Chest wall perforator flap partial breast reconstruction: a retrospective analysis of surgical, cosmetic and survival outcome.

Introduction: Oncoplastic breast surgery includes volume replacement as well as volume displacement. Autologous tissue is the preferred approach for volume replacement and includes chest wall perforator flaps (CWPF). Although described more than a decade ago, CWPFs have not been adopted widely in clinical practice till recently. We report the largest single-centre institutional data on CWPFs. Patients and methods: The study includes all patients who underwent breast conservation surgery (BCS) using CWPFs from January 2015 to December 2022. Data were retrieved from the institutional electronic record and Redcap database. The analysis was done using SPSS 23 and STATA 14. Results: 150 patients were included in the study. The mean age was 48.8 years (SD 10.4), and the body mass index was (26.6 kg/m2, SD 4.3). >50% of patients had breasts with small cup sizes (A&B) and mild ptosis (Non-ptotic and Grade 1 ptosis). 44.7% of patients underwent lateral intercostal artery perforator flap (LICAP), anterior intercostal artery perforator flap in 31.3%, lateral thoracic perforator flap (LTAP) in 12%, LICAP + LTAP in 11.3% and thoracodorsal artery perforator flap in 1%. Post-operatively, haematoma was seen in 1.3%, complete flap necrosis in 1.3%, seroma in 7%, wound dehiscence in 12%, and positive margin in 6.7%. 92 patients responded to the satisfaction assessment, of which >90% were happy with the surgical scars, comfortable going out in a public place, satisfied with the symmetry of the breast, and no one chose mastectomy in hindsight. The 5-year predicted disease free survival and overall survival were 86.4% and 94.7%, respectively. Conclusion: BCS with CWPF is an excellent option for reconstruction in small to medium-sized breasts. It is associated with minimal morbidity and comparable patient-reported cosmetic and survival outcomes.

Protocol for the development of a core outcome set and reporting guidelines for locoregional treatment in neoadjuvant systemic breast cancer treatment trials: the PRECEDENT project.

INTRODUCTION: Neoadjuvant systemic anticancer therapy (neoSACT) is increasingly used in the treatment of early breast cancer. Response to therapy is prognostic and allows locoregional and adjuvant systemic treatments to be tailored to minimise morbidity and optimise oncological outcomes and quality of life. Accurate information about locoregional treatments following neoSACT is vital to allow the translation of downstaging benefits into practice and facilitate meaningful interpretation of oncological outcomes, particularly locoregional recurrence. Reporting of locoregional treatments in neoSACT studies, however, is currently poor. The development of a core outcome set (COS) and reporting guidelines is one strategy by which this may be improved. METHODS AND ANALYSIS: A COS for reporting locoregional treatment (surgery and radiotherapy) in neoSACT trials will be developed in accordance with Core Outcome Measures in Effectiveness Trials (COMET) and Core Outcome Set-Standards for Development guidelines. Reporting guidance will be developed concurrently.The project will have three phases: (1) generation of a long list of relevant outcome domains and reporting items from a systematic review of published neoSACT studies and interviews with key stakeholders. Identified items and domains will be categorised and formatted into Delphi consensus questionnaire items. (2) At least two rounds of an international online Delphi survey in which at least 250 key stakeholders (surgeons/oncologists/radiologists/pathologists/trialists/methodologists) will score the importance of reporting each outcome. (3) A consensus meeting with key stakeholders to discuss and agree the final COS and reporting guidance. ETHICS AND DISSEMINATION: Ethical approval for the consensus process will be obtained from the Queen's University Belfast Faculty Ethics Committee. The COS/reporting guidelines will be presented at international meetings and published in peer-reviewed journals. Dissemination materials will be produced in collaboration with our steering group and patient advocates so the results can be shared widely. REGISTRATION: The study has been prospectively registered on the COMET website (https://www.comet-initiative.org/Studies/Details/2854).

Detection of Axillary Lymph Node Involvement in Early-Stage Breast Cancer: Comparison between Staging 18F-2-Fluoro-2-Deoxy-D-Glucose Positron Emission Tomography-Computed Tomography Scans, Mammography, and Sentinel Lymph Node Biopsy.

