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Background The first-in-class oral inhibitor of cyclin-dependent kinases 4 and 6 (CDK4/6) palbociclib, combined with hormonal therapy, is a new standard of treatment in the first and second line for hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) metastatic breast cancer (mBC). Purpose To describe the effectiveness and safety of palbociclib combination therapy for mBC in clinical practice. Material and methods Retrospective and observational study in which the effectiveness and safety of palbociclib was tested by reviewing medical and pharmaceutical records of all patients treated with the drug from December 2015 until April 2018 in a tertiary hospital. Dispensation data was obtained from the Pharmacy Department’s software, Farmatools. Collected data included: age, ECOG performance status, number of cycles received, duration and prior lines of treatment. Effectiveness endpoint was progression-free survival (PFS) according to RECIST version 1.1. Adverse events (AEs) related to treatment with palbociclib and registered in the patient’s medical records were included in the study. Toxicity was evaluated as defined by the NCI-CTCAE, version 4.0. Results Conclusion A significant difference in PFS was observed compared to published clinical trials PALOMA-2 (PFS 24.8 months) and PALOMA-3 (PFS 11.2 months). Otherwise, palbociclib showed a similar safety profile. However, further studies are required to establish effectiveness in clinical practice as 19/29 patients are still receiving treatment. References and/or acknowledgements 1. Palbociclib: EPAR-Summary for the public. EMA. 2. Pivotal studies PALOMA-2 and PALOMA-3. No conflict of interest.

Additional file 3. Treatments for bone metastasis per visit

Background: Bone is the most common lesion in metastatic breast cancer (MBC) patients. Pain due to bone disease is a very limiting and frequent symptom. We evaluated prospectively the BOMET-QoL questionnaire in the context of normal clinical practice, irrespectively of the treatment received, in order to assess the impact of bone metastasis on the Health-Related Quality of Life (HRQoL) of patients with MBC. Material and Methods: This is an observational, prospective, multicenter study conducted in Spain. Patients diagnosed of MBC with bone disease and a life expectancy ≥ 8 months were eligible. Patients completed the bone metastasis Quality of life questionnaire (BOMET-QoL), a Visual Analogue Scale (VAS) for pain and a self-perception of health status item at baseline and 4, 8, 12, 16, 20 and 24 months thereafter. Socio-demographic, clinical and therapeutic data were also collected. Assuming a level of significance of 0.05 and a 20% drop-out rate, 174 patients were to be included in the study in order to estimate the QoL with a precision of ±3.75. Results: From October-2007 to May-2010 172 evaluable patients were included in 15 Spanish institutions. Median age was 58 years (29.6-88.6). Bone disease was most frequently localized in the backbone (76.2% of patients), pelvis (53.5%) and ribs (45.3%). Seventy patients (40.5%) had visceral disease. Most patients (147, 88.5%) had ECOG 0-1. At study entry, 65 patients were receiving analgesic therapy (44 with NSAIDs and 21 with opioids) and 136 were receiving bisphosphonates. The values obtained on the BOMET-QoL and pain VAS scores at the different visits showed a moderate positive correlation (0.2-0.5; p Conclusions: The BOMET-QoL questionnaire is a consistent instrument to evaluate the HRQoL of patients with bone metastasis from breast cancer in regular clinical practice conditions, with regards to cross-sectional and longitudinal validity, feasibility and sensitivity to change. BOMET-QoL is easy to understand and can be completed in a short time by the majority of patients. Citation Information: Cancer Res 2013;73(24 Suppl): Abstract nr P3-10-02.

Purpose To determine the frequency of breast cancer (BC) patients with hereditary risk features in a wide retrospective cohort of patients in Spain. Methods a retrospective analysis was conducted from 10,638 BC patients diagnosed between 1998 and 2001 in the GEICAM registry ªElAÂ lamo IIIº, dividing them into four groups according to modified ESMO and SEOM hereditary cancer risk criteria: Sporadic breast cancer group (R0); Individual risk group (IR); Familial risk group (FR); Individual and familial risk group (IFR) with both individual and familial risk criteria. Results 7,641 patients were evaluable. Of them, 2,252 patients (29.5%) had at least one hereditary risk criteria, being subclassified in: FR 1.105 (14.5%), IR 970 (12.7%), IFR 177 (2.3%). There was a higher frequency of newly diagnosed metastatic patients in the IR group (5.1% vs 3.2%, p = 0.02). In contrast, in RO were lower proportion of big tumors (> T2) (43.8% vs 47.4%, p = 0.023), nodal involvement (43.4% vs 48.1%, p = 0.004) and lower histological grades (20.9% G3 for the R0 vs 29.8%) when compared to patients with any risk criteria. Conclusions Almost three out of ten BC patients have at least one hereditary risk cancer feature that would warrant further genetic counseling. Patients with hereditary cancer risk seems to be diagnosed with worse prognosis factors

