Deeper molecular response is a predictive factor for treatment-free remission after imatinib discontinuation in patients with chronic phase chronic myeloid leukemia: the JALSG-STIM213 study
Deeper molecular response is a predictive factor for treatment-free remission after imatinib discontinuation in patients with chronic phase chronic myeloid leukemia: the JALSG-STIM213 study
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DOI：
10.1007/s12185-017-2334-x
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发表时间：
2018-02-01
影响因子：
2.1
通讯作者：
Naoe, Tomoki
中科院分区：
文献类型：
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作者：
Takahashi, Naoto;Tauchi, Tetsuzo;Naoe, Tomoki
这项前瞻性临床试验（JALSG-STIM 213，UMIN 000011971）的目的是评估慢性髓性白血病（CML）患者停用伊马替尼后的无治疗缓解（TFR）率。接受伊马替尼治疗至少3年且持续深度分子学缓解至少2年的CML患者符合条件。分子学复发定义为主要分子学缓解（MMR）丧失。在68例合格患者中，38.2%为女性，中位年龄为55.0岁，伊马替尼治疗的中位持续时间为97.5个月。12个月TFR率为67.6%。失去MMR的患者立即再次接受伊马替尼治疗;所有患者均重新获得MMR。使用Kaplan-Meier方法估计3年无治疗生存率（TFS）为64.6%。检测不到的分子残留病（UMRD）定义为使用国际规模的聚合酶链反应在> 100，000个ABL 1对照基因中没有BCR-ABL 1。发现研究基线时的UMRD可预测TFR的持续。我们的研究结果表明，符合TFR试验中常用的所有合格标准的CML患者能够安全地停用伊马替尼。因此，TFR可能是日本CML治疗的一个新目标。
The objective of this prospective clinical trial (JALSG-STIM213, UMIN000011971) was to evaluate treatment-free remission (TFR) rates after discontinuation of imatinib in chronic myeloid leukemia (CML). CML patients who received imatinib treatment for at least 3 years and sustained deep molecular response for at least 2 years were eligible. Molecular recurrence was defined as loss of major molecular response (MMR). Of the 68 eligible patients, 38.2% were women, the median age was 55.0 years, and the median duration of imatinib treatment was 97.5 months. The 12-month TFR rate was 67.6%. Patients who lost MMR were immediately treated with imatinib again; all re-achieved MMR. Three-year treatment-free survival (TFS) was estimated as 64.6% using the Kaplan-Meier method. Undetectable molecular residual disease (UMRD) was defined as no BCR-ABL1 in > 100,000 ABL1 control genes using international scale polymerase chain reaction. UMRD at the study baseline was found to be predictive of continuation of TFR. Our findings suggest that CML patients who meet all the eligibility criteria that have commonly been used in the TFR trials are able to discontinue imatinib use safely. TFR may thus be valuable as a new goal for CML treatment in Japan.