Aims: The aim of this study was to evaluate the role of 18F-2-fluoro-2-deoxy-D-glucose (18F-FDG) positron emission tomography-computed tomography (PET-CT) scan in the detection of axillary lymph node (ALN) involvement and comparison with sentinel lymph node biopsy (SLNB) in operable early-stage breast cancer (EBC). Settings and Design: It is a retrospective analysis of staging PET-CT scan of EBC. Methods: A total of 128 patients with histopathologically proven breast cancer (BC) were included in the study. Preoperative mammography supplemented with ultrasonography and staging 18F-FDG PET-CT scan was done for all patients. Surgery was done within 30 (mean ± standard deviation = 13.8 ± 10.5) days of staging. SLNB was performed in patients without PET-positive ALNs. All patients with positive sentinel nodes and PET-positive ALNs underwent axillary lymph node dissection (ALND). Statistical Analysis Used: The comparison between categorical variables was made by Chi-square/Fisher's exact test as applicable. For continuous variables comparisons, Student's t-test and one-way analysis of variance tests were used. Results: Sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) of PET-CT scan for detection of ALN involvement were 41.7%, 93.2%, 92.1%, and 45.6%, respectively. Sensitivity, specificity, PPV, and NPV of mammography were 84.5%, 54.5%, 78.0%, and 68.6%, respectively. Sixteen out of 46 (34.7%) patients with negative ALNs in PET-CT scan finally showed involvement in histopathology report after SLNB resulting in upstage of the disease. The size of tumor deposits in sentinel nodes was significantly smaller than PET-positive ALNs (P = 0.01). Our observations correlate with the results of earlier studies published in the literature. Conclusions: 18F-FDG PET-CT scan cannot substitute SLNB for ALN screening in EBC. The limitations are most marked in smaller and micrometastatic tumor deposits in ALNs and may be attributed to limitations of PET resolution. However, PET-positive nodes showed good specificity for disease involvement in our study. Therefore, ALND can safely be performed by omitting SLNB in such cases.

Oncologic safety of breast conservation following NACT in women with locally advanced breast cancer.

Introduction: Breast conservation surgery (BCS) is the accepted standard of treatment for early breast cancer, with evidence from randomized controlled and population-based studies. The oncological outcome of BCS in locally advanced breast cancer (LABC) is mainly available from retrospective series with a small sample size and a shorter follow-up duration. Methods: A retrospective observational study of 411 non-metastatic LABC patients who received neoadjuvant chemotherapy (NACT) followed by surgery from 2011 to 2016. We retrieved the data from a prospectively maintained database and electronic medical records. Survival data were analyzed by Kaplan-Meier curves and Cox regression using Statistical Package for the Social Sciences 25 and STATA 14. Results: 146/411 (35.5%) women had BCS with a margin positivity rate of 3.42%. With a median follow-up of 64 months (IQR 61, 66), the local relapse rate was 8.9% in BCS and 8.3% after mastectomy. The estimated 5-year locoregional recurrence-free survival (LRFS), recurrence-free survival (RFS), distant disease-free survival (DDFS) and overall survival (OS) rates of BCS were 86.9%, 63.9%, 71% and 79.3%, and 90.1%, 57.9%, 58.3% and 71.5% in the mastectomy group. On univariate analysis, BCS showed superior survival outcomes compared to mastectomy (unadjusted HR (95% CI) for RFS: 0.70 (0.50-1), DDFS: 0.57 (0.39-0.84), OS: 0.58 (0.36-0.93)). After adjusting for age, cT stage, cN stage, poorer chemotherapy response (ypT0/is, N0) and radiotherapy, BCS and mastectomy groups were found comparable in terms of LRFS (HR: 1.1, 0.53-2.3), DDFS (HR: 0.67, 0.45-1.01), RFS (HR: 0.80, 0.55-1.17) and OS (HR: 0.69, 0.41-1.14). Conclusion: BCS is technically feasible in LABC patients. LABC patients who respond well to NACT can be offered BCS without compromising survival outcomes.

Alleviating Morbidity From Locally Advanced Breast Cancer Using a Practical and Short Radiation Therapy Regimen: Results of the HYPORT Palliative Studies.

