Table 1.

Summary of included trials



Treatment protocol

8525a
8923b
9022c
9222d
9420e
9621f
9720g
Years of patient accrual   10/85-10/90   2/90-11/93   10/90-3/92   7/92-12/95   1/95-7/97   2/97-3/00   1/98-3/99  
Trial phase   3   3   2   3   1   1/2   3  
Patientsh        
   Total   1036   360   213   407   103   340   111  
   White, no. (%)   920 (89)   334 (93)   192 (90)   354 (87)   94 (91)   301 (89)   105 (95)  
   African American, no. (%)   116 (11)   26 (7)   21 (10)   53 (13)   9 (9)   39 (11)   6 (5)  
   Cytogenetics available, no. (%)   563 (54)   210 (58)   124 (58)   269 (66)   62 (60)   270 (79)   82 (74)  
Induction 1l  Yes   Yesi  Yes   Yes   Yesj  Yesj  Yesj 
Etoposide used in inductions 1 (and 2, if needed)   No   No   No   No   Yes: 60 or 100 mg/m2/d × 3 days   Yes: 60-150 mg/m2/d × 3 days   Yes: 60 or 100 mg/m2/d × 3 days  
Induction 2, if needed   Yes   Yes   Yes   Yes   Yesk  Yesk  Yesk 
Intensification or consolidation therapy randomized, by arm  Yes, arms A, B, C   Yes, arms A, B   No   Yes, arms A, B   No   Yes, risk-adapted, arms A, B   No  
   Intensification or consolidation therapy 1, by arm   A: SDAC; B: IDAC; C: HDAC   A: SDAC; B: M + IDAC   HDAC   A: HDAC; B: HDAC   5 + 2 + 2   A:HDAC; B: HDAC + E   5 + 2 + 2  
   Intensification or consolidation therapy 2, by arm   A: SDAC; B: IDAC; C: HDAC   A: SDAC; B: M + IDAC   E + C   A: HDAC; B: E + C   -   A: HDAC; B: SCT   -  
   Intensification or consolidation therapy 3, by arm   A: SDAC; B: IDAC; C: HDAC   A: SDAC; B: None   M + D   A: HDAC; B: M + D   -   A: HDAC; B: None   -  
   Intensification or consolidation therapy 4, by arm   A: SDAC; B: IDAC; C: HDAC   A: SDAC; B: None   -   -   -   -   -  
Maintenance therapy
 
Yes
 
No
 
No
 
No
 
Yes
 
Yes
 
Yes
 


Treatment protocol

8525a
8923b
9022c
9222d
9420e
9621f
9720g
Years of patient accrual   10/85-10/90   2/90-11/93   10/90-3/92   7/92-12/95   1/95-7/97   2/97-3/00   1/98-3/99  
Trial phase   3   3   2   3   1   1/2   3  
Patientsh        
   Total   1036   360   213   407   103   340   111  
   White, no. (%)   920 (89)   334 (93)   192 (90)   354 (87)   94 (91)   301 (89)   105 (95)  
   African American, no. (%)   116 (11)   26 (7)   21 (10)   53 (13)   9 (9)   39 (11)   6 (5)  
   Cytogenetics available, no. (%)   563 (54)   210 (58)   124 (58)   269 (66)   62 (60)   270 (79)   82 (74)  
Induction 1l  Yes   Yesi  Yes   Yes   Yesj  Yesj  Yesj 
Etoposide used in inductions 1 (and 2, if needed)   No   No   No   No   Yes: 60 or 100 mg/m2/d × 3 days   Yes: 60-150 mg/m2/d × 3 days   Yes: 60 or 100 mg/m2/d × 3 days  
Induction 2, if needed   Yes   Yes   Yes   Yes   Yesk  Yesk  Yesk 
Intensification or consolidation therapy randomized, by arm  Yes, arms A, B, C   Yes, arms A, B   No   Yes, arms A, B   No   Yes, risk-adapted, arms A, B   No  
   Intensification or consolidation therapy 1, by arm   A: SDAC; B: IDAC; C: HDAC   A: SDAC; B: M + IDAC   HDAC   A: HDAC; B: HDAC   5 + 2 + 2   A:HDAC; B: HDAC + E   5 + 2 + 2  
   Intensification or consolidation therapy 2, by arm   A: SDAC; B: IDAC; C: HDAC   A: SDAC; B: M + IDAC   E + C   A: HDAC; B: E + C   -   A: HDAC; B: SCT   -  
   Intensification or consolidation therapy 3, by arm   A: SDAC; B: IDAC; C: HDAC   A: SDAC; B: None   M + D   A: HDAC; B: M + D   -   A: HDAC; B: None   -  
   Intensification or consolidation therapy 4, by arm   A: SDAC; B: IDAC; C: HDAC   A: SDAC; B: None   -   -   -   -   -  
Maintenance therapy
 
