Cortes, Jorge E; Gambacorti-Passerini, Carlo; Kim, Dong-Wook; Kantarjian, Hagop M; Lipton, Jeff H; Lahoti, Amit; Talpaz, Moshe; Matczak, Ewa; Barry, Elly; Leip, Eric; Brummendorf, Tim H; Khoury, H Jean
Clinical lymphoma, myeloma & leukemia
2017Oct ; 17 ( 10 ) :684-695.e6.
PMID : 28807791
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Cortes, Jorge E -
Gambacorti-Passerini, Carlo -
Kim, Dong-Wook -
Kantarjian, Hagop M -
Lipton, Jeff H -
Lahoti, Amit -
Talpaz, Moshe -
Matczak, Ewa -
Barry, Elly -
Leip, Eric -
Brummendorf, Tim H -
Khoury, H Jean -
ABSTRACT
BACKGROUND: The purpose of the study was to assess renal function in patients with Philadelphia chromosome-positive leukemias receiving bosutinib or imatinib. PATIENTS AND
METHODS: Patients received first-line bosutinib (n?= 248) or imatinib (n?= 251; phase III trial), or second-line or later bosutinib (phase I/II trial; n?= 570). Adverse events (AEs) and changes from baseline in estimated glomerular filtration rate (eGFR) and serum creatinine were assessed.
RESULTS: Time from the last patient's first dose to data cutoff was???48 months. Renal AEs were reported in 73/570 patients (13%) receiving second-line or later bosutinib, and in 22/248 (9%) and 16/251 (6%) receiving first-line bosutinib and imatinib, respectively. eGFR in patients receiving bosutinib declined over time with more patients developing Grade???3b eGFR (< 45 mL/min/1.73 m(2) according to the Modification of Diet in Renal Disease method) with second-line or later bosutinib (139/570, 24%) compared with first-line bosutinib (26/248, 10%) and imatinib (25/251, 10%); time to Grade???3b eGFR was shortest with second-line or later bosutinib. Similar proportions of patients receiving second-line or later bosutinib (74/139, 53%), first-line bosutinib (15/26, 58%), and first-line imatinib (15/25,?60%) improved to???45 mL/min/1.73 m(2) eGFR as of the last follow-up. In a regression analysis, first-line treatment with bosutinib versus imatinib was not a significant predictor of Grade???3b eGFR. CONCLUSION: Long-term bosutinib treatment is associated with an apparently reversible decline in renal function with frequency and characteristics similar to renal decline observed with long-term imatinib treatment. Patients with risk factors for Grade???3b eGFR should be monitored closely. CI - Copyright ??2017 Elsevier Inc. All rights reserved.
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