Rate Of Breast-conserving Surgery Research Articles

Oncologic Safety of Immediate Oncoplastic Surgery Compared with Standard Breast-Conserving Surgery for Patients with Invasive Lobular Carcinoma.

Invasive lobular carcinoma (ILC) of the breast grows in a diffuse pattern, resulting in a high risk of positive margins at surgical resection. Oncoplastic approaches have been shown to reduce this risk, but concerns persist around the safety of immediate oncoplastic surgery for those with ILC. This study evaluated the short- and long-term oncologic outcomes of immediate oncoplastic surgery for patients with ILC. This study retrospectively analyzed an institutional database of stages I to III ILC patients who underwent breast-conserving surgery (BCS) with or without immediate oncoplastic surgery (oncoplastic closure or oncoplastic reduction mammoplasty [ORM]). The study compared positive margin rates, rates of successful BCS, and recurrence-free survival (RFS) by type of surgery. For 494 patients the findings showed that the use of immediate ORM was associated with significantly lower odds of positive margins (odds ratio [OR], 0.34; 95 % confidence interval [CI], 0.17-0.66; p = 0.002). Both lumpectomy with oncoplastic closure and ORM were significantly associated with higher rates of successful BCS than standard lumpectomy (94.2 %, 87.8 %, and 73.9 %, respectively; p < 0.001). No difference in RFS was observed between those undergoing immediate oncoplastic surgery and those undergoing standard lumpectomy alone. The patients with stages I to III ILC who underwent immediate oncoplastic surgery had significant benefits including lower odds of positive margins and higher rates of successful BCS, with both types of immediate oncoplastic surgery showing similar RFS compared with lumpectomy alone. This supports the oncologic safety of immediate oncoplastic surgery for diffusely growing tumors such as ILC, providing it an ideal option for patients desiring BCS.

Abstract PO1-28-04: PILHLE-001: neoadjuvant pyrotinib combined with chemotherapy in HR-positive, HER2-low (IHC 2+/FISH-negative) early breast cancer

Abstract Background: Hormone receptor (HR)-positive/HER2-low (IHC 2+/FISH negative or IHC 1+) breast cancers (BCs) represent the largest proportion of breast carcinomas. However, its response to neoadjuvant chemotherapy or endocrine therapy is the lowest, with a residual cancer burden (RCB) 0/I rate around 15%. Previous studies have demonstrated that pyrotinib (P), a pan-HER tyrosine kinase inhibitor, exhibits excellent response in HER2-positive early or advanced BC (E/ABC). In-vitro experiments have shown that pyrotinib can effectively inhibit colony formation in HER2-low (IHC 2+/FISH negative) BC cells. This PILHLE-001 study (NCT05165225) aimed to evaluate the efficacy and safety of neoadjuvant pyrotinib plus chemotherapy in HR-positive/HER2-low (IHC 2+/FISH negative) EBC patients with potential biomarkers. Methods: PILHLE-001, as a single-arm, single-center phase Ⅱ trial, enrolled patients with previously untreated HR-positive (ER or PR &amp;gt; 1%) and HER2-low (IHC 2+/FISH negative) invasive EBC (TNM stage II-III) to receive pyrotinib 320mg QD and four Q3W of epirubicin-cyclophosphamide followed by four Q3W of docetaxel. MammaPrint/BluePrint at baseline (t0) was assessed. Breast magnetic resonance imaging (MRI) was conducted at t0, the end of cycle 2 neoadjuvant therapy (t1), and the end of all neoadjuvant therapy. Immune cell subpopulations assay and gene sequencing of tumor tissues with whole blood control samples were performed at t0 and surgery (t2). Additional core biopsy was administered to reassess Ki67 and tumor infiltrating lymphocytes (TILs) at t1. The primary outcome was RCB 0/I rate. The short-term secondary outcomes included pathological complete response (pCR, ypT0/is ypN0) rate, objective response rate (ORR), breast conservation surgery (BCS) rate, safety, and exploratory biomarkers analysis. Results: From July 2021 to March 2023, 48 patients were enrolled and treated. The median age of the patients was 48 years (range 28-66), 43 (90%) had cT1-2 tumors, 30 (63%) showed no node involvement, 37 (77%) had tumours with TNM stage II, and 47 (98%) had ER expression ≥ 50%. Twenty-eight (61%) of 46 patients had MammaPrint high risk. Out of the 48 patients, 26 (54.2%) achieved RCB 0/I, with a 95% confidence interval of 39.2% to 68.6%. The RCB 0/I rate was particularly higher in tumors with no lymph node involvement (73.3%), TNM stage II (64.9%), or abundant tumor-infiltrating lymphocytes (66.7%). Three (6.3%) patients obtained a pCR. The rate of BCS was 60.4% (29/48). The ORR was 45.8% (22/48) at t1 and 81.3% (39/48) at the end of all neoadjuvant therapy, respectively. No patients had progressive disease. All treatment-related adverse events (AEs) were mostly of grade 1 or 2 severity. Grade ≥ 3 AEs occurred in 21 (44%) patients, with the most prevalent being diarrhea [10 (21%)]. All AEs were reversible with symptomatic treatment and no treatment-related deaths occurred. Patients with MammaPrint risk-low BC had a lower RCB 0/I rate than those with risk-high BC (60.7% vs. 44.4%), although the difference was not statistically significant. Baseline specific immune cell subpopulations (lower PD-1, higher CD3, etc.) or the presence of non-altered PIK3CA were significantly associated with a higher likelihood of achieving RCB 0/I. Similarly, objective response, greater declines in specific MRI quantitative parameters (Ktrans and Kep), greater declines in Ki67, or more increased TILs at t1 were also significantly associated with a higher rate of RCB 0/I. Conclusions: The PILHLE-001 trial first revealed that neoadjuvant pyrotinib plus chemotherapy has encouraging efficacy and acceptable toxicity in patients with HR-positive/HER2-low (IHC 2+/FISH negative) EBC, and this regimen warrants further investigation in phase III randomized controlled trials. Citation Format: Chang Gong, Yuan Xia, Yingying Zhu, Yaping Yang, Wenqian Yang, Louis W.C. Chow, Li Ling, Yunjie Zeng, Jiajie Zhong, Ziliang Cheng, Jun Shen, Qun Lin, Yinduo Zeng, Qiang Liu, Erwei Song. PILHLE-001: neoadjuvant pyrotinib combined with chemotherapy in HR-positive, HER2-low (IHC 2+/FISH-negative) early breast cancer [abstract]. In: Proceedings of the 2023 San Antonio Breast Cancer Symposium; 2023 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2024;84(9 Suppl):Abstract nr PO1-28-04.

