Tuesday 24 November 2020

Real life efficacy of palbociclib and endocrine therapy in HR positive, HER2 negative advanced breast cancer

 

Real life efficacy of palbociclib and endocrine therapy in HR positive, HER2 negative advanced breast cancer

by B. Porte, M. Carton, F. Lerebours, E. Brain, D. Loirat, L. Haroun, A. Bellesoeur, S. Bach Hamba, Y. Kirova, P. Cottu

The Breast: Open Access, November 13, 2020

Highlights

• Efficacy and safety of palbociclib in the treatment of advanced breast cancer in real-life are very close to those from the pivotal trials.

• In the endocrine naive and endocrine sensitive population, we have highlighted three poor prognostic factors ECOG performance status 2, previous endocrine therapy for advanced breast cancer and three metastatic sites or more.

ABSTRACT

Background Palbociclib is indicated for the treatment of hormone receptor-positive (HR+), HER2-negative (HER2-) advanced breast cancer (ABC), in combination with endocrine therapy. Emerging real-life data suggest that the efficacy of a palbociclib-based therapy is highly conserved. We report the Institut Curie hospital experience.Patients and methods We retrospectively reviewed all patients with HR+ HER2- ABC treated with a palbociclib-based therapy as first or second line for ABC, with an initial prescription from November 2016 to December 2018. Clinical, laboratory and imaging data were retrieved from electronic records. Data lock was December 31st, 2019. Descriptive analyses, univariate and multivariate Cox regression analyses were performed. Results We included 310 consecutive patients. Median age was 61.8 years old. Palbociclib was prescribed in first line in 225 patients (72.6%). Before palbociclib-based therapy initiation, 122 patients (39.3%) were endocrine naive, 96 (31.0%) endocrine sensitive and 92 (29.7%) endocrine resistant. Median follow-up was 20.7 months. Median progression free survival (PFS) was 23.4 months (95%CI: 21.6-NR) in endocrine naive patients, 22.7 months (95%CI: 14.7-NR) in endocrine sensitive, and 13.4 months (95%CI: 10.7-20.8) in endocrine resistant. At 12 months from the initiation of palbociclib, 94.5% of patients were alive. By multivariate analysis, poor prognosis factors for PFS were identified in the endocrine naive/sensitive population: initial ECOG status 2, previous endocrine therapy for ABC, 3 metastatic sites or more. Toxicity profile was similar to previously published data.Conclusion In a non-selected population of patients with HR+ HER2- ABC, the efficacy and safety data are strikingly similar to those previously reported.

Palbociclib combined with endocrine therapy in heavily pretreated HR+/HER2- advanced breast cancer patients: results from the Compassionate Use Program in Spain (PALBOCOMP)

 

Palbociclib combined with endocrine therapy in heavily pretreated HR+/HER2- advanced breast cancer patients: results from the Compassionate Use Program in Spain (PALBOCOMP)

 

The Breast:  VOLUME 54, P286-292, DECEMBER 01, 2020

 

Highlights

• CDK4/6 inhibitors combined with endocrine therapy have been widely accepted as a new standard therapy for hormone receptor-positive metastatic breast cancer patients in first or second line.

• Palbociclib alone or in combination with aromatase inhibitors, fulvestrant, or tamoxifen was effective and safe in heavily pretreated HR+/HER2- metastatic breast cancer patients.

• Palbociclib could be of higher benefit to patients with endocrine-sensitive disease that had a long duration of response to previous endocrine therapy.

• Real-world evidence of effectiveness and safety of use of palbociclib in heavily pretreated advanced breast cancer patients complements data from randomized clinical trials.

Abstract

Background

This study evaluated efficacy and safety of palbociclib, a CDK4/6 inhibitor, in heavily-pretreated hormone receptor-positive and human epidermal growth factor receptor 2-negative (HR+/HER2-) metastatic breast cancer (mBC) patients during the compassionate use program in Spain from February 2015 to November 2017.

Patients and methods

Patient data were collected retrospectively from 35 hospitals in Spain. Patients with HR+/HER2- mBC who had progressed on ≥4 treatments for advanced disease were eligible.