Doxorubicin and gemcitabine are active as single agents in breast cancer, have different mechanisms of action, and mainly have non-overlapping side effects. Dose-dependent doxorubicin-related cardiac toxicity is the principal limitation in the metastatic setting. This open, multicenter, single-arm phase I/II study assessed the safety and activity of gemcitabine in combination with non-pegylated liposomal doxorubicin (Myocet), a more cardiac-friendly anthracycline, in the first-line treatment of patients with advanced breast cancer. We aimed to determine the optimal recommended dose (RD) of gemcitabine combined with Myocet in a population, with performance statusor=2 and LVEFor=50%. A formal phase II study was performed afterwards. A total of 53 patients were recruited. Gemcitabine 900 mg/m(2) intravenously day 1 and 8 combined with Myocet 55 mg/m(2) intravenously day 1, every 21 days, was the final RD. The principal toxicity observed was hematological, and 48% of patients developed grade 3-4 neutropenia. Other toxicities were mild and infrequent, including nausea and vomiting. There were no symptomatic cardiac events despite the fact that 36% of the patients had received prior treatment with adjuvant anthracyclines. Objective responses were observed in 51.1% of 47 evaluable patients (95% CI: 36-66%), including two complete response. In addition, 14 patients (29.8%) demonstrated stable disease. The combination of Myocet and gemcitabine at the RD is safe and has encouraging clinical activity in patients with advanced breast cancer, without apparent cardiac toxicity in anthracycline-pretreated patients. These data support further development of this combination.

Background: Objectives: Characterize 1) the frequency of mutations in patients with clinical criteria for HBOC using a 25-gene panel in a Spanish population (FAMOSA study). 2) The psychological impact of these tests and patient''s counseling preferences. Methods: Patients with breast or ovarian cancer who met the NCCN criteria for genetic testing with a) prior testing for BRCA genes with NO mutation identified; or b) recently diagnosed (

At the present time, there is not a standard regimen in upfront metastatic setting for breast cancer. A wide variety of regimens which includes anthracyclines, taxanes, gemcitabine or capecitabine are currently used, however, there is evidence to support the use of many of these drugs in early breast cancer and consequently limiting their use in first line treatment. The aim of this review is to evaluate every randomized phase III trials conducted in first line metastatic breast cancer. For this reason, all randomized studies that evaluated the role of chemotherapy in advanced breast cancer were analyzed and classified according to their protocol design. So far, sixteen major randomized clinical trials have evaluated the role of chemotherapy as front line in metastatic breast cancer. Some of them have analyzed a different anthracyclines-based regimen as the control arm versus new combinations or new drugs. In others, the aim is to evaluate the most effective therapy after progression to an adjuvant anthracyclines-containing regimen. The suitability of the control arm, the prospective definition of patient's subgroups as well as the statistical methodology have been taken into account.

