PROs vs clinician-reported adverse events in a large clinical trial: findings from the phase 3 POLARIX study
Jazyk angličtina Země Spojené státy americké Médium print
Typ dokumentu časopisecké články, klinické zkoušky, fáze III, randomizované kontrolované studie, multicentrická studie, srovnávací studie
PubMed
40997297
PubMed Central
PMC12824648
DOI
10.1182/blood.2025028848
PII: 547473
Knihovny.cz E-zdroje
- MeSH
- cyklofosfamid škodlivé účinky aplikace a dávkování terapeutické užití MeSH
- difúzní velkobuněčný B-lymfom * farmakoterapie MeSH
- dospělí MeSH
- doxorubicin škodlivé účinky aplikace a dávkování terapeutické užití MeSH
- hodnocení výsledků péče pacientem * MeSH
- humanizované monoklonální protilátky škodlivé účinky aplikace a dávkování MeSH
- kvalita života MeSH
- lidé středního věku MeSH
- lidé MeSH
- prednison škodlivé účinky aplikace a dávkování terapeutické užití MeSH
- protokoly protinádorové kombinované chemoterapie * škodlivé účinky terapeutické užití aplikace a dávkování MeSH
- rituximab škodlivé účinky aplikace a dávkování MeSH
- senioři nad 80 let MeSH
- senioři MeSH
- vinkristin škodlivé účinky aplikace a dávkování terapeutické užití MeSH
- Check Tag
- dospělí MeSH
- lidé středního věku MeSH
- lidé MeSH
- mužské pohlaví MeSH
- senioři nad 80 let MeSH
- senioři MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- klinické zkoušky, fáze III MeSH
- multicentrická studie MeSH
- randomizované kontrolované studie MeSH
- srovnávací studie MeSH
- Názvy látek
- cyklofosfamid MeSH
- doxorubicin MeSH
- humanizované monoklonální protilátky MeSH
- prednison MeSH
- R-CHOP protocol MeSH Prohlížeč
- rituximab MeSH
- vinkristin MeSH
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.
1st Faculty of Medicine Charles University General Hospital Prague Czech Republic
Atrium Health Levine Cancer Institute Wake Forest School of Medicine Charlotte NC
Centre Henri Becquerel and University of Rouen Rouen France
Centre Hospitalier Universitaire Dijon Bourgogne Dijon France
Cross Cancer Institute University of Alberta Edmonton AB Canada
Department of Hematology University Hospitals of Leicester NHS Trust Leicester United Kingdom
Division of Hematology Oncology University of Maryland School of Medicine Baltimore MD
Division of Oncology Washington University School of Medicine St Louis MO
Florida Cancer Specialists North Sarah Cannon Research Institute St Petersburg FL
Genentech Inc South San Francisco CA
Hematology Department of Translational and Precision Medicine Sapienza University Rome Italy
Hoffmann La Roche Ltd Mississauga ON Canada
Mayo Clinic College of Medicine Rochester MN
MD Anderson Cancer Center The University of Texas Houston TX
Memorial Sloan Kettering Cancer Center New York City NY
National Taiwan University Hospital Taipei Taiwan
Prince of Wales Hospital and University of New South Wales Sydney Australia
Seoul National University Hospital Seoul Republic of Korea
Sungkyunkwan University School of Medicine Seoul Republic of Korea
Tianjin Medical University Cancer Hospital Tianjin China
University of Pennsylvania Hospital Philadelphia PA
Willamette Valley Cancer Institute US Oncology Eugene OR
Wilmot Cancer Institute University of Rochester Rochester NY
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ClinicalTrials.gov
NCT03274492