Results

A total of 219 patients received palbociclib in combination with aromatase inhibitors (110; 50.2%), fulvestrant (87; 39.7%), tamoxifen (8; 3.6%) or as single agent (10; 4.6%). Mean age of the patients was 58 years; 31 patients (16.1%) were premenopausal and 162 (83.9%) were postmenopausal at the beginning of treatment with palbociclib. Patients had received a median of 3 previous lines of endocrine therapy (ET) for advanced disease. Real-world tumor response (rwTR) and clinical benefit rate were 5.9% (n = 13) and 46.2% (n = 101), respectively. The median real world progression-free survival (rwPFS) was 6.0 months (95% CI 5.7–7.0) and the median overall survival was 19.0 months (95% CI 16.4–21.7). Subgroup analysis revealed a significant difference in median rwPFS in patients treated with palbociclib plus fulvestrant depending on the duration of prior treatment with fulvestrant monotherapy (>6 versus ≤6 months; HR 1.93, 95% CI 1.37–2.73, p < 0.001). The most frequently reported toxicities were neutropenia, asthenia, thrombopenia and anemia.

Conclusions

Palbociclib can be an effective and safe treatment option in patients with heavily pretreated endocrine-sensitive mBC, especially in those with longer PFS to previous ET.

Peripheral cytotoxic T lymphocyte predicts first-line progression free survival in HER2-positive advanced breast cancer

 

Peripheral cytotoxic T lymphocyte predicts first-line progression free survival in HER2-positive advanced breast cancer

 

by Xiao-Ran Liu, Jian-Jun Yu, Guo-Hong Song, Li-Jun Di, Han-Fang Jiang, Ying Yan, Xu Liang, Ru-Yan Zhang, Ran Ran, Jing Wang, Han Bai, Shi-Dong Jia, Hui-Ping Li

 

The Breast: Open Access, November 11, 2020

 

Highlights

•High pCTL level predicts shorter first-line PFS in HER2-positive patients receiving anti-HER2 based regimens.

•The predictive role of pCTL level found in HER2-positive patients was not applicable in hormone-positive and triple-negative breast cancer patients.

•High level of pCTL was associated with immunosuppressive status and FGFR1 mutations in HER2-positive breast cancer patients.

Abstract 

Background

The role of peripheral blood lymphocyte (pBL) in breast cancer has long been studied. However, the predictive role of pBL in advanced breast cancer (ABC) is poorly understood.

Methods

A total of 303 patients with ABC were consecutively recruited at our center between January 2015 and September 2019. At baseline, pBL subtypes were detected in all patients with 229 blood samples available for circulating tumor DNA (ctDNA) detection. pBL was analyzed through flow cytometry. ctDNA-based gene mutations were detected using next generation sequencing. The cutoff value of pCTL was estimated by X-tile software. Progression free survival (PFS) was estimated by Kaplan-Meier curve and Cox hazard proportion regression model, with difference detection by log-rank test.

Results

Median follow-up time of the study was 21.0 months. The median age of diagnosis was 52.0 years. Among the pBL subtypes, only pCTL level was found predictive for PFS in the HER2+ patients whom received anti-HER2 therapy (13.1 vs. 5.6 months, P = 0.001). However, the predictive role of pCTL was not found in HR-positive (P = 0.716) and TNBC (P = 0.202). pCTL high associated with suppressive immune indictors including lower CD4/CD8 ratio (P = 0.004) and high level of Treg cell (P = 0.004). High occurrence of FGFR1 amplification which has been reported as immune suppressor was also found in HER2+ patients with pCTL high (22.2% vs. 4.3%, P = 0.048).

Conclusions

Higher pCTLs level associated with shorter PFS and FGFR1 mutation in HER2+ ABC patients.

Breast ultrasound in breast cancer surveillance; incremental cancers found at what cost?

 

Breast ultrasound in breast cancer surveillance; incremental cancers found at what cost?

