bluuebunny/crossref_metadata_2025_split huggingface dataset:
Abstract P3-08-14: Could the preoperative systemic therapy be a risk factor for breast cancer-related lymphedema in stage II/III breast cancer?
Authors: Jung SY , Song EJ , You JY , Lee MH , Kwon Y , Ko KL , Park IH , Lee KS , Ro J , Lee S , Kang H-S , Lee E , Shin KH 
Published: August 2014

Abstract
Background: The breast cancer-related lymphedema (LE) has been known to be closely related to axillary lymph nodes dissection (ALND), chemotherapy, and radiation therapy. In this study, we evaluated whether the sequence of systemic chemotherapy and surgery could be a predictive factor in stage II/III breast cancer.
Methods and Materials: A total of 867 patients with stage II/III breast cancer, who underwent curative surgery with adequate systemic therapy from 2004 to 2009, were retrospectively analyzed. Adjuvant chemotherapy (ACT) was performed in 571 patients (65.9%) and preoperative systemic chemotherapy (PSC) in 296 (34.1%). We evaluated the incidence of LE by clinicopathologic factors and treatments.
Results: At a median follow-up of 5.1 years (range, 3.0-8.3 years), 360 patients (41.5%) had experienced LE, 244 patients have retained LE (permanent LE), and 116 patents were normalized. The overall 5-year cumulative incidence of LE was 17%. LE occurred in 188 patients (32.9%) in patients with ACT, 172 patients (58.1%) with PSC (P&lt;0.001), permanent LE in 121 (21.2%) with ACT, 123 (41.6%) with PSC (P&lt;0.001), respectively. Multivariate analysis showed that PSC (hazard ratio [HR], 1.65; P&lt;.001), radiotherapy (HR, 2.24; P&lt;0.01), ALND (HR, 1.41; P = 0.04), and nodal stage (HR, 1.93; P = 0.04) were independent risk factors for LE occurrence. For the permanent LE, PSC (HR, 1.44; P = 0.05), radiotherapy (HR, 2.79; P&lt;0.01), ALND (HR, 1.77; P&lt;0.01), and nodal stage (HR, 3.01; P = 0.02) showed the associations.
Conclusions: The risk factors associated with LE were advanced stage, ALND and radiotherapy. PSC was one of predictors for transients LE. However, further evaluation should be done whether it is a risk factor for permanent LE.
This research was supported by National Cancer Center Grant NCC-1210181-2 by the National Cancer Center, Republic of Korea.
Citation Information: Cancer Res 2013;73(24 Suppl): Abstract nr P3-08-14.
Abstract P3-09-17: One year of adjuvant hormone therapy does not increase patient fatigue: Results of a prospective early stage breast cancer trial
Authors: Lower EE , Kennedy D , Adams P 
Published: August 2014

Abstract
INTRODUCTION: The diagnosis and treatment of breast cancer may alter a patient's mental and physical quality of life. Estrogen effects on the brain may be neuroprotective or detrimental, and adjuvant endocrine therapy may influence cognitive functions including fatigue. We previously reported that three months of adjuvant hormone therapy was not associated with change in fatigue. The purpose of this study was to prospectively determine the incidence of fatigue in early stage breast cancer patients during one year of adjuvant hormone therapy. METHODS: Seventy-four consecutive patients of a single medical oncologist with newly diagnosed hormone dependent breast cancer prescribed adjuvant hormone therapy enrolled in this prospective study. Data collected included age, race, menopausal status, breast cancer stage, body mass index, Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT)-F, Fatigue Assessment Scale (FAS), short form 36 (SF-36), and cognitive failure questionnaire (CFQ). All tests were administered by one nurse prior to hormone initiation (0 mo) and after 3, 6, 9, and 12 months (mo) of therapy. Statistical analysis was performed using Student t test for paired data with a p value of &lt;0.05 considered significant. RESULTS: Prior to starting therapy, a third of patients had a FAS score of &gt;22, consistent with moderate to severe fatigue. After 12 months of therapy, 52 patients (13 premenopausal, 39 postmenopausal) were still receiving adjuvant hormone therapy and had completed serial testing. Twenty patients received chemotherapy prior to institution of hormone treatment. There were no significant changes in FACIT-F, FAS, SF-36, or CFQs scores during the first 12 months of treatment.