Abstract PO5-19-08: Neoadjuvant HER2-targeted Therapy +/- Immunotherapy with Pembrolizumab (neoHIP): An Open Label Randomized Phase II Trial

Abstract Background: Immune checkpoint inhibition (ICI) is synergistic with HER2-directed therapy in pre-clinical models. Clinically, pembrolizumab (K)-mediated ICI plus HER2-directed therapy with trastuzumab (H) was safe and demonstrated modest activity in H-resistant HER2-positive (HER2+) metastatic breast cancer. Because ICI may confer more robust activity when administered earlier in the course of disease, H and K administered in the curative-intent, treatment-naive setting may allow for de-escalation of cytotoxics; confer life-long, tumor-specific immunity; and ultimately, improve cure rates. Moreover, the synergy of H and K with paclitaxel (T) may overcome the need for dual HER2-blockade with H plus pertuzumab (P). In this randomized, multicenter, phase II, open-label trial the efficacy and safety of neoadjuvant THP vs THP-K vs TH-K are explored. Methods: Patients (pts) ≥18y with previously untreated, stage II-III, HER2+ breast cancer are being randomized and stratified by clinical nodal status (positive vs. negative) and hormone receptor status (positive vs. negative). In arm A, pts receive T at 80mg/m2 weekly for 12 weeks, H at 8mg/Kg (loading dose) and then 6mg/Kg every 3 weeks x 3 doses, P at 840 mg (loading dose) and then 420mg/Kg every 3 weeks x 3 doses (THP). In arm B, pts receive THP plus K at 200mg every 3 weeks x 4 doses (THP-K). In arm C, pts receive TH-K. After enrollment of 22 pts to arm C, a prespecified interim efficacy analysis was conducted, and enrollment to this arm was subsequently terminated. Enrollment to the other arms continues with 32/58 pts enrolled to arm A and 33/58 pts enrolled to arm B as of 2/14/2023. Definitive surgery is 3-6 weeks after the last dose. After surgery, pts are treated per the treating physician’s discretion per local clinical standard. The primary end point is pathologic complete response (pCR) rate in the breast and axilla (ypT0/Tis ypN0). Secondary end points include pCR rate by ypT0ypN0 and ypT0/Tis, residual cancer burden index, event free survival, breast conserving surgery rate, safety and overall survival. Exploratory correlative studies will characterize potential immune biomarkers predictive of efficacy and/or toxicity. Funding sources: BCRF, Merck NCT03747120 Citation Format: Heather McArthur, Jorge Henrique Santos Leal, Isaac Chan, Nisha Unni, Stephen Shiao, Joshua Gruber, Samira Syed, Namrata Peswani, Navid Sadeghi, Glenda Delgado, Dawn Klemow, Reva Basho, Meredith Carter, Mai Badran, Nasir Qureshi, Jessica Curtin, Joshua Weese, Stephanie Rice, Michelle Phillips, David Chan, Hugo Hool, Dorothy Park, Mary El-Masry, Philomena McAndrew, Swati Sikaria, Laura Spring, Aditya Bardia, Mourad Tighiouart, Farnaz Dadmanesh, Armando Giuliano, Katherine Sanchez, David Page. Neoadjuvant HER2-targeted Therapy +/- Immunotherapy with Pembrolizumab (neoHIP): An Open Label Randomized Phase II Trial [abstract]. In: Proceedings of the 2023 San Antonio Breast Cancer Symposium; 2023 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2024;84(9 Suppl):Abstract nr PO5-19-08.

Abstract PO1-27-01: Comparing the Efficacy and Safety of TQB2440 versus the Reference Pertuzumab for the Treatment of HER2-Positive Early or Locally Advanced Breast Cancer: A Multicenter, Randomized, Double-Blind, Parallel-Controlled Phase 3 Trial

