bluuebunny/crossref_metadata_2025_split huggingface dataset:
Breast cancer and renal insufficiency.
Authors: Wildiers H , Janus N , Byloos E , Machiels J , Duck L , Kerger J , Wynendaele W , Canon J , Lybaert W , Nortier J , Deray G , Launay-Vacher V 
Published: December 2010

Abstract
Abstract #6086
Background:&#x2028; The Belgian IRMA study (Renal Insufficiency and Anticancer Medications) reported the high prevalence of renal insufficiency (RI) in 1208 cancer patients, with a glomerular filtration rate (GFR) &lt;90 ml/min for 64%. Furthermore, 78.1% were receiving potentially nephrotoxic drugs and 78.8% drugs necessitating dosage adjustment in case of renal dysfunction. We present here the results for the 510 BIRMA patients with breast cancer.&#x2028; Methods:&#x2028; Data were collected for patients presenting at one of the 7 BIRMA centers in March 2006: tumor, sex, age, weight, height, serum creatinine (SCR), bone metastasis (BM) and anticancer drugs (including dose modification). Glomerular Filtration Rate (GFR) was estimated by the aMDRD formula.&#x2028; Results:&#x2028; 510 breast cancer patients were included: mean age 58.7 years, weight 68.1 kg, height 161.6 cm, 4 men, 46.9% of patients had BM. The prevalence of elevated SCR (&gt;=1.2 mg/dL) was 7.3%, of GFR&lt;90 ml/min/1.73m² 67.8%, and of GFR&lt;60 (threshold for many anticancer drugs to consider dose modification) 15.9% (Table). 86.6% of treated patients (n=486) were receiving at least one drug needing dosage adjustment in case of renal dysfunction and 73.4% received at least one potentially nephrotoxic drug. Furthermore, the prevalence of GFR&lt;90/60 was 74.9/24.3% for breast cancer patients with BM (Table). When comparing the prevalence of GFR&lt;90 between patients with or without BM (for patients with available GFR), the frequency of RI was significantly higher for BM patients (78.9 vs 69.9%, p=0.03).&#x2028; Conclusions:&#x2028; The results of the BIRMA study showed that RI is highly frequent in breast cancer patients in Belgium and that nearly 94% of the patients receive potentially nephrotoxic drugs and/or drugs for which dosage must be adjusted in RI. Furthermore, patients with BM had a higher rate of RI than patients without. These frequencies are higher compared to data from the NHANES study in the US general population, especially for breast cancer patients with a stage 3 RI for whom SCR was normal in 55.7% of the cases. This underlines that estimating renal function with formulae such as aMDRD is mandatory in every breast cancer patient, even when SCR is within the normal range.&#x2028; &#x2028;
Citation Information: Cancer Res 2009;69(2 Suppl):Abstract nr 6086.
Obesity and postmenopausal breast cancer: impact on risk, tumour stage and survival in an Irish population.
