1. Oral arsenic plus imatinib versus imatinib solely for newly diagnosed chronic myeloid leukemia: a randomized phase 3 trial with 5-year outcomes.
- Author
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Tian J, Song YP, Zhang GC, Wang SF, Chu XX, Chai Y, Wang CL, He AL, Zhang F, Shen XL, Zhang WH, Yang LH, Nie DN, Wang DM, Zhu HL, Gao D, Lou SF, Zhou ZP, Su GH, Li Y, Lin JY, Shi QZ, Ouyang GF, Jing HM, Chen SJ, Li J, and Mi JQ
- Subjects
- Humans, Imatinib Mesylate adverse effects, Pandemics, Treatment Outcome, Antineoplastic Agents adverse effects, Arsenic therapeutic use, Leukemia, Myelogenous, Chronic, BCR-ABL Positive drug therapy
- 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 (MR
4 ), 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)., (© 2024. The Author(s).)- Published
- 2024
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