast Explantation Surgery

 

by Tanna, Neil; Calobrace, M. Bradley; Clemens, Mark W.; Hammond, Dennis C.; Nahabedian, Maurice Y.; Rohrich, Rod J.; Zhang, Ben H.; Bregman, Dana; Perry, Adam D. 

 

Plastic and Reconstructive Surgery: April 2021 - Volume 147 - Issue 4 - p 808-818

 

Summary:

Breast implant removal and replacement has been a common secondary breast procedure in the long-term maintenance of breast augmentation, but more recently growing concerns about silicone-related systemic illness, breast implant-associated anaplastic large cell lymphoma (BIA-ALCL), and changing perceptions of aesthetic beauty have seen breast implant removal without replacement become increasingly requested by patients. Explantation can be challenging, especially when performed with a total capsulectomy. Currently, there is no evidence regarding whether a partial or total capsulectomy has any effect on BIA-ALCL risk mitigation in patients that have textured implants without disease. Total capsulectomy with incomplete resection of a mass can contribute to hyperprogression of BIA-ALCL and death. There have also been cases of BIA-ALCL diagnosed years after removal of the textured device and “total capsulectomy.” Therefore, the common practice of simple prophylactic capsulectomy in a textured implant to mitigate future disease has not been established and at the current time should be discouraged. In addition, aesthetic outcomes can be quite variable, and patients should have appropriate preoperative counseling regarding the indications and contraindications for explantation, associated risks, financial implications, and postoperative appearance. The authors review salient aspects related to the planning and management of breast implant removal.