Page 67 - Haematologica August 2018

Long-term second-line bosutinib for CP CML
without on-treatment PD/death before year 5. Long-term outcomes are reported according to age in Online Supple- mentary Table S3.
Kaplan-Meier probability of OS at year 5 was 84% (IM- R, 81%; IM-I, 90%) versus 91% (IM-R, 88%; IM-I, 98%) at year 2; 40% of patients were censored prior to year 5, and
31% enrolled in the extension study for continued treat- ment or follow up for longer-term survival (Figure 3). A total of 45 (16%) deaths occurred on study, 24 through year 2, 5 after year 5, and 10 within 30 days of the last bosutinib dose. Patients aged under 65 years had a higher OS rate compared with those aged 65 years or over (85%
Figure 2. Predictors of response loss, disease progression, and death. Closed circles represent major cytogenetic response (MCyR) duration and open circles rep- resent complete cytogenetic response. Based on multivariate Cox regression models. Parameters failing to meet elimination criteria (0.20) not shown. Hazard ratios >1 indicate worse outcome. P-values were not adjusted for multiple comparisons; significant P-values are in bold. Definitions of covariates can be found in the Online Supplementary Methods. On-treatment characteristics are Cox time-dependent covariates. *Baseline factor for durable response model. BOS: bosutinib; IM: ima- tinib; LFT: liver function test; Ph+: Philadelphia chromosome positive; y: years; CI: confidence interval.
Figure 3. Kaplan-Meier estimated overall sur- vival. Open circles indi- cate censored observa- tions. Overall survival was calculated as the first date of study dosing until the date of death; patients without events were censored at the last contact. Per proto- col, patients were fol- lowed for overall survival for two years after treat- ment discontinuation. Analysis includes data from a long-term exten- sion study. IM-I: imatinib- intolerant; IM-R: ima- tinib-resistant; n: num- ber.
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