Abstract
BackgroundTo assess the relationship between responses within 1 year and health-related quality of life (HRQoL) outcomes by exploring profiles of patients with CML-CP who were treated with front-line imatinib or nilotinib.MethodsA prospective, longitudinal, single-center study was conducted to assess the response to treatment with imatinib or nilotinib and the HRQoL profile of patients who were newly diagnosed with CML in chronic phase enrolled in the ENESTchina study.ResultsFifty-nine patients were randomized to receive imatinib (n = 31) or nilotinib (n = 28). With a median follow-up of 5 years, there was no difference in HRQoL profile observed between patients receiving imatinib and nilotinib. Achieving optimal response at 12 months was associated with better role limitations due to physical health problems (RP; P = 0.0019) and emotional problems (RE; P = 0.0110) and was the sole factor associated with significantly improving physical component summary over time (PCS; P = 0.0160). Achieving optimal response at 6 months had high probability of better physical functioning (PF; P = 0.0674), better social functioning (SF; P = 0.0571), and reduced role limitations due to emotional problems (RE; P = 0.0916). In addition, factors including age < 40 years, female gender, and higher level of education were also associated with better HRQoL subscale scores. However, optimal response at 3 months had no impact on HRQoL profile. The proportions of patients with failure-free survival and PFS at 5 years were significantly higher among patients who achieved optimal response at 3, 6, or 12 months than among those who did not achieve optimal response (warning or failure), and the OS rate at 5 years was significantly higher among those who achieved optimal response at 12 months. In a multivariate analysis, treatment received (nilotinib vs imatinib) was identified as an independent factor for the achievement of optimal response at both 6 months (OR, 3.9; 95% CI, 1.0–14.9) and 12 months (OR, 5.6; 95% CI, 1.7–17.9).ConclusionsAchieving optimal response at 12 months was not only associated with longer OS and reduced treatment failure rates and disease progression but also better HRQoL in newly diagnosed patients with CML-CP receiving front-line tyrosine kinase inhibitor treatment.Trial registrationChinese Clinical Trial Registry (http://www.chictr.org.cn): ChiCTR-OCH-11001699.
Highlights
To assess the relationship between responses within 1 year and health-related quality of life (HRQoL) outcomes by exploring profiles of patients with chronic myeloid leukemia (CML)-CP who were treated with front-line imatinib or nilotinib
Second-generation tyrosine kinase inhibitors (TKIs) such as nilotinib and dasatinib further contributed to the remarkable improvement in clinical efficacy in terms of major molecular response (MMR, BCR-ABLIS ≤ 0.1%) and molecular response 4.5 (MR4.5, BCR-ABLIS ≤ 0.0032%) rates than imatinib as observed in the ENESTnd [5], DASISION [6], and ENESTchina [7] trials, despite no difference in the survival benefit compared with imatinib
Decreased HRQoL may be associated with poor adherence to TKI therapy, which is a key factor contributing to treatment failure and unfavorable prognosis in patients with CML
Summary
To assess the relationship between responses within 1 year and health-related quality of life (HRQoL) outcomes by exploring profiles of patients with CML-CP who were treated with front-line imatinib or nilotinib. Improvement in survival associated with treatment, necessitates the need for better understanding on the health-related quality of life (HRQoL) profile in these patients and is recognized as an important component in the management of CML. Several studies have shown that imatinib significantly improves HRQoL in patients with CML-CP compared with hydroxyurea or interferon [9, 10]; younger aged patients and female patients had lower HRQoL scores than the general population. Decreased HRQoL may be associated with poor adherence to TKI therapy, which is a key factor contributing to treatment failure and unfavorable prognosis in patients with CML
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