Biosimilar Versus Originator Pegfilgrastim for Preventing Chemotherapy-Induced Neutropenia: A Phase III Randomized, Multicenter, Evaluator-Blinded, Noninferiority Study.

PURPOSE: This study evaluated the efficacy, safety, and immunogenicity of biosimilar pegfilgrastim (PegFilBS) and originator pegfilgrastim (PegFilOR) in patients with stage 2-4 breast cancer. METHODS: This phase III randomized, multicenter, evaluator-blinded, noninferiority study recruited women with stage 2-4 breast cancer in Argentina who were scheduled to receive chemotherapy. Stratification was based on the breast cancer stage. The primary end point was the duration of severe neutropenia (DSN, noninferiority margin: 1 day) in the first chemotherapy cycle. Secondary end points assessed were incidence of severe neutropenia, grade 3 neutropenia, febrile neutropenia, infections, postchemotherapy hospitalization and duration, and the incidence of adverse drug reactions (ADRs). RESULTS: A total of 120 patients were randomly assigned to receive PegFilBS (58 patients) or PegFilOR (62 patients). Severe neutropenia occurred in 52 of 283 cycles (18.4%) for 27 patients who received PegFilBS and in 48 of 297 cycles (16.2%) for 20 patients who received PegFilOR (P = .48). During the first cycle, severe neutropenia occurred in 16 patients who received PegFilBS (DSN: 0.78 ± 1.53 days) and in 11 patients who received PegFilOR (DSN: 0.53 ± 1.25 days; 95% CI, -0.26 to 0.76 days). In the intention-to-treat analysis, the mean DSN values were 0.90 ± 1.79 days for the PegFilBS group and 0.50 ± 1.21 for the PegFilOR group (95% CI, -0.15 to 0.95 days). No significant differences were observed for the secondary efficacy end points. Three patients experienced seven ADRs in the PegFilBS group while 10 patients experienced 31 ADRs in the PegFilOR group. The most common ADR was myalgia. CONCLUSION: Relative to PegFilOR, PegFilBS provided noninferior efficacy outcomes in Argentinian women with stage 2-4 breast cancer who were treated using myelosuppressive chemotherapy.

Efficacy and Safety of Nivolumab in Previously Treated Patients With Non-Small-cell Lung Cancer: Real World Experience in Argentina.

BACKGROUND: Nivolumab was the first anti-programmed cell death 1 drug approved in Argentina for non-small-cell lung cancer treatment in the second-line setting. MATERIALS AND METHODS: The present study was a multicenter, observational, retrospective study of patients with progression to stage IV NSCLC during platinum-based chemotherapy who had received nivolumab monotherapy in a drug-expanded access program in Argentina. RESULTS: The data from 109 patients were assessed retrospectively for safety and clinical outcomes. The follow-up period was 8.83 months (interquartile range, 3.4-12.67); 57.8% were men, 29.4% were current smokers, and 78.0% had a diagnosis of nonsquamous cell cancer. The median number of chemotherapy lines before nivolumab was 2 (range, 1-4). Also, 59.6% had received radiotherapy and 89% had received platinum-based chemotherapy. The drug-related toxicity rate was 78.9%, the grade 2-3 toxicity rate was 28.4%, and 33.9% of patients had required corticosteroids. The treatment response was evaluated in 104 patients. The best response was a complete response in 2 (2%), partial response in 28 (27%), stable disease in 33 (32%), and progressive disease in 41 (39%). Univariate analysis revealed that the absence of corticosteroid use (P = .034), toxicity grade 1-3 (P = .0025), and performance status of ≤ 1 (P = .049) were associated with longer disease-free survival, performance status of ≤ 1 (P < .001), and toxicity grade 1-3 (P = .001) were associated with longer overall survival. On multivariate Cox regression analysis, toxicity grade 1-3 (hazard ratio [HR], 0.44; 95% confidence interval [CI], 0.24-0.81; P = .008) and age ≤ 50 years (HR, 0.28; 95% CI, 0.13-0.61; P = .001) were associated with longer progression-free survival and corticosteroid use was associated with shorter progression-free survival (HR, 2.06; 95% CI, 1.22-3.48; P = .007). CONCLUSIONS: The use of nivolumab in the real world setting in patients with heavily pretreated NSCLC was well tolerated and showed promising clinical efficacy. The performance status, use of corticosteroids, and immune-mediated toxicity seem to be the conditions that can affect the clinical outcomes.

