bluuebunny/crossref_metadata_2025_split huggingface dataset:
Quality of life evaluation and decision-making after mastectomy for breast reconstruction of breast cancer patients.
Authors: Kalder M , Eibisch T , Hadji P , Wagner U , Albert U 
Published: December 2010

Abstract
Abstract #4098
Background:&#x2028; What is the level of information and the information needs of Breast Cancer patients after mastectomy regarding secondary breast reconstruction. Evaluation of the impact of a mastectomy regarding Quality of Life, satisfaction with the surgical result and personal job situation as well as the influence of a partnership according to the Quality of Life parameters.&#x2028; Material and Methods:&#x2028; From January 2000 until May 2003 a number of 282 women suffering from Breast Cancer underwent a mastectomy for various indications. During the routinely Breast Cancer follow-up Quality of Life was assessed using the EORTC QLQ-C30 questionnaire and the breast cancer specific module BR23 in patients at least one year after the mastectomy. 149 (52.8%) patients were excluded for the following reasons: Local recurrence (5%), pT4 stage cancer (3.5%), performed secondary breast reconstruction (22%) and an age of over 75 years (22.3%). 3.5% of the remaining 133 (47.2%) patients died, 3.5% moved with unknown address and 7.1% refused the questionnaire. All together 86 (30.5%) questionnaires could be evaluated.&#x2028; Results:&#x2028; 93% of the patients were aware of the possibility to have a breast reconstruction.&#x2028; Patients satisfied with the results of the surgical procedure comprised a higher level of content with their body image and reported higher overall Quality of Life compare to less satisfied patients.&#x2028; Patients with a good body image had significantly less problems showing themselves nude to their partner (p &lt; .0001) and accepted physical touch by them in the breast region significantly more frequently (p &lt; .004) compared to those with a poor body image.&#x2028; 16% of the patients underwent secondary breast reconstruction between the last follow-up and the start of the questionnaire. 8% of the patients made the decision for breast reconstruction after filling in the questionnaire due to more information.&#x2028; Discussion:&#x2028; Although the majority of patients were well informed about the modalities of breast reconstruction, an additional 8% of the patients made a decision for breast reconstruction. In conclusion, due to our observation, additional information to patients about the possibility of secondary breast reconstruction even after one or more years, can lead to an unexpected high number of secondary breast reconstruction. We believe that this further information should be integrated into routine clinical practice.
Citation Information: Cancer Res 2009;69(2 Suppl):Abstract nr 4098.
Adjuvant chemotherapy with or without darbepoetin in node-positive breast cancer: a safety analysis from the phase III ARA plus trial.
Authors: Nitz U , Oberhoff C , Reimer T , Schumacher C , Hackmann J , Warm M , Uleer C , Runde V , Gluz O , Zuna I 
Published: December 2010

Abstract
Abstract #4100
Background: Modern adjuvant chemotherapy regimens may cause considerable anemia. Epoetins are currently used to reduce chemotherapy-associated anemia (CAA) rates in a variety of solid tumors. The discussion of potential effects on survival rates is highly controversial. The ARA Plus trial is a prospective randomized trial comparing adjuvant chemotherapy +- darbepoetin (ARA+ / ARA-) in node-positive breast cancer patients.&#x2028; Methods: Inclusions criteria were: age of 18 to 65 years, positive lymph nodes (LN) after resection of &gt;10 LN, free margins , M0 status confirmed by conventional staging. At the discretion of the investigating centre patients could receive 6 cycles T75A50C500 or 6 cycles F500E100C500) q3w. They were randomized to darbepoetin (ARA+) 500μg q3w until completion of radiotherapy or to standard supportive care. Darbepoetin was started at Hb level &lt;13 g/dl (amendment 01/2008 at Hb &lt;12g/dl) and stopped at 14 g/dl.&#x2028; Event free survival (EFS) is the primary endpoint. Overall survival, toxicity, Hb-levels and quality of life are secondary endpoints.&#x2028; Results: 1234 pts (616 ARA+/618 ARA-) from 70 centres in Germany were randomized from 01/04 to 05/08. 1130 received TAC and 104 FE100C. Baseline characteristics are well balanced in ARA+ and the ARA- patients: median age 53/53, median tumor size 2.4/2.4cm, median number of + LN is 3/3, HR+. 78%/ 75% , G3 36%/40%.&#x2028; Deaths: There was 1 therapy-related death due to septic fever in the ARA+ group.&#x2028; SAEs: in 1234 patients 279 serious adverse events (SAE) were reported (150 ARA+ vs. 129 ARA-). Most frequent SAEs were: leucopenia, febrile neutropenia (ARA+ 14 vs. ARA- 21)., infections and thrombosis. In ARA+ patients we observe a modest higher rate of thrombosis and cardiovascular events (ARA+ 24 vs. ARA- 13),&#x2028; Toxicity: In 3429 documented cycles in 624 patients, there was significantly more anemia and diarrhea in ARA- patients and leucopenia, vomiting and nausea in ARA+ patients. In the ARA+ patients Hb-levels were stable over the whole treatment period (mean values from cycle 1-6: 12.9- 12.4g/dl, median of all cycles: 12.5 g/dl). In ARA- patients Hb-levels decreased during therapy (mean values from cycle 1-6 :13.0 -11.2g/dl, median of all cycles 11.6g/dl). Overstimulation in ARA+ patients were rare (highest reported Hb 15.8g/dl).&#x2028; Conclusions: The ARA plus trial is the largest prospectively randomized trial ever done in early breast cancer exclusively focusing on the impact of adjuvant darbepoetin on outcome. The majority of the patients received 6 cycles TAC. In these patients overstimulation is an rare event. Short term toxicity and safety data are reassuring. Toxicity analysis and events on 1000 intensively monitored patients will be available in 11/08.
