Underwent Breast Conservation Surgery Research Articles

Postoperative cosmetic outcome of intraoperative radiotherapy in comparison to whole breast radiotherapy in early stage breast cancer; a retrospective cohort study

BackgroundIn this study, we aim to evaluate the cosmetic outcome differences between Intraoperative electron beam radiation therapy (IOERT) and whole breast radiotherapy (WBR) with further investigation of boosted IOERT.MethodsThis retrospective cohort study was conducted in two referral centers in Tehran, Iran. 116 women aged 30 to 79 with early-stage breast cancer (T0-2N0-1M0) eligible for breast conservation were divided into two groups of 58 based on the intervention they received, and further subgroups were defined based on receiving boosted IOERT. Patients in both groups underwent breast conservation surgery and those in the IOERT group received either a 21 Gy radical dose (radical IOERT) or 12 Gy boosted electron beam radiotherapy and a routine fractionated dose of 50 Gy in 25 sessions of WBR (boosted IOERT). Those in the WBR group were administered 50Gy in 32 sessions. Physician-assessed cosmetic outcome was defined as the primary result and incidence of fat necrosis and fibrosis and post-operative chronic pain were secondary outcomes.ResultsPost-operative cosmetic outcome scores and chronic pain, showed no significant difference between the two groups. The median cosmetic score in both groups was 9. Fat necrosis and fibrosis had significantly higher rates in the IOERT group (P. Value: 0.001). However, the majority (21/34 or 61.8%) of this complication was observed in the boosted IOERT subgroup and no statistical significance was recorded between the radical IOERT subgroup and the WBR group.ConclusionsIn early-stage breast cancer treatment, radical IOERT has noninferiority compared to WBR in terms of cosmesis. Regarding fat necrosis and fibrosis, boosted IOERT was associated with higher rates in comparison to other groups. Therefore, radical IOERT seems to be a better treatment option for selected patients.

Sarcopenia using pectoralis muscle area and lymphocyte-to-monocyte ratio (LMR) are independent prognostic factors in patients for nonmetastatic breast cancer.

Sarcopenia is defined as loss of skeletal muscle mass and strength. This can lead to adverse clinical outcomes in patients with advanced cancer. The lymphocyte-to-monocyte ratio (LMR), a converted inflammatory response, is associated with poor prognosis in patients with malignancies. Herein, we examined the prognostic influence of sarcopenia status assessed by pectoralis muscle area (PMA), inflammatory status calculated by LMR, and its association with disease-free survival (DFS) in a cohort of women diagnosed with nonmetastatic breast cancer. A total of 293 patients with nonmetastatic breast cancer who underwent primary mass resection and radiotherapy between January 2011 and December 2017 were enrolled. The cross-sectional area of the muscle (cm2) at PMA was measured using computed tomography before radiation therapy. Baseline monocyte and lymphocyte counts were obtained from the complete blood count to calculate the LMR. Most of the patients (248/293, 84.6%) underwent breast conservation surgery. Lymph node involvement at diagnosis (hazard ratio [HR], 5.08; P < .001), low LMR (HR, 2.79; P = .007), and low PMA (HR, 3.80; P < .001) were independent poor prognostic factors in multivariate analysis. The mean DFS of sarcopenic and nonsarcopenic patients was 89.8 months and 118.8 months, respectively (P < .001). Sarcopenic patients with low LMR showed the worst outcomes, whereas nonsarcopenic patients with high LMR showed the best outcomes. Low PMA and low LMR were independent poor prognostic factors for DFS in patients with nonmetastatic breast cancer.

A single centre experience of local perforator flaps in oncoplastic breast surgery; a cross-sectional study.

Various oncoplastic techniques have emerged over the years to preserve breast cosmesis and symmetry without compromising the principles of tumor excision. One of the newer techniques for breast volume replacement to achieve symmetry and cosmesis is the use of fasciocutaneous pedicled chest wall perforator flaps or local perforator flaps (LPF). The objectives of this study were to document the details of the surgical procedure as well as patient-reported satisfaction and well-being following the procedure using a validated BREAST-Q tool among Pakistani women. This cross-sectional study was conducted from March 2019 to February 2021 enrolling 25 female patients who underwent breast conservative surgery using LPF for breast tumors at The Aga Khan University Hospital, Karachi. Data related to the procedure was collected on a pre-designed proforma. Cosmetic outcomes and patient satisfaction were evaluated using 2 scales from BREAST-Q BCT domain version 2.0. The questionnaire was self-administered by the patients during their routine follow-up in the clinic. Data was analyzed using the Statistical Package for Social Sciences (SPSS) version 23. Mean (SD)/median (IQR) were computed for quantitative variables and frequency and percentages were calculated for qualitative variables. 2 sample t-test was applied. P-value ≤0.05 was considered significant. 25 patients underwent LPF with a mean age of 47±13.1 years. 8 LICAP, 7 AICAP, and 10 LTAP flaps were performed. Two postoperative complications of wound site erythema were encountered. 23 women were eligible for the BREAST-Q survey. Median (IQR) postoperative satisfaction with breasts and physical well-being chest (equivalent Rasch transformed score) was 100 (41) and 76 [18] respectively. We found high satisfaction with breasts and comparable physical well-being among Pakistani women after LPF surgeries. Local perforator flaps in oncoplastic breast-conserving surgery are a good option showing high satisfaction with breasts and physical well-being in Pakistani women.

