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Key Prognostic Factors in Patients with Relapsed/Refractory Follicular Lymphoma: An Evidence Based Systematic Literature and Medical Review
Introduction: A multi-center multi-country retrospective cohort study (FLORA [NCT05338879]), using real-world data (RWD) from electronic medical records (EMRs) and research databases, for patients with relapsed/refractory follicular lymphoma grade 1-3a (r/r FL) treated with standard of care is being...
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| Published in: | Blood 2023-11, Vol.142 (Supplement 1), p.7261-7261 |
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| Main Authors: | , , , , , , , , |
| Format: | Article |
| Language: | English |
| Online Access: | Get full text |
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| Summary: | Introduction: A multi-center multi-country retrospective cohort study (FLORA [NCT05338879]), using real-world data (RWD) from electronic medical records (EMRs) and research databases, for patients with relapsed/refractory follicular lymphoma grade 1-3a (r/r FL) treated with standard of care is being conducted to contextualize treatment outcomes in a single-arm trial. A systematic literature review (SLR) was carried out to identify baseline prognostic factors that will be evaluated for imbalances between cohorts in the single-arm trial and RWD study. This SLR was followed by an evidence-based clinical expert review and ranking of prognostic variables in order of importance for the FLORA study as described herein.
Methods: The approach and methods of the SLR (International Prospective Register of Systematic Reviews [PROSPERO] CRD42022307561) were informed by guidelines set forth by the Cochrane Handbook for Systematic Reviews of Interventions (Higgins et. al. 2021) and PRISMA (Page et. al. BMJ 2021) and described previously (Hampp et. al. ISPOR 2023). Following the conduct of the SLR, the identified potential prognostic variables were evaluated by the FLORA study team to remove treatment-specific and outcome variables, determine their availability in the single-arm trial and FLORA RWD study, and develop a questionnaire. In the questionnaire, prognostic variables were grouped by type of variable - clinical, laboratory data, or treatment characteristic. Each prognostic variable was reviewed by an international panel consisting of 3 clinical experts in the field of lymphoma who categorized the prognostic impact on treatment response and survival on a 5-point scale ranging from “Very high importance” to “Not important”. The clinicians were asked to consider possible correlation among the variables, possible effect modifiers, specific variable definitions (e.g., chemoresistant), and whether there were any other prognostically important variables not captured in the questionnaire. For each variable the clinical experts categorized the availability within routine care on a 3-point scale ranging from “Readily available” to “Limited availability”. The results of the 3 expert completed questionnaires were reviewed and the top 10 highest ranking variables were determined by summing the clinicians' categorization of prognostic impact and considering variable availability in the event of a tie. Individual interviews with each clinical expert were held to clarify variable |
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| ISSN: | 0006-4971 1528-0020 |
| DOI: | 10.1182/blood-2023-186303 |