bluuebunny/crossref_metadata_2025_split huggingface dataset:
Abstract P2-14-07: Predictors of Employment Outcomes in Breast Cancer (BrCa) Patients: An Analysis from E2Z02 (ECOG's SOAPP Study)
Authors: Tevaarwerk AJ , Lee J-w , Sesto MC , Cleeland CS , Wagner LI , Chang VTS , Fisch M. 
Published: April 2011

Abstract
Cancer survivors are more likely to be unemployed than healthy counterparts (de Boer et al, JAMA 2009). BrCa patients comprise roughly one-fourth of the survivor population and face challenges in their ability to work. Age and cancer therapy may increase the risk for unemployment (Hassett et al, Cancer 2009). We analyzed data from E2Z02 to examine factors affecting employment in BrCa patients.
Methods: E2Z02 prospectively enrolled patients with breast, colon, lung and prostate cancer irrespective of therapy or stage. We limited this analysis to white or black BrCa patients with age at registration ≥65 yrs (those over 65 were excluded as likely to be retired; other minorities were excluded due to small numbers). Patients and oncologists answered the MDASI-ECOG regarding symptoms; additional baseline data regarding disease and treatment were collected. Change in employment was assessed by “Has your employment status changed due to illness?’ [Answer = Yes/No]; and level of employment by “What is your current employment status?” [Answer = full-time; part-time; not in the workforce]. We developed a multivariate logistic regression model for each employment outcome (change in employment, level of employment). Explanatory variables included treatment number (TNs), age (≥45 vs 46-65 yrs), race (white vs black), stage (nonmetastatic vs metastatic), therapy status (off vs on), and ECOG PS (0 vs 1 vs 2-4). TNs were counted as 0 (no medical therapy [MT] or radiotherapy [RT]), 1 (either) or 2 (both). MT encompassed both hormone and chemotherapy.
Results: E2Z02 accrued 3123 patients from 3/06 to 5/08 at academic (n=6) and community (n=32) medical oncology clinics (see demographics table); 50% of E2Z02 patients had BrCa. Patients with nonmetastatic BrCa (OR 2.16, 95% CI 1.53-3.05), off therapy (OR 1.79, 95% CI 1.31-2.44), and white race (OR 1.64, 95% CI 1.10-2.46) had a higher chance of remaining employed than their counterparts. Patients with PS 0 were more likely to remain employed compared to patients with PS 1 (OR 1.85 95%CI 1.36-2.5) or PS 2-4 (OR 2.61, 95% CI 1.25-5.44). Age and TNs were not significant. As to the level of employment, nonmetastatic patients (OR=1.60, 95% CI = 1.17-2.21) and patients with better PS (P&lt;0.0001) worked more hours in the workforce than their counterparts. Conclusions: This analysis identifies additional risk factors for employment changes in BrCa patients. Further research is needed to understand the complex relationship between race, other predictors and employment status. These findings could define a group of BrCa survivors at risk for changes in employment outcomes, and potentially allow for targeted interventions.

Citation Information: Cancer Res 2010;70(24 Suppl):Abstract nr P2-14-07.
Abstract P2-14-08: Patient Perspectives on Information Communicated Regarding Effects of Treatment on Fertility
Authors: Goldfarb SB , Kelvin JF , Thom B , Kaplan J , Corcoran S , Margolies A , McCabe MS , Norton L , Hudis C , Basch E , Dickler MN. 
Published: April 2011