A Phase II Randomized Study of Lapatinib Combined With Capecitabine, Vinorelbine, or Gemcitabine in Patients With HER2-Positive Metastatic Breast Cancer With Progression After a Taxane (Latin American Cooperative Oncology Group 0801 Study).

BACKGROUND: Novel targeted agents and combinations have become available in multiple lines of treatment for human epidermal growth factor receptor 2-positive (HER2(+)) metastatic breast cancer (MBC). In this context, alternatives to the lapatinib (L) and capecitabine (C) regimen, evaluating L combined with other cytotoxic drugs, are warranted. PATIENTS AND METHODS: In the present phase II, multicenter study, patients with HER2(+) MBC with progression after taxane were randomized between L, 1250 mg, combined with C, 2000 mg/m(2) on days 1 to 14 (LC), vinorelbine (V), 25 mg/m(2) on days 1 and 8 (LV), or gemcitabine (G), 1000 mg/m(2) on days 1 and 8 (LG), every 21 days. The primary endpoint was the overall response rate. RESULTS: A total of 142 patients were included from 2009 to 2012. No differences were found in the patient baseline characteristics. The median age was 51 years, 69% were postmenopausal, 32% had liver metastasis, 57% were hormone receptor negative, and 48% had been previously treated with trastuzumab. The overall response rate was 49% (95% confidence interval [CI], 34.8%-63.4%), 56% (95% CI, 40%-70.4%), and 41% (95% CI, 27%-56.8%) in the LC, LV, and LG groups, respectively. The median progression-free survival was 9 months in the LC arm and 7 months in the other 2 arms (P = .28). The most common grade 3 and 4 adverse events were hand-foot syndrome (18%), diarrhea (6%), and increased alanine aminotransferase/aspartate aminotransferase (4%) in the LC arm; neutropenia (36%), diarrhea (9%), and febrile neutropenia (6%) in the LV arm; and neutropenia (47%), alanine aminotransferase/aspartate aminotransferase (13%), and rash (4%) in the LG arm. CONCLUSION: LV and LG seem to be active combinations in patients with HER2(+) MBC after taxane failure. The overall toxicity was manageable in all regimens.

Alteration of serum and tumoral neural cell adhesion molecule (NCAM) isoforms in patients with brain tumors.

The neural cell adhesion molecule (NCAM) is involved in the intercellular junctions of neurons and glial cells. We investigated its relevance as a biomarker in gliomas which main characteristic is their high invasiveness. We studied by Western blot the pattern of serum NCAM bands in patients with gliomas (n = 34), with brain metastasis of different primary cancers (n = 27) and with benign brain tumors (n = 22)] compared with healthy controls (n = 69). For densitometric analysis NCAM bands > or = 130 kDa (HMW) and <130 kDa (LMW) were clustered. We observed that glioma patients presented higher NCAM HMW and lower NCAM LMW levels than control subjects (P < 0.01). A similar pattern was found in patients with brain metastasis or brain benign tumors, suggesting that the pattern of serum NCAM bands would be useful to detect brain tumor pathology. On the other hand, serum NCAM expression was not associated with the main clinicopathological features of gliomas, including overall survival. Interestingly, we found that 9/12 patients with glioma showed a significant decrease in NCAM HMW/LMW ratio between 1-3 months after successful tumor removal. Thus, serum NCAM could be a useful marker for monitoring treatment.NCAM expression was also analyzed at tissular level in 59 glioma sections from paraffined tumors. We observed that NCAM immunostaining was inversely correlated with the histological grade of malignancy, remaining this association in a multivariate analysis. Besides, loss of NCAM staining was significantly associated with bad prognosis in an univariate analysis.

