bluuebunny/crossref_metadata_2025_split huggingface dataset:
Abstract P5-16-07: Short-term outcomes and QoL following autologous fat transfer in oncoplastic and reconstructive breast surgery
Authors: Bjelic-Radisic V , Oberfichtner K , Wurzer P , Trapp E , Rappl T , Reisniger J , Kamolz L-P , Tamussino K 
Published: May 2019

Abstract
Background: Breast cancer (BC) is with 30% among all cancers the most common cancer among women in Austria. Regarding therapy and management of BC, surgical treatments with resection and reconstruction play a crucial role. Breast-conserving therapy (BCT) represents a common procedure. However, mastectomy is still needed in about 30% of the patients with the diagnosis BC and as prophylactic surgery in indicated cases. Recently, autologous fat transfer (AFT, lipofilling) has been used to improve cosmesis in oncoplastic and reconstructive breast surgery. There is a gap of evidence for the oncological safety as well as the benefit for quality of life (QoL) in patients who had an AFT after the BC or prophylactic surgery.
Material and methods: We assessed peri-and postoperative results, oncological outcomes and QoL in 55 patients undergoing AFT after BCT or mastectomy at our department between 2013 and 2018. QoL was assessed with the EORTC QLQ C30 and QLQ-BRECON23 questionnaires.
Results: Overall, 55 patients (73 breasts) underwent AFT after BCT or mastectomy. 39 patients had a diagnosis of invasive BC (four bilateral) and six patients a diagnosis of DCIS. 24 mastectomies were done as prophylactic surgery. AFT was done in 22 cases with nipple sparing mastectomy (NSM), in 30 cases with skin sparing mastectomy (SSM), in 9 cases with simple mastectomy ± reconstruction and in 12 cases with BCT. The number of AFT sessions was 1-8 (mean 1.8). The injected fat volume per session was 30-390 ml. There were 10 (14%) complications: 3 hematomas (none needed reintervention), local inflammation requiring antibiotic therapy (n=3), formation of an oil cyst (n=1), and fat necrosis (n=3). In two cases of fat necrosis biopsy was performed to confirm the diagnosis. After a median follow-up of 34 months there was one recurrence (Paget´s disease after BC). QoL data will be presented at the meeting.
Conclusion: Lipofilling after mastectomy for cancer appears to be oncologically safe. Our complication rate is relatively high, although additional surgical intervention (biopsy) was only necessary in two cases. Patients considering AFT should be informed about additional risk for biopsy, as well as other common complications.
Citation Format: Bjelic-Radisic V, Oberfichtner K, Wurzer P, Trapp E, Rappl T, Reisniger J, Kamolz L-P, Tamussino K. Short-term outcomes and QoL following autologous fat transfer in oncoplastic and reconstructive breast surgery [abstract]. In: Proceedings of the 2018 San Antonio Breast Cancer Symposium; 2018 Dec 4-8; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2019;79(4 Suppl):Abstract nr P5-16-07.
Abstract P5-18-07: Withdrawn
Authors: Yang F , Wu S , Mo M , Liu Y , Liu G 
Published: May 2019

Abstract
This abstract was withdrawn by the authors.
Citation Format: Yang F, Wu S, Mo M, Liu Y, Liu G. Withdrawn [abstract]. In: Proceedings of the 2018 San Antonio Breast Cancer Symposium; 2018 Dec 4-8; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2019;79(4 Suppl):Abstract nr P5-18-07.
Abstract P6-02-04: Ultrasound assessment of residual disease after neoadjuvant chemotherapy (NACT) in node positive triple negative breast cancer (TNBC)
Authors: Adrada BE , Valero V , Reddy SM , Barcenas CH , Candelaria R , Wei W , Rauch GM 
Published: May 2019

