RESUMEN
We conducted a randomized phase II trial of two different schedules of topotecan in patients with advanced-stage non small lung cancer (NSCLC) without prior cytotoxic chemotherapy. All patients had histologic or cytologic confirmation of stage IV (M1) or III-B NSCLC. Patients were stratified by performance status, stage and weight loss. Patients were randomized to receive topotecan at intravenous doses of 1.5 mg/m(2)/day over 30 min for 5 days every 3 weeks (Arm A) or 1.3 mg/m(2)grade 3 in both arms included leukopenia, thrombocytopenia, malaise, constipation, diarrhea, lethargy, pulmonary, vomiting, infection and myalgia. Severe (> or = grade 3) thrombocytopenia occurred in 15.8% of Arm A patients and 37.8% of Arm B patients and this difference was statistically significant (P=0.03). The median times to progression are 101 and 63 days (P=0. 75) and the median survival times are 257 and 179 days (P=0.83) for Arms A and B, respectively. These differences in time to progression and overall survival are not statistically significant. Topotecan has limited, single agent activity in advanced NSCLC when given as 1. 5 mg/m(2)/day over 30 min for 5 days every 3 weeks. We do not intend to pursue further investigations with topotecan in patients with NSCLC.
Asunto(s)
Antineoplásicos/administración & dosificación , Carcinoma de Pulmón de Células no Pequeñas/tratamiento farmacológico , Neoplasias Pulmonares/tratamiento farmacológico , Topotecan/efectos adversos , Adulto , Anciano , Anciano de 80 o más Años , Antineoplásicos/efectos adversos , Carcinoma de Pulmón de Células no Pequeñas/patología , Progresión de la Enfermedad , Relación Dosis-Respuesta a Droga , Esquema de Medicación , Femenino , Humanos , Infusiones Intravenosas , Neoplasias Pulmonares/patología , Masculino , Persona de Mediana Edad , Análisis de Supervivencia , Trombocitopenia/inducido químicamente , Resultado del TratamientoRESUMEN
This report describes two cases of T-cell chronic lymphocytic leukemia (T-CLL) treated with purine nucleoside analogues. One patient had CD8+, CD3+ large granular lymphocytosis (LGL) producing transfusion-dependent anemia and was refractory to chemotherapy. Treatment with four cycles of fludarabine produced a clinical complete remission and a molecular genetic partial remission that has been durable for > 15 months. The other patient had CD4+ T-prolymphocytic leukemia and was unresponsive to both fludarabine and 2-chlorodeoxyadenosine. Further trials of these agents are warranted in T-CLL, especially the LGL variant.