[Comparison of two formulae for the calculation of glomerular filtration in the dosage of zoledronic acid]. / Comparación de dos fórmulas de cálculo de filtrado glomerular en la dosificación del ácido zoledrónico.

OBJECTIVE: To validate the use of a formula that does not require the patient's weight (Levey formula) for calculating creatinine clearance in the adjustment of the dosage of zoledronic acid. METHOD: Prospective observational study in which zoledronic acid prescriptions in the Oncology and Haematology departments were recorded over the course of 8 months. The adjustment of the dose of zoledronic acid was carried out in accordance with creatinine clearance obtained using two different equations; the Cockcroft-Gault equation which is based on medical records, and the Levey formula which does not require the patient's weight for the calculation. The results of zoledronic acid dosage from both equations were compared using the SPSS statistics programme, via the comparison of the two measurements using the t Student-Fisher (T-test.) RESULTS: The T-Test provided a t-test value of t = 3,366, with 112 degrees of freedom and a degree of bilateral importance of p = 0.001. The difference between both measurements was d = 0.051 +/- 0.162) and the confidence interval was 95 %, 0.082 to 0.021. From the data obtained in the T-Test, the degree of bilateral importance (p = 0.001 < 0.05) indicated that the results of the test were statistically significant. CONCLUSIONS: The difference between the dosages obtained when comparing both methods of glomerular filtration is statistically significant, although not clinically relevant, therefore the MDRD-4 formula (Levey) could be used if the patient's weight is not available.

Comparación de dos fórmulas de cálculo de filtrado glomerular en la dosificación del ácido zoledrónico / Comparison of two formulae for the calculation of glomerular fi ltration in the dosage of zoledronic acid

Objetivo: Validar la utilización de una fórmula que no requiera del peso del paciente (fórmula de Levey) para el cálculo del aclaramiento de creatinina en el ajuste de la dosificación del ácido zoledrónico. Método: Estudio observacional prospectivo en el que se recogen durante un período de 8 meses las prescripciones de ácido zoledrónico realizadas en los servicios de Oncología y Hematología. Se realiza el ajuste de la dosis de ácido zoledrónico de acuerdo con el aclaramiento de creatinina obtenido mediante 2 ecuaciones diferentes: a) la fórmula de Cockcroft-Gault, que es la propuesta en la ficha técnica del medicamento, y b) la fórmula de Levey, que no requiere del peso del paciente para su cálculo. Se comparan los resultados de dosificación de ácido zoledrónico de ambas ecuaciones con el programa estadístico SPSS, mediante la prueba de comparación de 2 medias calculando la t de Student-Fisher (T-test). Resultados: La prueba t proporcionó un valor t = ¿3,366, con 112 grados de libertad y un grado de significación bilateral p = 0,001. La diferencia entre ambas medias ± desviación estándar fue de ¿0,051 ± 0,162, y el intervalo de confianza del 95 %, ¿0,082 a ¿0,021. A partir de los datos obtenidos en la prueba estadística T-test, el grado de significación bilateral p = 0,001 < 0,05 indicó que el resultado de la prueba era estadísticamente significativo. Conclusiones: La diferencia de dosis obtenida al comparar ambos métodos de cálculo del filtrado glomerular es estadísticamente significativa, aunque sin relevancia clínica, con lo que se podría utilizar la fórmula de la Modification of Diet in Renal Disease 4 (Levey), si no disponemos del peso del paciente (AU)

Objective: To validate the use of a formula that does not require the patient’s weight (Levey formula) for calculating creatinine clearance in the adjustment of the dosage of zoledronic acid.Method: Prospective observational study in which zoledronic acid prescriptions in the Oncology and Haematology departments were recorded over the course of 8 months. The adjustment of the dose of zoledronic acid was carried out in accordance with creatinine clearance obtained using two different equations; the Cockcroft-Gault equation which is based on medical records, and the Levey formula which does not require the patient’s weight for the calculation. The results of zoledronic acid dosage from both equations were compared using the SPSS statistics programme, via the comparison of the two measurements using the t Student-Fisher (T-test.)Results: The T-Test provided a t-test value of t = —3,366, with 112 degrees of freedom and a degree of bilateral importance of p = 0.001. The difference between both measurements was d = —0.051 ± 0.162) and the confidence interval was 95 %, —0.082 to —0.021. From the data obtained in the T-Test, the degree of bilateral importance (p = 0.001 < 0.05) indicated that the results of the test were statistically significant. Conclusions: The difference between the dosages obtained when comparing both methods of glomerular filtration is statistically significant, although not clinically relevant, therefore the MDRD-4 formula (Levey) could be used if the patient’s weight is not available (AU)

[Retrospective analysis of the carboplatin dosage and relationship with toxicity in cancer patients]. / Análisis retrospectivo de la dosificación de carboplatino y relación con su toxicidad en pacientes oncológicos.