Abstract
Purpose: To determine accuracy of preoperative ultrasound after NACT to predict residual disease in triple negative breast cancer (TNBC) patients with confirmed axillary nodal metastasis.
Methods: This is an institutional review board approved retrospective study of TNBC patients who received NACT at MD Anderson Cancer Center from January 1999 - June 2015. We identified 327 TNBC patients who had cytologically confirmed breast and nodal disease at baseline evaluation and had preoperative ultrasound evaluation of residual disease. Ultrasound response was divided in tree categories: radiologic complete response (rCR) - complete resolution of the malignant mass); near-rCR - no discernible mass, only an isoechoic flat tumoral bed); and residual disease (RD) - a discernible mass is seen. Axillary ultrasound images were evaluated for lymph node size, cortical thickness and residual morphological type after NAC (type I-VI). Ultrasound breast and axillary findings were compared with final surgical pathology.
Results: In 89 cases (27%), pCR was achieved. 74% (242/327) were unifocal and 26% (86/327) multifocal. Ultrasound rCR was seen in 11% patients (36/327). Of those, 64% (23/36) showed pCR and 36% (13/36) showed residual disease. Ultrasound near-rCR was seen in 26% (84/327). Of those, pCR was seen 49 % (41/84) and residual disease in 51% (43/84). Residual disease was seen in 63% (207/327), 12% (25/207) showed pCR and 88% (182/207) showed residual disease. Regarding axillary lymph nodes, long axis diameter mean was 1.57 cm for patients with pCR and 1.6 cm for no pCR, short axis diameter mean was 0.67 cm for pCR and 0.87 cm for no pCR. Cortical thickness mean was 2 mm for pCR versus 9 mm for no pCR.
Sensitivity of ultrasound for assessment residual disease (ultrasound was considered positive if either breast ultrasound or axillary ultrasound showed residual disease) was 97%. Specificity is 22.47% with a NPV of 74% and PPV of 77%.
Conclusion: Breast and axillary ultrasound performed after NACT showed low specificity but high sensitive to detect residual disease. rCR and near rCR were related with pCR in 64% and 49 % of the cases respectively.
Citation Format: Adrada BE, Valero V, Reddy SM, Barcenas CH, Candelaria R, Wei W, Rauch GM. Ultrasound assessment of residual disease after neoadjuvant chemotherapy (NACT) in node positive triple negative breast cancer (TNBC) [abstract]. In: Proceedings of the 2018 San Antonio Breast Cancer Symposium; 2018 Dec 4-8; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2019;79(4 Suppl):Abstract nr P6-02-04.
Abstract P6-07-03: A live tissue platform allows dynamic measurement of neovascularization and prediction of clinical response in human breast cancer samples, ex vivo
Authors: Smalley M , Alam N , Murmu N , Somashekhar S , Ulaganathan B , Thayakumar A , Maciejko L , Ganesh J , Lawson M , Gertje H , Shanthappa BU , Goldman A 
Published: May 2019

Abstract
Background: Outgrowth of new blood vessels (neovascularization) allows tumors to supply themselves with oxygen and nutrients, and to rapidly metastasize throughout the body. Triple negative breast cancer (TNBC) is particularly susceptible to neovascularization. However, success with anti-angiogenics is highly variable and often patient-specific. This is particularly true as anti-angiogenics are being combined with immunotherapies. Thus, there is a huge unmet need for clinicians to test and predict clinical efficacy of anti-angiogenics at the individual patient level, prior to treatment.
Methods: Here, we characterize a patient-autologous, ex-vivo tumor model, termed CANscript, as a platform to study the intratumor microvascular density (iMVD) of breast cancer samples (N=15). To profile iMVD we used immunohistochemical (IHC) analysis of CD34, an early biomarker of neovascularization. We then introduced anticancer and anti-angiogenic agents (e.g. Avastin) for 72 hours, and subsequently quantified phenotypic response to drugs by testing viability, cell death, proliferation and morphology. These quantitative data were then fed into a machine learning algorithm that provides a clinical response prediction (M-Score).
Results: We determined that ex-vivo culture reliably retains baseline heterogeneity of iMVD based on expression of CD34+ nodes per visual field by IHC. Furthermore, we show that anticancer and anti-angiogenic agents will dynamically alter iMVD, ex-vivo, in a patient-specific manner. Finally, we show that prediction of clinical response using the 'M-Score' algorithm associates with diminished expression of CD34 per visual field of IHC after drug pressure.
Summary: Neovascularization and iMVD are features of aggressive cancers, such as TNBC. CANscript provides a rapid assessment of clinical response to anticancer drugs, many of which induce their antitumor effect by targeting the tumor vasculature. We show that pharmacodynamics of antiangiogenics can be captured during acute ex-vivo culture under drug pressure, which associate to clinical response prediction. Therefore, we highlight the ability of CANscript as a platform to predict clinical response to anti-angiogenic drugs, and may therefore be a logical 'testing ground' to predict clinical efficacy of antiangiogenic drugs combined with immunotherapies.
Citation Format: Smalley M, Alam N, Murmu N, Somashekhar S, Ulaganathan B, Thayakumar A, Maciejko L, Ganesh J, Lawson M, Gertje H, Shanthappa BU, Goldman A. A live tissue platform allows dynamic measurement of neovascularization and prediction of clinical response in human breast cancer samples, ex vivo [abstract]. In: Proceedings of the 2018 San Antonio Breast Cancer Symposium; 2018 Dec 4-8; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2019;79(4 Suppl):Abstract nr P6-07-03.
Abstract P6-13-06: Estrogen-based hormone replacement [HRT] therapy is substantially more effective than tamoxifen in reducing breast cancer mortality and breast cancer case fatality ratio: Emergence of a new paradigm
Authors: Ragaz J , Shakeraneh S , Qian H , Wilson KS , Wong H , Spinelli JJ 
Published: May 2019

