Development and testing of a lymphoma clinical trial-specific frailty index: a secondary analysis of the NCIC-CTG LY.12 clinical trial

Abstract

The prevalence of frailty in clinical trials of lymphoma is unknown. We conducted a secondary analysis of the phase III LY.12 trial in which patients with relapsed aggressive non-Hodgkin lymphoma were randomized to different salvage regimens before autologous stem cell transplant. The primary objective was to construct a lymphoma clinical trials-specific frailty index (LyFI) using previously described methods. The secondary objective was to describe the association of frailty withover all and event-free survival (OS, EFS). The LyFI was constructed using 619 patients, and11% (N = 70) were classified as frail. Frailty was associated with EFS (HR 1.94, 95%CI 1.53–2.46) and OS (HR 2.01, 95%CI 1.57–2.58) in univariable analysis, but was only significant as a continuous (not binary) variable in multivariable analysis controlling for prognostic score, suggesting limitations of a FI in this trial population. Future work could validate the FI using clinical assessments and/or apply it to an older trial population.

Keywords:

• Lymphoma
• frailty
• transplant

Acknowledgements

The AUTHORS wish to thank all patients and family members who participated in the NCIC-CTG LY.12 trial.

Disclosure

No potential conflict of interest was reported by the author(s).

Additional information

Funding

AV, XL,MC, LS,BEC: None; This work was supported by AEH: Research funding from Roche, AbbVie, Janssen, Karyopharm, Merck, Seattle Genetics, Incyte; RM, MD: Research funding from Canadian Cancer Research Society, Eli Lilly; AP: Honoraria from Astra-Zeneca, Kite Gilead, Abbvie