Breast Conservation Therapy Rates Research Articles

Real-World Outcomes with the KEYNOTE-522 Regimen in Early-Stage Triple-Negative Breast Cancer.

This study aimed to determine if the neoadjuvant (NAT) KEYNOTE-522 regimen was associated with higher rates of pathologic complete response (pCR), corresponding to higher rates of breast conservation therapy (BCT) in early-stage triple-negative breast cancer (TNBC) patients. Stage II-III TNBC patients diagnosed between 2019 and 2022 who underwent NAT were analyzed retrospectively. NAT with KEYNOTE-522 versus control NAT were compared for rates of BCT, axillary node dissection (ALND), pCR, and survival outcomes. The prevalence of immune-related adverse events (irAE) from chemoimmunotherapy was recorded. Of 240 patients identified: 86 received KEYNOTE-522 and 154 received control. The frequency of pCR was significantly higher in KEYNOTE versus the control cohort, 59.3% and 33.1%, respectively (p = 0.001). There was no significant difference in the rate of BCT between the control (33.1%) and the KEYNOTE-522 (32.1%) groups (p = 0.47). Rates of ALND were significantly lower with KEYNOTE-522 (25.6%) as compared with control (39.6%); p = 0.03. The rate of development of grade 2 or higher irAEs was 34.9%. At a median follow-up of 2.4 years, there was no difference in survival outcomes. BRCA1 patients had high rates of pCR regardless of treatment group, KEYNOTE-522: 80.0% (4/5) and control: 75% (9/12), (p = 1). This real-world evidence supports the use of the KEYNOTE-522 regimen in patients with early-stage TNBC given the higher pCR rate and corresponding decrease in the rate of ALND. The majority of patients in both NAT cohorts became BCT eligible, but the rate of BCT did not differ between the two groups.

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.

Impact of Neoadjuvant Paclitaxel/Trastuzumab/Pertuzumab on Breast Tumor Downsizing for Patients with HER2+ Breast Cancer: Single-Arm Prospective Clinical Trial.

The impact of abbreviated neoadjuvant regimens for HER2+ breast cancer on rates of breast conservation therapy (BCT) is unclear. We aimed to determine BCT rates in a single-arm prospective trial of neoadjuvant paclitaxel/trastuzumab/pertuzumab (THP) in patients with stage II-III HER2+ breast cancer. BCT eligibility was prospectively recorded before and after THP. Pre- and post-treatment mammogram and breast ultrasound were required; breast MRI was encouraged. Patients with a large tumor to breast size ratio were eligible for downsizing. Multifocal/multicentric tumors, extensive calcifications, and contraindications to radiation were considered BCT contraindications. Overall, 92 patients who received neoadjuvant THP on trial were included. At presentation, 39 (42.4%) were considered eligible for BCT and 53 (57.6%) were not. BCT-eligible patients were older (median 54 years versus 47 years, respectively, p=0.006) and had smaller tumors by palpation (median 2.5 cm versus 3 cm, respectively, p=0.004). Of 53 BCT-ineligible patients, 28 were candidates for tumor downsizing, whereas 25 had contraindications to BCT. Overall, 51(55.4%) patients underwent BCT. Of the 28 patients who were candidates for downsizing, 22 (78.6%) became BCT-eligible after THP and 18/22 (81.8%) underwent BCT. In total, 44/92 (47.8%) patients experienced breast pathologic complete response (pCR, ypT0), including 11/25 (44.0%) patients with BCT contraindications at presentation. De-escalated neoadjuvant systemic therapy led to high BCT rates in this cohort. The impact of de-escalated systemic therapy on local therapy and outcomes in early stage HER2+ breast cancer warrants further investigation.

Abstract P3-05-55: The Effects of Comorbidities on the Effectiveness of Neoadjuvant Chemotherapy in Breast Cancer

