Operable Breast Cancer Research Articles

Intensive chemotherapy versus standard chemotherapy among patients with high risk, operable, triple negative breast cancer based on integrated mRNA-lncRNA signature (BCTOP-T-A01): randomised, multicentre, phase 3 trial

ObjectiveTo evaluate the feasibility of using a multigene signature to tailor individualised adjuvant therapy for patients with operable triple negative breast cancer.DesignRandomised, multicentre, open label, phase 3 trial.Setting7 cancer centres...

Further Optimizing Care of Patients With Operable Hormone Receptor-Sensitive Breast Cancer.

Harmonized global collaborations are crucial to improving outcomes in hormone sensitive operable breast cancer.

Prevalence of Distant Metastases in High-Risk Operable Breast Cancer (HROBC) pT1-2 N2a or Higher at Diagnosis

AbstractCurrent standard guidelines do not recommend a routine staging workup in early operable breast cancer (OBC) as the incidence of de novo metastasis is only 1–2%. Some of these patients are at high risk for relapse based on the higher axillary nodal burden. This prospective study evaluated the presence of de novo asymptomatic distant metastases in HROBC with pT1/2 N2a/N3 on upfront surgery. A single-centre study was carried out in upfront operated OBC patients with four or more axillary nodes positive after definitive surgery. Comprehensive metastatic workup was carried out, including an ultrasound abdomen, bone scan, and CT scan (thorax-abdomen-pelvis) or PET scan before initiating adjuvant treatment. If a distant disease was detected, the adjuvant treatment intent was tailored accordingly. The study accrued a prospective consecutive cohort of 97 women with pT1-2 N2a-3 during 2015–2018 operated upfront for OBC with cT1-2 N0-1. Forty percent of women were premenopausal, 54 (55.6%) had pN2a, and 43 (44.3%) had pN3 disease. Distant disease was seen in 8 of 97 women (8.24%) of these high-risk early cancers, 5 had oligometastatic denovo disease (5.15%), and 3 had polymetastatic (3.09%). Between the 2 groups, the pickup rate of distant disease was higher in pN3 (11.4%) as against pN2a (5.6%), p = NS. Only 3.09% of patients with extensive metastases were treated with palliative intent. The study shows potential to optimize the management of HROBC with heavy nodal disease identified post-primary surgery by selective staging investigations, adequate resource stratification, and thereby improved management, including modifying treatment plans early.

Delays in receipt of neoadjuvant chemotherapy compared to upfront surgery in patients with operable breast cancer.

100 Background: Delays in time from breast cancer (BC) diagnosis to BC treatment initiation (BCTI) including upfront breast surgery (UBS) or neoadjuvant chemotherapy (NACT), can negatively impact BC survival. We evaluated odds of delay in BCTI among patients (pts) who received NACT compared to pts who received UBS. Methods: We conducted a retrospective cohort study using the National Cancer Database. Eligibility included age ≥18 years, diagnosis of non-metastatic BC between 1/1/2010 – 12/31/2020, who were treated with NACT followed by surgery or UBS followed by adjuvant chemotherapy (AC). Pts who did not receive NACT or UBS within 180 days of diagnosis were excluded. The cohort was stratified by first BC treatment (NACT or UBS), and time to NACT (TTNACT) or time to surgery (TTS) was recorded for each patient in days. Pts were categorized into sub-cohorts by receptor status and clinical stage: 1) Hormone Receptor positive/HER-2 negative (HR+/HER2-) lymph node (LN)+; 2) HER-2 positive (HER2+) cT2+ or LN+; and 3) triple negative BC (TNBC) cT2+ or LN+. Logistic regression adjusted for demographic, socioeconomic, and tumor characteristics was used to identify delays in BCTI > 60 days. Multiple imputation was used for missing data. Inverse probability treatment weighting (IPTW) was done as a sensitivity analysis. Results: We identified 218,049 eligible pts, 75% were White, 18% were Black, and 8.6% were Hispanic. Median age was 53 years (range 18-90). There were 145,697 (67%) pts who received NACT with median TTNACT of 32days (range 0-180), and 9.8% had a delay > 60 days (Table). There were 72,353 (33.0%) pts who received UBS followed by AC, with a median TTS of 33 days (range 0-180), and 13% with a delay > 60 days. In multivariable analysis, pts who received UBS had higher odds of BCTI delays compared to NACT, with OR 1.50 (95%CI 1.42-1.57) [HR+/HER2-], OR 1.49 (95%CI 1.41-1.58) [HER2+], and OR 1.26 (95%CI 1.18-1.34) [TNBC]. Results from IPTW analysis were similar, groups were well balanced, and pts who received UBS had higher odds of BCTI OR 1.50 (95%CI 1.44-1.57) [HR+/HER2-], OR 1.75 (95%CI 1.67-1.83) [HER2+], and OR 1.46 (95%CI 1.38-1.53) [TNBC]. Conclusions: Among high clinical risk BC patients who received surgery and chemotherapy, those who underwent NACT were less likely to experience delays in BCTI compared to pts who received UBS first. Among eligible pts, use of NACT may reduce delays in BCTI. Patients who received NACT and UBS and associated delays by sub-cohort (n = 218,050). Neoadjuvant Chemotherapy Upfront Surgery N (%) Median TTNACT in Days N (%) Delayed >60 Days N (%) Median TTS in Days N (%) Delayed >60 days Total Cohort 145,697 (67.0) 32 14,221 (9.8) 72,353 (33.0) 33 9,725 (13) HR+/HER2 40,345 (27.7) 34 4,773 (11.8) 29, 676 (41.0) 36 4,754 (16.0) HER+ 56,868 (39.0) 32 5,135 (9.0) 21,759 (30.1) 32 2,771 (12.7) TNBC 48,484 (33.3) 31 4,313 (8.9) 20,917 (28.9) 30 2,200 (10.5)

