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- Title
Oral arsenic plus imatinib versus imatinib solely for newly diagnosed chronic myeloid leukemia: a randomized phase 3 trial with 5-year outcomes.
- Authors
Tian, Jie; Song, Yong-Ping; Zhang, Gao-Chong; Wang, Shu-Fang; Chu, Xiao-Xiang; Chai, Ye; Wang, Chun-Ling; He, Ai-Li; Zhang, Feng; Shen, Xu-Liang; Zhang, Wei-Hua; Yang, Lin-Hua; Nie, Da-Nian; Wang, Dong-Mei; Zhu, Huan-Ling; Gao, Da; Lou, Shi-Feng; Zhou, Ze-Ping; Su, Guo-Hong; Li, Yan
- Abstract
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).
- Publication
Journal of Cancer Research & Clinical Oncology, 2024, Vol 150, Issue 4, p1
- ISSN
0171-5216
- Publication type
Article
- DOI
10.1007/s00432-024-05700-x