Abstract Background: Pertuzumab is a recombinant humanized monoclonal antibody targeting the extracellular dimerization domain II of HER2. On September 30, 2013, the FDA have granted accelerated approval of a pertuzumab regimen for neoadjuvant treatment of patients (pts) with high-risk, HER2-positive early stage breast cancer. TQB2440 is a pertuzumab (Perjeta®, Roche) biosimilar. This study aimed to compare the efficacy and safety of TQB2440 and the reference pertuzumab combined with trastuzumab and docetaxel in pts with HER2-positive early or locally advanced breast cancer. Methods: In this multicenter, randomized, double-blind phase 3 study, eligible pts were aged 18-75 with operable HER2-positive (IHC 3+ or ISH+) clinical stage II-IIIC breast cancer negative for ER/PR and had an ECOG PS of 0-1. The pts were randomly assigned to receive either TQB2440 or the reference pertuzumab (Perjeta®) (840 mg on day 1, cycle 1, followed by 420 mg on cycle 2-4, q3w) added to trastuzumab (8 mg/kg on day 1, cycle 1, followed by 6 mg/kg for cycles 2-4, q3w) + docetaxel (75 mg/m2, cycle 1-4, q3w). The pts then underwent surgery followed by adjuvant treatment with FEC regimens (fluorouracil 600 mg/m², epirubicin 90 mg/m², cyclophosphamide 600 mg/m², cycle 5-7, q3w), then TQB2440 (840 mg on day 1, cycle 8, followed by 420 mg on cycle 9-20, q3w) + trastuzumab (8 mg/kg on day 1, cycle 8, followed by 6 mg/kg for cycles 9-20, q3w) or until disease progression or intolerable toxicity. The primary endpoint was total pathologic complete response (tpCR) by independent review committee (IRC). Equivalence was established if the 90% confdence intervals (CIs) of the relative ratio [RR] within the interval of 0.76 to 1.32. Secondary endpoints included breast pathologic complete response (bpCR) by IRC, tpCR &amp; bpCR by investigator, breast conserving surgery (BCS) rates, objective response rate (ORR), event-free survival (EFS), disease-free survival (DFS), OS and safety. Results: Between October 21, 2020, and November 21, 2022, 412 pts were enrolled (TQB2440 group, n=207; the reference pertuzumab group, n=205). Data cutoff was November 30, 2022. In the intention-to-treat (ITT) population, the tpCR by IRC of the TQB2440 group and the reference drug group were 58.94% and 58.05%, respectively. The RR was 1.02 (90% CI, 0.89, 1.16), which was within the predefined equivalence interval of 0.76 to 1.32. There was no statistically significant difference in the bpCR by IRC between the TQB2440 group and the reference pertuzumab group (67.63% [95% CI, 60.80%, 73.95%] vs. 63.90% [95% CI, 56.92%, 70.48%], P=0.4249). The BCS rate also comparable between the two groups with 13.04% (95% CI, 8.77%, 18.41%) vs. 13.17% (95% CI, 8.86%, 18.58%) (P=0.9695). Additionally, the results of the PP (per-protocol) population were similar to those of the ITT population. The incidence of treatment-related adverse events (TRAEs) and grade ≥3 TRAEs were similar between the TQB2440 group and the reference pertuzumab group with 79.71% vs. 75.98% and 49.28% vs. 41.67%, respectively. Conclusion: In patients with HER2-positive early or locally advanced breast cancer, TQB2440 demonstrated equivalent efficacy and similar safety to the reference pertuzumab. Clinical trial information: NCT05985187. Research Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd Citation Format: Qingyuan Zhang, Shusen Wang, Nanlin Li, Qiao Cheng, Yu ren, Xuchen Cao, Jianjun Huang, Caigang Liu, Hongwei Yang, Limin Wei, Zhangjun Song, Huadong Zhao, Fangling Ning, Xiaojia Wang, Dehong Zou, Xiaohua Zeng, Jie Hao, Yunjiang Liu, Huijuan Wang, Nie Jianyun, Liang Li, Lina Liu, Tao Sun, Xiaobo Hu, Zhenhua Zhai, Huihua Xiong, Yuanqi Zhang, Enxiang Zhou, Jing Sun, Zhenhai Cai, Antai Zhang, Shui Wang, Junyang Mo, Qun Su, Xiuheng Qi, Guoren Zhou, Shuqun Zhang, Guozhong Cui, Wei Wang, Mingjiang Fan, Xinyu Qian, Xinhong Wu, Zhihong Wang, Jiuda Zhao, Yonghui Luo, Yanming Zhang, Fuguo Tian, Jiye Zhang, Dongning Chai, Qingshan Li. Comparing the Efficacy and Safety of TQB2440 versus the Reference Pertuzumab for the Treatment of HER2-Positive Early or Locally Advanced Breast Cancer: A Multicenter, Randomized, Double-Blind, Parallel-Controlled Phase 3 Trial [abstract]. In: Proceedings of the 2023 San Antonio Breast Cancer Symposium; 2023 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2024;84(9 Suppl):Abstract nr PO1-27-01.

Abstract PO1-14-12: Quantitative Biomarkers and 21-Gene Assay Results Predict Breast-Conserving Surgery Following Neoadjuvant Therapy in Early-Stage, Hormone Receptor-Positive, HER2-Negative Breast Cancer

