bluuebunny/crossref_metadata_2025_split huggingface dataset:
Reliable data on 5- and 10-year survival in early-stage breast cancer provides accurate estimates of 15-year survival.
Authors: Herold CI , Djulbegovic B , Hozo I , Lyman GH 
Published: December 2010

Abstract
Abstract #4076
Background: Evidence-based medicine encourages utilization of empirical evidence from controlled clinical trials in decision making both at the bedside and in health policy. However, the applicability of this approach may be limited by the lack of long-term results from efficacy studies. Decision analytic methods that model outcomes beyond empirically available evidence, typically over the lifetime horizon, have been proposed. There have been few studies of the accuracy of model-based survival projections utilizing reliable but early empiric results for estimating long-term survival. Such results, however, would have direct clinical and health policy implications.&#x2028; Methods: We took advantage of recently published individual-patient data meta-analysis by Early Breast Cancer Trialists' Collaborative Group (EBCTCG) (Lancet 2005;365:1687-1717) which regularly updates their results at 5-year intervals. A Markov model was built to compare empirical results with those modeled beyond the time horizon for which data was available. We first modeled breast cancer mortality rates comparing the effects of 5 years of tamoxifen versus no treatment. We then modeled the 15-year probability of death from breast cancer using the 5- and 10-year mortality data reported in the overview. Finally, we estimated the effect of breast cancer on life expectancy in women ranging in age from 40 to 70 years by decade.&#x2028; Results: Verification of the model produced 5-, 10-, and 15-year survival data that were identical to the empirical data reported in the EBCTCG overview. Modeling 15-year survival based on 5- and 10-year empirical data resulted in an average error estimate in breast cancer mortality of 0.75% [range: -0.83 to 2.19%]. Although modeling of differences in life expectancies ranged from an underestimate of -7.93% to an overestimate of 12.64%, in absolute terms over the span of 15 years this corresponded to a loss of 18 days or a gain of 40 days of life, respectively. Regardless of the assumptions used in the model, the decision remained stable: tamoxifen remained the better choice compared to no therapy.&#x2028; Conclusions: We conclude that reliable data generated at 5 or 10 years may be used to generate models that estimate 15-year survival. Whether 5-year data can be employed over the lifetime horizon remains to be demonstrated.
Citation Information: Cancer Res 2009;69(2 Suppl):Abstract nr 4076.
Development and validation of Korean breast cancer risk assessment tool.
Authors: Chang M 
Published: December 2010

Abstract
Abstract #4083
Introduction: The NCI breast cancer risk assessment tool of Gail model was used for counseling and chemoprevention of western breast cancer. Because Korean women have different incidence rates and risk factors, the Gail model can not properly estimate the breast cancer risk for Korean women. The author developed and validated a Korean breast cancer risk assessment tool, which would display the absolute breast cancer risks of Korean women.&#x2028; Methods: A risk model was established from a case-control study of 1687 cases of invasive carcinoma and 1238 controls. The risk factors selected were age, family history of the first and second relatives, body mass index, age at the first delivery, breast-feeding and a special test on the breasts. A baseline risk and individual breast cancer risk were calculated by a competing risk analysis. A discriminatory accuracy of the program was evaluated by a receiver operating characteristic (ROC) curve analysis.&#x2028; Results: The risk assessment tool was developed in the Internet web page, http://home.dankook.ac.kr/breast/brca/brca-e.htm. It calculated the relative risk and the estimated absolute risks following 5, 10 years and up to age 64, 74. The estimated risks of Korean women using this tool were less than the result of NCI risk assessment tool. The risk of breast cancer was highest in the age of forties. In the discriminatory accuracy, the area under curve (AUC) was 0.587. The curve presented a tendency of high specificity and low sensitivity.&#x2028; Conclusion: A web-based breast cancer risk assessment tool was developed for Korean women. This program had a limited discriminatory accuracy, but would be useful for the assessment of individual breast cancer risks, the selection of screening tools and preventive options of risk reduction for Korean women.
Citation Information: Cancer Res 2009;69(2 Suppl):Abstract nr 4083.
Breast complaints and cancer: age stratified predictors of risk from a prospective database.