Abstract Background: Neoadjuvant chemotherapy has been used in a variety of cancer treatments to transform inoperable tumors to operable tumors. Within breast cancer treatment, it has successfully been used to increase the rates of breast conservation therapy. Neoadjuvant chemotherapy is being used to downgrade locally advanced breast cancer, as well as treat inflammatory breast cancer, and node negative breast cancers with genetic expression profiling results that predict the need for adjuvant chemotherapy. There have been several studies that have evaluated the effects of age and comorbidities of patients with breast cancer on treatment decisions, particularly chemotherapy. However, very few studies have reviewed additional factors outside of tumor characteristics for predicting complete response to neoadjuvant chemotherapy. The purpose of this study is to determine if there are any patient factors, particularly comorbidities, that play a role in modifying chemotherapy regimens and if that affects the patient’s response to chemotherapy. Methods: A retrospective chart review was performed on patients between 18-89 years of age at the time of their breast cancer diagnosis, who underwent neoadjuvant between 1/1/2014 and 1/1/2019. Patients included were treated by Dr. Kara Friend or Dr. Jennifer Reed at Sentara Leigh Memorial Hospital. Data collected included demographics, tumor characteristics, treatment regimens (chemotherapy, radiation therapy, antihormone therapy, and surgery), noting when chemotherapy regimens had to be modified, pathologic response to neoadjuvant chemotherapy, and long term outcomes. Comorbidities were identifed and used to calculate the Charleson Comorbidity Index (CCI), which was used to categorize patients. Results: A total of 111 patients were reviewed. All patients were female and ages ranged from 24 to 84, with most patients being in their fourth or fifth decade. 30% of the patients had triple negative tumors, and 48% had HER2+ tumors. Most patients had invasive ductal carcinoma, with only 6 patients (5.4%) having invasive lobular carcinoma. 26 patients had positive genetic panels, 10 of which were BRCA positive. 28 patients had negative panels, and 57 were not tested. The most common chemotherapy regimens were TCHP, AC/T, and TCH. Two patient’s cycles were reduced from the beginning due to low ejection fractions, 3 were modified due to pulmonary reactions, 1 for renal failure, 1 for Hepatitis C activation, and 10 for neutropenia or infections. One patient self-discontinued chemotherapy in favor of alternative medicine. 65.7% of the patients underwent antihormone therapy. 27% of the patients underwent radiation. Most patients had CCI scores of 0. Of those with a CCI score of 0, 4 needed modified regimens (8.3%). Of those with a CCI score of 1, three needed modified regimens (10.3%). Of those with a CCI score of 2, three patients needed modified regimens (23.3%). Of those with a CCI score of 3 or greater, 8 needed modified regimens (38.1%) When evaluating the effect of a CCI of 0-2 compared to 3 or greater on likelihood of reduced chemotherapy, there was not a statistically significant result (p = 0.99). However, the appeared to be a trend of increasing need for modified regimen with increasing CCI score. When evaluating if a reduced chemotherapy regimen led to progression during neoadjuvant chemotherapy or no response, the result was not statistically significant (p=0.24). Conclusion: Our study suggests that an increasing CCI score corresponds to an increased likelihood of needing a modified regimen, however this result was not statistically significant. Increased comorbidities and the need for modifying chemotherapy regimens do not appear to have an effect on pathologic response to neoadjuvant chemotherapy. This study is limited by the sample size, and a greater sample size will be necessary to make further conclusions. Citation Format: Kara Friend, Rebecca Breese, Tracey Pu, Jasmine Wood, Fatima Arif. The Effects of Comorbidities on the Effectiveness of Neoadjuvant Chemotherapy in Breast Cancer [abstract]. In: Proceedings of the 2022 San Antonio Breast Cancer Symposium; 2022 Dec 6-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2023;83(5 Suppl):Abstract nr P3-05-55.

The underused potential of breast conserving therapy after neoadjuvant system treatment – Causes and solutions

Breast conserving therapy (BCT), consisting of breast conserving surgery and subsequent radiotherapy, is an equivalent option to mastectomy for women with early breast cancer. Although BCT after neoadjuvant systemic treatment (NAST) has been routinely recommend by international guidelines since many years, the rate of BCT worldwide varies largely and its potential is still underused. While the rate of BCT in western countries has increased over the past decades to currently about 70%, the rate of BCT is as low as 10% in other countries. In this review, we will evaluate the underused potential of breast conservation after NAST, identify causes, and discuss possible solutions. We identified clinical and non-clinical causes for the underuse of BCT after NAST including uncertainties within the community regarding oncologic outcomes, the correct tumor localization after NAST, the management of multifocal and multicentric tumors, margin assessment, disparities of socio-economic aspects on a patient and national level, and psychological biases affecting the shared decision-making process between patients and clinicians. Possible solutions to mitigate the underuse of BCT after NAST include interdisciplinary teams that keep the whole patient pathway in mind, optimized treatment counseling and shared decision-making, and targeted financial support to alleviate disparities.

Comparing Survival Differences Between Breast-Conserving Therapy and Mastectomy in Patients with Early-Stage Breast Cancer