OBJECTIVE: To analyse carboplatin dosage in cancer patients in order to establish whether they are over- or underdosed in comparison to the theoretical dose calculations during the first cycle of chemotherapy and to find a relationship between the dosage in the first cycle and dose reduction in subsequent cycles, as a result of adverse effects related to the same. METHOD: Retrospective analysis over a one year period of prescriptions of chemotherapy with carboplatin. Patients were stratified into 4 groups according to body mass index and serum creatinine values. The mean percent error (MPE) was used to determine the relationship between the dose received and the theoretical dose calculation during the first cycle. The Mann-Whitney U test was used to study the possible relationship between patients dosage during the first cycle and dose reduction in subsequent cycles. RESULTS: A total of 86 patients were selected. Only the cohort of patients who were overweight/obese showed significant differences between the theoretical dose calculation and the dose actually received. The mean MPE value with the standard error for this group was 7.963 +- 2.610%. No links were found with the dose reduction in subsequent cycles for this cohort of patients. CONCLUSIONS: Not using adjusted weight or serum creatinine values in the Cockcroft-Gault equation may lead to incorrect doses of carboplatin in obese patients. Studies including a larger number of patients are required to confirm the relationship between overdosing during the first cycle and dose reduction in subsequent cycles, as a result of carboplatin toxicity.

Análisis retrospectivo de la dosificación de carboplatino y relación con su toxicidad en pacientes oncológicos / No disponible

Objetivo: Realizar un análisis de la dosificación de carboplatinoen pacientes oncológicos para conocer si están sobre- o infradosificadoscon respecto a la dosis teórica calculada en el primerciclo de quimioterapia. Relacionar esta dosificación en primerciclo y la reducción de dosis en ciclos sucesivos por aparición deefectos adversos relacionados con la misma.Método: Análisis retrospectivo de un año de duración de lasprescripciones de quimioterapia con carboplatino. Los pacientes seestratificaron en 4 grupos en función de los valores de índice demasa corporal y creatinina sérica. Para determinar la relación entrela dosis recibida y la dosis teórica calculada en primer ciclo se utilizóel porcentaje medio de error (MPE). La posible relación de la dosificaciónde pacientes en primer ciclo y la reducción de dosis en ciclossucesivos se estudió mediante el test de Mann-Whitney.Resultados: Se seleccionaron 86 pacientes. Únicamente lacohorte de pacientes con sobrepeso/obesidad mostró diferenciassignificativas entre la dosis teórica calculada y la dosis real recibida.El valor medio de MPE con su error estándar para este grupofue de 7,963 ± 2,610%. No se encontró relación con la reducciónde dosis en ciclos sucesivos en esta cohorte de pacientes.Conclusiones: La no utilización del peso ajustado o de la creatininasérica ajustada en la ecuación de Cockcroft-Gault puede llevara dosificaciones inapropiadas de carboplatino en pacientes obesos.Son necesarios estudios con mayor número de pacientes parademostrar la relación entre sobredosificación en primer ciclo yreducción de dosis en ciclos sucesivos por toxicidad a carboplatino

Objective: To analyse carboplatin dosage in cancer patientsin order to establish whether they are over or underdosed in comparisonto the theoretical dose calculations during the first cycle ofchemotherapy and to find a relationship between the dosage inthe first cycle and dose reduction in subsequent cycles, as a resultof adverse effects related to the same.Method: Retrospective analysis over a one year period of prescriptionsof chemotherapy with carboplatin. Patients were stratifiedinto 4 groups according to body mass index and serum creatininevalues. The mean percent error (MPE) was used to determine therelationship between the dose received and the theoretical dose calculationduring the first cycle. The Mann-Whitney U test was used tostudy the possible relationship between patients’ dosage during thefirst cycle and dose reduction in subsequent cycles.Results: A total of 86 patients were selected. Only the cohortof patients who were overweight/obese showed significant differencesbetween the theoretical dose calculation and the dose actuallyreceived. The mean MPE value with the standard error for thisgroup was 7.963 ± 2.610%. No links were found with the dosereduction in subsequent cycles for this cohort of patients.Conclusions: Not using adjusted weight or serum creatininevalues in the Cockcroft-Gault equation may lead to incorrect dosesof carboplatin in obese patients. Studies including a larger numberof patients are required to confirm the relationship between overdosingduring the first cycle and dose reduction in subsequentcycles, as a result of carboplatin toxicity

Revisión del tratamiento quimioterápico del cáncer de colon metastásico / A review of chemotherapy for metastatic colon cancer

