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haematologica | 2018; 103(5)
Ibrutinib: treatment toxicities and outcomes
stratified by whether the drug was being used in the front-line versus relapsed/refractory setting, is shown in Online Supplementary Figure S2A,B. Notably, there was no significant difference in progression-free survival by front-line versus relapsed/refractory use (P=0.27, log-rank test) (Figure 2A) or at first, second or third relapse (P=0.45) (Online Supplementary Figure S3). Progression-free survival was similar when stratified by ibrutinib use in the clinical practice setting as compared to the clinical trial setting (P=0.14, log-rank test) (Figure 2B). Patients who discontinued due to toxicity had significantly longer progression-free survival and overall survival than those who discontinued due to disease progression (P=0.01 and P=0.02, respectively, log-rank test) (Figure 2C,D).
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Investigator-assessed depth of response (complete response versus partial response versus partial response with lymphocytosis versus stable disease versus progres- sive disease) appeared to correlate with a longer progres- sion-free survival (Figure 2E). We also stratified progres- sion-free survival by deletion 17p status and complex karyotype status (≥3 abnormalities) in CLL patients treat- ed in the relapsed/refractory setting. Progression-free sur- vival was not significantly different in patients with dele- tion 17p (P=0.70), but was significantly shorter in patients with a complex karyotype (hazard ratio=1.8, 95% confi- dence interval: 1.1-3.0, P=0.01). The Kaplan Meier curves for these analyses are shown in Online Supplementary FigureS4A-C.
Figure 2. Outcomes stratified by line of therapy, clinical trial participation, reason for discontinuation and depth of response. Kaplan Meier curves showing outcomes stratified by (A) line of therapy (progression-free survival), (B) clinical trial participation (progression-free survival), (C) reason for dis- continuation (progression-free survival), (D) reason for discontinuation (over- all survival), and (E) depth of response. CR: complete response; PR: partial response; PR-L: partial response with lymphocytosis; SD: stable disease; PD: progressive disease.
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