PURPOSE: Locally advanced breast cancers lead to debilitating local symptoms. Treatment of these women encountered commonly in less resourced countries is not backed by strong evidence. We formulated the  HYPORT and HYPORT B phase 1/2 studies to evaluate the safety and efficacy of hypofractionated palliative breast radiation therapy. METHODS AND MATERIALS: Two studies (35 Gy/10 fractions; HYPORT ) and (26 Gy to breast/32 Gy tumor boost in 5 fractions; HYPORT B) were designed with increasing hypofractionation to save overall treatment time from 10 to 5 days. We report the acute toxicity, symptomatic, metabolic response, and quality of life (QOL) changes after radiation therapy. RESULTS: Fifty-eight patients, the majority of whom were pretreated with systemic therapy, completed the treatment. No grade 3 toxicity was reported. Response assessment at 3 months showed improvement in ulceration (58% vs 22%, P = .013) and bleeding (22% vs 0%, P = .074) within the HYPORT study. Similarly, in the HYPORT B study, ulceration (64% and 39%, P = .2), fungating (26% and 0%, P = .041), bleeding (26% and 4.3%, P = .074), and discharge (57% and 8.7%, P = .003) was reduced. Metabolic response was noted in 90% and 83% of patients, respectively, in the 2 studies. Improvement in the QOL scores were evident in both studies. Only 10% of the patients relapsed locally within 1 year. CONCLUSIONS: Palliative ultrahypofractionated radiation therapy to the breast is well tolerated, is effective, and results in a durable response with improved QOL. This could be considered a standard for locoregional symptom control.

Diagnostic performance and survival outcome following sentinel lymph node biopsy in breast cancer patients from a tertiary cancer centre in India.

Background: Sentinel lymph node biopsy (SLNB) has replaced axillary lymph node dissection (ALND) for axillary staging in early node-negative breast cancer (BC) patients in developed countries. However, in resource-constrained developing countries, adoption of SLNB is slow due to logistic issues and lack of outcome data from non-screened BC cohort. Therefore, we aim to report diagnostic performance, surgical morbidity and survival outcome of SLNB in BC patients from a tertiary care cancer centre in India. Methodology: 1,521 consecutive early node-negative T1-3N0 BC patients having SLNB from 2011 to 2020 were included in the study. Data were retrieved from the institutional Redcap database and electronic medical records. Analysis was done using Stata14. Results: SLNB was done by dual dye (methylene blue (MB) + radioisotope (RI)/indo cyanine green (ICG)) in 57.7%, MB only in 39.3%, and RI alone in 3% of patients. The identification rate (IR) and SLNB positivity rate were 96% and 27.7%, respectively. IR was highest (98%) with MB + ICG and lowest (94%) with MB alone SLNB. UltraSonoGraphy guided fine needle aspiration cytology of radiological suspicious nodes has significantly reduced the SLNB positivity rate from 34.6% to 26.4% (p < 0.01). One patient had skin necrosis, and 16 had persistent blue staining of the skin in the MB injection site. All were managed conservatively. The lymphedema rate was significantly higher (5.2%) in the ALND versus 0.5% in the SLNB alone patients (p < 0.05). In a median follow up of 27 months, the axillary recurrence rate was 0.04% (4/1,023), and false-negative rate was 0.9% in SLNB negative patients. There were 35 recurrences and 25 deaths in SLNB negative patients, with 10 years predicted disease-free survival of 81% (95% CI 66% to 89%) and overall survival of 79% (95% CI 59% to 90%). Conclusions: SLNB should be offered as an axillary staging procedure to all eligible BC patients from developing countries to avoid the morbidity associated with ALND. Fluorescent dye can be used as an alternative for RI in a resource-constrained setup.

Assessment of skin response in T4b breast carcinoma patients post-neoadjuvant chemotherapy.

BACKGROUND: Breast cancer patients with skin ulcerations, satellite nodules or Peau d'orange at presentation are classified with stage 4 breast cancer (T4b). Neoadjuvant chemotherapy (NACT), followed by mastectomy, is the commonly accepted treatment in such patients for fear of adverse outcomes with breast conservation surgery (BCS) and uncertainty over sparing initially involved skin irrespective of the response to chemotherapy. Identifying patients with skin resolution post-NACT can help surgeons in decision-making. AIM: To assess skin response in T4b breast cancer patients post-NACT and find the correlation between various clinical and pathological factors associated with no skin involvement on final histology. METHODOLOGY: Records of breast cancer patients managed at the Tata Medical Center, Kolkata, with NACT for T4b breast carcinoma patients who underwent mastectomy were reviewed between January 2014 and December 2018. Final histology was checked for dermal involvement with the tumour. The Mann-Whitney U test was used for continuous variables for descriptive data, and Pearson's chi-squared and Fischer's exact tests were applied for categorical data. p-value < 0.05 was taken as significant. RESULTS: A total of 285 records mentioning skin involvement were reviewed, out of which 111 patients fulfilled the AJCC criterion. The median age at diagnosis of T4b breast cancer was 50 years. The median clinical size pre-chemotherapy was 7 cm. Residual median tumour size on final histology was reported as 1 cm. 78/111 patients showed a post-NACT response of 50% or more, and 43/111 showed a response of more than 90%. 57 (51.4%) patients showed skin involvement on final histopathology, while 54 (48.6%) patients did not.ER negative tumours were more likely to show no dermal involvement (p = 0.006). Residual tumour size of less than 1 cm on final histology (p < 0.05) and nodal stage were significant predictors of dermal response. CONCLUSION: Approximately half of the T4b breast cancer patients showed resolution of dermal skin involvement post-NACT. ER negative and those with residual tumour size less than 1 cm post-NACT are more likely to show dermal resolution. This can help surgeons plan a BCS or skin sparing mastectomy for such patients who usually end up having a mastectomy.

