Early Rituximab Monotherapy Significantly Delays Need for Chemotherapy in Low Tumor Burden Follicular Lymphoma.

The long-term results of an international, randomized phase 3 trial (Lancet Haematology, 2025) provide robust evidence on the role of early rituximab monotherapy in patients with advanced-stage, asymptomatic, low tumor burden follicular lymphoma.

• Study design: 455 patients were randomized to watchful waiting (n=183), rituximab induction (n=82), or rituximab maintenance (n=190). Median follow-up was 14.7 years.
• Primary endpoint (TTNT – time to initiation of new treatment):
• Median TTNT: 5.6 years with watchful waiting, 14.8 years with rituximab induction, and not reached with rituximab maintenance.
• At 15 years, 65% of patients in the rituximab maintenance arm, 48% in the induction arm, and 34% in the watchful waiting group had not required new treatment.
• Hazard ratios: rituximab induction vs watchful waiting HR 0.55 (p=0.0019); rituximab maintenance vs watchful waiting HR 0.36 (p<0.0001).
• Secondary outcomes:
• No differences in overall survival or cause-specific mortality across groups.
• Rates of high-grade transformation were low and similar (17% maintenance, 15% induction, 20% watchful waiting).
• TT2NT (time to second new treatment) showed no detrimental impact of early rituximab.
• Safety: Rituximab was well tolerated, with few grade ≥3 adverse events (mainly infections or cytopenias). The risk of second primary malignancies was similar across groups.

Conclusion

These mature data confirm that early rituximab monotherapy—either as induction alone or followed by maintenance—substantially delays the need for chemotherapy in low tumor burden follicular lymphoma, without affecting long-term survival or transformation risk. This strategy offers patients the opportunity to defer chemotherapy, with a favorable safety profile, and should be considered a standard treatment option for appropriately selected individuals.

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