Abstract
Background: Many breast cancer survivors diagnosed during their reproductive years desire to have children after treatment and are distressed about the possibility of treatment-induced infertility. Informing patients about fertility preservation options before therapy may optimize quality of life after treatment. This study was undertaken to evaluate the information patients received about effects of therapy on fertility, early menopause, and fertility preservation options. Methods:
An IRB approved cross-sectional study was performed to evaluate patient perceptions of the impact of treatment on fertility and early menopause. The survey was developed at Memorial Sloan-Kettering Cancer Center (MSKCC) for patients ages 18-45, with items derived from existing surveys in the literature and input from a multidisciplinary committee. We evaluated two groups of patients, one who had completed treatment and the other who was currently undergoing therapy. Surveys were mailed to 395 women who began treatment (all modalities) for breast cancer at MSKCC between 7/1/07 and 6/30/08. A second cohort of patients (n=35) completed surveys during patient visits to breast cancer medicine ambulatory clinics
between 3/22/2010 and 4/8/2010.
Results:
The survey was completed by 159 pts. (129/395 and 30/35). At the time of diagnosis, 69% (110/159) had children and 45% (70/156) were interested in having children. 79% (123/155) reported that the impact of treatment on fertility was discussed with them before initiating therapy. A healthcare provider initiated the discussion 54% (83/155) of the time. However, only 35% (54/152) and 47% (71/150) of women felt they received an adequate amount of information about the effect of cancer treatment on fertility and menopause, respectively. Based on their ranking, patients preferred to receive fertility information in person either from their physician or a fertility specialist, or through written material. After treatment, 5 patients attempted pregnancy (7 naturally, 1 with assisted technology), yielding 8 live births. Conclusions:
Many breast cancer survivors wish to have children after treatment. To optimize success, patients should be adequately informed about the effects of therapy on fertility, early menopause, and options for fertility preservation. These findings are informing an institution-wide fertility program.
Citation Information: Cancer Res 2010;70(24 Suppl):Abstract nr P2-14-08.
Abstract P2-14-10: Self Reported Cognitive Function in Breast Cancer Survivors: A 12 Month Longitudinal Descriptive Study
Authors: Barton D , Burger K , Novotny P , Sloan J. 
Published: April 2011

Abstract
Background: Changes in cognitive function are commonly reported in breast cancer (BC) survivors. Longitudinal studies have only recently been completed and are few. In particular, long term studies are lacking. The purpose of this abstract is to describe self-reported cognitive changes in women before the start, or after the first cycle of chemotherapy, through 12 months.
Methods: The data for this analysis were collected as part of a placebo-controlled randomized trial evaluating ginkgo biloba for the prevention of cognitive decline during adjuvant chemotherapy for BC. As there was no evidence that gingko biloba impacted cognitive function in any way, the sample was combined. Descriptive statistics were calculated to obtain the percent of women reporting worse perceived functioning or changes in their cognitive function at the start of chemotherapy, at the completion of treatment, and at 6, 12 and 24 months later (24 month data still being analyzed). 210 women, mostly white and mostly beginning anthracycline based chemotherapy, completed self report measures of cognition throughout the study. Women rated 10 areas of functioning by choosing a number from 1, signifying “functioning extremely less than normal”, to 7, signifying “extremely better than normal”. A score of 4 represented functioning perceived as “normal” for the respondent. Results: At baseline and after chemotherapy, the means for all 10 self reported cognitive items indicated “less than normal” functioning. Areas with the worst functioning included memory, ability to think clearly, staying focused, and planning ahead. At 6 and 12 months after chemotherapy, a percentage of participants reported worse functioning compared to baseline in every area. Changes in functioning are in the table below.
Table 1
At 12 months, the mean for only 4 items indicated these areas were at “normal” functioning. These were the ability to learn, solve problems, react quickly and balance a checkbook.
Discussion: For a subgroup of women, cognitive changes continue to worsen throughout 12 months and for many, perceived deficits remain.
Areas most negatively impacted relate to attention, memory and executive function. Future research should focus on identifying predictors of worse functioning and continued research is needed to elucidate targets for intervention research to prevent unwanted cognitive changes.

Citation Information: Cancer Res 2010;70(24 Suppl):Abstract nr P2-14-10.
Abstract P2-14-12: Contents Preferred for a Post Treatment Survivorship Care Plan for Breast Cancer Survivors
Authors: Singh-Carlson S , Gotz C 
Published: April 2011