0 mo3 mo6 mo9 mo12 moFACIT-F44 (7-52)*42 (3-52)43 (3-52)43 (2-52)44 (6-52)FAS17 (10-43)18 (10-48)17 (10-48)20 (10-48)19 (10-50)Weight, lb.159 (102-256)162 (102-258)161 (102-258)163 (102-263)164 (101-258)SF-36 Total72 (12-100)68 (15-99)83 (15-99)76 (15-99)82 (7-100)CFQ70 (39-94)69 (34-92)68 (34-94)67 (28-96)70 (20-96)* Median (Range)
Although during the first six months, a small but significant increase in body weight occurred, there was no significant difference between the initial and 12 month body weight. CONCLUSION: Prior to adjuvant hormone therapy institution, breast cancer patients often have significant problems with fatigue. However, the first 12 months of adjuvant hormone therapy does not appear to affect fatigue or cognitive failure.
Citation Information: Cancer Res 2013;73(24 Suppl): Abstract nr P3-09-17.
Abstract P3-11-04: The effect of group intervention therapy for young breast cancer patients under 35 years old
Authors: Kitano A , Hosaka T , Iwata T , Osaka W , Kitagawa H , Ohde S , Yamauchi H 
Published: August 2014

Abstract
Background: Coping with cancer plays an important role in cancer survivorship. Especially in young patients, coping is significant because of anxieties regarding fertility, body image, heredity, symptoms of premature menopause, and psychosocial stress. According to previous studies, the group intervention therapy is effective in improving emotional difficulties for breast cancer patients. However, there is few demonstrating the efficacy of group intervention for young breast cancer patients.
Methods: Since September 2010, we have conducted a clinical trial of a group intervention, facilitated by breast surgeons, psycho-oncologists, and nurses, for young breast cancer patients who were diagnosed under 35, or 36 years old due to enrolling period, and they had no metastasis. at St Luke's International Hospital (SLIH) in Tokyo, Japan. Each group consisted of 7 to 10 breast cancer patients, who received five weekly sessions. We evaluated the changes in coping strategies, emotional levels, and quality of life (QOL) before, after and 6 month after the group intervention, by using three scales: MAC (Mental Attitude to Cancer) for coping, POMS (Profile of Mood States) for emotional states, and FACT-B (Functional Assessment of Cancer Therapy-Breast) for QOL. MAC scale includes five coping strategies such as Fighting Spirit(FS), Hopelessness(H), Anxious Preoccupation(AP), Anxiety(A), and Fatalism(F). This is an interim report of this clinical trial. Paired T-test was used to statistical evaluation.
Results: At this point, 65 young patients finished the group intervention. Complete data were taken from 61 patients for evaluating score changes between before and after the group interventions. POMS and FACT-B score improved statistically (p = 0.004, p = 0.003). Among MAC's five components, Hopelessness and Anxious Preoccupation improved statistically (p&lt;0.01, p&lt;0.001).
Discussion: This study suggests that the group intervention is promising to improve emotion states, QOL, and coping strategies for young breast cancer patients.
Citation Information: Cancer Res 2013;73(24 Suppl): Abstract nr P3-11-04.
Abstract P3-13-01: Primary efficacy endpoint analysis of the CARIN trial: Capecitabine (Cap) and bevacizumab (Bev) with or without vinorelbine (Vin) in first line metastatic breast cancer (MBC)
Authors: Welt A , Lerchenmüller C , Decker T , Marschner N , Salat C , Hegewisch-Becker S 
Published: August 2014

Abstract
Background:
In RIBBON-1, the combination of Bev with Cap as 1st-line therapy for MBC significantly improved progression-free survival (PFS) compared with Cap alone, with limited impact on tolerability. Vin and Cap are active agents with few overlapping toxicities. The combination of both cytotoxic drugs in phase I/II trials showed good tolerability and promising clinical activity. The CARIN trial aims to further improve efficacy by adding Vin to Cap/Bev to establish a less toxic alternative to taxane-based 1st line therapy.
