bluuebunny/crossref_metadata_2025_split huggingface dataset:
P5-17-03: The Association between Breast Cancer Related Lymphedema's Risk Factors and Likelihood of Edema Progression.
Authors: Skolny MN , Miller CL , O'Toole J , Sadek B , Ancukiewicz M , Taghain AG 
Published: June 2012

Abstract
Purpose/Objective(s): Breast cancer related lymphedema (BCRL) is one of the most feared long term side effects of treatment. Although emergence of the sentinel lymph node biopsy (SLNB) has decreased the rate of BCRL, it continues to be an issue for this population. The goal of this study is to evaluate the prognostic risk factors for BCRL development and progression based on longitudinal prospective limb volume (LV) measurements and associated surgical, radiation and medical oncology factors.
Materials/Methods: Since 2005 newly diagnosed breast cancer (BC) patients were prospectively screen via perometery (Pero-System). For this analysis patients were required to have undergone at least four measurements and have at least 24 months of follow up to allow for adequate time for LE development. Bilateral pre-operative volume measurements of the upper extremity were compared to postoperative measurements and at 4 to 6 month intervals to assess for limb volume changes. At each time point (tx), relative volume change (RVC) of the treated arm was calculated using volume ratios of treated (T) to non-treated (N) side compared to the pre-operative baseline (t1) (RVC=(Ttx/Ntx)/(Tt1/Nt1)-1) as described in Ancukiewicz et al 2010. Our institution utilizes &gt;5% RVC as an indicator of lymphedema. For this analysis, mild lymphedema was classified as a RVC of 5–9.9% and moderate lymphedema was classified as a RVC ≥ 10%. A univariate analysis was performed to identify risk factors and likelihood to LE progression.
Results: In a cohort of 415 women, 14.4 %(60) and 6.7% (28) developed mild and moderate BCRL, respectively. Twenty percent (14) and 75 %(21) of patients in the mild and moderate cohorts, respectively, had a persistent edema that was documented at a least 2 consecutive data points. Eighty percent (56) and 25% (7) of patients that had a documented incidence of an elevated RVC had returned below an RVC&lt;5% and their subsequent visits. Based on Kendall's Tau P-value of &lt;0.0001 persistent edemas were associated with axillary lymph node dissection (ALND), number of lymph nodes removed, axillary fields and dose of radiation.
Conclusion: Breast cancer related lymphedema is a feared long term side effects and negatively impacts the physical and psychological aspects of an individual's life. A condition that is considered manageable but not curable, it is essential providers identify high risk individuals. Establishing a a lymphedema screening program may identify early lymphedema which could be potentially be treated successfully.
Citation Information: Cancer Res 2011;71(24 Suppl):Abstract nr P5-17-03.
P5-17-04: Association between Breast Cancer and Osteoporosis among Women 85 Years or Older.
Authors: Okanami Y , Honma N , Arai T , Sawabe M , Maeda I , Takagi M , Younes M , Takubo K 
Published: June 2012