Authors: Healy LA , Ryan AM , Rowley S , Connolly EM , Kennedy MJ , Boyle T , Reynolds JV 
Published: December 2010

Abstract
Abstract #6089
Background &#x2028; The evidence that obesity adversely affects women's health is overwhelming and indisputable. The risk of postmenopausal breast cancer increases with obesity. Furthermore it is reported that obesity is associated with poorer prognosis of breast cancer.&#x2028; Objective&#x2028; To assess the relationship between obesity and postmenopausal breast cancer by examining the incidence, tumour size, pathological stage, axillary nodal involvement and survival in an Irish population.&#x2028; Design & Setting&#x2028; A retrospective case control study was undertaken in 200 patients presenting to a tertiary centre between 1998-2006. Data were compared to 519 healthy female controls. Multivariate logistic regression models were used to calculate the odds ratio (OR) of developing postmenopausal cancer according to body mass index (BMI), as well as the impact BMI has on tumour size, nodal involvement, pathological stage and survival. Actuarial survival was calculated from date of diagnosis by the Kaplein-Meier method and comparisons between the groups were made by the log rank test.&#x2028; Results&#x2028; Postmenopausal breast cancer patients were significantly heavier than age matched controls with 65% being overweight or obese versus 54% of controls (p=0.030). A dose dependent relationship existed between BMI and postmenopausal breast cancer incidence. The adjusted odds ratio was 2.2 (95%CI 1.3-3.7) for individuals in the highest BMI quartile compared to the lowest BMI quartile (P=0.002). Using common cut-offs for BMI, obese patients had double the risk of postmenopausal breast cancer compared to normal weight patients OR 2.04 (95%CI 1.3-3.3; p=0.004). There was no difference in symptomatic detection, assessment or treatment of breast cancer, however operative times were significantly longer for obese patients (P=0.05). Obesity was associated with larger tumours (P= 0.002) and a later stage of disease at presentation (P=0.026) but not with axillary nodal involvement (P=0.332). Median and overall survivals were equivalent (P=0.172) when comparing obese to non obese.&#x2028; Conclusion&#x2028; Obese women are twice as likely to get postmenopausal breast cancer compared to normal weight women. Understanding why obese women have a higher breast cancer incidence may lead to more effective breast cancer prevention and treatment interventions. Obesity is a preventable risk factor for breast cancer and given the high and increasing prevalence of obesity in Ireland, obesity needs to be addressed on a national level with targeted lifestyle treatment programs.
Citation Information: Cancer Res 2009;69(2 Suppl):Abstract nr 6089.
Ethnic and geographical variability of breast cancer at the Osh region in Kyrgyzstan.
Authors: Makimbetov EK , Samieva N , Karabaeva J , Dgumabaev AR , Rzaev R 
Published: December 2010

Abstract
Abstract #6096
Background. To study age, regional and ethnic breast cancer incidence at the Osh region of the Kyrgyz republic.&#x2028; Material and methods. Calculated the incidence of breast cancer between 1995 and 2005. There were registered 386 females with a new diagnoses of breast cancer. Collected dates from histological or cytological findings, and deaths certificates.&#x2028; Estimated population relative risk (RR) for breast cancer in the urban and rural areas. The population figures and cancer incidence rates for this report were provided in for age groups (0-4, 5-9, 75 &gt;) and ethnic groups. Counted crude, age-standardized rates (ASR) per 100 000. The classification scheme used by ICD-10.&#x2028; Results. Only one patient (0.3%) has T1N0M0 stage of disease. Stage distribution: II – 107 (28%), III – 233 (60.9%), IV – 41 (10.8%).&#x2028; ASR annual incidence in breast cancer was 6.51 (1995), 8.54 (2000), and 12.53 in 2005. Cancer incidence was significantly higher at the Osh city (17.87). Average rate was registered at the Karasu (8.06), Uzgen (7.09), Aravan (6.09), Naukat (6.4), and Karakuldga (6.14) regions. Low incidence was registered at the Alay (2.12), and Chonalay (4.55) areas.&#x2028; High incidence of breast cancer was registered in the urban (ASR-16.6) compared with rural regions with ASR 5.16 (RR=3.21, CI 95%- 2.7; 3.8)&#x2028; Relative risk for breast cancer was significantly higher in the Slavic ethnic groups (Ukraines and Russians with ASR of 66.4 cases per 100 000) compared with 3.75 for Kyrgyzs (RR=17.7), or 7.16 for Uzbek females (RR=9.27).&#x2028; High incidence rate of breast cancer was registered in female with the richest socioeconomic status (more than 80% cases), compared with poorest status. Also high incidence was demonstrated in female in reproductive time of live (53.1%), dysmenorrheal status (78.8%), and aborts in anamnesis (65.4%).&#x2028; Discussion. Breast cancer incidence at the Osh region of Kyrgyzstan is very low and similar to those reported from some developing countries. These analyses suggest that relative high risk in Russians compared with native ethnic groups may be related to some reproductive characteristics, number of child, socioeconomic status, and other.
Citation Information: Cancer Res 2009;69(2 Suppl):Abstract nr 6096.
