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J Clin Oncol. 2013 Nov 20;31(33):4215-21. doi: 10.1200/JCO.2013.48.8312. Epub 2013 Oct 14.

Oral tetra-arsenic tetra-sulfide formula versus intravenous arsenic trioxide as first-line treatment of acute promyelocytic leukemia: a multicenter randomized controlled trial.

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  • 1Hong-Hu Zhu, Hao Jiang, and Xiao-Jun Huang, Peking University People's Hospital, Beijing; De-Pei Wu, First Affiliated Hospital of Soochow University, Suzhou, Jiangsu; Jie Jin, First Affiliated Hospital of Zhejiang University, Hangzhou, Zhejiang; Jian-Yong Li, First Affiliated Hospital of Nanjing Medical University, Jiangsu Province Hospital, Nanjing; Jun Ma, Harbin Institute of Hematology and Oncology, Harbin; Jian-Xiang Wang, Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Tianjin; and Sai-Juan Chen, Rui Jin Hospital affiliated with Shanghai Jiao Tong University School of Medicine, Shanghai, People's Republic of China.

Abstract

PURPOSE:

This randomized, multicenter, phase III noninferiority trial was designed to test the efficacy and safety of an oral tetra-arsenic tetra-sulfide (As4S4) -containing formula named the Realgar-Indigo naturalis formula (RIF) compared with intravenous arsenic trioxide (ATO) as both induction and maintenance therapies for newly diagnosed acute promyelocytic leukemia (APL).

PATIENTS AND METHODS:

In all, 242 patients with APL were randomly assigned (1:1) to oral RIF (60 mg/kg) or ATO (0.16 mg/kg) combined with all-trans retinoic acid (ATRA; 25 mg/m(2)) during induction therapy. After achieving complete remission (CR), all patients received three courses of consolidation chemotherapy and maintenance treatment with sequential ATRA followed by either RIF or ATO for 2 years. The primary end point was the rate of disease-free survival (DFS) at 2 years, which was assessed for noninferiority with a 10% noninferiority margin.

RESULTS:

The median follow-up time was 39 months. DFS at 2 years was 98.1% (106 of 108) in the RIF group and 95.5% (107 of 112) in the ATO group. The DFS difference was 2.6% (95% CI, -3.0% to 8.0%). The lower limit of the 95% CI of DFS difference was greater than the -10% noninferiority margin, confirming noninferiority (P < .001). No significant differences were noted between the RIF and ATO groups with regard to the CR rate (99.1% v 97.2%; P = .62) or the overall survival at 3 years (99.1% v 96.6%; P = .18). The rates of adverse events were similar in the two groups.

CONCLUSION:

Oral RIF plus ATRA is not inferior to intravenous ATO plus ATRA as first-line treatment of APL and may be considered as a routine treatment option for appropriate patients.

PMID:
24127444
[PubMed - indexed for MEDLINE]
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