In 1990 breast-conserving therapy (BCT) was recommended as a preferred treatment for early-stage breast cancer by the NIH consensus statement based on randomized trials demonstrating BCT to have equivalent survival outcomes as mastectomy for early-stage breast cancer patients. BCT became more common while total mastectomy (TM) rates decreased. More recently, patients with early-stage breast cancer are undergoing TM with increasing frequency. In light of increasing TM rates and given significant changes in radiation, surgery and systemic therapies, several groups have examined long-term outcomes for patients undergoing TM vs BCT. Local-regional recurrence (LRR) rates with BCT have been reported to be lower than the 8-10% LRR range reported with the initial randomized trials. In addition, several groups have published slightly improved survival rates in patients undergoing BCT compared with TM. The aim of this study was to evaluate trends in TM rates for treatment of early-stage breast cancer at a single institution and compare overall survival (OS), distant metastasis-free survival (DMFS), LRR and disease-specific survival (DSS) between breast conservation and TM. We identified clinical stage T1–2, N0–1, M0 breast cancer patients who underwent primary surgery from 1/1/2000 to 12/31/2014. TM and BCT rates were evaluated, and multivariable Cox proportional hazards models were used for comparison of survival differences between breast conserving surgery alone (BCS), BCT and TM with or without radiation therapy (RT). Of 12,034 patients included, 800 (6.7%) underwent BCS, 5,986 (49.7%) underwent BCT, 3.618 (30.1%) underwent TM without RT and 1,630 (13.5%) underwent TM with RT. Patients who underwent TM were younger, with more advanced and aggressive disease (larger tumors, positive lymph nodes, higher grade, and more likely to be ER/PR-negative or HER2-positive). TM rates increased over time in patients <=50 years old. At median follow-up time of 6.2 years, multivariable Cox model showed that patients who underwent BCT had a better DSS (HR: 0.8, P=0.02) and OS (HR: 0.7, P<0.001) and had a similar DMFS (HR: 0.9, P=0.3), but had increased LRR (HR: 1.3, P=0.04) compared to patients who underwent TM without RT. In patients undergoing TM with RT, there was no survival benefit found in OS, DSS and DMFS on multivariable analyses compared with patients who underwent BCT. Patients who underwent BCS alone had a worse OS, LRR and DMFS compared to patients undergoing BCT. 5-year LRR and DSS rates were similar between TM without RT and BCT groups. After adjusting for confounding variables, BCT showed improved OS and DSS compared with TM in early-stage breast cancer. These contemporary data may help physicians in surgical decision making for patients who are candidates for either mastectomy or breast conservation since they suggest that BCT is at least equivalent to TM with respect to OS and DSS.

Abstract OT2-02-03: NSABP FB-13: An assessment of the biological and clinical effects of palbociclib with ovarian suppression and letrozole in the neoadjuvant treatment of pts (pts) with premenopausal (preM) estrogen-receptor positive/HER2-negative primary breast cancer

Abstract Background: There have been few studies of neoadjuvant endocrine therapy in premenopausal (preM) women despite low pathologic complete response (pCR) rates using neoadjuvant chemotherapy in ER+/HER2− pts. Suppression of Ki67, particularly complete cell cycle arrest (CCCA) defined as Ki67 &amp;lt;2.7% after 2 wks of neoadjuvant endocrine therapy has been demonstrated to correlate with recurrence-free survival. PALLET, a randomized, neoadjuvant endocrine trial evaluated letrozole (AI) v palbociclib (pal) in combination with AI for 14 wks in post-menopausal women. This study demonstrated a modest improvement in clinical response (54.3% with the combination v 49.5% with AI alone) but showed a significant difference in achievement of CCCA (Ki67&amp;lt;2.7%) with the combination of pal and AI v AI alone (90% v 59%). We seek to evaluate this combination, given over a longer duration in the neoadjuvant setting, in preM women with early-stage breast cancer. Trial design: FB-13 is a phase II, open-label study to examine the biological and clinical effect of neoadjuvant endocrine therapy with AI, pal, and ovarian suppression in preM pts with ER+, HER2-negative early invasive breast cancer. 76 pts will be stratified into one of two approximately equal sized cohorts based on Oncotype DX Breast Recurrence Score (RS) (cohort 1: pts with RS &amp;lt;11 or cohort 2: pts with RS 11 to &amp;lt;26). A baseline tumor biopsy prior to start of therapy (tx) for RS and Ki67 will both be centrally determined. Pts in both cohorts will receive letrozole 2.5 mg by mouth daily, pal 125 mg by mouth daily for 21 days of a 28-day cycle, and goserelin 3.6 mg SQ injection every 28 days. At wk 6, pts will have core-cut biopsies for real-time evaluation of Ki67. Pts from both cohorts who have Ki67 &amp;lt;10% will continue tx for a total of 6 cycles. Pts with a persistent Ki67 ≥10% will permanently discontinue tx and begin neoadjuvant chemotherapy or proceed to surgery at physician discretion. Eligibility: FB-13 is enrolling preM women newly diagnosed with ER+/HER2− early breast cancer who are candidates for neoadjuvant endocrine therapy. Pts must be preM based on standard definitions. Primary tumor size must be &amp;gt;2 cm. RS must be &amp;lt;26. Mandatory pre-treatment and post-surgical samples will be collected and analyzed for RS and Ki67, as well as additional biomarkers to correlate with response. Blood will be collected at baseline, 4 wks, and at 24 wks for estradiol levels to demonstrate ovarian suppression. A 4-wk estradiol level in the postmenopausal range will be required to receive further treatment. Specific aims: The primary aim is to determine complete cell cycle arrest as indicated by a Ki67 &amp;lt;2.7% at 6 wks. Secondary aims are to determine overall response rate (ORR) by clinical exam and ultrasound, the pCR, to generate a Preoperative Endocrine Prognostic Index (PEPI score), to compare the change in Ki67 at baseline, after 6 wks and 24 wks, and to determine the rate of breast-conservation therapy. Statistical methods: We anticipate that the addition of palbociclib to ovarian suppression and AI will result in a measurable drop in Ki67 and a high ORR. The null hypothesis is ORR &amp;lt;40% and alternative hypothesis is ORR &amp;gt;60%. We anticipate that &amp;gt;60% of pts in each cohort will have 6 wk Ki67 &amp;lt;2.7% and clinical response &amp;gt;35%. Present accrual and target accrual: Currently 12 of a planned 76 pts have been enrolled. NSABP Operations contact information: Diana Gosik, Diana.Gosik@nsabp.org NCT03628066 SUPPORT: Genomic Health Inc, Pfizer, NSABP Foundation Citation Format: Shannon Puhalla, Greg Yothers, Amy P Sing, Thomas B Julian, Norman Wolmark, Samuel A Jacobs. NSABP FB-13: An assessment of the biological and clinical effects of palbociclib with ovarian suppression and letrozole in the neoadjuvant treatment of pts (pts) with premenopausal (preM) estrogen-receptor positive/HER2-negative primary breast cancer [abstract]. In: Proceedings of the 2019 San Antonio Breast Cancer Symposium; 2019 Dec 10-14; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2020;80(4 Suppl):Abstract nr OT2-02-03.

