RESUMO
ABSTRACT: We assessed the preliminary efficacy and toxicity of intrapleural instillation of nivolumab in patients with large pleural effusion. Patients with metastatic cancers who have a large volume of pleural effusion and required evacuation were eligible. Thoracentesis followed by nivolumab (40 mg, single intrapleural instillation) was performed. The primary endpoint was 3-month recurrence-free survival. A total of 13 patients were enrolled. The study was terminated after stage 1 as no efficacy was observed; 7 patients (54%) had a recurrence of pleural effusion at 3 months. Thirteen (100%) patients had no recurrence, dyspnea, or cough within 1 month, and the median time to recurrence was 1.9 months (95% confidence interval [CI], 1.35-2.5). No adverse events were identified. We concluded that a single intrapleural instillation of the nivolumab at 40 mg was ineffective and well-tolerated in cancer patients with pleural effusion.
Assuntos
Nivolumabe , Derrame Pleural Maligno , Humanos , Nivolumabe/administração & dosagem , Nivolumabe/efeitos adversos , Nivolumabe/uso terapêutico , Feminino , Masculino , Idoso , Pessoa de Meia-Idade , Derrame Pleural Maligno/tratamento farmacológico , Derrame Pleural Maligno/patologia , Neoplasias/tratamento farmacológico , Neoplasias/complicações , Neoplasias/patologia , Toracentese/métodos , Idoso de 80 Anos ou mais , Derrame Pleural/etiologia , Derrame Pleural/tratamento farmacológico , Derrame Pleural/patologia , Adulto , Resultado do Tratamento , Antineoplásicos Imunológicos/uso terapêutico , Antineoplásicos Imunológicos/efeitos adversos , Antineoplásicos Imunológicos/administração & dosagemRESUMO
About 40% of patients with non-small cell lung cancer (NSCLC) developed pleural effusions at some time during the course of their disease. Preliminary results from our Phase 2 multicentre clinical trial (Cohort 1) demonstrated the safety of intrapleural nivolumab in cancer patients. In Cohort 2 we assessed the preliminary efficacy and toxicity of intrapleural instillation of the nivolumab in patients with metastatic NSCLC and large pleural effusion requiring evacuation. Thoracentesis followed by nivolumab (40 mg, single intrapleural instillation) was performed. The primary endpoint was 3-month recurrence-free survival. Simon's two-stage design was used, with 13 patients planned for stage 1. If 11 or more patients did not have a pleural effusion after 3 months, an additional 35 patients were planned to be accrued for a total of 48. A total of 13 patients were enrolled. This study did not meet its primary endpoint and was terminated. Eight patients (61.5%) had a recurrence of pleural effusion at 3 months. The median time to recurrence was 1.84 months (95% CI 1.19-2.49). No adverse events were identified. We concluded that a single intrapleural instillation of the nivolumab at 40 mg was ineffective and well-tolerated in patients with metastatic NSCLC and pleural effusion.
