bluuebunny/crossref_metadata_2025_split huggingface dataset:
Abstract P6-09-06: Oral Contraceptive Use and Overall Breast Disease Risk: Cross Sectional Retrospective Study
Authors: Hamy AS , Agopian A , Porcher R , Giacchetti S , de Roquancourt A , Espié M. 
Published: April 2011

Abstract
Background: Oral contraception (OC) is one of the most widely used means for birth control in the world. In several studies, OC has been associated with a slightly increased risk of breast cancer in current user, and with a decreased risk of benign disease. Little is known about atypical high risk lesions. Our goal was to investigate whether OC use was a risk factor or a protective factor for benign, high risk or malignant breast lesions. Material and methods : From 2001 to 2007, all non-palpable breast lesions referred to biopsy or cytology in Saint Louis hospital were prospectively registered. Demographic and clinical data including oral contraceptive pill use extent were reported. We defined benign lesions (fibroadenoma, blunt duct adenosis, fibrocystic changes, epithelial hyperplasia, others), high risk lesions (atypical ductal hyperplasia, atypical lobular hyperplasia, lobular carcinoma in situ and malignant lesions (ductal carcinoma in situ, invasive ductal or lobular carcinoma). The aim was to analyse the correlation between the duration of OC use and the occurrence of the breast disease classified by histology groups. Patients with previous history of benign breast disease or malignancy were excluded.
Results: The analysis was performed on 1329 breast lesions. The breakdown of the lesions were as follows: 819 benign lesions (fibroadenoma n=155, blunt duct adenosis n=169, fibrocystic disease n=194, epithelial hyperplasia n=132, others n=170), 104 high risk lesions (atypical ductal hyperplasia n=54, atypical lobular hyperplasia n=29, lobular carcinoma in situ n=21), and 406 malignant lesions (ductal carcinoma in situ n=158, invasive ductal or lobular carcinoma n=248). The duration of oral contraception use was not significantly associated with the occurrence of benign, high risk or malignant breast disease. When focusing on benign lesion subtypes, no association was observed either. Older age was significantly correlated to the occurrence of atypia or carcinoma. Significant difference existed in the median age of apparition 55 y.o and 57 y.o respectively, versus 53 y.o for benign lesion (p&lt; 0,0001), as well as menopausal status at diagnosis (57.7% and 68.3%, respectively, versus 53% for benign lesion) (p&lt; 0,0001).
Conclusion: In this cross sectional retrospective study, the duration of OC use was not associated with differential occurrence of benign, high risk and malignant breast lesion. Although a lack of statistical power may be invoked to explain the results, we are called to believe that the magnitude of an effect of OC use is small, if ever it exists.
Results [Table 1]

Citation Information: Cancer Res 2010;70(24 Suppl):Abstract nr P6-09-06.
Abstract P6-09-09: Dual Estrogen Effects on Breast Cancer: Endogenous Estrogen Stimulates, Exogenous Estrogen Protects. Further Investigation of Estrogen Chemoprevention Is Warranted
Authors: Ragaz J , Wilson K , Muraca G , Budlovsky J , Froehlich J. 
Published: April 2011

Abstract
Introduction
Until the randomized Women Healths Initiative [WHI] trials 1,2, most hormone replacement therapy (HRT) studies showed an association of HRT with higher BrCa risk. However, our recent reviews of the WHI trials suggested that Estrogen alone can be protective while HRT based on Estrogen + Progestin can be carcinogenic 3, 4. In this analysis, we expand this concept to examine the difference between “Exogenous” Estrogen — delivered as part of HRT, versus “Endogenous” Estrogen — i.e. E produced by human tissues. Rationale 1: Endogenous E is carcinogenic.
Reducing E levels through oophorectomy, selective oestrogen receptor modulators (SERMs) or with aromatase inhibition is effective at all stages of oestrogen receptor positive breast cancer and is significantly protective against BrCa in high risk women 5. Rationale 2: Exogenous E Protective:
Updates of the WHI trial 2 [women with hysterectomy, randomized to E alone versus Placebo, 1,2 ] with analyses according to prior history of Benign Breast Disease (PH BrD); a first degree relative with BrCa (PH 1st Rel BrCa); or prior HRT use, show:
Results of the WHI trial 2
CONCLUSIONS
These data are compatible with a dual estrogen effect where Exogenous Estrogen is protective, in contrast to the carcinogenic impact of Endogenous Estrogen. The protective effect of Estrogen is comparable in magnitude to that reported with tamoxifen in high risk women. Based on these data, we propose that:
1. In selected women - [i.e. the majority of the WHI HRT trial 2 participants, 71.5 - 80%] - the use of HRT based on Estrogens alone may be appropriate to manage menopausal symptoms, as it is associated with a significant reduction of BrCa rates.
2. The use of Exogenous Estrogen in chemoprevention merits validation, with the optimum Estrogen regimen determination [type of Estrogens; dose; mode of delivery, etc.] high priority.
References:
1. WHI working Group Reports, JAMA 2002; 2004; 2006
2. JCO, June 2010; 16; 2690-97
3. Cancer Res 2009; 69; # 908
4. HRT: A Critical Review. In: Management of Breast Diseases, 2010; Springer, New York, pp, 451-473.
5. Diseases of Breast, the 3rd Edition, 2005