Abstract
Background: The pathogenesis of breast cancer in very elderly women is of interest, because estrogen levels are likely to be extremely low during the development of the disease. Estrogens have opposing effects on the pathogenesis of breast cancer and osteoporosis. In an effort to understand the significance of estrogens in the pathogenesis of breast cancer in this group, we examined the association between breast cancer and osteoporosis in women at least 85 years old, taking body mass index (BMI) and hormone receptors status into consideration.
Methods:Clinical records of consecutive elderly women (≥ 85 y/o) who underwent breast cancer surgery at Tokyo Metropolitan Geriatric Hospital (BC) and control women of the same age group (Cont) were reviewed; osteoporosis and BMI status in both groups were recorded and compared. The status of estrogen receptor (ER) and progesterone receptor (PR) of breast cancers was examined immunohistochemically and compared between BC with and without osteoporosis (BC-OP and BC-nonOP, respectively).
Results:Frequency of osteoporosis was significantly lower among BC than Cont. There was no difference in BMI measured after 85 y/o between BC and Cont; however, percentage of women, whose BMI measured when they were in their sixties or seventies was ≥ 20% higher than BMI measured when they were 85 y/o or older, was significantly higher among BC than Cont (31% and 2%, respectively. P = 0.0001). ER positivity of breast cancer did not differ between BC-OP and BC-nonOP, whereas PR positivity was significantly higher among BC-nonOP than BC-OP (P = 0.0359).
Discussion: The inverse relationship between the incidence of breast cancer and osteoporosis suggests an important role for estrogens in the pathogenesis of breast cancer in the very elderly women. Our finding that one third of BC had ≥ 20% higher BMI when they were in their sixties or seventies suggests they may also had elevated serum estrogens during these earlier years, because increased BMI has been reported to be associated with increased serum estrogens in postmenopausal women. Expression of PR is regulated by estrogen-ER signaling, and PR positivity is considered to reflect the effectiveness of estrogen-ER pathway. Significant difference of PR positivity between BC-nonOP and BC-OP suggests the more importance of estrogens in BC-nonOP than BC-OP.
Conclusion:Estrogens seem to play an important role in the pathogenesis of breast cancers in very elderly women, especially without osteoporosis. With increasing aging population in developed countries, those findings may have implications for breast cancer prevention in this age group.
Citation Information: Cancer Res 2011;71(24 Suppl):Abstract nr P5-17-04.
P5-19-06: Highly Effective of Gemcitabine and Cisplatin (GP) as First-Line Combination Therapy in Patients with Triple-Negative Metastatic Breast Cancer: Final Report of a Phase II Trial.
Authors: Wang Z , Hu X , Wang B , Wang L , Zhang J , Wang H , Liu G , Hu Z , Wu J , Shao Z 
Published: June 2012

Abstract
Background
Triple-negative breast cancer (TNBC) contributes to poor prognosis and there is no established standard chemotherapy this subtype of patients. It has been postulated that related cancers would confer sensitivity to certain cytotoxic agents like cisplatin. Cisplatin and gemcitabine have single-agent activity in metastatic breast cancer and preclinical data support synergy of the combination. The objective of this study was to evaluate doublet with gemcitabine/Cisplatin (GP) as first-line therapy in patients with metastatic TNBC.
Material and Methods: This is a prospective single-institutional, open-label, phase II trial. The primary endpoint was progression free survival (PFS). Eligible subjects were aging from 18 to 75 years old, with no prior chemotherpay for MBC, with tumors negative for ER, PR or HER2, with at least one measurable disease according to the RECIST criteria, with ECOG PS of 0–1, and with adequate organ function. All patients received 21-day cycles of gemcitabine 1,000mg/m2 on days 1 and 8 and cisplatin 25 mg/m2 on days 1 through 3. Treatment was continued until disease progression or unacceptable toxicity or up to 8 cycles. (ClinicalTrials.gov number, NCT00601159)
Results: A median age was 49 years (range: 29–74 years). 58 patients had received neo/adjuvant chemotherapy (53 patients with anthracycline and/or taxane). The median number of treatment cycles was six (range: 2–8 cycles). In 64 assessable patients, we observed 10 complete response (CR; 15.6%), 30 partial responses (PR; 46.9%), 17 patients (26.6%) with stable disease (SD), and 7 patients (10.9%) with progressive disease, for an overall response rate of 62.5% (95% CI, 50.3% to 74.7%)..*** The median PFS was 7.7 months (95% CI, 6.0 to 9.4). With a median follow-up time of 28 months, the median overall survival was 19.1 months (95% CI, 12.5 to 25.7). Grade 3 or 4 toxicities were neutropenia 42.2%, thrombocytopenia 29.7%, anemia 18.8%, nausea/vomiting 15.6%, fatigue 14.1%, constipation 3%, sensory neuropathy 1.6%, 2 patients developed febrile neutropenia. The chemotherapy doses were reduced in 13.3% (6 pts) because of toxicity. There were no treatment-related deaths.
Conclusion: Significant activity and favorable toxicity profile of GP regimen as first-line chemotherapy in patients with metastatic TNBC. It provided a basis for considering GP for further evaluation in phase III trials for women with metastatic TNBC in China. (ClinicalTrials. gov number, NCT01287624)
Citation Information: Cancer Res 2011;71(24 Suppl):Abstract nr P5-19-06.
P5-21-02: The Susan G. Komen for the Cure® Tissue Bank at the IU Simon Cancer Center: The Source for Normal Breast Tissue and Biospecimens.
Authors: Clare SE , Mathieson T , Henry JE , Zhang H , Way ES , Ridley KE , Badve S , Herbert B-S , Rufenbarger CA , Storniolo AMV 
Published: June 2012