Trends in Axillary Management of Early Breast Cancer: a Questionnaire-Based Pattern of Practice Survey for India.

Surgical management of breast cancer (BC) has evolved from radical surgeries to conservative with better cosmetic and comparable oncological outcomes. For axillary staging, it has evolved from axillary lymph node dissection (ALND) to sentinel lymph node biopsy (SLNB). No detailed information exists in terms of the clinical practice pattern of surgical management of axilla for BC patients in India. A questionnaire-based survey was developed. The survey was done at the annual meeting of the Association of Breast Surgeons of India (ABSI) in November 2018. Responses were recorded and analysed by SPSS 23. One hundred twelve out of 400 (28%) responded to the survey. Half of the respondents were surgical oncologist and 36.6% were performing > 150 BC surgeries/year. The primary technique for axillary staging in node-negative BC was SLNB for 68.5% of respondents. Majority of surgeons (47%) reported performing SLNB by methylene blue dye only. Unavailability of radioisotope (46.7%) and lack of frozen section (26.7%) were reported as two major barriers for not performing SLNB. Twenty-three percent did perform SLNB in post-NACT setting. Only 15.8% have omitted completion ALND in Z0011 trial eligible SLN-positive patients. 45.9% skipped completion ALND in SLN positive with micro metastasis only. Many surgeons in India are adopting SLNB as a method of axillary staging into their clinical practice. However, large number of surgeons still believe in conservative approach, most probably due to unavailability of resources and lack of Indian data. Barrier identified in this survey may be useful for future development.

PDL1 expression and its correlation with outcomes in non-metastatic triple-negative breast cancer (TNBC).

PURPOSE: Triple-negative breast cancer (TNBC) has a poor outcome compared to other subtypes, even in those with early disease. Immune checkpoint inhibitors (ICIs) have been approved in metastatic diseases and are being tested as a neoadjuvant strategy also. The response to ICIs is largely determined by the programmed death ligand 1 (PDL1) score, which also acts as a prognostic marker for outcomes. Here, we report the proportion of PDL1 expression in non-metastatic TNBC and its correlation with response to chemotherapy and outcomes. METHODS: We included all patients who had non-metastatic TNBC treated with neoadjuvant chemotherapy, followed by surgery with/without adjuvant radiotherapy between September 2011 and November 2017. PDL1 testing was carried out on pre-treatment tumour cells with immunohistochemistry (Ventana SP142) and was correlated with pathological response, relapse-free survival (RFS) and overall survival (OS). PDL1 staining was interpreted as negative or positive (more than 1% staining). RESULTS: A total of 107 patients were included for analysis with a median age of 47 years (28-65 yrs). The PDL1 expression of more than 1% was seen in 31 (28.97%) patients. After a median follow-up of 55 months (range: 4-93 months), median RFS and OS were not reached. PDL1 expression did not affect the achievement of pathological complete response (pCR). However, PDL1 expression improved OS (p = 0.016) and trend towards RFS (p = 0.05). Patients who achieved pCR had better RFS and OC compared to those who did not. CONCLUSION: Our study shows PDL1 expression in 29% of the cases. PDL1 expression leads to better RFS and OS. Also, pCR improves survival.

Reliability of Ki67 visual scoring app compared to eyeball estimate and digital image analysis and its prognostic significance in hormone receptor-positive breast cancer.

