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
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.