bluuebunny/crossref_metadata_2025_split huggingface dataset:
Abstract P5-11-06: Impact of Educational Material on Compliance and Persistence Rates with Adjuvant Aromatase Inhibitors: First Year Data in Patients Recruited in France (CARIATIDE STUDY)
Authors: Serin D , Clippe S , Resbeut M , Radji A , Jovenin N , Benoit C , Spaeth D , Puyuelo L , Jaubert D , Cowen D , Ferrero J-M , Marty M , Buyse M , El Amiri H , Piedbois P. 
Published: April 2011

Abstract
Rationale: Issues have been reported with aromatase inhibitors (AI) compliance in adjuvant breast cancer. The present study was performed in order to better assess patient (pt) compliance, and to test whether educational material (EM) can improve compliance rate. Methods: This 2-year observational study (NCT00681122) was conducted on 2,758 patients in 18 countries, and completed in March 2009. Pts were allocated to Standard Therapy AI (anastrozole or letrozole), Group A, or to Standard Therapy + EM (Group B) following a 1:1 randomisation. EM consisted of a range of information on breast cancer-related topics. Primary endpoint was compliance rate for AI: patient is defined as being compliant if she took more than 80% of her tablets during the last year. Secondary endpoints were: persistence rate at 1 and 2 years (patient is classified as a persistent user of adjuvant AI medication when the data supports the persistent intake of adjuvant AI medication during the one-year period), and reasons for and time to AI discontinuation. Specialised questionnaires were used to evaluate pt compliance and behaviour (EORTC-INPATSAT-32, OPTIMA-X, GHQ-12, FACT-ES, compliance questionnaire and EM feedback in Group B).Results: 711 pts were randomised in France, 348 in Groupe A and 363 in Groupe B. Pt characteristics were well balanced across randomised arms. Mean age was 65 years, mean BMI was 26, 20% of pts had received hormone replacement therapy, and 68% had associated co-morbidities, including musculoskeletal disorders in 12%. Preliminary analysis showed that compliance rate at 1 year was only 74%, with no difference between the 2 groups (73% in Group A vs. 74% in Group B).
Persistence rates were also similar (77% vs.78%). AI discontinuations were mainly attributed to AI related side effects. Prognostic factor analysis showed no baseline characteristics associated with compliance behaviours.Conclusion: At 1 year, Cariatide preliminary analysis showed that compliance rate of adjuvant AI in France does not exceed 74%, and is not improved by EM.
Citation Information: Cancer Res 2010;70(24 Suppl):Abstract nr P5-11-06.
Abstract P5-11-13: Tamoxifen and Ovarian Function
Authors: Berliere M , Dalenc F , Piquard N , Leconte I , Fellah L , Baurain J-F , Galant C , Duhoux F , Machiels J-P. 
Published: April 2011

Abstract
Background: to study and compare ovarian function (clinical and biological data) among premenopausal breast cancer patients receiving tamoxifen alone (group I) or tamoxifen following chemotherapy (group II), because some studies suggest that amenorrhea is an insufficient parameter to define menopausal status.
Material and methods: between 1999 and 2003, 138 premenopausal patients, treated for early breast cancer, were included: 68 patients in the group of tamoxifen alone and 70 patients in de group of tamoxifen administered after chemotherapy (6 cycles of FEC 100 on day 1 every 3 weeks -5 fluorouracil 500 mg/m2, epirubicin 100 mg/m2 and cyclophosphamide 500 mg/m2- or 4 cycles of EC on day 1 every 3 weeks -epiadriamycine 75 mg/m2, cyclophosphamide 500 mg/m2-). All patients had a confirmed premenopausal status (biological data) at the entry of the study. The median age in group I was 44.5 (36 to 48) and 42 in group II (35 to 47.5). In group I, all were stage I and in group II, 34 were stage I and 36 were stage II. They were followed prospectively every 3 months for 3 years: date about menses, physical examination and blood tests (LH, FSH, 17-bêta-estradiol). Vaginal echography was added every 6 months. After 3 years, prospective evaluation was closed. Retrospective evaluation of all data was performed in 2009.
Results: three patients were out of study in the group I and 2 were out of study in the group II. According to clinical data, patients were devided in 4 subgroups:
a: regular menses (≥10 cycles/year) b: spaniomenorrhea (5 to 9 cycles/year) c: severe spaniomenorrhea (1 to 4 cycles/year) d: complete amenorrhea.
The number of patients in each subgroup is respectively:
- For group I (65 patients): 3 (4%), 19 (29%), 38 (58%) and 5 (8%).
- For group II (68 patients): 2 (3%), 21 (30%), 38 (55%) and 7 (10%). The most interesting parameter to be studied wass the estradiol levels.
Median values of estrogen levels
For patients of subgroup a, tamoxifen mimicked an ovulatory cycle such as observed in patients receiving citrate of clomifen. For patients of subgroup b, the variations corresponded to nearly a normal ovulatory cycle. For patients of subgroups c and d, tamoxifen induced low levels of estradiol, LH and FSH, and very few variations. Estrogen levels did not to seem have an impact on disease free survival rate after 3 years of follow-up (100% in group I and 98.6% in group II and after 5 years (98.5% and 97%). In the two groups I and II, estrogen levels from patients of subgroups a and b were significantly higher than in subgroups c and d (p &lt; 0.001). Conclusion: amenorrhea is an insufficient parameter to define menopausal status of patients receiving tamoxifen. Low estradiol level must be coupled to other biological parameters to characterize endocrine status. These data are very important in the choice of endocrine therapy.