Authors: Parkinson M , Tsang M , Tilley A , George R 
Published: December 2010

Abstract
Abstract #4086
Surgical clinics are presented with a variety of breast complaints. This study looks at major reasons for referral and correlates them to the likelihood of a benign or malignant disease.&#x2028; Data comes from a prospective database of new referrals for surgical assessment. Male patients and presentations of recurrent cancer were excluded. Reasons for presentation were sorted into 7 categories defined as breast asymmetry, palpable mass, non-inflammatory skin changes, inflammatory changes, nipple discharge, nipple changes, pain or abnormal imaging. The dominant complaint was applied. Some patients are included twice if they had another problem in the opposite breast, or a second presentation of a new problem. Patient demographics were recorded and all patients were followed to a benign or malignant diagnosis.&#x2028; Chi-square testing, odds ratios, and confidence intervals were used for the categorical data. Fisher's exact test was employed for categories with a low cell count.&#x2028; Three hundred and ninety of 1050 patients were found to have breast cancer. The most common presentations of malignancy were a palpable mass and abnormal imaging. Less common presentations that also predicted cancer were persistent inflammation, skin changes, and nipple changes. Breast pain (p=0.00001), breast asymmetry (p=0.00001), and nipple discharge (p=0.00001) were significantly correlated with benign disease. The most common diagnosis varied significantly with age. Fibroadenomas were most common in young women, while cysts were frequent in the peri-menopausal group (p=0.0001). A new mass in a woman over 65 years old was malignant 83% of the time (p=0.000001).&#x2028; Reason for referral can be significantly correlated with a benign or malignant diagnosis. Breast asymmetry, pain, and nipple discharge were associated with a benign diagnosis, while a new mass in an older woman was more likely to be malignant than benign. This information can be used to help stratify referrals into high and low risk categories, and identify patients for expedited assessment.
Citation Information: Cancer Res 2009;69(2 Suppl):Abstract nr 4086.
Patient reported causes of fatigue in relation to adjuvant radiotherapy after breast conserving surgery.
Authors: Langkjer ST , Rucinska M 
Published: December 2010

Abstract
Abstract #4094
Background: Fatigue is one of the most frequent symptoms experienced by cancer patients, and it adversely affects the quality of life. Fatigue is multidimensional and associated with the malignancy itself, but also with anti-neoplastic treatment and probably with several other causes. The aim of the study was to assess the level of fatigue during and after adjuvant radiotherapy in breast cancer patients and to uncover the kind of factors believed by patients to play a role in the generation of fatigue in relation to radiotherapy.&#x2028; Methods: 70 patients (ages 33-76 years, mean 57 years) with early-stage breast cancer were included after breast conserving surgery. Patients were treated with adjuvant radiotherapy (48Gy/24 fractions/5 weeks; 20 patients received boost 10Gy/5 fractions/1 week with tumor-bed). The subjective feeling of fatigue was measured according to the 10-score visual analog scale (VAS). RTOG Acute Radiation Morbidity Scoring Criteria (0-4) were used for the estimation of the acute skin reaction.&#x2028; Results: 53% of the patients demonstrated no fatigue (VAS 0-1) before the start of adjuvant postoperative radiotherapy. Patients after adjuvant chemotherapy manifested a little higher level of fatigue; there were no differences between patients with or without anti estrogen therapy. Fatigue intensity increased gradually during radiotherapy, but about 1/3 of the patients felt no fatigue. The majority of the patients reported radiotherapy as a cause of fatigue (33 of 47 patients (70%) with fatigue VAS ≥ 2 at the end of radiotherapy). 25% of the patients believed that their fatigue was still associated with previously given adjuvant chemotherapy, but in fact, the patients after chemotherapy did not demonstrate a higher fatigue level at the end of the radiotherapy course. 5 patients (10%) associated their fatigue with the anti estrogen therapy. There was correlation between fatigue level and intensity of radiotherapy-induced skin toxicity – patients with strong acute skin reaction demonstrated a higher fatigue level. But only 8 patients (17%) indicated the skin reaction as a cause of fatigue. Fatigue level was associated with traveling time to the hospital, especially when the journey took 2 hours or more/day. 45% of the patients gave the transport time to the hospital as a reason for fatigue.&#x2028; Conclusion: Fatigue increased over the course of adjuvant radiotherapy of breast cancer patients after breast conserving surgery. Fatigue seems to be multidimensional, but most of the patients indicate radiotherapy treatment as the cause of fatigue.
Citation Information: Cancer Res 2009;69(2 Suppl):Abstract nr 4094.