Abstract
Background: Current evidence indicates that the range of survivorship issues that patients can encounter is broad and can include physical, psychological, social and spiritual aspects. Studies also show that breast cancer survivors (BCS) may feel isolated and uninformed after completion of active treatment, when they have less interaction with health professionals. Although, Institute of Medicine's report on cancer survivorship recommends that cancer patients completing treatment should be provided with a comprehensive care summary and follow up plan that is clearly and effectively explained, it is not always practiced in oncology care.
Methods: A qualitative approach was used to explore impacts of breast cancer on survivors at different life stages and to determine preferred content and format of survivorship care plan (SCP). Focus group and face-face interviews were audio-recorded and transcribed with women who had non-metastatic breast cancer, 3-48 months post-treatment and were 18-75 years of age. Groups were stratified by age into &lt;44, 45-54, 55-64, and &gt;65. Transcripts were subjected to thematic and content analysis by age group (life stage).
Results: Results from16 women interviewed from the 4 age groups show that the impacts of breast cancer were broad and varied by age group. Physical, emotional and social effects were more intense in younger patients with women in the middle age group experiencing more concerns centered on financial and social support issues. Fatigue, fear of the unknown, and fear of recurrence were the most universal effects. Although customized SCP was preferred, important elements include: treatment summary, information on nutrition/exercise, expected side effects, signs/symptoms of recurrence, follow-up schedule, and updates on changes to recommended care. Preferred format for SCP is similar for all groups. Women preferred oncology nurses to provide the SCP at the beginning or at the end of the treatment and preferred written materials in lay language, telephone follow-up resource person and electronic bulletins for communicating updates.
Discussions: BCS are diversely impacted by the breast cancer experience. Effects vary by life stage, which impacts preferred content of SCP, but not format. Qualitative information on the impact of breast cancer at different life stages can be used to help customize content of SCPs.
Citation Information: Cancer Res 2010;70(24 Suppl):Abstract nr P2-14-12.
Abstract P2-16-04: Plasma Biomarker Analyses in the AVADO Phase III Randomized Study of First-Line Bevacizumab + Docetaxel in Patients with Human Epidermal Growth Factor Receptor (HER) 2-Negative Metastatic Breast Cancer
Authors: Miles DW , de Haas SL , Dirix L , Chan A , Pivot X , Tomczak P , Provencher L , Delmar P , Scherer S. 
Published: April 2011

Abstract
Background: Inhibition of vascular endothelial growth factor (VEGF) signaling by bevacizumab (Bv; Avastin) combined with chemotherapy (chemo) is associated with improved clinical benefit in several malignancies, including metastatic breast cancer (mBC). Bv+chemo was evaluated in HER2 negative mBC in AVADO where baseline biomarker (BM) sampling was included as an optional element to identify prognostic and predictive biomarkers. Different angiogenic markers have been evaluated in trials containing Bv, with most trials having focused on circulating VEGF. Thus far, VEGF seems to have more a prognostic than predictive value as demonstrated across different indications (lung, renal, and colorectal cancer [Bernaards et al. ASCO 2010]). Trends for the predictive value of intracellular adhesion molecule-1 (ICAM-1) have been noted in two NSCLC studies (E4599 and AVAiL) and for basic fibroblast growth factor in AVAiL. The value of angiogenic plasma markers has not yet been established in mBC.
Material and Methods: In AVADO, 736 mBC patients (pts) were randomized to docetaxel 100mg/m2 plus either Bv7.5mg/kg, Bv15mg/kg or placebo. Primary endpoint was progression-free survival (PFS). Baseline plasma samples were analyzed for VEGF, ICAM-1, VEGF Receptor 1 and 2 (VEGFR1, 2), E-selectin and vascular cell adhesion molecule-1 using a novel ELISA based multiplex assay. Samples for BM analysis were available for 396 pts, equally distributed across treatment arms. Median levels of these markers were pre-specified as a cut point to categorize pts as low or high. Pre-treatment values were correlated with PFS (before start of subsequent antineoplastic therapy) using simple and multiple regression approaches as well as subgroup analyses.
Results: All subgroups had HR point estimates in favor of the Bv arms, with the exception of pts with low VEGFR2 levels at a Bv dose of 7.5mg/kg. In general, high plasma levels of VEGF and VEGFR2 were associated with better treatment effect in this study. Low ICAM-1 levels did not show the trend towards a larger treatment effect previously seen in E4599 and AVAiL. Further analyses will be presented.
Discussion: We report the first plasma BM data in a phase III placebo-controlled randomized study in mBC with Bv. In this subset analysis, using a novel ELISA assay, VEGF and VEGFR2 were identified as promising candidates for predictive value for PFS. A similar observation has been made in an independent BM analysis of pancreatic cancer (AVITA; data on file). Plasma data have so far not shown these trends in mCRC and mNSCLC. Further prospective evaluation of these markers is warranted. Authors D.W.M. and S.L.d.H. contributed equally.