 

by Dr. Luke Bromley, Dr. Jennifer Xu, Mr. Su-Wen Loh, Dr. Grace Chew, Eddie Lau, Dr. Belinda Yeo 

 

The Breast: VOLUME 54, P272-277, DECEMBER 01, 2020

 

Highlights

• Breast ultrasound in asymptomatic surveillance after breast cancer surgery was found to have a sensitivity of 44.1%.

• Breast ultrasound detected 7 recurrences in 390 patients who did not meet criteria for adjunct breast US and had normal mammography

• Breast ultrasound generated 26 additional biopsies per 1000 US compared to mammography in surveillance, creating considerablecosts.

• Cancer detection by breast US alone did not lead to statistically significant survival benefit over mammography.

Abstract

Purpose

To determine the diagnostic parameters of breast ultrasound (US) in the setting of routine radiological surveillance after a diagnosis of breast cancer and evaluate costs of the inclusion of breast US as well as any survival benefit of US detected cases of recurrence in surveillance.

Methods

622 patients underwent breast cancer surgery and follow up at Austin Health from July 2009 to December 2015. Retrospective data analysis was performed to determine; diagnostic parameters, financial costs of US and survival outcomes of US detected cases of recurrence.

Results

Patients underwent 1–9 years of breast cancer surveillance, with a median of 4.24 years. 390 (62.7%) patients underwent additional breast US surveillance to mammography. 232 (38.3%) fit criteria for use of additional breast US. 199 abnormal imaging episodes occurred, leading to 16 screen detected-cases of locoregional recurrence. US alone generated 107 abnormal images and found 9 cancers. US had a sensitivity of 44.1%, specificity of 95.2% and positive predictive value of 11.7% in comparison to mammography; 20.6%, 97.4% and 9.9% respectively. US had a biopsy rate of 4.0% and lead to an incremental cancer detection rate of 0.38%. The cost of incremental cancer found was $31,463.72 AUD. Survival outcomes based on method of detection of recurrence were insignificant (p value = 0.71).

Conclusions

Breast US has a sensitivity of 44.1% and detected seven recurrences that were mammographically occult. Breast US has a similar PPV to mammography in surveillance. Breast US generated considerable biopsy rates and costs. Survival analysis was not able to detect any benefit of US detected cases of recurrence.

Individualized-thresholding Shear Wave Elastography Combined with Clinical Factors Improves Specificity in Discriminating Breast Masses

 Individualized-thresholding Shear Wave Elastography Combined with Clinical Factors Improves Specificity in Discriminating Breast Masses

 

by Juanjuan Gu, Eric C. Polley, Redouane Ternifi, Rohit Nayak, Judy C. Boughey, Robert T. Fazzio, Mostafa Fatemi, Azra Alizad

 

The Breast:  VOLUME 54, P248-255, DECEMBER 01, 2020

 

Highlights

•Larger mass size and lower mass depth increase false positives in breast SWE.

•Smaller mass size and increased mass depth increase false negatives in breast SWE.

•Individualized elasticity cutoffs based on lesion size and depth improves the specificity.

•Multifactorial analysis including age, individualized cutoffs, BIRADS improves sensitivity/specificity.

•Mammographic breast density does not affect the SWE measurements of breast masses.

Abstract

Purpose

To investigate the diagnostic role of new metrics, defined as individualized-thresholding of Shear Wave Elastography (SWE) parameters, in association with clinical factors (such as age, mammographic density, lesion size and depth) and the BI-RADS features in differentiating benign from malignant breast lesions.

Methods

Of 644 consecutive patients (median age, 55 years), prospectively referred for evaluation, 659 ultrasound detected breast lesions underwent SWE measurements. Multivariable logistic regression analysis was used to estimate the probability of malignancy. The area under the curve (AUC), optimal cutoff value, and the corresponding sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) were determined.