Patients and Methods:
CARIN is a multicenter randomized study comparing the efficacy of Cap plus Bev versus the same regimen combined with Vin. From 04/2009 until 10/2012 598 pts in 61 participating centers were randomized (1:1) to receive Cap 1000 mg/m2 bid days 1–14 + Bev 15 mg/kg q3w (Arm A) or Cap/Bev combined with Vin 25 mg/m2 days 1+8 (Arm B). Randomization was stratified by prior therapy with anthracycline and/or taxane (yes/no) and hormone receptor status (ER/PR +/-). Treatment was continued until progression or unacceptable toxicity. Key eligibility criteria included Her-2 negative metastatic or locally recurrent disease, no prior palliative chemotherapy for MBC, ECOG ≤2, and absence of brain metastases. Primary endpoint was progression-free survival (PFS); secondary endpoints included objective response rate, overall survival, and safety & tolerability. Baseline demographics, prior therapy and disease characteristics were well balanced. 21.5% of pts had triple negative BC, 10.6% had bone metastases only. Progression free survival data for the two treatment arms will be compared using a log-rank test. The influence of pretreatment, hormone receptor status and predictive variables on progression free survival will be analyzed within a cox regression model.
Results:
Data Cleaning and analysis will be complete by October 2013 and results for the primary endpoint PFS and secondary endpoints will be presented at the meeting.
Citation Information: Cancer Res 2013;73(24 Suppl): Abstract nr P3-13-01.
Abstract P3-14-11: Microarray data analysis and long term outcomes of NCIC-CTG MA.22: Neoadjuvant epirubicin and docetaxel with pegfilgrastim support for locally advanced breast cancer
Authors: Trudeau M , Chapman J-A , Guo B , Clemons M , Dent R , Jong R , Kahn H , Shepherd L , Pritchard K , Xu J , O'Brien P , Parissenti A 
Published: August 2014

Abstract
Background: 93 patients were enrolled in sequential phase 1 and 2 trials of epirubicin (E) and docetaxel (D) given at 3 (cohort A) or 2 weekly (cohort B) intervals. We previously reported clinical (93%) and pathologic response rates (pCR 7%) as well as the association of fall in tumour RNA integrity (RIN) with response (ASCO 2010). Here we report the results of microarray analysis of tumor specimens pre-and mid-treatment to determine genes which are differentially expressed in different groups. Methods: 6 core biopsies were collected for all patients pre-, mid- and post-treatment with ED. 3 cores were used for standard pathologic assessment while 3 were used for gene expression assessment using Agilent full genome microarrays. Pre- and mid-treatment cores were used with Agilent Feature Extraction Software to assess microarrays; and baseline continuous (% positive) immunohistochemical ER, PR, HER2, and Topo2 were investigated by schedule and dose. RNAs with RIN &gt; = 5.0 were subjected to microarray analysis. NIH BRB array tools were used for investigations of differential gene expressions. K-M curves were generated for the phase 2 cohorts for disease free (DFS) and event free survival (EFS), and for ER− PR− and ER or PR+ subgroups. Results: Of the 93 patients, 47 were in cohort A and 46 in cohort B. Median overall survival was 6.34 years on study. DFS at 50 months was 55% for A (phase 2) and 67% for B (phase 2), while EFS was 55% for A and 63% for B. For ER or PR+ DFS and EFS were 60% and for ER− PR− DFS and EFS were 63%. 134 arrays were available in total: 57 from A, 68 from B with 11 reference breast tumour RNAs for standardization. Patients with and without microarrays were not significantly different. Pre-treatment, we found 3 differentially expressed genes in A and 6 in B between patients who did and did not have RIN &gt; = 5.0 at mid-treatment. Comparing CR to non-CR (PR, SD, PD), 40 genes were found for A and 2 genes for B. Many genes were also differentially expressed in A and B when analyzed by pathologic factors ER, PR, HER2, Topo2, schedule and dose. Mid-treatment, 4,365 genes in A and 18,770 genes in B were significantly different from pre-treatment. Conclusion: At 50 months, DFS was 55% for 3 weekly and 67% for 2 weekly schedules of ED. The genes identified in each cohort pretreatment will be investigated further for relevance to predicting sensitivity or resistance to E or D.