Citation Information: Cancer Res 2010;70(24 Suppl):Abstract nr P2-16-04.
Abstract P2-16-12: First-Line Bevacizumab Combined with Paclitaxel in Triple-Negative Locally Recurrent/Metastatic Breast Cancer: Subpopulation Analysis of 115 Patients Treated in Routine Oncology Practice in Germany
Authors: Schneeweiss A , Foerster FG , Hollburg W , Tesch H , Klare P , Wuelfing P , Distelrath A , Schumacher C , Steffens C-C , Schubert R , Widing A , Kasper C , Schmidt M. 
Published: April 2011

Abstract
Background: Both progression-free survival (PFS) and response rate (RR) are significantly improved when bevacizumab (Bev) is combined with first-line chemotherapy for locally recurrent/metastatic breast cancer (LR/mBC), as demonstrated in three randomized, phase III trials (E2100, AVADO, RIBBON-1). The benefit derived from Bev appears to be similar in triple-negative (TN) and non-TN LR/mBC according to subanalyses of the randomized trials. We conducted a subpopulation analysis of TN patients treated with first-line Bev-paclitaxel (Pac) in a large German observational study in the context of routine oncology practice. Methods: Patients with HER2-negative LR/mBC received first-line Bev-Pac according to the European label at the time of study design. Safety and efficacy data were collected for up to 1 year (or until progression, death, or Bev discontinuation if earlier). The endpoints were safety and efficacy (PFS and RR). We conducted an exploratory analysis of the subset of patients with TN disease.
Results: Of the 567 patients for whom data are currently available, 115 (20%) had TN disease. Baseline characteristics and efficacy are summarized below. Overall survival data are immature and follow-up is continuing.
Conclusions: In this ongoing study, first-line Bev-Pac demonstrated a 51% RR and median PFS of 7.7 months in patients with TN LR/mBC. These data are consistent with findings from retrospective analyses of randomized phase III trials and a subpopulation analysis of the ATHENA study. Prospective trials evaluating Bev combination regimens in TN breast cancer are ongoing.

Citation Information: Cancer Res 2010;70(24 Suppl):Abstract nr P2-16-12.
Abstract P2-16-13: Phase II Open Label Trial Bevacizumab in Combination with Paclitaxel and Gemcitabine as First Line in Patients with HER-2 Negative Recurrent or Metastatic Breast Cancer (AVALUZ): First Analysis
Authors: Salvador J , Jaen A , Ciruelos E , Codes de Villena M , Gil M , Murias A , Galan A , de la Haba J , Jara C , Bayo J , Baena JM , Casal J , Mel JR , Blancas I , Gonzalez E , Perez D , Manso L. 
Published: April 2011

Abstract
Background:
The combination of bevacizumab with taxanes, capecitabine or anthracyclines has shown increased progression-free survival in patients with metastatic breast carcinoma. The aim of this study is to evaluate the efficacy and toxicity profile of the combination of bevacizumab with gemcitabine and paclitaxel, providing a preliminary analysis of response in patients included for whom at least one response assessment and the toxicity experienced in all patients treated.
Methods:
A Phase II multicenter, national, open-label study in patients diagnosed of recurrent or metastatic HER-2 negative breast carcinoma, treated with first-line bevacizumab 10 mg/kg, paclitaxel 150 mg/m2 and gemcitabine 2000 mg/m2 day 1 and 15 c/28d until disease progression, unacceptable toxicity, or medical decision. This abstract evaluates efficacy by the response rate and the toxicity profile of the combination in all cycles of all patients included. The primary end-point of the study is PFS. Toxicity is evaluated according to NCI CTC v 3.0 criteria. Results:
From January 2009 to December 2009, 82 evaluable patients were recruited in 23 sites, with at least one response assessment available in 69. Median age 51.5 (26-81), ER+ 59 pts, PR+ 51 pts, triple negative patients 16 and previous chemotherapy (neoadj or adj) 58 pts. Of the 69 pts with response assessment, the last assessment is in cycle 3 for 31.88% of patients, cycle 6: 33.33%, cycle 9: 4.35%, cycle 12: 1.45% and at the end of treatment 29%. The median cycles administered per patient is 6 (1-14) and the relative median dose intensity is 0.93 for bevacizumab, 0.91 for paclitaxel, and 0.93 for gemcitabine.
The overall response obtained was 69.57%, with a clinical benefit of 89.86% (CR 8.7% (6), PR 60.87% (42), SD 20.29%, and DP 10.14%). Of the 82 patients with a median follow-up of 7.19 m (0.16-13.98), grade 3-4 toxicity affected 41%, with treatment discontinuation for adverse events in 19.51%. Eighteen SAEs were reported: pyrexia (4), infection at catheter site (2), urine infection and a single case of angor, hypertension, pulmonary embolism, pleural effusion, febrile neutropenia, neutropenia, vomiting, diarrhoea, dehydration, atrial fibrillation, and dizziness. Toxicity was generally easily controlled. Conclusions:
Although data from the primary study endpoint (PFS) are not yet available, the treatment regimen obtained a high overall response in patients treated and was well tolerated by this patient group.
Citation Information: Cancer Res 2010;70(24 Suppl):Abstract nr P2-16-13.
Abstract P2-20-01: Safety and Clinical Efficacy of Multiple Booster Inoculations with the E75 Adjuvant Breast Cancer Vaccine
Authors: Vreeland TJ , Clifton GT , Patil R , Clive KS , Sears AK , Holmes JP , Mittendorf EA , Ponniah S , Peoples GE. 
Published: April 2011

