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SUMMARY
This analysis from the phase 3 ALPINE trial evaluated longitudinal health–related quality of life (HRQoL) in patients with relapsed/refractory chronic lymphocytic leukemia or small lymphocytic lymphoma treated with zanubrutinib versus ibrutinib, with prespecified stratification by baseline HRQoL impairment. Baseline impairment was defined using clinician–informed thresholds for the EuroQol 5–dimension visual analog scale (EQ VAS) and the EORTC QLQ–C30 fatigue scale. Longitudinal patient–reported outcomes were analyzed using mixed models for repeated measures across all post–baseline assessments. A total of 573 patients were included in the EQ VAS analysis and 575 in the QLQ–C30 fatigue analysis. Zanubrutinib was associated with significantly better overall EQ VAS scores compared with ibrutinib (−3.52; 95% CI, −5.58 to −1.46; P=0.0008), regardless of baseline impairment status. Among patients with baseline EQ VAS impairment, between–group differences favored zanubrutinib (−6.08; 95% CI, −10.40 to −1.76; P=0.0018), with a significant difference observed at month 6. No overall or month–specific between–arm differences were observed for QLQ–C30 fatigue.
ClinicalTrials.gov ID: NCT03734016
| Population | Intervention | Comparator | Outcome Measures |
|---|---|---|---|
| Patients with relapsed/refractory chronic lymphocytic leukemia or small lymphocytic lymphoma enrolled in the phase 3 ALPINE trial | Zanubrutinib | Ibrutinib | Longitudinal HRQoL assessed by EQ VAS and EORTC QLQ–C30 fatigue scale |
The objective of this analysis was to evaluate longitudinal patient–reported health–related quality of life (HRQoL) with zanubrutinib versus ibrutinib in patients with relapsed/refractory chronic lymphocytic leukemia or small lymphocytic lymphoma enrolled in the phase 3 ALPINE trial, and to assess whether treatment effects differed by baseline HRQoL impairment.
Patients completed 2 validated patient–reported outcome instruments, the EQ VAS and the EORTC QLQ–C30 fatigue scale. Baseline HRQoL impairment was defined as EQ VAS <70 or QLQ–C30 fatigue >39. Lower EQ VAS scores and higher QLQ–C30 fatigue scores indicated greater impairment. Longitudinal PRO data were analyzed using a mixed model for repeated measures with visit treated nominally, incorporating all available post–baseline PRO assessments. Prespecified contrasts evaluated overall treatment effects, treatment–by–baseline–impairment differences, and month–specific treatment effects by impairment status at months 6 and 12. P–values for prespecified contracts were adjusted using the Tukey–Kramer method.
A total of 573 patients were included in the EQ VAS analysis and 575 in the QLQ–C30 fatigue analysis. Zanubrutinib was associated with significantly better EQ VAS scores versus ibrutinib overall (−3.52; 95% CI, −5.58 to −1.46; P=0.0008), regardless of baseline impairment status. Among patients with baseline EQ VAS impairment, the between–group difference favored zanubrutinib (−6.08; 95% CI, −10.40 to −1.76; P=0.0018). Month–specific analyses in the impaired subgroup showed a significant difference at month 6 (−6.73; 95% CI, −12.49 to −0.96; P=0.0098), with a directionally consistent clinically relevant between-arm difference observed at month 12 (−5.43; 95% CI, −11.21 to 0.35; P=0.0833). For QLQ–C30 fatigue, no overall or month–specific between–arm differences were observed.