Citation Information: Cancer Res 2013;73(24 Suppl): Abstract nr P3-14-11.
Abstract P3-14-15: Nabrax: Neoadjuvant therapy of breast cancer with weekly nab-paclitaxel: Final safety of GEICAM 2011-02
Authors: Martin M , Antolin S , Anton A , Plazaola A , Garcia-Martinez E , Segui MA , Sanchez-Rovira P , Esteban C , Garcia-Valdes E , Calvo L , Quindos M , Carrasco E , Rodriguez-Martin C , Chacon JI 
Published: August 2014

Abstract
Aims: nab-paclitaxel is an innovative chemotherapy that consists of nano-particles of human serum albumin bound paclitaxel. It exploits the role of albumin as the natural carrier of hydrophobic molecules in human to increase paclitaxel delivery to tumor cells. Weekly nab-paclitaxel showed a superior efficacy compared to every 3-weeks docetaxel in a randomized phase II study in metastatic breast cancer (Gradishar JCO 2009, Clin. Breast Cancer 2012). This single arm phase II trial has been designed to evaluate the activity and safety of weekly nab-paclitaxel as neoadjuvant treatment of early stage breast cancer patients with positive estrogen receptors and negative HER2.
Methods: Stage II-III patients were included and treated with nab-paclitaxel weekly at a dose of 150 mg/m2 on days 1, 8 and 15 every 4 weeks for 4 cycles. Following chemotherapy, patients undergo surgery and adjuvant therapy (with radiation, chemo and endocrine therapy) under the investigator criteria. The primary objective is to determine the residual cancer burden class III as measured by the Symmans criteria (JCO 25:4422,2007). Secondary objectives include pathological complete response, overall response, invasive disease free survival, safety and potential correlative biomarkers.
Results: Eighty-three patients have been recruited in the study in 13 Spanish institutions. Here we report safety data from 77 patients. Median age was 48 years, 62% were postmenopausal and 94% had ECOG PS 0; most patients were stage II (23% IIa and 36% IIb). A total of 259 cycles have been administered to date; 47 patients completed 4 cycles as planned, 5 patients discontinued treatment early (due to grade 2-3 sensory neuropathy in 4 patients), the remaining patients are still under treatment. The treatment was delayed in 8.1% of patients; nab-paclitaxel doses were omitted and reduced in 3.9% and 9.7% of cycles respectively, for a relative dose intensity of nab-paclitaxel of 97.3%. The most frequent reasons for dose modifications were neutropenia (5.4%) and neuropathy (2.7%). The main grade 2/3 adverse events are described in table 1.
Table 1Related adverse events.Per patient (N = 74)Per Cycle (N = 259)NCI-CTCAE vs 4.0. (&gt;5% grade 2-4)Grade 2, N (%)Grade 3, N (%)Grade 2, N (%)Grade 3, N (%)Leukopenia6 (8.1)1 (1.4)11 (4.2)1 (0.4)Neutropenia17(23)7 (9.5)30 (11.6)9 (3.5)Alopecia47(63.5)—121 (46.7)—Fatigue11 (14.9)2 (2.7)17 (6.6)2 (0.8)Neuropathy: Sensory17 (23)2 (2.7)25(9.6)5 (1.9)Musculoskeletal Pain11 (14.9)0 (0)13 (5.0)0 (0)
Conclusions: Neoadjuvant therapy with weekly nab-paclitaxel at dose of 150 mg/m2 on days 1, 8 and 15 every 4 weeks was well tolerated. Final safety data for the entire treated patients will be mature and presented at the meeting.
Citation Information: Cancer Res 2013;73(24 Suppl): Abstract nr P3-14-15.
