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. 2021 May 26;38(7):3489–3505. doi: 10.1007/s12325-021-01738-2
Rituximab chemotherapy and obinutuzumab chemotherapy are effective treatments for patients with previously untreated follicular lymphoma.
There are challenges in designing modern clinical trials to demonstrate further benefit achieved with new therapies.
Endpoints such as overall survival are often not feasible to achieve due to the need for large numbers of patients and long follow-up.
Progression-free survival is often used as the primary measure of efficacy in registrational clinical trials, although it has some limitations.
Other endpoints, e.g. complete response rate at 30 months and progression of disease within 24 months, may be considered for future trials, but they too have limitations and their clinical relevance should be explored further.
Risk-adaptive trials to direct treatment should be explored.