We analysed the reproducibility of Ki67 labelling index (LI) between two scorers using the International Ki67 Working Group (IKWG) global methods on an Android application (APP), correlated the APP and eyeball estimate (EBE) with digital image analysis (DIA) scores and determined the prognostic significance of Ki67LI. Global weighted (GW) and global unweighted (GUW) Ki67 app scores of hormone receptor-positive and HER2 (human epidermal growth factor receptor 2)-negative breast cancer patients were obtained. Reproducibility of Ki67LI between 2 scorers and correlation of APP and EBE scores with DIA scores were performed. The prognostic significance of APP scores and its correlation with other clinico-pathologic variables were evaluated. The intra-class correlation coefficient (ICC) between 2 scorers showed excellent reliability with both GW and GUW methods. ICC between DIA and APP scores was significantly greater than DIA versus EBE. The three categories of APP scores based on median value and cut points of 10%, 18% and 38% were significantly associated with poor DFS. On multivariate analysis, significant association between Ki67LI, tumour size, nodal involvement and DFS was noted. Our study shows that the visual Ki67 scoring app is effective in bringing consistency to KI67LI and APP scores showed significant correlation with DFS.

Effect of non-sentinel metastasis on adjuvant treatment decisions and survival in Z0011 eligible non-screened detected breast cancer population.

BACKGROUND: The Z0011 trial results have shown that axillary lymph node dissection (ALND) can be avoided in cT1-2 patients undergoing breast conservation surgery with 1-2 metastatic sentinel lymph nodes (SLNs). We compared the clinicopathological characteristics of the Z0011 eligible non-screen detected breast cancer patients' cohort with the Z0011 trial study population. Additionally, we have explored the effect of non-sentinel metastasis on adjuvant treatment decisions and survival. METHODS: The details of early breast cancer (EBC) patients fulfilling Z0011 eligibility criteria were retrieved from a prospectively maintained database (2013-2017) and electronic medical records. We used Statistical Package for the Social Sciences 25 and Stata V15 for the data analysis. RESULTS: 128/194 (66%) sentinel lymph node biopsy positive patients had fulfilled the Z0011 inclusion criteria. Compared to the Z0011 study, our cohort patients were younger, with more aggressive disease (higher T2, Grade 3), had a higher rate of macrometastasis (82.8% versus 58.8%) and non-SLN metastasis (48% versus 27%). The information gained by ALND had changed decisions for chemotherapy in 3% and no change of radiotherapy in Z0011 eligible patients. Further nodal positivity in completion ALND was not significantly associated with overall survival (p = 0.86) and disease-free survival (p = 0.5). CONCLUSION: Z0011 eligible Indian EBC patients are significantly different from the Z0011 study population, with younger age of presentation, higher grade, a higher rate of both SLN macro metastasis and non-SLN positivity. The impact of non-sentinel metastasis on adjuvant treatment decisions and survival is minimal.

AutoIHC-Analyzer: computer-assisted microscopy for automated membrane extraction/scoring in HER2 molecular markers.

Human epidermal growth factor receptor 2 (HER2) is one of the widely used Immunohistochemical (IHC) markers for prognostic evaluation amongst the patient of breast cancer. Accurate quantification of cell membrane is essential for HER2 scoring in therapeutic decision making. In modern laboratory practice, expert pathologist visually assesses the HER2-stained tissue sample under the bright field microscope for cell membrane assessment. This manual assessment is time consuming, tedious and quite often results in interobserver variability. Further, the burden of increasing number of patients is a challenge for the pathologists. To address these challenges, there is an urgent need with a rapid HER2 cell membrane extraction method. The proposed study aims at developing an automated IHC scoring system, termed as AutoIHC-Analyzer, for automated cell membrane extraction followed by HER2 molecular expression assessment from stained tissue images. A series of image processing approaches have been used to automatically extract the stained cells and membrane region, followed by automatic assessment of complete and broken membrane. Finally, a set of features are used to automatically classify the tissue under observation for the quantitative scoring as 0/1+, 2+ and 3+. In a set of surgically extracted cases of HER2-stained tissues, obtained from collaborative hospital for the testing and validation of the proposed approach AutoIHC-Analyzer and publicly available open source ImmunoMembrane software are compared for 90 set of randomly acquired images with the scores by expert pathologist where significant correlation is observed [(r = 0.9448; p < 0.001) and (r = 0.8521; p < 0.001)] respectively. The output shows promising quantification in automated scoring. LAY DESCRIPTION: In cancer prognosis amongst the patient of breast cancer, human epidermal growth factor receptor 2 (HER2) is used as Immunohistochemical (IHC) biomarker. The correct assessment of HER2 leads to the therapeutic decision making. In regular practice, the stained tissue sample is observed under a bright microscope and the expert pathologists score the sample as negative (0/1+), equivocal (2+) and positive (3+) case. The scoring is based on the standard guidelines relating the complete and broken cell membrane as well as intensity of staining in the membrane boundary. Such evaluation is time consuming, tedious and quite often results in interobserver variability. To assist in rapid HER2 cell membrane assessment, the proposed study aims at developing an automated IHC scoring system, termed as AutoIHC-Analyzer, for automated cell membrane extraction followed by HER2 molecular expression assessment from stained tissue images. The input image is preprocessed using modified white patch and CMYK and RGB colour space were used in extracting the haematoxylin (negatively stained cells) and diaminobenzidine (DAB) stain observed in the tumour cell membrane. Segmentation and postprocessing are applied to create the masks for each of the stain channels. The membrane mask is then quantified as complete or broken using skeletonisation and morphological operations. Six set of features were assessed for the classification from a set of 180 training images. These features are: complete to broken membrane ratio, amount of stain using area of Blue and Saturation channels to the image size, DAB to haematoxylin ratio from segmented masks and average R, G and B from five largest blobs in segmented DAB-masked image. These features are then used in training the SVM classifier with Gaussian kernel using 5-fold cross-validation. The accuracy in the training sample is found to be 88.3%. The model is then used for 90 set of unknown test sample images and the final labelling of stained cells and HER2 scores (as 0/1+, 2+ and 3+) are compared with the ground truth, that is expert pathologists' score from the collaborative hospital. The test sample images were also fed to ImmunoMembrane software for a comparative assessment. The results from the proposed AutoIHC-Analyzer and ImmunoMembrane software were compared with the expert pathologists' score where significant agreement using Pearson's correlation coefficient [(r = 0.9448; p < 0.001) and (r = 0.8521; p < 0.001) respectively] is observed. The results from AutoIHC-Analyzer show promising quantitative assessment of HER2 scoring.