Citation Information: Cancer Res 2010;70(24 Suppl):Abstract nr P5-11-13.
Abstract P5-12-02: Long Term Cardiac Toxicity after Adjuvant Trastuzumab for Early Breast Cancer: Implications for Life-Expectancy and Cost-Effectiveness
Authors: Hall PS , McCabe C , Plummer CJ , Cameron DA. 
Published: April 2011

Abstract
Introduction: Trastuzumab has significantly improved survival outcomes for women with HER2 over-expressing early breast cancer. Observed short term cardiac toxicity appears reversible in the majority of cases and confidence in the long term safety is growing. Despite this, reported follow-up from adjuvant trastuzumab clinical trials does not extend beyond six years. If trastuzumab causes myocardial cell death with loss of cardiac reserve in addition to reversible myocardial stress alone, this may lead to an increased long term risk of congestive heart failure (CHF). The future incidence of this possible late cardiac toxicity remains uncertain. The aim of this study is to quantify the consequences of scenarios of late cardiac toxicity on the survival benefit and cost-effectiveness of adjuvant trastuzumab for women treated for HER2 over-expressing early breast cancer.
Methods: A cost-utility analysis was performed using a discrete-state time-dependent semi-Markov model to calculate expected costs and benefits over the lifetime of an average cohort of women with HER2 over-expressing early breast cancer when treated with or without one year of adjuvant trastuzumab. The perspective was the UK NHS. Scenarios across the full range of possibility were explored along with estimates based on expert opinion to determine the impact of possible long-term cardiac toxicity on life-expectancy, quality of life and treatment costs. Probabilistic sensitivity analysis was used to characterise uncertainly around expected outcomes.
Results: With a willingness-to-pay threshold of £30,000 (GBP) per quality adjusted life-year, trastuzumab is cost-effective if the lifetime increased risk of CHF is no more than three times the average level expected in an anthracycline treated population of women diagnosed with HER2 overexpressing early breast cancer (figure 1). Life-expectancy gains from using adjuvant trastuzumab persist even if there is a high consequent lifetime risk of congestive cardiac failure (figure 2). Conclusion: The use of adjuvant trastuzumab remains the optimal clinical and economic treatment strategy even if its use leads to moderately increased levels of cardiac disease in later life. This study supports current confidence in its cost-effectiveness and safety. Long-term follow-up after current and future adjuvant breast cancer trials is essential in to reduce the uncertainty around these estimates.

Citation Information: Cancer Res 2010;70(24 Suppl):Abstract nr P5-12-02.
Abstract P5-13-08: Factors Affecting Delivery of Planned Chemotherapy for Breast Cancer in Older Women
Authors: Ngamphaiboon N , Edge SB , Groman A , Wilding GE , Ademuyiwa F , Levine EG , Watroba N , O'Connor TL. 
Published: April 2011

