Table 6

Comparison of treatment regimens and outcomes for representative contemporary protocolsa

ReferenceNo. (age restriction)Median followup, yNo. of arsenic treatment daysbIdarubicin equivalent, mg/m2cCytarabine, g/m2bOther cytotoxic agents in induction and/or consolidationOSdDFSdEFSd
Adès (APL 2000)28  178 (< 65) 5.2  99 10.8-22.8e  94% (3 y)  86% (3 y) 
Sanz (LPA 2005) 402 2.3  105-125e 0-5.8e  88% (4 y) 90% (4 y)  
Lo Coco (AIDA 2000) 445 (< 62) 4.9  121.7 0-6.3e Etoposidef
6-thioguaninef 
87% (6 y) 86% (6 y)  
Matthews (Vellore) 72 5.0 112-158   Hydroxyureag
Low-dose anthracyclineg 
74% (5 y) 80% (5 y) 69% (5 y) 
Ghavamzadeh (Tehran)10  197 3.2 (patients in CR) 58-142h   Hydroxyureag 64% (5 y) 67% (5 y)  
Lu (Beijing)22 i 19 1.1 546-597     77% (3 y)  
Powell (North American Intergroup C9710)13  243 2.4 50 100 1.4 Hydroxyureag 86% (3 y) 90% (3 y) 80% (3 y) 
Gore (Baltimore)25  45 2.7 30 72 2.0 Hydroxyureag 88% (3 y) 89% (3 y) 76% (3 y) 
Hu (Shanghai)11  85 5.8 175 81 17.7-26.7e Hydroxyureag
Idarubicin + cytarabineg
Homoharringtoninej 
92% (5 y) 95% (5 y)k 89% (5 y) 
Dai (Changsha)26 j 90 2.7 68-84 135 2.6-3.6e Hydroxyureag
Homoharringtonineg,j 
 93% (2.5 y)  
Ravandi (Houston)12  82 1.9 99-110h   Gemtuzumab ozogamicing 85% (3 y) 81% (3 y)m  
Iland APML4 (current study) 124 2.0 81 48   93% (2 y) 98% (2 y) 88% (2 y) 
ReferenceNo. (age restriction)Median followup, yNo. of arsenic treatment daysbIdarubicin equivalent, mg/m2cCytarabine, g/m2bOther cytotoxic agents in induction and/or consolidationOSdDFSdEFSd
Adès (APL 2000)28  178 (< 65) 5.2  99 10.8-22.8e  94% (3 y)  86% (3 y) 
Sanz (LPA 2005) 402 2.3  105-125e 0-5.8e  88% (4 y) 90% (4 y)  
Lo Coco (AIDA 2000) 445 (< 62) 4.9  121.7 0-6.3e Etoposidef
6-thioguaninef 
87% (6 y) 86% (6 y)  
Matthews (Vellore) 72 5.0 112-158   Hydroxyureag
Low-dose anthracyclineg 
74% (5 y) 80% (5 y) 69% (5 y) 
Ghavamzadeh (Tehran)10  197 3.2 (patients in CR) 58-142h   Hydroxyureag 64% (5 y) 67% (5 y)  
Lu (Beijing)22 i 19 1.1 546-597     77% (3 y)  
Powell (North American Intergroup C9710)13  243 2.4 50 100 1.4 Hydroxyureag 86% (3 y) 90% (3 y) 80% (3 y) 
Gore (Baltimore)25  45 2.7 30 72 2.0 Hydroxyureag 88% (3 y) 89% (3 y) 76% (3 y) 
Hu (Shanghai)11  85 5.8 175 81 17.7-26.7e Hydroxyureag
Idarubicin + cytarabineg
Homoharringtoninej 
92% (5 y) 95% (5 y)k 89% (5 y) 
Dai (Changsha)26 j 90 2.7 68-84 135 2.6-3.6e Hydroxyureag
Homoharringtonineg,j 
 93% (2.5 y)  
Ravandi (Houston)12  82 1.9 99-110h   Gemtuzumab ozogamicing 85% (3 y) 81% (3 y)m  
Iland APML4 (current study) 124 2.0 81 48   93% (2 y) 98% (2 y) 88% (2 y) 
a

References 3, 4, and 28 are ATRA/chemotherapy protocols; references 9, 10, and 22 are single-agent arsenic protocols (ATO or As4S4); references 13 and 25 are ATRA/chemotherapy protocols with ATO in consolidation; references 11 and 26 are ATRA/ATO/chemotherapy protocols; and reference 12 is an ATRA/ATO protocol with gemtuzumab ozogamicin for high-risk patients.

b

Data for arsenic exposure (ATO or As4S4) include amounts used in induction, consolidation, and (where appropriate) maintenance; data for idarubicin equivalent and cytarabine doses include amounts used in induction and consolidation.

c

Idarubicin equivalent calculated as follows41 : 10 mg of idarubicin = 12 mg of mitoxantrone = 50 mg of daunorubicin.

d

OS: overall survival; DFS: disease-free survival; EFS: event-free survival; survival data are single time-point figures at the times shown in parentheses.

e

Higher dose for high-risk patients, except LPA 2005, in which the intermediate-risk group received the highest idarubicin equivalent dose of anthracycline (idarubicin) plus anthraquinone (mitoxantrone).

f

Additional chemotherapy during consolidation for high-risk patients.

g

Additional chemotherapy during induction for high-risk patients.

h

Based on median number of days to CR = 30.

i

This study used single-agent As4S4 rather than ATO.

j

Additional chemotherapy during consolidation for all patients.

k

Data were reported as RFS with no deaths in CR and are therefore included as DFS here.

l

Results shown are for the group B1 patients who received ATRA and ATO during induction; the total cytarabine dose ranged from 4.5-6.3 g and has been adjusted for an average body surface area of 1.73 m2.

m

EFS in this series was measured from the date of CR until relapse or death and is therefore listed here as DFS.

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