Objetivo: Mostrar y discutir los resultados de los ensayos clínicospublicados sobre el tratamiento quimioterápico del cáncercolorrectal metastásico (CCRm) con el fin de esclarecer y definirlas líneas de tratamiento.Método: Se realizó una búsqueda en la base de datos biomédicay farmacéutica EMBASE (enero de 1998-enero de 2006) deensayos clínicos en fases II y III o metanálisis que estudiaban el tratamientoquimioterápico del CCRm.Resultados: El papel preponderante que ha mantenido el 5-fluorouracilo en las últimos 40 años se mantiene, y su modulacióncon la adición de ácido folínico o mediante su administración enperfusiones más prolongadas ha conseguido aumentar ligeramentela supervivencia de estos pacientes y mejorar el perfil de toxicidaddel fármaco. El desarrollo del irinotecán primero y posteriormentedel oxaliplatino ha logrado extender en unos meses lasupervivencia cuando se combinan en esquemas con 5-fluorouraciloy folínico. Todos los pacientes debieran tener garantizada ladisponibilidad de ambos fármacos durante el transcurso de suenfermedad ya que ello incrementa su supervivencia. El raltitrexedno consigue mejorar la supervivencia y, además, disminuye la calidadde vida de estos pacientes por lo que su uso queda relegado aensayos clínicos.El bevacizumab, en combinación con los esquemas clásicos dequimioterapia, consigue supervivencias ligeramente superiores.Los resultados de los estudios del cetuximab no son tan contundentesy su uso debería quedar relegado a pacientes en recaídatras el uso de irinotecán y sin otras alternativas de tratamiento.Conclusiones: Los nuevos fármacos contra el cáncer colorrectalmetastásico abren nuevas líneas de tratamiento que permitenconseguir supervivencias cada vez mejores. Sin embargo, losesquemas óptimos, así como el orden de administración no hansido completamente definidos todavía

Objective: To report and discuss the results of clinical trialspublished concerning chemotherapy for metastatic colorectal cancerin order to elucidate and define treatment guidelines.Method: The biomedical and pharmaceutical databaseEMBASE was searched for phase-II and -III clinical trials or metaanalysisthat examined chemotherapy for mCRC (January 1998 -January 2006).Results: 5-fluorouracil still maintains its preponderant roleafter 40 years, and its modulation by adding folinic acid or administeringit in more prolonged infusions has managed to slightlyincrease survival in these patients, as well as to improve the drug’stoxicity profile. The development of irinotecan first, and thenoxaliplatin has lengthened survival by a few months when in combinationwith 5-fluorouracil and folinic acid-based regimens. Allpatients should have access to these two drugs guaranteed duringthe course of the disease, as it will increase survival. Raltitrexedfails to improve survival, and also diminishes quality of life in thesepatients; hence its use has been relegated to clinical trials.Bevacizumab, combined with classic chemotherapy regimens,attains slightly longer survivals. Results from studies with cetuximabare not that conclusive, and its use should be restricted topatients with relapsing disease after irinotecan and no other treatmentoptions left.Conclusions: New drugs for metastatic colorectal canceropen up new therapy lines allowing increasingly improved survival.However, optimal schemes, as well as their order of administration,have yet to be fully devised

[A review of chemotherapy for metastatic colon cancer]. / Revisión del tratamiento quimioterápico del cáncer de colon metastásico.

OBJECTIVE: To report and discuss the results of clinical trials published concerning chemotherapy for metastatic colorectal cancer in order to elucidate and define treatment guidelines. METHOD: The biomedical and pharmaceutical database EMBASE was searched for phase-II and -III clinical trials or metaanalysis that examined chemotherapy for mCRC (January 1998-January 2006). RESULTS: 5-fluorouracil still maintains its preponderant role after 40 years, and its modulation by adding folinic acid or administering it in more prolonged infusions has managed to slightly increase survival in these patients, as well as to improve the drug s toxicity profile. The development of irinotecan first, and then oxaliplatin has lengthened survival by a few months when in combination with 5-fluorouracil and folinic acid-based regimens. All patients should have access to these two drugs guaranteed during the course of the disease, as it will increase survival. Raltitrexed fails to improve survival, and also diminishes quality of life in these patients; hence its use has been relegated to clinical trials. Bevacizumab, combined with classic chemotherapy regimens, attains slightly longer survivals. Results from studies with cetuximab are not that conclusive, and its use should be restricted to patients with relapsing disease after irinotecan and no other treatment options left. CONCLUSIONS: New drugs for metastatic colorectal cancer open up new therapy lines allowing increasingly improved survival. However, optimal schemes, as well as their order of administration, have yet to be fully devised.