In a population-based sample, after excluding alcohol consumption, hepatotoxic drugs and hepatitis Band C infected, we investigated if alanine-aminotransferase (ALT) was associated with metabolic syndrome and insulin resistance, and if this association was caused by non-alcoholic fatty liver disease (NAFLD). The sample (432 female and 119 male) was divided into two ALT thresholds corresponding to the 50th and 75th percentiles (P) (female ≤ 15 and ≤ 19 U/L; male ≤ 17 and ≤ 23 U/l, respectively). Blood pressure, body mass index, waist circumference, cholesterol, HDL cholesterol (HDLc), triglyceride (TG), TG/HDLc ratio, glycemia and homeostasis model assessment of insulin resistance (HOMA-IR) were compared between those above and below each ALT threshold. Female placed above the 50th P of ALT had higher levels of TG/HDLc ratio (p=0.029), glycemia (p=0.028), and homeostasis model assessment of insulin resistance, (p=0.045), and above the 75th P had higher SBP (p=0.036), DBP (p=0.018), TG (p=0.024), TG/HDLc ratio (p=0.028), glycemia (p=0.004) and HOMA-IR (p=0.0014). Male placed above the 50th P of ALT had higher BMI (p=0.017) and TG/HDLc ratio (p=0.048), and above the 75th P had lower values of HDLc (p=0.042). Only 16.5% of women and 14.5% of men, above the 75th P of ALT, showed an increase in liver brightness in the echography. This work shows in woman an early association of ALT with TG/HDLc ratio and HOMA-IR. Since the last two are independent predictors of cardiovascular risk, attention should be drawn to ALT values near the upper limit of the normal range even in the absence of NAFLD and obesity.En una muestra poblacional, luego de excluir a quienes consumían alcohol y drogas hepatotóxicas y a los infectados con virus B y C de la hepatitis, investigamos si la alanino-aminotransferasa (ALT), o transaminasa glutámico pirúvica (TGP), se asociaba con el síndrome metabólico y con resistencia a la insulina y si esta asociación se explicaba por enfermedad hepática grasa no alcohólica (NAFLD). La muestra (432 mujeres y 119 varones) se dividió por los percentilos (P) 50 y 75 de la distribución de ALT (mujeres ≤ 15 y ≤ 19 U/l; varones ≤ 17 y ≤ 23 U/l, respectivamente). Las mujeres a partir del P50 de ALT tuvieron valores más altos de índice triglicéridos (TG)/HDLc (p=0.029), glucemia (p=0.028) y de la valoración del modelo homeostático de insulino-resistencia (HOMA-IR) (p=0.045); a partir del P75 tuvieron valores más altos de presión arterial sistólica (PAS) (p=0.036), presión arterial diastólica (PAD) (p=0.018), TG (p=0.024), índice TG/HDLc (p=0.028), glucemia (p=0.004) y HOMA-IR (p=0.001). Los varones a partir del P50 de ALT tuvieron valores más altos del índice de masa corporal (p=0.017) y del índice (TG/HDLc (p=0.048); a partir del P75 mostraron valores más bajos de HDLc (p=0,042). Sólo 16.5% de las mujeres y 14.5% de los varones, a partir del P75 de ALT, mostraron aumento del brillo hepático en la ecografía. Este trabajo muestra, en mujeres, asociación temprana de ALT con el índice TG/HDLc y el HOMA-IR. Dado que estos dos últimos son predictores independientes del riesgo cardiovascular se debería prestar atención a los valores de ALT cercanos al límite superior aun en ausencia de NAFLD y de obesidad.

Background: The aim of the study was to analyse the toxicity and health related quality of life (HRQoL) of breast cancer patients treated with FAC (5-fluorouracil, doxorubicin, cyclophosphamide) and TAC (docetaxel, doxorubicin, cyclophosphamide) with and without primary prophylactic G-CSF (PPG). Patients and methods: This was a phase III study to compare FAC and TAC as adjuvant treatment of high-risk node-negative breast cancer patients. After the entry of the first 237 patients, the protocol was amended to include PPG in the TAC arm due to the high incidence of febrile neutropenia. A total of 1047 evaluable patients from 49 centres in Spain, two in Poland and four in Germany were included in the trial. Side-effects and the scores of the EORTC QLQ-C30 and QLQ BR-23 questionnaires were compared in the three groups (FAC, TAC pre-amendment and TAC post-amendment). Results: The addition of PPG to TAC significantly reduced the incidence of neutropenic fever, grade 2–4 anaemia, asthenia, anorexia, nail disorders, stomatitis, myalgia and dysgeusia. Patient QoL decreased during chemotherapy, more with TAC than FAC, but returned to baseline values afterwards. The addition of PPG to TAC significantly reduced the percentage of patients with clinically relevant Global Health Status deterioration (10 or more points over baseline value) at the end of chemotherapy (64% versus 46%, P < 0.03). Conclusions: The addition of PPG significantly reduces the incidence of neutropenic fever associated with TAC chemotherapy as well as that of some TAC-induced haematological and extrahaematological side-effects. The HRQoL of patients treated with TAC is worse than that of those treated with FAC but improves with the addition of PPG, particularly in the final part of chemotherapy treatment.