Ixabepilone plus capecitabine vs capecitabine in patients with metastatic breast cancer receiving ixabepilone in the first line setting: a pooled analysis from two phase III studies.
Authors: Vahdat L , Fein LE , Karwal MW , Campone M , Peck R , Mukhopadhyay P , Jassem J 
Published: December 2010

Abstract
Abstract #6117
Background: Patients (pts) with breast cancer who progress within 1 year of adjuvant anthracycline (A) / taxane (T) therapy have limited options for first line treatment. Ixabepilone (ixa), the first in a new class of antineoplastic agents, showed clinical benefit in combination with capecitabine (C) in 2 large clinical trials in metastatic breast cancer (MBC) pts whose tumors were resistant to (study 046; JCO, 2007) or pretreated with A and T (study 048). In 048, ixa plus C, compared to C alone, demonstrated significant increases in PFS (HR 0.79 [0.69-0.90]) and ORR (43 vs. 29%). A trend towards increased OS was seen in both 048 (HR 0.90 [0.78-1.03] and 046 (HR 0.90 [0.77-1.05]) which did not reach statistical significance. Here we present a pooled analysis of efficacy outcomes (ORR, PFS and OS) from the 2 studies of pts who recurred within 1 year of adjuvant A/T therapy and received no prior metastatic treatment.&#x2028; Methods: 1973 pts with MBC previously treated with A and T were randomized in open-label, multinational trials (046 and 048) to receive either ixa (40 mg/m2 IV over 3h Q3w) + C (1000 mg/m2 PO BID x 14d Q3w) or C alone (1250 mg/m2 PO BID x 14d Q3w). Due to the similarity of the study populations, individual patient data from both studies was pooled to better evaluate treatment effect within pre-planned patient subgroups. 293 pts were randomized to ixa + C or C alone in the first line setting.&#x2028; Results: ORR and PFS favored ixa + C in this pt population, and there was a trend towards increased OS, which did not reach statistical significance (see table).&#x2028; &#x2028; Conclusions: Pooled analysis of individual studies confirmed significant ORR and PFS benefit of ixa + C compared to C in pts whose disease relapsed within 12 months of adjuvant A/T.
Citation Information: Cancer Res 2009;69(2 Suppl):Abstract nr 6117.
Phase II study of pegylated liposomal doxorubicin (PLD) and carboplatin (Cb) can be administered with trastuzumab (H) in patients with metastatic breast cancer.
Authors: Collea RP , Kruter FW , Cantrell JE , George TK , Kruger S , Favret AM , Lindquist DL , Melnyk Jr. AM , Pluenneke RE , Shao SH , Crockett MW , Asmar L , O'Shaughnessy JA 
Published: December 2010

Abstract
Abstract #6118
Background: PLD and Cb are active in metastatic breast cancer (MBC) but no data exist regarding the antitumor activity of the combination. Both agents are synergistic with H in preclinical studies. The primary objective of this study was to determine the objective response rates (ORR) produced by PLD+Cb ± H.&#x2028; Patients and Methods: 133 patients (pts) were registered to the study; 125 pts were treated and were stratified by HER2 status; 124 pts are currently evaluable for response. Pts had measurable disease per RECIST criteria and had received no more than 1 prior chemotherapy regimen for MBC; HER2+ pts received therapy first-line therapy for metastatic and 4% received prior adjuvant H. All pts received PLD 30 mg/m2 IV followed by Cb, AUC=5 IV on Day 1 of 28-day cycles. In addition to PLD+Cb, HER2+ pts received H on Day 1 and Day 15 (8 mg/kg IV first dose; 4 mg/kg IV subsequent doses).&#x2028; Results: 79 pts and 46 pts received at least 1 dose of study drug on PLD+Cb (Arm 1) and PLD+Cb+H (Arm 2), respectively. Median age was 56 years. Estrogen receptor (ER) or progesterone receptor (PR) + pts and ER and PR- pts in Arm 1/Arm 2 were 63%/55% and 36%/45%, respectively, 49%/43%; pts were treated with prior doxorubicin in Arm 1/Arm 2 and 51%/30%. With prior taxane in Arm 1/Arm 2, of 79 pts on Arm 1 evaluable for response, 27% had an objective response compared with 53% of the 45 pts currently evaluable on Arm 2. Median overall survival was 17 months in Arm 1 and as not been reached in Arm 2. Median PFS is 5 and 10 months for Arm 1 and 2, respectively. The most common Grade 3-4 treatment-related toxicities for Arm 1/Arm 2 were: neutropenia 23%/35%, leukopenia 13%/22%, thrombocytopenia 20%/17%, fatigue 6%/13%, and anemia 11%/9%.&#x2028; Conclusion: PLD+Cb in combination have moderate activity in MBC; also, the addition of H to PLD+Cb in HER2+ pts enhanced its activity. Preliminary toxicity results suggest that PLD can be safely combined with H with minimal cardiac toxicity. Final data analyses from this fully enrolled study will be reported at SABCS 2008.&#x2028; This research was supported, in part, by a research grant from Ortho Biotech Clinical Affairs, LLC, Bridgewater, NJ.
