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剂量调整 EPOCH 作为高危成人急性淋巴细胞白血病初始治疗的 II 期研究。

Phase II study of dose-adjusted EPOCH as initial therapy for adults with high-risk acute lymphoblastic leukemia.

机构信息

Department of Medicine, University of Washington, Seattle, WA, USA.

Clinical Research Division, Fred Hutchinson Cancer Center, Seattle, WA, USA.

出版信息

Leuk Lymphoma. 2023 May;64(5):927-937. doi: 10.1080/10428194.2023.2189803. Epub 2023 Mar 20.

Abstract

Treatments for adults with newly-diagnosed acute lymphoblastic leukemia (ALL) may be prohibitively toxic and/or resource-intense. To address this, we performed a phase II study of dose-adjusted etoposide, prednisone, vincristine, cyclophosphamide, and doxorubicin (DA-EPOCH). Imatinib or dasatinib was added for Ph + disease; rituximab was added when CD20+. Fifty-three patients were evaluable: 28 with Ph + disease, and 25 with Ph-. All patients had ≥1 high-risk clinical feature. Measurable residual disease-negativity by multiparameter flow cytometry within 4 cycles was achieved in 71% in patients with Ph + ALL and 64% in Ph - ALL. Median overall survival (OS) was 49 months, with a 2-year OS of 71%. Median relapse-free survival (RFS) in the 47 patients that attained morphologic remission was 24 months, with a 2-year RFS of 57%. Early mortality was 2%. In summary, DA-EPOCH yields deep and durable remissions in adults with ALL comparable to some resource-intense strategies but with a low rate of treatment-related death.

摘要

新诊断的成人急性淋巴细胞白血病 (ALL) 的治疗可能具有极高的毒性和/或资源密集性。为了解决这个问题,我们进行了一项剂量调整依托泊苷、泼尼松、长春新碱、环磷酰胺和多柔比星 (DA-EPOCH) 的 II 期研究。对于 Ph+疾病,加用伊马替尼或达沙替尼;当 CD20+时,加用利妥昔单抗。53 例患者可评估:28 例 Ph+疾病,25 例 Ph-疾病。所有患者均有≥1 个高危临床特征。Ph+ALL 患者中有 71%在 4 个周期内通过多参数流式细胞术达到可测量残留病阴性,Ph-ALL 患者中有 64%达到可测量残留病阴性。总体生存 (OS) 的中位数为 49 个月,2 年 OS 为 71%。47 例达到形态缓解的患者中,无复发生存 (RFS) 的中位数为 24 个月,2 年 RFS 为 57%。早期死亡率为 2%。总之,DA-EPOCH 在成人 ALL 中产生了深度和持久的缓解,与一些资源密集型策略相当,但治疗相关死亡率较低。

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