Abstract
Background: Recent studies suggest that older women derive the same benefits from adjuvant systemic chemotherapy (AST) as younger women. In older women, the ability to successfully complete chemotherapy may be complicated by other health conditions and performance status. This study examines the frequency of inability to complete planned AST and factors associated with difficulty administering AST in older women.
Methods: We performed a retrospective analysis of breast cancer patients (age≥65) who received adjuvant/neoadjuvant chemotherapy at Roswell Park Cancer Institute from 9/1997 to 1/2010. Endpoints considered collectively as “difficulty “ in delivering AST were delay in treatment, hospitalization, dose reduction and discontinuation of AST. Factors defined a priori that could affect these outcomes were creatinine clearance (CCr), obesity (BMI ≥30), cardiac disease, hypertension, psychiatric disorders, diabetes, cerebrovascular disease, previous malignancy, COPD/asthma, Charlson comorbidity index, and use of anthracycline-based chemotherapy. The Pearson chi-squared test was used to identify the significant categorical factors associated with each of the five binary responses indicating difficulty administering AST. Logistic regression was used to obtain crude and adjusted odds ratios to further examine the relationships. Kaplan-Meier methods were used to estimate survival distributions, progression free and overall survival. The log-rank test was used for comparison between women experiencing difficulty with treatment and those with no difficulty with treatment. A 0.05 nominal significance level was used in all testing. Statistical analysis and plots were completed using SAS, version 9.2, statistical software (SAS Institute Inc., Cary, NC).
Results: 193 women age 65 and over received AST (median age of 70 years - range 65-86). Median follow up was 40.9 months. 73% received anthracycline-based AST. Factors associated with difficulty, delay, dose reduction, hospitalization, or failure to complete planned AST are shown in the Table. Women who completed planned AST had better OS than those who did not complete AST (p=0.01). Women who completed therapy with difficulty had no difference in outcome compared to those without difficulty [DFS (p=0.07) and OS (p=0.18)].
Conclusions: Age, cardiac disease, diabetes, hypertension, CCr, obesity, CCI, and sum of comorbidity significantly impact the ability to deliver and complete AST in older women with BC. Completing planned chemotherapy is associated with improved survival.
Figures available in online version.

Citation Information: Cancer Res 2010;70(24 Suppl):Abstract nr P5-13-08.
Abstract P5-14-06: Relationship between Surgery and Survival in Elderly Breast Cancer Patients over 75 Years of Age
Authors: Dordea M , Jones R , Pujol Nicolas A , Sar S , Batson S , Fetherston A , Truran P , John S , Iwuchukwu O. 
Published: April 2011

Abstract
Background: There is an increasing interest in the reporting of breast cancer characteristics, treatment and survival in the elderly age group (&gt;75). Studies suggest that elderly women receive less aggressive treatment, experience higher disease progression and mortality from breast cancer. We report on a single institutional experience of 256 consecutive cases of symptomatic breast cancer in a population of over 75 years of age. Methods: We undertook a retrospective review of 256 consecutive cases of breast cancer in patients over the age of 75 treated at the Sunderland Royal Hospital between August 1998 and August 2005. Therapeutic/surgical decision was a joint affair involving our multidisciplinary team, the patient and her family. Patient demographic data, tumour biology data, therapeutic data and outcome data were recorded. Statistical analysis was performed by the Newcastle Industrial Statistics Unit. Results: 142/256 patients underwent surgical intervention, 114/256 did not. Mean follow up was 6.4 years. The findings as well and their statistical significance are illustrated below:
Physiological reserve, treatment and outcomes
Table 1
Our results show a weak but statistically significant association between surgery and survival (p=0.05, CI 0.00046 - 0.19641) and a strong statistically significant association between surgery and disease progression/recurrence (p=0.001, CI 0.08713 - 0.03145). The morbidity of our surgical group is low. We experienced one postoperative death.
Discussion: We are cautious in affirming that our elderly group suffers from under treatment. There may be reasons for the observed pattern. Apart from a discrepancy in our axillary staging procedures (15/142), all suitable patients received adjuvant radiotherapy. Adjuvant chemotherapy was omitted in most cases, however this may be the result of multidisciplinary decisions guided by AdjuvantOnline calculations and patient's wishes. Women in the group treated conservatively are significantly less fit hence suffering high cancer unrelated mortality. As a consequence of their unfitstate the elderly group (treated conservatively) suffers higher disease related progression and mortality.
Overall, in our retrospective study surgical treatment with adjuvant endocrine and/or radiotherapy was associated with a statistically significant advantage in terms of disease related mortality and local disease control. We suggest that treatment pathways should be guided by physiological reserve and geriatric assessment tools rather than age alone.

