‘Real-life’ study of imatinib therapy in chronic phase-chronic myeloid leukemia: A novel retrospective observational longitudinal analysis

Figures & data

Table 1 Patients’ characteristics

Variable	Description
No. of patients	138
Sex (M/F)	57/43%
Age at diagnosis (years), median (range)	53 (18–78)
Total no. of time periods	893
No. of time periods/patient, median (range)	5 (1–49)
No. (%) time periods according to type of treatment
IM	483 (54.1%)
NIL	32 (3.6%)
DAS	40 (4.5%)
HU	54 (6.0%)
IFN	52 (5.8%)
NO	232 (26.0%)
No. (%) time periods according to IM dosage
Low dose (100–300 mg/day)	163 (34%)
Standard dose (400 mg/day)	242 (50%)
High dose (>400–800 mg/day)	78 (16%)
Duration of IM at constant dosage (days), median (range)	258 (7–4526)

Notes: IM: imatinib; NIL: nilotinib; DAS: dasatinib; HU: hydroxyurea; IFN: interferon; NO: no treatment.

Figure 1 Treatments after a period at constant IM dose

Figure 2 Sequential evaluations of BCR–ABL level in three of the five patients who discontinued IM for at least 12 months and who are still off treatment. For clarity, patients 51 and 74 have not been included in the graph because all their readings are zero

Figure 3 Sequential evaluations of BCR–ABL level in six patients who discontinued IM for at least 12 months and who then re-started treatment. Patients with only one qPCR measurement have not been included in the graph

Table 2 Therapy characteristics in the period following the treatment with imatinib according to dosage

	Low (L) dose (n = 163)	Standard (S) dose (n = 242)	High (H) dose (n = 78)	P-value L vs. S	P-value L vs. H	P-value S vs. H
Change in therapy in period subsequent to IM therapy				0.013	<0.001	<0.001
IM, n (%)	77 (60.6%)	98 (54.8%)	61 (81.3%)
AMN, n (%)	3 (2.4%)	3 (1.7%)	4 (5.3%)
BMS, n (%)	0 (0.0%)	11 (6.1%)	4 (5.3%)
HU, n (%)	0 (0.0%)	3 (1.7%)	1 (1.3%)
Discontinuation, n (%)	47 (37.0%)	64 (35.7%)	5 (6.8%)
(No other periods)	36	63	3
Days of suspended therapy subsequent to IM therapy				0.103	0.963	0.379
Median (range)	20 (6–3574)	37 (2–2042)	21 (13–156)
Change in IM dosage				<0.001	<0.001	<0.001
Low dose, n (%)	35 (45.5%)	53 (54.1%)	0 (0.0%)
Standard dose, n (%)	39 (50.7%)	3 (3.1%)	41 (67.2%)
High dose, n (%)	3 (3.9%)	42 (42.9%)	20 (32.8%)

Notes: n: number of time periods; IM: imatinib; AMN: nilotinib; BMS: dasatinib; HU: hydroxyurea.

Table 3 Response to treatment in the period following imatinib according to dosage

	Low (L) dose (n = 163)	Standard (S) dose (n = 242)	High (H) dose (n = 78)	P-value L vs. S	P-value L vs. H	P-value S vs. H
Cytogenetic response*				0.019	0.882	0.044
CR, n (%)	113 (69.3%)	192 (79.7%)	53 (68.0%)
<CR, n (%)	50 (30.7%)	49 (20.3%)	25 (32.0%)
Molecular response				0.006	0.051	<0.001
CR, n (%)	44 (27.0%)	98 (40.5%)	12 (15.4%)
<CR, n (%)	119 (73.0%)	144 (59.5%)	66 (84.6%)
Molecular response				0.001	>0.900	0.006
CMR + MMR, n (%)	87 (53.4%)	169 (69.8%)	41 (52.6%)
<MMR/NR, n (%)	76 (46.6%)	73 (30.2%)	37 (47.4%)

*One value missing. CR: complete response; CMR: complete molecular response; MMR: major molecular response; NR: no response.

Table 4 Cytogenetic and molecular progression according to imatinib dosage

	Low (L) dose (n = 163)	Standard (S) dose (n = 242)	High (H) dose (n = 78)	P-value L vs. S	P-value L vs. H	P-value S vs. H
Cytogenetic progression*				>0.900	0.292	0.319
Yes	10 (6.1%)	16 (6.7%)	8 (10.5%)
No	153 (93.9%)	224 (93.3%)	68 (89.5%)
Molecular progression*				0.360	0.843	0.687
Yes	24 (14.8%)	27 (11.3%)	10 (13.0%)
No	138 (85.2%)	211 (88.7%)	67 (87.0%)

*Missing values.