Prognostic value of Mdm2, p53 and p16 in patients with astrocytomas.

Surgical cure of gliomas infiltrating into the brain is practically impossible and their clinical course is primarily determined by the biological behavior of the tumor cell. The purpose of this study was to analyze retrospectively prognostic input of p53, Mouse double minute-2 (Mdm2) and p16 in 103 uniformly treated patients with astrocytic tumors. The expression of these molecules was measured by immunohistochemical procedure. Prognostic evaluation was performed with the multivariate proportional hazards model. The follow-up period lasted 19 (5-122) months for the survivors. We observed that 66% of gliomas showed mutated p53, while only 17% overexpressed Mdm2, the p53-regulatory molecule. Besides, almost 50% of gliomas lost p16 immunopositivity. Only p53 labeling showed a positive correlation with the grade of malignancy, according with the WHO classification. The association between mutated p53 and histological grade remained when prognostic variables were considered in a multivariate analysis. No association between p53 status and overall survival was found. On the other hand, Mdm2 overexpression and, unexpectedly, p16 immunopositivity were associated with a shorter survival in an univariate analysis. However, Cox-regression analysis showed that only Mdm2 in female patients was an independent prognostic factor, associated with shorter survival. In conclusion, our results suggest that Mdm2 could be a relevant marker in determining the evolution of glioma patients and could provide a more objective way to classify astrocytomas.

EGF-R and PDGF-R, but not bcl-2, overexpression predict overall survival in patients with low-grade astrocytomas.

BACKGROUND AND OBJECTIVES: Therapy of malignant glioma tumors is based on histology and clinical factors. However, comparable lesions may correspond with important prognostic differences. Our purpose was to analyze retrospectively the prognostic input of platelet-derived growth factor receptor (PDGF-R), epidermal growth factor (EGF-R), and bcl-2 expression in 103 malignant gliomas from uniformly treated patients. METHODS: The expression of the antigens was analyzed by immunohistochemistry (IHC). Prognostic evaluation was performed with the multivariate proportional hazards model. The follow-up period lasted 19 (5-122) months for survivors. RESULTS: We observed that almost 50% of gliomas showed high expression of PDGF-R, while a lower expression of EGF-R and bcl-2 was found. No association between the main prognostic factors in malignant glioma (sex, age, histological grade, and Karnofsky score) and the labeling index (LI) of these antigens was observed. We found that only PDGF-R and EGF-R overexpression were associated with a shorter survival in patients with World Health Organization (WHO) II astrocytomas, being both associations independent of known prognostic factors, as shown by Cox model. Besides, we confirmed other authors' results that high histological grade and low performance score were associated with worse prognosis. CONCLUSIONS: PDGF-R and EGF-R expression could be relevant in determining the prognosis of low-grade astrocytomas (LGAs) and in providing a more objective mechanism for their classification.

Neural cell adhesion molecule in human serum. Increased levels in dementia of the Alzheimer type.

Memory impairment is a process associated with alterations in neuronal plasticity, synapses formation, and stabilization. As the neural cell adhesion molecule (NCAM) plays a key role in synaptic bond stabilization, we analyzed the usefulness of soluble NCAM isoforms in the diagnosis of patients with dementia of the Alzheimer type (DAT). NCAM was measured in the sera of 70 control subjects and 43 DAT patients (with different severity of cognitive impairment, GDS), employing Western blot and densitometric quantification. LMW-NCAM bands (100-130 kDa) decreased significantly with age independently of sex. DAT patients presented values of LMW-NCAM and HMW-NCAM significantly higher than healthy controls of similar age (higher than 130 kDa). Only LMW-NCAM was associated with GDS. Our results suggest that NCAM could be involved in the pathogenesis of DAT disorder and that serum NCAM levels could be useful as differential diagnostic markers of the disease.

