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.

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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.

Reference

  1. 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]