{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,13]],"date-time":"2026-10-13T13:09:14Z","timestamp":1791896954354,"version":"4.3.4"},"reference-count":29,"publisher":"American Society of Hematology","issue":"3","content-domain":{"domain":["ashpublications.org"],"crossmark-restriction":true},"short-container-title":[],"published-print":{"date-parts":[[2026,1,15]]},"abstract":"<jats:sec>\n                    <jats:title>Abstract<\/jats:title>\n                    <jats:p>Diffuse large B-cell lymphoma (DLBCL) poses a challenge in hematology given its varied symptoms, and the complex interplay between disease and treatment effects on health-related quality of life (HRQoL). The phase 3 POLARIX study demonstrated superior progression-free survival and a similar safety profile with polatuzumab vedotin plus rituximab, cyclophosphamide, doxorubicin, and prednisone (Pola-R-CHP) vs R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone) in patients with previously untreated DLBCL. Here, we evaluate HRQoL through patient-reported outcome (PRO) instruments to fully characterize the patient experience in the POLARIX study. Changes from baseline in HRQoL, lymphoma symptoms, and gastrointestinal (GI) symptoms were assessed, as well as incidence and severity of common symptoms by PROs vs clinician-reported adverse events (AEs). Baseline characteristics of PRO-evaluable patients (N = 874) were consistent. Comparison between PROs and clinician-reported AEs revealed a notable discordance; patients generally reported a higher incidence of symptoms than clinicians, emphasizing the need for patient-centric tools to accurately capture the patient experience. Both treatments exhibited rapid and sustained improvements in HRQoL and lymphoma symptoms, with the most substantial improvements seen in global health status\/QoL, lymphoma symptoms, fatigue, role, emotional, and social functioning. GI symptoms (diarrhea, constipation, nausea, and vomiting) were generally similar between treatment arms and returned to baseline levels after treatment completion. These HRQoL data underscore the complementarity of PROs, as an adjunct to clinician-reported AEs, in evaluating the efficacy and tolerability of new treatments, including Pola-R-CHP, which may represent a new benchmark for patient-reported HRQoL in previously untreated DLBCL. This trial was registered at www.clinicaltrials.gov as NCT03274492.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1182\/blood.2025028848","type":"journal-article","created":{"date-parts":[[2025,9,25]],"date-time":"2025-09-25T20:03:31Z","timestamp":1758830611000},"page":"254-265","update-policy":"https:\/\/doi.org\/10.1182\/blood.2019cm0000","source":"Crossref","is-referenced-by-count":5,"title":["PROs vs clinician-reported adverse events in a large clinical trial: findings from the phase 3 POLARIX study"],"prefix":"10.1182","volume":"147","author":[{"given":"Carrie","family":"Thompson","sequence":"first","affiliation":[{"name":"1Mayo Clinic College of Medicine, Rochester, MN"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6952-6073","authenticated-orcid":false,"given":"Marek","family":"Trn\u011bn\u00fd","sequence":"additional","affiliation":[{"name":"2First Faculty of Medicine, Charles University, General Hospital, Prague, Czech 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NY"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mark","family":"Hertzberg","sequence":"additional","affiliation":[{"name":"6Prince of Wales Hospital and University of New South Wales, Sydney, Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Huilai","family":"Zhang","sequence":"additional","affiliation":[{"name":"7Tianjin Medical University Cancer Hospital, Tianjin, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Catherine","family":"Thieblemont","sequence":"additional","affiliation":[{"name":"8Hemato-oncology Department, Saint-Louis Hospital, University of Paris Cit\u00e9, Assistance Publique\u2013H\u00f4pitaux de Paris, Paris, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4325-0929","authenticated-orcid":false,"given":"Bei","family":"Hu","sequence":"additional","affiliation":[{"name":"9Atrium Health Levine Cancer Institute, Wake Forest School of Medicine, Charlotte, NC"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gustavo","family":"Fonseca","sequence":"additional","affiliation":[{"name":"10Florida Cancer Specialists North\/Sarah Cannon Research Institute, St. Petersburg, FL"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Won Seog","family":"Kim","sequence":"additional","affiliation":[{"name":"11Sungkyunkwan University School of Medicine, Seoul, Republic of Korea"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Maurizio","family":"Martelli","sequence":"additional","affiliation":[{"name":"12Hematology Department of Translational and Precision Medicine, Sapienza University, Rome, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Amitkumar","family":"Mehta","sequence":"additional","affiliation":[{"name":"13Division of Hematology and Oncology, Department of Medicine, The University of Alabama at Birmingham, Birmingham, AL"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Avrita","family":"Singh","sequence":"additional","affiliation":[{"name":"14Genentech, Inc., South San Francisco, CA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mark","family":"Yan","sequence":"additional","affiliation":[{"name":"15Hoffmann-La Roche Ltd, Mississauga, ON, Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0002-7373-362X","authenticated-orcid":false,"given":"Jamie","family":"Hirata","sequence":"additional","affiliation":[{"name":"14Genentech, Inc., South San Francisco, CA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Matthew","family":"Sugidono","sequence":"additional","affiliation":[{"name":"14Genentech, Inc., South San Francisco, CA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Calvin","family":"Lee","sequence":"additional","affiliation":[{"name":"14Genentech, Inc., South San Francisco, CA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jeff P.","family":"Sharman","sequence":"additional","affiliation":[{"name":"16Willamette Valley Cancer Institute\/US Oncology, Eugene, OR"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5744-0670","authenticated-orcid":false,"given":"Neha","family":"Mehta-Shah","sequence":"additional","affiliation":[{"name":"17Division of Oncology, Washington University School of Medicine, St. Louis, MO"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9524-3990","authenticated-orcid":false,"given":"Christopher R.","family":"Flowers","sequence":"additional","affiliation":[{"name":"18MD Anderson Cancer Center, The University of Texas, Houston, TX"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Herv\u00e9","family":"Tilly","sequence":"additional","affiliation":[{"name":"19Centre Henri-Becquerel and University of Rouen, Rouen, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Neil","family":"Chua","sequence":"additional","affiliation":[{"name":"20Cross Cancer Institute, University of Alberta, Edmonton, AB, Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1156-8983","authenticated-orcid":false,"given":"Ren\u00e9-Olivier","family":"Casasnovas","sequence":"additional","affiliation":[{"name":"21Centre Hospitalier Universitaire Dijon Bourgogne, Dijon, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4073-3973","authenticated-orcid":false,"given":"Fiona","family":"Miall","sequence":"additional","affiliation":[{"name":"22Department of Hematology, University Hospitals of Leicester NHS Trust, Leicester, United Kingdom"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6145-4426","authenticated-orcid":false,"given":"Tae 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