[Predictive response variables to recombinant human erythropoietin treatment in patients with anemia and cancer]. / Variables predictivas de respuesta a la eritropoyetina recombinante humana en pacientes con anemia y cáncer.

The use of human recombinant erythropoietin (rHuEpo) has been approved by the Food and Drug Administration (FDA) in patients with anemia and cancer. Although good results have been obtained, it is too expensive to permit its use massively. For the purpose of evaluating the therapeutic effect of rHuEpo, including toxicity, predictive response variables and quality of life parameters, a prospective trial was carried out in patients with anemia and cancer. Hematimetric parameters, ferritin, Epo, cytokines, transfusions and quality of life were registered. A total of 36 patients were treated in the protocol (34 were evaluable): 16 men and 20 women, with a medium age 56.4 years; 27 patients were treated with chemotherapy (16 with cisplatinum); 15 patients presented medullar infiltration. In 73.5% patients an increase in the level of hemoglobin was registered, and in 64.7% its normalisation was attained. Transfusional requirements were reduced by 50%. The hemoglobin increase greater than 0.5 g/dl at the second week of treatment was the most significant variable of early response. Patients treated with cisplatinum, seric ferritin lower than 1,100 ng/dl and those without medullar tumoral infiltration responded best. Serum Epo, cytokines (IL-1, IL-6 and TNF) and reticulocyte count at the second week did not correlate with response. Quality of life parameters were better in patients with good response to rHuEpo. It can be concluded that good results in the treatment of patients with anemia and cancer are obtained with rHuEpo.

CD44 expression in human gliomas.

BACKGROUND AND OBJECTIVES: Glioma invasiveness involves the attachment of tumor cells to the brain extracellular matrix, rich in hyaluronic acid (HA). CD44, the principal receptor for HA is found as a standard molecule (CD44s) or as variants (CD44v). We undertook a retrospective study to evaluate the expression pattern of CD44s, the isoforms CD44v3, v4/5 and v6 and to correlate their expression with clinical-anatomopathological parameters and survival rate. METHODS: The expression of these molecules was evaluated immunohistochemically in 84 gliomas. RESULTS: No expression of CD44v was detected in any tumors. CD44s staining of tumor cells was found in 70 of 84 (83.3%) of the gliomas. In 23 of 39 (59.0%) of the GBM more than the 70% of the cells were stained, while only 2 of 21 (9.5%) of LGA showed high expression. The association between CD44 and histological grade remained when the prognostic variables were considered in a multivariate analysis. Higher expression of CD44 was associated with worse overall survival rate; however, the Cox analysis indicated that survival was not associated with CD44. CONCLUSIONS: Our results suggest that overexpression of CD44s could be relevant in determining the highly invasive behaviour of gliomas, though it does not behave as an independent prognostic factor for survival.

Expression of CD44s and CD44 splice variants in human melanoma.

The ability of tumor cells to adhere and detach from extracellular matrix and endothelial cells, is a crucial step in the metastatic process and may alter the clinical prognosis of some human tumors such as melanomas. CD44, the major cell surface receptor for hyaluronate, has been implicated in cell adhesion and in tumor progression. We studied the expression of standard CD44 molecule (CD44s) and its variants v3 and v6 in 57 human primary melanoma biopsies, without previous treatment. We analyzed the association between CD44 expression and the principal clinicopathological features, including survival. Fifty-six of 57 tumors expressed CD44s, associated to the cytoplasmic membrane. No expression of CD44v3 or CD44v6 was detected. No association between CD44s expression and prognostic factors such as tumor thickness, growth type, stage or anatomic site of the lesion was found. However, a positive correlation between CD44s expression and Clark level (Spearman, p<0.001) was found. While only 33.3% of melanomas Clark I + II showed high expression of CD44s (more than 50% of positive cells), 82.6% of melanomas Clark IV + V did so. Kaplan-Meier analysis revelead that patients whose melanomas had high expression of CD44s showed a reduced relapse free survival (RFS) rate, though without statistical significance. No difference between the level of CD44 expression and overall survival (OS) was found. We conclude that melanomas only expressed CD44s, and that its level was associated with Clark's stage. CD44s seems not to be useful as a tumor marker, because it does not predict either RFS or OS.