Factors associated with delays in receipt of neoadjuvant chemotherapy in patients with operable breast cancer.

126 Background: Delays in neoadjuvant chemotherapy initiation (NACTI) after breast cancer (BC) diagnosis have been associated with worse outcomes. We evaluated incidence and predictors of delays of NACTI among high clinical risk patients treated with NACT on a national level. Methods: We conducted a retrospective cohort study using the National Cancer Database. Eligibility included age ≥18 years, diagnosis of non-metastatic BC between 1/1/2010 – 12/31/2020, who were treated with NACT within 180 days of diagnosis. Patients who received neoadjuvant endocrine therapy were excluded. Time to chemotherapy (TTC) in days was recorded. Patients were categorized into sub-cohorts by receptor status and clinical stage: 1) Hormone Receptor positive/HER-2 negative (HR+/HER2-) and were lymph node (LN) LN+; 2) HER-2 positive (HER2+) cT2+ or LN+; and 3) triple negative BC (TNBC) cT2+ or LN+. Multivariable logistic regression, adjusted for demographic, socioeconomic and tumor characteristics, was used to identify characteristics associated with delays > 60 days from diagnosis to NACTI. Multiple imputation was used for missing data. Results: We identified 145,697 eligible patients, 74% were White, 18% were Black, 3.3% were Asian, and 4.6% were Other/Unknown. Across all racial categories, 9.2% were Hispanic. Median age at diagnosis was 52 years (range 18-90), median TTC was 32 days (range 0-180), and 10% had a delay > 60 days. There were 40,345 patients in the HR+/HER2- cohort, 56,868 in the HER2+ cohort, and 48,484 in the TNBC cohort; 12%, 9.0%, and 8.9% (p < 0.001) had a delay in NACTI, respectively. In multivariable analysis among the HR+/HER2- sub-cohort, characteristics associated with delays in NACTI included Black race (OR 1.71, 95%CI 1.57-1.86) and Hispanic ethnicity (OR 1.76, 95%CI 1.60-1.94) compared to White and non-Hispanic patients. Patients with Medicare, Medicaid, or who were uninsured were more likely to be delayed (OR 1.44 95%CI 1.30-1.58, 2.10, 95%CI 1.92-2.29, 2.28, 95%CI 1.99-2.61) compared to those with commercial insurance. Results were similar in the HER2+and TNBC cohorts, as seen (Table). Conclusions: Among patients with operable BC who received NACT, patients who were Black, Hispanic, had Medicaid or no insurance had as high as a twofold increase in odds of a delay in NACTI. Targeted interventions to address these racial and socioeconomic disparities are necessary to ensure equitable care. Multivariable logistic regression adjusted for demographic, socioeconomic, and tumor characteristics variables (n = 145,697). HR+/HER2-N= 40,345 HER2+N= 56,868 TNBCN= 48,484 OR 95%CI OR 95%CI OR 95%CI Black Race 1.71 1.57-1.86 1.89 1.74-2.04 1.90 1.76-2.06 Hispanic Ethnicity 1.76 1.60-1.94 2.18 2.00-2.36 2.00 1.80-2.21 Medicare 1.44 1.30-1.58 1.46 1.34-1.61 1.45 1.32-1.61 Medicaid 2.10 1.92-2.29 2.13 1.96-2.31 2.14 1.96-2.34 No Insurance 2.28 1.99-2.61 2.36 2.07-2.70 2.25 1.96-2.59

322P Incidence patterns for locally advanced operable breast cancer by receptor status: SEER 2010-2021

322P Incidence patterns for locally advanced operable breast cancer by receptor status: SEER 2010-2021

Can negative axillary ultrasound reliably predict pathologically negative axillary lymph node status in breast cancer patients with cT ≤3 cm, cN0, and HER2-positive?-a retrospective, single-institution study.

