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Oral arsenic plus imatinib versus imatinib solely for newly diagnosed chronic myeloid leukemia: a randomized phase 3 trial with 5-year outcomes

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机构： [1]State Key Laboratory of Medical Genomics, Shanghai Institute of Hematology, National Research Center for Translational Medicine at Shanghai, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China [2]The Affiliated Cancer Hospital of Zhengzhou University, Zhengzhou, Henan, China [3]Yifan Research & Development, Hefei, Anhui, China [4]Lanzhou University Second Hospital, Lanzhou, Gansu, China [5]The Affiliated Huaian No 1 People’s Hospital of Nanjing Medical University, Huaian, Jiangsu, China [6]The Second Affiliated Hospital of Xi’an Jiaotong University, Xi’an, Shaanxi, China [7]The First Affiliated Hospital of Bengbu Medical College, Bengbu, Anhui, China [8]Heping Hospital Affiliated to Changzhi Medical College, Changzhi, Shanxi, China [9]The First Hospital of Shanxi Medical University, Taiyuan, Shanxi, China [10]The Second Hospital of Shanxi Medical University, Taiyuan, Shanxi, China [11]The Second Affiliated Hospital of Sun Yat-Sen University, Guangzhou, Guangdong, China [12]Hengshui People’s Hospital, Hengshui, Hebei, China [13]West China Hospital of Sichuan University, Chengdu, Sichuan, China [14]The Affiliated Hospital of Inner Mongolia Medical University, Hohhot, Inner Mongolia, China [15]The Second Affiliated Hospital of Chongqing Medical University, Chongqing, China [16]The Second Affiliated Hospital of Kunming Medical University, Kunming, Yunnan, China [17]Cangzhou Central Hospital, Cangzhou, Hebei, China [18]The First Affiliated Hospital of China Medical University, Shenyang, Liaoning, China [19]The People’s Hospital of Guangxi Zhuang Autonomous Region, Nanning, Guangxi, China [20]The Second Affiliated Hospital of Nanchang University, Nanchang, Jiangxi, China [21]Ningbo First Hospital, Ningbo, Zhejiang, China [22]Peking University Third Hospital, Beijing, China

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关键词： Chronic myeloid leukemia Arsenic Imatinib Efficacy and safety

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The synergistic effects of combining arsenic compounds with imatinib against chronic myeloid leukemia (CML) have been established using in vitro data. We conducted a clinical trial to compare the efficacy of the arsenic realgar-indigo naturalis formula (RIF) plus imatinib with that of imatinib monotherapy in patients with newly diagnosed chronic phase CML (CP-CML).In this multicenter, randomized, double-blind, phase 3 trial, 191 outpatients with newly diagnosed CP-CML were randomly assigned to receive oral RIF plus imatinib (n = 96) or placebo plus imatinib (n = 95). The primary end point was the major molecular response (MMR) at 6 months. Secondary end points include molecular response 4 (MR4), molecular response 4.5 (MR4.5), progression-free survival (PFS), overall survival (OS), and adverse events.The median follow-up duration was 51 months. Due to the COVID-19 pandemic, the recruitment to this study had to be terminated early, on May 28, 2020. The rates of MMR had no significant statistical difference between combination and imatinib arms at 6 months and any other time during the trial. MR4 rates were similar in both arms. However, the 12-month cumulative rates of MR4.5 in the combination and imatinib arms were 20.8% and 10.5%, respectively (p = 0.043). In core treatment since the 2-year analysis, the frequency of MR4.5 was 55.6% in the combination arm and 38.6% in the imatinib arm (p = 0.063). PFS and OS were similar at five years. The safety profiles were similar and serious adverse events were uncommon in both groups.The results of imatinib plus RIF as a first-line treatment of CP-CML compared with imatinib might be more effective for achieving a deeper molecular response (Chinadrugtrials number, CTR20170221).© 2024. The Author(s).

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大类 | 3 区医学

小类 | 4 区肿瘤学

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Q3 ONCOLOGY

影响因子： 2.7 最新[2023版] 3.1 最新五年平均 2.7 出版当年[2023版] 0 出版当年五年平均 2.7 出版前一年[2023版]

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第一作者机构： [1]State Key Laboratory of Medical Genomics, Shanghai Institute of Hematology, National Research Center for Translational Medicine at Shanghai, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China

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Oral arsenic plus imatinib versus imatinib solely for newly diagnosed chronic myeloid leukemia: a randomized phase 3 trial with 5-year outcomes

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