Ethanol steam reforming has been carried out in a catalytic membrane reactor consisting of cobalt hydrotalcite [Co2Mg4Al2(OH)16]CO3-4H2O-derived catalyst doped with potassium supported over cordierite and a composite PdeAg selective membrane. No sweep gas has been used, therefore, pure hydrogen has been obtained in the permeate stream, which has been maintained at atmospheric pressure. The configuration with the catalyst bed packed around the membrane has shown values of STP LH2, permeate mLETOH, liquid-1 gcat-1 up to 3 times higher than the observed for the staged membrane reactor, where the catalyst has been placed in-serieswith themembrane. The influence of the temperature (673-873 K), the waterethanol ratio (S/C = 1.8-3) and the retentate pressure (1-18 bar) on different performance parameters such as the hydrogen production and the pure hydrogen recovery has been evaluated. No carbon accumulation has been observed by SEM and XPS after 650 h operation. Fil: Espinal, Raúl. Universidad Politecnica de Catalunya; España Fil: Anzola Escobar, Andres Mauricio. Consejo Nacional de Investigaciones Científicas y Técnicas. Centro Científico Tecnológico Conicet - Bahía Blanca. Planta Piloto de Ingeniería Química. Universidad Nacional del Sur. Planta Piloto de Ingeniería Química; Argentina Fil: Adrover, María Esperanza. Consejo Nacional de Investigaciones Científicas y Técnicas. Centro Científico Tecnológico Conicet - Bahía Blanca. Planta Piloto de Ingeniería Química. Universidad Nacional del Sur. Planta Piloto de Ingeniería Química; Argentina Fil: Roig , M.. Universidad Politecnica de Catalunya; España Fil: Chimentao, R.. Universitat Rovira I Virgili; España Fil: Medina, F.. Universitat Rovira I Virgili; España Fil: Lopez, Eduardo. Consejo Nacional de Investigaciones Científicas y Técnicas. Centro Científico Tecnológico Conicet - Bahía Blanca. Planta Piloto de Ingeniería Química. Universidad Nacional del Sur. Planta Piloto de Ingeniería Química; Argentina Fil: Borio, Daniel Oscar. Consejo Nacional de Investigaciones Científicas y Técnicas. Centro Científico Tecnológico Conicet - Bahía Blanca. Planta Piloto de Ingeniería Química. Universidad Nacional del Sur. Planta Piloto de Ingeniería Química; Argentina Fil: Llorca, Jordi. Universidad Politecnica de Catalunya; España

3% of human cancers are renal cell carcinomas (RCC). The most common chromosome abnormality found in this tumor is loss of heterozygosity (LOH) on the short arm of chromosome 3, which suggests that there must be one or more tumor suppressor genes between 3p14 and 3p21 near the VHL gene which play a relevant role in renal cancer development. DNA from normal and tumor tissue from 40 patients at various stages of RCC was analyzed for LOH at three microsatellites mapped to 3p (3p14.1–14.3; 3p21.2–21.3 and 3p25) by polymerase chain reaction). 42.5% of the tumors studied showed LOH on at least one locus. 30% showed LOH on only one locus; 5% on two loci and 7.5% on the three loci tested. LOH occurred only on nonpapillary tumors (p = 0.03). Interestingly, all the tumors with LOH on 3p21 were ≥25 mm (p = 0.04; relative risk 1.76, confidence interval: 1.3–2.3).

The expression of p53 protein was examined in a series of 111 colorectal cancer adenocarcinomas with a long follow-up. A quantitative luminometric immunoassay (LIA) was used for the measurement of wild-type and mutant p53 protein in extracts from colorectal tumour cytosols, p53 being detected in 42% of the samples (range 0.0–52 ng mg−1). Using an arbitrary cut-off value of 2.7 ng mg−1, 25% of the tumours were classified as manifesting high p53 levels. There was no association of p53 expression with patient age, sex, serum preoperative carcinoembryonic antigen (CEA) levels, tumour site and size, nodal status or TNM stage. Significant and independent correlation was found to exist between high p53 levels and prolonged disease-free survival (P = 0.05) at a median follow-up of 60 months. This survival advantage was most apparent among stage III cancer patients. The results from this study would suggest that expression of high p53 levels appear to be useful in selecting a group of colorectal cancer patients with a better prognosis. © 1999 Cancer Research Campaign

The following manuscript summarises the content of the Breast Symposium that was held in May 2008 in Barcelona in which four controversies regarding the management of breast cancer were discussed. The design of the symposium included two speakers per controversy, one in favour and one diverging, and the audience had to vote before and after the presentations to assess changes in the participants' views. The four controversies included: (1) the role of non-conventional predictive factors in selecting treatment for breast cancer; (2) the role of surgery in disseminated disease; (3) are taxanes indicated in the adjuvant treatment of patients with lymph-node-negative disease?; (4) is treatment with tamoxifen (TAM) always required after surgery in patients with ductal carcinoma in situ (DCIS)? The symposium concluded with the presentation titled: 'Features of a well designed clinical trial in the adjuvant treatment of breast cancer'.

