Observational study on adjuvant trastuzumab in HER2-positive early breast cancer patients.

AIM: This observational study investigates the use of adjuvant trastuzumab (AT) in HER2-positive breast cancer patients in a real-life setting, focusing on relapse and discontinuation rates. PATIENTS & METHODS: Data on a group of HER2-positive patients collected from 13 oncology centers of northeast Italy were analyzed. RESULTS: In total, 1245 patients were analyzed. 13.1% of patients were excluded from AT because of comorbidities, age, tumor stage, refusal or other reasons; 8.2% of patients who received AT interrupted the therapy, mainly for toxicity. Overall the relapse rate was 10.9% in the AT-treated population versus 22.6% in nontreated patients (follow-up: 37.4 and 62.1 months, respectively). Disease-free survival (DFS) was lower in AT-relapsed patients than in not-relapsed. Statistical analysis showed a correlation between DFS and estrogen receptor status in AT-treated patients. CONCLUSION: Relapse rates are lower in clinical setting compared to clinical trials. Overall, AT is effective in HER2-positive early-stage breast cancer patients.

Carboplatin and gemcitabine in first-line treatment of elderly patients with advanced non-small cell lung cancer: data from a retrospective study.

We retrospectively evaluated elderly patients with advanced non-small cell lung cancer (NSCLC) treated with carboplatin (AUC 4-5) and gemcitabine (1,000-1,200 mg/m²). Thirty-six patients with performance Status (pS) 0-1 and median age 73 (range 70-78 years) were considered. Histology was squamous cell carcinoma (8 patients), adenocarcinoma (22) and NSCLC not otherwise specified (6). 149 cycles of chemotherapy were administered with a median of 3 per patient (range 3-6). Grade 3 non-hematologic toxicities were dyspnea (1 patient) and fever (1). Grade 3/4 hematologic toxicities were anemia (6), neutropenia (6) and thrombocytopenia (10), with dose reduction required in 13 patients. The overall disease control rate was 44.4%. We recorded no complete response, 8 partial response, 8 stable disease and 20 progressive disease. After a medium follow-up of 11 months, median progression- free survival and median survival were 5 and 11 months, respectively. Carboplatin and gemcitabine is a safe and active regimen in elderly advanced NSCLC patients with good PS.

Mortalidad perioperatoria en pacientes diabéticos sometidos a amputación no traumática de miembros inferiores en la Comunidad de Madrid de 1997 a 2005 / Perioperative mortality in diabetic patients after non traumatic lower extremity amputations in Madrid from 1997 to 2005

Introducción: Las complicaciones crónicas de la diabetes condicionanlos costes relacionados con la salud, la productividad y la economía,entre las que destacan el pie diabético. Objetivos: Análisis de latendencia y los factores relacionados con la mortalidad por amputaciónno traumática de miembros inferiores (AMI). Material y método: Estudio observacional retrospectivo de las AMI ocurridas en Madridentre 1997 y 2005. Fuente documental: Conjunto Mínimo Básicode Datos. Se seleccionaron las altas con un procedimiento 84.1X y undiagnóstico 250.XX (CIE-9-MC). Se defi nió amputación menor comodistal a la articulación tarsometatarsiana. La tendencia de la mortalidadse evaluó mediante modelos segmentados de regresión de Poisson yse expresó como porcentaje anual de cambio (PAC). Se estudió elriesgo de muerte mediante regresión logística multivariante para lassiguientes variables independientes: edad, sexo, tipo de amputación ydiabetes. Resultados: Se produjeron 278 muertes en diabéticos (7,3%). En la evolución de la mortalidad se obtuvo un PAC del 1,99% (intervalo de confi anza del 95%: –2,7 a 6,9), no signifi cativo. El riesgo de mortalidad (odds ratio; intervalo de confi anza del 95%) fue en mayores de 65 años de 3,16 (2,03-4,91; p= 0,0001) y en la AMI mayorde 2,75 (2,08-3,64; p= 0,0001). Conclusiones: La mortalidadperioperatoria de la AMI permanece elevada y no muestran tendenciadescendente en el periodo de estudio con un mayor riesgo para losmayores de 65 años y AMI mayor(AU)

Introduction: Chronic diabetic complications greatly affect thecost in health, economic productivity, with an emphasis on diabeticfoot. Objectives: Analysis of mortality trends and related factorsassociated with LEA. Material and methods: A retrospective observational study of LEA in Madrid between 1997 and 2005. Documentarysource: MBDS (discharge minimum basic data set). We selected cases that included an 84.1X procedure and 250.XX diagnosis (ICD-9-CM). Minor amputation was defined as distal to theankle joint and a perioperative death that occurred during hospitalization.The trend of mortality was assessed using joinpoint regressionanaly sis and expressed as percentage of annual change (PAC). We studied the risk of death by multivariate logistic regression using the independent variables age, sex, type of amputationand diabetes. Results: During the study period there were 278 deaths (7.3%) in diabetic patients. Mortality trends: PAC 1.99% (–2.7 to 6.9) was not significant. Risk of death (OR; 95%CI), patients over 65 years old (3.16; 2.03-4.91; p= 0.0001) and major LEA (2.75; 2.08-3.64; p= 0.0001). Conclusions: The perioperativemortality of LEA remains high and showed no downward trend duringthe study period with an increased risk of death for adults over65 years and major LEA(AU)