Citation Information: Cancer Res 2010;70(24 Suppl):Abstract nr P6-09-09.
Abstract P6-09-11: Wide Scale, Automated Breast Cancer Risk Assessment and Decision Support for High Risk Women: www.BreastHealthDecisions.org
Authors: Ozanne EM , Bechtold T , Boortz S , Esserman LJ. 
Published: April 2011

Abstract
Purpose: Despite compelling evidence indicating chemopreventive agents can reduce the risk of developing breast cancer, they remain underused. This is common in elective therapies that hold the possibility of side effects. Effective risk stratification and patient-provider communication are critical for identifying those patients who stand to benefit most from these agents. However, there are few tools available for wide scale breast cancer risk assessment that also integrate decision support. To address this critical gap in healthcare delivery, we developed and performed preliminary evaluations of www.BreastHealthDecisions.org. This tool provides automated risk assessment and internet-based, patient-tailored decision support.
Development Methods: www.BreastHealthDecisions.org was developed to guide informed, value-driven, and patient-centered breast cancer prevention decisions. We implemented four commonly used breast cancer risk prediction models in the form of web-services to provide wide scale automated, individualized breast cancer risk assessments. Our internet-based decision aid is then tailored to individual patients based on risk predictions from these models. The decision aid is designed to integrate patient data from multiple sources including electronic surveys, electronic medical record (EMR), and other databases.
Evaluation Methods: Under Institutional Review Board approval, we evaluated the risk assessment tool and decision aid through patient focus groups, usability testing, and provider interviews (including breast specialist, primary care physicians, and genetic counselors). This included demonstrations and data collection at two scientific conferences (2009 International Shared Decision Making Conference, 2009 San Antonio Breast Cancer Symposium)
Result: Overall, the evaluations were favorable. The patient focus group evaluations and usability testing (N=34) provided qualitative feedback about the format and design of the decision aid; 88% of these participants found the tool useful and 94% found it easy to use. 91% of the providers (N=23) indicated that they would use the risk assessment tool and decision aid in their clinical setting.
Conclusion: www.BreastHealthDecisions.org represents a new approach to breast cancer prevention care and a framework for high quality preventive healthcare. The ability to integrate wide scale risk assessment and decision support in real time will allows for informed, value-driven, and patient-centered breast cancer prevention decisions. The tool is being further evaluated in a randomized controlled trial designed to determine the optimal mode of delivery in the primary care setting.

Citation Information: Cancer Res 2010;70(24 Suppl):Abstract nr P6-09-11.
Abstract P6-10-04: Outcome of Triple Negative Breast Cancer in Patients with or without Deleterious BRCA Mutations
Authors: Arun BK , Gutierrez-Barrera AM , Akar U , Litton JK , Albarracin C , Gonzalez-Angulo AM , Hortobagyi GN. 
Published: April 2011

