The effect of guideline-consistent antiemetic therapy on chemotherapy-induced nausea and vomiting (CINV): the Pan European Emesis Registry (PEER).

BACKGROUND: While guidelines for preventing chemotherapy-induced nausea and vomiting (CINV) are widely available, clinical uptake of guidelines remains low. Our objective was to evaluate the effect of guideline-consistent CINV prophylaxis (GCCP) on patient outcomes. PATIENTS AND METHODS: This prospective, observational multicenter study enrolled chemotherapy-naive adults initiating single-day highly or moderately emetogenic chemotherapy (HEC or MEC) for cancer. Patients completed 6-day daily diaries beginning with cycle 1 for up to three chemotherapy cycles. The primary study end point, complete response (no emesis and no use of rescue therapy) during 120 h after cycle 1 chemotherapy, was compared between GCCP and guideline-inconsistent CINV prophylaxis (GICP) cohorts using multivariate logistic regression, adjusting for potential confounding factors. RESULTS: In cycle 1 (N=991), use of GCCP was 55% and 46% during acute and delayed phases, respectively, and 29 % for the overall study period (acute plus delayed phases). Complete response was recorded by 172/287 (59.9%) and 357/704 (50.7%) patients in GCCP and GICP cohorts, respectively (P=0.008). The adjusted odds ratio for complete response was 1.43 (95% confidence interval 1.04-1.97; P=0.027) for patients receiving GCCP versus GICP. CONCLUSION: GCCP reduces the incidence of CINV after single-day HEC and MEC.

External validation of the European and American equations for calculating cardiovascular risk in a Spanish working population.

INTRODUCTION AND OBJECTIVE: This work aims to externally validate the European and American models for calculating cardiovascular risk in the primary prevention. METHODS: This is a cross-sectional study of a nation-wide cohort of individuals who are active in the work force. Workers without a medical history cardiovascular disease who attended occupational health check-ups between 2004 and 2007 were included. They were followed-up on until December 2017. RESULTS: A total of 244,236 subjects participated. Of them, 24.5% were women and the mean age was 48.10 years (SD 6.26). According to the European SCORE risk chart, the mean risk was 1.70 (SD 1.81) for men and 0.37 (SD 0.53) for women. According to the North American PCE model, the mean risk was 6.98 (SD 5.66) for men and 1.97 (SD 1.96) for women. A total of 1177 events (0.51%) were registered according to the SCORE tool and 2,330 events (1.00%) were registered according to the PCE tool. The Harrell's C-statistic was 0.746 for SCORE and 0.725 for PCE. Sensitivity and specificity for the SCORE'S 5% cut-off point were 17.59% (95%CI 15.52%-19.87%) and 95.68% (95%CI 95.59%-95.76%). Sensitivity and specificity for the PCE's 20% cut-off point were 9.06% (95%CI 7.96%-10.29%) and 97.55% (95%CI 97.48%-97.61%), respectively. CONCLUSIONS: The European SCORE and North American PCE models overestimate the risk in our population but with an acceptable discrimination. SCORE showed better validity indices than the PCE. The population's risk is continuously changing; therefore, it is important continue updating the equations to include information on current populations.

Comparative study of whole-body MRI and bone scintigraphy for the detection of bone metastases.

AIM: To assess and compare the diagnostic accuracy of whole-body magnetic resonance imaging (MRI) and bone scintigraphy in the detection of metastases to bone. MATERIAL AND METHODS: Forty randomly selected patients with known malignant tumours were prospectively studied using bone scintigraphy and whole-body MRI. Two patients were excluded. Symptoms of bone metastasis were present in 29 (76%) patients and absent in nine (24%). Findings were classified into four categories according to the probability of bone metastasis: (1) negative, (2) probably negative, (3) probably positive, and (4) positive. Diagnostic accuracy was determined according to the area under the receiver operating characteristic (ROC) curve. The definitive diagnosis was reached using other imaging techniques, biopsy, or 12 months clinical follow-up. RESULTS: Metastases were present in 18 patients. The sensitivity, specificity, and diagnostic accuracy were 94, 90, and 92%, respectively, for whole-body MRI and 72, 75, and 74%, respectively, for bone scintigraphy. Diagnostic accuracy measured by the area under the ROC curve was significantly higher for whole-body MRI (96%) than for bone scintigraphy (77%; p<0.05). Interobserver agreement measured by the kappa index was significantly higher for whole-body MRI (0.895) than for bone scintigraphy (0.524; p<0.05). Whole-body MRI detected lesions in tissues other than bone in 17 (45%) patients. CONCLUSIONS: Whole-body MRI is more accurate and more objective than bone scintigraphy for the detection of bone metastases. Whole-body MRI can also detect lesions in tissues other than bone.