The aim of this study was to determine whether the response rate for the paclitaxel-carboplatin combination is superior to carboplatin alone in the treatment of patients with platinum-sensitive recurrent ovarian carcinoma.Patients with recurrent ovarian carcinoma, 6 months after treatment with a platinum-based regimen and with no more than two previous chemotherapy lines, were randomized to receive carboplatin area under the curve (AUC) 5 (arm A) or paclitaxel 175 mg/m(2) + carboplatin AUC 5 (arm B). The primary end point was objective response, following a 'pick up the winner' design. Secondary end points included time to progression (TTP), overall survival, tolerability and quality of life (QoL).Eighty-one patients were randomized and included in the intention-to-treat analysis. The response rate in arm B was 75.6% [26.8% complete response (CR) + 48.8% partial response (PR)] [95% confidence interval (CI) 59.7% to 87.6%] and 50% in arm A (20% CR + 30% PR) (95% CI 33.8% to 66.2%). No significant differences were observed in grade 3-4 hematological toxicity. Conversely, mucositis, myalgia/arthralgia and peripheral neurophaty were more frequent in arm B. Median TTP was 49.1 weeks in arm B (95% CI 36.9-61.3) and 33.7 weeks in arm A (95% CI 25.8-41.5). No significant differences were found in the QoL analysis.Paclitaxel-carboplatin combination is a tolerable regimen with a higher response rate than carboplatin monotherapy in platinum-sensitive recurrent ovarian carcinoma.

Drug addicts frequently have liver diseases for different reasons: alcohol abuse, the drugs themselves, but more often hepatitis B and C infections. AIDS is common in this population as well and could also affect the liver directly or in the form of hepatocellular or biliary damage. We conducted this study to determine the prevalence of liver diseases, alcoholism, hepatitis B and C infections, and HIV positivity in this population. We studied a cohort of 137 persons, all with a history of drug abuse, and investigated the quantity of alcohol intake, the kind of drug used, and he routes of drug administration.We found liver disease in 33.6%. The prevalence of alcoholism was 65.4%, of HCV 67.3%, and of HBV 17.3%. HDV was undetectable, whereas we found HIV at a frequency of 17.3%. HCV RNA was detected in 85.4% of HCV. The drug most often used was cocaine at 90.4%, followed by marihuana at 88.3%; LSD use occurred in 17.5%. We found parenteral drug use in 43.1%. We performed 22 liver biopsies, 21 associated with HCV, and detected histological changes consistent with chronic hepatitis in 17, with cirrhosis in 4, and with hepatocellularcarcinoma in 1.

In order to establish the present prevalence of HCV in hemodialyzed patients (HD) from the city of La Plata, and to know the association between the prevalence and different variables, we have studied 217 hemodialyzed patients belonged to the Hemodialysis Unit of a Public Hospital and other 7 private Units. Serological reactivity to Anti HCV and Anti HBc IgG were investigated in all of them, as well as age, sex, number of transfusions, the time under dialysis treatment, the use of erythropoietin and hepatitis episodes were taken into account. We have found a prevalence of Anti HCV of 18.4% which was significantly superior to the blood donors' prevalence (P0.01) and significantly inferior to the one found in 1993 in HD patients of the same city (p = 0.002). We have found an association between the presence of Anti HCV and transfusions exposure, as well as more hemodialysis time. Our results may agree with the ones that suggest the aminotransferases are not good markers for hepatocellular injuries in Anti HCV (R) HD patients.

We present 12 patients with CHC, 11 men and one woman, median age, 59.9 +/- 10.1 cared for in two hospitals from La Plata city. The median age, the predominance of men and presence of cirrhosis in the 75% are similar findings to European 41% of the patients, consulted of the CHC has increased in our environment. The fact that all the patients have been symptomatic at the moment of the consultation, that one of them had normal liver function tests and that only two of them had nodule of less than 5 cm of diameter, suggest advanced stage of the disease. At the same time, the median of survival of 8.3 +/- 9 (DS) months post-diagnosis and of 3.6 +/- 8 (DS) months post surgery. 90.9% had a risk factor to undergo CHC (alcohol, HBC, HCV). Because of one patient, the risk of hemodyalizer patients to have CHC is emphasized. Therefore, it is important to prevent and treat viral infections. In this study, the diagnosis of the echography was of 100% and the histologic corroboration was done by percutaneous biopsy with ultrasound or TC assessment. We observed that the levels of alpha-fetoprotein had a weak, negative correlation, not significative, with the diameters of the nodules. Although it is true that the size of the sample and the retrospective character of the investigation inhibits us to draw definitive conclusions, the behaviour of alfafetoprotein creates doubts about its value in the diagnosis and screening of the CHC.