Integrated analysis of efficacy and safety of palonosetron (PALO) 0.75 mg IV for preventing chemotherapy-induced nausea and vomiting (CINV) in anthracycline and cyclophosphamide (AC/EC) combination chemotherapy in Japan: PALO Japanese breast cancer cooperative study group.
Authors: Suzuki Y , Tokuda Y , Inoue K , Aogi K , Saito M , Yanagita Y 
Published: December 2010

Abstract
Abstract #4099
Background: In the treatment of breast cancer, combination chemotherapy of AC/EC has been widely used for neoadjuvant, adjuvant chemotherapy or standard treatment of metastatic breast cancer. AC/EC frequently induces severe nausea and vomiting, that it is important to adequately prevent and control. PALO is the first novel serotonine antagonist approved for prevention of delayed nausea and vomiting in moderately emetogenic chemotherapy in US and other countries. Integrated analysis was done on the data from phase 2 and 3 trials that have been completed in Japan. The purpose of this analysis was to assess efficacy and safety of PALO for preventing CINV induced by AC/EC regimens.&#x2028; Methods: Three Japanese studies with single/repeated IV dose of PALO in pts receiving AC/EC were used. In all these studies, PALO 0.75 mg IV was administrated 30 min prior to AC/EC. Dexamethasone was administrated before AC/EC on day 1, and also on days 2-3 for the phase 3 trial. This integrated analysis assessed the efficacy and safety by difference in regimens (AC or EC), assessed the efficacy by difference in FEC (EC with 5-FU) or EC regimen and by difference in epirubicin (E) dosage in EC. Apart from the integrated analysis, efficacy of PALO in repeated cycles of chemotherapy was assessed by different regimens (AC or EC).&#x2028; Results: Total of 266 pts administrated AC/EC were evaluated for efficacy in single dose. Overall CR(CR = no emesis or rescue medication)% for PALO in acute phase was 70.7%. Overall CR% in delayed phase was 61.3%. CR% in acute and delayed phase for (a) AC (n=76) vs EC (n=190), (b) FEC (n=141) vs EC (n=49), (c) low (n=109) vs high (n=81) dosage of E (&lt;=90, &gt;90 mg/m2) in EC were as follows; (a) acute: 80.3 vs 66.8, delayed: 68.4 vs 58.4, (b) acute: 61.7 vs 81.6, delayed: 56.7 vs 63.3, (c) acute: 72.5 vs 59.3, delayed: 61.5 vs 54.3. Total of 155 pts administrated AC/EC were evaluated for efficacy of PALO in repeated cycles of chemotherapy, and similar efficacy between AC and EC was confirmed. Total of 474 pts administered AC/EC were evaluated for safety in all Japanese studies. There was no significant difference in the incidence of adverse drug reactions between AC and EC.&#x2028; Conclusion: This integrated analysis suggested that high antiemetic activity of PALO in CINV was shown for breast cancer pts receiving either AC or EC. In addition, in the FEC regimen and high dosage of E, all showed CR rate of more than 50% in both acute and delayed phases in the efficacy analysis, revealing a long lasting antiemetic activity of palonosetron.
Citation Information: Cancer Res 2009;69(2 Suppl):Abstract nr 4099.
Preliminary safety results: addition of bevacizumab to 3 docetaxel regimens as adjuvant therapy for early stage breast cancer.
