Oral arsenic plus imatinib versus imatinib solely for newly diagnosed chronic myeloid leukemia : a randomized phase 3 trial with 5-year outcomes
© 2024. The Author(s)..
PURPOSE: 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).
METHODS: 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.
RESULTS: 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.
CONCLUSION: 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).
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2024 |
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| Erschienen: |
2024 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:150 |
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| Enthalten in: |
Journal of cancer research and clinical oncology - 150(2024), 4 vom: 11. Apr., Seite 189 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Tian, Jie [VerfasserIn] |
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| Links: |
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| Anmerkungen: |
Date Completed 15.04.2024 Date Revised 15.04.2024 published: Electronic Citation Status MEDLINE |
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| doi: |
10.1007/s00432-024-05700-x |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
NLM370945719 |
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| 100 | 1 | |a Tian, Jie |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a Oral arsenic plus imatinib versus imatinib solely for newly diagnosed chronic myeloid leukemia |b a randomized phase 3 trial with 5-year outcomes |
| 264 | 1 | |c 2024 | |
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| 500 | |a Date Revised 15.04.2024 | ||
| 500 | |a published: Electronic | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a © 2024. The Author(s). | ||
| 520 | |a PURPOSE: 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) | ||
| 520 | |a METHODS: 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 | ||
| 520 | |a RESULTS: 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 | ||
| 520 | |a CONCLUSION: 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) | ||
| 650 | 4 | |a Randomized Controlled Trial | |
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| 650 | 4 | |a Journal Article | |
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| 700 | 1 | |a Song, Yong-Ping |e verfasserin |4 aut | |
| 700 | 1 | |a Zhang, Gao-Chong |e verfasserin |4 aut | |
| 700 | 1 | |a Wang, Shu-Fang |e verfasserin |4 aut | |
| 700 | 1 | |a Chu, Xiao-Xiang |e verfasserin |4 aut | |
| 700 | 1 | |a Chai, Ye |e verfasserin |4 aut | |
| 700 | 1 | |a Wang, Chun-Ling |e verfasserin |4 aut | |
| 700 | 1 | |a He, Ai-Li |e verfasserin |4 aut | |
| 700 | 1 | |a Zhang, Feng |e verfasserin |4 aut | |
| 700 | 1 | |a Shen, Xu-Liang |e verfasserin |4 aut | |
| 700 | 1 | |a Zhang, Wei-Hua |e verfasserin |4 aut | |
| 700 | 1 | |a Yang, Lin-Hua |e verfasserin |4 aut | |
| 700 | 1 | |a Nie, Da-Nian |e verfasserin |4 aut | |
| 700 | 1 | |a Wang, Dong-Mei |e verfasserin |4 aut | |
| 700 | 1 | |a Zhu, Huan-Ling |e verfasserin |4 aut | |
| 700 | 1 | |a Gao, Da |e verfasserin |4 aut | |
| 700 | 1 | |a Lou, Shi-Feng |e verfasserin |4 aut | |
| 700 | 1 | |a Zhou, Ze-Ping |e verfasserin |4 aut | |
| 700 | 1 | |a Su, Guo-Hong |e verfasserin |4 aut | |
| 700 | 1 | |a Li, Yan |e verfasserin |4 aut | |
| 700 | 1 | |a Lin, Jin-Ying |e verfasserin |4 aut | |
| 700 | 1 | |a Shi, Qing-Zhi |e verfasserin |4 aut | |
| 700 | 1 | |a Ouyang, Gui-Fang |e verfasserin |4 aut | |
| 700 | 1 | |a Jing, Hong-Mei |e verfasserin |4 aut | |
| 700 | 1 | |a Chen, Sai-Juan |e verfasserin |4 aut | |
| 700 | 1 | |a Li, Jian |e verfasserin |4 aut | |
| 700 | 1 | |a Mi, Jian-Qing |e verfasserin |4 aut | |
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