KEY TAKEAWAYS
- Phase 3 clinical trials (NCT01829568) were conducted by the Alliance for Clinical Trials in Oncology and the SWOG Cancer Research Network.
- The study’s primary aim was to assess the role of bone marrow biopsy in response evaluation and outcome prediction for PFS and OS in individuals with FL.
- The study analyzed data from seven clinical trials comprising 580 individuals with FL who underwent treatment from 2008 to 2016.
- The study found that bone marrow biopsy was insignificant in eliciting a response in 99% of the participants.
- The study recommends excluding BMB from clinical trial prerequisites for individuals with FL who undergo treatment.
- The researchers concluded that bone marrow biopsy may not significantly contribute to patient response evaluation and outcome prediction.
Bone marrow biopsies (BMBs) are conducted pre- or post-treatment to verify complete response (CR) in lymphoma patients participating in clinical trials. The study’s objective was to determine the potential of bone marrow biopsy (BMB) in evaluating the response and predicting the outcomes of progression-free survival (PFS) and overall survival (OS) in individuals with follicular lymphoma (FL) in a vast, multicenter, and multiracial group. The data were aggregated from seven clinical trials comprising 580 individuals without prior treatment for follicular lymphoma. These trials were conducted by the Alliance for Clinical Trials in Oncology and the SWOG Cancer Research Network, with enrollment spanning from 2008 to 2016. Out of the 580 cases, merely 5 (0.9%) exhibited affirmative baseline bone marrow biopsy, complete response on imaging, and ensuing positive bone marrow biopsy with a statistical significance of P < .0001. Thus, bone marrow biopsies were found to be insignificant in eliciting a response in 99% of the participants.
The study incorporated a sensitivity analysis of 385 subjects with FL who underwent treatment under the Eastern Cooperative Oncology Group. Within the Eastern Cooperative Oncology Group cohort, 5 out of 385 individuals (1.3%) exhibited bone marrow biopsies that impacted the response evaluation. As confirmatory bone marrow biopsy (BMB) was not conducted on certain subjects, a landmark survival analysis was conducted using data from 580 subjects from Alliance and SWOG, starting from the time of their first radiologic complete response (CR). Among the subjects who exhibited complete response on imaging, consisting of 187 individuals, there was no significant difference in progression-free survival and overall survival between those who did not undergo repeat bone marrow biopsy to confirm complete response, consisting of 47 individuals, and those who did not undergo repeat biopsy, consisting of 140 individuals. The adjusted hazard ratio for progression-free survival was 1.10, with a 95% confidence interval ranging from 0.62 to 1.94 and a log-rank P =.686. The hazard ratio for overall survival was 0.59, with a 95% confidence interval ranging from 0.23 to 1.53 and a log-rank P = .276.
The study findings suggest that bone marrow biopsy (BMB) may not significantly contribute to response evaluation in individuals with follicular lymphoma (FL) who undergo treatment in clinical trials. Therefore, researchers recommend that BMB be excluded from diagnostic guidelines for FL, except in cases where it may impact management decisions, such as confirming limited stage and evaluating cytopenias. This intervention has the potential to decrease expenses, minimize patient discomfort, optimize resource allocation, and eliminate an obstacle to participation in clinical trials.
Source: https://pubmed.ncbi.nlm.nih.gov/35787017/
Clinical Trial: https://clinicaltrials.gov/ct2/show/NCT01829568
Rutherford SC, Yin J, Pederson L, Perez Burbano G, LaPlant B, Shadman M, Li H, LeBlanc ML, Kenkre VP, Hong F, Blum KA, Dockter T, Martin P, Jung SH, Grant B, Rosenbaum C, Ujjani C, Barr PM, Unger JM, Cheson BD, Bartlett NL, Kahl B, Friedberg JW, Mandrekar SJ, Leonard JP. 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 Jan 10;41(2):336-342. doi: 10.1200/JCO.21.02301. Epub 2022 Jul 5. PMID: 35787017; PMCID: PMC9839232.