Abstract
OBJECTIVE: To compare, in the setting of breast cancer (BrCa) prevention, the impact of estrogen-based hormone replacement therapy (E-HRT) vs. tamoxifen (TAM) on breast cancer mortality (BrCa-M) and breast cancer case fatality ratio (BrCa-CFR), by analyzing data from the Women's Health Initiative Trial 2 (WHI HRT Trial 2, E-HRT vs. placebo [P])1 and the International Breast Cancer Intervention Study 1 (IBIS-1), TAM vs. P.2
METHODS: Hazard ratios (HR) and confidence intervals (CI) for BrCa incidence and mortality were extracted from the original WHI HRT Trial 2 and IBIS-1 trials.1,2 BrCa-CFRs were estimated by dividing the mortality HR by the incidence HR. Subsequently, to compare E-HRT vs. TAM outcomes, the ratios of HRs (HR1/HR2) between the two trials were estimated separately for BrCa-M and BrCa-CFR. The 95% CI was derived through logarithmic transformation of the 95% CI originally reported.
RESULTS:
Mortality and Case Fatality Outcomes: Impact of E-HRT versus TAM, expressed as ratio of HRs E-HRT vs. Placebo, HR1TAM vs. Placebo, HR2HR1/HR2pMortality0.55 (0.33-0.92)1.19 (0.68-2.10)0.46 (0.22-0.99)0.046Case Fatality0.70 (0.40-1.20)1.68 (0.93-3.01)0.42 (0.18-0.94)0.040
CONCLUSIONS: While acknowledging between-trial comparisons including eligibility differences, E-HRT yields significant reductions in BrCa mortality and case fatality as compared with TAM (54% and 58% respectively). These unexpected breast cancer mortality reductions represent major public health gains, additional to the already known superiority of E-HRT over TAM in terms of skeletal fracture rates and Alzheimer's dementia mortality reduction, and, in women entering menopause, also of cardiac and all-cause mortality reductions.
REFERENCES:
1. Manson JE, Aragaki AK, Rossouw JE, et al. Menopausal Hormone Therapy and Long-term All-Cause and Cause-Specific Mortality: The Women's Health Initiative Randomized Trials. JAMA 2017;318:927-38.
2. Cuzick J, Sestak I, Cawthorn S, et al. Tamoxifen for prevention of breast cancer: extended long-term follow-up of the IBIS-I breast cancer prevention trial. The Lancet Oncology 2015;16:67-75.
Citation Format: Ragaz J, Shakeraneh S, Qian H, Wilson KS, Wong H, Spinelli JJ. Estrogen-based hormone replacement [HRT] therapy is substantially more effective than tamoxifen in reducing breast cancer mortality and breast cancer case fatality ratio: Emergence of a new paradigm [abstract]. In: Proceedings of the 2018 San Antonio Breast Cancer Symposium; 2018 Dec 4-8; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2019;79(4 Suppl):Abstract nr P6-13-06.
Abstract P6-14-04: Not presented
Authors: Mohd Taib NA , Islam T , Su TT , Musthaffa S , Abdullah Din N , Rahman Z , Mohamed KNB , Kaur S , Filza J , Shaheera F , Ellsworth Beaumont C 
Published: May 2019

Abstract
This abstract was not presented at the conference.
Citation Format: Mohd Taib NA, Islam T, Su TT, Musthaffa S, Abdullah Din N, Rahman Z, Mohamed KNB, Kaur S, Filza J, Shaheera F, Ellsworth Beaumont C. Not presented [abstract]. In: Proceedings of the 2018 San Antonio Breast Cancer Symposium; 2018 Dec 4-8; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2019;79(4 Suppl):Abstract nr P6-14-04.
Abstract P6-14-07: Not presented
Authors: Lai J , Antill Y , Richardson G , Vereker M , David S 
Published: May 2019

