TY - JOUR
T1 - 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
AU - Kantarjian, Hagop M.
AU - Mamolo, Carla M.
AU - Gambacorti-Passerini, Carlo
AU - Cortes, Jorge E.
AU - Brümmendorf, Tim H.
AU - Su, Yun
AU - Reisman, Arlene L.
AU - Shapiro, Mark
AU - Lipton, Jeff H.
N1 - Funding Information:
Hagop M. Kantarjian reports institutional research funding to MD Anderson from Amgen, Ariad, Astex, Bristol-Myers Squibb, Novartis, and Pfizer and consultant fees from AbbVie, Actinium, Ariad, ImmunoGen, Orsinex, and Pfizer. Carla M. Mamolo is a shareholder and employee of Pfizer. Jorge E. Cortes reports grants from Ariad, Bristol-Myers Squibb, Novartis, Pfizer, and Teva and personal fees for consulting from Ariad, Bristol-Myers Squibb, Novartis, and Pfizer. Tim H. Br?mmendorf reports grants and other (manuscript preparation) from Pfizer and Novartis during the conduct of the study and has a patent issued for his work on imatinib and hypusination inhibitors. Yun Su is a shareholder and employee of Pfizer. Arlene L. Reisman is a shareholder and employee of Pfizer. Mark Shapiro was a shareholder and employee of Pfizer at the time of the writing of the manuscript. Jeff H. Lipton reports other (manuscript writing) from Pfizer during the conduct of the study and research funding from Pfizer, Bristol-Myers Squibb, Ariad, and Novartis for work outside the submitted work. This study was sponsored by Pfizer Inc. Editorial support was provided by Lauren D'Angelo, PhD (Complete Healthcare Communications, LLC), and was funded by Pfizer.
Funding Information:
This study was sponsored by Pfizer Inc. Editorial support was provided by Lauren D’Angelo, PhD (Complete Healthcare Communications, LLC), and was funded by Pfizer.
Publisher Copyright:
© 2017 The Authors. Cancer published by Wiley Periodicals, Inc. on behalf of American Cancer Society.
PY - 2018/2/1
Y1 - 2018/2/1
N2 - BACKGROUND: Health-related quality of life (HRQOL) in patients with chronic-phase chronic myeloid leukemia (CML) is important because of the requirement for long-term treatment. This study assessed HRQOL in bosutinib-treated patients with Philadelphia chromosome–positive CML and resistance or intolerance to 1 (chronic-phase second-line [CP2L]) or more (chronic-phase third-line [CP3L]) tyrosine kinase inhibitors who had 264 weeks or more of follow-up (ClinicalTrials.gov identifier NCT00261846). METHODS: Patient-reported HRQOL was assessed with the EuroQol 5-Dimensions Questionnaire (EQ-5D) and the Functional Assessment of Cancer Therapy–Leukemia (FACT-Leu). RESULTS: In total, 284 and 119 patients composed the CP2L and CP3L cohorts, respectively. At treatment completion, more than 50% of the patients in the CP2L and CP3L cohorts completed the EQ-5D and FACT-Leu assessments. The EQ-5D and EQ-5D visual analog scale scores were stable in both cohorts throughout treatment. The mean FACT-Leu scores were generally stable over time but were lower in magnitude in the CP3L cohort versus the CP2L cohort. The FACT-Leu scale scores of a subset of patients with chronic diarrhea (CP2L, n = 101; CP3L, n = 30) were similar to the scores of the larger cohorts. Minimally important differences (MIDs) from baseline for the FACT-Leu scale scores were observed for the following: emotional well-being (EWB), Functional Assessment of Cancer Therapy–General (FACT-G) Total, FACT-Leu Total, and Functional Assessment of Cancer Therapy Trial Outcome Index (FACT-TOI) in the CP2L cohort and FACT-Leu Total in the CP3L cohort. Among patients with chronic diarrhea, MIDs were observed for EWB, FACT-G Total, FACT-Leu Total, and FACT-TOI in the CP2L cohort and for EWB, FACT-G Total, and FACT-Leu Total in the CP3L cohort. CONCLUSIONS: HRQOL was maintained with long-term bosutinib treatment for patients with CP2L and CP3L CML. Cancer 2018;124:587-95.
AB - BACKGROUND: Health-related quality of life (HRQOL) in patients with chronic-phase chronic myeloid leukemia (CML) is important because of the requirement for long-term treatment. This study assessed HRQOL in bosutinib-treated patients with Philadelphia chromosome–positive CML and resistance or intolerance to 1 (chronic-phase second-line [CP2L]) or more (chronic-phase third-line [CP3L]) tyrosine kinase inhibitors who had 264 weeks or more of follow-up (ClinicalTrials.gov identifier NCT00261846). METHODS: Patient-reported HRQOL was assessed with the EuroQol 5-Dimensions Questionnaire (EQ-5D) and the Functional Assessment of Cancer Therapy–Leukemia (FACT-Leu). RESULTS: In total, 284 and 119 patients composed the CP2L and CP3L cohorts, respectively. At treatment completion, more than 50% of the patients in the CP2L and CP3L cohorts completed the EQ-5D and FACT-Leu assessments. The EQ-5D and EQ-5D visual analog scale scores were stable in both cohorts throughout treatment. The mean FACT-Leu scores were generally stable over time but were lower in magnitude in the CP3L cohort versus the CP2L cohort. The FACT-Leu scale scores of a subset of patients with chronic diarrhea (CP2L, n = 101; CP3L, n = 30) were similar to the scores of the larger cohorts. Minimally important differences (MIDs) from baseline for the FACT-Leu scale scores were observed for the following: emotional well-being (EWB), Functional Assessment of Cancer Therapy–General (FACT-G) Total, FACT-Leu Total, and Functional Assessment of Cancer Therapy Trial Outcome Index (FACT-TOI) in the CP2L cohort and FACT-Leu Total in the CP3L cohort. Among patients with chronic diarrhea, MIDs were observed for EWB, FACT-G Total, FACT-Leu Total, and FACT-TOI in the CP2L cohort and for EWB, FACT-G Total, and FACT-Leu Total in the CP3L cohort. CONCLUSIONS: HRQOL was maintained with long-term bosutinib treatment for patients with CP2L and CP3L CML. Cancer 2018;124:587-95.
KW - bosutinib
KW - chronic myeloid leukemia
KW - patient-reported outcomes
KW - quality of life
KW - tyrosine kinase inhibitors
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U2 - 10.1002/cncr.31082
DO - 10.1002/cncr.31082
M3 - Article
C2 - 29072772
AN - SCOPUS:85032303529
SN - 0008-543X
VL - 124
SP - 587
EP - 595
JO - Cancer
JF - Cancer
IS - 3
ER -