Variables predictivas de respuesta a la eritropoyetina recombinante humana en pacientes con anemia y cáncer. / [Predictive response variables to recombinant human erythropoietin treatment in patients with anemia and cancer]

The use of human recombinant erythropoietin (rHuEpo) has been approved by the Food and Drug Administration (FDA) in patients with anemia and cancer. Although good results have been obtained, it is too expensive to permit its use massively. For the purpose of evaluating the therapeutic effect of rHuEpo, including toxicity, predictive response variables and quality of life parameters, a prospective trial was carried out in patients with anemia and cancer. Hematimetric parameters, ferritin, Epo, cytokines, transfusions and quality of life were registered. A total of 36 patients were treated in the protocol (34 were evaluable): 16 men and 20 women, with a medium age 56.4 years; 27 patients were treated with chemotherapy (16 with cisplatinum); 15 patients presented medullar infiltration. In 73.5

patients an increase in the level of hemoglobin was registered, and in 64.7

its normalisation was attained. Transfusional requirements were reduced by 50

. The hemoglobin increase greater than 0.5 g/dl at the second week of treatment was the most significant variable of early response. Patients treated with cisplatinum, seric ferritin lower than 1,100 ng/dl and those without medullar tumoral infiltration responded best. Serum Epo, cytokines (IL-1, IL-6 and TNF) and reticulocyte count at the second week did not correlate with response. Quality of life parameters were better in patients with good response to rHuEpo. It can be concluded that good results in the treatment of patients with anemia and cancer are obtained with rHuEpo.

Quistes y tumores del timo: enfoque multidisciplinario de diagnóstico y tratamiento / Thymic cysts and tumors: multispeciality diagnostic methods and treatment

Objetivo: Analizar los resultados de una serie de tumores de timo. Población: 43 pacientes asistidos en el período de 1977-97, sobre un total de 114 tumores de mediastino (37,7 por ciento). Método: Se analizó específicamente la sintomatología, metodología de diagnóstico, características tumorales locales (grado de invasión en los timomas), tratamiento instituido, mortalidad, supervivencia y causa de muerte. Resultados: Los 43 tumores se presentaron en 25 mujeres y 18 hombres, edad promedio 48 años. El timoma (28 casos) fue la variedad más frecuente (65 por ciento). Quince pacientes no tuvieron síntomas (34,9 por ciento), la Miastenia Gravis (MG) con 10 casos fue la sintomatología más común. La Rx y la TAC de tórax fueron estudios suficientes para la detección y evaluación general de los tumores. En 12 tumores malignos/invasores se obtuvo diagnóstico preoperatorio, 7 por punción percutánea y 5 por mediastinoscopía, mediastinotomía o biopsia cervical. Hubo 12 timomas no invasores y 16 invasores (9 Estadio II, 5 Estadio III y 2 Estadio IV). Se operaron 42 pacientes, el abordaje más frecuente fue la esternotomía mediana (23 casos), todos fueron resecados, 30 con resección simple y 12 ampliadas. Un paciente (linfoma de timo) sólo recibió irradiación y quimioterapia (QMT), 21 recibieron irradiación P.O., 13 timomas, 5 linfomas y 3 carcinomas. Tres pacientes recibieron QTM neoadyuvante con resultados favorables, y 9 adyuvante. Fallecieron 2 pacientes en el P.O. inmediato, ambos portadores de MG, y 6 en el P.O. alejado, 3 por progresión tumoral, los restantes por crisis de MG tromboembolismo pulmonar y complicación de la QMT. La supervivencia actuarial global posoperatoria (P.O.) de los 28 timomas fue a 5 y 10 años del 73 por ciento, 3 de los 5 carcinomas fallecieron por progresión tumoral entre los 2 y 27 meses. Conclusiones: El 34,9 por ciento de los tumores del timo fueron asintomáticos. El timoma fue la variedad más frecuente (65 por ciento), su malignidad se determinó por el grado de invasión, siendo el 43 por ciento no invasivos. Para los tumores invasivos/malignos la punción percutánea fue un método de diagnóstico muy efectivo. El tratamiento de elección de ser la resección quirúrgica con criterio agresivo, y de ser necesaria localmente extendida. La irradiación P.O. fue efectiva en los timomas invasores, la QMT neoadyuvante presentó buen índice de respuesta favorable. Se observó peor evolución P.O. inmediata en los pacientes portadores de M.G...

