Single-Agent Monoclonal Antibody Efficacy in Bulky Non-Hodgkin's Lymphoma: Results of a Phase II Trial of Rituximab

摘要: PURPOSE: A phase II trial was performed to evaluate the safety and efficacy of rituximab, a chimeric anti-CD20 monoclonal antibody, in patients with bulky (> 10-cm lesion) relapsed or refractory low-grade follicular non-Hodgkin's lymphoma (NHL). PATIENTS AND METHODS: Thirty-one received intravenous infusions rituximab 375 mg/m2 weekly for four doses. All had at least one prior therapy (median, three; range, 13) progressive disease study entry. Patients were median 4 years from diagnosis. RESULTS: No patient treatment discontinued because an adverse event. developed human antichimeric antibody. The overall response rate 28 assessable 43% time progression 8.1 months (range, 4.5 18.6+ months) duration 5.9 2.8 12.1+ months). average decrease lesion size who achieved partial 76%, stable a...