Citation Information: Cancer Res 2009;69(2 Suppl):Abstract nr 6118.
Efficacy of palliative chemotherapy for metastatic breast cancer according to HER2-status and basal cytokeratin expression.
Authors: Kahlert S , Mainka P , Knall E , Bauer K , Mayr D 
Published: December 2010

Abstract
Abstract #6123
Introduction: The majority of patients (pts.) with metastatic breast cancer (MBC) will receive cytotoxic therapy (CT) at one time. Predictive factors for the choice of the optimal regimen are not available with the exception of the Her2-status. Triple-negative tumors, especially basal-like tumors are associated with impaired prognosis and sensitivity to CT in several studies without the option of endocrine or anti-her2 targeted treatment. Usually identification of these cases is done by gene expression assays. We tried to identify effective CT regimens in a retrospective trial for this subgroup.&#x2028; Methods: We reviewed all patient files of women receiving at least one line of palliative CT in our institution from 1991 to 2005 and searched the archive of the institute of pathology for evaluable paraffin embedded tissue. In available material estrogen receptor (ER), progesterone receptor (PgR), Her2 Status and basal cytokeratins CK 5/6 and CK14 were determined by IHC and/or FISH (Her2). A tumor was defined as basal-like, if CK5/6 or CK14 were expressed in more than 10% off all tumor cells. The tumors were divided into four subgroups: ER/PgR positive and HER2 negative (ER/PgR+), Her2 positive (HER+), triple negative and no expression of CK5/6 or CK 14 (non-basal) and triple negative basal-like tumors (basal).&#x2028; Results: We identified 240 pts. receiving 455 lines of palliative CT (240 1st line, 114 2nd line, 53 3rd line and 48 4th – 7th line). Regimens contained anthracyclines (44%), taxanes (27%), vinca alkaloids (15%), capecitabine (8%), platinum salts (4%) and trastuzumab (15%). 43% of the regimens were combination therapies.&#x2028; The subgroups were ER/PgR+ (46%), HER+ (28%), non-basal (10%) and basal (16%). Survival of basal tumors was significantly shorter (10.7 months (mo.)) than the other groups (non-basal 23.7, HER+ 22.0 and ER/PgR+ 28.1 mo., p=0.001). Mean time to treatment failure (TTF) in the four groups was 2.1 (basal), 4.0 (non-basal), 5.5 (HER+) and 5.7 mo. (ER/PgR+).&#x2028; Although anthracycline based therapies showed longer TTF in all four groups, the difference reached significance only in ER/PgR+ pts. (5.0 vs. 7.2 mo., p=0.004). Taxanes showed significantly lower TTF in ER/PgR+ pts. (6.3 vs. 4.3 mo., p=0.03). Use of combination therapy showed significant benefit for ER/PgR+ pts. (6.0 vs. 9.4 mo., p=0.008 (1st line only)).&#x2028; Capecitabine, vinca alkaloids and platinum salts were used too seldom to draw conclusions.&#x2028; Conclusions: Use of IHC for CK5/6 and CK14 helped to identify a subgroup of pts. with adverse prognosis of MBC compared to the other groups. This finding is consistent for all types of CT. We were not able to detect regimens of superior efficacy for this subgroup. The availability of IHC can ease additional studies in larger cohorts.