A small series of 34 renal transplanted patients (RTx) were studied, 18 males and 16 females in order to know the prevalence of Anti HCV in this type of patients and their influence on early morbi-mortality. The follow-up mean was 8.44 months SD 6.7, and Age 38.32 SD 13.97. All patients were under the same immunosuppressive scheme, and rejection episodes were treated with methilprednisolone pulses. The results were: 7 (20.6%) Anti HCV seroreactives (R) (EIA II Abbott and Immunoblotting of synthetic Peptides LIA TEK Organon Teknika); and 27 (79.4%) non-serorectives (NR), 14 patients received grafts from cadaveric donor; 4 (57.1%) Anti HCV (R), and 10 (37.0%) Anti HCV (NR). 20 patients have received grafts from lived-related donors: 3 (42.9%) Anti HCV (R), and 17 (63.0%) Anti HCV (NR). 6 (85.7%) of the 7 patients Anti HCV (R) had hepatitis history: 2 chronic hepatitis, 4 acute hepatitis (2HBV) and 2 no A no B (NANBV) and 6 (22.2%) of the 27 Anti HCV (NR). The mean time of hemodialysis treatment before transplantation in the Anti HCV (R) group was of 63.0 months SD27.0, and it was significantly superior (P0.05) to the Anti HCV (NR) group with 27.3 months SD 20.7. There were no significant differences between the Anti HCV (R) and (NR) patients with regard to rejection episodes, post-transplant hepatopathies, and survival of graft and patient.1) Anti HCV prevalence is of 20.6%. 2) Time of hemodialysis prior to transplantation and an hepatitis history during hemodialysis came out to be significantly higher in Anti HCV (R) RTx. 3) Morbi-mortality is no modified by the presence of Anti HCV during a mean follow-up period of 8.44 months.

Data from 219 hemodyalized patients receiving attention in our Hospital and other private centers in our city are shown. Mean age was 46.9 (range: 14-85), and 132 were male; mean time under dialysis was 20 months, and subjects received an average of 5 transfusions per patient year. Serological reactivity to HBs Ag, Anti HBs and IgG anti HBc by ELISA were investigated in all of them, and anti HCV by second generation enzimo-immunoassay (EIA II) in 73 HBe Ag/anti HBe system were determined in HBs Ag positive patients and those reactive to anti HCV (EIA II) were confirmed by LIA (immunoblotting of synthetic peptides LIA-TEK Organos Teknica). Recombinant anti HBV vaccine 40 mcg at 0-1 and six month were received by 81 cases without HBV markers in their sera and a protective response was considered when anti HBs titration of 10 mU/ml or more were obtained two months later. Prevalence for anti HBc and anti HBs were 38.8% respectively and that for HBs Ag was 21% with 78% of them reactive for HBs Ag. True reactivity for anti HCV (confirmed by LIA) was present in 35.6%, but it was 9.7% in our Hospital and 54.8% in private units (p0.0002). Anti HBs titration was done in 69/81 patients who received anti HBV vaccine, and a protective response in 49% were obtained; the other 12 patients underwent acute hepatitis B during the vaccination period.(ABSTRACT TRUNCATED AT 250 WORDS)

e11093 Background: The standard treatment for HER2-positive breast cancer patients is trastuzumab, which improves disease-free survival when used in the adjuvant setting, in combination or followin...

22151 Background: Studies with Tissue Microarray (TMA) technology in the preoperative setting of breast cancer have been done using thousands of genes, searching for the most relevant genes associa...

542 Background: Adjuvant docetaxel improves disease-free survival (DFS) and overall survival (OS) in node-positive breast cancer (BC) patients (pts). However, most BC pts at diagnosis are node-negative, and the role of taxanes in such pts is not established. Methods: Pts aged 18–70, with T1-T3, N0, M0 operable BC and at least one high-risk St Gallen 1998 criterion (grade II/III, size >2 cm, age 5 cm. Tamoxifen was given for 5 years to all pts with HR-positive tumors. The primary endpoint was DFS defined as BC recurrence, second primary malignancy including contralateral BC, or death from any caus...

