TY - JOUR
T1 - Imatinib front-line therapy is safe and effective in patients with chronic myelogenous leukemia with pre-existing liver and/or renal dysfunction
AU - Tong, Wei Gang
AU - Kantarjian, Hagop
AU - O'Brien, Susan
AU - Faderl, Stefan
AU - Ravandi, Farhad
AU - Borthakur, Gautam
AU - Shan, Jianqin
AU - Pierce, Sherry
AU - Rios, Mary Beth
AU - Cortes, Jorge
PY - 2010/7/1
Y1 - 2010/7/1
N2 - BACKGROUND: Imatinib 400 mg daily is the standard treatment for patients with chronic myelogenous leukemia (CML). The safety and efficacy of imatinib in CML patients with pre-existing liver and/or renal dysfunction has not been analyzed. METHODS: The authors analyzed the outcome of 259 patients with early chronic phase CML treated with imatinib (starting dose 400 mg in 50, 800 mg in 209). Pre-existing liver and/or renal dysfunction was seen in 38 (15%) and 11 (4%) patients, respectively. RESULTS: Dose reductions were required in 91 (43%) of 210 patients with normal organ function, compared with 8 (73%) of 11 (P=.065) with renal dysfunction, and 19 (50%) of 38 (P=.271) with liver dysfunction. Grade 3-4 hematologic toxicities including anemia (29%, 10%, and 7% of patients with renal dysfunction, liver dysfunction, and normal organ function, respectively), neutropenia (57%, 30%, and 30%), and thrombocytopenia (43%, 30%, and 26%) were more frequent in patients with pre-existing renal dysfunction treated with high-dose imatinib. Grade 3-4 nonhematologic toxicities were observed at similar frequencies. Complete cytogenetic response rates, event-free survival, and overall survival were similar in all groups. CONCLUSIONS: Although patients with pre-existing liver and/or renal dysfunction might have a higher rate of hematologic toxicity and require more frequent dose reductions, most patients can be adequately managed, resulting in response rates and survival similar to those without pre-existing organ dysfunction.
AB - BACKGROUND: Imatinib 400 mg daily is the standard treatment for patients with chronic myelogenous leukemia (CML). The safety and efficacy of imatinib in CML patients with pre-existing liver and/or renal dysfunction has not been analyzed. METHODS: The authors analyzed the outcome of 259 patients with early chronic phase CML treated with imatinib (starting dose 400 mg in 50, 800 mg in 209). Pre-existing liver and/or renal dysfunction was seen in 38 (15%) and 11 (4%) patients, respectively. RESULTS: Dose reductions were required in 91 (43%) of 210 patients with normal organ function, compared with 8 (73%) of 11 (P=.065) with renal dysfunction, and 19 (50%) of 38 (P=.271) with liver dysfunction. Grade 3-4 hematologic toxicities including anemia (29%, 10%, and 7% of patients with renal dysfunction, liver dysfunction, and normal organ function, respectively), neutropenia (57%, 30%, and 30%), and thrombocytopenia (43%, 30%, and 26%) were more frequent in patients with pre-existing renal dysfunction treated with high-dose imatinib. Grade 3-4 nonhematologic toxicities were observed at similar frequencies. Complete cytogenetic response rates, event-free survival, and overall survival were similar in all groups. CONCLUSIONS: Although patients with pre-existing liver and/or renal dysfunction might have a higher rate of hematologic toxicity and require more frequent dose reductions, most patients can be adequately managed, resulting in response rates and survival similar to those without pre-existing organ dysfunction.
KW - Chronic myelogenous leukemia
KW - Dose reduction
KW - Imatinib
KW - Liver and/or renal dysfunction
KW - Survival
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U2 - 10.1002/cncr.25071
DO - 10.1002/cncr.25071
M3 - Article
C2 - 20564631
AN - SCOPUS:77954261761
SN - 0008-543X
VL - 116
SP - 3152
EP - 3159
JO - Cancer
JF - Cancer
IS - 13
ER -