Accelerated Partial Breast Irradiation vs. Intraoperative Radiation Therapy for Early-Stage Breast Cancer and Ductal Carcinoma In Situ

<h3>Purpose/Objective(s)</h3> Accelerated partial breast irradiation (APBI) delivered with intensity modulated radiation therapy (IMRT) over 5 fractions represents an attractive and convenient method of delivering adjuvant radiation therapy without compromising oncologic or aesthetic outcomes. Intraoperative radiation therapy (IORT) is another method of delivering radiation therapy to the lumpectomy cavity. Initial results reported in clinical trials utilizing IORT were encouraging; however, with longer follow up, higher rates of local recurrence have been observed in contrast to APBI. We report the outcomes of a large cohort of patients treated with 5 fraction APBI and IORT at our institution after undergoing breast conservation surgery (BCS) for stage 0-IIA breast cancer. <h3>Materials/Methods</h3> We performed a retrospective review of 482 patients with stage I-IIA stage breast cancer and ductal carcinoma in situ (DCIS) treated with lumpectomy and APBI at our institution. In total, 267 patients in our cohort received IMRT from December of 2015 to May of 2021 while 215 patients received IORT from October of 2011 to May of 2019. All patients in the IMRT group received 30 Gy in 5 fractions. All patients in the IORT group received 20 Gy in 1 fraction prescribed to the applicator surface delivered at the time of surgery without additional radiation. Kaplan-Meier analysis was used to estimate locoregional control (LRC) and overall survival (OS) among the 2 groups. <h3>Results</h3> Mean age at diagnosis of the patients was 67 years in the IMRT group and 71 years in the IORT cohort. The IMRT group included 220 patients with Stage I breast cancer (82%), 4 patients with Stage IIA breast cancer (1%), and 43 (16%) patients with DCIS. The IORT group had 198 (92%) with stage I breast cancer, 12 patients (6%) had Stage IIA breast cancer, and 5 patients (2%) had DCIS. After a median follow up of 16 months in the APBI group, only 1 (0.4%) patient experienced a local recurrence, and no patients experienced a regional or distant recurrence. After a median follow up of 55 months in the IORT group, 12 patients (5.6%) experienced a local recurrence, 1 patient (0.5%) experienced a nodal recurrence, and 4 patients (1.9%) experienced a distant recurrence. There was no significant statistical difference in hormonal therapy receipt between both groups (75.3% vs 76.7%, p=0.64). There was no significant difference in 2-year LRC between the APBI and the IORT groups (98.9% in the APBI group vs. 99% in the IORT group, p=0.32). There were no differences in 2-year OS between the two groups (99.6% vs 98.5%, p=0.33). The 5-year LRC was 92.7% in the IORT group. <h3>Conclusion</h3> In a large institutional series of patients with Stage 0-IIA breast cancer treated with BCS followed by 5 fraction APBI or IORT, despite having low risk features and high rates of endocrine therapy use, IORT was associated with high rates of locoregional recurrence of approximately 7% at 5 years. Longer term follow up is needed for comparative effectiveness observations between the two groups.

A Pilot Study of CONcurrent ChEmotherapy and RadioTherapy in Adjuvant Treatment of Breast Cancer (CONCERT)

