Relevance of Bone Marrow Biopsies for Response Assessment in US National Cancer Institute National Clinical Trials Network Follicular Lymphoma Clinical Trials.

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  • Additional Information
    • Source:
      Publisher: American Society of Clinical Oncology Country of Publication: United States NLM ID: 8309333 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1527-7755 (Electronic) Linking ISSN: 0732183X NLM ISO Abbreviation: J Clin Oncol Subsets: MEDLINE
    • Publication Information:
      Publication: 2003- : Alexandria, VA : American Society of Clinical Oncology
      Original Publication: New York, N.Y. : Grune & Stratton, c1983-
    • Subject Terms:
      Lymphoma, Follicular*/drug therapy; United States ; Humans ; Bone Marrow/pathology ; National Cancer Institute (U.S.) ; Survival Analysis ; Biopsy
    • Abstract:
      Purpose: 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.
      Methods: 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.
      Results: Only 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).
      Conclusion: 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.
    • References:
      Am Soc Clin Oncol Educ Book. 2019 Jan;39:105-114. (PMID: 31099636)
      J Clin Oncol. 2012 Sep 20;30(27):3368-75. (PMID: 22915662)
      J Clin Oncol. 2014 Sep 20;32(27):3059-68. (PMID: 25113753)
      Ann Oncol. 2021 Mar;32(3):298-308. (PMID: 33249059)
      Br J Haematol. 2017 Oct;179(2):242-245. (PMID: 28677889)
      J Clin Oncol. 2014 Sep 20;32(27):3048-58. (PMID: 25113771)
      J Clin Oncol. 2017 Nov 20;35(33):3753-3759. (PMID: 28968172)
      Ann Intern Med. 2002 Feb 5;136(3):243-6. (PMID: 11827500)
      Nat Med. 2019 Jan;25(1):119-129. (PMID: 30455436)
      Haematologica. 2006 Apr;91(4):482-9. (PMID: 16585015)
      J Clin Oncol. 1989 Nov;7(11):1630-6. (PMID: 2809679)
      Ann Oncol. 2018 Oct 1;29(Suppl 4):iv19-iv29. (PMID: 29796651)
      J Clin Oncol. 2012 Dec 20;30(36):4508-14. (PMID: 23150698)
      Blood Adv. 2018 Apr 10;2(7):807-816. (PMID: 29636326)
      Am Soc Clin Oncol Educ Book. 2017;37:216-221. (PMID: 28561724)
      J Clin Oncol. 1999 Apr;17(4):1244. (PMID: 10561185)
      Oncotarget. 2017 Jan 31;8(5):8765-8774. (PMID: 28060738)
      Clin Cancer Res. 2014 Dec 15;20(24):6398-405. (PMID: 25316810)
      J Clin Oncol. 2007 Feb 10;25(5):579-86. (PMID: 17242396)
      Blood. 2015 Sep 17;126(12):1407-14. (PMID: 26239087)
      Eur J Nucl Med Mol Imaging. 2014 Mar;41(3):565-74. (PMID: 24281821)
      N Engl J Med. 2017 Oct 5;377(14):1331-1344. (PMID: 28976863)
      J Nucl Med. 2013 Aug;54(8):1244-50. (PMID: 23674577)
      Blood Adv. 2020 Apr 28;4(8):1589-1593. (PMID: 32298429)
      Cancer Res. 1971 Nov;31(11):1860-1. (PMID: 5121694)
      Blood. 2013 Jul 4;122(1):61-7. (PMID: 23660958)
      J Natl Compr Canc Netw. 2019 Jun 1;17(6):650-661. (PMID: 31200358)
    • Grant Information:
      U10 CA180882 United States CA NCI NIH HHS; UG1 CA233247 United States CA NCI NIH HHS; UG1 CA233253 United States CA NCI NIH HHS; U10 CA180888 United States CA NCI NIH HHS; UG1 CA233339 United States CA NCI NIH HHS; U10 CA180821 United States CA NCI NIH HHS; UG1 CA233277 United States CA NCI NIH HHS; U10 CA180819 United States CA NCI NIH HHS; UG1 CA233328 United States CA NCI NIH HHS
    • Molecular Sequence:
      ClinicalTrials.gov NCT00553501; NCT01145495; NCT01829568; NCT00770224; NCT00006721; NCT01286272; NCT00075946; NCT01190449
    • Publication Date:
      Date Created: 20220705 Date Completed: 20230109 Latest Revision: 20240111
    • Publication Date:
      20240111
    • Accession Number:
      PMC9839232
    • Accession Number:
      10.1200/JCO.21.02301
    • Accession Number:
      35787017