Yes
 
No
 
No
 
No
 
Yes
 
Yes
 
Yes
 

SDAC indicates 100 mg/m2 cytarabine by ci every day × 5 days; IDAC, 400 mg/m2 cytarabine by ci every day × 5 days; HDAC, 3 g/m2 cytarabine by intravenous bolus (ivb) over 3 hours every 12 hours on days 1, 3 and 5; HDAC + E, 2 mg/m2 cytarabine by ivb over 2 hours every 12 hours on days 1-4 and 40 mg/kg etoposide by ci every day for 4 days; M + IDAC, 5 mg/m2 mitoxantrone every 12 hours and 500 mg/m2 cytarabine every 12 hours for 6 doses each; E + C, 1800 mg/m2 etoposide by ci day 1 plus 50 mg/kg cyclophosphamide ivb on days 2 and 3; M + D, 12 mg/m2 mitoxantrone ivb plus 24 mg/m2 diaziquone by ci days 1, 2, and 3 plus 5 μg/kg filgrastim subcutaneously days 4 through 28; 5 + 2 + 2, 100 mg/m2 cytarabine by continuous infusion every day × 5 days plus 2 days of daunorubicin and etoposide at doses equivalent to those received in induction 1, ± PSC 833. Maintenance therapy for study 8525 consisted of 45 mg/m2 daunorubicin ivb on day 1 plus 100 mg/m2 cytarabine subcutaneously every 12 hours on days 1 through 5 repeated monthly × 4; for studies 9420, 9621, and 9720, maintenance therapy consisted of interleukin-2 as specified by Farag et al30  and Baer et al.31  ivp indicates intravenous push; SCT, stem cell transplantation; and -, not applicable.

a

Mayer et al.24 

b

Stone et al.25,36 

c

Moore et al.26 

d

Moore et al.27 

e

Lee et al.28 

f

Kolitz et al.29 

g

Baer et al.31 

h

Patient population data are as follows: total, N = 2570; white, n = 2300 (89.5% of total); African American, n = 270 (10.5% of total); and cytogenetics available, n = 1580 (61% of total)

i

50% of enrolled patients received granulocyte-macrophage colony-stimulating factor (GM-CSF) during induction

j

Patients in 9420 received daunorubicin at doses ranging from 30 to 60 mg/m2/d × 3 days and also received the multidrug resistance modulator PSC 833 at a loading dose of 1.5 mg/kg and a continuous infusion of 10 mg/kg/d for 3 days; patients in 9621 received daunorubicin at doses ranging from 40 to 90 mg/m2/d × 3 days depending on their randomization to PSC 833 at a loading dose of 2.8 mg/kg and a continuous infusion of 10 mg/kg/d for 3 days; patients in 9720 received daunorubicin at doses of 40 or 60 mg/m2/d × 3 days depending on their randomization to PSC 833 at a loading dose of 2.8 mg/kg and a continuous infusion of 10 mg/kg/d for 3 days

k

Doses were equivalent to those received in induction 1. Patients receiving PSC 833 for induction 1 received it for induction 2 over 2 days

l

Induction 1 consisted of daunorubicin 45 mg/m2 ivp × 3 days and cytarabine 100 or 200 mg/m2 by continuous infusion (ci) × 7 days. Induction 2, which was administered if needed, consisted of daunorubicin 45 mg/m2 ivp × 2 days and cytarabine 100 or 200 mg/m2 by ci × 5 days

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