Abstract
Background
Our efforts to prevent and treat breast cancer are significantly impeded by a lack of knowledge of the biology and developmental genetics of the normal mammary gland. This ignorance has been the consequence of the lack of access to richly annotated, high quality normal breast specimens. The Susan G. Komen for the Cure® Tissue Bank at the IU Simon Cancer Center (KTB) was established expressly to remedy this deficiency. The KTB is a repository of specimens from volunteer donors with no clinical evidence of breast malignancy. The Bank's mission is to make available specimens that will enable an understanding of the developmental biology of the normal breast, to provide insight into breast oncogenesis, and to provide a normal control for breast cancer research. The purpose of this presentation is to increase the awareness of this unique and rich research resource and to actively solicit the use of its specimens.
Methods: The KTB has been prospectively banking fresh frozen breast tissue since mid-2006. Coincident with the tissue donation two tubes of blood are obtained, which are processed for lymphocyte DNA, serum and plasma. These specimens are richly annotated with detailed information regarding the donors’ reproductive history, medical history, family history, and medications. Standard Operating Procedures have been constructed so as to control, limit and identify potential sources of bias. All of this information is recorded in an Oracle-based, searchable database.
Results: As of June 2011, the KTB and its predecessor bank, Mary Ellen's Bank, have available fresh frozen breast tissue (10 gauge cores) from 1469 donors; formalin-fixed, paraffin-embedded tissue from 1055; DNA from 7507; serum from 2382; and plasma from 3771 donors. The KTB has also established 28 epithelial and 33 stromal cell lines from the cores; 4 of the epithelial cell lines have been immortalized using hTERT. Donors range in age from 18–86 years of age. 9% of donors to the KTB describe themselves as Hispanic/Latino. 5.2% of donors are Black or African-American. Using the Gail Risk Model, there is a bimodal distribution of life-time breast cancer risk among the donors: the largest peak is at 10% and a smaller one at 18%.
Conclusions: The KTB is a unique and invaluable research resource which is now open for business and accessible to researchers across the globe. We encourage researchers to avail themselves of this unique tissue resource and to also acquaint themselves with other sources of healthy breast tissue, i.e., the Love/Avon Army of Women [http://www.armyofwomen.org/].
Citation Information: Cancer Res 2011;71(24 Suppl):Abstract nr P5-21-02.
P5-23-02: Clinicopathological Features of Young Patients Age &lt;35 Years with Breast Cancer in Japan.
Authors: Kataoka A , Tokunaga E , Masuda N , Shien T , Ohno S , Kinoshita T , Shimizu C 
Published: June 2012

Abstract
Background: The aim of this study is to clarify clinicopathological features of breast cancer in young women.
Materials and methods: Clinicopathological characteristics were compared between young (&lt;35) patients and non-young (≥35) patients among 109,617 records of JBCS database registered from 2004 to 2009, and overall survival (10-yr OS) were calculated among 146,690 records from 1975 to 2000 with 8.6 years of median follow up period. Results: Clinicopathological factors of 2,982 young patients (2.7%) were compared with 106,295 non-young patients. Young patients had more familial history of breast cancer, more subjective symptom, less bilateral tumor, lower BMI, larger tumor, more inflammatory breast cancer, more positive node, less ER-positive, more HER2−positive, more triple-negative tumor, and more advanced TNM-stage.
Comparison of clinicopathological factors between young and non-young patients with breast cancer

Young patients were received more neoadjuvant chemotherapy and breast conserving therapy (BCT), compared with non-young patients.
Comparison of treatments between young and non-young patients with breast cancer