Citation Information: Cancer Res 2010;70(24 Suppl):Abstract nr P5-14-06.
Abstract P5-15-03: Patient Characteristics and Clinical Outcome of Patients with Secondary Inflammatory Breast Cancer. M.D. Anderson Cancer Center, Retrospective Review
Authors: Alvarez RH , Cristofanilli M , Hsu L , Ueno NT , Alizadeh PA , Lucci A , Reuben JM , Buchholz TA , Hortobagyi GN , Valero V. 
Published: April 2011

Abstract
Background: Inflammatory breast cancer (IBC) is the most aggressive form of breast cancer accounting for 1 to 5% of all breast cancers (BC). Secondary inflammatory breast cancer (S-IBC) is the development of inflammatory breast cancer clinical featurs such erythema, edema or skin changes that mimic IBC in either a breast that already had cancer or contralateral previously unaffected breast. (Dawood S, 2008). Currently there are sparse available data to help determine whether S-IBC differs from the P-IBC. The purpose of this analysis was to evaluate the clinical outcomes of pts with S-IBC.
Methods: This is a retrospective analysis from prospective M.D. Anderson Cancer Center (MDACC) database that includes 522 pts with P-IBC and 44 pts (8.5%) with S-IBC treated between 1988 and 2009 at MDACC.
Results: Median age of the S-IBC pts was 54 years (range 25-75); 33 pts (75%) were postmenopausal; 21 pts (47.7%) had hormone-receptor negative and 9 pts (20.5%) HER-2/neu-amplified. 32 pts (72.7%) had S-IBC stage III and 12 pts (27.3%) stage IV disease. The median interval to develop S-IBC from the primary BC was 147 months (mo) (range 4-310). In a cohort of 13 pts with primary BC who received no radiation therapy (RT) all (100%) pts developed S-IBC in the contralateral breast. Among the 33 pts with primary BC who received RT, 13 pts developed ipsilateral S-IBC whereas the remaining 20 pts developed contralateral S-IBC (p = 0.013). Comparing the S-IBC cohort with the P-IBC cohort, we found the rate of pCR to be higher in P-IBC than in S-IBC (13.6% vs. 3.1%; p = 0.09). Both cohorts had similar distribution in race, menopausal status, hormone-receptor and, HER2 status, and nuclear grade. Moreover, the median PFS was 28.4 mo vs. 22.1 mo. for P-IBC and S-IBC, respectively (p = 0.31). The median OS was 59.5 mo and 53.2 mo for P-IBC and S-IBC, respectively (p = 0.17). In a Cox multivariate analysis of the S-IBC cohort, after adjusting for age, ER/PR-status, LVI, nuclear grade and pCR, HER2/neu-amplified disease was associated with shorter RFS (HR 2.19; CI 0.87-5.50; p = 0.001) and the ER-positive group was associated with a marginal increase in overall survival (HR 0.18; CI 0.03-1.02; p = 0.05). Conclusion: In this retrospective analysis, S-IBC was associated with a lower rate of pCR but with similar RFS and OS compared with P-IBC.
Citation Information: Cancer Res 2010;70(24 Suppl):Abstract nr P5-15-03.
Abstract P5-15-06: Evaluation of Treatment of Primary Early Breast Cancer in the Elderly
Authors: Visser RPJ , Faneyte IF , Heymans HJ , Kouwenhoven EA. 
Published: April 2011