Quistes y tumores del timo: enfoque multidisciplinario de diagnóstico y tratamiento / Thymic cysts and tumors: multispeciality diagnostic methods and treatment

Objetivo: Analizar los resultados de una serie de tumores de timo. Población: 43 pacientes asistidos en el período de 1977-97, sobre un total de 114 tumores de mediastino (37,7 por ciento). Método: Se analizó específicamente la sintomatología, metodología de diagnóstico, características tumorales locales (grado de invasión en los timomas), tratamiento instituido, mortalidad, supervivencia y causa de muerte. Resultados: Los 43 tumores se presentaron en 25 mujeres y 18 hombres, edad promedio 48 años. El timoma (28 casos) fue la variedad más frecuente (65 por ciento). Quince pacientes no tuvieron síntomas (34,9 por ciento), la Miastenia Gravis (MG) con 10 casos fue la sintomatología más común. La Rx y la TAC de tórax fueron estudios suficientes para la detección y evaluación general de los tumores. En 12 tumores malignos/invasores se obtuvo diagnóstico preoperatorio, 7 por punción percutánea y 5 por mediastinoscopía, mediastinotomía o biopsia cervical. Hubo 12 timomas no invasores y 16 invasores (9 Estadio II, 5 Estadio III y 2 Estadio IV). Se operaron 42 pacientes, el abordaje más frecuente fue la esternotomía mediana (23 casos), todos fueron resecados, 30 con resección simple y 12 ampliadas. Un paciente (linfoma de timo) sólo recibió irradiación y quimioterapia (QMT), 21 recibieron irradiación P.O., 13 timomas, 5 linfomas y 3 carcinomas. Tres pacientes recibieron QTM neoadyuvante con resultados favorables, y 9 adyuvante. Fallecieron 2 pacientes en el P.O. inmediato, ambos portadores de MG, y 6 en el P.O. alejado, 3 por progresión tumoral, los restantes por crisis de MG tromboembolismo pulmonar y complicación de la QMT. La supervivencia actuarial global posoperatoria (P.O.) de los 28 timomas fue a 5 y 10 años del 73 por ciento, 3 de los 5 carcinomas fallecieron por progresión tumoral entre los 2 y 27 meses. Conclusiones: El 34,9 por ciento de los tumores del timo fueron asintomáticos. El timoma fue la variedad más frecuente (65 por ciento), su malignidad se determinó por el grado de invasión, siendo el 43 por ciento no invasivos. Para los tumores invasivos/malignos la punción percutánea fue un método de diagnóstico muy efectivo. El tratamiento de elección de ser la resección quirúrgica con criterio agresivo, y de ser necesaria localmente extendida. La irradiación P.O. fue efectiva en los timomas invasores, la QMT neoadyuvante presentó buen índice de respuesta favorable. Se observó peor evolución P.O. inmediata en los pacientes portadores de M.G... (AU)

