Maziarz, Richard T., Waller, Edmund K. ORCID: 0000-0003-0816-6729, Jaeger, Ulrich, Fleury, Isabelle, McGuirk, Joseph, Holte, Harald ORCID: 0000-0001-9799-9428, Jaglowski, Samantha ORCID: 0000-0002-4335-2554, Schuster, Stephen J., Bishop, Michael R., Westin, Jason R., Mielke, Stephan ORCID: 0000-0002-8325-9215, Teshima, Takanori, Bachanova, Veronika, Foley, Stephen R., Borchmann, Peter, Salles, Gilles A., Zhang, Jie, Tiwari, Ranjan, Pacaud, Lida B., Ma, Qiufei and Tam, Constantine S. (2020). Patient-reported long-term quality of life after tisagenlecleucel in relapsed/refractory diffuse large B-cell lymphoma. Blood Adv., 4 (4). S. 629 - 638. WASHINGTON: AMER SOC HEMATOLOGY. ISSN 2473-9537

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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.

Item Type: Journal Article
Creators:
CreatorsEmailORCIDORCID Put Code
Maziarz, Richard T.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Waller, Edmund K.UNSPECIFIEDorcid.org/0000-0003-0816-6729UNSPECIFIED
Jaeger, UlrichUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Fleury, IsabelleUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
McGuirk, JosephUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Holte, HaraldUNSPECIFIEDorcid.org/0000-0001-9799-9428UNSPECIFIED
Jaglowski, SamanthaUNSPECIFIEDorcid.org/0000-0002-4335-2554UNSPECIFIED
Schuster, Stephen J.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Bishop, Michael R.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Westin, Jason R.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Mielke, StephanUNSPECIFIEDorcid.org/0000-0002-8325-9215UNSPECIFIED
Teshima, TakanoriUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Bachanova, VeronikaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Foley, Stephen R.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Borchmann, PeterUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Salles, Gilles A.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Zhang, JieUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Tiwari, RanjanUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Pacaud, Lida B.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Ma, QiufeiUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Tam, Constantine S.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
URN: urn:nbn:de:hbz:38-344049
DOI: 10.1182/bloodadvances.2019001026
Journal or Publication Title: Blood Adv.
Volume: 4
Number: 4
Page Range: S. 629 - 638
Date: 2020
Publisher: AMER SOC HEMATOLOGY
Place of Publication: WASHINGTON
ISSN: 2473-9537
Language: English
Faculty: Unspecified
Divisions: Unspecified
Subjects: no entry
Uncontrolled Keywords:
KeywordsLanguage
IBRITUMOMAB TIUXETAN RADIOIMMUNOTHERAPY; FACT-G SCALE; FUNCTIONAL ASSESSMENT; CANCER-THERAPY; HEALTH-STATUS; OUTCOMES; POPULATION; VALIDATION; SURVIVORS; VALIDITYMultiple languages
HematologyMultiple languages
URI: http://kups.ub.uni-koeln.de/id/eprint/34404

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