Results

265 of 659 (40.2%) masses were malignant. Using two Emean cutoffs, 69.6 kPa for large superficial lesions (size >10 mm, depth ≤5 mm) and 39.2 kPa for the rest, the overall specificity, sensitivity, PPV and NPV were 92.6%, 86.8%, 88.8% and 91.3%, respectively. Combining multiple factors, including Emean with two cutoffs, age and BI-RADS, the new ROC curve based on the malignancy probability calculation showed the highest AUC (0.954, 95% CI: 0.938–0.969). Using the optimal probability threshold of 0.514, the corresponding specificity, sensitivity, PPV and NPV were 92.9%, 89.1%, 89.4% and 92.7%, respectively.

Conclusions

The false-positive rate can be significantly reduced when applying two Emean cutoffs based on lesion size and depth. Moreover, the combination of age, Emean with two cutoffs and BI-RADS can further reduce the false negatives and false positives. Overall, this multifactorial analysis improves the specificity of ultrasound while maintaining a high sensitivity.

Neoumbilicus after Selective Excision in Deep Inferior Epigastric Perforator Flap Breast Reconstruction

 Neoumbilicus after Selective Excision in Deep Inferior Epigastric Perforator Flap Breast Reconstruction

 

by Haddock, Nicholas T.; Kelling, Joseph A.; Teotia, Sumeet S. 

 

Plastic and Reconstructive Surgery: November 2020 - Volume 146 - Issue 5 - p 548e-551e

 

Summary:

The umbilicus offers no functional importance to the adult human but remains a key aesthetic landmark of the anterior abdominal wall, and its absence can be a cause for concern in aesthetic and reconstructive patients. Umbilical reconstruction or transposition for abdominoplasty and abdominally based flap operations is frequently complicated by umbilical death, infections, development of wounds needing prolonged wound care, and generally poor aesthetic outcomes. A multitude of techniques have been described to create the “ideal” neoumbilicus, but none has proven to be superior to the technique that comes before it. Our data demonstrate that, in a select set of patients, it may be beneficial to electively remove the umbilicus. Thus, umbilical reconstruction can be performed as an adjunct procedure to the primary operation with a superior aesthetic result and minimal risk for complications. This article describes the authors’ approach to delayed neoumbilical reconstruction in patients undergoing elective umbilical resection.

 

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Neoadjuvant chemotherapy and HER2 dual blockade including biosimilar trastuzumab (SB3) for HER2-positive early breast cancer: population based real world data from the Danish Breast Cancer Group (DBCG)

 

Neoadjuvant chemotherapy and HER2 dual blockade including biosimilar trastuzumab (SB3) for HER2-positive early breast cancer: population based real world data from the Danish Breast Cancer Group (DBCG)

 

by Tobias Berg, Maj-Britt Jensen, Erik H. Jakobsen, Sami Al-Rawi, Julia Kenholm, Michael Andersson 

 

The Breast: VOLUME 54, P242-247, DECEMBER 01, 2020

 

Highlights

•Real world data on 215 patients with HER2-positive early breast cancer.

•SB3 (biosimilar trastuzumab) and pertuzumab with neoadjuvant chemotherapy.

•pCR in 56% and node conversion in 68% of the patients.

•pCR rate associated with ER-status and malignancy grade.

Abstract

Background

Dual blockade with trastuzumab and pertuzumab combined with neoadjuvant chemotherapy (NACT) has been increasingly used for HER2-positive tumours >2 cm and/or with positive axillary lymph nodes in order to evaluate pathologic response and obtain better surgical management. SB3 is a registered biosimilar trastuzumab approved following a phase III trial demonstrating similar efficacy in the neoadjuvant setting as trastuzumab. However, the study was done without pertuzumab.

Method

The database of the Danish Breast Cancer Group was used to extract data on all patients who started NACT with SB3 and pertuzumab between September 1, 2018 and August 31, 2019. The primary endpoint was pathological complete response (pCR) rate.

Results

In total 215 patients received NACT and dual blockade. The median age was 55 (24–81). NACT used was cyclophosphamide and epirubicin followed by weekly paclitaxel (62% on six cycles, 35% on eight cycles) or other chemotherapy followed by weekly paclitaxel (3%). Overall, 56% of patients achieved pCR. 60 of 88 node-positive patients pre-NACT achieved ypN0(i-) after neoadjuvant treatment. pCR rate was significantly associated with estrogen receptor status and malignancy grade. An association with CEP17/HER2-ratio was assessed.

