title: Health-related quality of life and symptoms in patients with rituximab-refractory indolent non-Hodgkin lymphoma treated in the phase III GADOLIN study with obinutuzumab plus bendamustine versus bendamustine alone.
abstract: We present health-related quality of life (HRQoL) data from GADOLIN, comparing bendamustine (B) alone or combined with obinutuzumab (G-B) in rituximab-refractory indolent non-Hodgkin lymphoma patients. The Functional Assessment of Cancer Treatment-Lymphoma (FACT-Lym) questionnaire was administered on day 1 of cycles 1, 3, and 5 during treatment, at end of induction (EOI), bi-monthly for 2 years during maintenance/follow-up, and annually during extended follow-up until progression/death. Time to first ≥6-point worsening from baseline in the FACT-Lym trial outcome index (TOI) was estimated. Minimally important differences at individual subscale and total score level were used to define the proportion of patients reporting improvement on the FACT-Lym lymphoma-specific subscale (≥3 points), FACT-Lym TOI (≥6 points), and FACT-Lym total score (≥7 points). Overall, 396 patients were randomized. Analysis was conducted when 175 Independent Review Committee-assessed progression-free survival (PFS) events were observed. Questionnaire completion rates were generally balanced between arms at baseline, EOI, and final follow-up. Median time to ≥6-point worsening from baseline on the FACT-Lym TOI was 8.0 months in the G-B arm and 4.6 months in the B arm (HR 0.74; 95% CI 0.56-0.98). More G-B patients reported meaningful improvements on the FACT-Lym questionnaire subscales. Results were similar when follicular lymphoma patients were analyzed separately. The delayed time to worsening and greater proportion of patients reporting meaningful improvement in HRQoL in the G-B arm suggest that benefit in PFS is not at the expense of an increase in treatment-related toxicity that could lead to reduced HRQoL.
authors.affiliation: Lombardi Comprehensive Cancer Center, Georgetown University Hospital, 3800 Reservoir Road, NW, Washington, DC, 20007, USA. bdc4@georgetown.edu.
authors.forename: Bruce D
authors.initials: BD
authors.lastname: Cheson
authors.affiliation: Genentech, Inc., 1 DNA Way, South San Francisco, CA, 94080, USA.
authors.forename: Peter C
authors.initials: PC
authors.lastname: Trask
authors.affiliation: Barts Cancer Institute, Queen Mary University of London, Charterhouse Square, London, EC1M 6BQ, UK.
authors.forename: John G
authors.initials: JG
authors.lastname: Gribben
authors.affiliation: Roche Products Ltd, Hexagon Place, 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, UK.
authors.forename: Natalie
authors.initials: N
authors.lastname: Dimier
authors.affiliation: Karolinska University Hospital, SE-14186, Stockholm, Sweden.
authors.forename: Eva
authors.initials: E
authors.lastname: Kimby
authors.affiliation: Erasmus MC Cancer Institute, Wytemaweg 80, 3015 CN, Rotterdam, The Netherlands.
authors.forename: Pieternella J
authors.initials: PJ
authors.lastname: Lugtenburg
authors.affiliation: AP-HP Hôpital Saint-Louis, 1 Avenue Claude Vellefaux, 75010, Paris, France.
authors.forename: Catherine
authors.initials: C
authors.lastname: Thieblemont
authors.affiliation: F. Hoffmann-La Roche Ltd, Grenzacherstrasse 124, CH-4070, Basel, Switzerland.
authors.forename: Elisabeth
authors.initials: E
authors.lastname: Wassner-Fritsch
authors.affiliation: F. Hoffmann-La Roche Ltd, Grenzacherstrasse 124, CH-4070, Basel, Switzerland.
authors.forename: Aino
authors.initials: A
authors.lastname: Launonen
authors.affiliation: British Columbia Cancer Agency and the University of British Columbia, 675 West 10th Avenue, Vancouver, BC, V5Z 1L3, Canada.
authors.forename: Laurie H
authors.initials: LH
authors.lastname: Sehn
mesh_terms: D000368:Aged; D061067:Antibodies, Monoclonal, Humanized / Q000008:administration & dosage*; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage*; D000069461:Bendamustine Hydrochloride / Q000008:administration & dosage*; D005260:Female; D006801:Humans; D008228:Lymphoma, Non-Hodgkin / Q000175:diagnosis / Q000188:drug therapy* / Q000523:psychology; D008297:Male; D008875:Middle Aged; D011788:Quality of Life / Q000523:psychology; D000069283:Rituximab / Q000008:administration & dosage*; D016896:Treatment Outcome
chemical_list: D061067:Antibodies, Monoclonal, Humanized; D000069283:Rituximab; D000069461:Bendamustine Hydrochloride; C543332:obinutuzumab
keywords: FACT-Lym; Follicular lymphoma; GADOLIN; Non-Hodgkin lymphoma; Obinutuzumab; Quality of life