Citation Information: Cancer Res 2009;69(2 Suppl):Abstract nr 4100.
Cardiac safety of adjuvant bevacizumab (B) plus dose-dense doxorubicin/cyclophosphamide (AC) followed by nanoparticle albumin-bound paclitaxel (nab-P) in patients with early stage breast cancer.
Authors: McArthur HL , Rugo H , Nulsen B , Traina T , Patil S , Zhou Q , Steingart R , Dang C , Park J , Moasser M , Melisko M , Sugarman S , Norton L , Hudis C , Dickler MN 
Published: December 2010

Abstract
Abstract #4104
Background: Dose dense (dd) q2wk AC-paclitaxel (P) is superior to q3wk AC-P. Both regimens are associated with a &lt;1% incidence of CHF. In MBC, q3wk nanoparticle albumin-bound paclitaxel (nab-P) is superior to q3wk P and bevacizumab (B) improves progression-free survival when added to P. Based on the MBC data, B may be more effective when targeting minimal residual disease in the adjuvant setting and nab-P may offer superior efficacy with reduced toxicity. However, it is uncertain whether AC plus B increases the risk of CHF. We evaluated the cardiac safety of ddAC-nab-P with concurrent B as adjuvant therapy for BC.&#x2028; Methods: Based upon the accepted cardiac event (CE) rate of approximately 4% in trials with adjuvant trastuzumab, this study was designed with similar monitoring and tolerability thresholds. The primary endpoint is cardiac safety: symptomatic CHF or death from LV dysfunction. Secondary endpoints are toxicity, DFS, OS, and biomarkers for efficacy and toxicity. Eligible pts have resected HER2(-) BC and normal LVEF. B is administered concurrently (10 mg/kg IV q2wk x 8) with chemotherapy (AC at 60/600 mg/m2 q2wk x 4 then nab-P at 260 mg/m2 q2wk x 4) and continues at 15 mg/kg q3wk thereafter for a total one year of B therapy. Pegfilgrastim is administered Day 2 of each chemotherapy cycle. Radiation and endocrine therapy are administered per standard of care. MUGAs are obtained at baseline and mos 2, 6, 9 and 18. Although asymptomatic LVEF declines are not considered CEs, B may be held per protocol and long-term cardiac monitoring initiated. If 3 CEs or &gt; 1 cardiac death from LV dysfunction occur, B + ddAC-nab-P will not be considered safe.&#x2028; Results: The target accrual of 80 pts has been met. Median age is 47y (27-75). As of May 31, 2008, median follow-up is 14 mo (1-21) and 51 pts have completed 1y of planned therapy. No patients have developed symptomatic LV dysfunction at any point during study therapy. Sixteen pts have discontinued treatment due to toxicity: asymptomatic LVEF decline (N=3), hypertension (N=3), wound healing (N=3), headache (N=2), sensory neuropathy (N=2), pain (N=1), hypersensitivity reaction (N=1), and pneumonitis (N=1). Three pts had disease progression, and 8 pts withdrew consent.&#x2028; &#x2028; Conclusions: At the time of this analysis, no symptomatic LV dysfunction has been observed with B + ddAC-nab-P. Follow-up is ongoing. Correlative studies, including analysis of troponin, renin, and circulating endothelial and tumor cells, are underway.