Conclusion

Real world data on dual blockade with SB3 and pertuzumab in combination with NACT in a nationwide population-based study show a pCR rate comparable to that seen in previous clinical studies.

Long-term outcome and prognostic value of Ki67 after perioperative endocrine therapy in postmenopausal women with hormone-sensitive early breast cancer (POETIC): an open-label, multicentre, parallel-group, randomised, phase 3 trial

 

 Long-term outcome and prognostic value of Ki67 after perioperative endocrine therapy in postmenopausal women with hormone-sensitive early breast cancer (POETIC): an open-label, multicentre, parallel-group, randomised, phase 3 trial

by Ian Smith, John Robertson, Lucy Kilburn, Maggie Wilcox, Abigail Evans, Chris Holcombe, Kieran Horgan, Cliona Kirwan, Elizabeth Mallon, Mark Sibbering, Anthony Skene, Raghavan Vidya, Maggie Cheang, Jane Banerji, James Morden, Kally Sidhu, Andrew Dodson, Judith M Bliss, Mitch Dowsett

The Lancet Oncology: ARTICLES| VOLUME 21, ISSUE 11, P1443-1454, NOVEMBER 01, 2020

Background

Preoperative and perioperative aromatase inhibitor (POAI) therapy has the potential to improve outcomes in women with operable oestrogen receptor-positive primary breast cancer. It has also been suggested that tumour Ki67 values after 2 weeks (Ki672W) of POAI predicts individual patient outcome better than baseline Ki67 (Ki67B). The POETIC trial aimed to test these two hypotheses.

Methods

POETIC was an open-label, multicentre, parallel-group, randomised, phase 3 trial (done in 130 UK hospitals) in which postmenopausal women aged at least 50 years with WHO performance status 0–1 and hormone receptor-positive, operable breast cancer were randomly assigned (2:1) to POAI (letrozole 2·5 mg per day orally or anastrozole 1 mg per day orally) for 14 days before and following surgery or no POAI (control). Adjuvant treatment was given as per UK standard local practice. Randomisation was done centrally by computer-generated permuted block method (variable block size of six or nine) and was stratified by hospital. Treatment allocation was not masked. The primary endpoint was time to recurrence. A key second objective explored association between Ki67 (dichotomised at 10%) and disease outcomes. The primary analysis for clinical endpoints was by modified intention to treat (excluding patients who withdrew consent). For Ki67 biomarker association and endpoint analysis, the evaluable population included all randomly assigned patients who had paired Ki67 values available. This study is registered with ClinicalTrials.govNCT02338310; the European Clinical Trials database, EudraCT2007-003877-21; and the ISRCTN registry, ISRCTN63882543. Recruitment is complete and long-term follow-up is ongoing.

Findings

Between Oct 13, 2008, and April 16, 2014, 4480 women were recruited and randomly assigned to POAI (n=2976) or control (n=1504). On Feb 6, 2018, median follow-up was 62·9 months (IQR 58·1–74·1). 434 (10%) of 4480 women had a breast cancer recurrence (280 [9%] POAI; 154 [10%] control), hazard ratio 0·92 (95% CI 0·75–1·12); p=0·40 with the proportion free from breast cancer recurrence at 5 years of 91·0% (95% CI 89·9–92·0) for patients in the POAI group and 90·4% (88·7–91·9) in the control group. Within the POAI-treated HER2-negative subpopulation, 5-year recurrence risk in women with low Ki67B and Ki672W (low–low) was 4·3% (95% CI 2·9–6·3), 8·4% (6·8–10·5) with high Ki67B and low Ki672W (high–low) and 21·5% (17·1–27·0) with high Ki67B and Ki672W (high–high). Within the POAI-treated HER2-positive subpopulation, 5-year recurrence risk in the low–low group was 10·1% (95% CI 3·2–31·3), 7·7% (3·4–17·5) in the high–low group, and 15·7% (10·1–24·4) in the high–high group. The most commonly reported grade 3 adverse events were hot flushes (20 [1%] of 2801 patients in the POAI group vs six [<1%] of 1400 in the control group) and musculoskeletal pain (29 [1%] vs 13 [1%]). No treatment-related deaths were reported.