Latest progress in molecular biology and treatment in genitourinary tumours.

The management of genitourinary cancer, including bladder, prostate, renal and testicular cancer, has evolved dramatically in recent years due to a better understanding of tumour genetic mutations, alterations in molecular pathways, and to the development of new kinds of drugs such as targeted therapies and immunotherapies. In the field of immunotherapy, new drugs focused on stimulating, enhancing and modulating the immune system to detect and destroy cancer, have been recently discovered. Research in oncology moves quickly and new data of great relevance for clinical practice are communicated every year. For this reason, a group of experts, focused exclusively on the treatment of genitourinary tumours and who get together every year in the BestGU conference to assess the latest progress in this field have summarized the most important advances in a single review, along with a critical assessment of whether these results should alter daily clinical practice.

A definition for aggressive disease in patients with HER-2 negative metastatic breast cancer: an expert consensus of the Spanish Society of Medical Oncology (SEOM).

PURPOSE: To converge on an expert opinion to define aggressive disease in patients with HER2-negative mBC using a modified Delphi methodology. METHODS: A panel of 21 breast cancer experts from the Spanish Society of Medical Oncology agreed upon a survey which comprised 47 questions that were grouped into three sections: relevance for defining aggressive disease, aggressive disease criteria and therapeutic goals. Answers were rated using a 9-point Likert scale of relevance or agreement. RESULTS: Among the 88 oncologists that were invited to participate, 81 answered the first round (92%), 70 answered the second round (80%), and 67 answered the third round (76%) of the survey. There was strong agreement regarding the fact that identifying patients with aggressive disease needs to be adequately addressed to help practitioners to decide the best treatment options for patients with HER2-negative mBC. The factors that were considered to be strongly relevant to classifying patients with aggressive HER2-negative mBC were a high tumor burden, a disease-free interval of less than 12-24 months after surgery, the presence of progressive disease during adjuvant or neoadjuvant chemotherapy and having a triple-negative phenotype. The main therapeutic goals were controlling symptoms, improving quality of life and increasing the time to progression and overall survival. CONCLUSIONS: High tumor burden, time to recurrence after prior therapy and having a triple-negative phenotype were the prognostic factors for which the greatest consensus was found for identifying patients with aggressive HER2-negative mBC. Identifying patients with aggressive disease leads to different therapeutic approaches.

Adjuvant regimens with trastuzumab administered for small HER2-positive breast cancer in routine clinical practice.

PURPOSE: Trastuzumab has proven to improve the prognosis of HER2-positive breast cancer, but the information available about its administration for small tumors is still limited. Therefore, we assessed the use of adjuvant regimens with trastuzumab for the treatment of small HER2-positive breast cancer in routine clinical practice. METHODS: This observational study was conducted in patients with HER2-positive breast adenocarcinoma ≤1.5 cm who received trastuzumab-based adjuvant treatment in clinical practice. Clinical/histopathological data were retrieved from patients' medical charts. RESULTS: A total of 101 evaluable patients were enrolled (median age [range], 56.7 [49.0-64.8] years; ECOG 0, 98.0 %; ductal carcinoma, 88.1 %; lymph nodes N0, 79.2 %). Only five (5.0 %) patients received neoadjuvant treatment, while all patients underwent tumor surgery. Adjuvant trastuzumab was administered at a mean (±SD) dose of 5.9 ± 1.5 mg/kg/cycle, and mostly in a three-weekly schedule (89 [89.0 %] patients). The most frequent adjuvant therapy used with trastuzumab was chemotherapy (87 [86.1 %] patients), followed by radiotherapy (63 [62.4 %] patients) and hormone therapy (52 [51.5 %] patients). Chemotherapy regimens mainly included doxorubicin, cyclophosphamide and paclitaxel/docetaxel (n = 30), docetaxel and cyclophosphamide (n = 15), docetaxel and carboplatin (n = 13). Hormone therapy mainly included letrozole (n = 17) and tamoxifen (n = 17). Nine (8.9 %) patients reported trastuzumab-related adverse events; only one allergic reaction reached grade 3 toxicity. CONCLUSION: This study shows that trastuzumab-based adjuvant treatment of small HER2-positive breast cancer is mostly based on chemotherapy-mainly paclitaxel/docetaxel. Adjuvant administration of trastuzumab for small HER2-positive breast cancer seems to be similar to that used for larger tumors.

