. Author manuscript; available in PMC: 2017 Jun 5.

Published in final edited form as: Curr Hematol Malig Rep. 2015 Jun;10(2):145–157. doi: 10.1007/s11899-015-0254-5

Table 4.

Summary of Major Clinical Trials Evaluating TKI Discontinuation in CML Patients

Clinical Characteristics	STIM⁸²	TWISTER⁸³	French CML Group⁸⁵	EURO-SKI⁸⁴
Number of pts	100	40	52	200
Eligibility Criteria	MR^4.5	MR^4.5	MR^4.5	MR⁴
Discontinued TKI	IM	IM	NIL/DAS	IM/NIL/DAS
Median follow-up (months)	50	43	32	NR^*
Definition of relapse	Loss of MMR	Loss of MMR	Loss of MMR	Loss of MMR
Number of pts in remission (%)	39 (39)	18 (45)	28 (54)	123 (72)
Number of relapsed pts (%)	61 (61)	22 (55)	24 (46)	67 (38)
early relapse^¥	58 (95)	15 (68)	19 (80)	67
late relapse^¥	3 (5)	7 (32)	5 (20)	NR^*
Incidence of AP or BP	0	0	0	0

TKI, tyrosine kinase inhibitor; Pts, patients; MR^4.5, BCR-ABL1 transcript ≤ 0.0032%; MR⁴, BCR-ABL1 transcript ≤ 0.01%; IM, imatinib; NIL, nilotinib; DAS, dasatinib; NR, not reported; MMR, BCR-ABL1 transcript ≤ 0.1%; AP, accelerated phase; BP, blast phase

Median follow-up was not reported in this interim analysis but all patients had at least 6 months molecular response data

^¥

Depending on trial, early relapse reflects the ones that occurred within 6 or 12 months, and late relapses after 6 or 12 months