<h3>Purpose/Objective(s)</h3> The study hypothesis was that concurrent adjuvant chemoradiation (CTRT) is safe in adjuvant treatment of breast cancer. This was tested in a prospective interventional pilot study with dose-limiting toxicity as the primary endpoint. It also assesses the compliance rate, toxicity rate and short-term disease related outcomes. CTRI/2019/02/017411 <h3>Materials/Methods</h3> Stage II-III invasive breast cancer patients who were planned for adjuvant taxane-based chemotherapy and adjuvant radiotherapy were screened for the study during April 2019 to December 2020. Patients received standard 3D conformal radiotherapy (40 Gy in 15 fractions over 3 weeks ± boost in case of breast conservation) which was started with the third cycle of adjuvant taxanes in a 3-weekly schedule, or with the eighth cycle of adjuvant taxanes in weekly schedule. <h3>Results</h3> Sixty patients were analyzed. Median age of the study cohort was 46 years (28-66 years). Large majority (60%) women were pre-menopausal and had ECOG performance status 0 (95%) 32 patients (54%) had right sided tumors. Patients either underwent breast conservation surgery (48%) or modified radical mastectomy (52%) with axillary sampling in only small proportion of the patients (20%). 59 patients (98%) received all four cycles of anthracycline based chemotherapy (50 in the neoadjuvant setting) All the patients were compliant with taxane based chemotherapy with dose reduction in three patients in view of peripheral neuropathy. All patients completed adjuvant radiotherapy without any treatment interruption either for taxanes or radiotherapy. No dose-limiting toxicity was documented for any patient. Minimal chemotherapy-related toxicities have been reported in the form of 7 patients (11.6%) having Grade I-II fatigue and 8 patients (13.3%) having Grade I-II peripheral neuropathy. Radiotherapy-related toxicity was also minimal. The incidence of grade 0, 1 and 2 dermatitis were 4%, 84% and 12% respectively while grade 0, 1 and 2 dysphagia were 31%, 57 and 12% respectively. There was no difference between weekly and 3-weekly regimens with respect to compliance rate or toxicity. Dermatitis as well as dysphagia subsided completely by 4 weeks post-completion of CTRT. The median duration between first and last cycle of taxanes was 74 days (range 62 to 107) and radiotherapy start and conclusion was 23 days (range 19 to 28). Four patients had recurrence, one had local and distant recurrence and rest had distant recurrence only. At the median follow up of 23 months, median DFS of 17.5 months (9-22 months) and median OS of 26 months (11-33 months). The 3-year actuarial rate of DFS and OS was 75% and 98.3% respectively. <h3>Conclusion</h3> Concurrent taxane-based adjuvant CTRT is safe and feasible alternative to sequential chemotherapy and radiotherapy. There is minimal toxicity and excellent compliance for both 3-weekly as well as weekly schedules. Hence, it will be worthwhile to test concurrent CTRT in randomized setting with health-economics and disease-related endpoints.

A Prospective, Multicenter, Randomized, Double-Arm Trial to Determine the Impact of the Perimeter B-Series Optical Coherence Tomography and Artificial Intelligence System on Positive Margin Rates in Breast Conservation Surgery

Introduction: Optical coherence tomography (OCT) enables high-resolution, real-time tissue-imaging up to 2mm deep. The Perimeter B-Series OCT System combines wide field-OCT (WF-OCT) with artificial intelligence (AI) to help identify areas suspicious for cancer. The objective of this trial is to assess adjunctive use of WF-OCT and standard care (SOC) in identifying unaddressed positive margins (UPMs). Methods: Prospective, multicenter, randomized, double-arm trial in up to 309 adult women undergoing breast conservation surgery (BCS) for biopsy-confirmed Stage 0-III invasive ductal cancer and/or DCIS, including post-neoadjuvant therapy (NCT05113927). After BCS and SOC intraoperative margin assessment participants will be randomized (2:1) to device or SOC arm. Controls may undergo intraoperative pathology or frozen section analysis, per routine. WF-OCT will be done on all device arm specimens, with an opportunity to excise tissue from the cavity post-analysis, up to 6 total shaves and 2 in each orientation. Results: The study hypothesis is that WF-OCT & AI use will reduce the proportion of subjects with UPM. The primary endpoint is occurrence of ≥1 UPM for a subject; the secondary endpoint is the number of UPMs per subject. Safety includes Adverse Events; false-positive shaves/subject; and BREAST-Q Satisfaction with Breasts. Other outcomes are total excised tissue volume, initial and all procedures; and margin-level effectiveness (sensitivity, specificity, NPV and PPV). Conclusion: Primary endpoint was powered assuming a 15% UPM rate, 90% power, 2:1 allocation, and 10% loss of subjects. Both primary and secondary effectiveness endpoints are based on within-subject comparison of the 2 treatments in the device arm (SOC+WF-OCT).

Health-related quality of life among breast cancer patients in India.