Abstract
Background: Triple-negative breast cancer (TNBC) affects 10-17% of all breast cancers and is associated with a poor prognosis. The biology of TNBC is poorly understood; however, it has been shown that up to 60% of BRCA1 mutation carriers develop TNBC. The aim of this study was to determine if there were differences in the progression-free survival (PFS) and overall survival (OS) rates of BRCA mutation-associated TNBC and Non-BRCA mutation-associated TNBC.
Methods: Patients with TNBC who were referred between 1997 and 2010 for genetic counseling were included in the analysis. Data was collected from a prospectively maintained IRB-approved research database. All patients with one primary breast cancer and negative expression of ER, PR, and Her2 were included in this study. A Kaplan-Meier survival analysis was performed to determine survival outcomes. Results: Out of 98 TNBC patients, 48 (48 %) were BRCA negative, and 47 (49%) were found to have a deleterious BRCA mutation (42 BRCA1 and 5 BRCA 2); 3 (3%) patients had a variant of uncertain significance in BRCA2 and were removed from study. The median age of diagnosis for BRCA positive TNBC was 42 years (range, 21-71) and for BRCA negative TNBC was 40.5 years (range, 21-64). There were no significant differences between age at diagnosis, nuclear grade, stage (I-III), or tumor histology of BRCA positive and BRCA negative TNBCs. The PFS for BRCA positive patients was 230.7 (range, 2-271) months and for BRCA negative was 203.1 (range, 2-258) months (p = 0.19). The overall survival (OS) for BRCA positive patients was 263.4 (range, 2-292) months and for BRCA negative 236.2 (2-279) months (p = 0.39). Conclusion: Outcome of triple-negative breast cancer is not different in BRCA mutation carriers versus non carriers. Further studies need to evaluate whether different therapies will change the outcome in these subgroups of TNBC.
Citation Information: Cancer Res 2010;70(24 Suppl):Abstract nr P6-10-04.
Abstract P6-10-06: Metachronous Contralateral Breast Cancer (CBC) Has More Aggressive Biology and Clinical Characteristics Compared to Synchronous Bilateral Breast Cancer (BBC)
Authors: Pistamaltzian NF , Papadimitriou C , Panopoulos C , Koumakis G , Demiri S , Tsoukalas N , Yannoukakos D , Apostolikas N , Panagopoulos E , Efremidis A. 
Published: April 2011

Abstract
Purpose: Bilateral breast cancer is an uncommon clinical entity. There is no specific treatment strategy and controversial issues concerning diagnostic criteria, management and classification exist.
Method: In order to address some of these issues, a prospective analysis (data recorded upon patients first presentation) of an electronic breast cancer database at a tertiary cancer centre was performed. Patients’ epidemiologic characteristics, clinical profile, genomic analysis information and the tumours’ histopathology were analyzed.
Results: Out of 900 patients treated for breast cancer between 2006 and 2009, 44 diagnosed with bilateral disease (5% of total)having a median age of 53 years(range 32-73). 16 of them (36%)suffered from synchronous disease and 28 (64%)from metachronous { &gt;3 months apart between the initial diagnosis and subsequent contralateral breast tumour).
Genetic analysis revealed 3 patients with inherited breast cancer syndromes (2 with BRCA1 and one with CDH-1 mutation). Among those with synchronous BBC 63% (10/16)were postmenopausal, 50% (8/16)had a positive family history for breast cancer and upon initial diagnosis 80% (13/16)of them presented with early stage disease (stages I,II).Contralateral disease was diagnosed incidentally. In contrast to these patients with synchronous BBC,57% of the patients (16/28)with metachronous CBC were premenopausal and 68% (19/28)had advanced disease (stages III,IV) upon the second diagnosis. Etrogens’ use didn't differ among the two groups, obesity was more common in patients with metachronous CBC, and smoking in the synchronous BBC patients.
Of the 88 tumours, 81(92%) were invasive, with ductal adenoCa being the more common (53% of specimens).
Of synchronous BBC tumours 12/16 (75%)were HR+ positive and 80%(13/16) expressed the same biologic features bilaterally. Of the metachronous tumours, upon initial diagnosis,26% were triple negative and only 7% were found with HER2 amplification, compared with 41% and 26% respectively in the second diagnosis. Conclusions: Synchronous BBC is less prevalent than Metachronous CBC, has more favourable characteristics (earlier stage at diagnosis, hormonal receptor positivity), and occurs mainly among postmenopausal women with positive family history.
Metachronous CBC is more common in premenopausal women and has a tendency to change its biological and clinical characteristics to a more aggressive phenotype (triple negative, HER2 amplification) between initial and latter diagnosis.
If this phenomenon is a result of previously given chemo/radio-therapy or it reperesents the natural evolution to a second primary, remains a challenging question to be answered.
Citation Information: Cancer Res 2010;70(24 Suppl):Abstract nr P6-10-06.
Abstract P6-11-10: Full-Oral, Metronomic Schedule of Vinorelbine (VNB) and Capecitabine (CAPE) in Locally Advanced or Metastatic Breast Cancer (BC) Patients (Pts): A Single Institution, Dose-Finding Study
Authors: Cazzaniga ME , Torri V , Villa F , Giuntini N , Zeppelini A , Cortinovis D , Bidoli P. 
Published: April 2011

