Time to deterioration (TTD) in health-related quality of life (HRQoL) with carfilzomib plus dexamethasone (Kd56) versus bortezomib plus dexamethasone (Vd) in the ENDEAVOR trial. — Katja Weisel (2018) | RDL Network
Time to deterioration (TTD) in health-related quality of life (HRQoL) with carfilzomib plus dexamethasone (Kd56) versus bortezomib plus dexamethasone (Vd) in the ENDEAVOR trial.
e20011 Background: In ENDEAVOR, Kd56 demonstrated superiority over Vd with improvements of 9.3 and 7.6 months in progression-free and overall survival and higher global health status/quality of life scores. We compared differences in TTD between Kd56 and Vd across the The European Organization for Research and Treatment (EORTC) Quality of Life Questionnaire-Core 30-item module (QLQ-C30), the MM module (QLQ-MY20), and the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity subscales (FACT/GOG-Ntx). Methods: TTD events were recorded as a worsening of ≥10 points for each subscale from baseline. Patients were censored if they progressed or died prior to event, or the day after baseline if additional assessments were not made, or at last visit for patients without an event. TTD was compared using Cox proportional hazards models accounting for stratification factors. Results: In contrast to the Kd56 arm, the Vd group experienced a more rapid deterioration (median: 113 vs 85 days) in GHS/QoL (HR: 0.77; 95% CI 0.65 to 0.92). Compared to the Kd56 group, the Vd group also reported a more rapid deterioration in physical function (median: 169 vs 114 days; HR: 0.82; 95% CI 0.68 to 0.99), cognitive function (median: 142 vs 113 days; HR: 0.83; 95% CI: 0.69 to 1.00), nausea/vomiting (537 vs 251 days; HR: 0.78; 95% CI 0.62 to 0.98;), insomnia (111 vs 85 days; HR: 0.80; 95% CI: 0.67 to 0.95), appetite loss (337 vs 166 days; HR: 0.66; 95% CI: 0.54 to 0.81), constipation (NR vs 141 days; HR: 0.47; 95% CI: 0.038 to 0.59), diarrhea (309 vs 169 days; HR: 0.71; 95% CI: 0.58 to 0.88), and side effects (196 vs 113 days; HR: 0.65; 95% CI 0.54 to 0.78). TTD in neurotoxicity symptoms was also more rapid in the Vd group (FACT/GOG-Ntx: 11.1 vs 5.5 months; HR: 0.69; 95% CI 0.56 to 0.85). No TTD differences were observed for other subscales. Conclusions: Compared with Kd56, patients treated with Vd experienced a more rapid deterioration in GHS/QOL, physical and cognitive function, side-effects, and neurotoxicity symptoms. Kd56 offers superior outcomes that lead to improved and prolonged HRQoL compared with Vd in patients with ≥1 prior therapy. Clinical trial information: NCT01568866.
Heinz Ludwig, Philippe Moreau, Meletios A Dimopoulos, María‐Victoria Mateos, Martin Kaiser, Roman Hájek, Shibao Feng, Kim Cocks, Jaqueline Buchanan, Katja Weisel
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