This study evaluated the health-related quality of life (HRQoL) among breast cancer patients during various phases of treatment and with different treatment modalities, which helps in monitoring treatment outcomes, assessing the well-being of patients, and conducting health technology assessments. A total of 534 interviews were conducted among the patients of breast cancer recruited at different stages of disease and with different treatment modalities. HRQoL was determined using EuroQoL five dimensions questionnaire with five levels (EQ-5D-5L), EuroQoL Visual Analogue Scale (EQ VAS), and the EORTC QLQ-BR23 instrument. The utility values were determined based on the Indian EQ-5D-5L value set. The socio-demographic and clinico-therapeutic determinants of HRQoL were evaluated using multiple linear regression. The mean utility value of breast cancer patients was 0.602 (SD = 0.311) and mean EQ VAS score was 75 (SD = 12.3). The mean utility value at diagnosis was 0.628, whereas utility value was 0.55, 0.595, and 0.64 for post-surgery, post-chemotherapy, and post-radiotherapy treatment groups, respectively. The most frequently reported problem was pain/discomfort (in 84.3% patients), followed by anxiety/depression (83.5%). On EORTC QLQ-BR23, the maximum symptom scale scores for systemic therapy side effects were reported in the post chemotherapy group. The body image score and future perspective score were better in patients undergoing breast conservative surgery (BCS) compared to patients undergoing modified radical mastectomy. Age, education, and employment status of the patient, type of treatment modality, and use of taxanes are the determinants of HRQoL in breast cancer patients. Clinical interventions should focus upon management of pain and anxiety. BCS should be offered to all eligible patients as it is associated with better HRQoL. Addressing the factors that independently affect the HRQoL will help in improving the treatment compliance and outcomes.

The need to tailor the omission of axillary lymph node dissection to patients with good prognosis and sentinel node micro-metastases.

Results of IBCSG-23-01-trial which included breast cancer patients with involved sentinel nodes (SN) by isolated-tumor-cells or micro-metastases supported the non-inferiority of completion axillary-lymph-node-dissection (cALND) omission. However, current data are considered insufficient to avoid cALND for all patients with SN-micro-metastases. To investigate the impact of cALND omission on disease-free-survival (DFS) and overall survival (OS), we analyzed a cohort of 1421 patients <75 years old with SN-micro-metastases who underwent breast conservative surgery (BCS). We used inverse probability of treatment weighting (IPTW) to obtain adjusted Kaplan-Meier estimators representing the experience in the analysis cohort, based on whether all or none had been subject to cALND omission. Weighted log-rank tests comparing adjusted Kaplan-Meier survival curves showed significant differences in OS (p-value=0.002) and borderline significant differences in DFS (p-value=0.090) between cALND omission versus cALND. Cox's regression using stabilized IPTW evidenced an average increase in the risk of death associated with cALND omission (HR=2.77, CI95%=1.36-5.66). Subgroup analyses suggest that the rates of recurrence and death associated with cALND omission increase substantially after a large period of time in the half sample of women less likely to miss cALND. Using IPTW to estimate the causal treatment effect of cALND in a large retrospective cohort, we concluded cALND omission is associated with an increased risk of recurrence and death in women of <75 years old treated by BCS in the absence of a large consensus in favor of omitting cALND. These results are particularly contributive for patients treated by BCS where cALND omission rates increase over time.

OPTimizing Irradiation through Molecular Assessment of Lymph node (OPTIMAL): a randomized clinical trial

Background and purposeIn breast cancer (BC) patients, the involvement of four or more lymph nodes (LN) is an indication of regional irradiation. The optimal treatment strategy remains unclear when fewer nodes are involved and lymphadenectomy is not performed. We designed a clinical trial to show the non-inferiority of Incidental (INC) compared to intentional (INT) irradiation of axillary nodes in patients with early-stage BC and low burden LN involvement. Materials and methodsBC patients, cN0 (n = 487) undergoing breast conservation surgery and sentinel node biopsy, with total tumor load assessed by OSNA (One-Step Nucleic Acid Amplification) of 250–15,000 copies mRNA CK19/µL in sentinel LN were randomized to receive INC or INT nodal irradiation. The primary endpoint was 5-year disease-free survival (DFS). Secondary endpoints were locoregional recurrence (LRR), distant recurrence (DR), and acute and chronic toxicity (CT). ResultsFive-years DFS were 93.7% (INC) and 93.8% (INT) (difference 0.1% [one-sided 95% CI < 5.7%]; non-inferiority p = 0.075). Cumulative Incidences of LRR were 3.5% (INC) and 3.4% (INT) (difference of 0.1% [<4.8%]; p = 0.021), and 5% (INC) and 3.5% (INT) (difference 1.4% [<6.0%]; non-inferiority p = 0.101) for DR. CT was more Incident with INT (26.9%) than with INC (19.2%), though the difference was not statistically significant (HR 1.39 [95% CI: 0.92, 2.10]; p = 0.11). ConclusionIntentional does not outperform incidental irradiation by more than 5.7% in terms of 5-year DFS, 4.8% for LRR, and 6% for DR.Registration Number: ClinicalTrials.gov Identifier: NCT02335957.

