Good QOL Maintained in TKI-Resistant CML With Long-Term Bosutinib Treatment

In patients with chronic myeloid leukemia (CML) treated with bosutinib who were resistant or intolerant to previous tyrosine kinase inhibitors (TKIs), health-related quality of life (HRQOL) was well maintained over the long term, according to a new study.

“Patients with chronic-phase CML require treatment for many years; therefore, an understanding of how therapy affects long-term HRQOL is of high importance,” wrote study authors led by Hagop M. Kantarjian, MD, of the University of Texas MD Anderson Cancer Center in Houston. Previous research has shown that tolerability can be an issue in TKI therapy for CML, and that it can affect both treatment adherence and thus efficacy, as well as HRQOL.

The new study assessed HRQOL in patients receiving bosutinib. Patients were divided into two groups: one group that was resistant or intolerant to one or two TKIs (CP2L; 284 patients), and another that was resistant or intolerant to two or more TKIs (CP3L; 119 patients). All patients had at least 264 weeks of follow-up, and were assessed using the EuroQol 5-Dimensions Questionnaire (EQ-5D) and the Functional Assessment of Cancer Therapy-Leukemia (FACT-Leu). The results of the analysis were published online ahead of print in Cancer.

At baseline, the mean EQ-5D score was 0.83 in the CP2L cohort and 0.80 in the CP3L cohort, and this remained “relatively stable” throughout 384 weeks of therapy. Improvements over the baseline score were seen in the CP2L cohort at weeks 36, 96, 192, and 360.

At the end of the study period, most patients in both cohorts reported “no problems” on the EQ-5D. For example, 77.3% of CP2L patients and 76.7% of CP3L patients reported no problems with mobility; 64.7% and 54.8%, respectively, reported no problems with anxiety or depression. “Some problems” were reported with pain/discomfort in 36.6% of CP2L patients and in 39.7% of CP3L patients, and with usual activities in 26.6% and 31.5%, respectively.

FACT-Leu scores were also generally stable over time, and FACT-Leu scores in a subset of patients with chronic diarrhea were similar to the larger groups. There were consistent improvements from baseline-with the exception of at treatment completion-in terms of emotional well-being, the FACT-Leu total score, and other scores in the CP2L cohort. There were no clear trends seen in the FACT-Leu changes over time in the CP3L group.

“This analysis showed that HRQOL is largely maintained over the long term in patients who received bosutinib for CP2L and CP3L CML, indicating that bosutinib is able to preserve HRQOL in patients who are treated after frontline therapy and in more heavily treated patients such as those in later lines of therapy,” the authors wrote. “These results place the favorable efficacy and distinct safety profile of bosutinib treatment into a context that considers patients’ capacity to manage their disease over the long term.”