scholarly journals HEALTH‐RELATED QUALITY OF LIFE AMONG PATIENTS WITH RELAPSED/REFRACTORY CLASSICAL HODGKIN LYMPHOMA (R/R CHL) IN A PHASE 3 STUDY OF PEMBROLIZUMAB VERSUS BRENTUXIMAB VEDOTIN

2021 ◽  
Vol 39 (S2) ◽  
Author(s):  
P. L. Zinzani ◽  
M. Raut ◽  
T. Saretsky ◽  
R. Ramchandren ◽  
A. Santoro ◽  
...  
Author(s):  
Pier Luigi Zinzani ◽  
Radhakrishnan Ramchandren ◽  
Armando Santoro ◽  
Ewa Paszkiewicz-Kozik ◽  
Robin Gasiorowski ◽  
...  

KEYNOTE-204 (NCT02684292) demonstrated progression-free survival (PFS) advantage for pembrolizumab over brentuximab vedotin (BV) in patients who had relapsed or refractory classical Hodgkin lymphoma (R/R cHL) following, or who were ineligible for, autologous stem cell transplantation (ASCT). Health-related quality of life (HRQoL), measured by patient-reported outcomes (PROs) from KEYNOTE-204, are reported from patients who received ≥1 dose of study treatment and completed ≥1 PRO assessment. QLQ-C30 and EuroQoL EQ-5D were administered at baseline, every 6 weeks until week 24, and every 12 weeks thereafter. Prespecified end points included least squares mean (LSM) changes from baseline to week 24 and time to deterioration (TTD; ≥10-point decline from baseline). Comparisons were evaluated using two-sided P values uncontrolled for multiplicity. High compliance at baseline (>90%) and through week 24 (>80%) was demonstrated across treatment groups (PRO analysis set: pembrolizumab, N=146; BV, N=150). QLQ-C30 Global Health Status (GHS)/quality of life (QoL) improved from baseline to week 24 on pembrolizumab and worsened on BV, demonstrating significant LSM differences at 24 weeks (GHS/QoL: 8.60 [95% CI, 3.89-13.31]; P = 0.0004) and each QLQ-C30 domain, except emotional and cognitive functioning. Compared with BV, pembrolizumab prolonged TTD for GHS/QoL (HR, 0.40 [95% CI, 0.22-0.74]; P = 0.003) and each QLQ-C30 domain except cognitive functioning. In conclusion, pembrolizumab demonstrated overall improvements in PROs of HRQoL measures over BV in the KEYNOTE-204 study. These data and previously reported efficacy results support pembrolizumab as the preferred treatment option for patients with R/R cHL who are ineligible for or experience relapse after ASCT.


2018 ◽  
Vol 13 (1) ◽  
pp. 139-140 ◽  
Author(s):  
Julian Panés ◽  
Séverine Vermeire ◽  
James O Lindsay ◽  
Bruce E Sands ◽  
Chinyu Su ◽  
...  

2020 ◽  
Vol 38 (25) ◽  
pp. 2839-2848 ◽  
Author(s):  
Stefanie Kreissl ◽  
Horst Müller ◽  
Helen Goergen ◽  
Julia Meissner ◽  
Max Topp ◽  
...  

PURPOSE Many important details of health-related quality of life (HRQoL) after diagnosis and treatment of Hodgkin lymphoma (HL) are still unknown because large longitudinal studies of HRQoL are rare. Therefore, we analyzed a systematically assessed, comprehensive range of HRQoL domains in patients with HL of all stages from diagnosis up to 5 years of survivorship. PATIENTS AND METHODS We included patients with HL age 18-60 years at diagnosis from the German Hodgkin Study Group trials HD13, HD14, and HD15. We analyzed HRQoL using all functional and symptom scales of the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 including deviations from reference values. We estimated the effect of different disease, patient, and treatment characteristics using multiple regression and repeated measures analysis and computed correlations of HRQoL scores. RESULTS We analyzed 4,215 patients with any HRQoL assessment within 5 years after treatment. Higher tumor burden at diagnosis was associated with impaired baseline scores in many HRQoL domains. During survivorship, cognitive, emotional, role, and social functioning and fatigue, dyspnea, sleep, and financial problems were severely and persistently affected. From year 2 on, mean deviations from reference values ranged between 12 and 29 points, with 10 points being a commonly used margin of clinical relevance. In all 3 trials, HRQoL domains 2 and 5 years after therapy were significantly influenced by baseline scores and age but not by randomized treatments. Fatigue was most closely correlated with other symptoms and scales. CONCLUSION Our results show a high and persistent amount of different HRQoL deficits in survivors of HL that are largely independent of the applied chemotherapies. Our analysis underscores the high, unmet medical need of these rather young survivors of HL regarding the psychosocial adverse effects of the cancer experience.


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