Abstract P3-14-18: Dose-dense neoadjuvant chemotherapy in locally advanced breast cancer. Long term results of a cooperative retrospective study
Authors: Ionta MT , Notari F , Murgioni S , Cugudda S , Marongiu M , Solinas C , Pala L , Lepori S , Demurtas L , Olmeo N , Valle E , Sarobba G , Frau B , Pusceddu V , Defraia S , Serci C , Fanzecco M , Tanca FM , Atzori F 
Published: August 2014

Abstract
BACKGROUND: Dose-dense chemotherapy results in better overall (OS) and disease free survival (DFS) in women with hormone receptor-negative early breast cancer as shown with a systematic review and meta-analysis by Bonilla et al (JNCI 2010). Aim of our study was to compare neoadjuvant dose-dense chemotherapy with standard dose schedule in T4 patients in terms of DFS and OS, according to hormone-receptor status.
PATIENTS AND METHODS: we analysed, retrospectively, 160 consecutive T4 patients, of median age 52 ys (range 29-73) who received neoadjuvant anthra-based chemotherapy with and without taxanes, observed from 1989 to 2009; 74 patients (46%) received dose-dense schedule (q14) and 86 (54%) conventional dose (q21); 68 (42%) patients were ER-negative (32 q14; 36 q21) and 92 (58%) patients were ER-positive (42 q14; 50 q21). No Trastuzumab was allowed during neoadjuvant treatment.
RESULTS: at a median follow-up of 130 months (range 8-241 months), overall, 10 y DFS was 41.9% and 30.2% on q14 and q21 schedules, respectively (p = 0.085); 10 y OS was 48.6% on q14 and 44.2% on q21 schedule, (p = 0.343). ER-negative patients who received q14 schedule had better DFS (46.9%) than those on q21 schedule (16.7%), (p = 0.007) [Relative Risk 0,63 and Odds Ratio 0,22] and better OS (50%) than those on q21 schedule (30.6%) (p = 0.083) [Relative Risk 0,61 and Odds Ratio 0,44]. DFS and OS did not differ on q14 and q21 schedules in ER- positive patients.
CONCLUSIONS: Our findings are consistent with published data and suggest that there is no appreciable survival benefit from increasing dose density among T4 ER-positive patients. Dose-dense neoadjuvant chemotherapy may be justified in LABC patients with T4 ER-negative tumors.
DFS OS q 14q 21pq 14q 21pER-46,9%16,7%0.00750%30,6%0.083ER+38,1%40,0%0.51247,6%54,0%0.344
Citation Information: Cancer Res 2013;73(24 Suppl): Abstract nr P3-14-18.
Abstract P3-15-04: A French prospective pilot study to identify dihydropyrimidine dehydrogenase (DPD) deficiency in breast cancer patients receiving capecitabine
Authors: Milano G , Ferrero J-M , Thomas F , Bobin-Dubigeon C , Merlin J-L , Pinguet F , Ferrand C , Boyer J-C , Romieu G , Bachelot T , Pivot X , Dieras V , Largillier R , Mousseau M , Goncalves A , Roche H , Bonneterre J , De Clercq B , Etienne-Grimaldi M-C 
Published: August 2014

Abstract
Background: Health Authorities point out that DPD deficiency confers a significant risk of major toxicity for patients receiving capecitabine. Identification of at-risk patients is thus of major concern. This multicentric prospective study of the French GPCO group (Groupe de Pharmacologie Clinique Oncologique, Unicancer) evaluated the sensitivity, specificity and predictive values of DPD phenotyping and genotyping to predict severe cap-related toxixity in metastatic breast cancer patients.
Methods: 303 patients were included between February 2009 and February 2011 (15 institutions). Eighty-eight% received capecitabine as monotherapy, 28% were treated as first line (mean dose at 1st cycle 1957 mg/m2/d). Pre-treatment uracil (U, physiological DPD substrate) plasma concentration was measured in 286 patients (HPLC assay). DPD genotyping (IVS14+1G&gt;A, 2846A&gt;T, 1679T&gt;G, 464T&gt;A) was performed on 281 patients. Severe toxicity (G3-4 CTCAE v3 criteria) was measured over cycles 1-2.
