scholarly journals The Real World of Arsenic Uses in Chinese with Acute Promyelocytic Leukemia: A Cross-Sectional Survey

Blood ◽  
2016 ◽  
Vol 128 (22) ◽  
pp. 5955-5955
Author(s):  
Hong-Hu Zhu ◽  
Feng-Mei Zheng ◽  
Xiao-Jun Huang

Abstract OBJECTIVE: Arsenic has become first-line treatment of acute promyelocytic leukemia (APL) since 2013 according to NCCN Guidelines Acute Myeloid Leukemia Version 2.2013, but little information is available about the real world of arsenic uses in China. We aimed to evaluate the usage of arsenic and assess the current status of the treatment of APL in China. METHODS: Noninterventional, cross-sectional survey using electronic questionnaires distributed to APL patients and answered anonymously. RESULTS: In total, 237 respondents were evaluable and 120 respondents (50.6%) were male. Median age was 40 years (range 15-68 years). Median time from diagnosis to this survey was 15 months. Valid submissions came from 28 of 34 provinces and municipalities. There were 77.64% respondents hospitalized within three days since diagnosis. The percentage of respondents received arsenic during induction treatment was 73.8% (175/237), including arsenic trioxide (ATO) (n=136) and oral arsenic (n=39). However, the percentage increased up to 100% (237/237) during the post-remission treatment phase, including ATO (n=137) and oral arsenic (n=100). Interestingly, 32.9% respondents considered the costs of ATO acceptable by themselves. However, 92.4% respondents regarded the burden of oral arsenic was high because it was not covered by health insurance, and 95.8% respondents appeal to oral arsenic covered by health insurance. The proportion of respondents covered by Basic Insurance for Urban Employees, Basic Insurance for Urban Residents, the New Rural Cooperative Medical Scheme and Commercial insurance were 3.8%, 44.3%, 38.4% and 5.9%. In total, 99.16% respondents hope to receive a chemotherapy-free outpatient treatment protocol CONCLUSIONS: High proportion of APL patients received arsenic as first-line treatment in China, which may result from the relative low price of arsenic. A chemotherapy-free outpatient treatment model worthy to explore. Disclosures No relevant conflicts of interest to declare.

2012 ◽  
Vol 30 (14) ◽  
pp. 1641-1646 ◽  
Author(s):  
Cecile Bally ◽  
Jehane Fadlallah ◽  
Guy Leverger ◽  
Yves Bertrand ◽  
Alain Robert ◽  
...  

Purpose Acute promyelocytic leukemia (APL) is rare in children. All-trans-retinoic acid (ATRA) combined with chemotherapy, the reference treatment of APL, is generally considered to produce similar results in children and adults. However, previously published childhood APL studies have generally analyzed all patients age < 18 years as a group, without further dividing according to age. Patients and Methods We compared disease characteristics and outcomes of children (age ≤ 12 years), adolescents (13 to 18 years), and adults (> 18 years) included in two multicenter APL clinical trials (APL 93 and 2000 trials). Results Of the 833 patients age ≤ 60 years included in the two trials, 26 (3%), 58 (7%), and 749 (90%) were children, adolescents, and adults, respectively. Children had significantly higher baseline WBC counts (P < .001). The complete remission (CR) rate (92%, 100%, and 94.5%, respectively) and 5-year cumulative incidence of relapse (CIR; 28%, 20%, and 23%, respectively) did not differ between children, adolescents, and adults, whereas adolescents had significantly better overall survival (OS; 5-year OS, 93.6% v 80.4% in adults and 80.4% in children; P = .03). However, in children age ≤ 4 years, the 5-year CIR was 52%, compared with 17.6% in children age 5 to 12 years (P = .006), although most of the younger children who relapsed experienced durable salvage with autologous or allogeneic stem-cell transplantation. Conclusion Adolescents and children age > 4 years with APL treated with ATRA and chemotherapy have outcomes at least as favorable as those of adults. Younger children seem to experience more relapses and may require reinforcement of first-line treatment.


2013 ◽  
Vol 31 (33) ◽  
pp. 4215-4221 ◽  
Author(s):  
Hong-Hu Zhu ◽  
De-Pei Wu ◽  
Jie Jin ◽  
Jian-Yong Li ◽  
Jun Ma ◽  
...  

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/m2) 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.


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