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    Patient-reported long-term quality of life after tisagenlecleucel in relapsed/refractory diffuse large B-cell lymphoma

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    Author
    Maziarz, RT; Waller, EK; Jaeger, U; Fleury, I; McGuirk, J; Holte, H; Jaglowski, S; Schuster, SJ; Bishop, MR; Westin, JR; ...
    Date
    2020-02-25
    Source Title
    Blood Advances
    Publisher
    AMER SOC HEMATOLOGY
    University of Melbourne Author/s
    Tam, Constantine
    Affiliation
    Medicine and Radiology
    Metadata
    Show full item record
    Document Type
    Journal Article
    Citations
    Maziarz, R. T., Waller, E. K., Jaeger, U., Fleury, I., McGuirk, J., Holte, H., Jaglowski, S., Schuster, S. J., Bishop, M. R., Westin, J. R., Mielke, S., Teshima, T., Bachanova, V., Foley, S. R., Borchmann, P., Salles, G. A., Zhang, J., Tiwari, R., Pacaud, L. B. ,... Tam, C. S. (2020). Patient-reported long-term quality of life after tisagenlecleucel in relapsed/refractory diffuse large B-cell lymphoma. BLOOD ADVANCES, 4 (4), pp.629-637. https://doi.org/10.1182/bloodadvances.2019001026.
    Access Status
    Access this item via the Open Access location
    URI
    http://hdl.handle.net/11343/254173
    DOI
    10.1182/bloodadvances.2019001026
    Open Access URL
    http://doi.org/10.1182/bloodadvances.2019001026
    Abstract
    The JULIET phase 2 trial evaluated a single infusion of tisagenlecleucel in adult patients with relapsed/refractory (r/r) diffuse large B-cell lymphoma (DLBCL). The objective of the current analysis was to evaluate patient-reported health-related quality of life (HRQoL) with a median follow-up of 19.3 months among patients infused with a single dose of tisagenlecleucel. Patients enrolled were ≥18 years of age with r/r DLBCL after ≥2 lines of therapy and had either undergone a failed autologous stem cell transplant or were ineligible for the procedure. Two validated HRQoL instruments, Functional Assessment of Cancer Therapy-Lymphoma (FACT-Lym) and Short Form-36 (SF-36) Health Survey, were used to measure HRQoL at baseline and months 3, 6, 12, and 18. At data cutoff (21 May 2018), 115 patients had received tisagenlecleucel infusion. Among the 99 patients evaluated, overall response rate was 54%, and 40% of patients achieved complete response (CR). Initially, 108 patients completed the HRQoL assessments at baseline, including 57 patients who eventually achieved CR or partial response (PR). Further, 30 and 21 patients in clinical response who completed assessments at baseline also completed assessments at months 12 and 18, respectively. Patients who achieved CR or PR sustained HRQoL improvement in all FACT scores at all time points. SF-36 instruments showed improvement above the minimal clinically important differences on 5 of 8 subscales. Long-term follow-up in the phase 2 JULIET study demonstrated that patients with r/r DLBCL who respond to tisagenlecleucel therapy had sustained, clinically meaningful improvements in HRQoL. This trial was registered at www.clinicaltrials.gov as #NCT02445248.

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