RESUMEN
INTRODUCTION: To conduct a phase II study evaluating the efficacy of rationally sequenced paclitaxel, gemcitabine, and carboplatin in patients with stage IV or select stage IIIB non-small cell lung cancer (NSCLC). METHODS: Patients with select stages IIIB (pleural effusion) and IV NSCLC with an ECOG performance status of 0-1 and no prior chemotherapy for their disease were eligible to participate. Treatment was delivered as follows: paclitaxel at 70 mg/m2 followed by gemcitabine at 300 mg/m2 on day 1, with carboplatin (AUC 5) on day 2 of a 28-day cycle. Response was assessed after every two cycles of therapy. The primary endpoint of this trial was response rate, with secondary endpoints of time to progression and 1 year overall survival. RESULTS: Twenty patients were enrolled on protocol, one of whom never received chemotherapy. The median number of cycles delivered was 3 (range 0-8). A partial response rate of 42% (8/19; 95% CI: 20-67%) and a stable disease rate of 11% (2/19; 95% CI: 1-33%) were observed. The median overall survival time was 9.6 months (95% CI: 4.6-16.6), with a 1 year overall survival rate of 42.1% (95% CI: 24.9-71.3%). Eight patients (42%) stopped treatment due to toxicity. CONCLUSION: Paclitaxel followed by gemcitabine and then carboplatin is an active, albeit complex, regimen in the treatment of patients with advanced NSCLC with insufficient advantage to justify continuation of this regimen.
Asunto(s)
Protocolos de Quimioterapia Combinada Antineoplásica/uso terapéutico , Carcinoma de Pulmón de Células no Pequeñas/tratamiento farmacológico , Carcinoma de Pulmón de Células no Pequeñas/patología , Neoplasias Pulmonares/tratamiento farmacológico , Neoplasias Pulmonares/patología , Anciano , Protocolos de Quimioterapia Combinada Antineoplásica/efectos adversos , Carboplatino/administración & dosificación , Carboplatino/efectos adversos , Desoxicitidina/administración & dosificación , Desoxicitidina/efectos adversos , Desoxicitidina/análogos & derivados , Progresión de la Enfermedad , Relación Dosis-Respuesta a Droga , Esquema de Medicación , Femenino , Humanos , Masculino , Persona de Mediana Edad , Estadificación de Neoplasias , Paclitaxel/administración & dosificación , Paclitaxel/efectos adversos , Derrame Pleural/tratamiento farmacológico , Derrame Pleural/patología , Análisis de Supervivencia , Resultado del Tratamiento , GemcitabinaRESUMEN
OBJECTIVES: The aim of the study was to assess the clinical efficacy and toxicity of single-agent imatinib mesylate in patients with advanced, unresectable metastatic pancreatic cancer. METHODS: Previously treated or untreated patients with histologically proven, unresectable pancreatic adenocarcinoma with adequate organ and bone marrow function were enrolled. Patients received imatinib 400 mg orally twice a day for a 28-day cycle. Response was evaluated every 4 weeks by imaging scans. Response was defined as lack of tumor progression at 3 months. RESULTS: Eleven patients were enrolled, and 9 were evaluable for response. Best response was stable disease in 3 patients after 2 cycles of therapy. All of them subsequently progressed. No patients remained on treatment for 3 months or longer, which was the response end point. Median time to tumor progression was 47 days (range, 19-76 days) and median overall survival was 118 days (range, 40-221 days). The first 3 patients received imatinib 400 mg orally twice a day. Due to unexpected grades 2 and 3 toxicities, the dose was reduced to 600 mg daily which was well tolerated. Most common adverse events included grades 1 to 2 edema, liver enzyme elevations, nausea, and rash. CONCLUSION: Single-agent imatinib does not have a significant activity in pancreatic cancer.