17520 Background: Development of an economic evaluation model to be applied to the costs of the systemic treatment of Colorectal (CRC) and Non-small Cell Lung Cancer (NSCLC) in Spain. Assess the di...

We have examined the effect of axotomy on the conduction velocity of unmyelinated sensory fibres in the vagus nerve of the rabbit. In an in vitro preparation of the nodose ganglion, conduction velocity was calculated for each cell from the latency of the intracellularly recorded action potential evoked by vagus nerve stimulation. The average velocity of sensory fibres conducting at less than 1.1 m/s, was 0.53 m/s in 287 control cells and 0.45 m/s in 269 neurones recorded 10 days after cutting the vagus nerve. Therefore, peripheral axotomy decreases conduction velocity in mammalian unmyelinated sensory axons.

10561 Background: Screening mammography has shown to decrease breast cancer specific death rate by 20–25% and has been recommended in women aged 40 and above, nevertheless, some country service screen programs stop screening in women older than 69, even though the sensitivity and specificity of screening mammography is highest in older women, especially those older than 80 years. The size of the older population is growing exponentially and old women have the highest incidence of breast cancer; one third of breast cancer diagnosis and half the deaths of breast cancer in USA occurred in women aged 70 and above in the year 2000. The aim of this study is to estimate the impact of mammographic screening in women aged 70 and above on breast cancer mortality. Methods: US Census, SEER, CISNET, CDC, HMD, ULTD databases were searched to obtain population data and rates of incidence and mortality of breast cancer by age. In addition, mammography screening bibliography from randomized clinical trials, meta-analysis, and service health programs publications were reviewed to estimate the impact of screening mammography on results for different strata. Analytical and simulation methods were applied for modeling the data with the aid of Mathematica to calculate breast cancer reduction rate. Results: A reduction in breast cancer mortality was observed with a magnitude proportional to age, even after taking into account competing risks of death by other causes in the aging population. Simulation of different scenarios revealed a decrease in breast cancer mortality in the range of 5 to15% for women younger than 50 years, 15 to 25% in the group of women aged 50 to 69, and 25 to 35% in women older than 69. Factors such as population life expectancy, breast cancer incidence, attrition rate in screening or cross-over, overall specificity of mammographic detection, interval of screening, impact the estimations, explaining in part some of the negative results of prevention trials. Conclusions: Reduction of breast cancer mortality by mammographic screening is proportional to age. Women aged 70 and above benefit more from mammographic screening than younger women. No significant financial relationships to disclose.

10651 Background: We designed a phase I-II trial to determine the combination dose of liposomal doxorubicin (Myocet) plus gemcitabine (Gemzar), and to evaluate the safety and feasibility of the regimen Methods: Patients with histologically confirmed breast cancer, untreated distant metastasis, age >18 years old, left ventricular ejection fraction (LVEF) >50% and adequate bone marrow, renal and hepatic function were included in the study. Patients received up to six cycles of treatment. No G-CSF support was used prophylactically. LVEF was repeated at 3, and 6 months, and every 6 months thereafter. Results: Phase I: After 6 patients, the recommended dose was M (55 mg/m2) D1 and G (900 mg/m2) D1 and 8, administered every 21 days. Phase II: 53 patients have been enrolled; 52 are included in the safety analysis and 42 in the efficacy analysis. The median age of the population was 61 years of age (32–79). ECOG PS was 0 in 55%, 1 in 41%, 2 in 4%. Postmenopausal status in 87%. Main histology was ductal carcinoma (85%). Prior adjuvant anthracyclines had been administered in 19 cases (median dose of doxorubicin: 300 mg/m2, or epirubicin: 425 mg/m2). Metastasic lesions were in liver (25), lung (17), bone (16), and lymph nodes (25). Patients received a median number of 5 cycles (range 1–6). Median relative dose intensity was 83% for M and 75% for G. Grade III-IV hematologic toxicity per administered cycles was: leukopenia (21.9%), neutropenia (31.2%), febrile neutropenia (4 %), and thrombocytopenia (7.4%). Grade III-IV non-hematologic toxicities were stomatitis (4.8%), nausea (1.7%), vomiting (2.2%), asthenia (2.6%) and diarrhea (0.8%). Thirteen of 52 pts (25%) had alopecia grade III-IV. No signs or symptoms of cardiac impairment have been seen. An objective response rate of 62% was obtained (95% CI: 45.6- 76.4%). Two patients had complete response (4.8%), 24 partial response (57.1%), 10 stable disease and 6 progressive disease. The response rate was similar in patients with or without previous adjuvant anthracyclines (68.5% and 61%, respectively). Conclusions: The combination of liposomal doxorubicin plus gemcitabine has high efficacy and low toxicity in advanced breast cancer patients, and may be a valuable option in patients that have received adjuvant anthracyclines. [Table: see text]

