biostudies-literatureRutherford SCNCI NIH HHS336-342https://www.ebi.ac.uk/biostudies/studies/S-EPMC9839232biostudies-literatureUnknown41(2)<h4>Purpose</h4>Bone marrow biopsies (BMB) are performed before/after therapy to confirm complete response (CR) in patients with lymphoma on clinical trials. We sought to establish whether BMB add value in assessing response or predict progression-free survival (PFS) or overall survival (OS) outcomes in follicular lymphoma (FL) subjects in a large, multicenter, multitrial cohort.<h4>Methods</h4>Data were pooled from seven trials of 580 subjects with previously untreated FL through Alliance for Clinical Trials in Oncology (Alliance) and SWOG Cancer Research Network (SWOG) completing enrollment from 2008 to 2016.<h4>Results</h4>Only 5/580 (0.9%) had positive baseline BMB, CR on imaging, and subsequent positive BMB (<i>P</i> < .0001). Therefore, BMB were irrelevant to response in 99% of subjects. A sensitivity analysis of 385 FL subjects treated on an Eastern Cooperative Oncology Group study was included. In the Eastern Cooperative Oncology Group cohort, 5/385 (1.3%) had BMB that affected response assessment. Since some subjects do not undergo confirmatory BMB, we performed a landmark survival analysis from first radiologic CR with data from 580 subjects from Alliance and SWOG. Of subjects with CR on imaging (n = 187), PFS and OS were not significantly different among those with negative BMB to confirm CR (n = 47) versus those without repeat BMB (n = 140; PFS: adjusted hazard ratio, 1.10, 95% CI, 0.62 to 1.94, log-rank <i>P</i> = .686; OS: hazard ratio, 0.59, 95% CI, 0.23 to 1.53, log-rank <i>P</i> = .276).<h4>Conclusion</h4>We conclude that BMB add little value to response assessment in subjects with FL treated on clinical trials and we recommend eliminating BMB from clinical trial requirements. 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. This would reduce cost, patient discomfort, resource utilization, and potentially remove a barrier to trial enrollment.Journal of clinical oncology : official journal of the American Society of Clinical OncologyRelevance of Bone Marrow Biopsies for Response Assessment in US National Cancer Institute National Clinical Trials Network Follicular Lymphoma Clinical Trials.PMC9839232UG1 CA233247U10 CA180882U10 CA180819UG1 CA233339UG1 CA233328U10 CA180821U10 CA180888UG1 CA233277UG1 CA233253Barr PMUjjani CLeBlanc MLLaPlant BCheson BDShadman MMartin PBartlett NLPerez Burbano GKahl BJung SHLi HDockter TMandrekar SJFriedberg JWHong FKenkre VPPederson LRutherford SCUnger JMGrant BRosenbaum CLeonard JPBlum KAYin JfalseRelevance of Bone Marrow Biopsies for Response Assessment in US National Cancer Institute National Clinical Trials Network Follicular Lymphoma Clinical Trials.<h4>Purpose</h4>Bone marrow biopsies (BMB) are performed before/after therapy to confirm complete response (CR) in patients with lymphoma on clinical trials. We sought to establish whether BMB add value in assessing response or predict progression-free survival (PFS) or overall survival (OS) outcomes in follicular lymphoma (FL) subjects in a large, multicenter, multitrial cohort.<h4>Methods</h4>Data were pooled from seven trials of 580 subjects with previously untreated FL through Alliance for Clinical Trials in Oncology (Alliance) and SWOG Cancer Research Network (SWOG) completing enrollment from 2008 to 2016.<h4>Results</h4>Only 5/580 (0.9%) had positive baseline BMB, CR on imaging, and subsequent positive BMB (<i>P</i> < .0001). Therefore, BMB were irrelevant to response in 99% of subjects. A sensitivity analysis of 385 FL subjects treated on an Eastern Cooperative Oncology Group study was included. In the Eastern Cooperative Oncology Group cohort, 5/385 (1.3%) had BMB that affected response assessment. Since some subjects do not undergo confirmatory BMB, we performed a landmark survival analysis from first radiologic CR with data from 580 subjects from Alliance and SWOG. Of subjects with CR on imaging (n = 187), PFS and OS were not significantly different among those with negative BMB to confirm CR (n = 47) versus those without repeat BMB (n = 140; PFS: adjusted hazard ratio, 1.10, 95% CI, 0.62 to 1.94, log-rank <i>P</i> = .686; OS: hazard ratio, 0.59, 95% CI, 0.23 to 1.53, log-rank <i>P</i> = .276).<h4>Conclusion</h4>We conclude that BMB add little value to response assessment in subjects with FL treated on clinical trials and we recommend eliminating BMB from clinical trial requirements. 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. This would reduce cost, patient discomfort, resource utilization, and potentially remove a barrier to trial enrollment.2023-01-01T00:00:00Z2023 Jan2025-04-19T19:00:45.596Z2025-04-19T19:00:45.596ZS-EPMC98392323578701710.1200/JCO.21.0230110.1200/jco.21.02301