Imatinib mesylate discontinuation in patients with chronic myeloid leukemia who have received front-line imatinib mesylate therapy and achieved complete molecular response

Yhim, Ho‐Young; Lee, Na-Ri; Song, Eun-Kee; Yim, Chang-Yeol; Jeon, So Yeon; Shin, Saeam; Kim, Jeong‐A; Kim, Hee Sun; Cho, Eun Hae; Kwak, Jae-Yong

doi:10.1016/j.leukres.2012.02.011

Cited by 57 publications

(66 citation statements)

References 18 publications

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“…In the ISAV study 48% of patients relapsed, with an overall risk of relapse at 36 months of 52%. The fact that imatinib can be interrupted was already demonstrated in other trials such as the STIM and the TWISTER studies [16][17][18]22,23]. The relapse of approximately 50% of patients after 2 years of FUP is now a consistent figure across several studies, including patients treated with second generation TKIs [24].…”

Section: Discussionmentioning

confidence: 93%

Age and dPCR can predict relapse in CML patients who discontinued imatinib: The ISAV study

et al. 2015

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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(v 2 ) < 0.0001]. Relapse rates ranged between 100% (<45 years, dPCR1) and 36% (>45 years, dPCR-). Imatinib can be safely discontinued in the setting of continued PCR negativity; age and dPCR results can predict relapse.

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Section: Discussionmentioning

confidence: 93%

Age and dPCR can predict relapse in CML patients who discontinued imatinib: The ISAV study

et al. 2015

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“…Indeed, with the introduction of second generation TKIs and the achievement of deeper molecular responses, it is possible to hypothesize a future discontinuation. Several studies showed that from 40 to 50% of patients who discontinued imatinib, remained in molecular response without relapse if discontinuation occurred in deep long-lasting molecular response [16][17][18][19][20]. Very recent CML protocols are also further testing this possibility [21].…”

Section: Discussionmentioning

confidence: 99%

Adherence and future discontinuation of tyrosine kinase inhibitors in chronic phase chronic myeloid leukemia. A patient-based survey on 1133 patients

et al. 2015

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“…[14][15][16]23,24,30,32,34,[37][38][39] Comparing patients in Table 1 (clinical trials) and Table 2 (case series), it is apparent that durable stable CMR before discontinuation is important to limit molecular relapse. Multivariate analyses have identified factors associated with molecular relapse and with prolonged TFR.…”

Section: Discussionmentioning

confidence: 99%

“…When applying limits of studies published in the last 10 years in the English language, this resulted in 80 references and these were then limited to only clinical trials, [12][13][14][15][16] case series, and case reports. [17][18][19][20][21][22] Lastly, all abstracts submitted to the 2011 and 2012 ASH annual meeting with the term "CML" were reviewed and resulted in one abstract from 2011 and 2 from 2012 describing relevant clinical trials or case series/reports.…”

Section: Methodsmentioning

confidence: 99%

Discontinuation of tyrosine kinase inhibitors in chronic myeloid leukemia: when is this a safe option to consider?

Sweet

2013

Hematology

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Mrs G is a 54-year-old woman with a diagnosis of chronic-phase chronic myeloid leukemia dating back 8 years. She had a low-risk Sokal score at diagnosis and was started on imatinib mesylate at 400 mg orally daily within one month of her diagnosis. Her 3-month evaluation revealed a molecular response measured by quantitative RT-PCR of 1.2% by the International Scale. Within 6 months of therapy, she achieved a complete cytogenetic response, and by 18 months, her BCR-ABL1 transcript levels were undetectable using a quantitative RT-PCR assay with a sensitivity of Ն 4.5 logs. She has maintained this deep level of response for the past 6.5 years. Despite her excellent response to therapy, she continues to complain of fatigue, intermittent nausea, and weight gain. She is asking to discontinue imatinib mesylate and is not interested in second-line therapy. Is this a safe and reasonable option for this patient?

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Imatinib mesylate discontinuation in patients with chronic myeloid leukemia who have received front-line imatinib mesylate therapy and achieved complete molecular response

Cited by 57 publications

References 18 publications

Age and dPCR can predict relapse in CML patients who discontinued imatinib: The ISAV study

Age and dPCR can predict relapse in CML patients who discontinued imatinib: The ISAV study

Adherence and future discontinuation of tyrosine kinase inhibitors in chronic phase chronic myeloid leukemia. A patient-based survey on 1133 patients

Discontinuation of tyrosine kinase inhibitors in chronic myeloid leukemia: when is this a safe option to consider?

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