Abstract
BACKGROUND: Choice of chemotherapy is a major problem in locally advanced (LABC) or metastatic BC pts already treated with anthracyclines and taxanes, or not suitable for these drugs. VNB and CAPE are two valid options, both tested as single agents or in combination in this setting of pts. Different studies have demonstrated that the metronomic treatment could achieve a significant rate of clinical response with an acceptable toxicity profile. Based on the results of metronomic Phase I/II trial, which fixed the dose of VNB at 60 mg/tot thrice a week and considering that the two drugs have a different safety profile, we designed a dose-finding study, aiming to determine the optimal dose of oral VNB in combination with CAPE, both administered in a metronomic way. PATIENTS AND METHODS: Fixed dose of CAPE was 500 mg thrice a day, continuously. Level I dose of VNB was 20 mg/tot, three times a week for 3 weeks (1 cycle); subsequent cohorts started with 30 mg/tot Level II), 40 mg/tot (Level III) and 50 mg/tot (Level IV), respectively, if no Grade 3-4 toxicity was observed in the same dose level of the previous cohort.
Results: Twelve consecutive pts were enrolled. Median age was 67.5 years (49-81), 4 pts were LABC or metastatic at diagnosis, HR status was positive in 11/12 pts (91.6%), 2 pts were HER2+ but could not or no longer receive antiHER2 agents due to cardiac failure. All pts but 2 (83.3%) received anthracyclines, taxanes or both. Mean number of metastatic sites was 3 (1-5). At the 50 mg level of dose, 1 pt developed G3 neurological toxicity during the 3rd week of cycle 1 and 1 pt G4 neutropenia in the 2nd week of cycle 2. No pts treated with the 40 mg level of dose experienced G3 toxicity. The Maximum Tolerated Dose (MTD) was fixed at 40 mg thrice a week.
CONCLUSION: MTD of metronomic full-oral schedule of VNB in combination with fixed dose of CAPE was 40 mg thrice a week and was the recommended dose for the further ongoing Phase II study.
Citation Information: Cancer Res 2010;70(24 Suppl):Abstract nr P6-11-10.
Abstract P6-11-11: Trastuzumab beyond Progression in HER2-Positive Advanced Breast Cancer: The Royal Marsden Experience
Authors: Waddell T , Kotsori A , Constantinidou A , Yousaf N , Ashley S , Parton M , Johnston S , Smith I. 
Published: April 2011

