Bosutinib Safe, Effective in Second and Third Line Among Patients With CML
Researchers evaluated long-term HR-QoL data from patients with chronic phase CML who received bosutinib in the second or third and later TKI line.
Patients with chronic myeloid leukemia (CML) who receive bosutinib in the second or third line of therapy do not have a worse health-related quality of life (HR-QoL) after at least 264 treatment-weeks, according to a study published in Cancer.1
As tyrosine kinase inhibitor (TKI) treatment for CML is used long-term, HR-QoL is a serious issue for patients who develop adverse events (AEs). Low HR-QoL may lead to missed treatment doses, which are linked to inferior survival. Bosutinib is often used for patients resistant or intolerant to imatinib; the former is, however, linked to diarrhea, nausea, vomiting, and thrombocytopenia.
For this study, researchers provided long-term HR-QoL data from patients with chronic phase CML who received bosutinib in the second or third and later TKI line (CP2L and CP3L, respectively). Data were obtained from the Euro-QOL 5-Dimensions Questionnaire (EQ-5D) and the Functional Assessment of Cancer Therapy–Leukemia (FACTLeu).
Of 403 total included patients, 284 were in the CP2L cohort and 119 were in the CP3L cohort. The median age was 52.4 years; more than 99% of patients had an ECOG status of 0 or 1. All patients in CP2L and CP3L were intolerant or resistant to imatinib; 77.3% and 26.1% of patients in CP3L had also received dasatinib and nilotinib, respectively.
About a quarter of patients in each cohort discontinued bosutinib because of an AE. About two-thirds of all assessments were collected in both cohorts by treatment completion. Despite discontinuations, HR-QoL was maintained for most evaluated variables in both groups.
The most common noted AE was diarrhea; 101 patients in the CP2L group and 30 patients in the CP3L group had chronic diarrhea. By study close, patients in the CP2L group with chronic diarrhea at baseline had higher FACT-Leu scores than others.
The authors concluded that patients with “[chronic phase CML] and resistance or intolerance to prior therapy who remained in the study largely maintained [HR-QoL] for 264 weeks or more of treatment with bosutinib.”
- Kantarjian HM, Mamolo CM, Gambacorti-Passerini C, et al. Long-term patient-reported outcomes from an open-label safety and efficacy study of bosutinib in Philadelphia chromosome–positive chronic myeloid leukemia patients resistant or intolerant to prior therapy. Cancer. 2017 Oct 26. doi: 10.1002/cncr.31082 [Epub ahead of print]