Abstract Background: Neoadjuvant chemotherapy (NACT) and neoadjuvant endocrine therapy (NET) are often used to downstage tumors and/or enable breast-conserving surgery (BCS) in patients (pts) with early-stage, hormone receptor-positive/HER2-negative (HR+/HER2-) breast cancer. Given the increasing use of neoadjuvant therapy for HR+ breast cancer, studies are needed to better quantify the success of NACT/NET in downstaging tumors as a function of estrogen (ER), progesterone (PR), and Ki-67 expression, and 21-gene recurrence score (RS) in this patient population. Methods: Data were from pts with stage I-III, HR+/HER2- breast cancer diagnosed from 2010-2020 in the National Cancer Database (NCDB). Quantitative ER, PR, and Ki-67 data became available in 2018. We included pts who received either NACT or NET, with surgical plan categorized as mastectomy or BCS. Pts who received NACT for 12–30 weeks or NET for 4–36 months prior to surgery were eligible. Predicted rates of BCS by quantitative biomarkers (ER, PR, Ki-67 percentage, and RS) were estimated using restricted cubic spline logistic regression. Multivariable logistic regression models were fit to examine the associations between surgical plan and quantitative biomarkers for the two neoadjuvant cohorts. Adjusted odds ratios (aOR) and 95% confidence intervals (CI) were calculated per 10% increase in percentages of ER, PR, and Ki-67 expression. Results: Of 44,589 pts treated with NACT, the mean age was 53 years, the median amount of time they were on NACT before surgery was 21 weeks, and 65% had cT1-2 disease. Of 10,466 pts treated with NET, the mean age was 68 years, the median amount of time they were on NET before surgery was 6 months, and 76% had cT1-2 disease. Overall, 42% of pts underwent BCS after NACT; while 64% did after NET. In the NACT cohort, 13,752 of the pts with available quantitative biomarker data were included in regression analyses; in the NET cohort, 4,003 were included. After adjusting for demographic and clinicopathologic factors, increasing ER% (aOR=0.96, 95% CI: 0.94–0.97) and PR% (aOR=0.98, 95% CI: 0.96–0.99) were associated with lower odds of BCS after NACT. Increasing Ki-67% was associated with greater odds of BCS after NACT (aOR=1.07, 95% CI: 1.04–1.10). Pts with a low (aOR=0.50, 95% CI: 0.29–0.88) or intermediate (aOR=0.58, 95% CI: 0.41–0.81) RS were significantly less likely than pts with a high RS to undergo BCS after NACT. Asian pts were less likely than White pts to have BCS (aOR=0.75, 95% CI: 0.56–0.99), while rates of BCS after NACT were similar to pts from other racial and ethnic groups. In the NET cohort, increasing ER% was associated with greater odds of BCS (aOR=1.09, 95% CI: 1.01–1.17). There was no significant association between baseline PR% or Ki-67% and BCS after NET. Pts with a low (aOR=0.92, 95% CI: 0.60–1.43) or intermediate (aOR=0.96, 95% CI: 0.65–1.41) RS were numerically less likely than pts with a high RS to have BCS after NET, though not statistically significant. Compared with White pts, Asian pts were less likely to have BCS after NET (aOR=0.60, 95% CI: 0.40–0.91). Conclusions: In this analysis of pts from the NCDB who received neoadjuvant therapy for early-stage, HR+/HER2- breast cancer, we found that BCS after NACT was higher for patients with a high RS or high Ki-67, suggesting that NACT is unlikely to downstage tumors with a low/intermediate RS or low Ki-67. Most pts receiving NET underwent BCS (likely due to a smaller clinical tumor size); BCT after NET was most dependent on ER expression. Asian pts were less likely to undergo BCS after either NACT or NET, which is consistent with previous reports. These data could facilitate appropriate neoadjuvant treatment selection based on tumor biology and improve patient counseling on the likelihood of successful BCS. Citation Format: Jincong Freeman, Sarah Shubeck, Nan Chen, Rita Nanda, Dezheng Huo, Frederick Howard. Quantitative Biomarkers and 21-Gene Assay Results Predict Breast-Conserving Surgery Following Neoadjuvant Therapy in Early-Stage, Hormone Receptor-Positive, HER2-Negative Breast Cancer [abstract]. In: Proceedings of the 2023 San Antonio Breast Cancer Symposium; 2023 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2024;84(9 Suppl):Abstract nr PO1-14-12.

Abstract PO2-23-05: Practice patterns and outcomes in the ongoing neoadjuvant ATNEC trial: node marking, response to NACT and breast conservation rates

Abstract Background In ATNEC trial, cT1-3N1M0 patients receive NACT followed by SNB/TAD. If the sentinel nodes(SNs) have converted to benign(ypN0), patients are randomly assigned to Axillary Treatment vs no Axillary Treatment. The study promotes standardized node marking procedures and includes a radiotherapy quality assurance program. Objectives – This study prospectively evaluates practice patterns, NACT response, adoption of node marking, rates of marked node identification, and breast conservation rates in the ongoing ATNEC trial across 70 centers in the UK. The trial aims to recruit 1900 patients. Materials and Methods Data from 196 randomized patients (median age: 54 [range: 28-79] years; median BMI: 26.5 [range: 17.6-51.1]) from December 2021 to June 28, 2023, across 70 UK centers were analyzed. These patients presented with cT1-3N1M0 breast cancer, received NACT, and exhibited no residual nodal disease (ypN0) on SNB/TAD. Results Among the randomised patients 54%(106) were post-menopausal, 71%(140) underwent breast conserving surgery(BCS) and 29%(56) mastectomy. At presentation, 12% (23) had T3, 63% (124) had T2, and 23% (46) had T1 tumors. Grade 3 tumors accounted for 70% (138) of cases. Among the patients, 60% (117) were HER2 positive, 31% (61) were triple negative, and 9% (18) were HER2 negative (ER or PgR positive). Anthracycline and taxane-based NACT were administered to 57% (106), while 38% (71) received a platinum-containing regimen. During SNB/TAD, a median of 4 nodes (interquartile range, 3-5) were removed. Among 184 patients with node marking data, 74% (136) had the involved node marked. The marked node was successfully removed in 94% (128) of these patients. Clip/coil only, Magseed and black dye were the commonest techniques used for node marking. The marked node was the sentinel node in 83% (106) of cases. Among 185 randomized patients with post-NACT response data, 68% (125) achieved a complete pathological response (pCR) in the breast, while 8% (15) had DCIS only and 22% (41) had invasive cancer. Among 105 patients with complete breast tumor response on imaging, 15% (16) had residual DCIS or invasive cancer. In the subset of patients with partial response or stable breast tumors on imaging (69 patients), 46% (32) had no residual tumor on histology (ypT0). Furthermore, 14% (26) exhibited partial or stable disease in the axilla on imaging but achieved complete pathological response on histology. Conclusions HER2-positive and triple-negative breast cancer cases predominate among patients undergoing NACT in the UK. Although 68% achieved a complete pCR (ypT0) in the breast, rates of BCS remain low. Notably, around 75% of randomized patients underwent node marking, with an intra-operative identification rate of 94%, demonstrating the successful implementation of node marking in the UK through the ATNEC trial. Citation Format: Amit Goyal, Andrea Marshall, Sophie Nicholls, Natalie Hammonds, Beatrix Elsberger, Duncan Wheatley, Janice Rose, Helen-Teresa Edwards, Abeer Shaaban, Roeum Butt, Gareth Jackson, Tara Homer, Luke Vale, Samreen Ahmed, Shama Puri, Sophie Gasson, Julie Bruce, Helen Higgins, Janet Dunn. Practice patterns and outcomes in the ongoing neoadjuvant ATNEC trial: node marking, response to NACT and breast conservation rates [abstract]. In: Proceedings of the 2023 San Antonio Breast Cancer Symposium; 2023 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2024;84(9 Suppl):Abstract nr PO2-23-05.

