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Patients were randomized 1:1 to receive induction therapy with obinutuzumab- or rituximab-chemotherapy and maintenance in responders. Health-related quality of life was assessed using the Functional Assessment of Cancer Treatment-Lymphoma questionnaire, incorporating well-being and lymphoma-specific subscales. Assessments were performed at baseline, and during induction, maintenance, and follow-up (maximum 84\u00a0months). Clinically meaningful responses were defined by minimally important difference values. Of 1202 randomized patients (median follow-up 57.4\u00a0months), 557\/601 (92.7%; obinutuzumab-chemotherapy) and 548\/601 (91.2%; rituximab-chemotherapy) completed all Functional Assessment of Cancer Treatment-Lymphoma scales at baseline. Mean baseline health-related quality of life scores were similar between both arms, with all patients having some functional impairment and lymphoma symptoms. Over the course of treatment, mean health-related quality of life remained similar in both arms. Equal proportions of patients in both arms achieved minimally important difference by the Functional Assessment of Cancer Treatment-Lymphoma lymphoma-specific subscale and summary scales throughout induction, maintenance, and follow-up. On each summary scale, ~\u200950% of patients in each arm achieved minimally important difference by maintenance month 2. In GALLIUM, similar improvements in health-related quality of life were seen with obinutuzumab- and rituximab-chemotherapy, suggesting that both treatments reduced lymphoma-related symptoms, and treatment-related side effects did not abrogate these improvements in well-being. <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"uri\" xlink:href=\"http:\/\/clinicaltrials.gov\">ClinicalTrials.gov<\/jats:ext-link> identifier: NCT01332968.<\/jats:p>","DOI":"10.1007\/s00277-020-04021-6","type":"journal-article","created":{"date-parts":[[2020,4,20]],"date-time":"2020-04-20T15:04:29Z","timestamp":1587395069000},"page":"2837-2846","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":10,"title":["Health-related quality of life in the phase III GALLIUM study of obinutuzumab- or rituximab-based chemotherapy in patients with previously untreated advanced follicular lymphoma"],"prefix":"10.1007","volume":"99","author":[{"given":"Andrew","family":"Davies","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Peter","family":"Trask","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Judit","family":"Demeter","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Axel","family":"Florsch\u00fctz","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Mathias","family":"H\u00e4nel","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Tomohiro","family":"Kinoshita","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ruth","family":"Pettengell","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Hang","family":"Quach","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Stephen","family":"Robinson","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Shalal","family":"Sadullah","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Juan-Manuel","family":"Sancho","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Miklos","family":"Udvardy","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Mathias","family":"Witzens-Harig","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Andrea","family":"Knapp","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Wenxin","family":"Liu","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"297","published-online":{"date-parts":[[2020,4,20]]},"reference":[{"key":"4021_CR1","doi-asserted-by":"crossref","unstructured":"(1997) A clinical evaluation of the International Lymphoma Study Group classification of non-Hodgkin's lymphoma. 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Hoffmann-La Roche Ltd., Gilead\/Kite, Takeda, GSK, Karyopharm, Pfizer, Acerta Pharma), advisory board participation (Celgene, F. Hoffmann-La Roche Ltd., Gilead\/Kite,Takeda, Karyopharm, Acerta Pharma), honoraria (Celgene, F. Hoffmann-La Roche Ltd., Gilead\/Kite, Takeda, Janssen, Pfizer, Acerta Pharma), and travel to scientific conferences (Takeda). PT, employment (Genentech Inc). HQ, research funding (Celgene, Amgen) and advisory board participation (Celgene, Amgen, GSK, Karyopharm, Takeda). SR, advisory board participation, speaker fees, and honoraria (F. Hoffmann-La Roche Ltd., Takeda, Novartis, Gilead, Sandoz). TK, research funding (Chugai, Takeda, Solaisia, Ono, Gilead, MSD, Zenyaku) and personal fees (Chugai, Ono, Gilead, MSD, Zenyaku, Bristol, Kyowa Kirin, Eisai, Janssen). RP, personal fees (CTI Life Sciences Ltd., Roche, Servier, Takeda) and advisory board participation (CTI Life Sciences Ltd., G1 Therapeutics Inc., Immune Design, Pfizer, F. Hoffmann-La Roche Ltd., Servier, Takeda, TEVA). JMS, honoraria (F. Hoffmann-La Roche Ltd., Gilead, Janssen, Celgene, Novartis, Mundipharma, Kern-Pharma, Sanofi) and advisory board participation (F. Hoffmann-La Roche Ltd., Gilead, Janssen, Celgene, Celltrion, Sandoz, Bristol-Myers Sqibb). MH, honoraria (Novartis, Amgen, F. Hoffmann-La Roche Ltd) and advisory board participation (Celgene, Takeda). SS, advisory board participation (Takeda, NAPP Pharmaceuticals) and personal fees (Janssen, Novartis). AK and WL, employment (F. Hoffmann-La Roche Ltd). The remaining authors declare no conflicts of interest.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflict of interest"}},{"value":"GALLIUM was conducted in accordance with the Declaration of Helsinki and the International Council for Harmonisation guidelines for Good Clinical Practice. The protocol was approved by the ethics committees of participating centers and is registered at .","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethical approval"}},{"value":"Informed consent was obtained from all individual participants included in the study.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Informed consent"}}]}}