Data Support Front-Line Rituximab in Advanced, Low-Tumor Burden Follicular Lymphoma

First-line treatment with rituximab delayed disease progression and initiation of cytotoxic chemotherapy compared with watchful waiting in patients with low-tumor-burden follicular lymphoma, according to authors of the JCOG1411/FLORA study.

“We recommend the early administration of rituximab as an initial treatment approach for such patients,” wrote first author, Noriko Fukuhara, MD, in the article published in Blood.

The researchers enrolled 292 patients from 54 hospitals in Japan between December 2016 and March 2023. Participants were classified as having very low tumor burden (largest mass ≤5 cm, two or fewer nodal sites of ≥3 cm, and no effusion) or intermediate tumor burden (one or more of the following: largest mass 5-7 cm, three nodal sites of ≥3 cm, and no serious effusion).

Front-Line Rituximab Monotherapy in Follicular Lymphoma

Patients were randomized to watchful waiting (n=148) or immediate initiation of treatment with rituximab (n=144). The groups had comparable baseline median age, sex, Ann Arbor stage III/IV disease, and Follicular Lymphoma International Prognostic Index (FLIPI) low/intermediate/high risk score characteristics.

The primary endpoint was event-free survival (EFS), defined as progression to high tumor burden (HTB), initiating cytotoxic chemotherapy or radiation, histologic transformation, or death.

Over a median follow-up of 2.5 years (range, 0–6.9), the rituximab group had significantly better EFS compared with the watchful waiting group (hazard ratio, 0.625; 95% CI, 0.425-0.918; one-sided log-rank P=.0078 < .0123 alpha adjusted for multiplicity). Most detailed EFS events were progression to HTB and chemotherapy initiation in both groups, according to the authors.

The three-year progression-free survival rates were 50.6% and 49.6% with watchful waiting and rituximab, respectively, and three-year overall survival rates were 98.4% and 97.3%, respectively. There were seven deaths in each arm. The study was terminated early after the second preplanned interim analysis.

“Rituximab induction has been confirmed to delays disease progression to HTB and the initiation of cytotoxic chemotherapy in patients with untreated advanced-stage very low tumor burden FL,” Dr. Fukuhara and colleagues wrote.

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Reference

Fukuhara N, Maruyama D, Ishizawa K, et al. Randomized phase III study of watchful waiting vs. rituximab as first-line treatment in patients with advanced stage low tumor burden follicular lymphoma: JCOG1411/Flora study. Blood 2024;144 (suppl 1):338. doi: https://doi.org/10.1182/blood-2024-199868