Long-term oncological outcomes of oncoplastic breast-conserving surgery after a 10-year follow-up - a single center experience and systematic literature review.

AimWhile many studies reported the oncological outcomes of oncoplastic breast-conserving surgery (OBCS), there were inherent differences in the study population, surgeons’ expertise, and classifications of techniques used. There were also limited studies with long term follow up oncological outcomes beyond 5 years. This current study aimed to compare long-term oncological outcomes of ipsilateral breast tumor recurrence (IBTR) disease-free survival (DFS) and overall survival (OS) following conventional and oncoplastic breast-conserving surgery using volume displacement and replacement techniques.MethodsBetween 2009 and 2013, 539 consecutive patients who underwent breast conservation surgery including 174 oncoplastic and 376 conventional procedures were analysed. A systematic review of studies with at least five years of median follow up were performed to compare long term oncological outcomes.ResultsAt a median follow-up of 82.4 months, there were 23 (4.2%) locoregional recurrences, 17 (3.2%) metachronous contralateral breast cancer, 26 (4.8%) distant metastases, and 13 (2.4%) deaths. The hazard ratio of OBCS for IBTR, DFS and OS were 0.78 (95% confidence interval [CI] 0.21–2.94, p=0.78), 1.59 (95% CI, 0.88 to 2.87, p=0.12), and 2.1 (95% CI, 0.72 to 5.9, p=0.17) respectively. The 10-year IBTR-free, DFS and OS rate were 97.8%, 86.2%, and 95.7% respectively.ConclusionThere remained a dearth in well-balanced comparative studies with sufficient long-term follow-up, and our study reported long-term oncological outcomes for OBCS which were favourable of either VD or replacement techniques.

Limberg Flap in Breast Oncoplasty for Carcinoma Breast Revisited-a Tertiary Cancer Centre Experience.

Limberg flap is currently not commonly used in breast oncoplasty. We present our experience with Limberg flap reconstruction in breast cancer patients who underwent breast conservation surgery. This study was conducted at a tertiary cancer centre in Kerala, India. We reviewed the records of patients with breast cancer who underwent Limberg flap reconstruction with breast conservation surgery from 1st January 2020 to 31st October 2021. Data collected included age, quadrant of tumour, side of tumour, T and N stage, status at surgery (primary or post neoadjuvant therapy), type of surgery, flap complications following surgery and breast deformity following surgery. Seventeen patients underwent Limberg flap reconstruction during the study period. The median age of the patients was 51years. The commonest stage was cT1N0M0. Twelve patients underwent primary surgery and 5 post neoadjuvant chemotherapy. No patient had postoperative flap complications or breast deformity. Limberg flap is simple, versatile and robust and should be a part of the armamentarium of breast surgeons.

Abstract CT230: A prospective, multi-center, randomized, double-arm trial to determine the impact of the Perimeter B-Series OCT System on positive margin rates in breast conservation surgery

Abstract Background: Optical coherence tomography (OCT) is a high-resolution tissue-imaging modality that enables real-time imaging up to 2mm deep. The Perimeter B-Series OCT System combines wide field-OCT (WF-OCT) with an artificial intelligence system, ImgAssist, to assist clinicians in the detection of lesions suspicious for breast cancer. The objective of this investigational device trial is to assess adjunctive Perimeter B-Series OCT System use compared to standard care in identifying and addressing positive margins intraoperatively. Design: Prospective, multicenter, randomized, double-arm trial in females with biopsy-confirmed cancer undergoing breast conservation surgery (BCS) (NCT05113927). Following lumpectomy and standard-of-care intraoperative margin assessment participants will be randomized to a device or control arm (2:1 schema). Controls may undergo intraoperative pathology or frozen section analysis, per routine. WF-OCT will be done on all device arm specimens, with an opportunity to excise tissue from the lumpectomy cavity post-analysis. The new margin will be imaged with WF-OCT and the surgeon may take up to a maximum of 6 total shaves, including up to 2 shaves in each orientation. Eligibility: Adult females undergoing breast conservation surgery for biopsy-confirmed Stage 0-III invasive ductal and/or DCIS are eligible, including post-neoadjuvant therapy. Pregnant or lactating, those with Stage IV cancer, lobular carcinoma as primary diagnosis, previous ipsilateral breast surgery, multi-centric or bilateral disease, use of cryolocalization, or any treatment affecting margin integrity will be excluded. Specific Aim: The study hypothesis is that use of the Perimeter B-Series OCT System in BCS will reduce the proportion of subjects with at least 1 unaddressed positive margin. The primary endpoint is occurrence of aat least 1 unaddressed positive margin for a subject. The secondary endpoint is the number of unaddressed positive margins per subject. Safety includes Adverse Events; false-positive shaves per subject (device arm); and BREAST-Q Satisfaction with Breasts subscale. Other outcomes are total excised tissue volume, initial and all procedures including repeat surgeries; margin-level effectiveness (sensitivity, specificity, NPV and PPV); and operative time. Statistical Methods: The study was powered via the primary endpoint, assuming a 15% unaddressed margin rate, 90% power, 2:1 device-to-control ratio, and 10% loss of subjects due to screen or device failure. Both the primary and secondary effectiveness endpoints are based on within-subject comparison of the 2 treatments in the device arm (SOC+WF-OCT). Planned Accrual: 309 subjects (206 device, 103 control) will be enrolled at 8 centers over approximately 12 months. Citation Format: David Rempel, Andrew Berkeley, David Moos, Allison A. DiPasquale, Maryam Elmi, Richard E. Fine, Marie Lee, Bridget O’Brien, John F. Turner, Lee G. Wilke, Alastair Thompson. A prospective, multi-center, randomized, double-arm trial to determine the impact of the Perimeter B-Series OCT System on positive margin rates in breast conservation surgery [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2022; 2022 Apr 8-13. Philadelphia (PA): AACR; Cancer Res 2022;82(12_Suppl):Abstract nr CT230.

