Bone marrow biopsies “add little value” to response assessment in patients with follicular lymphoma, according to researchers.
Based on study findings, the researchers recommend eliminating bone marrow biopsies from clinical trial requirements and diagnostic guidelines for follicular lymphoma, except in certain cases.
The researchers made these recommendations and reported their findings in the Journal of Clinical Oncology.
The researchers pooled data from 7 trials including a total of 580 patients with previously untreated follicular lymphoma. The trials completed enrollment from 2008 to 2016.
The researchers hypothesized that it would be rare for bone marrow assessment to change response determination in these trials. Specifically, it would be unlikely for a patient to have a positive bone marrow biopsy at baseline, a complete response (CR) on imaging after treatment, and a subsequent positive bone marrow biopsy.
The results confirmed this theory, suggesting that bone marrow biopsies were irrelevant to response in nearly all patients. Less than 1% of patients (5/580; 0.9%) had a positive baseline bone marrow biopsy, a CR on imaging, and a subsequent positive bone marrow biopsy.
When analyzing only those patients with a CR on imaging, the researchers found that 1.5% of patients (5/344) had a bone marrow biopsy that altered response assessment.
The researchers also conducted a landmark survival analysis to compare outcomes in patients who did not undergo bone marrow biopsies with patients who did. The analysis included 187 patients who had a CR on imaging.
There was no significant difference in progression-free survival (PFS) or overall survival (OS) between patients who had a negative bone marrow biopsy to confirm the CR and patients who did not. The adjusted hazard ratio was 1.10 (P =.686) for PFS and 0.59 (P =.276) for OS.
“We conclude that BMB [bone marrow biopsies] add little value to response assessment in subjects with FL [follicular lymphoma] treated on clinical trials, and we recommend eliminating BMB from clinical trial requirements,” the researchers wrote. “BMB should also be removed from diagnostic guidelines for FL, except in scenarios in which it may change management, including confirmation of limited stage and assessment of cytopenias.”
Disclosures: This research was supported, in part, by Celgene and GlaxoSmithKline. Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of disclosures.
Rutherford SC, Yin J, Pederson L, et al. Relevance of bone marrow biopsies for response assessment in US National Cancer Institute National Clinical Trials Network follicular lymphoma trials. J Clin Oncol. Published online July 5, 2022. doi:10.1200/JCO.21.02301