Abstract
Background: We are conducting clinical trials of the HER2/neu E75-peptide+GM-CSF vaccine in clinically disease-free breast cancer patients at high risk for recurrence. Our Phase I/II trials have shown that the vaccine is safe and effective in stimulating clonal expansion of E75-specific CD8+ T-cells; however, this peptide-specific immunity decreases over time. Due to this waning immunity, a voluntary booster program was initiated. Methods: Node-positive and high-risk node-negative patients who were clinically disease-free after surgery and standard adjuvant therapy were enrolled. HLA-A2/A3+ patients were vaccinated (VG), while HLA-A2/A3-patients were followed as controls (CG). Patients who were ≥6 months from the completion of their primary vaccination series (PVS) were offered booster inoculations every 6 months. Patients were monitored for local and systemic toxicity. Orthagonal mean of local reactions (LR) were measured after each booster inoculation. In HLA-A2+ patients, E75-specific CD8+ T-cells were quantified using the HLA-A2:IgG dimer immediately before and 1 month after each booster administration. Patients were monitored clinically and radiographically for recurrences.
Results: 188 patients were enrolled (109 VG, 79 CG). Fifty-three of the VG patients received at least one booster (B1), with 33 receiving a second booster (B2), and 20 a third booster (B3). Booster inoculations were well-tolerated with only grade 1 and 2 local and systemic toxicities. Compared to the LR at the end of the PVS (mean = 82±3mm), the mean LR increased at B1 (88±3 mm, p=0.13), B2 (94±6, p=0.02), and B3 (93±10 mm, p=0.04). Average CD8+ E75-specific T-cells did not change significantly prebooster (1.1±0.1%) compared to post-B1 (1.1± 0.1%, p=0.71) or post-B2 (1.4±0.2%, p=0.27) but did increase significantly post-B3 (2.4±0.3%, P&lt;0.01). Additionally, the percentage of HLA-A2+ patients with significant residual immunity (defined as &gt;0.5% CD8+E75-specific T cells) increased from pre-booster (29/43, 67%) to post-B3 (16/16, 100%; p=0.01). With 24 month clinical follow-up complete in all enrolled patients, there has been a nonsignificant decrease in recurrences observed in the VG compared to the CG (6.5% vs 13.1%, p=0.19), with no recurrences in patients who had received at least one booster inoculation by 24 months (0/40, 0%, vs 13.1% in CG, p=0.03).
Conclusions: The HER2/neu E75 peptide vaccine stimulates immunity that is maintained or increased with booster inoculations in disease-free breast cancer patients. The booster inoculations are safe, with minimal toxicity. The clinical efficacy of the E75 vaccine with booster inoculations will be further evaluated in a phase III trial.
Citation Information: Cancer Res 2010;70(24 Suppl):Abstract nr P2-20-01.