Ateneo radiológico / Radiology conference

Se trata de un paciente de sexo masculino de 35 años de edad que consulta a nuestro Hospital por un cuadro de cólico renal y hematuria. Se le descubre un cálculo en el uréter izquierdo, internándose posteriormente a fin de realizar tratamiento del mismo. El examen prequirúrgico muestra en la radiografía (Rx) de tórax múltiples lesiones nodulares en ambos campos pulmonares. Posteriormente se le realiza una tomografía computada (TC) y una fibrobroncoscopía revelando el estudio citológico procedente del lavado bronquial células carcinomatosas

Ateneo radiológico / Radiology conference

Se trata de un paciente de sexo masculino de 35 años de edad que consulta a nuestro Hospital por un cuadro de cólico renal y hematuria. Se le descubre un cálculo en el uréter izquierdo, internándose posteriormente a fin de realizar tratamiento del mismo. El examen prequirúrgico muestra en la radiografía (Rx) de tórax múltiples lesiones nodulares en ambos campos pulmonares. Posteriormente se le realiza una tomografía computada (TC) y una fibrobroncoscopía revelando el estudio citológico procedente del lavado bronquial células carcinomatosas

Ferritina urinaria: un nuevo indicador de nefrotoxicidad por cisplatino? / Urinary ferritin: a new marker of cisplatin nephrotoxicity?

Con el objetivo de relacionar las variaciones de ferritina urinaria (FU) con diversos indicadores de nefrotoxicidad por cisplatino (cisP), 26 pacientes recibieron 6 ciclos de quimioterapia que incluían CisP (sin otras drogas nefrotóxicas). El grupo control (CONT, N = 20) fue tratado con seis ciclos de quimioterapia sin drogas nefrotóxicas. Las edades fueron similares en ambos grupos (50,2 ñ 2,6 y 47,7 ñ 2,8 años). En el grupo CisP la FU (ng/mL) basal (B) fue 2,05 ñ 0,19 y luego del 2do ciclo (2C) 50,37 ñ 8,94 (p < 0,001); los valores de ß sub2 microglobulina (ßµG, ng/mL) fueron 248 ñ 10 (B) y 295 ñ 44 (2C; p < 0,01); los de magnesio sérico (MgS, meq/L), 2,03 ñ 0,03 (B) y 1,67 ñ 0,04 (2C; p < 0,001) y los clearances de creatinina (CLCr, mL/min), 109 ñ 3,6 (B) y 94,8 ñ 3,4 (2C; p < 0,001). FU se correlacionó significativamente (p < 0,0001; N = 208) con ßµG (r = 0,550), MgS (r = 0,465) y CLCr (r = 0,375), pero no con la ferritina sérica. En CONT no hubo modificaciones de FU. ßµG, MgS ni CLCr. Los resultados sugieren que el incremento de FU podría ser un indicador de nefrotoxicidad por cisP, cuya utilidad clínica es necesario evaluar

Ferritina urinaria: un nuevo indicador de nefrotoxicidad por cisplatino? / Urinary ferritin: a new marker of cisplatin nephrotoxicity?

Con el objetivo de relacionar las variaciones de ferritina urinaria (FU) con diversos indicadores de nefrotoxicidad por cisplatino (cisP), 26 pacientes recibieron 6 ciclos de quimioterapia que incluían CisP (sin otras drogas nefrotóxicas). El grupo control (CONT, N = 20) fue tratado con seis ciclos de quimioterapia sin drogas nefrotóxicas. Las edades fueron similares en ambos grupos (50,2 ñ 2,6 y 47,7 ñ 2,8 años). En el grupo CisP la FU (ng/mL) basal (B) fue 2,05 ñ 0,19 y luego del 2do ciclo (2C) 50,37 ñ 8,94 (p < 0,001); los valores de ß sub2 microglobulina (ßAG, ng/mL) fueron 248 ñ 10 (B) y 295 ñ 44 (2C; p < 0,01); los de magnesio sérico (MgS, meq/L), 2,03 ñ 0,03 (B) y 1,67 ñ 0,04 (2C; p < 0,001) y los clearances de creatinina (CLCr, mL/min), 109 ñ 3,6 (B) y 94,8 ñ 3,4 (2C; p < 0,001). FU se correlacionó significativamente (p < 0,0001; N = 208) con ßAG (r = 0,550), MgS (r = 0,465) y CLCr (r = 0,375), pero no con la ferritina sérica. En CONT no hubo modificaciones de FU. ßAG, MgS ni CLCr. Los resultados sugieren que el incremento de FU podría ser un indicador de nefrotoxicidad por cisP, cuya utilidad clínica es necesario evaluar (AU)