Interpretation

POAI has not been shown to improve treatment outcome, but can be used without detriment to help select appropriate adjuvant therapy based on tumour Ki67. Most patients with low Ki67B or low POAI-induced Ki672W do well with adjuvant standard endocrine therapy (giving consideration to clinical–pathological factors), whereas those whose POAI-induced Ki672W remains high might benefit from further adjuvant treatment or trials of new therapies.

Funding

Cancer Research UK.

A multivariable prognostic score to guide systemic therapy in early-stage HER2-positive breast cancer: a retrospective study with an external evaluation

 A multivariable prognostic score to guide systemic therapy in early-stage HER2-positive breast cancer: a retrospective study with an external evaluation

The Lancet Oncology : ARTICLES| VOLUME 21, ISSUE 11, P1455-1464, NOVEMBER 01, 2020

Background

In early-stage HER2-positive breast cancer, escalation or de-escalation of systemic therapy is a controversial topic. As an aid to treatment decisions, we aimed to develop a prognostic assay that integrates multiple data types for predicting survival outcome in patients with newly diagnosed HER2-positive breast cancer.

Methods

We derived a combined prognostic model using retrospective clinical–pathological data on stromal tumour-infiltrating lymphocytes, PAM50 subtypes, and expression of 55 genes obtained from patients who participated in the Short-HER phase 3 trial. The trial enrolled patients with newly diagnosed, node-positive, HER2-positive breast cancer or, if node negative, with at least one risk factor (ie, tumour size >2 cm, histological grade 3, lymphovascular invasion, Ki67 >20%, age ≤35 years, or hormone receptor negativity), and randomly assigned them to adjuvant anthracycline plus taxane-based combinations with either 9 weeks or 1 year of trastuzumab. Trastuzumab was administered intravenously every 3 weeks (8 mg/kg loading dose at first cycle, and 6 mg/kg thereafter) for 18 doses or weekly (4 mg/kg loading dose in the first week, and 2 mg/kg thereafter) for 9 weeks, starting concomitantly with the first taxane dose. Median follow-up was 91·4 months (IQR 75·1–105·6). The primary objective of our study was to derive and evaluate a combined prognostic score associated with distant metastasis-free survival (the time between randomisation and distant recurrence or death before recurrence), an exploratory endpoint in Short-HER. Patient samples in the training dataset were split into a training set (n=290) and a testing set (n=145), balancing for event and treatment group. The training set was further stratified into 100 iterations of Monte-Carlo cross validation (MCCV). Cox proportional hazard models were fit to MCCV training samples using Elastic-Net. A maximum of 92 features were assessed. The final prognostic model was evaluated in an independent combined dataset of 267 patients with early-stage HER2-positive breast cancer treated with different neoadjuvant and adjuvant anti-HER2-based combinations and from four other studies (PAMELA, CHER-LOB, Hospital Clinic, and Padova) with disease-free survival outcome data.

Findings

From Short-HER, data from 435 (35%) of 1254 patients for tumour size (T1 vs rest), nodal status (N0 vs rest), number of tumour-infiltrating lymphocytes (continuous variable), subtype (HER2-enriched and basal-like vs rest), and 13 genes composed the final model (named HER2DX). HER2DX was significantly associated with distant metastasis-free survival as a continuous variable (p<0·0001). HER2DX median score for quartiles 1–2 was identified as the cutoff to identify low-risk patients; and the score that distinguished quartile 3 from quartile 4 was the cutoff to distinguish medium-risk and high-risk populations. The 5-year distant metastasis-free survival of the low-risk, medium-risk, and high-risk populations were 98·1% (95% CI 96·3–99·9), 88·9% (83·2–95·0), and 73·9% (66·0–82·7), respectively (low-risk vs high-risk hazard ratio [HR] 0·04, 95% CI 0·0–0·1, p<0·0001). In the evaluation cohort, HER2DX was significantly associated with disease-free survival as a continuous variable (HR 2·77, 95% CI 1·4–5·6, p=0·0040) and as group categories (low-risk vs high-risk HR 0·27, 0·1–0·7, p=0·005). 5-year disease-free survival in the HER2DX low-risk group was 93·5% (89·0–98·3%) and in the high-risk group was 81·1% (71·5–92·1).