Authors: Yardley DA , Hart L , Waterhouse DM , Badarinath S , Daniel B , Cook D , Thompson J , Childs BH , Burris HA 
Published: December 2010

Abstract
Abstract #4107
Background: Docetaxel-containing chemotherapy regimens improve disease-free survival (DFS) and overall survival in early stage breast cancer (BC) patients (pts). Bevacizumab (Bev) improves response rate and DFS in metastatic BC. This trial evaluates the feasibility of adding Bev to 3 adjuvant docetaxel BC regimens. Primary endpoint is cardiac safety (G3/4 congestive heart failure [CHF]).&#x2028; Materials and Methods: Phase IIb, randomized, non-comparative study. Planned accrual: 225 pts (75/arm) with previously-untreated node-positive or high-risk node-negative BC. Eligibility: operable invasive adenocarcinoma ≥4 wks from surgery, normal cardiac function, known HER2 status. Pts with cardiac disease/risk of cardiac disease were not eligible. HER2 normal pts were randomized to (mg/m2 unless stated otherwise) Arm A (ACT): doxorubicin (A) 60 + cyclophosphamide (C) 600 q3w x 4 followed by docetaxel (T) 100 x 4 or Arm B (TAC): T 75 + A 50 + C 500 q3w x 6. FISH HER2+ pts received Arm C (TCH): T 75 + carboplatin AUC 6 q3w x 6 + trastuzumab (H) 6 mg/kg q3w x 52 wks. Bev 15 mg/kg q3w beginning Day 1 x 52 wks was administered in all arms. Granulocyte growth factor prophylaxis was mandated in all arms.&#x2028; Results: Safety data are available for the first 138 pts (Arm A=53, Arm B=52, Arm C=33) receiving ≥4 cycles of treatment. Grade 3/4 toxicities (Arms A, B, C) included: neutropenia (n = 24, 22, 2), febrile neutropenia (5, 9, 0), leukopenia (10, 14, 1), thrombocytopenia (3, 7, 0) and fatigue (11, 3, 0). One on-study death occurred in Arm B from neutropenic enterocolitis. Documented CHF was reported in 3 pts (A=1, B=2), 2 occurring at the start of maintenance therapy. No cardiac events have been noted with Bev and H in Arm C. A total of 29 (21%) pts prematurely discontinued study treatment. Radiation therapy prior to study entry was administered in 4 pts (1, 1, 2). Concurrent Bev and adjuvant breast irradiation was administered in: Arm A=7 (13.2%), Arm B=15 (28.8%), Arm C=5 (15.2%). Most common AEs (Arms A, B, C) in these pts were: radiation skin injury (2, 2, 2), arthralgia (6, 4, 1), myalgia (4, 4, 1), bone pain (0, 4, 2), extremity pain (2, 1, 2), and rash (3, 3, 0).&#x2028; Discussion: Preliminary data show an acceptable early safety profile, with no unexpected toxicity, when Bev was added to docetaxel adjuvant BC regimens. The addition of Bev did not result in increased risk of toxicity from standard radiotherapy administered either prior to or while on-study. Three early CHF events were observed; all occurred in pts receiving anthracyclines. No cardiac events have been identified with the Bev/trastuzumab combination. Accrual to the trial is ongoing. Updated results will be presented.&#x2028; Support: sanofi-aventis,US.
Citation Information: Cancer Res 2009;69(2 Suppl):Abstract nr 4107.
Preliminary safety results from a multicenter phase II noncomparative two arm pilot of bevacizumab with anastrozole or fulvestrant as 1st line metastatic breast cancer therapy.
Authors: Yardley DA , Peacock N , Arrowsmith E , Harwin W , Miletello G , Raefsky E , Shipley D , Spigel DR , Hanson S , Greco F 
Published: December 2010

Abstract
Abstract #4113
Background: Estrogen modulates angiogenesis through effects on endothelial cells and by induction of vascular endothelial growth factor (VEGF) expression. Increased VEGF promotes tumor growth and is associated with a poor response to anti-estrogen therapy. This trial evaluates the impact of bevacizumab (B) combined with anastrozole (A) or fulvestrant (F) on progression free survival (PFS) as first line endocrine therapy in metastatic breast cancer (MBC).&#x2028; Methods: Study design: Two arm nonrandomized, noncomparative trial of A or F in combination with B. Eligibility: 0 prior hormonal or chemotherapy for MBC, measureable or evaluable disease, normal LVEF, postmenopausal, normal organ function. Treatment: Arm 1: Patients (pts) who either were endocrine therapy naïve, ≥ 12 months from adjuvant endocrine therapy, or who had intolerance to or progression on tamoxifen were treated with anastrozole 1 mg po daily. Arm 2: Patients who were ≤ 12 months from adjuvant aromatase inhibitors (AIs), intolerant of or progressed on adjuvant AIs, or at physician's discretion were treated with fulvestrant 500 mg IM loading dose, 250 mg D15 and every q28 days thereafter. B 10 mg/kg q2wks beginning day 1 was administered in both arms. Concurrent trastuzumab (T) was administered in HER2+ patients. Response assessments were performed q8 wks. Pts were treated until disease progression or toxicity.&#x2028; Results: 44 pts have been enrolled with data available for 29 pts. 18 pts (62%) were treated with anastrozole and 11 pts (38%) with fulvestrant. Median age: 64 yrs (range 44-88), ECOG PS 0-17 pts (59%) and PS 1 -12 pts (41%). 7 pts (24%) presented with de novo stage IV disease. 52% had 2 or more metastatic disease sites with bone metastases predominating 16 pts (55%), 7 pts (24%) with bone only disease. There were no G3/4 heme toxicities. G3/4 non-hematologic events consisted of G3 hypertension in 3 pts (10%), arthralgias 1 pt (3%), and CHF 1 pt (3%). This symptomatic LVEF of 40% occurred in arm 1 during cycle 3 and was noted to recover to 50-55% within 1 wk. This pt did not receive T. A median of 4.5 cycles have been administered. PRs were noted in 7 pts (24%) and 14 pts (48%) demonstrated SD. PD was noted in 3 pts and 5 pts were not yet evaluable. 73% of pts are progression free at 12 months. At a median follow up of 7.5 months, median PFS and overall survival has not been reached.&#x2028; Conclusions: The combination of bevacizumab with anastrozole or fulvestrant is feasible and well tolerated with adverse events as expected, reflecting standard bevacizumab related toxicities. Bevacizumab in combination with endocrine therapy is promising with early evidence of a high rate of clinical benefit at 72%. Further follow up is warranted.