A real-world experience of TCH (docetaxel/carboplatin/trastuzumab) regimen in early, locally advanced and oligometastatic HER2 positive breast cancer from tertiary care center in North India.

e12505 Background: In HER2 positive breast cancer, TCH is a safe and efficacious anthracycline free regimen used as both adjuvant and neoadjuvant modality. Three is scarcity of data regarding its long term safety and efficacy from India. Methods: This retrospective study comprised of 210HER2 positive breast cancer female patients treated with TCH [docetaxel (75mg/m2), carboplatin (AUC=6) and trastuzumab (8mg/kg loading followed by 6mg/kg) q 21 days with GSF prophylaxis] protocol for 6 cycles at our centre between Jan 2014 and Dec 2021. All eligible patients received maintenance trastuzumab, hormonal therapy and radiotherapy as per institutional protocol. The information regarding baseline clinico-demographic characteristics, treatment details, outcomes and toxicities were collected and evaluated. Results: The median age was 49 years (23-72), 113 (53.8%) were post-menopausal and 100 (47.6%) were Estrogen receptor/Progesterone receptor positive. Sixty-eight (32.4%) patients were stage I and II, 112 (53.3%) stage III and 30 (14.3%) were oligometastatic. TCH regimen was given as neoadjuvant chemotherapy (NACT) in 130 (61.9%) patients and as adjuvant chemotherapy in 80 (38.1%) patients. Of the patients receiving NACT, 114 (87.6%) patients underwent surgery. Twenty-two (19.3%) patients underwent breast conservation surgery and 92 (80.7%) underwent modified radical mastectomy. Over the study period, 62 (29.5%) patients had progression of the disease and 22 (10.5%) patients died. With a median follow up of 31.9 months, 3-year disease free survival (DFS) was 63.5% and overall survival (OS) was 90.8%. Median DFS was 31 months in patients with node positive disease and was not reached in patients with node positive disease. Of the patients who received NACT, pathologic complete response (pCR) was recorded in 42 (36.8%) patients. Three-year DFS was 59.1% in patients who achieved pCR and 44.8% in those who did not achieve pCR. Any grade 3/4 toxicity was seen in 26.7% patients which caused dose modification in 13.9% patients. The most common grade 3/4 hematological toxicity was anemia (15.1%) and thrombocytopenia (10.4%), while non-hematological toxicity was diarrhea (11.6%). Febrile neutropenia was seen in 4 (1.9%) patients. Four patients (1.9%) had reversible decrease in cardiac left ventricular ejection fraction. Conclusions: Anthracycline free TCH regimen is an effective and safe regimen for use in curative (adjuvant and neoadjuvant) setting for HER2 positive breast cancer in Indian women with outcomes comparable to the anthracycline based regimens reported in literature.

Outcomes and toxicity following post-operative hypofractionated radiotherapy to the regional nodes and the breast or the chest wall in locally advanced breast cancer.

