Universität zu Köln

Al-Sawaf, Othman ORCID: 0000-0001-9895-0570, Gentile, Brittany ORCID: 0000-0002-6302-5593, Devine, Jacob, Zhang, Can, Sail, Kavita, Tandon, Maneesh, Fink, Anna-Maria, Kutsch, Nadine, Wendtner, Clemens-Martin, Eichhorst, Barbara, Hallek, Michael and Fischer, Kirsten (2021). Health-related quality of life with fixed-duration venetoclax-obinutuzumab for previously untreated chronic lymphocytic leukemia: Results from the randomized, phase 3 CLL14 trial. Am. J. Hematol., 96 (9). S. 1112 - 1120. HOBOKEN: WILEY. ISSN 1096-8652

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Abstract

Chronic lymphocytic leukemia (CLL)-related symptoms impair the well-being of patients, making improvement of health-related quality of life (QoL) a goal of treatment. The CLL14 trial demonstrated higher efficacy of fixed-duration venetoclax-obinutuzumab (Ven-Obi) compared to chlorambucil-obinutuzumab (Clb-Obi) in patients with previously untreated CLL. To assess patients' QoL, the following patient-reported outcomes (PRO) measures were assessed: the M.D. Anderson Symptom Inventory (MDASI) core instrument and CLL module and the EORTC Quality of Life Questionnaire Core 30 (EORTC QLQ-C30). At treatment start, physical functioning (mean 75.9 [standard deviation (SD) +/- 20.1] in the Clb-Obi arm and 76.9 [+/- 19.4] in the Ven-Obi arm), role functioning (73.6 [+/- 27.86] and 72.6 [+/- 26.9]) and GHS/QoL (63.6 [+/- 21.0] and 60.3 [+/- 20.5]) were comparable between treatment arms per EORTC QLQ-C30 scale scores. Baseline levels of physical and role functioning were maintained throughout treatment and follow-up, with no relevant improvement or deterioration. On average, patients treated with Ven-Obi showed a meaningful improvement of GHS/QoL during treatment and follow-up by at least eight points at cycle three, whereas improvement was delayed until cycle eight with Clb-Obi. According to MDASI scores, CLL symptoms (1.5 [+/- 1.2] and 1.6 [+/- 1.3]), core cancer symptoms (1.5 [+/- 1.4] and 1.8 [+/- 1.7]) and symptom interference (2.1 [+/- 2.3] and 2.3 [+/- 2.3]) were generally low and comparable between treatment arms at baseline and were maintained throughout treatment and follow-up. This analysis demonstrates that the higher efficacy of Ven-Obi is not associated with QoL impairment and that Ven-Obi achieves early relief of CLL-related symptoms in elderly unfit patients.

Item Type:	Journal Article
Creators:	Creators Email ORCID ORCID Put Code Al-Sawaf, Othman UNSPECIFIED orcid.org/0000-0001-9895-0570 UNSPECIFIED Gentile, Brittany UNSPECIFIED orcid.org/0000-0002-6302-5593 UNSPECIFIED Devine, Jacob UNSPECIFIED UNSPECIFIED UNSPECIFIED Zhang, Can UNSPECIFIED UNSPECIFIED UNSPECIFIED Sail, Kavita UNSPECIFIED UNSPECIFIED UNSPECIFIED Tandon, Maneesh UNSPECIFIED UNSPECIFIED UNSPECIFIED Fink, Anna-Maria UNSPECIFIED UNSPECIFIED UNSPECIFIED Kutsch, Nadine UNSPECIFIED UNSPECIFIED UNSPECIFIED Wendtner, Clemens-Martin UNSPECIFIED UNSPECIFIED UNSPECIFIED Eichhorst, Barbara UNSPECIFIED UNSPECIFIED UNSPECIFIED Hallek, Michael UNSPECIFIED UNSPECIFIED UNSPECIFIED Fischer, Kirsten UNSPECIFIED UNSPECIFIED UNSPECIFIED
URN:	urn:nbn:de:hbz:38-590139
DOI:	10.1002/ajh.26260
Journal or Publication Title:	Am. J. Hematol.
Volume:	96
Number:	9
Page Range:	S. 1112 - 1120
Date:	2021
Publisher:	WILEY
Place of Publication:	HOBOKEN
ISSN:	1096-8652
Language:	English
Faculty:	Unspecified
Divisions:	Unspecified
Subjects:	no entry
Uncontrolled Keywords:	Keywords Language PATIENT-REPORTED OUTCOMES; OPEN-LABEL; CHLORAMBUCIL; IMPACT Multiple languages Hematology Multiple languages
URI:	http://kups.ub.uni-koeln.de/id/eprint/59013