Single-agent monoclonal antibody efficacy in bulky non-Hodgkin's lymphoma:Results of a phase II trial of rituximab

Citation
Ta. Davis et al., Single-agent monoclonal antibody efficacy in bulky non-Hodgkin's lymphoma:Results of a phase II trial of rituximab, J CL ONCOL, 17(6), 1999, pp. 1851-1857
Citations number
42
Categorie Soggetti
Oncology,"Onconogenesis & Cancer Research
Journal title
JOURNAL OF CLINICAL ONCOLOGY
ISSN journal
0732183X → ACNP
Volume
17
Issue
6
Year of publication
1999
Pages
1851 - 1857
Database
ISI
SICI code
0732-183X(199906)17:6<1851:SMAEIB>2.0.ZU;2-7
Abstract
Purpose: A phase II trial was performed to evaluate the safety and efficacy of rituximab, a chimeric anti-CD20 monoclonal antibody in patients with bu lky(> 10-cm lesion) relapsed or refractory low-grade or follicular non-Hodg kin's lymphoma (NHL). Patients and Methods: Thirty-one patients received intravenous infusions of rituximab 375 mg/m(2) weekly for four doses. All patients herd at least on e prior therapy (median, three; range, one to 13) and had progressive disea se at study entry. Patients were a median of 4 years from diagnosis. Results: No patient had treatment discontinued because of an adverse event. No patient developed human antichimeric antibody. The overall response rat e in 28 assessable patients was 43% with a median time to progression of 8. 1 months (range, 4.5 to 18.6+ months) and median duration of response of 5. 9 months (range, 2.8 to 12.1+ months). The average decrease in lesion size in patients who achieved a partial response was 76%, and patients with stab le disease had a decrease in average lesion size of 26%. Median serum antib ody concentration was higher in responders compared with nonresponders, and a negative correlation was shown between antibody concentration and tumor bulk at baseline. Conclusion: Rituximab single-agent outpatient therapy is safe and shows sig nificant clinical activity in patients with bulky relapsed or refractory to w-grade ar follicular B-cell NHL. (C) 1999 by American Society of Clinical Oncology.