Chest wall perforator flaps in partial breast reconstruction after breast conservation surgery: an additional oncoplastic surgical option.

Partial breast reconstruction using chest wall perforator flaps (CWPF) is a recent option used by breast surgeons, mainly for lateral quadrant defects with a relatively large volume of excision. We report a single-centre experience of CWPF with surgery details, complications, re-excision, aesthetic and oncological outcomes. This was a prospective observational cohort study of patients who had undergone breast conservation surgery (BCS) plus CWPF reconstruction. All variables were recorded prospectively in the institutional database. A survey was done to analyse patient satisfaction at about 6 months after completion of radiotherapy. Forty patients had CWPF based reconstruction in 3 years. 57.5 % of patients had lateral intercostal artery perforator (LICAP) flap, 5% had lateral thoracic artery perforator (LTAP) flap, 27.5% had combined LICAP plus LTAP and 10% patients had anterior intercostal artery perforator (AICAP) flap. Tumour excision cavity defect was of the lateral quadrant in 82.5%, central quadrant in 10% and medial quadrant in 7.5% of patients. The margin was positive for five patients, out of which four required cavity shave and one had a mastectomy. One patient had complete flap loss, and two patients developed surgical site infection. 96% of patients were satisfied with the scar, and 88% were happy with the treated breast in comparison to the opposite breast. 92% were comfortable going out in public and felt that in retrospect their decision not to have a mastectomy was correct. With a median follow up of 18 (10, 22) months, one patient died, and four had recurrences. CWPF may be used for partial breast reconstruction in the small non-ptotic breast with excellent outcome and high patient satisfaction scores.

Diagnostic Performance of Indocyanine Green Plus Methylene Blue Versus Radioisotope Plus Methylene Blue Dye Method for Sentinel Lymph Node Biopsy in Node-Negative Early Breast Cancer.

PURPOSE: Sentinel lymph node biopsy (SLNB) by dual-dye method (radioisotope plus blue) is the gold standard for axillary staging in patients with breast cancer, but in developing countries, logistic issues and financial constraint play a vital role. Recently, indocyanine green (ICG) has emerged as an alternative to radioisotope (technetium-99 [Tc-99]) for SLNB in breast cancer. This study compared the diagnostic performance of Tc-99 plus methylene blue (MB) dye versus ICG + MB dye SLNB. METHODS: Two hundred seven patients with early breast cancer (T1-3N0) were included in the study from 2017 to 2019. SLNB was done either with Tc-99 + MB or with ICG + MB as per availability of radioisotope. SLN identification rate (IR), SLN positivity rate, and metastatic SLN counts were compared between the 2 groups. RESULTS: IR was 199 (96%) of 207. IR was 95% in Tc-99 + MB compared with 97% with ICG + MB. The mean number of SLNs identified were 3.17 (standard deviation [SD], 1.84), with > 1 SLN identified in 87% patients by Tc-99 + MB. SLN was positive in 31.3% of patients with a metastatic SLN count of 0.37 (SD, 0.76). With ICG + MB, the number of SLNs was 2.73 (SD, 1.55), with > 1 SLN identified in 79% of patients. Twenty-eight percent of patients had positive SLNs, with a metastatic SLN count of 0.41 (SD, 0.77). A sharp decline in the availability of Tc-99 was observed, with 58% of patients in 2014 and only 12% of patients in 2018. CONCLUSION: ICG is equivalent to Tc-99 for SLNB in early breast cancer and has a good potential to be adopted by surgeons in resource-constrained setups.