Phase II study of carboplatin and 1-h intravenous etoposide and paclitaxel in a novel sequence as first-line treatment of patients with small-cell lung cancer.

PURPOSE: To evaluate the efficacy and tolerability of paclitaxel, carboplatin and etoposide when administered in combination to previously-untreated small-cell lung cancer (SCLC) patients. PATIENTS AND METHODS: Patients (n=95) with limited-stage disease (LSD; n=45) or extensive-stage disease (ESD; n=50) from 14 Spanish hospitals were entered into the study. Etoposide was administered 80 mg/m(2)/day intravenous (i.v.) on days 1, 2 and 3, paclitaxel 175 mg/m(2) i.v. on day 3 and carboplatin area-under-the-concentration-time-curve=6; i.v. on day 3, of a 3-week cycle, and repeated for up to 6 cycles. RESULTS: The overall response (OR) rate was 74% (n=70; 32 complete, 38 partial). Although the OR in LSD and ESD patients was similar (73 vs 74%, respectively), the percentage complete response was significantly higher among the former (49 vs 20%). The main toxicities were grade 3-4 neutropenia and febrile neutropenia (62 and 18%, respectively) and there were 3 toxic deaths. Other toxicities were rare or easily manageable. Disease-free survival and overall survival rates at 1 year were 53 and 70% in LSD and 18 and 39% in ESD patients, respectively. CONCLUSION: The results indicate that the combination of paclitaxel, etoposide and carboplatin has an anti-tumour activity in SCLC that is comparable to other combination regimens, and is well tolerated.

Fetal dysmorphism in spontaneous abortions in a Mexican population.

OBJECTIVE: The purpose of this research was to find out the frequency and type of fetal dysmorphism in spontaneous abortions among the Mexican population. METHOD: A prospective study was carried out in all the cases of spontaneous miscarriages occurring at the 'Dr. Manuel Gea González' General Hospital in Mexico City, from July 1989 to June 1999. RESULT: Two hundred and one empty sacs and 1555 well-defined embryos or fetuses were analyzed. Dysmorphism was observed in 48% of the cases, malformations being the most frequently found. Among malformations the largest group corresponded to morphological alterations not recognized in the postnatal life, facial clefts and closure defects of the abdominal wall were the known malformations of the postnatal period most frequently found. The most common syndromic entities were suggestive of bone dysplasia and Turner phenotype. CONCLUSION: The frequency of fetal dysmorphism in spontaneous abortions is higher than in newborns. Its diagnosis is very important for genetic counseling.

[Clinical outcome and health related quality of life in patients undergoing coronary angioplasty with balloon or stent. A prospective multicenter study]. / Resultados clínicos y de calidad de vida de los pacientes tratados con angioplastia coronaria con balón o stent. Estudio multicéntrico prospectivo.

INTRODUCTION AND OBJECTIVES: Clinical outcome and health related quality of life after coronary angioplasty with stent or balloon are insufficiently studied in routine practice. The aim of the present study was to assess the impact of angioplasty on the clinical results and quality of life in real clinical practice. PATIENTS AND METHODS: All the consecutive patients undergoing angioplasty with stent or balloon attending two Spanish tertiary hospitals from October, 1997 to July, 1998 were evaluated at baseline and one year after discharge from hospital with a structured clinical questionnaire and the generic SF-36 quality of life questionnaire. RESULTS: Three hundred ninety-seven patients with a mean age of 63 years were included in the study. A stent (or stent plus balloon) was implanted in 342 patients and angioplasty with a single balloon was performed in 55 patients. More advanced coronary disease and suboptimal lesions for treatment were found in patients treated with only balloon. At one year of follow up the total mortality was 6% and 54% of the patients were free of angina. Mean baseline scores of the SF-36 questionnaire were remarkably low (35 for physical health and 45 for mental health). At one year the scores achieved levels similar to those of the general Spanish population matched for age and sex (45 for physical health and 52 for mental health). Independent predictors of quality of life at one year were the following: baseline quality of life, age, sex, comorbidity, previous hospitalizations, hospital where the patient was attended, symptoms at admission and late angina. CONCLUSIONS: a) After percutaneous myocardial revascularization the mean quality of life achieved was similar to that of the general population; b) different clinical subgroups did not achieve these levels, although improvement was similar to that of the remaining subgroups

[Outcomes of coronary artery surgery: determinants of quality of life related to postoperative health]. / Resultados después de cirugía coronaria: determinantes de calidad de vida relacionada con la salud postoperatoria.

