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.