Citation Information: Cancer Res 2009;69(2 Suppl):Abstract nr 4113.
Phase I study of sunitinib in combination with metronomic dosing of cyclophosphamide and methotrexate in patients with metastatic breast cancer.
Authors: Lyandres J , Melisko M , Moasser M , Goga A , Park JW , Rugo HS 
Published: December 2010

Abstract
Abstract #4119
Background&#x2028; Antiangiogenic therapy targeting VEGF with bevacizumab in combination with taxanes is effective in the treatment of metastatic breast cancer (MBC). Sunitinib (S) is a potent multitargeted tyrosine kinase inhibitor and has activity against VEGFR, PDGFR, c-Kit, and Flt-3. S has demonstrated activity in a variety of tumors and is approved at a dose of 50mg 4 wks on/ 2 wks off. Single agent continuous dosing (CD) at 37.5 mg/d is safe in phase II trials and may avoid a flare in angiogenesis with drug withdrawal. The effects of metronomic chemotherapy in preclinical studies are enhanced in combination with antiangiogenic agents, and cyclophosphamide and methotrexate (CM) have demonstrated limited efficacy in MBC. We combined S with CM in a phase I dose escalation study to evaluate an all oral regimen with CD. Serial measurements of circulating tumor cells (CTC) and endothelial cells (CEC) were performed in patients receiving study therapy.&#x2028; Methods&#x2028; Eligible patients (pts) have measurable or evaluable progressing MBC. Study treatment includes a two week lead-in course of S, followed by CD of S combined with CM. The primary endpoint is to determine the MTD of S + CM, secondary endpoints include toxicity and response. Quantitative analysis for CTC and CEC is performed at baseline, before starting CM then every 3 weeks. 3 patients are enrolled in each cohort starting at 12.5mg/d of S; 6 patients will be enrolled at the MTD followed by a phase II trial. Efficacy is assessed at week 8 then every 6 weeks.&#x2028; Results&#x2028; 15 pts have been treated to date (median age 57 (range 36-86); PS 0-2; median number prior chemo regimens 5 (range 2-9) in three dose cohorts (12.5, 25, 37.5 mg/d). 3 pts discontinued during the “run-in” due to symptomatic PD. 3 of 6 evaluable pts at 25 mg/d had asymptomatic grade 3 neutropenia responding to a dose reduction in CM. 4 pts had grade 2 neutropenia. One pt receiving 37.5 mg/d of S developed grade 4 thrombocytopenia. Other adverse events (all grade 1/2 ) included fatigue (7/12), elevated LFTs (5/12), nausea (5/12), mucositis (5/12) and thrombocytopenia (3/12). One pt had grade 2 fingertip desquamation resolving in two weeks off all study therapy. At week 8, 4/6 evaluable pts at 25 mg/d S with CM had stable disease (SD), 1 pt had a PR at week 14 and one pt had SD for 47 weeks. Enrollment to the third cohort at 37.5 mg S and CM is complete and tumor response is pending.&#x2028; Conclusion&#x2028; The combination of S with CM is well tolerated in heavily pretreated pts with MBC and has shown preliminary evidence of efficacy. Final phase I data, including the third cohort, CTC and CEC data will be presented.
Citation Information: Cancer Res 2009;69(2 Suppl):Abstract nr 4119.