TY - JOUR
T1 - Relevance of Bone Marrow Biopsies for Response Assessment in US National Cancer Institute National Clinical Trials Network Follicular Lymphoma Clinical Trials
AU - Rutherford, Sarah C.
AU - Yin, Jun
AU - Pederson, Levi
AU - Perez Burbano, Gabriela
AU - Laplant, Betsy
AU - Shadman, Mazyar
AU - Li, Hongli
AU - Leblanc, Michael L.
AU - Kenkre, Vaishalee P.
AU - Hong, Fangxin
AU - Blum, Kristie A.
AU - Dockter, Travis
AU - Martin, Peter
AU - Jung, Sin Ho
AU - Grant, Barbara
AU - Rosenbaum, Cara
AU - Ujjani, Chaitra
AU - Barr, Paul M.
AU - Unger, Joseph M.
AU - Cheson, Bruce D.
AU - Bartlett, Nancy L.
AU - Kahl, Brad
AU - Friedberg, Jonathan W.
AU - Mandrekar, Sumithra J.
AU - Leonard, John P.
N1 - Publisher Copyright:
© American Society of Clinical Oncology.
PY - 2023/1/10
Y1 - 2023/1/10
N2 - PURPOSEBone 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.METHODSData 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.RESULTSOnly 5/580 (0.9%) had positive baseline BMB, CR on imaging, and subsequent positive BMB (P <.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 P =.686; OS: hazard ratio, 0.59, 95% CI, 0.23 to 1.53, log-rank P =.276).CONCLUSIONWe 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.
AB - PURPOSEBone 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.METHODSData 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.RESULTSOnly 5/580 (0.9%) had positive baseline BMB, CR on imaging, and subsequent positive BMB (P <.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 P =.686; OS: hazard ratio, 0.59, 95% CI, 0.23 to 1.53, log-rank P =.276).CONCLUSIONWe 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.
UR - http://www.scopus.com/inward/record.url?scp=85145668626&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85145668626&partnerID=8YFLogxK
U2 - 10.1200/JCO.21.02301
DO - 10.1200/JCO.21.02301
M3 - Article
C2 - 35787017
AN - SCOPUS:85145668626
SN - 0732-183X
VL - 41
SP - 336
EP - 342
JO - Journal of Clinical Oncology
JF - Journal of Clinical Oncology
IS - 2
ER -