STIM
Evaluation of the Persistence of the Complete Molecular Remission After Stopping Imatinib Chronic Myeloid Leukemia (STIM)
N = 100NCT00478985
- Population
- Adults (18 years and older) with CML in complete molecular remission on imatinib for more than 2 years; people who had received immunomodulatory treatment other than interferon alfa, treatment for other malignancies or allogeneic stem-cell transplantation were not included.
- Design
- Prospective, multicentre, non-randomised single-arm study at 19 institutions in France. Imatinib was stopped in adults in complete molecular remission (more than 5-log reduction in BCR-ABL and undetectable transcripts on quantitative RT-PCR) after more than 2 years of imatinib; imatinib was reintroduced on molecular relapse. The first report is an interim analysis of patients with at least 12 months of follow-up.
- Arms
- Imatinib discontinuation (experimental, n = 100): Imatinib stopped after sustained complete molecular remission; reintroduced on molecular relapse
- People
- Mahon FX, Intergroupe Français des Leucémies Myéloïdes Chroniques
Show the numbers
| Endpoint | Analysis | Imatinib discontinuation | Control | Effect |
|---|---|---|---|---|
| MRFS69 of the 100 patients enrolled, those with at least 12 months of follow-upProbability of persistent complete molecular remission (no molecular relapse) at 12 months after stopping imatinib. The 2010 abstract does not state how molecular relapse was defined. | interimmedian follow-up 24 monthsMahon 2010 | 41% at 12 mo (29–52%) | — | Median follow-up of 24 months applies to these 69 patients (range 13 to 30); median for all 100 patients was 17 months. 42 of the 69 patients (61%) relapsed: 40 before 6 months, one at month 7 and one at month 19. All 42 responded to imatinib reintroduction: 16 had lower BCR-ABL levels and 26 reached complete molecular remission that was sustained after rechallenge. |
| MRFSAll 100 patients who stopped imatinibMolecular recurrence-free survival. Molecular recurrence: BCR-ABL transcript positivity on quantitative RT-PCR confirmed at a second time point showing a one-log rise at two successive assessments, or loss of major molecular response at one time point. | finalmedian follow-up 77 monthsEtienne 2017 | 43% at 6 mo (33–52%); 38% at 5 y (29–47%) | — | Median molecular follow-up after stopping was 77 months (range 9 to 95). 61 patients lost undetectable minimal residual disease after a median of 2.5 months (range 1 to 22); one patient died with undetectable disease at 10 months. Treatment was restarted in 57 of the 61 patients with molecular recurrence and 55 reached a second undetectable response (median 4 months). No patient had CML progression. Sokal risk score and duration of imatinib treatment were associated with the probability of recurrence. |
| Endpoint | Analysis | Imatinib discontinuation | Control | Effect |
|---|---|---|---|---|
| MRFS69 of the 100 patients enrolled, those with at least 12 months of follow-upProbability of persistent complete molecular remission (no molecular relapse) at 12 months after stopping imatinib. The 2010 abstract does not state how molecular relapse was defined. | interimmedian follow-up 24 monthsMahon 2010 | 41% at 12 mo (29–52%) | — | Median follow-up of 24 months applies to these 69 patients (range 13 to 30); median for all 100 patients was 17 months. 42 of the 69 patients (61%) relapsed: 40 before 6 months, one at month 7 and one at month 19. All 42 responded to imatinib reintroduction: 16 had lower BCR-ABL levels and 26 reached complete molecular remission that was sustained after rechallenge. |
| MRFSAll 100 patients who stopped imatinibMolecular recurrence-free survival. Molecular recurrence: BCR-ABL transcript positivity on quantitative RT-PCR confirmed at a second time point showing a one-log rise at two successive assessments, or loss of major molecular response at one time point. | finalmedian follow-up 77 monthsEtienne 2017 | 43% at 6 mo (33–52%); 38% at 5 y (29–47%) | — | Median molecular follow-up after stopping was 77 months (range 9 to 95). 61 patients lost undetectable minimal residual disease after a median of 2.5 months (range 1 to 22); one patient died with undetectable disease at 10 months. Treatment was restarted in 57 of the 61 patients with molecular recurrence and 55 reached a second undetectable response (median 4 months). No patient had CML progression. Sokal risk score and duration of imatinib treatment were associated with the probability of recurrence. |
Appears in
Sources
Mahon FX, Réa D, Guilhot J, Guilhot F, Huguet F, Nicolini F, et al. Discontinuation of imatinib in patients with chronic myeloid leukaemia who have maintained complete molecular remission for at least 2 years: the prospective, multicentre Stop Imatinib (STIM) trial. Lancet Oncol. 2010;11(11):1029-35.
Etienne G, Guilhot J, Rea D, Rigal-Huguet F, Nicolini F, Charbonnier A, et al. Long-Term Follow-Up of the French Stop Imatinib (STIM1) Study in Patients With Chronic Myeloid Leukemia. J Clin Oncol. 2017;35(3):298-305.