Breast cancer (BC) is the leading cancer in women globally, with human epidermal growth factor receptor 2 (HER2)-positive subtype accounting for 15-20% of cases and exhibiting aggressive behavior. The standard of care for operable BC has evolved to include neoadjuvant systemic therapy, which can guide treatment decisions and improve outcomes, particularly in HER2+ BC. This study aims to investigate whether axillary ultrasound has a good negative predictive value (NPV) for early HER2 BC patients and to identify clinicopathological factors that can impact the axillary lymph node metastasis. This retrospective, single-center study evaluated the medical records of 135 patients with HER2+ BC, cT ≤3 cm, and clinically negative axillary lymph nodes from 2018 to 2020. The study aimed to determine the NPV of axillary ultrasound for pathologically negative axillary lymph node status and to identify factors associated with axillary lymph node metastasis. The NPV of axillary ultrasound was 78.5%, increasing to 89.6% and 93.3% when considering 0-1 and 0-2 metastatic lymph nodes, respectively. Lymphovascular invasion (LVI) was significantly associated with axillary lymph node metastasis, with a 2.2-fold increased risk. Axillary ultrasound shows good predictive value for axillary lymph node negativity in HER2+ BC patients with small tumors. However, the presence of LVI increases the risk of metastasis, suggesting a need for neoadjuvant chemotherapy. These findings contribute to personalized treatment strategies for early HER2+ BC, emphasizing the role of axillary ultrasound in clinical decision-making.

Prognostic and Clinical Significance of the Proliferation Marker MCM7 in Breast Cancer.

Minichromosome maintenance complex component 7 (MCM7) plays an essential role in proliferation and DNA replication of cancer cells. However, the expression and prognostic significance of MCM7 in breast cancer (BC) remain to be defined. In this study, we aimed to evaluate the role of MCM7 in BC. We conducted immunohistochemistry staining of MCM7 in 1,156 operable early-stage BC samples and assessed MCM7 at the transcriptomic levels using publicly available cohorts (n = 13,430). MCM7 expression was evaluated and correlated with clinicopathological parameters including Ki67 labelling index and patient outcome. At the transcriptomic level, there was a significant association between high MCM7 mRNA levels and shorter patient survival in the whole cohort and in luminal BC class but not in the basal-like molecular subtype. High MCM7 protein expression was detected in 43% of patients and was significantly associated with parameters characteristic of aggressive tumour behaviour. MCM7 was independently associated with shorter survival, particularly in oestrogen receptor-positive (luminal) BC. MCM7 stratified luminal tumours with aggressive clinicopathological features into distinct prognostic groups. In endocrine therapy-treated BC patients, high MCM7 was associated with poor outcome, but such association disappeared with administration of adjuvant chemotherapy. Patients with high expression of Ki67 and MCM7 showed worst survival, while patients with double low expression BC showed the best outcome compared with single expression groups. The current findings indicate that MCM7 expression has a prognostic value in BC and can be used to identify luminal BC patients who can benefit from adjuvant chemotherapy.

Postoperative radiotherapy in women with early operable breast cancer (Scottish Breast Conservation Trial): 30-year update of a randomised, controlled, phase 3 trial