Eighty-percent of patients were received adjuvant therapy, among them, treatment rate of chemotherapy, molecular targeted therapy and radiation therapy was significantly higher in young patients than non-young patients. There was significant difference in 10-yr OS between young and non-young patients with Stage I-IIIA disease (Stage I 80% vs. 90%, IIA 78% vs. 85%, IIB 67% vs. 78%, IIIA 42% vs. 64%), but not with Stage IIIB and IIIC. Advanced TNM stage, lymph node metastasis and ER-negative tumor were significantly poorer prognostic factors for young patients by univariate analysis. Approximately 9% of young patients were at pregnancy at the time of diagnosis had more advanced disease and worse prognosis.
Conclusions: We conclude that young patients with breast cancer have an advanced or an endocrine-unresponsive tumor and have unfavorable outcome. Advocacy for awareness of breast cancer to young women and development of new targeted therapy against advanced, HER2−positve and triple-negative tumor are important to improve the survival of young patients with breast cancer.
Citation Information: Cancer Res 2011;71(24 Suppl):Abstract nr P5-23-02.
PD06-04: Uptake and Economic Impact of First-Cycle Colony Stimulating Factor Use during the Adjuvant Treatment of Breast Cancer.
Authors: Hershman DL , Wilde ET , Wright JD , Buono DL , Kalinsky K , Malin J , Tsai WY , Neugut AI 
Published: June 2012

Abstract
Background: In 2002, pegfilgrastim was approved by the FDA and the benefits of dose-dense breast cancer(BC) chemotherapy were reported. A meta-analysis revealed these benefits were limited to hormone receptor negative tumors (20% risk reduction), where hormone receptor positive cancers had a minimal 2% risk reduction. We examined first-cycle growth factor use(FC-CSF) before and after 2002 and estimated US expenditures for dose-dense chemotherapy by hormone receptor status.
Methods: We identified subjects in SEER-Medicare&gt;65 years oldwith stage I-III BC between 1998 and 2005who had≥1 chemotherapy claim within one year of diagnosis. We classified those with an average cycle length &lt;21 days as having had dose-dense therapy. The associations of patient, tumor, and physician-related factors with receipt of any CSF and FC-CSF use were analyzed using GEE. Costs and event-free life-years saved were estimated for patients by HR status.
Results: Among the 11,143 patients identified, 5,356(48.1%) hada CSF claim during therapy and 2095(18.8%) had FC-CSF. CSF use increased from 25.4% to 70.9%, FC-CSF increased from 6.4% to 46.9% and pegfilgrastim increased from 5% to 85%. During this time receipt of the combination of an anthracycline and a taxane increased from 12% to 47%. In a multivariable analysis, any CSF use was associated with age, treatment by an oncologist, and chemotherapy type; and negatively associated with black/Hispanic race, rural residence and shorter chemotherapy duration. FC-CSF use was associated also with higher SES. For hormone receptor negative patients, the cost per event-free life year saved was $5,512, with annual costs of $19.5 million. For hormone receptor positive patients, however, there was no savings in life years (and therefore no relevant cost per event-free life year saved) with annual costs of $38.8 million for those over 65. The annual costs were estimated at $86.1 million for the hormone receptor positive patient population incorporating all ages.
Conclusions: Our study demonstrated a widespread increase in the use of CSF's and specifically first cycle pegfilgrastim in elderly women receiving adjuvant chemotherapy for breast cancer. This 4-fold increase came shortly after published reports of the benefits of dose-dense therapy. While this approach is very cost-effective in women with hormone receptor negative tumors, it has come at great financial cost in women with hormone receptor positive tumors who are less likely to have a meaningful benefit. In order to reduce the total costs of cancer-care, efforts should be made to ensure that these treatments are reserved for only those who benefit substantially from their use.
Citation Information: Cancer Res 2011;71(24 Suppl):Abstract nr PD06-04.
PD09-01: Target-Based Therapeutic Matching in Early-Phase Clinical Trials in Patients with Advanced Breast Cancer and PIK3CA Mutations.
Authors: Janku F , Moulder SL , Wheler JJ , Stepanek V , Falchook GS , Naing A , Hong DS , Fu S , Piha-Paul SA , Luthra R , Tsimberidou AM , Kurzrock R 
Published: June 2012

