In:
Journal of Cancer Research and Clinical Oncology, Springer Science and Business Media LLC, Vol. 150, No. 4 ( 2024-04-11)
Abstract:
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 (MR 4.5 ), 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. MR 4 rates were similar in both arms. However, the 12-month cumulative rates of MR 4.5 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 MR 4.5 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).
Type of Medium:
Online Resource
ISSN:
1432-1335
DOI:
10.1007/s00432-024-05700-x
Language:
English
Publisher:
Springer Science and Business Media LLC
Publication Date:
2024
detail.hit.zdb_id:
1459285-X