Breast-conserving surgery, adjuvant systemic therapy, and radiotherapy are the standard of care for most women with early breast cancer. There are few reports of clinical outcomes beyond the first decade of follow-up of randomised trials comparing breast-conserving surgery with or without radiotherapy. We present a 30-year update of the Scottish Breast Conservation Trial. In this randomised, controlled, phase 3 trial across 14 hospitals in Scotland, women aged younger than 70 years with early breast cancer (tumours ≤4 cm [T1 or T2 and N0 or N1]) were included. They underwent breast-conserving surgery (1 cm margin) with axillary node sampling or clearance. Oestrogen receptor (ER)-rich patients (≥20 fmol/mg protein) received 20 mg oral tamoxifen daily for 5 years. ER-poor patients (<20 fmol/mg protein) received chemotherapy (cyclophosphamide 600 mg/m2, methotrexate 50 mg/m2, and fluorouracil 600 mg/m2 every 21 days intravenously in eight courses). Stratification was by menstrual status (within or more than 12 months from last menstrual period) and ER status (oestrogen concentration ≥20 fmol/mg protein, <20 fmol/mg protein, or unknown) and patients were randomly assigned (1:1) to high-dose (50 Gy in 20-25 fractions) local or locoregional radiotherapy versus no radiotherapy. No blinding was possible due to the nature of the treatment. We report the primary endpoint of the original trial, ipsilateral breast tumour recurrence, and the co-primary endpoint, overall survival. Clinical outcomes were compared by the log-rank test. Hazard ratios (HRs) are reported, with no radiotherapy as the reference group. Failures of the proportional hazards assumption are reported if significant. All analyses are by intention to treat. Between April 1, 1985, and Oct 2, 1991, 589 patients were enrolled and randomly assigned to the two treatment groups (293 to radiotherapy and 296 to no radiotherapy). After exclusion of four ineligible patients (two in each group), there were 291 patients in the radiotherapy group and 294 patients in the no radiotherapy group. Median follow-up was 17·5 years (IQR 8·4-27·9). Ipsilateral breast tumour recurrence was significantly lower in the radiotherapy group than in the no radiotherapy group (46 [16%] of 291 vs 107 [36%] of 294; HR 0·39 [95% CI 0·28-0·55], p<0·0001). Although there were differences in the hazard rate for ipsilateral breast tumour recurrence in the first decade after treatment (HR 0·24 [95% CI 0·15-0·38], p<0·0001), subsequent risks of ipsilateral breast tumour recurrence were similar in both groups (0·98 [0·54-1·79], p=0·95). There was no difference in overall survival between the two groups (median 18·7 years [95% CI 16·5-21·5] in the no radiotherapy group vs 19·2 years [16·9-21·3] in the radiotherapy group; HR 1·08 [95% CI 0·89-1 ·30], log-rank p=0·43). Our findings suggest that patients whose biology predicts a late relapse a decade or more after breast-conserving surgery for early breast cancer might gain little from adjuvant radiotherapy. Breast Cancer Institute (part of Edinburgh and Lothian Health Foundation) and PFS Genomics (now part of Exact Sciences).

Role of Diffusion Weighted Magnetic Resonance Imaging in Post- Operative Breast Cancer Patients

Role of Diffusion Weighted Magnetic Resonance Imaging in Post- Operative Breast Cancer Patients

Prognostic Significance of Circulating and Disseminated Tumor Cells in Breast Cancer Patients before and after Adjuvant Chemotherapy.

Despite the advances in treatment, breast cancer (BC) remains a major cause of death in women. This study aims to evaluate the prognostic significance of detecting circulating tumor cells (CTCs) and disseminated tumor cells (DTCs) in paired peripheral blood (PB) and bone marrow (BM) samples obtained both before and after adjuvant chemotherapy from patients with operable BC. In this experimental study, from 160 patients with primary BC, we collected 160 PB and BM samples before and we could be able to collect PB and BM samples from 100 of them after adjuvant chemotherapy. The expression level of cytokeratin 19 (CK19), carcinoembryonic antigen (CEA), mammaglobin 1 (MGB1), mucin 2 (MUC2) and trefoil factor 1 (TFF1) mRNAs in the PB/BM samples were analyzed by quantitative real-time polymerase chain reaction (PCR). Multivariate Cox regression analyses indicated that the detection of CK19 mRNA-positive CTCs/DTCs either before or after adjuvant chemotherapy was an independent factor for prognosis associated with decreased diseasefree survival (DFS). Patients with tumor cells detected in both PB and BM and patients with persistent detection of tumor cells before and after chemotherapy had worse outcomes compared to those with tumor cells detected in one or neither of the compartments. This study suggests that the detection of CK19 mRNA-positive CTCs/DTCs either before or after adjuvant chemotherapy could be an independent predictor of DFS in operable BC patients.

Impact of Presenting Stage on Overall Survival in Patients Treated with Neoadjuvant Chemotherapy for Triple Negative Breast Cancer.