Abstract
This abstract was not presented at the conference.
Citation Format: Lai J, Antill Y, Richardson G, Vereker M, David S. Not presented [abstract]. In: Proceedings of the 2018 San Antonio Breast Cancer Symposium; 2018 Dec 4-8; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2019;79(4 Suppl):Abstract nr P6-14-07.
Abstract P6-17-05: Independent validation of a combined biomarker based on the PAM50 HER2-enriched subtype and ERBB2 mRNA levels following HER2 blockade without chemotherapy in the PerELISA phase II trial
Authors: Prat A , Griguolo G , Dieci MV , Bisagni G , Frassoldati A , Bianchi GV , Pascual T , Pare L , Galvan P , Urso L , Conte P , Guarneri V 
Published: May 2019

Abstract
Background: A combined biomarker based on HER2-enriched subtype (HER2-E) and ERBB2 mRNA predicts response and survival in HER2+ breast cancer following trastuzumab +/- lapatinib in the absence of chemotherapy (Prat et al. ASCO 2018). Here, we tested the ability of the combined biomarker to predict pathological complete response (pCR) following neoadjuvant trastuzumab, pertuzumab and endocrine therapy.
Methods: RNA from 40 baseline tumor samples from the phase II PerELISA trial were evaluated. PerELISA evaluated the efficacy of a de-escalated, chemotherapy-free neoadjuvant regimen based on dual HER2 blockade with trastuzumab and pertuzumab in combination with letrozole in HER2+/hormone receptor-positive breast cancer selected on the basis of Ki67 response after short course letrozole-alone (Guarneri ASCO 2018). Ki67 response was defined by protocol as relative Ki67 reduction ≥20% from baseline at day 14. Gene-expression was measured using the nCounter platform. Intrinsic subtypes and ERBB2 levels were determined by the PAM50 gene expression predictor. A pre-specified ERBB2 cutoff was determined to define ERBB2-high. Univariate and multivariable logistic regression analyses were performed.
Results: The proportion of HER2-E disease within the ERBB2-high and ERBB2-low groups was 46.2% (6/13) and 18.5% (5/27), respectively. The discordance rate at the individual level was 30% (12/40). A total of 6 (15%) and 34 (85%) samples were HER2-E/ERBB2-high and others, respectively. The magnitude of Ki67 reduction of the HER2-E/ERBB2-high and others groups was 64.8% and 63.2%, respectively (p=0.88). The pCR rate of HER2-E/ERBB2-high was 66.7%. The pCR rate of the others group was 14.7%. The univariate odds ratio between HER2-E/ERBB2-high tumors and the others groups was 11.60 (95% CI 1.66-81.10; p=0.014). No other clinical-pathological variable was significantly associated with pCR.
Conclusion: The combined HER2-E/ERBB2-high biomarker can identify patients who might be good candidates to receive dual HER2 blockade alone without chemotherapy.
Citation Format: Prat A, Griguolo G, Dieci MV, Bisagni G, Frassoldati A, Bianchi GV, Pascual T, Pare L, Galvan P, Urso L, Conte P, Guarneri V. Independent validation of a combined biomarker based on the PAM50 HER2-enriched subtype and ERBB2 mRNA levels following HER2 blockade without chemotherapy in the PerELISA phase II trial [abstract]. In: Proceedings of the 2018 San Antonio Breast Cancer Symposium; 2018 Dec 4-8; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2019;79(4 Suppl):Abstract nr P6-17-05.
Abstract P6-17-18: Pathologic complete response (pCR) in locally advanced HER2+ (HER2+) breast cancer (BC) treated with anthracycline-free neoadjuvant therapy
Authors: Somlo G , Waisman J , Yuan Y , Kruper L , Frankel P , Jones V , Lusi T , Schmolze D , Yim J , Hurria A , Mortimer J 
Published: May 2019

