Researchers sponsored in part by Cancer Research UK explored whether patients with advanced-stage, low tumor burden follicular lymphoma could benefit from rituximab.
Rituximab has the potential to delay the need for chemotherapy or radiotherapy in a more proactive manner as compared to the current protocol of watchful waiting. They also explored whether this strategy had an effect on quality of life.
The study recruited 379 patients from 118 centers in the U.K., Australia, New Zealand, Turkey, and Poland. They were randomly assigned either to watchful waiting or maintenance rituximab.
Initially, 84 patients were recruited to rituximab induction, in which they received rituximsb once a week for four weeks but the arm was closed early.
Investigators found a significant difference in the time to start of new treatment at three years:
Compared with the watchful waiting group, patients in the maintenance rituximab group had significant improvements in the Mental Adjustment to Cancer scale score, and Illness Coping Style score between baseline and month 7. Patients in the rituximab induction group did not show improvements in their quality of life compared with the watchful waiting group.
There were 18 serious adverse events reported in the rituximab groups (four in the rituximab induction group and 14 in the maintenance rituximab group), 12 of which were grade 3 or 4 (five infections, three allergic reactions, and four cases of neutropenia), all of which fully resolved.
Researchers concluded that rituximab monotherapy should be considered as a treatment option for patients with asymptomatic, advanced-stage, low tumor burden follicular lymphoma.
Source: The Lancet