Abstract
Background: Routine clinical practice and a growing body of evidence support the continuation of trastuzumab (T) in patients with HER-2 positive (+ve) advanced breast cancer progressing on previous T-based therapy. Despite this, recent UK clinical guidance advises against continuing T on evidence of disease progression (PD) in the absence of brain metastases. This retrospective study therefore evaluated the outcome of patients (pts) with HER-2+ve locally advanced (LA) or metastatic breast cancer (MBC) who continued T beyond PD, treated in our Unit. Patients and methods: HER-2+ve pts receiving T for LA or MBC were identified from our prospectively maintained database and pharmacy records. Those receiving T beyond PD after adjuvant or one line of T for advanced disease were assessed for response and outcome. From thetimepoint of T continuation beyond PD we calculated the overall disease control rate (response or stable disease), time to progression (TTP), and overall survival (OS).
Results: 114 pts with HER-2+ve LA or MBC treated with T beyond PD were identified. At the time of analysis 35 (31%) pts were still alive with a median follow up of 20 months (mo). The main site of disease was visceral in 84 (74%) pts, including 37 (32%) pts with CNS involvement. 30 (26%) pts had soft tissue or bone metastases only. Fifty nine (52%) pts had received adjuvant chemotherapy and 13 (11%) pts had received adjuvant T. Seventy six (66%) pts had 1 line of chemotherapy prior to continuation of T beyond PD and 21 (19%) had 2 or more lines. Fifty three (46%) pts had previously received taxanes + T for their LA or MBC. Post-progression, 66 (58%) pts received T combined with chemotherapy; 12 (11%) taxane-based, 32 (28%) capecitabine and 22 (19%) vinorelbine. Information regarding response was not available in 21(18%) pts. Of the ninety three (82%) pts with documented clinical (n=16) or radiological (n=77) response evaluation, 68 (60%) pts were considered as having stable disease (SD) or better and 25 (22%) as having PD. The median duration of T was 10 mo (95% CI: 8-11 mo), the median TTP was 24wks (95% CI: 21-28 wks) and the median OS was 19 mo (95% CI:12-24mo). In a sub-group analysis of the 81(71%) pts who received T as first-line Rx or relapsed within 12 wks of adjuvant T, overall disease control was achieved in 50 (61%) pts, the median TTP was 25wks (95% CI:18-33 wks) and the median OS was 22 mo(95% CI:17-27mo). In terms of safety, only 6 (5%) pts overall had to discontinue T secondary to decline in left ventricular ejection fraction.
Conclusion: Our results from an unselected group of patients are supported by positive results from other studies and provide additional evidence that continuation of trastuzumab beyond disease progression is of clinical benefit.
Citation Information: Cancer Res 2010;70(24 Suppl):Abstract nr P6-11-11.
Abstract P6-11-14: Long-Term Disease Control with Vinorelbine, Cisplatin and Continuous Infusion of 5-Fluorouracil -ViFuP Regimen-in Metastatic Triple Negative Breast Cancer Patients
Authors: Sciandivasci A , Munzone E , Aurilio G , Adamoli L , Botteri E , Locatelli M , Esposito A , Minchella I , Cullura’ D , Curigliano G , Goldhirsch A , Nole’ F. 
Published: April 2011

Abstract
Background: Triple negative breast cancers (TNBCs) are characterized by lack of estrogen, progesterone, HER-2-neu receptors expression and comprise 15% to 20% of all breast cancers. Studies have suggested that
TNBCs may be more sensitive to DNA damaging agents like cisplatin. Our previous experience had identified a combination chemotherapy -the ViFuP regimen-with noteworthy efficacy and safety as a first or subsequent line treatment for metastatic breast cancer (MBC) patients (pts). In this view we retrospectively examined the activity of ViFuP regimen in 2 cohorts (A and B) of metastatic TNBC pts.
Material and Methods: From January 2000 to December 2008, 115 pts with MBC were treated with ViFuP regimen, at the European Institute of Oncology, Milan, Italy. Among these, 35 pts (30%) had TNBC. Pts received continuous infusion 5-fluorouracil 200 mg/m2/day, vinorelbine 20 mg iv on days 1 and 3 and cisplatin 60 mg/m2on day 1. Therapy was given every three weeks. In A 22 pts (63%) were triple negative on primary tumor and in B 13 pts (37%) were triple negative in metastatic site. Median age was 54 years (range 35-73), 11 pts (31%) were pre-treated for MBC and 21 pts (60%) had ≥3 metastatic sites.
Results: Thirty three pts were evaluable for response and 34 pts were assessable for toxicity. Median duration of treatment was 3.57 months (range 1-5.7). Four pts (12%) had complete responses, 14 pts (42%) had partial responses and 11 pts (33%) had stable disease with a clinical benefit (CB) of 73% (95% CI, 55%-87%). Four pts (12%) had progressive disease. Median time to progression was 6 months (95% CI, 5-8 months). Main toxicity was haematological with 62% of the pts showing grade 3/4 leuco-neutropenia. Alopecia was almost absent.
Discussion: Treatment with ViFuP regimen was effective and safe in metastatic TNBC providing long-term disease control in a high proportion of pts. The prolonged CB supports this regimen as an additional therapeutic opportunity in this category of pts.
Citation Information: Cancer Res 2010;70(24 Suppl):Abstract nr P6-11-14.