The impact of advanced oncoplastic surgery on breast-conserving surgery rates: A retrospective cohort study of 4,000 breast cancer procedures at a tertiary referral centre

The impact of advanced oncoplastic surgery on breast-conserving surgery rates: A retrospective cohort study of 4,000 breast cancer procedures at a tertiary referral centre

Immigration Status and Breast Cancer Surgery Quality of Care Metrics: A Population-Level Analysis.

As immigrant women face challenges accessing health care, we hypothesized that immigration status would be associated with fewer women with breast cancer receiving surgery for curable disease, fewer undergoing breast conserving surgery (BCS), and longer wait time to surgery. A population-level retrospective cohort study, including women aged 18-70 years with Stage I-III breast cancer diagnosed between 2010 and 2016 in Ontario was conducted. Multivariable analysis was performed to assess odds of undergoing surgery, receiving BCS and wait time to surgery. A total of 31,755 patients were included [26,253 (82.7%) Canadian-born and 5502 (17.3%) immigrant women]. Immigrant women were younger (mean age 51.6 vs. 56.1 years) and less often presented with Stage I/II disease (87.4% vs. 89.8%) (both p < .001). On multivariable analysis, there was no difference between immigrant women and Canadian-born women in odds of undergoing surgery [Stage I OR 0.93 (95% CI 0.79-1.11), Stage II 1.04 (0.89-1.22), Stage III 1.22 (0.94-1.57)], receiving BCS [Stage I 0.93 (0.82-1.05), Stage II 0.96 (0.86-1.07), Stage III 1.00 (0.83-1.22)], or wait time [Stage I 0.45 (-0.61-1.50), Stage II 0.33 (-0.86-1.52), Stage III 3.03 (-0.05-6.12)]. In exploratory analysis, new immigrants did not have surgery more than established immigrants (12.9% vs. 10.1%), and refugee women had longer wait time compared with economic-class immigrants (39.5 vs. 35.3 days). We observed differences in measures of socioeconomic disadvantage and disease characteristics between immigrant and Canadian-born women with breast cancer. Upon adjusting for these factors, no differences emerged in rate of surgery, rate of BCS, and time to surgery. The lack of disparity suggests barriers to accessing basic components of breast cancer care may be mitigated by the universal healthcare system in Canada.

207 (PB-114) Poster - The impact of advanced oncoplastic surgery on breast-conserving surgery rates: a retrospective study of 4,500 breast cancer procedures at a tertiary referral centre

207 (PB-114) Poster - The impact of advanced oncoplastic surgery on breast-conserving surgery rates: a retrospective study of 4,500 breast cancer procedures at a tertiary referral centre

The importance of the multidisciplinary team in the decision-making process of patients undergoing neoadjuvant chemotherapy for breast cancer.

Recent literature suggests that rates of breast conservation surgery (BCS) are lower than expected in patients submitted to neoadjuvant chemotherapy (NAC) for breast cancer. The aim of this study was to underscore the role of the multidisciplinary team (MDT) in the decision-making process of patients who underwent breast surgery after NAC. We conducted a retrospective study on patients with breast cancer treated according to an algorithm developed at the Breast Unit of Northern Sardinia between January 2019 and May 2023. Data collected included demographics, tumor characteristics, upfront treatment (surgery or NAC), type of primary surgery (BCS or mastectomy [Ma]) and patients' adherence to the treatment proposed by the MDT. Overall, 1061 women were treated during the study period, of whom 164 received NAC (Group A) and 897 upfront surgery (Group B). In group A, conversion from BCS ineligibility to BCS eligibility was observed in 47 patients (40.1%). Final surgery in patients who became BCS-eligible after NAC was BCS in 42 cases (89.3%) and Ma in 5 (10.6%). Rates of patients' adherence to the treatment proposed by the MDT were significantly better in the Group A (p = 0.02). Our results suggest that the MDT has a pivotal role in increasing the rates of breast conservation in women submitted to NAC.

Neoadjuvant endocrine treatment in hormone receptor-positive breast cancer: Does it result in more breast-conserving surgery?

Patients with locally advanced endocrine positive tumors who will not benefit from chemotherapy can be treated by either primary surgery or neoadjuvant endocrine therapy (NET). How often does NET result in breast-conserving surgery (BCS)? We conducted a literature search in PubMed and Embase, to identify articles on surgical treatment after NET. In 19 studies the pathological complete response (pCR) rate was reported after NET; an overall pCR rate of 1% was found. Compared with neoadjuvant chemotherapy (NCT), the BCS rate was significantly higher after NET (OR 0.60; 95% CI, 0.51-0.69; P < 0.00001). The surgical conversion rate was reported in eight studies [4-75.9%], with a mean of 30.2%. This review found that one out of three patients becomes eligible for BCS after treatment with NET.

2020 Annual Report of National Clinical Database-Breast Cancer Registry: 10-year mortality of elderly breast cancer patients in Japan.

