Assuntos
Neoplasias Pulmonares/etiologia , Fumar Maconha/efeitos adversos , Medicina Baseada em Evidências , Humanos , Neoplasias Pulmonares/epidemiologia , Neoplasias Pulmonares/prevenção & controle , Fumar Maconha/epidemiologia , Fumar Maconha/prevenção & controle , Medição de Risco , Fatores de Risco , Fumar/efeitos adversos , Abandono do Hábito de Fumar , Fatores de TempoAssuntos
Antineoplásicos/economia , Ensaios Clínicos como Assunto/economia , Drogas em Investigação/economia , Seguro Saúde/economia , Orçamentos/organização & administração , Ensaios Clínicos como Assunto/legislação & jurisprudência , Custo Compartilhado de Seguro , Humanos , Seguro Saúde/legislação & jurisprudência , Medicare/organização & administração , Seleção de Pacientes , Apoio à Pesquisa como Assunto/organização & administração , Estados Unidos , United States Food and Drug Administration/organização & administraçãoRESUMO
Cancer can be detected in asymptomatic patients by a blood draw for tumor biomarkers during routine examinations in a doctor's office. The reliability of tumor biomarkers to diagnose cancer in asymptomatic patients is a frequently asked question in general practice as well as in an oncology setting.
Assuntos
Biomarcadores Tumorais/sangue , Programas de Rastreamento/métodos , Neoplasias , Biópsia , Antígeno Ca-125/sangue , Antígeno CA-19-9/sangue , Antígeno Carcinoembrionário/sangue , Humanos , Programas de Rastreamento/normas , Neoplasias/sangue , Neoplasias/diagnóstico , Visita a Consultório Médico , Seleção de Pacientes , Antígeno Prostático Específico/sangue , Reprodutibilidade dos Testes , Sensibilidade e Especificidade , Tireoglobulina/sangueRESUMO
PURPOSE: This study intended to determine the maximum tolerated dose, safety, pharmacokinetic variables, clinical response, and pharmacodynamic markers of daily s.c. administration of Angiozyme. PATIENTS AND METHODS: Patients with refractory solid tumors were enrolled in a dose escalation and expanded cohort design. Dose escalation involved cohorts of patients at doses of 10, 30, 100, or 300 mg/m(2)/d for 29 days. A second component enrolled 15 additional patients at a daily dose of 100 mg/m(2). Patients were eligible to continue on therapy until disease progression. RESULTS: Thirty-one patients were enrolled and 28 were evaluable (range, 29-505 days; median, 89.5 days). A maximum tolerated dose was not defined by toxicity but rather by the maximal deliverable dose of 300 mg/m(2)/d. Grade 1 to 2 injection site reactions were the most common toxicities. One patient in the 300 mg/m(2) group experienced a reversible grade 3 injection site reaction. Angiozyme showed dose-dependent plasma concentrations with good bioavailability. Surrogate markers showed Angiozyme localization in tumor biopsies and a significant increase in serum von Willebrand factor antigen, a marker for endothelial cell dysfunction. Although Angiozyme-reactive antibody production was noted for some patients, no antibody-related adverse events were noted. Seven of 28 (25%) evaluable patients had stable disease for >or =6 months, with the longest treatment duration of > or =16 months. Two patients (nasopharyngeal carcinoma and melanoma) showed minor responses. CONCLUSION: Angiozyme was well tolerated with satisfactory pharmacokinetic variables for daily s.c. dosing. Results have provided the basis for subsequent clinical trials of this first-of-class biologically targeted therapeutic.