EURO-SKI
Multicenter Trial Estimating the Persistence of Molecular Remission in Chronic Myeloid Leukemia After Stopping TKI
N = 758NCT01596114
- Population
- Adults with chronic-phase CML on any TKI for at least 3 years with a confirmed deep molecular response for at least 1 year
- Design
- Prospective, multicentre, non-randomised trial at 61 European centres in 11 countries; prespecified interim analysis done once the 6-month molecular relapse-free survival status was known for 200 patients. Eligible patients had chronic-phase CML, had received any TKI for at least 3 years without ELN treatment failure and had a confirmed deep molecular response for at least 1 year. Primary endpoint: molecular relapse-free survival, defined by loss of major molecular response (more than 0.1% BCR-ABL1 on the International Scale).
- Primary endpoint
- MRFS
- Arms
- TKI discontinuation (experimental, n = 758): TKI stopped after sustained deep molecular response; restart on loss of major molecular response
- People
- Saussele S, EURO-SKI investigators
Show the numbers
| Endpoint | Analysis | TKI discontinuation | Control | Effect |
|---|---|---|---|---|
| MRFS755 of 758 enrolled patients, those evaluable for molecular responseMolecular relapse-free survival, with relapse defined as loss of major molecular response (more than 0.1% BCR-ABL1 on the International Scale) | interimmedian follow-up 27 monthsSaussele 2018 | 61% at 6 mo (57–64%); 50% at 2 y (46–54%) | — | Prespecified interim analysis; the study was ongoing when reported. Of the 755 patients, 371 (49%) lost major molecular response after TKI discontinuation, 4 (1%) died while in MMR from causes unrelated to CML and 13 (2%) restarted TKI while in MMR. No serious adverse events were reported. Median follow-up 27 months (IQR 21 to 34). |
| Endpoint | Analysis | TKI discontinuation | Control | Effect |
|---|---|---|---|---|
| MRFS755 of 758 enrolled patients, those evaluable for molecular responseMolecular relapse-free survival, with relapse defined as loss of major molecular response (more than 0.1% BCR-ABL1 on the International Scale) | interimmedian follow-up 27 monthsSaussele 2018 | 61% at 6 mo (57–64%); 50% at 2 y (46–54%) | — | Prespecified interim analysis; the study was ongoing when reported. Of the 755 patients, 371 (49%) lost major molecular response after TKI discontinuation, 4 (1%) died while in MMR from causes unrelated to CML and 13 (2%) restarted TKI while in MMR. No serious adverse events were reported. Median follow-up 27 months (IQR 21 to 34). |
Appears in
Sources
Saussele S, Richter J, Guilhot J, Gruber FX, Hjorth-Hansen H, Almeida A, et al. Discontinuation of tyrosine kinase inhibitor therapy in chronic myeloid leukaemia (EURO-SKI): a prespecified interim analysis of a prospective, multicentre, non-randomised, trial. Lancet Oncol. 2018;19(6):747-757.