. Author manuscript; available in PMC: 2014 Apr 1.

Published in final edited form as: Clin Lymphoma Myeloma Leuk. 2012 Dec 21;13(2):10.1016/j.clml.2012.11.006. doi: 10.1016/j.clml.2012.11.006

Table 1.

Doses of Ara-C Used in Different Studies and the Study Outcome

Study	Type of CBF AML (n = Number of Patients)	Dose of Consolidation Ara-C	Median Follow-Up	Median CR Duration (Months)	Cumulative Incidence of Relapse	Relapse Free Survival	Overall Survival
Bloomfield 1998³³	t(8;21), inv(16) t(16;16) and del(16) (n = 57)	4 Courses of 1 of the 3 regimens: 100 mg/m² per day for 5 days vs. 400 mg/m² per day for 5 days vs. 3 g/m² over 12 hours on days 1, 3, and 5	> 7 Years	14.3 vs. NR vs. NR^a		5-Year CR estimate of 78% vs. 57% vs. 16%^a
Byrd 1999³⁴	t(8;21) (n = 50)	3 g/m² over 12 hours on days 1, 3, and 5; single vs. 3–4 courses	4.7 Vs. 5.6 years for single vs. 3–4 courses	10.5 Vs. > 35^a		38% Vs. 71% at 5 years^a	44% Vs. 76% at 5 years^a
Byrd 2004³⁵	Inv(16) and t(16;16) (n = 48)	3 g/m² over 12 hours on days 1, 3, and 5; single vs. 3–4 courses	> 7 Years		70% Vs. 43% at 5 years^a	30% Vs. 57% at 5 years^a	70% Vs. 75% at 5 years^b
Bradstock 2005³⁶	t(8;21) and inv(16) (n = 33)	High-dose ara-C based induction therapy followed by ara-C (100 mg/m² per day on days 1–5) vs. ara-C (3 g/m² over 12 hours on days 1, 3, 5, and 7)^c	3.8 Years from consolidation randomization			69% Vs. 76% at 3 years	79% Vs. 88% at 3 years
Marcucci 2005¹⁰	t(8;21) (n = 96)	Single^d course vs. multicourse^e of high-dose ara-C	5.7 Years		64% Vs. 38% at 5 years^a		43% Vs. 56% at 5 years
Marcucci 2005¹⁰	Inv(16) (n = 101)		5.7 Years		70% Vs. 43% at 5 years^a		70% Vs. 69% at 5 years
Prebet 2009¹³	t(8;21) (n = 56)	Low-dose ara-C vs. ara-C ≥ 500 mg/m² per day for ≥ 2 days^f	4 Years			Median 10 months vs. NR^a
Prebet 2009¹³	Inv(16) (n = 73)		4 Years			23 Months in both arms

Abbreviations: AML = acute myelogenous leukemia; Ara-C = cytarabine; CBF = core binding factor; CR = complete remission; ICE = idarubicin (12 mg/m² on days 1–3, later reduced to 9 mg), high-dose ara-C (3 g/m² twice daily on days 1, 3, 5, and 7), and etoposide (75 mg/m² on days 1–7); IcE = attenuated ICE; OS = overall survival; NR = not reached; SCT = stem cell transplantation.

Signifies statistically significant difference.

The similar OS is the result of the higher salvage rate with SCT in patients receiving single course of high-dose ara-C therapy versus patients receiving multiple courses.

Ara-C was delivered as a part of ICE or IcE regimen (see text for details).

Single course of ara-C (3 g/m² over 12 hours on days 1, 3, and 5) was followed by 1 course each of etoposide/cyclophosphamide and diaziquinone/mitoxantrone.

Multicourse high-dose ara-C group included 3 to 4 courses of ara-C 3 g/m² over 12 hours on days 1, 3, and 5; or 4 courses of ara-C 400 mg/m² per day for 5 days: these 2 regimens did not differ in OS or cumulative incidence of relapse.

Ara-C was delivered as a part of combination chemotherapy (see text for details).