一线治疗失败后慢性期慢性髓性白血病患者达到不同水平细胞遗传学反应的临床意义：完全细胞遗传学反应是否是唯一理想的终点？
The clinical significance of achieving different levels of cytogenetic response in patients with chronic phase chronic myeloid leukemia after failure to front-line therapy: is complete cytogenetic response the only desirable endpoint?
机构信息
Department of Leukemia, The University of Texas, MD Anderson Cancer Center, Houston, USA.
出版信息
Clin Lymphoma Myeloma Leuk. 2011 Oct;11(5):421-6. doi: 10.1016/j.clml.2011.06.009. Epub 2011 Aug 10.
UNLABELLED
Many patients with chronic myeloid leukemia who have failed initial therapy with a tyrosine kinase inhibitor achieve a cytogenetic response that is not complete (ie, partial or minor). This study analyzes the clinical benefit of such responses and identifies value in achieving such responses. Patients with less than complete cytogenetic response to second -line therapy or beyond should be considered to have benefit from therapy and the value of this considered in the context of which alternative options are available.
BACKGROUND
Complete cytogenetic response (CCyR) is the gold standard for response to therapy for patients with chronic myeloid leukemia (CML) because it is associated with a survival benefit. However, patients who have failed initial therapy with a tyrosine kinase inhibitor (TKI) frequently achieve only partial or minor cytogenetic responses. The clinical benefit of such responses is unclear.
PATIENTS AND METHODS
We analyzed the records of all 165 consecutive patients treated in clinical trials with TKI as second-line therapy or beyond after failure to prior imatinib therapy.
RESULTS
A CCyR was achieved with second-line TKI therapy or beyond in 52% of patients, whereas 7% achieved a partial cytogenetic response (PCyR), 14% a minor cytogenetic response (mCyR), 14% complete hematologic response (CHR) only, and 17% no response. The 3-year survival probability was 98% for those with CCyR, compared to 83% with PCyR, 83% for mCyR, 76% for CHR, and 71% for no response. Survival free from transformation rates at 3 years were 93%, 73%, 84%, 88%, and 0%, respectively.
CONCLUSIONS
CCyR is associated with the greatest survival benefit among patients treated with second-line therapy or beyond and remains the optimal cytogenetic goal of therapy. However, patients with partial and minor cytogenetic response derive a benefit compared to patients who have no response. This benefit should be recognized and evaluated against any alternative option available to a given patient before a change in therapy is recommended.
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许多慢性髓性白血病患者在初始酪氨酸激酶抑制剂治疗失败后会出现不完全的细胞遗传学反应（即部分或轻微）。本研究分析了这种反应的临床获益，并确定了实现这种反应的价值。对于二线治疗或以上治疗反应不完全的患者，应考虑从治疗中获益，并在考虑可用替代方案的情况下评估这种获益的价值。
背景
完全细胞遗传学反应（CCyR）是慢性髓性白血病（CML）患者治疗反应的金标准，因为它与生存获益相关。然而，在初始酪氨酸激酶抑制剂（TKI）治疗失败的患者中，经常只能达到部分或轻微的细胞遗传学反应。这种反应的临床获益尚不清楚。
患者和方法
我们分析了在先前伊马替尼治疗失败后接受 TKI 二线或以上治疗的 165 例连续患者临床试验记录。
结果
52%的患者在二线 TKI 治疗或以上治疗中达到 CCyR，而 7%的患者达到部分细胞遗传学反应（PCyR），14%的患者达到轻微细胞遗传学反应（mCyR），14%的患者达到完全血液学反应（CHR），17%的患者无反应。CCyR 患者的 3 年生存率为 98%，而 PCyR 患者为 83%，mCyR 患者为 83%，CHR 患者为 76%，无反应患者为 71%。3 年无转化生存率分别为 93%、73%、84%、88%和 0%。
结论
CCyR 与二线或以上治疗患者的最大生存获益相关，仍然是治疗的最佳细胞遗传学目标。然而，与无反应患者相比，部分和轻微细胞遗传学反应的患者从中获益。在建议改变治疗之前，应认识到这种获益，并根据患者的具体情况评估任何可用的替代方案。
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