Table 1 Patient characteristics and PK... | American Society of Hematology

Table 1

Patient characteristics and PK data

Patient no.	Sex	Age at diagnosis, y	Height, cm	Weight, kg	Body mass index	Phase at starting imatinib	Concomitant medications*	Side effects	Indication for PK	Imatinib dose, mg	Observed trough concentration(s)	Trough concentration, ng/mL, observed in the phase 1 study	Clinical consequences	Best response	Last follow-up
1	F	12	161	50	19.2	CP1, newly diagnosed	Odansetron, esomeprazole, ziprasidone	Nausea, fatigue, arthralgia, myalgia	Unusually severe side effects	300 BID 200 BID	1937 1315	972 ± 317 NA	Dose reduction	2.2-log reduction in BCR-ABL transcripts	Switched to dasatinib
2	F	50	158	63	25.2	CP1, newly diagnosed	Levetiracetam, desferroxamine, desloratidine fluticasone	Myalgia, transfusion dependent anemia irresponsive to erythropoietin	Unusually severe side effects	300 BID 200 BID 300/200 QD alternating	3048 1997, 1990, 1890, 2250	972 ± 317 NA NA	Dose reduction	CMR	CMR; continues on alternating 300/200 mg QD
3	F	49	163	74	27.8	CP1, IFN failure	Prednisone, pantoprazole, diltiazem, L-thyroxine, azathioprine, zolpidem	Pulmonary infiltrates when increased to 400 BID	Unusually severe side effects	400 QD	2344	1216 ± 750*	Discontinuation	CMR	Off therapy
4	F	9	133	30	16.9	CP1, newly diagnosed	Lansoprazole	Dyspepsia	qPCR plateau	400 QD	2341	1216 ± 750*	Reassurance and continuation of current dose	2.2-log reduction in BCR-ABL transcripts	CCyR; continues on 400 mg QD
5	F	47	173	132	44.1	CP1, IFN failure	Quinapril, valproic acid, gabapentin, metformin, glipizide, hydrocodone, spirin, fentanyl, furosemide, allopurinol	Myalgia	Cytogenetic refractoriness	600 QD	1342	1214 ± 817	Switch to dasatinib considered	CHR	CHR, switch to dasatinib planned

Patient no.	Sex	Age at diagnosis, y	Height, cm	Weight, kg	Body mass index	Phase at starting imatinib	Concomitant medications*	Side effects	Indication for PK	Imatinib dose, mg	Observed trough concentration(s)	Trough concentration, ng/mL, observed in the phase 1 study	Clinical consequences	Best response	Last follow-up
1	F	12	161	50	19.2	CP1, newly diagnosed	Odansetron, esomeprazole, ziprasidone	Nausea, fatigue, arthralgia, myalgia	Unusually severe side effects	300 BID 200 BID	1937 1315	972 ± 317 NA	Dose reduction	2.2-log reduction in BCR-ABL transcripts	Switched to dasatinib
2	F	50	158	63	25.2	CP1, newly diagnosed	Levetiracetam, desferroxamine, desloratidine fluticasone	Myalgia, transfusion dependent anemia irresponsive to erythropoietin	Unusually severe side effects	300 BID 200 BID 300/200 QD alternating	3048 1997, 1990, 1890, 2250	972 ± 317 NA NA	Dose reduction	CMR	CMR; continues on alternating 300/200 mg QD
3	F	49	163	74	27.8	CP1, IFN failure	Prednisone, pantoprazole, diltiazem, L-thyroxine, azathioprine, zolpidem	Pulmonary infiltrates when increased to 400 BID	Unusually severe side effects	400 QD	2344	1216 ± 750*	Discontinuation	CMR	Off therapy
4	F	9	133	30	16.9	CP1, newly diagnosed	Lansoprazole	Dyspepsia	qPCR plateau	400 QD	2341	1216 ± 750*	Reassurance and continuation of current dose	2.2-log reduction in BCR-ABL transcripts	CCyR; continues on 400 mg QD
5	F	47	173	132	44.1	CP1, IFN failure	Quinapril, valproic acid, gabapentin, metformin, glipizide, hydrocodone, spirin, fentanyl, furosemide, allopurinol	Myalgia	Cytogenetic refractoriness	600 QD	1342	1214 ± 817	Switch to dasatinib considered	CHR	CHR, switch to dasatinib planned

BID indicates twice daily; CcyR, complete cytogenetic response; CHR, complete hematologic response; CMR, complete molecular respone; CP1, first chronic phase; IFN, interferon-alpha; NA, not applicable; PK, pharmacokinetic; QD, daily;

979 plus or minus 530 were reported in the IRIS trial.

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