Phase II clinical trial of PM00104 (Zalypsis(®)) in urothelial carcinoma patients progressing after first-line platinum-based regimen.

PURPOSE: This exploratory phase II clinical trial evaluated the antitumor activity, safety profile and pharmacokinetics of PM00104 (Zalypsis(®)) 3 mg/m(2) 1 h every 3-week intravenous infusion in patients with advanced and/or metastatic urothelial carcinoma progressing after first-line platinum-based chemotherapy. METHODS: The primary efficacy end point was the disease control rate (DCR), defined as the percentage of patients with confirmed objective response or progression-free at 3 months, according to the response evaluation criteria in solid tumors. RESULTS: In a first stage (n = 19 patients evaluable for efficacy), only one patient achieved DCR (stable disease as best response and progression-free survival of 3.1 months). According to the 2-stage design used, the primary efficacy objective was unmet, and therefore, the trial was finalized without opening the second stage. The most common adverse events related to PM00104 were fatigue, anorexia, nausea, troponin I increase and neutropenia, which were transient and manageable with dose modifications or administration delays. Mean PK results (Cmax = 48.57 µg/l and area under the curve (AUC) = 154.97 h µg/l) were similar to those observed in a previous phase I trial evaluating the same dose and schedule. Few troponin I concentrations were higher than 0.10 ng/ml, and none of them were related to parameters of PM00104 exposure such as AUC or Cmax. CONCLUSIONS: No recommendation is given for further evaluation of PM00104 as single-agent treatment of patients with pretreated advanced and/or metastatic urothelial carcinoma. No new safety signals were observed.

Carcinoma de células renales y mieloma múltiple: asociación sincrónica con posible patogenia inmunológica / Renal-cell carcinoma and multiple mieloma: synchronic association with posible immunologic pathogenesis

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[Study of effectiveness of 3 schedules of administration of erythropoietic colony-stimulating factors in anemic patients under chemotherapy for solid or hematology malignancy]. / Estudio de la efectividad de tres esquemas de administración de factores estimuladores de la eritropoyesis en pacientes con anemia asociada a quimioterapia por una neoplasia sólida o hematológica.

BACKGROUND AND OBJECTIVE: The treatment of chemotherapy associated anemia in patients with cancer has varied greatly in recent years. The objective of this study was to verify whether the most frequently used therapeutic schedules of erythropoietin administration demonstrate equivalent effectiveness. PATIENTS AND METHOD: Treatments corresponding to 1,103 patients with cancer receiving treatment with erythropoietic colony-stimulating factors from January 2003 to April 2006 were reviewed. After applying a selection algorithm, 170 cases were analysed: 55 treated with epoetin alpha 10,000 IU 3 times per week, 63 receiving darbepoetin alpha 150 microg weekly and 52 treated with darbepoetin alpha 500 microg every 3 weeks. The main variables used to compare effectiveness were the increase in serum hemoglobin levels during treatment and the percentage of patients with hemoglobin values > or = 120 g/l. RESULTS: The differences in maximum hemoglobin values achieved at baseline and during the study period, and those between the final and baseline hemoglobin values were similar in the 3 groups. The percentage of patients with hemoglobin values > or = 120 g/l during and at the end of treatment was equivalent for the group receiving epoetin alpha 10,000 IU three times per week and darbepoetin alpha 150 microg per week. However this parameter war inferior for the group treated with darbepoetin alpha 500 microg every 3 weeks. CONCLUSIONS: Epoetin alpha 10,000 IU 3 times per week was found to be as effective as darbepoetin alpha 150 microg per week in all the studied parameters, while darbepoetin alpha 500 microg every 3 weeks was not in one of them.

Estudio de la efectividad de tres esquemas de administración de factores estimuladores de la eritropoyesis en pacientes con anemia asociada a quimioterapia por una neoplasia sólida o hematológica / Study of effectiveness of 3 schedules of administration of erythropoietic colonystimulating factors in anemic patients under chemotherapy for solid or hematology malignancy

FUNDAMENTO Y OBJETIVO: El tratamiento de la anemia asociada a quimioterapia en los pacientes con cáncerha variado de forma notable en los últimos años. El objetivo de este estudio ha sido verificar si losesquemas terapéuticos de administración de eritropoyetina más utilizados en la práctica clínica habitualpresentan una efectividad equivalente.PACIENTES Y MÉTODO: Se han revisado los tratamientos correspondientes a 1.103 pacientes con tumoressólidos o neoplasias hematológicas que incluyeron factores estimuladores de la eritropoyesis desdeenero de 2003 a abril de 2006. Después de aplicar un algoritmo de selección se obtuvieron 170 casos:55 tratados con epoetina alfa, a dosis de 10.000 U 3 veces por semana; 63 con darbepoetinaalfa, 150 μg por semana, y 52 con darbepoetina alfa, 500 μg cada 3 semanas. Las variables principalesutilizadas para comparar la efectividad fueron el incremento de la hemoglobina plasmática duranteel tratamiento y el porcentaje de pacientes que consiguieron valores de hemoglobina iguales o superioresa 120 g/l.RESULTADOS: Las diferencias entre la cifra máxima de hemoglobina alcanzada en el período de tratamientoy la inicial, así como las diferencias entre las cifras de hemoglobina final y la inicial, fueron similaresen los 3 grupos. El porcentaje de pacientes que alcanzaron durante el tratamiento y al final deéste un valor de hemoglobina superior o igual a 120 g/l fue equivalente para los grupos de 10.000 Ude epoetina alfa 3 veces por semana y 150 μg de darbepoetina alfa por semana. Dicho porcentaje fueinferior en los pacientes del grupo que recibió 500 μg de darbepoetina alfa cada 3 semanas.CONCLUSIONES: En los pacientes con anemia asociada a quimioterapia por una neoplasia sólida o hematológica,los tratamientos con epoetina alfa a dosis de 10.000 U 3 veces por semana y darbepoetinaalfa, 150 μg por semana, han mostrado ser igualmente eficaces en todos los parámetros estudiados,mientras que la darbepoetina alfa a dosis de 500 μg cada 3 semanas no lo fue en uno de ellos

BACKGROUND AND OBJECTIVE: The treatment of chemotherapy associated anemia in patients with cancerhas varied greatly in recent years. The objective of this study was to verify whether the most frequentlyused therapeutic schedules of erythropoietin administration demonstrate equivalent effectiveness.PATIENTS AND METHOD: Treatments corresponding to 1,103 patients with cancer receiving treatment witherythropoietic colony-stimulating factors from January 2003 to April 2006 were reviewed. After applyinga selection algorithm, 170 cases were analysed: 55 treated with epoetin alpha 10,000 IU 3 timesper week, 63 receiving darbepoetin alpha 150 μg weekly and 52 treated with darbepoetin alpha500 μg every 3 weeks. The main variables used to compare effectiveness were the increase in serumhemoglobin levels during treatment and the percentage of patients with hemoglobin values 120 g/l.RESULTS: The differences in maximum hemoglobin values achieved at baseline and during the study period,and those between the final and baseline hemoglobin values were similar in the 3 groups. The percentageof patients with hemoglobin values 120 g/l during and at the end of treatment was equivalentfor the group receiving epoetin alpha 10,000 IU three times per week and darbepoetin alpha 150 μg perweek. However this parameter war inferior for the group treated with darbepoetin alpha 500 μg every 3weeks.CONCLUSIONS: Epoetin alpha 10,000 IU 3 times per week was found to be as effective as darbepoetinalpha 150 μg per week in all the studied parameters, while darbepoetin alpha 500 μg every 3 weekswas not in one of them