Results: Grade 3-4 toxicity (diarrhea, vomiting, hematoxicity, hand-foot syndrome) has been observed in 19.6% of patients (one toxic death). A marked trend for higher U concentrations has been noted in patients developing severe toxicity vs those who didn't (median 12.7 ng/ml (Q1-Q3 9-17) vs median 10.2 ng/ml (range 8-13), respectively, p = 0.014). However, ROC curve has showed that this difference was too small for use as a reliable toxicity predictor. The patient with toxic death had an elevated U concentration at 17 ng/ml. Among the 7 patients with a DPD mutation (3 pts IVS14+1, 3 pts 2846A&gt;T, one 1679T&gt;G, all heterozygous), 5 developed severe toxicity (including the toxic death, 2846A&gt;T), one did not, and the last one was not documented. Relative risk for developing severe toxicity was 4.60 in mutated patients vs wild-type patients (95%CI 2.95-7.16, p = 0.001); positive and negative predictive values were 83.3% and 81.9%, respectively; specificity was 99.5% and sensitivity was 9.8%.
Conclusions: Breast cancer patients harbouring a DPD variant allele are at risk to develop severe, up to lethal, capecitabine-related toxicity. Pre-treatment U measurement remains to be more firmly established as a reliable predictor of capecitabine toxicity. These observations are of major interest for breast cancer patients candidate for capecitabine therapy.
Citation Information: Cancer Res 2013;73(24 Suppl): Abstract nr P3-15-04.
Abstract P4-01-05: 3’-deoxy-3’-[18F]fluoro-thymidine (18F-FLT) positron emission tomography (PET): An accurate and effective tool for assessing tumor response in breast cancer
Authors: Couturier O , Rousseau C , Pierga J-Y , Berriolo-Riedinger A , Alberini J-L , Girault S , Fumoleau P , Brain E , Abadie-Lacourtoisie S , Vera P , Liehn J-C , Olivier P , Uwer L , Cachin F , Sagan C , Bouchet F , Lebas N , Mesleard C , Fourme E , Martin A-L , Lovinfosse P , Lacœuille F , Campone M 
Published: August 2014

Abstract
Objectives : A French multicenter study was promoted by the national French cancer federation (Unicancer R&D) to assess the potential of [18F]FLT (positron emission tomography (PET) biomarker of proliferation)to manage breast cancer neoadjuvant chemotherapy (NAC). The main objective was to compare changes in tumor [18F]FLT uptake to histopathological changes induced by NAC, assuming an arrest of tumor growth related to the effectiveness of NAC.
Methods : 97 patients (age 48.6 +/- 10.2 y.) were included in 13 nuclear medicine centers. All patients were eligible to anthracycline-based NAC for a de novo unifocal breast cancer (ductal n = 84, lobular = 11, other type = 2; stage II n = 75, stage III n = 21 et stage IV n = 1). 90 patients underwent a baseline PET before the onset of NAC (PET1) and a final PET after the end of NAC and before surgery (PET3). PET acquisitions were performed 60±7min after FLT injection. SUVmax (maximum standardized uptake value), SUVpeak (1 cm3 ROI including pixel max) and SUV41 (isocontour 41% of pixel max) were computed. Changes in SUV on PET3 vs PET1 were analyzed in relation to histopathological findings at the end of NAC (Sataloff criteria).
Results : Tumor FLT uptake decreased markedly between TEP1 and TEP3 (SUVmax = 6.2±4.8 vs 1.3±1.2 respectively; SUVpeak = 4.6±3.2 vs 0.9±0.9; SUV41 = 3.6±2.8 vs 0.8±0.7). Total or near-total therapeutic effect (grade A) were obtained in 20 patients, more than 50% therapeutic effect but less than total or near-total effect (grade B) in 37 patients, less than 50% therapeutic effect but visible effect (grade C) in 22 patients, or no therapeutic effect (grade D) in 11 patients. SUVmax decreased dramatically (87.5%) to background levels in all patients with a complete response (grade A). Overall, changes in SUV differed depending on the type of histological response (p&lt;0.01) i.e. SUVmax changes were more pronounced as pathological responses were good: 61% for grade D; 65.7% grade C and 69.8% grade B. The same results were obtained with the two other SUV types.
Conclusions : Pathologic response to NAC in breast cancer can be assessed accurately by FLT.
Citation Information: Cancer Res 2013;73(24 Suppl): Abstract nr P4-01-05.