Interpretation

The HER2DX combined prognostic score identifies patients with early-stage, HER2-positive breast cancer who might be candidates for escalated or de-escalated systemic treatment. Future clinical validation of HER2DX seems warranted to establish its use in different scenarios, especially in the neoadjuvant setting.

The Baker Classification for Capsular Contracture in Breast Implant Surgery Is Unreliable as a Diagnostic Tool

 

The Baker Classification for Capsular Contracture in Breast Implant Surgery Is Unreliable as a Diagnostic Tool

 

by de Bakker, Erik; Rots, Mathijs; Buncamper, Marlon E.; Niessen, Frank B.; Smit, Jan Maerten; Winters, Henri A. H.; Özer, Müjde; de Vet, Henrica C. W.; Mullender, Margriet G.

Plastic and Reconstructive Surgery: November 2020 - Volume 146 - Issue 5 - p 956-962

 

Background:

Breast implants are frequently used in cosmetic and reconstructive breast surgery. Capsular contracture, the most common long-term complication, is usually graded using the Baker classification. Despite its widespread use, the reliability of the Baker classification has never been established. The aim of this study was to determine the interobserver reliability and agreement of the Baker classification.

Methods:

Sixty women who had undergone cosmetic breast augmentation were included. They were examined independently by two plastic surgeons from an observer pool. The Baker score was determined, along with firmness, dislocation, symmetry, and pain using four-point scales. Patients were asked to complete the BREAST-Q postaugmentation module. The interobserver reliability and agreement were calculated for all variables with a quadratic weighted kappa.

Results:

The interobserver reliability of the Baker classification was poor (kappa, 0.55; 95 percent CI, 0.37 to 0.72). Interobserver reliability of the clinical parameters firmness (0.64; 95 percent CI, 0.49 to 0.79), dislocation (0.49; 95 percent CI, 0.26 to 0.73), and symmetry (0.61; 95 percent CI, 0.34 to 0.88) was also poor. Pain scores seemed more reliable (0.72; 95 percent CI, 0.56 to 0.89); however, most patients had no pain. The interobserver agreement for the Baker score was 48 percent; in 43 percent, the observers differed one category; and in 12 percent, the difference was more than one category.

Conclusions:

Interobserver reliability and observer agreement of the Baker classification for capsular contracture were poor. Consensus about how to adequately rate the symptoms of capsular complaints is lacking. A more reliable method of measurement or description is needed, especially for scientific research purposes, to assess the long-term problems associated with breast implants. CLINICAL QUESTION/LEVEL OF EVIDENCE: Diagnostic, IV.

Complications of Contralateral Prophylactic Mastectomy: Do They Delay Adjuvant Therapy?

 

Complications of Contralateral Prophylactic Mastectomy: Do They Delay Adjuvant Therapy?

 

by Sharabi, Safa E.; Baumann, Donald P.; Selber, Jesse C.; Killon, Elizabeth; Mericli, Alexander F.; Liu, Jun; Caudle, Abigail S.; Smith, Benjamin D.; Chavez-MacGregor, Mariana; Schaverien, Mark V.

 

Plastic and Reconstructive Surgery: November 2020 - Volume 146 - Issue 5 - p 945-953

 

Background:

There is ongoing debate regarding the optimal timing of contralateral prophylactic mastectomy fueled by concern that performing it at the time of the mastectomy for the index breast cancer may delay adjuvant therapy. The study objective was to examine the effect of simultaneous contralateral prophylactic mastectomy with immediate breast reconstruction on the complication rate and adjuvant therapy timing.