For operable triple-negative breast cancer (TNBC) treated with neoadjuvant chemotherapy (NAC), clinical prognostication and postoperative decision-making relies exclusively on whether a pathologic complete response (pCR) is achieved or not. We evaluated whether extent of disease at presentation further influenced overall survival (OS) among patients with pCR or with residual disease (RD) following NAC. Patients with stage I-III TNBC who underwent NAC were identified from the National Cancer Database from 2010 to 2019. Overall survival was assessed by disease extent using the Kaplan-Meier method and Cox proportional hazards regression for univariate and multivariable analysis. A total of 35,598 patients met inclusion criteria, and 11,967 achieved pCR. Ten-year OS was 88.5% and varied by cT and cN categoryat presentation. Best 10-year OS was seen in patients with cT1-2, cN0 (90.9%) and was worst in those with cT3-4, cN2-3 disease (72.0%). A total of 23,631 patients had RD. Ten-year OS was 60.1% and varied by cT and cN categoryat presentation. Best 10-year OS was seen in patients with cT1-2, cN0 (73.0%) and was worst in those with cT3-4, cN2-3 disease (36.3%). Notably, OS was significantly poorer for patients with cT3-4, cN2-3 diseaseat diagnosis and pCR versus those with cT1-2 cN0 and RD (aHR 1.30, 95% confidence interval 1.03-1.63, p = 0.03). Among patients with TNBC, extent of disease at presentation was prognostic for OS independently of response to NAC. Patients with advanced stage at presentation had poorer OS even in the context of pCR. Further investigation is needed to evaluate whether additional adjuvant therapy strategies should be considered for these patients.

Pre-treatment peripheral blood immunophenotyping and response to neoadjuvant chemotherapy in operable breast cancer

BackgroundTumor immune infiltration and peripheral blood immune signatures have prognostic and predictive value in breast cancer. Whether distinct peripheral blood immune phenotypes are associated with response to neoadjuvant chemotherapy (NAC) remains understudied.MethodsPeripheral blood mononuclear cells from 126 breast cancer patients enrolled in a prospective clinical trial (NCT02022202) were analyzed using Cytometry by time-of-flight with a panel of 29 immune cell surface protein markers. Kruskal–Wallis tests or Wilcoxon rank-sum tests were used to evaluate differences in immune cell subpopulations according to breast cancer subtype and response to NAC.ResultsThere were 122 evaluable samples: 47 (38.5%) from patients with hormone receptor-positive, 39 (32%) triple-negative (TNBC), and 36 (29.5%) HER2-positive breast cancer. The relative abundances of pre-treatment peripheral blood T, B, myeloid, NK, and unclassified cells did not differ according to breast cancer subtype. In TNBC, higher pre-treatment myeloid cells were associated with lower pathologic complete response (pCR) rates. In hormone receptor-positive breast cancer, lower pre-treatment CD8 + naïve and CD4 + effector memory cells re-expressing CD45RA (TEMRA) T cells were associated with more extensive residual disease after NAC. In HER2 + breast cancer, the peripheral blood immune phenotype did not differ according to NAC response.ConclusionsPre-treatment peripheral blood immune cell populations (myeloid in TNBC; CD8 + naïve T cells and CD4 + TEMRA cells in luminal breast cancer) were associated with response to NAC in early-stage TNBC and hormone receptor-positive breast cancers, but not in HER2 + breast cancer.Trial registrationNCT02022202. Registered 20 December 2013.

A pilot randomized controlled study to determine the effectiveness of video educational tool in BRCA1/2 pre‐test counseling for Japanese breast cancer patients

AbstractBRCA1/2 genetic testing has become clinically important in breast cancer care, but increasing demand may put a burden on the shortage of healthcare professionals. We performed a single‐center, pilot randomized controlled study to assess the effectiveness of employing a video educational tool that included standard pre‐test genetic counseling elements related to BRCA1/2. Patients with operable breast cancer who met the criteria for genetic testing based on age, sex, subtype, and family history were recruited. Sixty consenting participants were randomized 1:1 and placed in groups that received either traditional face‐to‐face pre‐test counseling or video‐viewing and face‐to‐face decisional support. To assess decisional conflict in the participants, surveys based on the Decisional Conflict Scale (DCS) were administered two times, once immediately after intervention and again 2–4 weeks later. The time taken for counseling and confirmation of whether the participants had undergone testing were also recorded. The difference in the total DCS scores between the two groups was not significantly different for either of the survey periods, and there was no significant difference in the number of participants who underwent testing (23/30 [76.7%] vs. 26/30 [86.7%]; p = 0.51). However, the “effective decision” subscale score was significantly higher in the video group 2–4 weeks after counseling (31.01 ± 16.82 vs. 21.43 ± 16.09; p = 0.04 [mean ± SD]). The time taken for counseling was significantly shorter in the video group (8.00 ± 4.5 vs. 27.00 ± 7.61 min; p &lt; 0.001 [median ± SD]). Our findings indicate the potential benefit of the video educational tool for providing BRCA1/2‐related information. These tools may also enable healthcare professionals to spend more time supporting psychological issues. Notably, after some time, patients may question whether their decision was appropriate. Therefore, it is necessary to identify those in conflict and provide them with proper support.

