RENOIR phase 3 rituximab-lenalidomide vs rituximab as maintenance treatment in relapsed/refractory follicular lymphoma.

What was studied

RENOIR was a multicenter, open-label, randomized trial of maintenance treatment. It was run by an Italian lymphoma group. It enrolled 152 older people with follicular lymphoma. The lymphoma had come back or had not responded after 1 or 2 earlier therapies. After 4 to 6 cycles of rituximab-based chemotherapy, 129 people had a response. They were randomized to rituximab alone or rituximab plus lenalidomide. The main aim was 2-year progression-free survival.

What they found

Median follow-up was 68 months. Adding lenalidomide did not significantly improve 2-year progression-free survival. A numerical benefit was seen. An unplanned subgroup analysis looked at people aged under 70 years. It showed a greater benefit with lenalidomide. Overall survival rates were similar. Grade 3 to 4 adverse events were more frequent with lenalidomide. These were mainly low neutrophils and gut problems.

What it means for patients

The authors say the main goal was not met. They say the pair showed a more favorable benefit-risk profile in people under 70. They say older people need careful thought about how well they tolerate it.

Why it is not certain yet

The under-70 result was an unplanned subgroup analysis. It was meant to generate ideas, not prove them. The main goal was not met. The study was open-label. The abstract does not give the size of the under-70 group.

Source

RENOIR phase 3 rituximab-lenalidomide vs rituximab as maintenance treatment in relapsed/refractory follicular lymphoma.

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