Phase II trial of oxaliplatin and capecitabine after progression to first-line chemotherapy in androgen-independent prostate cancer patients.

INTRODUCTION: Docetaxel plus prednisone is the current standard of care in first-line chemotherapy for metastatic hormone-refractory prostate cancer. However, there is no agent proven as effective after progression to standard docetaxel-based therapy. Platins and capecitabine have shown activity in this setting. PATIENTS AND METHODS: A total of 14 patients were included in this prospective, single-center trial. All patients had progressed to first-line docetaxel-based treatment. Patients received oxaliplatin 100 mg/sqm on D1 and capecitabine 1000 mg/sqm/bid on days 1 to 14 every 21 days. RESULTS: Median number of cycles was 3. No unexpected toxicity was observed. Only grade 3 toxicity reported was grade 3 anemia. Of the 14 patients, 3 presented grade 2 neuropathy which was spontaneously resolved. Prostate-specific antigenresponse rate was 57%, with a median time to progression of 14.5 weeks, and overall survival of 24 weeks. CONCLUSIONS: In the second-line setting, after receiving docetaxel-based chemotherapy, the combination of oxaliplatin and capecitabine offers promising activity with an excellent safety profile.

[Improvement of anemia and quality of life of patients with prostate cancer by treatment with human recombinant erythropoietin]. / Mejora de la anemia y calidad de vida de pacientes con cáncer de próstata mediante la administración de eritropoyetina humana recombinante.

OBJECTIVES: Anemia is a frequent finding in patients with prostate cancer. Reduction of erythropoiesis caused by androgenic blockade is among its etiologies. Therefore, quality of life of these patients results decreased, being origin of significant morbidity and mortality. Recombinant forms of human erythropoietin have demonstrated their effectiveness improving quality of life of patients with various solid tumors, but specific studies in prostate cancer are a few. Our objective is to evaluate the efficacy of human recombinant erythropoietin (EPO) correcting anemia and improving the quality of life of patients with prostate cancer. METHODS: Prospective study of patients with prostate cancer under combined androgenic blockade treatment having hemoglobin levels lower than 11 g/dl. We analyze clinical characteristics and quality of life prior to EPO dispense. We used the Triple Linear Analogical Scale for patients with cancer (CLAS) to evaluate quality of life. EPO was administered during 12 weeks (10.000 units subcutaneously, three times a week). We study the evolution of different parameters compared to baseline. RESULTS: We included a total of 17 patients. Average age was 75.5 +/- 5.9 yr. Average time of neoplasia evolution was 57.6 +/- 13.9 months. Eleven patients presented active disease (PSA > 1 ng/ml). Mean initial haemoglobin level was 10.3 +/- 0.4 mg/dl, reaching 12.2 +/ - 1.0 after treatment (p < 0.001). Patients with active disease and levels of initial haemoglobin smaller than 10.2 g/dl presented worse outcomes. There were not adverse events attributable to EPO. CONCLUSIONS: We consider that the administration of EPO increases significantly the levels of haemoglobin and the quality of life of patients with prostate adenocarcinoma, being the response worse in patients with low levels of baseline haemoglobin.

Mejora de la anemia y calidad de vida de pacientes con cáncer de próstata mediante la administración de eritropoyetina humana recombinante / Improvement of anemia and quality of life of patients with prostate cancer by treatment with human recombinant erythropoietin

OBJETIVOS: La anemia es un hecho frecuente en pacientes con carcinoma prostático. Entre sus causas está la reducción de la eritropoyesis provocada por el propio bloqueo androgénico. La calidad de vida de estos pacientes se siente por ello mermada, siendo origen de una importante morbimortalidad. Las formas recombinantes de eritropoyetina humana han demostrado, en diversos tumores sólidos, su eficacia en la mejora de la calidad de vida de estos pacientes; pero los estudios específicos en cáncer de próstata son muy escasos. Nuestro objetivo es evaluar la eficacia de la eritropoyetina humana recombinante (EPO) en la corrección de la anemia y mejora de la calidad de vida de los pacientes con carcinoma prostático. MÉTODOS: Estudio prospectivo de pacientes con adenocarcinoma prostático sometidos a bloqueo androgénico completo, con niveles de hemoglobina inferiores a 11 g/dL. Analizamos las características clínicas y calidad de vida previas a la administración de la EPO. Para evaluar la calidad de vida utilizamos la Triple Escala Analógica Lineal para pacientes con Cáncer (CLAS). Administramos EPO durante 12 semanas (10.000 Unidades, vía subcutánea, 3 veces por semana). Comparamos la evolución de los distintos parámetros analizados, respecto de la visita basal. RESULTADOS: Incluimos un total de 17 pacientes. La edad media fue de 75,5 +/- 5,9 años. El tiempo medio de evolución de la neoplasia ha sido de 57,6 +/- 13,9 meses. Presentaban enfermedad activa (PSA > 1 ng/mL) 11 pacientes. El nivel medio de hemoglobina (Hb) inicial fue de 10,3 +/- 0,4 mg/dL, alcanzando los 12,2 +/- 1,0 tras el tratamiento (p<0,001). En cuanto a la calidad de vida, pasamos de una puntuación inicial media de 6,5 +/- 2,2 a 14,4 +/- 3,3 (p<0,001). Presentaron peor respuesta aquellos pacientes con enfermedad activa y niveles de Hb inicial menores a 10,2 g/dL. No aparecieron efectos secundarios atribuibles a la EPO.CONCLUSIONES: Consideramos que la administración de EPO incrementa de forma significativa los niveles de hemoglobina y la calidad de vida de los pacientes con adenocarcinoma de próstata, presentando peor respuesta cuanto menor es el nivel de Hb inicial (AU)