Is COMBIPECS the answer to perioperative analgesia for breast surgery? A double blinded randomized controlled trial.

BACKGROUND AND AIMS: Pecs block and its variations provides perioperative analgesia, reduce PONV and other opioid related side effects. We hypothesized that COMIBPES block in addition to general anaesthesia will provide better postoperative analgesia when compared to general anaesthesia alone in breast cancer surgery patients. METHODS: After obtaining permission from the institutional review board and registering the trial with Clinical Trials Registry of India (CTRI), we conducted a double blinded randomized controlled trial of 100 patients posted for elective breast surgery with axillary dissection. Patients were divided into two groups, P (Pecs block) and C (control). Intraoperative analgesia, postoperative analgesia, postoperative nausea vomiting (PONV) and shoulder mobility on first postoperative day (POD1) were noted. Primary outcomes were the pain scores measured by visual analog scale (VAS) and cumulative intravenous morphine consumption from patient controlled analgesia (PCA) pump at measurement intervals of 0, 1, 4, 8, 12 and 24 hours postoperatively. RESULTS: Intraoperatively, Group P patients did not require any additional analgesia, whereas all the patients in Group C required additional intraoperative morphine (mean, SD: 5.12, 2.63 mg, compared to nil in group P, P< 0.01). COMBIPECS block group had lower pain scores and PCA morphine requirements, less PONV and better shoulder mobility on POD1. CONCLUSION: COMBIPECS block is a valuable addition to general anaesthesia for breast cancer surgery as it reduces pain and PONV while allowing better postoperative shoulder mobility.

Sentinel Lymph Node Biopsy After Initial Lumpectomy (SNAIL Study)-a Prospective Validation Study.

Tertiary oncology center clinicians are commonly faced with the problem of managing patients with a diagnosis of breast cancer made after lumpectomy in the Primary Health Care (PHC) setting. There are no studies or guidelines that address the further surgical management in this group of patients regarding sentinel lymph node biopsy (SLNB) and need for breast post-operative cavity excision. Prospective observational study was planned to evaluate the feasibility of SLNB and defining the need for definitive breast surgery in patients diagnosed with breast cancer after lumpectomy in PHC. The study was carried out from January 2015 to August 2017 in Tata Medical Center, India, approved by institutional review board (EC/TMC/36/14). Seventy patients who underwent lumpectomy with a definitive histological analysis of breast cancer were included in this study. Each patient had definitive breast surgery and SLNB using subareoral blue dye injection followed by validation axillary dissection. The identification rate (IR) for SLNB was 92% (64/70). The median number of SLNs removed was 2 (IQR 1, 3). There were 2 patients with false negative results resulting in false negative rate (FNR) of 11%. Overall, SLNB procedure has the sensitivity of 89%, NPV of 96%, and accuracy was 97%. Peri-areoral incision of initial surgery was associated with low IR (84%) and high FNR (33%). Final histopathology showed residual invasive cancer in 43% and ductal carcinoma in situ in 14% of patients. Among 21 patients where initial lumpectomy histopathology margin was free of cancer, residual malignancy was found in 57% of patients. Prior excision of lumps for breast cancer does not affect the accuracy of SLNB. Peri-areoral scar may be associated with high FNR and low IR, although further studies are needed to validate this statement. Definitive breast surgery is required for all patients, irrespective of initial lumpectomy histopathological margin status.

Quality Indicators for Sentinel Lymph Node Biopsy in Breast Cancer: Applicability and Clinical Relevance in a Non-screened Population.