We aimed to analyze the impact of a 3-week schedule of HypoFractionated (HF) radiotherapy (RT) after axillary dissection and breast surgery, in terms of safety and efficacy in patients with locally advanced breast cancer (BC). Eligible patients were females with Stage IIA - IIIC BC who underwent axillary dissection and breast surgery, either quadrantectomy or mastectomy. HF RT was delivered in 15 or 16 fractions for a total dose of 40.05 Gy or 42.56 Gy, respectively, to the clavicular nodal region along with the whole breast (HF WBRT) or the chest wall (HF PMRT), according to the type of surgery. Locoregional recurrence (LRR), distant metastases-free survival (DMFS), overall survival (OS) and acute and late treatment-related toxicities were estimated. 57 patients with a median age of 60 years (32-85) were retrospectively analyzed. 34 (60%) of patients underwent breast conservative surgery in the form of quadrantectomy and 23 (40%) were offered radical mastectomy. All patients underwent hypofractionated regional nodal irradiation (HF RNI). 34 (60%) of them underwent HF WBRT, while 23 (40%) received HF PMRT.At a median follow-up of 80 months (30-113), the 7-year LRR-free survival was 93% (95% CI, 74%-95%). The same features for DMFS and OS were 76% (95% CI, 52%-78%) and 67% (95% CI, 50%-80%), respectively. Only one (2%) patient experienced G3 acute skin toxicity. No grade ≥2 late toxicity was observed. Our study shows that HF RNI with HF RT to the whole breast or the chest wall after breast surgery is safe and effective in patients with locally advanced BC. Longer follow-up is needed to strengthen further analyses on late toxicity and clinical outcomes. This paper adds to the evidence that post-operative RNI with WBRT or PMRT can be safely and effectively delivered with 3-week HF regimen. Locally advanced BC patients can be offered HF RT to the regional nodes and the breast or the chest wall regardless the type of surgery.

Methodological optimisation of intraoperative margin assessment using confocal microscopy

Introduction: Approximately 20-30% of women who undergo breast-conservation surgery (BCS) for cancer will require further surgery due to a close or involved margin with associated psychological morbidity and financial cost. This study focuses on the methodological technique for capturing intraoperative cellular level images using the Histolog® Scanner (SamanTree Medical SA, Lausanne, Switzerland).

249P Significance of intraoperative frozen assessment of cavity shave margins in patients undergoing breast conservation surgery: A tertiary care centre experience

Breast conservation surgery (BCS) is the preferred surgical treatment modality for eligible breast cancer patients. Oncological safety and aesthetic outcomes remain the primary objective of breast conservation surgery. Positive margin status following BCS needs revision surgery, which leads to increased patient anxiety, cost of treatment and delay in start of adjuvant treatment. We evaluated the significance and accuracy of intraoperative frozen section assessment of cavity shave margins (IOFSA) in patients undergoing BCS.

Abstract P3-18-12: Achieving negative margin after repeated attempts for lumpectomy does not nullify the risk of ipsilateral breast tumor recurrences

Abstract Introduction: Currently, the widely accepted principle in managing lumpectomy margins in early breast cancer patients is to avoid the presence of tumor cell at the margin. The presence of tumor cells on lumpectomy margin can represent two different aspects of local control in breast cancer. One aspect is related to the potential technical failure that may lead to an incomplete resection of the tumor. The other aspect of positive margin is associated with a biologic nature of the tumor. For example, some tumors show features of extensive intraductal component which often result in positive lumpectomy margins and may lead to increased risk of local recurrence after breast conservation surgery. Therefore, the two-fold increase of IBTR risk with positive margin would be the reflection of the combined effect of both technical failure and the biologic features.In this study, we aimed to address this issue by investigating the IBTR rates of patients in whom negative margins were achieved by initial lumpectomy or by re-excision. Our assumption was if the IBTR rates of the two groups are identical, then the two-fold increase of IBTR risk is mostly caused by the technical incomplete resection and therefore the measures to achieve negative margins would be justified. Methods: We retrospectively reviewed the data of 5,633 patients who underwent breast conservation surgery and whole breast irradiation for invasive breast cancer between January 2004 and December 2018 from Seoul National University Hospital. During the period, a total of 828 patients had positive lumpectomy margin after their initial surgery. Among them, thirty-five patients who did not undergo re-operation were excluded due to the small sample size. Results: The median age of the studied patients was 49 years old (19-92), and nearly two third of the patients had T1 tumors (64.3%). 4,293 patients (76.7%) were node negative and 4,332 patients (77.4%) had hormone receptor positive tumors. During the median follow-up period of 76.6 ( ± 44.6) months, a total of 121 patients (2.2%) experienced IBTR. Patients who underwent re-excision to achieve negative margins experienced significantly higher rate of IBTR compared to patients in whom the margins were clear at the first lumpectomy (p=0.031, HR: 1.61; 95% C.I., 1.04-2.48). The survival curves began to separate around 4-5 years after surgery (98.5% vs 98.0% at 5 year and 97.4% vs 94.7% at 10 years of follow-up). The survival difference was more clearly observed for younger patients (p=0.033, HR 1.72; 95% C.I., 1.04-2.85 for age less than 50). When the patients were divided according to their hormone receptor and HER2 amplification status, we observed significant difference in HR+/HER2- and HR-/HER2- subtypes while the HER2-amplified tumors showed no significant differences.By using Cox regression analysis, we adjusted for other significant predictors of IBTR such as age, histologic grade, lymphovascular invasion, hormone receptor status, HER2 amplification status, and Ki-67 levels. The results of the Cox regression analysis showed that re-excision to achieve negative margin is significantly associated with the risk of IBTR after adjusting for these variables (p=0.023, HR: 1.72; 95% C.I., 1.08-2.74). Conclusion: Patients who underwent re-excision after lumpectomy for initial positive margin carry increased risk of developing IBTR even they achieve final negative margin when compared to patients with initially negative lumpectomy margin. Our observation indicate that a substantial proportion of the increasing risk of IBTR associated with positive lumpectomy margin can be attributed to the biologic characteristics of the tumor rather than technical incomplete resection. Citation Format: Jong Ho Cheun, Hong-Kyu Kim, Han-Byoel Lee, Wonshik Han, Hyeong-Gon Moon. Achieving negative margin after repeated attempts for lumpectomy does not nullify the risk of ipsilateral breast tumor recurrences [abstract]. In: Proceedings of the 2021 San Antonio Breast Cancer Symposium; 2021 Dec 7-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2022;82(4 Suppl):Abstract nr P3-18-12.