Abstract
Background: National guidelines for treatment of breast cancer are not applicable for the frail elderly. Treatment should be individualized for these patients.
Aim: Evaluation of treatment of the elderly (aged 70+) patient with primary early breast cancer: breast conservative surgery (BCS), guideline adherence and differences in (all cause and cancer specific) mortality risk and survival.
Materials and Methods: female patients with stage cT1-2N0-1 primary breast cancer, diagnosed from January 2002 - December 2008 were included in this retrospective analysis. Treatment was compared with national guidelines. Age categories were made for 80-plus, 70 to 80 and 70-minus. Differences in tumor biology and treatment were evaluated using X2- tests, differences in Hazard ratio using Cox-regression analysis and differences in survival using Kaplan-Meier analysis. Results: 1569 patients were included. Divided by age: 80 and up (n=148), 70 to 80 (n=256), 70 and below (n=1165). Median time of follow-up was 48 (1-99) months.
Tumor characteristics: there was no significant differences between patients aged 70 and up and below 70 for ER/PR status, Her2neu status, tumor grade and pathologic tumor size. There were significant differences for axillary lymph node involvement (pN0: 66,6% vs 56,6%, p=0,004) and tumor morphology (68,0% vs 77,8% ductal carcinoma, P&lt;0,001). Comparison of treatment: 80+ vs 70-80 vs 70-, BCS: 29,6% vs 57,9% vs 55,7% (P&lt;0,001 for 80+ vs 70-80), treatment according to guidelines: 38,9% vs 81,3% vs 93,3% (P&lt;0,001 for 80+ vs 70-80 vs 70-), surgical treatment: 54,3% vs 96,1% vs 99,5% (P&lt;0,001 for 80+ vs 70-80 vs 70-), radiotherapy following BCS: 56,5% vs 96,3% vs 98,4% (P&lt;0,001 for 80+ vs 70-80), adjuvant systemic therapy when indicated: 73,2% vs 68,9% vs 90,1% (P&lt;0,001 for 70-80 vs 70-).
Hazard Ratio for mortality: ages 80 and up: individualized vs guideline-adhered all cause HR = 1,903 (P&lt;0,001). Cancer specific HR = 0,601 (p = 0,431). Ages 70-80: individualized vs guideline-adhered HR = 3,184 (p &lt;0,001). Cancer specific HR = 2,842 (p = 0,083). 5-year all-cause survival: ages 70 and up vs 70-: 64% vs 91%, log rank P&lt;0,001 (fig.1). 5-year cancer specific survival: ages 70 and up vs 70-: 91% vs 94%, log rank p = 0,064 (fig.2). Conclusion: Individualized treatment was frequent in elderly breast cancer patients, especially in patients aged 80 and up. While overall survival was significantly lower for septuagenarians, there was no significant difference in cancer specific mortality and survival.
Figures available in online version.

Citation Information: Cancer Res 2010;70(24 Suppl):Abstract nr P5-15-06.
Abstract P6-01-01: Risk of Invasive Breast Cancer and Ductal Carcinoma In-Situ in Women with Atypical Papillary Lesions of the Breast
Authors: Cuneo KC , Dash RC , Wilke LG , Koontz BF. 
Published: April 2011

Abstract
Background: Benign papillary lesions of the breast including papilloma and papillomatosis are believed to be associated with a low risk of developing breast cancer. The risk of breast cancer development in patients who have an atypical papilloma or who have a papilloma in conjunction with atypical hyperplasia is not well defined.
Methods: All patients who underwent a biopsy at Duke University Medical Center between October 1992 and December 2009 for a papillary lesion of the breast were identified. Patients were excluded if they had a previous or concurrent diagnosis of invasive or in-situ malignancy or less than 6 months of follow up. The remaining patients were analyzed to determine the risk of developing breast cancer.
Results: Median follow up for the 167 patients with a papillary lesion of the breast included in the analysis was 4.6 years. 51 patients had an atypical papillary lesion. 111 patients had atypical hyperplasia in conjunction with a papilloma. 35 patients had a papilloma without atypia or atypical hyperplasia. Patients with an atypical papilloma were more likely to develop an invasive or in-situ breast cancer with a 5 year actuarial risk of 13.0% (24 patients at risk) versus 4.6% (49 patients at risk) (p=0.03). Patients who had atypical hyperplasia in conjunction with a papilloma were also more likely to develop invasive or in-situ breast cancer with a 5 year actuarial risk of 9.8% (48 patients at risk) versus 0% (15 patients at risk) (p=0.05). In the group with an atypical papillary lesion, the actuarial risk of ipsilateral breast cancer or DCIS development was 8.2% at 5 years (24 patients at risk) and 21.1% at 10 years (12 patients at risk). In the group with atypical hyperplasia in conjunction with a papilloma, the actuarial risk of ipsilateral breast cancer development was 3.9% at 5 years (48 patients at risk) and 8.5% at 10 years (18 patients at risk). The majority of patients underwent an excisional biopsy for their papilloma (150 patients). Patients who had a core needle biopsy alone had a 5 year actuarial risk of ipsilateral breast cancer or DCIS of 15.3% versus 2.0% for patients who had an excisional biopsy (p=0.03). All of the patients who had only a core biopsy and later developed an ipsilateral cancer or in-situ disease had an atypical papilloma.
Discussion: Papillary lesions of the breast with atypical features may be associated with an increased risk of breast cancer and DCIS. Atypical papillary lesions should be fully excised or followed closely.

Citation Information: Cancer Res 2010;70(24 Suppl):Abstract nr P6-01-01.