Current treatment strategies and future perspectives for gastrointestinal stromal tumors

Table 3 Clinical studies on adjuvant imatinib

Trial	ACOSOG Z9001	SSG XVIII/AIO	EORTC 62024	PERSIST-5
Study/yr	Phase III/2009	Phase III/2012, 2020	Phase III/2015	Phase II/2018
Number	359 (total: 713)	397 (199 vs 198)	454 (total: 908)	91
Eligible criteria	Tumor size ≥ 3 cm	High risk group	Intermediate and high-risk group	Intermediate and high-risk group
Treatment dose	400 mg/d	400 mg/d	400 mg/d	400 mg/d
Duration	1 yr vs placebo	1 yr vs 3 yr	2 yr vs placebo	5 yr
Risk classification
High risk	NA	178 (89%)	266 (58.6%)	67 (74%)
Intermediate risk		15 (8%)	186 (41%)	24 (26%)
Etc.		6 (3%)	2 (0.4%)
Residual tumor
R0	325 (90.5%)	169 (85%)	381 (83.9%)	90 (99%)
R1,2	34 (9.5%)	30 (15%)	73 (16.1%)	0 (0%) 1; unknown
Tumor rupture
No	NA	164 (82%)	404 (89%)	NA
Yes		35 (18%)	50 (11%)
End point
Primary endpoint	RFS	RFS	IFFS	RFS
Secondary endpoint		OS, safety	RFS, OS, safety	OS
Results	1-yr RFS; 98% vs 83% (HR = 0.35, P < 0.0001); OS: Not significant	5-yr RFS; 71% vs 53% (HR = 0.66, P = 0.003); 5-yr OS; 92% vs 86%; 10-yr OS; 79% vs 65%	5-yr IFFS; 87% vs 84% (HR = 0.79, P = 0.21); 3-yr RFS; 84% vs 66%; 5-yr RFS; 69% vs 63%	5-yr RFS; 90%; 5-yr OS; 95%; 45 (49%) pts early discontinuation of imatinib

NA: Not associated; RFS: Relapse-free survival; OS: Overall survival; IFFS: Imatinib failure-free survival.