Abstract
Background: Response to neoadjuvant therapy is a predictor of progression-free and overall survival in HER2+. To decrease treatment associated toxicities in patients with HER2+ breast cancers we utilized a non-anthracycline regimen with pertuzumab (pert), trastuzumab (trast), and nab-paclitaxel (nab). Pre- neoadjuvant therapy biopsies were procured to evaluated possible biological predictors of pathologic complete response (pCR).
Methods: Women with locally advanced HER2 positive breast cancers were recruited from our breast cancer clinics. After obtaining informed consent for this IRB-approved trial, patients were treated with 6 cycles of pertuzumab (day 1 every 21 days [d]), and weekly trastuzumab 2 mg/kg with and nab-paclitaxel 100 mg/m2. Formalin fixed paraffin embedded (FFPE) or frozen biopsies pre-NT and post-NT were collected, along with blood samples at pre-treatment, and at the end of study for correlative analysis.
Results: Accrual is complete, with 42 of the 45 HER2+ patients assessed for pCR rate (3 too early to evaluate). The median age was 54 yrs (range 31-77 years). 12 patients were stage 3, 26 stage 2, and 1 stage 1 patient. The pCR rate was 64.2% (27/42), with 73.7% (14/19) in ER/PR negative patients and 56.5% (13/23) in ER/PR positive patients. The initial primary tumor size was similar for in those who achieved pCR and non-pCR patients (mean 4.1 cm vs 3.2 cm, respectively). Most patients required dose modifications. Grade 3 AEs reported included 6 patients with hypertension, 3 patients with hematological AEs, 3 patients with elevated LFTs, and 2 patients with diarrhea.
Conclusions: This anthracycline-free regimen in HER2+ BC can achieve promising pCR response rates, with toxicities well-managed with dose modifications. Results of correlative analysis will be presented.
Citation Format: Somlo G, Waisman J, Yuan Y, Kruper L, Frankel P, Jones V, Lusi T, Schmolze D, Yim J, Hurria A, Mortimer J. Pathologic complete response (pCR) in locally advanced HER2+ (HER2+) breast cancer (BC) treated with anthracycline-free neoadjuvant therapy [abstract]. In: Proceedings of the 2018 San Antonio Breast Cancer Symposium; 2018 Dec 4-8; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2019;79(4 Suppl):Abstract nr P6-17-18.
Abstract P6-18-30: Phase Ib/II study of capecitabine 7/7 schedule with neratinib in patients with HER2-positive metastatic breast cancer (MBC)
Authors: Wang R , Singh J , Sterlin V , Goldstein M , Lake D , Wong S , Baselga J , Norton L , Dang C 
Published: May 2019

Abstract
Background: Neratinib (N) is a potent irreversible inhibitor of HER1, HER2, and HER4 and has been shown to have antitumor activity in patients (pts) with human epidermal growth factor receptor 2 (HER2) - positive breast cancer. A previous study of combination of neratinib with capecitabine (X) was associated with &gt; G 3 diarrhea in &gt; 20% of patients. Currently, the NALA study is evaluating this combination of N with X at standard schedule against control. X at 7 day on and 7 day off schedule (7/7) has been shown to be well-tolerated with less ≥G3 toxicities. We are conducting a phase Ib/II study of N with X (7/7) in pts with pretreated HER2+ MBC (NCT03377387). Methods: Eligible pts had HER2+ MBC, normal left ventricular ejection fraction (LVEF ≥ 50%); pts can have any and up to 4 prior chemotherapy-based treatments in phase Ib and II portions, respectively. Primary endpoints are to define maximum tolerated dose and efficacy in phase I and phase II portions, respectively. Secondary endpoints include safety and tolerability; exploratory endpoint is to quantify cell-free DNA to correlate with response for phase II portion. There were 4 cohorts for phase Ib with dose level 1 with starting dose of X at 1500 mg BID at 7/7 schedule with N at 240 mg daily. Results: As of July 1, 2018 8 pts have been enrolled in 2 cohorts. The median age is 63y (range: 57-79), and median ECOG is 0 (range: 0-1). 4 patients were treated at dose level 1 and 2 of 4 patients experienced dose-limiting toxicity with G3 diarrhea during cycle 1. Other significant toxicities included G3 hand foot syndrome (n=1), G3 fatigue (n=1) and G3 nausea (n=1). Three pts have now been treated at dose level -1 (X at 1000 mg twice daily 7/7 and N at 240 mg daily) and no ≥ G3 toxicities has been noted. Once MTD is reached, the phase II portion will occur to assess the efficacy and to further establish the safety and tolerability of capecitabine and neratinib at the MTD. Conclusions: The phase Ib/II study combining neratinib and capecitabine 7/7 is ongoing and updated result will be presented.
Citation Format: Wang R, Singh J, Sterlin V, Goldstein M, Lake D, Wong S, Baselga J, Norton L, Dang C. Phase Ib/II study of capecitabine 7/7 schedule with neratinib in patients with HER2-positive metastatic breast cancer (MBC) [abstract]. In: Proceedings of the 2018 San Antonio Breast Cancer Symposium; 2018 Dec 4-8; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2019;79(4 Suppl):Abstract nr P6-18-30.