Health-related quality of life outcomes associated with zanubrutinib versus ibrutinib monotherapy in patients with relapsed/refractory chronic lymphocytic leukemia and small lymphocytic lymphoma: results from the ALPINE Trial

Figures & data

Table 1. Patient demographics and disease characteristics.

	Zanubrutinib (n = 327)	Ibrutinib (n = 325)
Age, median (range)	67 (35–90)	68 (35–89)
≥65 years, n (%)	201 (61.5)	200 (61.5)
Male, n (%)	213 (65.1)	232 (71.4)
ECOG PS ≥1, n (%)	198 (60.6)	203 (62.5)
Prior lines of systemic therapy, median (range)	1 (1–6)	1 (1–12)
>3 prior lines, n (%)	24 (7.3)	30 (9.2)
del(17p) and/or TP53mut, n (%)	75 (22.9)	75 (23.1)
del(17p)	45 (13.8)	50 (15.4)
TP53mut without del(17p)	30 (9.2)	25 (7.7)
del(11q), n (%)	91 (27.8)	88 (27.1)
IGHV mutational status, n (%)
Mutated	79 (24.2)	70 (21.5)
Unmutated	239 (73.1)	239 (73.5)
Complex karyotype^a	56 (17.1)	70 (21.5)
Bulky disease (≥5 cm), n (%)	145 (44.3)	149 (45.8)

Abbreviation. ECOG PS, Eastern Cooperative Oncology Group performance status.

^aComplex karyotype is defined as having ≥3 abnormalities.

Table 2. Adjusted completion rates for HRQoL assessments.

	Zanubrutinib (n = 327)	Ibrutinib (n = 325)
Baseline
# of patients	327	325
# of completed questionnaire	315	312
Completion rate (%)^a	96.3	96.0
Adjusted completion rate (%)^b	96.3	96.0
Cycle 7
# of patients	307	292
# of completed questionnaire	275	256
Completion rate (%)^a	84.1	78.8
Adjusted completion rate (%)^b	89.6	87.7
Cycle 13
# of patients	296	271
# of completed questionnaire	279	250
Completion rate (%)^a	85.3	76.9
Adjusted completion rate (%)^b	94.3	92.3

Abbreviation. HRQoL, health-related quality of life.

^aCompletion rate = number of patients completed questionnaire/total number of patients in relevant treatment arm.

^bAdjusted completion rate = number of patients completed questionnaire/total number of patients in study at relevant visits in relevant treatment arm.

Figure 1. EORTC QLQ-C30 Mean change from baseline in GHS and functioning scales at cycle 7 (6 months) by treatment. Abbreviations. CI, confidence interval; EMTD, estimated mean treatment difference; EORTC QLQ-C30, European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire – Core 30; GHS, global health status.

Figure 2. EORTC QLQ-C30 Mean change from baseline in GHS and functioning scales at cycle 13 (12 months) by treatment. Abbreviations. CI, confidence interval; EMTD, estimated mean treatment difference; EORTC QLQ-C30, European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire – Core 30; GHS, global health status.

Figure 3. EORTC QLQ-C30 Mean change from baseline in symptom scales at cycle 7 (6 months) by treatment. Abbreviations. CI, confidence interval; EMTD, estimated mean treatment difference; EORTC QLQ-C30, European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire – Core 30.

Figure 4. EORTC QLQ-C30 Mean change from baseline in symptom scales at cycle 13 (12 months) by treatment. Abbreviations. CI, confidence interval; EMTD, estimated mean treatment difference; EORTC QLQ-C30, European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire – Core 30.

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