Defining therapy goals for major molecular remission in chronic myeloid leukemia: results of the randomized CML Study IV.
Defining therapy goals for major molecular remission in chronic myeloid leukemia: results of the randomized CML Study IV.
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DOI：
10.1038/s41375-018-0055-7
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发表时间：
2018-05
期刊：
影响因子：
11.4
通讯作者：
Lauseker M
中科院分区：
文献类型：
--
作者：
Saussele S;Hehlmann R;Fabarius A;Jeromin S;Proetel U;Rinaldetti S;Kohlbrenner K;Einsele H;Falge C;Kanz L;Neubauer A;Kneba M;Stegelmann F;Pfreundschuh M;Waller CF;Oppliger Leibundgut E;Heim D;Krause SW;Hofmann WK;Hasford J;Pfirrmann M;Müller MC;Hochhaus A;Lauseker M
主要分子缓解（MMR）是慢性粒细胞白血病（CML）的重要治疗目标。到目前为止，根据ELN管理建议，MMR不是失败标准，导致12个月后未达到MMR的CML患者何时改变治疗不确定。在每月的里程碑，对于不同的分子缓解状态，估计登记到CML研究IV的患者的风险比（HR），这些患者被分为学习样本和验证样本。MMR的最小HR为2.5年，为0.28（与未缓解的患者相比）。在验证样本中，可以检测到MMR患者的无进展生存期（PFS）的显著优势（p值0.007）。预测MMR患者PFS的最佳时间可以在2.5年的独立样本中进行验证。通过我们的模型，我们提供了一个建议，何时将缺乏MMR定义为治疗失败，因此应考虑改变治疗。确认了1% BCR-ABL的最佳缓解时间约为12-15个月，对于深度分子缓解，未检测到特定时间点。然而，已经证明，越早达到MMR，以后达到深度分子反应的机会就越高。
Major molecular remission (MMR) is an important therapy goal in chronic myeloid leukemia (CML). So far, MMR is not a failure criterion according to ELN management recommendation leading to uncertainties when to change therapy in CML patients not reaching MMR after 12 months. At monthly landmarks, for different molecular remission status Hazard ratios (HR) were estimated for patients registered to CML study IV who were divided in a learning and a validation sample. The minimum HR for MMR was found at 2.5 years with 0.28 (compared to patients without remission). In the validation sample, a significant advantage for progression-free survival (PFS) for patients in MMR could be detected (p-value 0.007). The optimal time to predict PFS in patients with MMR could be validated in an independent sample at 2.5 years. With our model we provide a suggestion when to define lack of MMR as therapy failure and thus treatment change should be considered. The optimal response time for 1% BCR-ABL at about 12–15 months was confirmed and for deep molecular remission no specific time point was detected. Nevertheless, it was demonstrated that the earlier the MMR is achieved the higher is the chance to attain deep molecular response later.
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影响因子：
11.4
作者：
Hoffmann, V. S.;Baccarani, M.;Pfirrmann, M.
通讯作者：
Pfirrmann, M.
影响因子：
158.5
作者：
Druker, Brian J.;Guilhot, Francois;Larson, Richard A.
通讯作者：
Larson, Richard A.
影响因子：
3.1
作者：
Hjorth-Hansen H;Stenke L;Söderlund S;Dreimane A;Ehrencrona H;Gedde-Dahl T;Gjertsen BT;Höglund M;Koskenvesa P;Lotfi K;Majeed W;Markevärn B;Ohm L;Olsson-Strömberg U;Remes K;Suominen M;Simonsson B;Porkka K;Mustjoki S;Richter J;Nordic CML Study Group
通讯作者：
Nordic CML Study Group
影响因子：
20.3
作者：
Saussele, Susanne;Krauss, Marie-Paloma;Mueller, Martin C.
通讯作者：
Mueller, Martin C.
影响因子：
45.3
作者：
Hehlmann, Ruediger;Lauseker, Michael;Saussele, Susanne
通讯作者：
Saussele, Susanne