BACKGROUND AND OBJECTIVES: Little is known of the clinical and nonclinical determinants of health related quality of life after coronary artery bypass graft in routine clinical practice. The aim of this study was to assess the quality of life and its determinants after a first coronary bypass in a representative population of Catalonia, Spain. PATIENTS AND METHOD: Clinical and quality of life questionnaires were given to all the patients (n = 710) undergoing a first coronary bypass in private and public Catalan hospitals, prior to surgery and at six months and one year of follow-up. Quality of life was assessed with the DASI and the SF-36. RESULTS: The rate of clinical events at one year was 23%. The mean quality of life improved to levels slightly below those in general population; with greater changes reported in physical than in mental condition although the latter was less impaired. In 24%, the quality of life scores at one year were below 1.5 standard deviations of those in the general population. Females, patients with comorbidity and those with public health care insurance showed lower quality of life scores. Independent predictors of one-year quality of life included initial quality of life scores, public insurance, comorbidity, gender, age and chronic disease. Postoperative angina and dyspnoea were also associated with quality of life. CONCLUSION: The mean quality of life improves after coronary bypass, although up to one fourth of the patients may have unsatisfactory one-year clinical or quality of life outcome. Female patients, public insurance and comorbidity predict a worse quality of life.

[The unequal clinical profile, quality of life and hospital mortality in patients undergoing aortocoronary bypass in the public and private centers of Catalonia. The CIRCORCA Study]. / Desigual perfil clínico, calidad de vida y mortalidad hospitalaria en pacientes operados de injerto aortocoronario en centros públicos y privados de Cataluña. El estudio CIRCORCA.

INTRODUCTION AND AIMS: The influence of the type of health care funding and management of hospital centres on hospital mortality in coronary artery bypass surgery (CABG) has not been analyzed in detail. We therefore assessed clinical and quality of life preoperative profiles and in-hospital mortality in public and private patients undergoing coronary bypass surgery in Catalonia. METHODS: Clinical questionnaires, Duke Activity Status Index (DASI) and SF-36 were preoperatively administered to all patients undergoing first coronary bypass surgery without associated procedures in Catalonia between November 1996-June 1997. In-hospital morbidity and mortality were recorded. RESULTS: Predictors of in-hospital death, including DASI, SF-36 and comorbidity scores, were significantly worse in public than in private patients. In-hospital mortality rate was more than ten times greater in public than in private patients (8.2% vs 0.7%; p < 0.001). Multivariate analysis identified private funding of health care, among others, as an independent predictor of in-hospital survival. Non evidence-based indications for surgery were significantly more common in private than in public patients (6% vs 0.7%, p < 0.001). CONCLUSIONS: a) In catalonia, the risk profile of public patients undergoing coronary bypass surgery was significantly higher than that of private patients, accounting, at least in part, for a remarkable mortality difference; b) non evidence-based indications for surgery were more common in private than in public patients; c) these unequal patterns raise questions about the adequacy of care and referral patterns in both private and public sectors.

[Therapeutic control and quality of life in coronary artery bypass surgery patients]. / Control terapéutico de los factores de riesgo y calidad de vida en los pacientes tratados mediante derivación aortocoronaria.

BACKGROUND: Description of measures of secondary prevention and of health related quality of life one year after the intervention in patients undergoing coronary artery bypass surgery. PATIENTS AND METHOD: One year follow up prospective study in patients undergoing first coronary bypass surgery without associated procedures and aged less than 80 in public and private hospitals in Cataluña, Spain. RESULTS: 710 patients were included, 85.4% were men, and mean age was of 63 years. When compared women and men, 74.8 vs 48.7% patients were diagnosed of hypertension, 70.2 vs 55% of hypercholesterolemia, and 42.3 vs 28.7% of diabetes (p < 0.01); on the other hand, 31.2% of men and 2.9% of women were active smokers (p < 0.01). After a year of follow-up, 7% of the total population remained smokers; a significant reduction of anti-anginal treatments and a significant improvement in health related quality of life were observed. Cholesterol lowering treatment in patients previously diagnosed of hypercholesterolemia increased significantly between hospital admission and one year after hospital discharged (from 44% at the beginning to a 58% at the year of follow up; p < 0.01). CONCLUSIONS: Patients undergoing coronary artery bypass surgery clinically improved one year after the intervention, improving also their health related quality of life. However, the percentage of smokers and the level of antihypertensive and lowering cholesterol treatment at the end of follow up suggest a suboptimal control of risk factor

[Adaptation of the MacNew QLMI quality of life questionnaire after myocardial infarction to be used in the Spanish population]. / Adaptación del cuestionario de calidad de vida postinfarto MacNew QLMI para su uso en la población española.