The Japanese Breast Cancer Society initiated the breast cancer registry in 1975, which transitioned to the National Clinical Database-Breast Cancer Registry in 2012. This annual report presents data from 2020 and analyzes the ten-year mortality rates for those aged 65 and older. We analyzed data from 93,784 breast cancer (BC) cases registered in 2020 and assessed 10-year mortality rates for 36,279 elderly patients diagnosed between 2008 and 2012. In 2020, 99.4% of BC cases were females with a median age of 61. Most (65%) were diagnosed at early stages (Stage 0 or I). Breast-conserving surgery rates varied with stages: 58.5% at cStage I, 30.8% at cStage II, and 13.1% at cStage III. Sentinel lymph node biopsy was done in 73.6% of cases, followed by radiotherapy in 70% of those post-conserving surgery and chemotherapy in 21.1% post-surgery. Pathology showed that 63.4% had tumors under 2.0cm, 11.7% had pTis tumors, and 77.3% had no axillary lymph node metastasis. ER positivity was seen in 75.1%, HER2 in 14.3%, and 30% had a Ki67 positivity rate above 30%. Across all stages and subtypes, there was a trend where the 10-year mortality rates increased for individuals older than 65years. In Stage I, many deaths were not directly linked to BC and, for those with HER2-type and triple-negative BC, breast cancer-related deaths increased with age. Within Stage II, patients older than 70years with luminal-type BC often experienced deaths not directly linked to BC, whereas patients below 80years with HER2-type and triple-negative BC, likely had breast cancer-related deaths. In Stage III, breast cancer-related deaths were more common, particularly in HER2 and triple-negative BC. Our prognostic analysis underscores distinct mortality patterns by stage, subtype, and age in elderly BC patients. It highlights the importance of personalized treatment strategies, considering subtype-specific aggressiveness, age-related factors, and comorbidities.

Sequential neoadjuvant chemotherapy using pegylated liposomal doxorubicin and cyclophosphamide followed by taxanes with complete trastuzumab and pertuzumab treatment for HER2-positive breast cancer: A phase II single-arm study.

Despite cardiotoxicity overlap, the trastuzumab/pertuzumab and anthracycline combination remains crucial due to significant benefits. Pegylated liposomal doxorubicin (PLD), a less cardiotoxic anthracycline, was evaluated for efficacy and cardiac safety when combined with cyclophosphamide and followed by taxanes with trastuzumab/pertuzumab in human epidermal growth factor receptor-2 (HER2)-positive early breast cancer (BC). In this multicenter, phase II study, patients with confirmed HER2-positive early BC received four cycles of PLD (30-35 mg/m2) and cyclophosphamide (600 mg/m2), followed by four cycles of taxanes (docetaxel, 90-100 mg/m2 or nab-paclitaxel, 260 mg/m2), concomitant with eight cycles of trastuzumab (8 mg/kg loading dose, then 6 mg/kg) and pertuzumab (840 mg loading dose, then 420 mg) every 3 weeks. The primary endpoint was total pathological complete response (tpCR, ypT0/is ypN0). Secondary endpoints included breast pCR (bpCR), objective response rate (ORR), disease control rate, rate of breast-conserving surgery (BCS), and safety (with a focus on cardiotoxicity). Between May 27, 2020 and May 11, 2022, 78 patients were treated with surgery, 42 (53.8%) of whom had BCS. After neoadjuvant therapy, 47 [60.3%, 95% confidence interval (95% CI), 48.5%-71.2%] patients achieved tpCR, and 49 (62.8%) achieved bpCR. ORRs were 76.9% (95% CI, 66.0%-85.7%) and 93.6% (95% CI, 85.7%-97.9%) after 4-cycle and 8-cycle neoadjuvant therapy, respectively. Nine (11.5%) patients experienced asymptomatic left ventricular ejection fraction (LVEF) reductions of ≥10% from baseline, all with a minimum value of >55%. No treatment-related abnormal cardiac function changes were observed in mean N-terminal pro-BNP (NT-proBNP), troponin I, or high-sensitivity troponin. This dual HER2-blockade with sequential polychemotherapy showed promising activity with rapid tumor regression in HER2-positive BC. Importantly, this regimen showed an acceptable safety profile, especially a low risk of cardiac events, suggesting it as an attractive treatment approach with a favorable risk-benefit balance.

Impact of oncoplasty in increasing breast conservation rates Post neo-adjuvant chemotherapy.

The essential goal of neoadjuvant chemotherapy (NACT) is to downstage the primary tumor making it amenable for breast conservation surgery (BCS). However, since the safety of this surgery is paramount, post-NACT breast conservation rates remain low. As per the recommendation of the 2018 Early Breast Cancer Trialists' Collaborative Group (EBCTCG) overview of long-term post-NACT follow-up, we have devised a protocol for imaging, localization, rad-path analysis, and documentation of radiotherapy techniques to ensure the safety of post-NACT breast conservation. This is a retrospective cohort of 180 breast cancer patients who received NACT and were operated on by a single surgical oncologist from 2015 to 2020. After selection based on published guidelines, patients were treated with neoadjuvant systemic (chemo or hormone) therapy. In cases where primary tumors responded and reduced to 1-2 cm in size mid-NACT, the residual tumors were localized by clips under ultrasound guidance and calcification was wire localized. All patients were treated using appropriate surgical and oncoplastic techniques where indicated. Negative margins were ensured by intra-operative rad-path analysis. Adjuvant chemotherapy and radiotherapy were given as per protocol. In 81 cases that required mastectomy at presentation, we were able to achieve a 72.8% post-NACT BCS rate with the help of oncoplasty. Overall, 142 of 180 (80%) patients were treated with breast conserving surgery of which 80% (121 of 142) were oncoplasty. Margins were assessed on intra-operative frozen and re-excised in the same setting. No positive margins were reported in final histopath of 142 breast conservation procedures. Post-operative complication rates after breast conservation in the first year were at 17% (24 of 142 including two major complications). Patient reported outcomes were satisfactory with increased satisfaction for breast conservation compared with immediate breast reconstruction. Employing oncoplastic breast surgery (OBS) techniques following stringent protocols for accurate localization of the residual tumor, intra-operative rad-path analysis, and adjuvant treatments, we show successful breast conservation in 72.8% of our mastectomy-qualified patients after downstaging by NACT. We also report satisfactory outcomes for post-NACT surgery, patient-reported satisfaction, and survival.

