Researchers who conducted a pooled analysis of clinical trials in previously untreated follicular lymphoma (FL) concluded that the results showed that the use of bone marrow biopsy (BMB) provided little value in assessing response in these trials. The researchers reported their findings in the Journal of Clinical Oncology.
“Based upon these results, BMB should be eliminated from diagnostic guidelines in FL, and no longer incorporated as response assessments in clinical trials for patients with FL,” they wrote in their report. The researchers noted that an exception to this should be made for scenarios in which management may be affected by BMB results, such as in confirming a limited stage of disease or in assessing cytopenias.
The researchers evaluated data from 7 clinical trials that together included 580 individuals with previously untreated FL. The included trials had results available for BMB in baseline and response assessments and data on best response by imaging. The trials were conducted by the Alliance for Clinical Trials of Oncology and SWOG Cancer Research Network, and they had enrollment completion dates from 2008 to 2016.
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Among patients with response assessments considered to be influenced by BMB, the researchers included patients who had positive BMB results at baseline, followed by complete response (CR) to treatment shown on imaging, and then a positive repeat BMB.
Overall, approximately 0.9% of patients in these studies had demonstrated positive BMB at baseline, with CR shown on imaging, and a positive repeat BMB (P <.0001). “On average, in the primary data set, one subject’s response assessment was altered for every 116 subjects required to undergo BMB,” the researchers wrote in their report.
Among 344 patients showing positive CR on imaging after treatment, BMB affected the response assessment in 1.5% of cases. The researchers also performed a separate sensitivity analysis with data from an Eastern Cooperative Oncology Group study of 385 patients with FL, which similarly indicated only 1.3% of these patients showed BMB results that impacted response assessment.
The researchers also examined survival outcomes in 187 patients from the Alliance and SWOG studies who had positive baseline BMB and later CR on imaging. Progression-free survival in patients who had CR confirmed by negative BMB was similar to that of patients who did not undergo repeat BMB (adjusted hazard ratio [HR], 1.10; 95% CI, 0.62-1.94; P =.686). Overall survival was also similar across these patient groups (HR, 0.59; 95% CI, 0.23-1.53; P =.276).
“BMB requirements may discourage participation in clinical trials and add pain, expense, and time without providing necessary information in enrolled FL subjects,” the researchers wrote in their report, highlighting what they determined to be a lack of benefit in assessing prognosis or response in this population.
Disclosures: Some authors have declared affiliations with or received grant support from the pharmaceutical industry. Please refer to the original study for a full list of disclosures.
Reference
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 clinical trials. J Clin Oncol. 2023;41(2):336-342. doi:10.1200/JCO.21.02301