Evaluation of early response in association with pathological response in patients with breast cancer receiving neoadjuvant chemotherapy.

e12628 Background: Neoadjuvant therapy (NAT) has now been widely used for patients with operable breast cancer (BC) to test drug sensitivity. Studies have indicated that early assessment of clinical response to NAT can help identify patients who are resistant to initial regimens, providing an additional opportunity to change treatment plan. However, there is a lack of evidence regarding the optimal timing for conducting early evaluations of clinical response. This prospective study was conducted to evaluate the association between early evaluation of clinical response at different timing (post 2 cycles versus post 4 cycles) and pCR post NAT, in order to determine the most appropriate timing for NAT response evaluation. Clinical evaluations using ultrasound and MRI (magnetic resonance imaging) were also compared. Methods: A prospective cohort study including BC patients who received NAT was conducted between January 2018 and December 2023. Multivariable logistic regression analysis was used to estimate the Odds Ratios (OR) and 95% confidence intervals (CI) for the clinical response evaluated at different timings in association with pCR. The heterogeneity of the associations for the post-cycle 2 and post-cycle 4 assessments was assessed. Linear regression analyses were used to assess the associations between extent of tumor reduction post 2 cycles and that post 4 cycles of NAT. Agreement of tumor measurements using ultrasound and MRI was also assessed. Results: A total of 186 BC patients were consecutively enrolled and included in this analysis. 55 (29.6%) of them achieved pCR. Partial response (PR) post 2 cycles and 4 cycles of NAT were both significantly associated with pCR post NAT, though the point estimate of association for PR post 2 cycles of NAT (OR=5.06, 95%CI:2.29-12.09) was more evident than that post 4 cycles (OR=2.79, 95%CI:1.20-7.21). Extent of tumor reduction post two cycles of NAT was highly correlated with that post four cycles (r=0.89, 95%CI=0.79-0.98, P&lt; 0.01). Poor concordance was observed between ultrasound and MRI measurements of tumor size, whether at initial diagnosis (r=0.66, adjusted r2=0.43) or after two cycles of NAT (r=0.59, adjusted r2=0.35). Among those patients who had PR post 2 cycles of NAT, tumor reduction by greater than 50% was not associated with higher probability of reaching pCR in comparison to those lower than 50% (OR=1.86, 95%CI=0.82-4.37, P=0.143). Conclusions: Tumor response assessed using MRI after two cycles of NAT was highly correlated with pCR, and may be adopted as an optimal strategy for early evaluation of the efficacy of NAT regimen. Further studies are warranted to evaluate changes in treatment plan at early phase of NAT for those resistant to initial regimens.

Multilevel factors associated with delays to neoadjuvant chemotherapy among young adults with operable breast cancer.

11091 Background: Breast cancer (BC) rates are increasing in young adults (YAs: age 18-39) and this population may experience unique barriers to treatment initiation. We identified factors associated with treatment initiation delays in a cohort of YAs with operable BC who received neoadjuvant chemotherapy (NACT). Methods: Using the National Cancer Database, we identified YAs diagnosed with non-metastatic BC from 2010-2020 who received NACT. We grouped patients by receptor status and clinical stage: 1) Hormone Receptor positive/HER-2 negative (HR+/HER2-) and were lymph node (LN) LN+; 2) HER-2 positive (HER2+) cT2+ or LN+; and 3) triple negative BC (TNBC) cT2+ or LN+. Primary outcome was delayed treatment initiation, defined as &gt; 60 days from diagnosis date to NACT. Multivariable (MV) logistic regression was used to model factors associated with delay and adjusted for sociodemographic, clinical, and facility-level factors. We also examined factors associated with delays by tumor type. Results: Of 23,078 included patients, 62% were non-Hispanic White (NHW) and 74% had private insurance. By tumor type, 28% (n=6,350) were ER/PR+, 39% (n=8,921) were HER2+, and 34% (n=7,807) had TNBC. Most patients were treated at academic comprehensive cancer programs (ACCP) or comprehensive community cancer programs (CCCP) (40% and 34%). Treatment delays were observed among 7% of patients (n=1,638) across all tumor types. In MV analysis, non-Hispanic Black (NHB) and Hispanic YAs had 2-fold higher odds of delays compared with NHW YAs. YAs with low-income had higher odds of delays compared with higher income (OR=1.41), and YAs with private insurance had lower odds of delays compared with Medicaid (OR=0.54). YAs treated at any non-ACCP facility were less likely to experience delays. The results were similar for each tumor type. Conclusions: While the overall incidence of delays was low, significant racial, ethnic, and institutional-level treatment initiation disparities were observed among YAs receiving NACT for BC. [Table: see text]