Estrogen Receptor-negative Ductal Carcinoma In Situ (DCIS) of the Breast - an Institutional Review of Outcomes.

Estrogen receptor (ER)-negative [ER(-)] invasive breast cancers (IBCs) are known to be more aggressive than their ER(+) counterparts. This is less well defined for ductal carcinoma in situ (DCIS). This study investigated the outcomes following the treatment of ER(-) DCIS. A total of 103 ER(-) DCIS patients diagnosed between 2004-2018 were retrospectively analyzed. Median follow-up was 63.9 months. Statistical analysis included descriptive statistics, non-parametric tests, T-test, logistic regression. The outcomes were compared to a group of 102 ER(+) DCIS patients from our institution. Any breast event (BE) occurred in 10 (9.7%) patients at a median of 3.2 (1.7-7.2) years. The incidence of ipsilateral breast events (IBEs) was 5.8% (6/103). All IBE cases were ER(-) DCIS. All (n=4) contralateral breast events (CBEs) were ER(+) including 3 IBCs. Cumulative incidence of any BEs at 1, 2, and 5 years was 0%, 1.1%, and 9.1%, respectively. Among patients with ER(-) DCIS who developed BE, breast conserving surgery (BCS) had been performed for the initial DCIS in 90% of cases. In those without any BE, the BCS rate (vs. mastectomy) was 58.1% (p=0.08). Adjuvant radiotherapy after BCS was used less often among patients with vs. without subsequent BE (55.5% vs. 77.4%) (p=0.22). Predictors for BE occurrence were not identified. The incidence of any BE among patients with ER(+) DCIS was 6.9% and was not significantly different compared to ER(-) DCIS group (p=0.46). ER(-) DCIS outcomes were similar to our institutional ER-positive DCIS group and the previously reported ones for predominantly ER-positive DCIS cohorts.

Clinical Features and Prognoses of Patients With Breast Cancer Who Underwent Surgery

Breast cancer (BC) remains a pervasive malignant neoplasm worldwide, with increasing incidence. However, there are a scarcity of studies examining the clinical characteristics and prognosis of Chinese patients with BC who have undergone surgery. To evaluate overall survival (OS) and disease-free survival (DFS) in patients with surgically treated BC in China, focusing on histopathology and surgical approach. This cohort study included a retrospective review of the medical records of patients with unilateral BC who underwent surgery between January 2009 and September 2017, with a median follow-up time of 7.69 years. Clinical features were extracted from these records, and survival analysis was performed. Data analysis was conducted in March 2023. Patients' OS and DFS. The study included 14 782 patients (14 724 [99.6%] female patients; mean [SD] age, 51.6 [10.9] years). Invasive ductal carcinoma (IDC) was the most prevalent type, observed in 12 671 patients (85.6%). Stages 0, I, II, III, and IV accounted for 6.4% (919 patients), 32.0% (4579 patients), 40.5% (5791 patients), 20.2% (2896 patients), and 0.9% (126 patients) of cases, respectively. Hormone receptor (HR) positivity was observed in 10 241 patients (75.1%), and 3665 (29.1%) tested positive for ERBB2 (formerly HER2/neu). The HR-negative-ERBB2-negative, HR-negative-ERBB2-positive, HR-positive-ERBB2-negative, and HR-positive-ERBB2-positive subtypes constituted 13.3% (1666 patients), 12.7% (1595 patients), 57.8% (7251 patients), and 16.2% (2034 patients) of cases, respectively. Breast-conserving surgery (BCS) was performed in 2884 patients (19.5%). The 5-year and 10-year OS rates were 92.9% (13 689 of 14 732) and 87.4% (3287 of 3760), while the 5-year and 10-year DFS rates were 89.0% (12 916 of 14 512) and 82.9% (3078 of 3713), respectively. Multivariate analysis found that for patients with IDC, age, BCS, invasive tumor size, tumor grade, lymphovascular invasion (LVI), the number of lymph node metastases (LNMs), distant metastasis, Ki67, and HR status were associated with OS, whereas invasive tumor size, tumor grade, LVI, the number of LNMs, HR status, and ERBB2 status were associated with DFS. After propensity score matching, BCS was equivalent to mastectomy with respect to survival in patients with IDC. This cohort study of patients with BC who underwent surgery in China provides valuable insights into the histopathological characteristics and survival outcomes of this population. The diverse histopathological features emphasize the necessity for customized treatment strategies. The relatively low BCS rate in the study population suggests the need for heightened awareness and adoption of this approach, considering its potential advantages for survival.

Successful Breast Conservation After Neoadjuvant Chemotherapy in Lobular Breast Cancer: The Role of Menopausal Status in Response to Treatment.

While neoadjuvant chemotherapy (NAC) has been shown to increase rates of breast conservation surgery (BCS) for breast cancer, response rates in invasive lobular carcinoma (ILC) appear lower than other histologic subtypes. Some data suggest higher response rates to NAC in premenopausal versus postmenopausal patients, but this has not been studied in ILC. We evaluatedthe rates of successful BCS after NAC in patients with ILC stratified by menopausal status. We analyzed data from a single-institution cohort of 666 patients with stage I-III hormone receptor positive HER-2 negative ILC. We used t-tests, chi-squared tests, and multivariable logistic regression to investigate rates of NAC use, attempted BCS, and associations between NAC and successful BCS by menopausal status. In 217 premenopausal and 449 postmenopausal patients, NAC was used more often in the premenopausal group (15.2% vs. 9.8%, respectively, p = 0.041). Among those who attempted breast conservation (51.3% of pre- and 64.8% of postmenopausal cohorts), NAC was not associated with successful BCS in either group. Interestingly, for postmenopausal patients, receipt of NAC was significantly associated with increased rates of completion mastectomy in those who had positive margins at thefirst attempt at BCS. NAC was not associated with successful BCS in either premenopausal or postmenopausal patients with ILC. Although premenopausal patients were more likely to receive NAC, these data suggest that menopausal status may not be a good predictor of response to chemotherapy. Better predictors of response and more efficacious treatment for patients with ILC are needed.