Citation Information: Cancer Res 2009;69(2 Suppl):Abstract nr 4104.
Toxicity analysis of a phase III study evaluating FEC-Doc vs. FEC-Doc in combination with gemcitabine as adjuvant treatment for breast cancer – the SUCCESS-trial.
Authors: Rack BK , Janni W , Genss E , Schneeweiss A , Rezai M , Hilfrich J , Lorenz R , Chatsiproios D , Schneider A , Sommer H , Lichtenegger W , Beckmann MW , Friese K 
Published: December 2010

Abstract
Abstract #4108
Background:&#x2028; Taxane containing regimens have been established as standard of care for node-positive primary breast cancer patients and have shown superiority to mere anthracycline containing regimens. The SUCCESS-trial evaluates, whether adjuvant taxane based treatment can be further improved by the addition of Gemcitabine.&#x2028; Methods:&#x2028; The SUCCESS-Study is an open-label randomized controlled, Phase III study comparing the disease free survival after randomisation in patients treated with 3 cycles of Epirubicin(100 mg/m²)-Fluorouracil(500)-Cyclophosphamide(500, FEC)-chemotherapy, followed by 3 cycles of Docetaxel(100 mg/mg², D) versus 3 cycles of FEC, followed by 3 cycles of Gemcitabine(1,000mg/m² d1,8)-Docetaxel(75 mg/m²)(DG). Complete, monitored toxicity data of 2.691 pts were available for this analysis.&#x2028; Results:&#x2028; Dose reduction &gt;20% (3.97% vs 2.90%) and postponement of treatment cycles &gt;7die (22,85% vs 14.19%) was rare, but more frequent in the FEC-DG arm (both p&lt; .001). Cytostatic treatment was prematurely stopped in 119 pts (4,4%) receiving FEC-DG and in 103 pts (3,8%) with FEC-D (p=0,21). G-CSF support was applied in 850 (29.2%) vs. 602 pts (20.7%, p&lt; .001). Toxicities NCI grade &gt; 2 which occurred with incidence &gt; 1% or significantly different in the two arms are depicted in Table 1. Afebrile and febrile neutropenia and anemia did not differ between the two arms, but thrombocytopenia was more frequent in FEC-DG (1.7%, p= .007). Hand-foot syndrome and neuropathy was more frequent in the FEC-D arm (p= .09 and p= .02, respectively).&#x2028; Conclusion:&#x2028; No unexpected toxicities were observed and severe adverse effects were rare in both treatment arms. With the addition of gemcitabine to FEC-D adjuvant chemotherapy toxicity was moderately increased. Outcome data will have to be awaited to further interpret these findings.
Citation Information: Cancer Res 2009;69(2 Suppl):Abstract nr 4108.
Adjuvant chemotherapy for breast cancer – prognostic impact of relative dose-intensity.
Authors: Kahlert S , Rosenfeld J , Mair K , Sorokina Y , Engel J , Friese K 
Published: December 2010

Abstract
Abstract #4109
Introduction: Maintenance of adequate dose intensity (DI) is an important aim in the use of adjuvant chemotherapy for early breast cancer. Some studies report a decreased survival, if the DI is below 80% of the planned dose. We evaluated the rate of decreased DI and its prognostic impact for patients (pts.) treated in our institution between 1990 and 2004. During the long observation period a variety of regimens were used: CMF, normal dosed anthracycline (norA) based regimens (Epirubicin less than 35 mg/sqm*week) and higher dosed anthracyclines (hiA; Epirubicin doses of more than 45 mg/sqm*week).&#x2028; Methods: All patient files were reviewed to calculate relative DI; cycles not applied were treated as a 100% dose reduction. Follow up-data were taken from our institutional prospective data base and the regional tumor registry. Excluded from the analysis were pts. with high dose chemotherapy with stem cell support, rare regimens (less than 10 cases / regimen), pts. switching institution during therapy and pts. progressing during chemotherapy.&#x2028; Results: From 966 pts. receiving adjuvant chemotherapy, 887 matched the inclusion criteria. Mean follow up is 70 months with 260 distant progressions and 234 deaths. 193 pts. received CMF, 442 norA and 252 hiA, 302 pts. received taxanes. Preterm termination of chemotherapy occurred in 77 pts (8.7%), dose reductions in 36 pts. (4.1%). Pts. receiving hiA were at higher risk for dose reductions than with norA and CMF (7.5% vs. 2.9% vs. 2.1%, p=0.015). Mean dose delays were 12.7 days (CMF), 6.4 days (norA) and 5.7 (hiA) (p&lt;0.01, Kruskal-Wallis-test). The mean rel. DI were 90% (CMF), 93% (norA) and 92% (hiA) and significantly different (p=0.01, Kruskal-Wallis-test).&#x2028; In univariate analysis, 5 year-metastasis free survival (MFS, 74% vs. 55%, p=0.002) and overall survival (OAS, 80% vs. 65%, p=0.009) are significantly lower for pts. with a rel. DI of less than 80%. This effect seems more pronounced for norA (OAS 80% vs. 45%), than for CMF (OAS 74% vs. 74%) and hiA (OAS 85% vs. 77%). The adverse effect of low DI was independent of taxan-use. In a cox-regression analysis low DI was not identified as independent predictor for MFS and OAS.&#x2028; Conclusions: Compared to DI reported from most prospective randomised trials the DI in this study seems lower, potentially reflecting patient selection. Dose reductions, delays and preterm termination are common findings, leading to impaired DI. In our study low DI is associated with adverse prognosis in univariate, but not in multivariate analysis. Nevertheless, unnecessary dose modifications should be avoided.
