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Age and d PCR can predict relapse in CML patients who discontinued imatinib: The ISAV study
Author(s) -
Mori Silvia,
Vagge Elisabetta,
le Coutre Philipp,
Abruzzese Elisabetta,
Martino Bruno,
Pungolino Ester,
Elena Chiara,
Pierri Ivana,
Assouline Sarit,
D'Emilio Anna,
Gozzini Antonella,
Giraldo Pilar,
Stagno Fabio,
Iurlo Alessandra,
Luciani Michela,
De Riso Giulia,
Redaelli Sara,
Kim DongWook,
Pirola Alessandra,
Mezzatesta Caterina,
Petroccione Anna,
Lodolo D'Oria Agnese,
Crivori Patrizia,
Piazza Rocco,
GambacortiPasserini Carlo
Publication year - 2015
Publication title -
american journal of hematology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 2.456
H-Index - 105
eISSN - 1096-8652
pISSN - 0361-8609
DOI - 10.1002/ajh.24120
Subject(s) - imatinib , discontinuation , medicine , gastroenterology , myeloid leukemia , imatinib mesylate , oncology , surgery
Imatinib is effective for the treatment of chronic myeloid leukemia (CML). However even undetectable BCR‐ABL1 by Q‐RT‐PCR does not equate to eradication of the disease. Digital‐PCR (dPCR), able to detect 1 BCR‐ABL1 positive cell out of 10 7 , has been recently developed. The ISAV study is a multicentre trial aimed at validating dPCR to predict relapses after imatinib discontinuation in CML patients with undetectable Q‐RT‐PCR. CML patients under imatinib therapy since more than 2 years and with undetectable PCR for at least 18 months were eligible. Patients were monitored by standard Q‐RT‐PCR for 36 months. Patients losing molecular remission (two consecutive positive Q‐RT‐PCR with at least 1 BCR‐ABL1/ABL1 value above 0.1%) resumed imatinib. The study enrolled 112 patients, with a median follow‐up of 21.6 months. Fifty‐two of the 108 evaluable patients (48.1%), relapsed; 73.1% relapsed in the first 9 months but 14 late relapses were observed between 10 and 22 months. Among the 56 not‐relapsed patients, 40 (37.0% of total) regained Q‐RT‐PCR positivity but never lost MMR. dPCR results showed a significant negative predictive value ratio of 1.115 [95% CI: 1.013–1.227]. An inverse relationship between patients age and risk of relapse was evident: 95% of patients <45 years relapsed versus 42% in the class ≥45 to <65 years and 33% of patients ≥65 years [ P (χ 2 ) < 0.0001]. Relapse rates ranged between 100% (<45 years, dPCR+) and 36% (>45 years, dPCR‐). Imatinib can be safely discontinued in the setting of continued PCR negativity; age and dPCR results can predict relapse. Am. J. Hematol. 90:910–914, 2015. © 2015 Wiley Periodicals, Inc.