Association of Race, Ethnicity, Insurance, and Language and Rate of Breast-Conserving Therapy Among Women With Nonmetastatic Breast Cancer at an Urban, Safety-Net Hospital

IntroductionBreast-conserving therapy (BCT), specifically breast-conserving surgery (BCS) and adjuvant radiation, provides an equivalent alternative to mastectomy for eligible patients. However, previous studies have shown that BCT is underused in the United States, particularly among marginalized demographic groups. In this study, we examine the association between race, ethnicity, insurance, and language and rate of BCS among patients treated at an academic, safety-net hospital. Materials and MethodsWe conducted a retrospective cohort study of 520 women with nonmetastatic breast cancer diagnosed and treated at an academic, safety-net hospital (2009-2014). We assessed eligibility for BCT and then differences in the rate of BCT among eligible patients by race, ethnicity, insurance, and language. Reasons for not undergoing BCT were documented. ResultsMedian age was 60 y; 55.9% were non-White, 31.9% were non-English–speaking, 15.6% were Hispanic, and 47.4% were Medicaid/uninsured. Three hundred seventy one (86.3%) underwent BCS; within this group, 324 (87.3%) completed adjuvant radiation. Among patients undergoing mastectomy, 30 patients (36.7%) were eligible for BCT; within this group, reasons for mastectomy included patient preference (n = 28) and to avoid possible re-excision or adjuvant radiation in patients with significant comorbidities (n = 2). Eligibility for BCT varied by ethnicity (Hispanic [100%], Non-Hispanic [92%], P = 0.02), but not race, language, or insurance. Among eligible patients, rate of BCS varied by age (<50 y [84.9%], ≥50 y [92.9%], P = 0.01) and ethnicity (Hispanic [98.5%], Non-Hispanic [91.3%], P = 0.04), but not race, language, or insurance. ConclusionsAt our safety-net hospital, the rate of BCS among eligible patients did not vary by race, language, or insurance. Excluding two highly comorbid patients, all patients who underwent mastectomy despite being eligible for BCT were counseled regarding BCS and expressed a preference for mastectomy. Further research is needed to understand the value of BCT in the treatment of breast cancer, to ensure informed decision-making, address potential misconceptions regarding BCT, and advance equitable care for all patients.

Comparison of clinicopathologic characteristics of Invasive Papillary Carcinoma with Invasive Ductal Carcinoma and their survival outcome

Background: Invasive Papillary Carcinoma (IPC) of the breast is a rare breast cancer subtype. This study aimed to evaluate the clinicopathologic characteristics of IPC of the breast, its differences from Invasive Ductal Carcinoma (IDC), and their survival outcomes.Materials and Methods: The medical records of 6599 patients were retrospectively reviewed at the Breast Disease Research Center from December 1993 to December 2021. The patients were divided into two groups: IPC and IDC. The tumor size, lymph node metastasis, pathologic stage, nuclear and histological grade, hormonal receptor status, and survival were reviewed and compared between the IPC and IDC groups.Results: Of the 6599 patients, 27 had IPC, and 6572 had IDC. The mean age of patients with IPC and IDC was 58.5 and 49 years, respectively (P=0.02). Patients with IPC were more likely to have a positive node status and had a significantly higher incidence of lymphovascular invasion (14.9% for IPCs and 53.3% for IDCs, P&lt;0.001). ER status was positive in 66.6% of IPCs and 78.1% of IDCs (P=0.23). Additionally, 62.5% of patients with IPC and 94.9% of those with IDC received adjuvant chemotherapy (P&lt;0.001). Disease-free survival (DFS) and overall survival (OS) were better in IPC patients for stage I (5-year DFS: 69% vs. 81%, P=0.008; 5-year OS: 75% vs. 85%, P=0.001).Conclusion: IPC is a rare tumor type that presents unique clinicopathological characteristics and is associated with a higher rate of breast-conserving surgery and a favorable prognosis than IDC

Association of FTH1-Expressing Circulating Tumor Cells With Efficacy of Neoadjuvant Chemotherapy for Patients With Breast Cancer: A Prospective Cohort Study.

The association between different phenotypes and genotypes of circulating tumor cells (CTCs) and efficacy of neoadjuvant chemotherapy (NAC) remains uncertain. This study was conducted to evaluate the relationship of FTH1 gene-associated CTCs (F-CTC) with/without epithelial-mesenchymal transition (EMT) markers, or their dynamic changes with the efficacy of NAC in patients with non-metastatic breast cancer. This study enrolled 120 patients with non-metastatic breast cancer who planned to undergo NAC. The FTH1 gene and EMT markers in CTCs were detected before NAC (T0), after 2 cycles of chemotherapy (T1), and before surgery (T2). The associations of these different types of CTCs with rates of pathological complete response (pCR) and breast-conserving surgery (BCS) were evaluated using the binary logistic regression analysis. F-CTC in peripheral blood ≥1 at T0 was an independent factor for pCR rate in patients with HER2-positive (odds ratio [OR]=0.08, 95% confidence interval [CI], 0.01-0.98, P = .048). The reduction in the number of F-CTC at T2 was an independent factor for BCS rate (OR = 4.54, 95% CI, 1.14-18.08, P = .03). The number of F-CTC prior to NAC was related to poor response to NAC. Monitoring of F-CTC may help clinicians formulate personalized NAC regimens and implement BCS for patients with non-metastatic breast cancer.