Which is Better, Starting Rituximab Early or Watch-and-Wait for Low-Burden Follicular Lymphoma?

People with low-tumor burden follicular lymphoma are usually recommended to observe the cancer without treatment (watch-and-wait/active observation) or be treated with a monoclonal antibody called rituximab. It's unclear when exactly patients should start rituximab. 

Once follicular lymphoma advances into high-tumor burden, it is recommended to begin chemotherapy. 

Can treating low-burden follicular lymphoma with rituximab early on reduce the risk of it advancing into high-burden disease? If so, it would help patients reduce their risk of needing chemotherapy later on. 

Noriko Fukuhara, MD, PhD, from Tohoku University in Japan, and colleagues reviewed in phase 3 of the Flora study whether it was better to give rituximab to untreated patients with low-burden follicular lymphoma or for patients to remain in watch-and-wait. 

Dr. Fukuhara presented the findings at the 2024 ASH conference. Read the study’s results below and watch HealthTree’s interview with Dr. Fukuhara. 

Is It Beneficial for People with Low-Burden Follicular Lymphoma to Start Rituximab Early? Dr. Fukuhara Says Yes

Phase 3 of the Flora study compared the outcomes of 292 low-tumor burden follicular lymphoma patients from 54 hospitals across Japan. The first group started rituximab immediately, and the second group, in watch-and-wait, waited for the cancer to progress before starting treatment. 

The main goal was to see which group had better event-free survival (EFS). EFS measures the length of time after primary treatment that a patient remains free of certain complications or events such as disease progression, need for new treatment, or death. 

Results

• The study had to be stopped early because results showed that those who started rituximab right away did significantly better than those who waited.
• The chance of the cancer not worsening was higher in the rituximab group compared to the watch-and-wait group.
• Both groups had similar survival rates, meaning the immediate use of rituximab mainly helped in controlling the cancer rather than prolonging life.

Summary

The Flora study found that starting rituximab treatment early for low-tumor burden follicular lymphoma reduces the risk of the cancer progressing to high-tumor burden. This also decreases the chance of patients needing high-burden treatments like chemotherapy.  

Dr. Fukuhara advises patients with low-tumor burden follicular lymphoma to start rituximab therapy right away instead of remaining in watch-and-wait. Talk with your follicular lymphoma specialist if you have questions about treatment. 

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Sources: 

• 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
• Rituximab for Low Tumor Burden Follicular Lymphoma