Methods:

A retrospective study was conducted of consecutive patients who underwent contralateral prophylactic mastectomy with immediate breast reconstruction and received adjuvant therapy over a 6-year period. Demographic, treatment, and outcomes data were collected, and relationships between multiple variables and outcomes were evaluated.

Results:

Of 241 patients (482 breasts) included, 186 (372 breasts) underwent simultaneous index breast mastectomy and contralateral prophylactic mastectomy with immediate breast reconstruction followed by adjuvant therapy (immediate group), and 55 (110 breasts) underwent index mastectomy, then adjuvant therapy, followed by delayed contralateral prophylactic mastectomy with immediate breast reconstruction (delayed group). Demographics were similar, although breast cancer stage (p < 0.001), tumor category (p = 0.0072), and nodal category (p < 0.001) were significantly higher in the delayed group. In the immediate group, complications before adjuvant therapy occurred in 31 patients (16.7 percent), and in six patients (3.2 percent) complications occurred only in the contralateral prophylactic mastectomy breast; delay to adjuvant therapy occurred in 11 patients (5.9 percent), in four (2.2 percent) of whom the contralateral prophylactic mastectomy breast was responsible for the delay.

Conclusions: Contralateral prophylactic mastectomy with immediate breast reconstruction can be performed safely at the time of the index mastectomy in carefully selected patients. These findings will engage patients seeking contralateral prophylactic mastectomy in shared decision-making regarding optimal timing with respect to the risks and benefits. CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, III.

Accelerated partial breast irradiation with 3-dimensional conformal and image-guided intensity-modulated radiotherapy following breast conserving surgery – 7-year results of a phase II trial

 

Accelerated partial breast irradiation with 3-dimensional conformal and image-guided intensity-modulated radiotherapy following breast conserving surgery – 7-year results of a phase II trial

 

by Norbert Mészáros, Tibor Major, Gábor Stelczer, Levente Jánváry, Zoltán Zaka, Dávid Pukancsik, Zoltán Takácsi-Nagy, János Fodor Md, Csaba Polgár

 

The Breast: October 29, 2020

 

Purpose

To present the 7-year results of accelerated partial breast irradiation (APBI) using three-dimensional conformal (3D-CRT) and image-guided intensity-modulated radiotherapy (IG-IMRT) following breast-conserving surgery (BCS).

Patients and methods

Between 2006 and 2014, 104 patients were treated with APBI given by means of 3D-CRT using 3–5 non-coplanar, isocentric wedged fields, or IG-IMRT using kV-CBCT. The total dose of APBI was 36.9 Gy (9 × 4.1 Gy) using twice-a-day fractionation. Survival results, side effects and cosmetic results were assessed.

Results

At a median follow-up of 90 months three (2.9%) local recurrences, one (0.9%) regional recurrence and two (1.9%) distant metastases were observed. The 7-year local (LRFS), recurrence free survival was 98.9%. The 7-year disease-free (DFS), metastases free (MFS) and overall survival (OS) was 94.8%, 97.9% and 94.8%, respectively. Late side effects included G1 skin toxicity in 15 (14.4%), G1, G2, and G3 fibrosis in 26 (25%), 3 (2.9%) and 1 (0.9%) patients respectively. Asymptomatic (G1) fat necrosis occurred in 10 (9.6%) patients. No ≥ G2 or higher late side effects occurred with IMRT. The rate of excellent/good and fair/poor cosmetic results was 93.2% and 6.8%, respectively.

Conclusion

7-year results of APBI with 3D-CRT and IG-IMRT are encouraging. Toxicity profile and local tumor control are comparable to other series using multicatheter interstitial brachytherapy. Therefore, these external beam APBI techniques are valid alternatives to whole breast irradiation and brachytherapy based APBI.

Collated responses to the Lancet Oncology Article of August 12th

 Collated responses to the Lancet Oncology Article of August 12th: Effect of mammographic screening from age 40 years on breastcancer mortality (UK Age trial): final results of a randomised, controlledtrial


 

https://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(20)30528-3/fulltext?rss=yes#section-7c530872-6235-4433-899c-b3f276970189