2124 Background: Dose density of chemotherapy has been advocated as a way to improve results in patients with cancer. While increasing dose, and the area under the curve of concentration-time (AUC), may increase response, it also increases toxicity, reducing the clinical benefit. For phase-specific agents such as TAX, different schedules with the same dose and AUC may produce different patterns of efficacy and toxicity. Partial comparisons between schedules in clinical trials may answer which of two or three schedules is better, but not which schedule is optimal. A systematic analysis of all different schedules of TAX, integrating clinical, pharmacodynamic and pharmacokinetic data in a mathematical model may provide an optimum, as was previously provided for fluorouracil (Proc ASCO 2004; 23:a2139). Methods: Clinical trials of single agent TAX in advanced breast and lung cancer have been searched in PubMed, references of published clinical trials, and presentations in cancer meetings. Prognostic factors (a...

This work reports the preparation of Cu-Zn and Au/TiO2 catalysts on anodized aluminum monoliths(AAM). The structured catalysts were studied for the generation of H2 by methanol steam reforming (MSR) and its purification by preferential oxidation of CO (CO-PrOx). Initially, it was possible to generate a surface with whiskers and larger surface area by hydrothermal treatment of the AAM. Subsequently, the structured catalysts were synthesized by incipient wetness impregnation (IWI) and ydrothermal synthesis (HS). IWI synthesis allowed for the deposition of a larger amount of catalytic material than HS, with very good adhesion. The TiO2-IWI structured catalyst presented a homogeneous catalytic coating, with the presence of agglomerated particles. On theother hand, Cu-Zn-IWI showed good dispersion of the deposited particles with a homogeneous surface coating. EDX analysis corroborated the presence of Ti, Cu and Zn in all the catalytic surfaces. The incorporation of Au over TiO2-IWI structured catalysts was successfully performed by IWI using a colloidal solution of gold nanoparticles.MSR was studied over the developed metallic monoliths functionalized with Cu-Zn by the IWI method. The samples showed promising results in terms of activity, selectivity, and stability. Both diluted and concentrated methanol + water feeds were assayed. Complete methanol conversion was achieved for the diluted feed. Maximum methanol conversions of 55% with 60% H2 yield were measured when the concentrated feed was selected. Promising results were also achieved for the Au-based structured catalysts in the CO-PrOx in an H2- rich atmosphere. Although CO conversions of approximately 60% were achieved, operating with higher catalyst loadings would be recommended to reach the high CO conversions required for PrOx catalysts. Fil: Adrover, María Esperanza. Consejo Nacional de Investigaciones Científicas y Técnicas. Centro Científico Tecnológico Conicet - Bahía Blanca. Planta Piloto de Ingeniería Química. Universidad Nacional del Sur. Planta Piloto de Ingeniería Química; Argentina Fil: Boldrini, Diego Emmanuel. Consejo Nacional de Investigaciones Científicas y Técnicas. Centro Científico Tecnológico Conicet - Bahía Blanca. Planta Piloto de Ingeniería Química. Universidad Nacional del Sur. Planta Piloto de Ingeniería Química; Argentina Fil: Jiménez Divins, Nuria. Universidad Politecnica de Catalunya; España Fil: Casanovas Hoste, Adria. Universidad Politecnica de Catalunya; España Fil: Tonetto, Gabriela Marta. Consejo Nacional de Investigaciones Científicas y Técnicas. Centro Científico Tecnológico Conicet - Bahía Blanca. Planta Piloto de Ingeniería Química. Universidad Nacional del Sur. Planta Piloto de Ingeniería Química; Argentina Fil: Lopez, Eduardo. Consejo Nacional de Investigaciones Científicas y Técnicas. Centro Científico Tecnológico Conicet - Bahía Blanca. Planta Piloto de Ingeniería Química. Universidad Nacional del Sur. Planta Piloto de Ingeniería Química; Argentina Fil: Llorca Piqué, Jordi. Universidad Politecnica de Catalunya; España