Abstract
Background: Therapeutic matching based on underlying molecular abnormalities showed promising results in early-phase clinical trials. PIK3CA mutations may predict response to therapies with PI3K/AKT/mTOR inhibitors.
Methods: Tumors from patients with breast cancer referred to the Clinical Center for Targeted Therapy (Phase I Program) were analyzed for PIK3CA mutations. Patients with PIK3CA mutations were treated, whenever feasible, with agents targeting the PI3K/AKT/mTOR pathway.
Results: Of 54 patients analyzed, 15 (28%) had PIK3CA mutations. PIK3CA mutations were found in 5/9 (56%) metaplastic, 3/8 (38%) HER2−positive, 7/29 (24%) hormone receptor-positive, and 0/8 (0%) triple negative (excluding metaplastic) breast cancers (P=0.07). Of the 15 patients with PIK3CA mutations, 12 (80%) were treated in clinical trials containing a PI3K/AKT/mTOR pathway inhibitor (median age, 54; median number of prior therapies, 3). Of these 12 patients, 3 (25%, 95% CI 0.09−0.53) had stable disease for more than 6 months (SD≥6 months; n=1) or a partial response (PR; n=2). Breast cancer patients without PIK3CA mutations treated on the same protocols had a rate of SD≥6 months/PR of 8% (1/12; 95% CI 0.01−0.35, p=0.6). Of the 4 patients with a H1047R mutation treated with agents targeting the PI3K/AKT/mTOR pathway, 3 (75%) had SD≥6 months (n=1) or a PR (n=2) compared to 0 of 8 patients (0%) with other PIK3CA mutations (P=0.045). Patients with H1047R mutations had a median progression-free survival (PFS) of 8.5 months compared to 2 months in patients with other PIK3CA mutations (p=0.13).
Conclusion: Heavily pretreated patients with PIK3CA-mutant advanced breast cancer had a SD≥6 months/PR rate of 25% on protocols incorporating PI3K/AKT/mTOR. Patients with mutation H1047R had significantly longer SD≥6 months/PR rate compared to those with other PIK3CA mutations. Our observations suggest that screening for PIK3CA mutations is warranted in larger numbers of patients with advanced breast cancer when treatment with PI3K/AKT/mTOR pathway inhibitors is planned.
Citation Information: Cancer Res 2011;71(24 Suppl):Abstract nr PD09-01.
Abstract A30: Evaluating Spanish audiovisual materials about cancer clinical trials: Improving awareness among Hispanic patients and families
Authors: Quinn Gwendolyn , Wells Kristen , Antonia Teresita , Antolino Prado , Lopez Natalia , Gonzalez Luis , Alsina Melissa 
Published: June 2012

Abstract
Introduction: Hispanic cancer patients are underrepresented in cancer clinical trials (CCTs). Recent research suggests lack of knowledge and low health literacy among non-English speaking Hispanics may contribute to low accrual rates. Audiovisual materials offer advantages to Hispanic populations in that they have been shown to have: high acceptability; easy dissemination; and can also be viewed with family. Hispanic cancer patients/survivors and caregivers participated in focus groups to aid in developing a Spanish language DVD and booklet intervention. This multi-media intervention was designed to meet the specific needs of cancer patients who prefer speaking Spanish by increasing knowledge and decreasing uncertainty about CCTs. This pilot project explored the feasibility, and effectiveness of the multimedia intervention developed by our team.
Methods: 25 patients were randomized to either: (1) an intervention condition in which they were asked to view the DVD and read the accompanying brochure (n=13); or (2) a control condition in which they were asked to read the National Cancer Institute's brochure entitled “Si tiene cáncer…Lo que debería saber sobre estudios clínicos” (If You Have Cancer…What You Should Know About Clinical Trials; n=12). Self-report data on knowledge, attitudes toward participation in CCT, self efficacy for participating in CCT, likelihood of participating in a CCT, and receptivity to CCT information, were collected at two time points: 1) in person, following study enrollment, but before receipt of the intervention assignment; and 2) by telephone interview between 7 and 28 days following study enrollment.
Results: Twenty-five of twenty eight eligible patients (89%) participated in the study, mean age: 51.5 years; 48% female; 72% currently married). Despite the small sample size, trends in the data suggest participants provided with the multimedia DVD and brochure intervention believed themselves to be more capable of participating in a CCT, more receptive to learning about a CCT, and reported greater likelihood of participating in a CCT compared to patients provided standard NCI educational materials. Patients in both conditions were more knowledgeable about CCTs at follow-up.
Preliminary pilot data should be confirmed in a larger randomized control trial. However, a multi-media intervention found to be effective in increasing Hispanic patients’ confidence in participating and intention to participate in a CCT has the potential to be widely disseminated. Dissemination of such an intervention may improve the quality of care for Hispanic cancer patients who are eligible for CCTs.
Citation Information: Cancer Epidemiol Biomarkers Prev 2011;20(10 Suppl):A30.