BACKGROUND: The advantage of specific quality of life instruments is its ability to evaluate specific issues related to the illness of interest. The aim of the present study is to develope a Spanish version of the self-administered questionnaire MacNew QLMI, specific for patients after myocardial infarction (MI). MATERIAL AND METHOD: Forward and back-translation method by bilinguals was performed; once the test for feasibility and comprehension was carried out. 143 patients with a first MI completed the Spanish version of the MacNew QLMI and principal components factor analysis was performed. Reliability was assessed in 50 patients with stable MI that completed twice the questionnaire (with an interval of two weeks), measuring reproducibility and internal consistency with Student t test, intraclass correlation and Cronbach's alpha. RESULTS: Factor analysis showed a similar three dimensional structure as the original version. Intraclass correlation coeficient were 0.83, 0.87 and 0.83, and Cronbach's alpha coeficients were 0.85, 0.88 and 0.83 for the emotional, physical and social dimensions respectively. CONCLUSIONS: The Spanish version of the MacNew QLMI questionnaire has a good equivalence with the original version, a good internal consistency and a good reproducibility; it can be used in the Spanish population to study its validity.

Breast cancer management in the elderly.

The increase in life expectancy in the western world means that we are faced with patients diagnosed with breast cancer in old age with increasing frequency. The management of these cases is a challenge for the oncologist, who must take into account the conditions associated with advanced age and the lack of trials in this population. In this review, we addressed the incorporation of geriatric assessment methods that may be useful in making decisions, the particular biological characteristics of breast cancer in elderly patients and their treatment in both localized and advanced disease. Finally, we collected recommendations based on scientific evidence regarding the monitoring and life-style after finishing treatment.

CD11c decrease in mouse thymic dendritic cells after vanadium inhalation.

Vanadium (V) is a transition metal found in air adsorbed onto suspended particles. As a result, urban populations are often exposed to this element as a constituent of particulate matter (PM). One aspect of the myriad toxicities that might arise from these exposures is altered immune responses. Previous reports from the laboratory reported modifications in splenic architecture - with germinal center hyperplasia and a suppressed humoral immune response - in mice that had been exposed to vanadium agents via inhalation. This paper reports a decrease in the presence of the CD11c surface marker on mouse thymic dendritic cells (DC) as a result of host exposure to vanadium (here, in the form of vanadium pentoxide; V(2)O(5)) over a period of 4 weeks. All results were obtained using immunohistochemistry and flow cytometry. It is surmised that this decrease might induce a dysfunction, including possible negative selection of T-cells, which could increase the presence of autoreactive clones in the exposed host. Such an outcome could, in turn, increase the risk for development of autoimmune reactions in different organs specifically, and of autoimmune diseases in general in these V-exposed hosts.

Diagnostic value of apparent diffusion coefficients to differentiate benign from malignant vertebral bone marrow lesions.

AIM: The aim of this study is to evaluate the value of the apparent diffusion coefficient (ADC) obtained in diffusion-weighted (DW) MR sequences for the differentiation between malignant and benign bone marrow lesions. METHOD: Forty-five patients with altered signal intensity vertebral bodies on conventional MR sequences were included. The cause of altered signal intensity was benign osteoporotic collapse in 16, acute neoplastic infiltration in 15, and infectious processes in 14; based on plain-film, CT, bone scintigraphy, conventional MR studies, biopsy or follow-up. All patients underwent isotropic DW MR images (multi-shot EPI, b values of 0 and 500 s/mm(2)). Signal intensity at DW MR images was evaluated and ADC values were calculated and compared between malignancy, benign edema and infectious spondylitis. RESULTS: Acute malignant fractures were hyperintense compared to normal vertebral bodies on the diffusion-weighted sequence, except in one patient with sclerotic metastases. Mean ADC value from benign edema (1.9+/-0.39 x 10(-3) mm(2)/s) was significantly (p<0.0001) higher than untreated metastasic lesions (0.9+/-1.3 x 10(-3)mm (2)/s). Mean ADC value of infectious spondilytis (0.96+/-0.49 x 10(-3) mm(2)/s) was not statistically (p>0.05) different from untreated metastasic lesions. ADC value was low (0.75 x 10(-3) mm(2)/s) in one case of subacute benign fracture. CONCLUSIONS: ADC values are a useful complementary tool to characterize bone marrow lesions, in order to distinguish acute benign fractures from malignant or infectious bone lesions. However, ADC values are not valuable in order to differentiate malignancy from infection.