McLaughlin Trial (Weekly ×4)
RITUXAN monotherapy provided durable responses in heavily pretreated NHL patients
McLAUGHLIN ×4 TREATMENT TRIAL DESIGN1,2
- Treatment in the trial consisted of RITUXAN 375 mg/m2 administered once weekly intravenously for a total of 4 infusions. Patients were required to have either failed to respond to primary chemotherapy or to have relapsed after chemotherapy (no more than 4 relapses). Patients had received up to 10 prior regimens (median: 3).1,2
- NHL=non-Hodgkin's lymphoma.
ORIGINAL PIVOTAL TRIAL: HEAVILY PRETREATED LOW-GRADE OR FOLLICULAR NHL2
|Patient characteristics||No. of patients|
|Age ≥60 years||67|
|Histology||Small lymphocytic Follicular small cleaved Follicular mixed Follicular large cell Other||
|Elevated β2 microglobulin||41|
|Bulky disease||<5 cm ≥5 cm||
|Median number of prior courses of chemotherapy||3|
- *Subset analyses conducted on the assessable group of 151 patients; results for the intent-to-treat group were virtually identical.
- LDH=lactate dehydrogenase.
RESPONSE DURATION IN HEAVILY PRETREATED PATIENTS1,2
- ITT=intent to treat.
- In responders (n=80), the median duration of response was 11.2 months1,2
- The overall response rate was 48% (6% CR, 42% PR)2
- CR=complete response; PR=partial response.
Single-agent RITUXAN for relapsed or refractory, low-grade or follicular NHL
- Grade 3 and 4 cytopenias were reported in 48% of patients and included lymphopenia (40%), neutropenia (6%), leukopenia (4%), anemia (3%), and thrombocytopenia (2%). Serious Grade 3 or 4 infections, including sepsis, occurred in <5% of patients
- The overall incidence of infections was 31%: bacterial (19%), viral (10%), unknown (6%), and fungal (1%)
- RITUXAN® (Rituximab) full prescribing information, Genentech, Inc., 2013.
- McLaughlin P, Grillo-López AJ, Link BK, et al. Rituximab chimeric anti-CD20 monoclonal antibody therapy for relapsed indolent lymphoma: half of patients respond to a four-dose treatment program. J Clin Oncol. 1998;16:2825-2833.