Adjuvant and neoadjuvant therapy for breast cancer.

Systemic therapies for operable breast cancer patients have improved outcomes and have thus become standard treatments. Recently, new molecular target drugs and regimens are being developed based on the predicted sensitivity for specific breast cancer histological types. Systemic therapy is selected according to recurrence risk, with the treatment for low-risk patients being de-escalated, while high-risk patients receive aggressive systemic treatment with an adequate dose and duration. Neoadjuvant systemic therapy has a different aim. The efficacy of systemic therapies, based on the sensitivities to drugs, is supported by improvements in the rate of breast-conserving therapy. The response to neoadjuvant systemic therapy is the most important factor for predicting outcomes and selecting the optimal adjuvant therapy. Novel biological markers unique to individual patients allow appropriate targeted therapy, which can achieve optimal efficacy.

Breast Conservation After Neoadjuvant Chemotherapy for Triple-Negative Breast Cancer

Neoadjuvant systemic therapy (NST) is often administered to enable breast-conserving therapy (BCT) in stages II to III breast cancer. To prospectively evaluate the role of NST in conversion from BCT ineligibility to BCT eligibility and to assess the association of response to NST, germline BRCA (gBRCA) status, and region of treatment with surgical choice in women with triple-negative breast cancer (TNBC). This prespecified secondary analysis of a multicentered, phase 3, double-blind, randomized clinical trial (BrighTNess) enrolled 634 eligible women across 145 centers in 15 countries in North America, Europe, and Asia. Women with operable, clinical stages II to III TNBC who underwent gBRCA mutation testing before initiating NST were eligible to participate. Data were collected from April 1, 2014, to December 8, 2016. This preplanned analysis was performed from January 5, 2018, to October 28, 2019. Study participants were randomized to receive 12 weeks of weekly paclitaxel alone or with the addition of carboplatin and/or veliparib, followed by 4 cycles of doxorubicin hydrochloride and cyclophosphamide. Surgeons assessed BCT candidacy by clinical and radiographic criteria before and after NST. Surgical choices and whether BCT eligibility was associated with the likelihood of pathologic complete response were then analyzed. Among the 634 randomized patients (median age, 51 [range, 22-78] years), pre- and post-NST assessments were available for 604 patients. Of 141 patients deemed BCT ineligible at baseline, 75 (53.2%) converted to BCT eligible. Overall, 342 (68.1%) of 502 patients deemed BCT eligible after NST underwent BCT, including 42 (56.0%) of the 75 who converted to BCT eligible. Patients treated in Europe and Asia were more likely to undergo BCT (odds ratio, 2.66; 95% CI, 1.84-3.84) compared with those treated in North America. Among patients without gBRCA mutation undergoing mastectomy, those treated in North America were more likely to undergo contralateral prophylactic mastectomy (57 of 81 [70.4%] vs 6 of 30 [20.0%]; P < .001). Rates of pathologic complete response were similar between patients deemed BCT eligible at baseline and those who were BCT ineligible but converted to BCT eligibility after NST (55.3 [235 of 425] vs 49.3% [37 of 75]; P = .38). This prospective analysis of NST and BCT eligibility in TNBC demonstrates a conversion from BCT ineligibility to BCT eligibility of 53.2%. Lower BCT rates among eligible patients and higher bilateral mastectomy rates among patients without gBRCA mutation in North America merit investigation. ClinicalTrials.gov identifier: NCT02032277.

