Significance of monitoring imatinib plasma concentration in second-line treatment decisions for c-kit 11 gene-mutated gastrointestinal stromal tumors

doi:10.4251/wjgo.v17.i3.98746

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World Journal of Gastrointestinal Oncology

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1948-5204

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Baishideng Publishing Group Inc, 7041 Koll Center Parkway, Suite 160, Pleasanton, CA 94566, USA

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World J Gastrointest Oncol. Mar 15, 2025; 17(3): 98746
Published online Mar 15, 2025. doi: 10.4251/wjgo.v17.i3.98746

Table 1 Baseline characteristics of the two groups of patients, n (%)

Characteristics	Group A (n = 32)	Group B (n = 43)	P value
Age	51 ± 16	53 ± 12	0.608
Sex			0.888
Male	25 (78)	33 (77)
Female	7 (22)	10 (23)
Primary tumor site			0.275
Stomach	12 (38)	10 (23)
Small intestine	14 (44)	19 (44)
Other	6 (19)	14 (33)
Mitotic count (/50 HPF)			0.142
≤ 5	13 (41)	27 (63)
5 to ≤ 10	10 (31)	7 (16)
> 10	9 (28)	9 (21)
Ki 67			0.189
≤ 10	16 (50)	28 (65)
> 10	16 (50)	15 (35)
Risk classification			> 0.999¹
Medium	1 (3)	1 (2)
High	31 (97)	42 (98)
Mutation type			0.518¹
Point mutation	6 (19)	13 (30)
Delete mutation	25 (78)	29 (67)
Other	1 (3)	1 (2)
Sum of largest diameter (cm)			0.317
≤ 5	10 (31)	12 (28)
5-10	10 (31)	8 (19)
> 10	12 (38)	23 (53)
Lesions > 3			0.435
Yes	18 (56)	28 (65)
No	14 (44)	15 (35)
R0 resection			0.350
Yes	13 (41)	13 (30)
No	19 (59)	30 (70)

¹Using the Fisher’s exact test.

HPF: High-power field.

Table 2 Baseline characteristics of patient subgroups, n (%)

Characteristics	LP (n = 28)			HP (n = 37)
Characteristics	Group A (n = 14)	Group B (n = 14)	P value	Group A (n = 18)	Group B (n = 29)	P value
Age	51 ± 12	53 ± 12	0.611	51 ± 19	52 ± 13	0.785
Sex			> 0.999¹			> 0.999
Male	11 (79)	10 (71)		14 (78)	23 (79)
Female	3 (21)	4 (29)		4 (22)	6 (21)
Primary tumor site			0.356¹			0.598¹
Stomach	6 (43)	2 (14)		6 (33)	8 (28)
Small intestine	5 (36)	7 (50)		9 (50)	12 (41)
Other	3 (21)	5 (36)		3 (17)	9 (31)
Mitotic count (/50 HPF)			0.184¹			0.408
≤ 5	7 (50)	12 (86)		6 (33)	15 (52)
5 to ≤ 10	4 (29)	1 (7)		6 (33)	6 (21)
> 10	3 (21)	1 (7)		6 (33)	8 (28)
Ki 67			> 0.999			0.096
≤ 10	8 (57)	8 (57)		8 (44)	20 (69)
> 10	6 (43)	6 (43)		10 (56)	9 (31)
Risk classification			> 0.999¹			> 0.999¹
Medium	1 (7)	0 (0)		0 (0)	1 (3)
High	13 (93)	14 (100)		18 (100)	28 (97)
Mutation type			0.209¹			> 0.999¹
Point mutation	2 (14)	6 (43)		4 (22)	7 (24)
Delete mutation	11 (79)	8 (57)		14 (78)	21 (72)
Other	1 (7)	0 (0)		0 (0)	1 (3)
Sum of largest diameter (cm)			0.797¹			0.520
≤ 5	6 (43)	5 (36)		4 (22)	7 (24)
5-10	4 (29)	3 (21)		6 (33)	5 (17)
> 10	4 (29)	6 (43)		8 (44)	17 (59)
Lesions > 3			0.450			0.869
Yes	6 (43)	8 (57)		12 (67)	20 (69)
No	8 (57)	6 (43)		6 (33)	9 (31)
R0 resection			> 0.999			0.236
Yes	5 (36)	5 (36)		8 (44)	8 (28)
No	9 (64)	9 (64)		10 (56)	21 (72)

¹Using the Fisher’s exact test.

HP: High plasma concentration group; HPF: High-power field; LP: Low plasma concentration group.

Table 3 Comparison of disease control rate and objective response rate between the two groups of patients in group low plasma concentration group, n (%)

Group	n	CR	PR	SD	PD	DCR	ORR
Group A	14	0 (0)	2 (14.2)	8 (57.1)	4 (28.5)	10 (71.4)	3 (21.4)
Group B	14	0 (0)	6 (42.8)	3 (21.4)	5 (35.7)	9 (64.3)	6 (42.9)
χ²						-	-
P value						> 0.99	0.42

CR: Complete response; DCR: Disease control rate; ORR: Objective response rate; PD: Progressive disease; PR: Partial response; SD: Stable disease.

Table 4 Comparison of disease control rate and objective response rate between the two groups of patients in group high plasma concentration group, n (%)

Group	n	CR	PR	SD	PD	DCR	ORR
Group A	18	0 (0)	0 (0)	6 (33.3)	12 (66.6)	6 (33.3)	0 (0)
Group B	29	0 (0)	4 (13.7)	17 (58.6)	8 (27.5)	21 (72.4)	4 (13.8)
χ²						6.94	-
P value						0.008^a	0.28

^aP < 0.05.

CR: Complete response; DCR: Disease control rate; ORR: Objective response rate; PD: Progressive disease; PR: Partial response; SD: Stable disease.

Table 5 Adverse effects in the dose-escalation group, n (%)

Types of adverse reactions	LP (n = 14)		HP (n = 18)
Types of adverse reactions	Before¹	After²	Before¹	After²
Fatigue	0 (0.0)	2 (14.3)	2 (11.1)	10 (55.6)^b
Rash	3 (21.4)	7 (50.0)	8 (44.4)	12 (66.7)
Muscle spasm	0 (0.0)	1 (7.1)	4 (22.2)	7 (38.9)
Anemia	5 (35.7)	10 (71.4)	13 (72.2)	15 (83.3)
Gastrointestinal reactions	2 (14.3)	9 (64.3)^b	4 (22.2)	18 (100.0)^b
Edema	4 (28.6)	8 (57.1)	10 (55.6)	17 (94.4)^a
Liver dysfunction	0 (0.0)	1 (7.1)	2 (11.1)	2 (11.1)
Granulocytopenia	3 (21.4)	5 (35.7)	8 (44.4)	11 (61.1)

^aP < 0.05.

^bP < 0.01.

¹Before increasing the dose of imatinib.

²After increasing the dose of imatinib.

HP: High plasma concentration group; LP: Low plasma concentration group.

Citation: Li HT, Du YY, Huang Z, Li JJ, Zhang J. Significance of monitoring imatinib plasma concentration in second-line treatment decisions for c-kit 11 gene-mutated gastrointestinal stromal tumors. World J Gastrointest Oncol 2025; 17(3): 98746
URL: https://www.wjgnet.com/1948-5204/full/v17/i3/98746.htm
DOI: https://dx.doi.org/10.4251/wjgo.v17.i3.98746