Delays in receipt of neoadjuvant chemotherapy compared to upfront surgery in patients with operable breast cancer.

e13561 Background: Delays in time from breast cancer (BC) diagnosis to BC treatment initiation (BCTI) including upfront breast surgery (UBS) or neoadjuvant chemotherapy (NACT), can negatively impact BC survival. We evaluated odds of delay in BCTI among patients (pts) who received NACT compared to pts who received UBS. Methods: We conducted a retrospective cohort study using the National Cancer Database. Eligibility included age ≥18 years, diagnosis of non-metastatic BC between 1/1/2010 – 12/31/2020, who were treated with NACT followed by surgery or UBS followed by adjuvant chemotherapy (AC). Pts who did not receive NACT or UBS within 180 days of diagnosis were excluded. The cohort was stratified by first BC treatment (NACT or UBS), and time to NACT (TTNACT) or time to surgery (TTS) was recorded for each patient in days. Pts were categorized into sub-cohorts by receptor status and clinical stage: 1) Hormone Receptor positive/HER-2 negative (HR+/HER2-) lymph node (LN)+; 2) HER-2 positive (HER2+) cT2+ or LN+; and 3) triple negative BC (TNBC) cT2+ or LN+. Logistic regression adjusted for demographic, socioeconomic, and tumor characteristics was used to identify delays in BCTI &gt; 60 days. Multiple imputation was used for missing data. Inverse probability treatment weighting (IPTW) was done as a sensitivity analysis. Results: We identified 218,049 eligible pts, 75% were White, 18% were Black, and 8.6% were Hispanic. Median age was 53 years (range 18-90). There were 145,697 (67%) pts who received NACT with median TTNACT of 32 days (range 0-180), and 9.8% had a delay &gt; 60 days (Table). There were 72,353 (33.0%) pts who received UBS followed by AC, with a median TTS of 33 days (range 0-180), and 13% with a delay &gt; 60 days. In multivariable analysis, pts who received UBS had higher odds of BCTI delays compared to NACT, with OR 1.50 (95%CI 1.42-1.57) [HR+/HER2-], OR 1.49 (95%CI 1.41-1.58) [HER2+], and OR 1.26 (95%CI 1.18-1.34) [TNBC]. Results from IPTW analysis were similar, groups were well balanced, and pts who received UBS had higher odds of BCTI OR 1.50 (95%CI 1.44-1.57) [HR+/HER2-], OR 1.75 (95%CI 1.67-1.83) [HER2+], and OR 1.46 (95%CI 1.38-1.53) [TNBC]. Conclusions: Among high clinical risk BC patients who received surgery and chemotherapy, those who underwent NACT were less likely to experience delays in BCTI compared to pts who received UBS first. Among eligible pts, use of NACT may reduce delays in BCTI. [Table: see text]

The efficacy of primary progesterone on survival in early breast cancer: A real world scenario.

e12522 Background: Surgery performed during progestogenic milieu improves survival in breast cancer patients. We previously proved efficacy of pre-operative progesterone in high-risk, operable breast cancer. In another multicenter randomized trial, intra-operative peri-tumoral local anesthetic injection showed 29% reduction in mortality. In this study, several patients had also received progesterone injection since this is adopted as standard of care across some centers including ours. We assessed the effectiveness of pre-operative progesterone in patients who were randomized in the local anesthetic study. Methods: We analyzed 1583 patients randomized on the local anesthetic study during December 2011-October 2018 with respect to receipt of progesterone. All patient who had breast lump of ≥2cm and/or node positive were eligible to receive progesterone injection before surgery. Kaplan Meier curves were plotted along with Cox regression analysis to study factors affecting disease-free and overall survival. Results: Of 1583, 454 patients did not receive, and 1129 patients received progesterone before surgery. The median age of whole cohort was 51 years, median pT size was 3 cm, 45% were node positive, 60% ER/PR+ and 24%TNBC. At median follow-up of 68 (0·5-72) months in surviving patients, there were a total of 292 DFS events (progesterone arm-193, no-progesterone arm-99). The 5-year disease-free survival (DFS) was 86.5% in the progesterone arm and 79.2% in the no-progesterone arm (HR-0.57,0.45-0.73, P&lt;0.001). The 5-year overall survival (OS) was 90.5% in the progesterone arm and 82.8% in the no-progesterone arm (HR-0.47,0.36-0.63,P&lt;0.001). On Cox Regression analysis (Table), administration of progesterone injection was an independent prognostic factor for DFS (HR-0.53,0-41-0.70, p&lt;0.001) and OS (HR-0.44,0-32-0.60, p&lt;0.001) both. Conclusions: The receipt of pre-operative progesterone improved outcomes in the setting of another randomized trial. It should be administered to all high risk (T2/N1) breast cancer patients who are planned for surgery first. [Table: see text]