Características de los tratamientos quimioterápicos / Characteristics of chemotherapy treatments

Generalmente se efectúan trabajos tendientes a demostrar la efectividad de los tratamientos propuestos pero olvidamos observar que le pasa al paciente mientras lo realiza. Con el objetivo de describir las características de los tratamientos, de los pacientes y del personal que lo asiste realizamos el siguiente trabajo: durante 10 meses fueron recolectados por enfermería oncológica datos referentes a las características de los tratamientos realizados. Se registraron 997 ciclos de quimioterapia (444 en hombres y 553 en mujeres). No hubo aumento en el número de intentos en colocar las vías parenterales según el número creciente de ciclos realizados, el tipo de vía utilizada, diferentes enfermeros o el sexo. Las mujeres tuvieron peor acceso vascular (p<0,024). No hubo diferencias en cuanto al uso de vías tipo "Abbocath" o "Butterfly". Las complicaciones más frecuentes fueron: la ansiedad 19,06 por ciento y la infiltración/extravasación 3,5 por ciento. En los días de trabajo más intenso se registraron mayor número de complicaciones. La infiltración/extravasación fue mayor a medida que aumentaba el número de ciclos que había recibido el paciente. Hubo diferencias significativas al considerar mejor la cooperación del paciente respecto al sexo masculino (p<0,018), número de intentos en colocar la vía (p<0,001) el tipo de acceso vascular (p<0,0001), si había tenido infiltración/extravasación (p<0,001) y según el uso de catéter implantable (p<0,02). Durante los tratamientos quimioterápicos entran en juego factores independientes del paciente, de la enfermera y del médico. Su conocimiento y mejoramiento pueden lograr una mejor calidad en la atención y bienestar para el paciente

Características de los tratamientos quimioterápicos / Characteristics of chemotherapy treatments

Generalmente se efectúan trabajos tendientes a demostrar la efectividad de los tratamientos propuestos pero olvidamos observar que le pasa al paciente mientras lo realiza. Con el objetivo de describir las características de los tratamientos, de los pacientes y del personal que lo asiste realizamos el siguiente trabajo: durante 10 meses fueron recolectados por enfermería oncológica datos referentes a las características de los tratamientos realizados. Se registraron 997 ciclos de quimioterapia (444 en hombres y 553 en mujeres). No hubo aumento en el número de intentos en colocar las vías parenterales según el número creciente de ciclos realizados, el tipo de vía utilizada, diferentes enfermeros o el sexo. Las mujeres tuvieron peor acceso vascular (p<0,024). No hubo diferencias en cuanto al uso de vías tipo "Abbocath" o "Butterfly". Las complicaciones más frecuentes fueron: la ansiedad 19,06 por ciento y la infiltración/extravasación 3,5 por ciento. En los días de trabajo más intenso se registraron mayor número de complicaciones. La infiltración/extravasación fue mayor a medida que aumentaba el número de ciclos que había recibido el paciente. Hubo diferencias significativas al considerar mejor la cooperación del paciente respecto al sexo masculino (p<0,018), número de intentos en colocar la vía (p<0,001) el tipo de acceso vascular (p<0,0001), si había tenido infiltración/extravasación (p<0,001) y según el uso de catéter implantable (p<0,02). Durante los tratamientos quimioterápicos entran en juego factores independientes del paciente, de la enfermera y del médico. Su conocimiento y mejoramiento pueden lograr una mejor calidad en la atención y bienestar para el paciente