Citation Information: Cancer Res 2009;69(2 Suppl):Abstract nr 6123.
Results of the German fulvestrant in practice evaluation programme to evaluate the efficacy, safety, tolerability and acceptance of fulvestrant under daily routine conditions.
Authors: Warm M , Kates R , Overkamp F , Zaun SG , Harbeck N 
Published: December 2010

Abstract
Abstract #6132
Material and Methods: Fulvestrant is an estrogen receptor (ER) antagonist with a distinct mode of action used in the treatment of postmenopausal women with advanced breast cancer progressing or recurring on an antiestrogen. 848 postmenopausal women with ER+ advanced mamma carcinoma, relapsed during or after adjuvant anti-estrogene treatment, or with a disease progression under an anti-estrogene therapy, were enrolled in this Fulvestrant In Practice Evaluation Programme (IPEP). Under daily routine conditions and without intervention by the sponsor regarding selection of subjects, diagnostic procedures or therapeutic decisions relevant data of the fulvestrant therapy was documented over a period of 9 months. Results: The median patient age was 64 years, 52 % of patients had a co-morbidity, 78 % one or more prior palliative therapies. Efficacy: Clinical benefit was observed in 627/848 patients, including 62 complete and 177 partial remissions. Best response was delayed in 115 patients (not seen at 3 months but at 6 months). Estimated 9-month overall survival (OS) was 89%; 9-month event-free survival (EFS) was 71%. Safety: 244 non-serious adverse events by patient were recorded, most commonly General disorders and administration site conditions, gastrointestinal and musculo-sceletal symptoms. Excluding deaths, 7 serious adverse events were recorded (none attributed to fulvestrant); no new or unexpected safety issues arose. 20 patients died during observation. Tolerability: Tolerability was judged as good to very good by the majority of both specialists and patients with stable values at 3, 6 and 9 months. Acceptance of injection: The vast majority of both doctors and patients found the application via injection to be acceptable or very acceptable, the handling was judged by the doctors as mostly good to very good. Conclusion: Fulvestrant treatment was well tolerated and well accepted in this palliative patient collective, no new safety findings occurred. The treatment showed good efficacy with any patient, who had achieved disease stabilization or better after three months being likely to gain survival benefit from prolonged Fulvestrant therapy. Best response often occured delayed.
Citation Information: Cancer Res 2009;69(2 Suppl):Abstract nr 6132.
Results of randomized phase II trial combining Iressa® (gefitinib) and arimidex in women with advanced breast cancer (ABC). EORTC protocol 10021.
Authors: Mauriac L , Cameron D , Dirix L , Blot E , Piccart M , Marreaud S , Tjan-Heijnen V , Cufer T , Bogaerts J , Atalay Basaran G 
Published: December 2010

Abstract
Abstract #6133
Background: Preclinical data suggest that EGFR inhibitors could overcome endocrine resistance in breast cancer. This European multicenter, double-blind, placebo-controlled trial was designed to test the hypothesis that Gefitinib (G), as inhibitor of the EGFR pathway, can delay the onset of endocrine resistance in ABC. Methods: Postmenopausal patients (pts) previously treated for ABC (including locally recurrent or metastatic or elderly with locally ABC or bone metastases only) were randomly assigned in a 1:1 ratio to G 250 mg/day plus anastrozole (A, 1 mg/day) or to placebo plus A. Prior treatment with an aromatase inhibitor in metastatic setting or trastuzumab or anti EGF or anti VEGF was not allowed. Treatment was given until progression of the disease, unacceptable toxicity or patient refusal and the progression free rate was assessed at one year with disease evaluations according to RECIST performed every 8 weeks.&#x2028; Results: The trial was prematurely closed in August 2007 due to slow recruitment. Seventy one out of a planned 108 pts were entered with a median age of 64 (range 42-84). 26 pts had prior chemotherapy and 43 prior endocrine therapy (adjuvant tamoxifen 60% and metastatic 16%). Median PS was 0 and 41 pts had visceral disease. To date, 326 months of treatment have been fully documented, for a median duration of 6 months. For 36 pts end of treatment has been reported: 26 due to progression and 6 due to toxicity (including one SAE: diarrhea gr 3 and spastic dyspnea gr 2). The most common adverse events were fatigue (49%), arthralgia/myalgia (39%), nausea (37%), diarrhea (35%), rash (35%), bone pain (29%), and hot flushes (26%).To date, the estimated progression free rate at one year is 42%. Conclusion: All patients will reach one year of follow up in August 2008. The database has not been unblinded yet. By the time of the conference unblinded final results will be available. A late breaking abstract will be sent in September.
