HRQoL improvements reported for bosutinib therapy in accelerated, blast phase CML
medwireNews: Patients with advanced phase chronic myeloid leukaemia (CML) may reap health-related quality of life (HRQoL) benefits from second-line or later treatment with bosutinib, study findings suggest.
The 76 patients with accelerated phase (AP) CML and the 64 patients with blast phase (BP) CML enrolled into the open-label, phase I/II trial were resistant or intolerant to first-line tyrosine kinase inhibitor (TKI) therapy with imatinib and up to two other TKIs.
The patients all had “minimal” HRQoL deficits at baseline, the researchers say, although there was slightly poorer HRQoL in the BP CML patients.
Nevertheless, the AP CML patients experienced a significant improvement from baseline in the Functional Assessment of Cancer Therapy–Leukemia (FACT–Leu) total score by week 24, which continued at weeks 36 and 48.
Similarly, BP CML patients showed a significant improvement from baseline in their FACT–Leu total score from week 4 of treatment and this was maintained at weeks 8, 12, 24, 36, 48 and 96.
“The magnitude of improvements in FACT-Leu scores observed in the AP and BP CML cohorts in this analysis was considerably higher than that reported previously for imatinib-resistant or imatinib-intolerant CP CML patients, highlighting the substantial benefits of TKI therapy for HRQoL, as perceived by patients with advanced CML”, the researchers write.
BP CML patients also showed a significant gain in the 5-item EuroQol instrument for general health status from baseline to weeks 4, 8, 12 and 36, although scores were stable over the treatment period among the AP CML participants.
And visual analogue scale results for overall health status, where 0 is the worst imaginable health and 100 the best, showed a significant increase in average score at weeks 8, 36 and 48 for the AP CML patients compared with baseline and weeks 4, 8, 12, 24, 36 and 96 for those with BP CML.
Acknowledging the potential impact of TKI side effects on HRQoL, the researchers analysed FACT–Leu physical well-being results and found significant improvements over the study in both AP and BP groups but the changes were only clinically meaningful in the BP CML group.
“These results suggest that side effects did not substantially affect the HRQoL of patients with advanced CML; in fact physical well-being improved in BP CML patients receiving bosutinib”, they report in Current Medical Research and Opinion.
Nevertheless, Mark Shapiro (Pfizer Inc, Cambridge, Massachusetts, USA) and co-authors caution that “[t]he lack of a comparison group limits attribution of improvements in HRQoL specifically to bosutinib treatment.”
And noting that the lower HRQoL measure completion rates in the BP CML patients might have contributed to their better HRQoL outcomes compared with the AP CML participants, the team writes that the “generalizability of these results can only be extended to those who continue on therapy for the length of time in the comparison.”
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