Citation Information: Cancer Res 2009;69(2 Suppl):Abstract nr 4109.
Incidence and impact of abnormal liver function in patients receiving adjuvant chemotherapy for early breast cancer.
Authors: Macpherson IR , Laskey J , Harden S , Canney P 
Published: December 2010

Abstract
Abstract #4112
Background: Abnormalities in liver function tests (LFTs) which complicate adjuvant polychemotherapy may prompt prescribers to institute a dose reduction or delay due to fears of altered pharmacokinetics and increased toxicity. However, inappropriate reduction in dose intensity is associated with reduced efficacy of adjuvant therapy. We wished to identify the incidence of abnormal liver function and its influence on decision-making and toxicity in patients (pts) receiving adjuvant chemotherapy for early breast cancer in the west of Scotland.&#x2028; Methods: Data including baseline characteristics, LFTs (bilirubin, AST, ALT) on day 1 of each chemotherapy cycle, hematologic and grade 3/4 non-hematologic toxicity, dose delay or dose reduction were prospectively collected for 160 female pts commencing adjuvant chemotherapy at the Beatson West of Scotland Cancer Centre between August 2005 and February 2006. Association between LFT abnormality on day 1 of each chemotherapy cycle and toxicity occurring within that cycle was determined.&#x2028; Results: The most common regimen administered was Epirubicin-CMF (n=128; epirubicin 100mg/m2 q3/52 x4; cyclophosphamide 600mg / m2, methotrexate 40mg/m2, 5-FU 600mg/m2 d1+8 q4/52 x 4) followed by AC (n=25; Doxorubicin 60mg/m2, Cyclophosphamide 600mg/m2 q3/52 x4), FEC (n=5) and CMF (n=3). Median age was 55 yrs. Febrile neutropenia or grade 3 /4 non-hematologic toxicity were recorded in 1.9% and 3.2% of cycles respectively. 8.5% of all cycles were delayed and 14% of pts (n=23) had a dose reduction. In only 1 patient was dose reduction due to abnormal LFTs. Grade 1, 2 or 3 hyperbilirubinemia occurred in 3%, 2% and 0% of pts respectively. Grade 1, 2 or 3 elevated ALT occurred in 39%, 9% and 3% of pts. Grade 1, 2 or 3 elevated AST occurred in 38%, 4%, and 1% of pts respectively. No episodes of grade 4 hyperbilirubinemia or elevated transaminases occurred. Despite receiving chemotherapy at full dose no patient with grade 2/3 elevated AST or ALT on day 1 of a chemotherapy cycle experienced either grade 3/4 non-hematologic toxicity or febrile neutropenia in that cycle.&#x2028; Discussion: Although grade 1 elevation in transaminases was common, particularly in the context of the Epirubicin-CMF regimen, grade 2 or 3 abnormalities were infrequent. The absence of grade 3/4 chemotherapy-related toxicity in pts with grade 2/3 LFT abnormality supports maintenance of full dose anthracycline-based polychemotherapy in this population.
Citation Information: Cancer Res 2009;69(2 Suppl):Abstract nr 4112.
Immunotherapy with MUC1/CEA vaccine alone or combined with chemotherapy in patients with metastatic breast cancer.
