The objective of this post–hoc analysis from the ALPINE trial was to assess the relationships between baseline Eastern Cooperative Oncology Group performance status (ECOG PS) categories and multidomain patient–reported outcome (PRO) profiles in patients with relapsed/refractory chronic lymphocytic leukemia or small lymphocytic lymphoma.
Baseline (pre–treatment) PRO data were pooled across treatment arms (zanubrutinib vs ibrutinib) from 627 patients enrolled in the ALPINE trial. Seven domains from the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (Global Health Status, physical functioning, role functioning, fatigue, pain, insomnia, and nausea/vomiting) and visual analog scale scores from the EQ–5D–5L were analyzed, with higher scores indicating greater impairment. Profile analysis using one–way multivariate analysis of variance compared PRO profiles across ECOG PS categories (0, 1, and 2), including three hierarchical hypothesis tests: (1) parallelism (profile shape across domains); (2) levels (mean differences between groups); (3) flatness (similarity of domain means overall [no difference vs. domain differentiated]). Domain–level contrasts were assessed using t–tests. Bivariate logistic regression analyses evaluated associations between baseline PRO impairment scores and ECOG PS classification as a sensitivity analysis.
PRO profiles differed significantly across ECOG PS categories, with rejection of parallelism, equal overall levels, and flatness (all P<0.001). Physical functioning, role functioning, and fatigue showed the most consistent separation, with significant differences across all ECOG PS contrasts (0 vs 1, 0 vs 2, and 1 vs 2; all P<0.001). Additional significant differences were observed for Global Health Status (0 vs 1 and 0 vs 2; P=0.001), pain (0 vs 1, P=0.008; 0 vs 2, P=0.019), and insomnia (0 vs 1, P=0.004). VAS scores also differed significantly by ECOG PS (0 vs 1, P=0.001; 0 vs 2, P=0.001; 1 vs 2, P=0.040). No associations were observed for nausea/vomiting. In logistic regression analyses, higher baseline impairment in physical functioning (OR 1.48; 95% CI, 1.34–1.79), role functioning (OR 1.22; 95% CI, 1.22–1.34), and fatigue (OR 1.22; 95% CI, 1.10–1.34) was associated with higher odds of worse ECOG PS (all P<0.001), with additional significant associations for Global Health Status (OR 1.34; 95% CI, 1.22–1.48; P<0.001), pain (OR 1.10; 95% CI, 1.10–1.22; P=0.001), insomnia (OR 1.10; 95% CI, 1.00–1.22; P<0.001), and VAS (OR 1.02; 95% CI, 1.01–1.03; P<0.001).