Association between socioeconomic factors and outcomes in breast cancer.

Persistent socioeconomic disparities are evident in the delivery of health care. Despite previous research into health disparities, the extent of the effect of economic inequalities in the management of breast cancer is not well understood. The purpose of our study is to perform a national assessment of the impact of economic factors on key aspects of breast cancer management. This is a retrospective study using data from the National Cancer Database. The population consisted of female patients with primary breast cancer diagnosed between 2011 and 2015. Patients were categorized based on household income and insurance status. Outcomes investigated were stage at diagnosis, rate of breast conservation therapy, use of immediate reconstruction following mastectomy, and administration of systemic therapy for stage 3 and 4 disease. Multivariable logistic regression analyses were performed to determine significant associations between economic factors and clinical outcomes. Survival analysis was performed to evaluate the influence of income and insurance on survival. In total, 666487 women were evaluated. Multivariable regression analyses revealed that patients with lower income (OR, 1.23) and no insurance (OR, 1.64) were more often diagnosed with later stage disease. Patients with lower income (OR, 1.08) and no insurance (OR, 1.05) had a higher likelihood of undergoing mastectomy instead of breast conserving therapy. Patients with lower income (OR, 0.51) and no insurance (OR, 0.27) were less likely to receive immediate breast reconstruction. Administration of systemic therapy was less frequent in patients with lower income (OR, 0.90) and no insurance (OR, 0.52). A survival benefit was demonstrated in patients with high income and insurance. Our findings demonstrate prevailing disparities in the delivery of care among patients with limited economic resources, which pertains to some of the most important aspects of breast cancer care. The full etiology of the observed disparities is complex and multifactorial, and a better understanding of these issues offers the potential to close the existing gap in quality of care.

Changing pattern of recurrences in patients with early HER2-positive breast cancer receiving neoadjuvant chemotherapy in the era of dual anti-HER2 therapy

BackgroundOver the last 10 years, there has been a major treatment revolution for early human epidermal growth factor receptor 2 (HER2)–positive breast cancer. We aimed to explore the outcome of...

Changes of breast and axillary surgery patterns in patients with primary breast cancer during the past decade.

Breast-conserving therapy (BCT) is the standard procedure for most patients with primary breast cancer (BC). By contrast, axillary management is still under transition to find the right balance between avoiding of morbidity, maintaining oncological safety, and performing a staging procedure. The rising rate of primary systemic therapy creates further challenges for surgical management. Patients with primary, non-metastatic BC treated between 01.01.2003 and 31.12.2016 under guideline-adherent conditions were included in this study. For this prospectively followed cohort, breast and axillary surgery patterns are presented in a time-trend analysis as annual rate data (%) for several subgroups. Overall, 6700 patients were included in the analysis. While BCT rates remained high (mean 2003-2016: 70.4%), the proportion of axillary lymph node dissection has declined considerably from 80.1% in 2003 to 16.0% in 2016, while the proportion for sentinel lymph node biopsy (SLND) has increased correspondingly from 10.3 to 76.4%. Among patients with cT1-2, cN0 breast cancer receiving BCT with positive SLND, the rate of axillary completion has decreased from 100% in 2008 to 24.4% in 2016. In the past decade, SLNB has been established as the standard procedure for axillary staging of clinically node-negative patients. Surgical morbidity has been further reduced by the rapid implementation of new evidence from the ACOSOG Z0011 trial into clinical routine. The results reflect the transition towards more individually tailored, less invasive treatment for selected patient subgroups, especially in regards to axillary lymph node management.

Regional variation in breast cancer surgery: Results from the National Cancer Database (NCDB)

BackgroundEarly studies have shown significant regional differences in the utilization of breast-conserving therapy (BCT) and mastectomy with reconstruction. It is expected that with the passage of time and the adoption of national treatment guidelines, these disparities would disappear. MethodsPatients with non-metastatic breast cancer who underwent surgery between 2004 and 2013 were analyzed using the National Cancer Database (NCDB). Trends in BCT and reconstruction were evaluated and multivariate logistic regression performed. ResultsThe highest rate of BCT was in New England (69%) and the lowest in East South Central (49%), p < 0.001. The rate of reconstruction was highest in the Middle Atlantic (44%) and the lowest in East South Central (26%), p < 0.001. Compared to East South Central, the odds ratio (OR) for BCT in New England was 2.2 (95% CI 2.1–2.3), and the OR for reconstruction in Middle Atlantic was 1.7 (95% CI 1.6–1.8). ConclusionThere continue to be significant regional differences in breast surgery.