Evaluation of a Wireless Localization System for Nonpalpable Breast Lesions - Feasibility and Cost-effectiveness in Everyday Clinical Routine.

Smaller, earlier-stage breast tumors are being found in breast cancer screening, and neoadjuvant chemotherapy is the gold standard when chemotherapy is indicated. Precise marking and localization of the tumor are thus becoming increasingly important. Wire-free localization techniques are under investigation in order to reduce presurgical radiography, pain, the risk of wire dislocation, and allow scheduling flexibility for patients and surgery departments. This single-center observational study from June 2020 to October 2021 included 15 patients with mammographically or sonographically detected nonpalpable breast lesions. Radiofrequency identification (RFID) tags were placed preoperatively under ultrasound or radiologic guidance to localize lesions for planned surgery. All patients underwent breast conservation surgery, including one bilateral and one targeted axillary dissection. Histology identified two benign and 13 malignant lesions, including three ductal carcinomas in situ and 11 invasive breast cancers. Placement, control radiography, and handling of the RFID tag were feasible in everyday routine for different radiologists and surgeons and managed cost-effectively. All of the RFID tags were found in the specimen radiographs. The feasibility and cost-effectiveness of this non-wire localization method were demonstrated in this rather small cohort of patients. Further studies including larger numbers of patients are needed to confirm the method's accuracy.

Efficacy of the Management of Node Negative Early Stage Breast Cancer Using 1% Methylene Blue in Sentinel Lymph Node Biopsy:prospective study, kasrAlaini University Hospital

Background:Accurate staging and proper management of axillary lymph nodes are important for the treatment of breast cancer. Sentinel lymph node biopsy (SLNB) provides accurate assessment of nodal status.Aimof work:Evaluation the safety, the accuracy and the cost of the application of SLNB using methylene blue 1% (MB 1%) in cases of node negative early stage breast cancer.Patients and methods:This study was conducted at Kasr Al-Ainy university Hospitals, Faculty of Medicine, Cairo University. Fifty-two female patients with node negative early stage breast cancer who agreed on undergoing breast conservative surgery( BCS), SLNB using 1% methylene blue and frozen section examination then managed according to ACOSOG Z0011 criteria .Results:Identification in 50 surgical specimens (identification rate 96.15%). By evaluating frozen section examination of the lymph nodes in relation to paraffin section examination we found that the sensitivity of the frozen section examination was 100% and specificity was 97.5% with positive predictive value 90.9%, negative predictive value 100% and overall accuracy was 98%.Conclusion:One % MB dye is very effective as a single agent in SLNB in node negative early stage breast cancer with very high identification rate compared to patent blue and radiocolloids. Implementation of ACOSOG Z0011 criteria proved its validity throughout our study as average 12 months follow up showed no locoregional recurrence

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

BackgroundThe 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.MethodsThe 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.Results128/194 (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).ConclusionZ0011 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.