Evaluación de la eficiencia en consultas externas: una aplicación del análisis envolvente de datos / Assessment of efficiency in out-patient clinics: an application of data envelopment analysis

Objetivo: Identificar unidades de oferta de consultas externas relativamente ineficientes. Método: Se ha utilizado el análisis envolvente de datos (AED) para el cálculo de la eficiencia relativa. La unidades de oferta analizadas son las consultas externas de alergología, cardiología, dermatología, endocrinología, gastroenterología, neumología, reumatología, ginecología, ORL, oftalmología, traumatología y urología de 10 hospitales públicos de la Comunidad de Madrid. La fuente de información ha sido el sistema de información de asistencia especializada (SIAE) y la base de recursos humanos del año 2001. Como medida de los insumos se ha utilizado el número de facultativos especialistas y la incidencia de derivaciones desde atención primaria, y como medida de los resultados, la frecuentación y presión asistencial en las consultas de atención especializada. Resultados: El nivel medio de eficiencia encontrado varía de 0,84 en alergología a 0,97 en endocrinología. La eficiencia media relativa alcanzada por hospital varía de 0,81 a 0,98.Conclusiones: El conocimiento de la eficiencia relativa de las unidades de producción puede ser una herramienta adicional para la planificación, reasignación de recursos e incentivación de unidades de oferta que presenten un mejor nivel de producción. No obstante, cuando interpretamos los resultados del análisis, no debemos perder de vista las dificultades propias de la aplicación de esta metodología relativas a la elección de las variables que definen los inputs y los outputs o la incapacidad de obtener una medida de eficiencia absoluta (AU)

Increased serum levels of IgA antibodies to hsp70 protein in patients with diabetes mellitus: their relationship with vascular complications.

We measured class-specific antibodies to the mycobacterial hsp70 protein in 67 patients with diabetes mellitus (27 type 1 and 40 type 2) with or without vascular complications. Using ELISA, the levels of IgG and IgM antibodies in the sera of diabetic patients did not significantly differ either from those of healthy control subjects or between both types of diabetes, regardless of gender, disease duration, HbA1 level, or type of vascular complication. In patients with type 2 diabetes, the mean serum IgA levels were significantly higher than those in their matched controls [274(71) mg/dl vs 208(88) mg/dl; P < 0.01]. In this group of patients, the IgA antibody titer was significantly correlated to the serum IgA level (r = 0.334; P < 0.01). Serological autoimmunity (IgG or IgM type) to hsp70 protein is common in both the normal and the diabetic population. The increased IgA levels and anti-hsp70 IgA titers in the sera of diabetics suggest a possible role of IgA in the pathogenesis of the vascular complications of diabetes mellitus.

pTNM stage distribution in breast cancer: a population-based survey in northern Italy. Collaborative Group of Pathologists for Cancer Registration in Verona.

AIMS AND BACKGROUND: The role of distribution by stage at diagnosis in breast cancer has been considered in many studies, with particular regard to evaluation of prognosis, impact of screening programs and quality of care. Nevertheless, international comparisons of descriptive data can be hampered by lack of homogeneity in staging methods. The TNM is presently the most common staging system used all over the world, although some criticism have been raised recently against its pragmatic value. The present study reports a population-based survey of pathologic TNM distribution in incident cases of female breast cancer in the Verona province, a geographical area of northern Italy covered by cancer registration. METHODS: All histologically proven incident cases of breast cancer were identified in the study period 1988-1990 and classified as for tumor size and nodal involvement according to the pathological TNM criteria. The type of surgical treatment was also registered for all cases diagnosed in 1990. RESULTS: one thousand two hundreds and fifty-four invasive and in situ breast cancers were observed and pT1 cases accounted for 44.4%. Nodal involvement was present in 41.5% of invasive cancers. A surgical treatment was performed in 1213 patients (96.7%). Axillary dissection was reported in 1080 cases, 820 of them (76.6%) having 10 or more lymph nodes examined. Radical mastectomy accounted for 74% of the 458 breast cancers diagnosed in 1990 and 31.6% of the eligible cases were conservatively treated. CONCLUSIONS: Cancer registries should be encouraged to report data on stage distribution in breast cancer (and in other malignancies). This practice could improve international comparisons and give an essential contribution to studies on survival, screening programs and quality of care.

Plasma C3d levels and ischemic heart disease in type II diabetes.