Breast conservation after neoadjuvant chemotherapy for triple-negative breast cancer: Surgical results from an international randomized trial (BrighTNess).

514 Background: Neoadjuvant systemic therapy (NST) increases the frequency of breast-conserving therapy (BCT) in stage II-III breast cancer, but there is little data on how often it converts patients (pts) from BCT-ineligible (BCT-I) to BCT-eligible (BCT-E) and on the impact of other factors on surgical choices. We collected surgical assessment and management data from an international randomized trial of NST in triple-negative breast cancer (TNBC). Methods: Women with operable TNBC were randomized to veliparib (V) with carboplatin (C) and paclitaxel (P), placebo with C and P or placebo with P followed by doxorubicin and cyclophosphamide. The surgeons assessed BCT candidacy by clinico-radiographic criteria before and after NST; surgical management was at surgeon and patient discretion. We assessed interactions between BCT eligibility pre- and post-NST, germline BRCA mutation ( gBRCA) status, continent of treatment and achievement of pathologic complete response(pCR) and percentage of pts who underwent BCT versus mastectomy. Results: Pre- and post-NST surgical assessments were available for 604 pts who underwent surgery. BCT rates are listed in the Table. The BCT rate was 68% among pts deemed BCT-E after NST. pCR rates were identical between BCT-E pts who chose BCT (55%) vs. mastectomy (53%). Of 141 pts deemed BCT-I at baseline, 75 (53%) converted to BCT-E but only 42 (56%) of these opted for BCT. pCR rates were 49% in BCT-E converts vs. 36% in those remained BCT-I. gBRCA pts (n = 84) were less likely to choose BCT even if they were BCT-E. Pts treated in North America (NA) were less likely to choose BCT (55% vs. 80% for Europe and Asia P&lt;0.0001) even among non- gBRCA considered BCT-E post-NST (61% vs. 85% P&lt;0.0001). Conclusions: This largest prospective analysis of the impact of NST in TNBC demonstrates a conversion rate from BCT-I to BCT-E of 53%. BCT rates were lower in pts with gBRCA; the much higher mastectomy rate among BCT-E pts in NA merits investigation. Clinical trial information: NCT02032277. [Table: see text]

Reconstruction in Breast Conservation Therapy-Single Tertiary Care Institution Experience with 472 Patients.

Breast conservation therapy (BCT) is now internationally accepted treatment for early breast cancer. Despite of high incidence of carcinoma breast in India, BCT rates are very low as compared to the west. In this article, we wish to share our experience of breast conservation with oncoplasty in Indian women. A retrospective analysis of case records of patients treated with oncoplastic breast conservation from January 2009 to June 2014 in a single surgical oncology unit in a tertiary cancer institute. Demographic patient data, stage of disease, location of primary tumour, use of neo-adjuvant chemotherapy if received, tumour size and breast size ratio, reconstruction method used, post-operative complications and aesthetic score of patients were analysed. Various methods of oncoplasty and partial breast reconstruction used are discussed. Four hundred and seventy-two patient records were found suitable for analysis. Most common stage of presentation was T2N0 in 189 patients (40%). Forty-one patients received neo-adjuvant chemotherapy (NACT). Tumour arising in upper outer quadrant was most common site, seen in 268 (56.7%). The most common method of reconstruction was volume displacement, done in 57.6% patients. Overall surgical complications included wound infection with or without dehiscence, seroma formation, partial flap necrosis and fat necrosis. Cosmesis was found to be excellent in 23.09% and good in 58.47% at 6-month follow-up. Breast conservation with oncoplasty is oncologically safe for early breast cancer treatment and has good cosmetic outcome with high patient satisfaction rates. Its practice should be encouraged in Indian set-up also.

Impact of neoadjuvant therapy on eligibility for and frequency of breast conservation in stage II-III HER2-positive breast cancer: surgical results of CALGB 40601 (Alliance).