Interpectoral nodal dissection for invasive breast cancer: A retrospective single institution study from India.

e12585 Background: Interpectoral lymph nodes are one of the axillary lymphatic drainage sites in breast carcinoma. Usually dissection of Interpectoral nodes (IPN) avoided during axillary dissection as they are not the primary lymphatic drainage site. Our study aims to identify the rate of positivity of Interpectoral nodes in invasive breast cancer, predictors of IPN positivity in relation to tumour location, size, grade and hormone receptor status and to evaluate the need for IPN clearance during axillary dissection. Methods: A retrospective analysis of histopathology reports of 367 patients who underwent Axillary dissection in a single centre from Jan 2017-Dec 2022 for breast cancer was analysed. Inclusion criteria: Female Patients with operable Invasive Breast cancer with node positive axilla who underwent axillary dissection (upfront and post chemotherapy). Exclusion criteria: metastatic breast cancer, node-negative patients/sentinel lymph node biopsy, inadequate nodal dissection, and incomplete clinicopathological information. Data was analysed looking for presence of nodes in interpectoral tissue in Axillary dissection and to identify the positivity of interpectoral lymph nodes in specimens. Results: Interpectoral nodal dissection was done in n=216 of the 367 patients. The clinicopathological characters are described in Table. IPN were identified in 35% (n=77) of the 216 Axillary dissection specimens. IPN were positive in 7.8% (17 of 216) of patients who had interpectoral nodal dissection. 22% of the interpectoral lymph nodes removed were positive. As regards tumour size, Rotter's nodes were identified commonly in T3 and T4 tumours and positive in people with N2 and N3 disease. By multivariate analysis, T stage and N stage were the most important determinants of IPN yield and positivity. Site of tumour, neoadjuvant therapy, molecular subtype or Ki 67 were not found to be associated with either presence or positivity of interpectoral nodes. In 5 cases IPN positivity upstaged the nodal stage and in 1 patient it was the only positive node. Conclusions: As IPN is positive in most LABC, whenever axillary dissection is done in such cases Interpectoral nodes can be safely removed while dissecting level III nodes. Nodal recurrence is the most common site of recurrence post mastectomy and hence Interpectoral nodes need to be routinely removed in patients undergoing Axillary dissection for operable breast cancer to enable accurate staging and to prevent local or systemic failure. [Table: see text]

Outcomes of the Electrothermal Bipolar Vessel Sealing Device and Electrocautery in Modified Radical Mastectomy Patients.

Introduction With the rising trends in breast cancer throughout the world, the traditional modus of intraoperative tissue dissection using a scalpel, scissors, or electrocautery needs to be re-evaluated in the wake of newer modalities, such as electrothermal bipolar vessel sealing (EBVS) devices, which may theoretically reduce the postoperative complications and morbidity in these patients. Aimand objective The objective of this study is to compare an EBVS device to electrocautery (diathermy) in modified radical mastectomy (MRM), based on selected intraoperative and postoperative outcomes. Study procedure This was a comparative cross-sectional section study that included 60 patients with operable breast cancer (stages I and II, TNM classification, and post-neoadjuvant stage III disease). Patients were divided into two groups for surgery: one group underwent an MRM using the EBVS device (Group A), while the other group had the procedure performed using conventional electrocautery (Group B), as per the surgeon's choice depending on theatre slot and equipment availability. Intraoperatively, the total operative time, time for raising the flaps, time taken for breast tissue dissection, time for axillary dissection, and blood loss were recorded. Postoperative parameters included total drainage volume, number of days of drainage, seroma formation, and other complications. Patients were followed up for one month after surgery, with early postoperative complications such as wound infection, upper limb lymphedema, seroma, flap necrosis, and nerve injuries being documented. Results The groups were found to be comparable in terms of the age distribution, TNM staging, stage grouping, and nodal status of the patients. The EBVS device group demonstrated statistically significant advantages in total operative time, axillary dissection time, flap raising time, breast tissue dissection time, intraoperative blood loss, total drainage volume, and days of drainage. However, no statistically significant difference was found between the two devices in terms of seroma formation, early postoperative complications, and duration of postoperative stay at the hospital. Conclusion While the use of EBVS in MRM provides a considerable decrement in the total operative duration, duration of the various steps of surgery, intraoperative blood loss, and postoperative volume and duration of drainage, these devices do not offer an evident advantage in terms of the postoperative complications or morbidity.