Citation Information: Cancer Res 2009;69(2 Suppl):Abstract nr 6133.
A prospective characterization of the resolution of ixabepilone induced peripheral neuropathy: data from a large registrational program in patients with metastatic breast cancer.
Authors: Perez E , Pivot X , Vrdoljak E , Sparano JA , Vogel C , Peck R , Mukhopadhyay P , Vahdat L 
Published: December 2010

Abstract
Abstract #6140
Background:&#x2028; Ixabepilone (ixa), the first in a new class of antineoplastic agents, showed clinical benefit in combination with capecitabine (C) in 2 large clinical trials in metastatic breast cancer (MBC) pts whose tumors were resistant to (study 046, JCO, 2007) or pretreated with anthracycline (A) and taxanes (T) (study 048). In 048, ixa + C, compared to C alone, demonstrated significant increases in PFS (HR 0.79 [0.69-0.90]) and ORR (43% vs 29%). A trend toward increased OS was seen both in 048 (HR 0.90 [0.78-1.03]) and in 046 (HR 0.90 [0.77-1.05]), which did not reach statistical significance. Similar to taxanes, dose-limiting peripheral neuropathy (PN) is a side effect associated with ixa treatment. Here we present the incidence rates, management of ixa-induced PN from 3 registrational studies in pts with MBC and an analysis of resolution time. Also, data on potential risk factors for PN are presented.&#x2028; Methods:&#x2028; Incidence of PN is summarized from a 2000 pt program from 3 multi-center clinical trials. In this program, almost 1100 pts with MBC received ixa either as a monotherapy (40 mg/m2 IV over 3h Q3w, N=126) in a phase II study, or in combination with C (1000 mg/m2 PO BID x14d Q3w) in 2 large phase III studies (N = 369 and N = 595). PN was evaluated every 4 weeks after completion of treatment until toxicity was resolved. Resolution of PN was defined as the time from onset of worst grade to baseline or grade 1. A Cox regression analysis was also performed on a dataset of 945 pts with different tumor types across multiple studies, receiving ixa as a monotherapy or in combination with C, to identify the potential risk factors for grade 3/4 PN.&#x2028; Results:&#x2028; Incidence rates of grade 3/4 PN and resolution time observed in 1 phase III study (046) and the phase II (081) have been published before (081: JCO, 25; 3407). Here we present the data from the final confirmatory phase III study (048).&#x2028; &#x2028; PN was effectively managed with dose reduction. After dose reduction, symptoms improved or did not worsen in the majority of pts, and a median of 2-3 additional treatment cycles were delivered. Pts with diabetes were at a higher risk of grade 3/4 PN (HR: 1.67 [1.00-2.78], p-value = 0.049).&#x2028; Conclusions:&#x2028; Incidence of ixa-associated PN was similar to that observed in trials of other T based regiments. Ixa-induced PN has a predictable median time to resolution of 5-6 weeks over 3 large studies.
Citation Information: Cancer Res 2009;69(2 Suppl):Abstract nr 6140.