It had been previously shown that patients who receive neoadjuvant systemic therapy (NST) are more likely to undergo breast-conserving therapy (BCT) than those who have primary surgery. However, the frequency with which patients who are not BCT-eligible prior to NST convert to BCT-eligible with treatment is unknown. To document this conversion rate in a subset of patients expected to have a high clinical response rate to NST, we studied surgical assessment and management of patients enrolled on a randomized neoadjuvant trial for stage II-III HER2-positive breast cancer (HER2+BC)(CALGB 40601). The treating surgeon assessed BCT candidacy based on clinico-radiographic criteria both before and after NST. Definitive breast surgical management was at surgeon and patient discretion. We sought to determine (1) the conversion rate from BCT-ineligible to BCT-eligible (2) the percentage of BCT-eligible patients who chose breast conservation, and (3) the rate of successful BCT. We also evaluated surgeon-determined factors for BCT-ineligibility and the correlation between BCT eligibility and pathologic complete response (pCR). Of 292 patients with pre- and post-NST surgical assessments, 59% were non-BCT candidates at baseline. Of the 43% of these patients who converted with NST, 67% opted for BCT, with an 80% success rate. NST increased the BCT-eligible rate from 41 to 64%. Common factors cited for BCT-ineligibility prior to NST including tumor size (56%) and probable poor cosmetic outcome (26%) were reduced by 67 and 75%, respectively, with treatment, while multicentricity, the second most common factor (33%), fell by only 16%. Since 23% of the BCT-eligible patients chose mastectomy, BCT was the final surgical procedure in just 40% of the patients. Patients considered BCT-eligible both at baseline and after NST had a pCR rate of 55%, while patients who were BCT-ineligible prior to NST had the same pCR rate (44%) whether they converted to BCT-eligible or not. Many patients with HER2+BC deemed ineligible for BCT at baseline can be converted to BCT-eligible with NST; excluding patients with multicentric disease substantially increases that percentage. In converted patients who opt for BCT, the success rate is similar to that of patients considered BCT-eligible at baseline. Whether a BCT-ineligible patient converts to BCT eligibility or not does not appear to affect the likelihood of achieving a pCR. Despite the efficacy of NST in this patient cohort, only 40% of patients had successful BCT; further research into why BCT-eligible patients often opt for mastectomy is needed.

Does Achieving Pathologic Complete Response From Neoadjuvant Chemotherapy (NAC) for Breast Cancer Lead to Higher Rates of Breast Conservation Therapy?

Does Achieving Pathologic Complete Response From Neoadjuvant Chemotherapy (NAC) for Breast Cancer Lead to Higher Rates of Breast Conservation Therapy?

Disparities in the Use of Breast-Conserving Therapy Among Patients With Early-Stage Breast Cancer.

Although breast-conserving therapy (BCT) is an accepted modality for treatment of early-stage breast cancer, many women continue to undergo mastectomy. Detailing the factors associated with choice of BCT may assist with overcoming barriers in the use of this treatment modality. To conduct a population-based examination of the factors that influence the use of BCT. Using the National Cancer Data Base, we examined the surgical choices of women with stage T1 or T2 breast cancer treated between 1998 and 2011. Logistic regression analysis conducted between September 19, 2013, and August 26, 2014, was used to assess the multivariate association between patient and facility variables and the probability of undergoing BCT. Factors associated with the use of BCT. A cohort of 727,927 women was identified in the National Cancer Data Base. Use of BCT, determined using odds ratio (OR) and 95% CI, was greater in patients aged 52 to 61 years compared with younger patients (1.14; 1.12-1.15) and in those with the highest educational level (1.16; 1.14-1.19). Rates of BCT were lower in patients without insurance compared with those with private insurance (0.75; 0.72-0.78) and in those with the lowest median income (0.92; 0.90-0.94). Academic cancer programs, US Northeast location, and residence within 27.8 km of a treatment facility were associated with greater BCT rates than were community cancer programs (1.13; 1.11-1.15), Southern location (1.50; 1.48-1.52), and residence farther from a treatment facility (1.25; 1.23-1.27). When comparing BCT use in 1998 with use in 2011, increases were seen across age groups (from 48.2% to 59.7%), in community cancer programs (48.4% in 1998 vs 58.8% in 2011), and in facilities located in the South (45.1% in 1998 vs 55.3% in 2011). Although the use of BCT has increased during the past 14 years, nonclinical factors, including socioeconomic demographics, insurance, and travel distance to the treatment facility, persist as key barriers to receipt of BCT. Interventions that address these barriers may facilitate further uptake of BCT.

Abstract P3-07-22: Predictors of neoadjuvant chemotherapy use in women with breast cancer: A review of 169,329 patients from the American College of Surgeons' National Cancer Database