OBJECTIVE--To test the hypothesis that the complement system may be activated in patients with type II diabetes and CAD. RESEARCH DESIGN AND METHODS--The plasma C3d concentration was measured in 106 type II diabetic patients and 25 nondiabetic control subjects. The patient group was subdivided according to AER, and the groups were adjusted for age, sex, and known duration of diabetes. For the assignment to a given subgroup, normoalbuminuria was defined as AER < 15 microns/min, microalbuminuria as AER 16-250 micrograms/min, and macroalbuminuria as AER > 250 micrograms/min. The presence or absence of coronary disease was assessed through clinical examination, ECG, and coronary angiography. An RIA system was used for measurement of urinary albumin levels, and the plasma C3d concentrations were measured by ELISA. RESULTS--Within each of the AER-defined subgroups, the plasma C3d levels were significantly higher in patients with IHD than in those without. Thus, in the normoalbuminuric group, plasma C3d levels were 16.3 AU/ml (95% CI 13.9-19) in patients with IHD vs. 11.6 AU/ml (95% CI 10.5-12.7) in those without (P < 0.001). The corresponding data for the microalbuminuric and macroalbuminuric groups were 21.8 (95% CI 18.1-26.3) vs. 13.6 (95% CI 12.3-15.1) and 31.6 (95% CI 24.9-40) vs. 17.5 (13.6-22.6) AU/ml (P < 0.01), respectively. Patients with IHD also had significantly higher plasma C3d levels than normal control subjects, regardless of AER subgroup. A multiple logistic regression analysis demonstrated an association between the plasma C3d concentration and IHD and AER. CONCLUSIONS--Activation of the complement system may play a role in the development of macrovascular disease in type II diabetes.

Recombinant alpha-interferon and vinblastine in metastatic renal cell carcinoma: efficacy of low doses.

Twenty-six patients with metastatic renal cell carcinoma (RCC) were treated in a phase I-II trial with recombinant interferon alpha-2b (alpha-IFN) and vinblastine (VBL) in combination. Patients received IFN at a starting dose of 3 x 10(6) IU/m2 subcutaneously three times a week and VBL 0.1 mg/kg intravenously every 3 weeks, with dose modification for toxicity. All patients were evaluable for toxicity; 18 patients were evaluable for efficacy. An objective response rate of 44% was observed (eight of 18 patients, with one complete response and seven partial responses). The median duration of response was 5 months. The actuarial survival of responding patients was significantly longer than that of nonresponding patients. In general, the toxicity was tolerable; the subjective toxicity and fever were similar to that reported for the same doses of IFN alone. Only a mild neurotoxicity, usually mixed polyneuropathy, occurred with increased frequency. Alpha-IFN and VBL administered at low doses in combination demonstrated the highest response rate so far reported in RCC without significant toxicity.

Early detection of breast cancer recurrences through periodic follow-up--is it useless?

The authors report on a multicentric consecutive series of 1120 breast cancer first recurrences. Cases detected as subjectively asymptomatic thanks to periodic follow-up examinations are compared to cases detected as symptomatic. The relapse-free interval from primary treatment was shorter for asymptomatic recurrences, confirming that an earlier diagnosis was achieved in these cases. In spite of this diagnostic anticipation, median and actuarial survival from primary treatment did not differ when asymptomatic recurrences were compared to symptomatic recurrences. The study results did not show any prognostic impact of periodic follow-up in breast cancer and urge for prospective controlled studies on this diffuse and expensive practice.

[Erythrocyte deformability: critical evaluation of the study methods]. / La deformabilità dell'eritrocita: valutazione critica dei metodi di studio.

The rheological behavior of red cells in macrocirculation and in capillaries is briefly described. The following methods measuring red cell deformability are critically evaluated: a. degree of red cell 'packing' after centrifugation; b. single erythrocyte passage through microchannels (micropipette technique, rigidometer); c. filtration techniques of washed red cells; d. polymicroviscosimetry (paper filtration, filtrometer) and viscosimetry (ektacytometer). It is considered the adequacy of each method in assessing the different factors responsible for the variations of red cell deformability (internal viscosity, surface area/volume ratio, viscoelastic properties of the membrane.

The diagnostic value of serum copper levels and other hematochemical parameters in malignancies.

An increase in the serum copper (Cu++) level has been described as a sensitive index of disease activity in several hematologic and nonhematologic malignancies. In order to explore the diagnostic value of Cu++ compared to other hematochemical parameters frequently abnormal in malignancies, Cu++, serum alpha2 globulin (alpha2), plasmatic fibrinogen (Fibr), the erythrocyte sedimentation rate (ESR), and serum iron (Fe++) have been detected and evaluated in 267 patients affected with the following diseases: Hodgkin's lymphoma (HL), non-Hodgkin's Lymphomas (NHL), Acute Leukemias (AL), Chronic Myeloid Leukemia (CML), Chronic Lymphocytic Leukemia (CLL), Myeloma (MM), and Breast Cancer (BC). The best correlation between Cu++ increase and disease activity has been found in HL, NHL, AL, and BC. In these diseases, when the considered parameters were compared, Cu++ and ESR showed a similar pattern, i.e., a high frequency of abnormalities in active disease. It is concluded that Cu++ represents a good complement to some other aspecific parameters in evaluating the activity and diffusion of neoplasias and the therapeutic results, particularly in HL, NHL, AL and BC.