Authors: Mohebtash M , Madan R , Arlen P , Jacquin J , Mary P , Oksook H , Myrna R , Jeffrey S , James G 
Published: December 2010

Abstract
Abstract #4123
Background: PANVAC is a recombinant pox viral vaccine that contains transgenes for the tumor-associated antigens (TAAs), MUC1 and CEA. PANVAC also contains three T-cell co-stimulatory molecules (B7.1, LFA-3, ICAM-1) to enhance immune response. Clinical studies with a similar vaccine have shown docetaxel does not diminish specific T-cell responses to the TAAs delivered in the pox viral vaccines. We are evaluating the use of PANVAC in two ongoing trials in patients with metastatic breast cancer.&#x2028; Methods: The primary end point of these two phase II trials is progression-free survival (PFS). As secondary end point specific T-cell response is measured using ELISPOT assay in HLA-A2 patients. One study uses vaccine alone, given monthly by SC injections and is accompanied by 4 days of low dose GM-CSF. The other trial randomizes to either vaccine + docetaxel or docetaxel alone; giving the same V regimen (as the first study) on day 1 followed by docetaxel at 35 mg/m2 on days 2, 9, and 16 of each 28 day cycle. The chemotherapy alone arm uses the same docetaxel dosing.&#x2028; Results: Twenty three patients have been accrued with a median age of 57.6 (31-75) years. Sixteen patietns had ER/PR+ tumors. The patients had a median of 4 (0-6) previous chemotherapy regimens; their median time since their last chemotherapy was 2 months with a 10th – 90th percentile of 1-8 months. Vaccine is well tolerated with few grade 3 and no grade 4 adverse events. Most of the grade 1-2 toxicities were self-limited site reactions and flu-like symptoms. Three of 13 patients on vaccine alone study have shown measurable clinical benefits. Two were on study for 6 months, of whom one had significant improvement in pain with reduction in vertebral lesions on MRI; another had a sustained &gt;20% decrease in bulky liver metastases. A third patient on vaccine alone was on study for 9 months with reduction in her mediastinal lymphadenopathy. Of the 6 patients who received vaccine + docetaxel, 5 had measurable disease. One achieved PR by RECIST criteria and remained on study for 19 months; another had a 50% reduction in the diameter of a chest wall lesion. A third patient with bone only disease was on study for 12 months with significant improvements on her bone scan.&#x2028; Conclusions: Vaccine given alone or in combination with docetaxel is shown to be safe in patient with metastatic breast cancer. There is preliminary evidence that there may be some clinical benefit from vaccine alone as well as its combination with chemotherapy. Confirmation of these results and PFS determination requires additional patient enrollment and follow up in both studies. Furthermore, immunologic studies including functional analysis of CD4 and CD8 T-cells will be performed to help elucidate the immune responses these regimens may elicit.
Citation Information: Cancer Res 2009;69(2 Suppl):Abstract nr 4123.
The role of systemic therapies in the development of lung sequelae after conformal radiotherapy in breast cancer patients.
Authors: Varga Z , Cserháti A , Boda K , Thurzó L , Kahán Z 
Published: December 2010

Abstract
Abstract #4125
Some data suggest that adjuvant systemic therapies like tamoxifen and paclitaxel play a role in the development of radiogenic lung toxicity.&#x2028; Early and late radiogenic lung sequelae were prospectively studied in patients receiving sequential taxane-based chemotherapy (Tax), concomittant hormone therapy with tamoxifen (Tam) or aromatase inhibitor (AI), or no systemic therapy (C) according to the institutional guidelines. Clinical signs, radiologic abnormalities and the mean lung density changes measured at the level of the left heart ventricle (MDCLHV) and the head of the clavicle (MDCHC) of the irradiated lung on CT were evaluated according to Kahan et al., Int. J. Radiat. Oncol. Biol. Phys., 2007.&#x2028; The incidence of pneumonitis grade I with or without clinical symptoms did not significantly differ between the 4 groups. None of the patients developed symptomatic radiogenic lung fibrosis one year after the radiotherapy, however, radiogenic CT changes were significantly more frequent in the group treated with Tam. No differences in the MDCLHV and MDCHC values according to systemic therapy were detected 3 months or 1 year after the radiotherapy (Table). Significant positive associations existed between radiogenic lung changes with or without clinical symptoms and the age of the patient, the ipsilateral mean lung dose (MLD), the volume of the ipsilateral lung receiving ≥20 Gy (V20 Gy) and the irradiation of the axillary and supraclavicular lymph nodes. Extended data and statistical analysis including multiple linear regression and multivariate logistic regression models will be presented.&#x2028; &#x2028; &#x2028; &#x2028;
Citation Information: Cancer Res 2009;69(2 Suppl):Abstract nr 4125.