Abstract Background: Randomized controlled trials have demonstrated that neoadjuvant chemotherapy (NAC) offers equivalent long-term outcomes when compared to adjuvant chemotherapy while improving rates of breast conservation therapy (BCT). We sought to evaluate the national use of NAC and the patient, tumor, and provider characteristics associated with its use among women with stage I-III breast cancer. We hypothesize that younger women with larger tumors and HER-2+ or triple negative disease are more likely to receive NAC than their older counterparts with ER+ disease, and that use of NAC varies by region and practice setting. Methods: Using the American College of Surgeons National Cancer Database, which captures data on approximately 70% of new cancer diagnoses in the U.S., we identified women with diagnosed with stage I-III invasive cancer between 2008-2013. Women treated with both surgery and chemotherapy were included in the study. Demographic and clinical factors including race, ethnicity, income, insurance type, region of treatment facility, treatment facility type, tumor size, hormone receptor status, HER-2 status and Charlson Comorbidity score were analyzed to determine predictors associated with receipt of NAC. Utilization of preoperative chemotherapy and rates of breast conserving therapy (BCT) were evaluated as outcomes. Results: 169,329 women with stage I-III breast cancer underwent treatment with chemotherapy and surgery during the study period. Of these, 81.0% were White, 14.4% were Black, 4.6% were classified as Other Race. 28.7% were 18-49, 46.8% were 50-64 and 24.5% were &amp;gt;65 years. 64.4% had private insurance while 35.6% had public insurance (Medicaid, Medicare and VA), and 71.4% were treated at Community-Based Clinics while 28.6% were treated at Academic Medical Centers. Patients with larger tumors (p&amp;lt;0.0001) and triple negative disease were significantly more likely to be treated with NAC than those with ER+ or HER2+ disease (p&amp;lt;0.0001). Among women who received NAC, the median age was 54 as compared to 57 in those receiving adjuvant chemotherapy (p&amp;lt;0.0001). Treatment facility type impacted rates of NAC use, with academic centers being more likely than community-based practices to give chemotherapy preoperatively (12.1% vs. 9.8%, p&amp;lt;0.0001) and urban vs. rural settings (10.4% vs 8.2%, p&amp;lt;0.0001). Rates of NAC utilization differed regionally with the highest rate being 14.0% and the lowest rate 7.9% (p&amp;lt;0.0001). The overall % of BCT following NAC was 36.1% compared to 59.0% for those receiving adjuvant chemotherapy. The proportion of BCT following NAC differed significantly by subtype, 54.6% for ER+, 54.5% for Her2 +, and 59.7% for triple negative breast cancer (TNBC) (p &amp;lt;0.0001). Conclusions: In the treatment of stage I-III breast cancer across the US, variations in the utilization of neoadjuvant chemotherapy exist across the country suggesting clinical uncertainty about its use. Further research about the use of NAC therapy and the relationship to clinical outcomes can identify patient subsets who might obtain greatest clinical benefit from preoperative systemic therapy. Citation Format: Lynn J Howie, Rachel Greenup, Kevin Houck, Julie A Sosa, E Shelley Hwang, Jeffrey M Peppercorn. Predictors of neoadjuvant chemotherapy use in women with breast cancer: A review of 169,329 patients from the American College of Surgeons' National Cancer Database [abstract]. In: Proceedings of the Thirty-Seventh Annual CTRC-AACR San Antonio Breast Cancer Symposium: 2014 Dec 9-13; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2015;75(9 Suppl):Abstract nr P3-07-22.

Disparities in utilization of breast-conserving therapy among breast cancer patients.

104 Background: Since 1990 breast conserving therapy (BCT) has become a widely accepted modality in the treatment of breast cancer. However, many women continue to undergo mastectomy over BCT. The objective of this study was to provide a comprehensive population based review of the factors that influence utilization of BCT. Methods: Using the National Cancer Database (NCDB), we evaluated women who underwent a mastectomy or BCT for T1/T2, any N breast cancer between 1998 and 2011. We conducted a retrospective review of patient and facility variables associated with undergoing BCT and the trends over time. Logistic regression analysis was used to assess the multivariate relationship between these variables and the probability of undergoing BCT. Results: Among the 727,927 patients who met study criteria, BCT rates increased from 54% in 1998 to 59% in 2006 and then stabilized. After adjusting for demographic and clinical characteristics, BCT utilization was more likely in patients aged 52-61 compared to younger patients (odds ratio (OR) 1.14 {95% CI 1.12-1.15}) and in those with the highest education level (OR 1.16 {95% CI 1.14-1.19}). BCT rates were higher in patients with private insurance compared to the uninsured (OR 1.33 {95% CI 1.28-1.38}) and in those with the highest median income (OR 1.09 {95% CI 1.06-1.11}) (all p &lt; 0.0001). Academic Cancer Programs, facilities in the Northeast and patients who lived within 17 miles of a treatment facility had higher utilization of BCT than Community Cancer Programs (OR 1.13 {95% CI 1.11-1.15}), facilities located in the South (OR 1.50 {95% CI 1.48-1.52}) and those who lived further from a treatment facility (OR 1.25 {95% CI 1.23-1.27}) (all p&lt;0.0001). When comparing BCT utilization in 1998 and 2011, increases were seen across age groups, in community cancer programs and in facilities located in the South; however, disparities by insurance status, income level and travel greater than 17 miles to a treatment facility persist. Conclusions: BCT rates have increased during the last two decades. Disparities based on age, geographic location and type of cancer program have improved. However, socio-economic status and travel distance to treatment facilities persist as key barriers to BCT utilization.