Quality Indicators for Sentinel Lymph Node Biopsy in Breast Cancer: Applicability and Clinical Relevance in a Non-screened Population: sentinel lymph node biopsy (SLNB) has replaced axillary lymph node dissection (ALND) as standard of care for management of early breast cancer. This study assessed our SLNB program against 11 published quality indicators (QIs). All breast cancer patients who underwent SLNB in our centre from June 2013-Dec 2015 were included. Clinical, pathological and follow-up data were extracted from the institutional REDCap data system. Analysis was done with SPSS 23. Following validation, 234 patients had SLNB, always performed along with primary surgery. Identification rate was 95.3% and > 1 SLN was identified in 72% of patients. SLNB positivity was 33%, of these, 100% underwent ALND. Overall 91% of QI eligible patients underwent SLNB. No ineligible patients (T4) underwent SLNB. For the patients who had radio colloid, injection criteria were met for 100%. Pathological evaluation and reporting criteria were met for 100% of patients. There were no axillary recurrences in a median follow-up of 2 years. 7.6% patients had SLN negative on frozen section but positive on final histology. 7.2% of patients with clinical negative nodes had pN2 disease in final histopathology report after surgery. Sixty percent of patients who had completion ALND had only positive SLN. This study supports the applicability of published QI of SLNB in a non-screened cohort of early breast cancer patients. Although QI were useful, modification based on patient characteristics and resource availability may be needed. These indicators can be used as audit tools to improve the overall accuracy of the procedure.

Resource requirements and reduction in cardiac mortality from deep inspiration breath hold (DIBH) radiation therapy for left sided breast cancer patients: A prospective service development analysis.

INTRODUCTION: Use of deep inspiration breath hold (DIBH) radiation therapy may reduce long-term cardiac mortality. The resource and time commitments associated with DIBH are impediments to its widespread adoption. We report the dosimetric benefits, workforce requirements, and potential reduction in cardiac mortality when DIBH is used for left-sided breast cancers. METHODS AND MATERIALS: Data regarding the time consumed for planning and treating 50 patients with left-sided breast cancer with DIBH and 20 patients treated with free breathing (FB) radiation therapy were compiled prospectively for all personnel (regarding person-hours [PH]). A second plan was generated for all DIBH patients in the FB planning scan, which was then compared with the DIBH plan. Mortality reduction from use of DIBH was calculated using the years of life lost resulting from ischemic heart disease for Indians and the postulated reduction in risk of major cardiac events resulting from reduced cardiac dose. RESULTS: The median reduction in mean heart dose between the DIBH and FB plans was 166.7 cGy (interquartile range, 62.7-257.4). An extra 6.76 PH were required when implementing DIBH as compared with FB treatments. Approximately 3.57 PH were necessary per Gy of reduction in mean heart dose. The excess years of life lost from ischemic heart disease if DIBH was not done in was 0.95 per 100 patients, which translates into a saving of 12.8 hours of life saved per PH of work required for implementing DIBH. DIBH was cost effective with cost for implementation of DIBH for all left-sided breast cancers at 2.3 times the annual per capita gross domestic product. CONCLUSION: Although routine implementation of DIBH requires significant resource commitments, it seems to be worthwhile regarding the projected reductions in cardiac mortality.

Screening of over 1000 Indian patients with breast and/or ovarian cancer with a multi-gene panel: prevalence of BRCA1/2 and non-BRCA mutations.

PURPOSE: Breast and/or ovarian cancers are among the most common cancers in women across the world. In the Indian population, the healthcare burden of breast and/or ovarian cancers has been steadily rising, thus stressing the need for early detection, surveillance, and disease management measures. However, the burden attributable to inherited mutations is not well characterized. METHODS: We sequenced 1010 unrelated patients and families from across India with an indication of breast and/or ovarian cancers, using the TruSight Cancer panel which includes 14 genes, strongly associated with risk of hereditary breast and/or ovarian cancers. Genetic variations were identified using the StrandNGS software and interpreted using the StrandOmics platform. RESULTS: We were able to detect mutations in 304 (30.1%) cases, of which, 56 mutations were novel. A majority (84.9%) of the mutations were detected in the BRCA1/2 genes as compared to non-BRCA genes (15.1%). When the cases were stratified on the basis of age at diagnosis and family history of cancer, the high rate of 75% of detection of hereditary variants was observed in patients whose age at diagnosis was below 40 years and had first-degree family member(s) affected by breast and/or ovarian cancers. Our findings indicate that in the Indian population, there is a high prevalence of mutations in the high-risk breast cancer genes: BRCA1, BRCA2, TP53, and PALB2. CONCLUSION: In India, socioeconomic inequality limiting access to treatment is a major factor towards increased cancer burden; therefore, incorporation of a cost-effective and comprehensive multi-gene test will be helpful in ensuring widespread implementation of genetic screening in the clinical practice for hereditary breast and/or ovarian cancers.