Thirty-month complete response is an accurate predictive endpoint for progression-free survival in follicular lymphoma clinical trials, according to a study published in the Journal of Clinical Oncology.1
The average length of progression-free survival with follicular lymphoma is between 6 and 8 years. Without a predictive measure for this endpoint, clinical trials are prolonged unnecessarily, and patients are treated with therapies that may be ineffective. As patients who achieve a complete response tend to have a longer time to disease progression, researchers conducted this pooled analysis to determine whether a complete response rate at a particular time point would be a useful surrogate trial endpoint.
Of 346 identified studies, 13 randomized trials were included in this analysis of individual patient data for 3838 participants; 8 trials were of induction therapy and 5 were of maintenance therapy.
Across all evaluated studies, a consistent relationship was found between complete response at 30 months and progression-free survival. This relationship was particularly strong for patients with high Follicular Lymphoma International Prognostic Index (FLIPI) scores.
Thirty-month complete response after treatment initiation is, according to this study’s authors, a surrogate endpoint for progression-free survival in follicular lymphoma. The use of this surrogate should be used with the patient population and treatment type in mind.
- Shi Q, Flowers CR, Hiddemann W, et al. Thirty-month complete response as a surrogate end point in first-line follicular lymphoma therapy: an individual patient-level analysis of multiple randomized trials. J Clin Oncol. 2016 Dec 27. doi: 10.1200/JCO.2016.70.8651 [Epub ahead of print]