. Author manuscript; available in PMC: 2017 Feb 1.

Published in final edited form as: Clin Geriatr Med. 2016 Feb;32(1):155–173. doi: 10.1016/j.cger.2015.08.010

Table 4.

Selected randomized trials of induction chemotherapy for older adults with AML

Chemotherapy regimens^*	Age range (years)	N	CR (%)	Median OS (months)	P value for OS	Induction death rate (%)	Comments
Intensive versus supportive care
Ara-C, daunorubicin, vincristine Supportive care [32]	65-85	31	58	5.3	<0.05	9.7	No difference in days hospitalized
Ara-C, daunorubicin, vincristine Supportive care [32]		29	0	2.8		N/A	No difference in days hospitalized

Type and dose of anthracycline
Ara-C, daunorubicin 80 mg/m²	50-70	156	70	No difference	0.16	8	Median OS 17 months forentire study cohort
Ara-C, Idarubacin 12 mg/m² ×3days		155	83			3
Ara-C, Idarubacin 12 mg/m² ×4days [47]		157	78			6
Ara-C, daunorubicin 45mg/m² [43]	60-83	411	54	No difference	0.16	11	Benefits suggested among patients aged 60-65
Ara-C, daunorubicin 90mg/m²		402	64			12	Benefits suggested among patients aged 60-65

Dose attenuated induction
Rubidazone, Ara-C	65-83	46	52	12.8	0.12	31
Low-dose Ara-C [46]		41	32	8.8		10

Growth factor support
Ara-C, daunorubicin [45]	60-80^**	195	54	9.4	0.10	16
Ara-C, daunorubicin,+GM-CSF		193	51	9.4		20

MDR1 modulation
Ara-C, daunorubicin, etoposide	60-84	61	46	No difference	0.48	20
Ara-C, daunorubicin, etoposide, +PSC-833 [41]		59	39			44

Addition of gemtuzumab ozogamicin
Ara-C, daunorubicin [39]	50-70	139	75^***	11	<0.05	4
Ara-C, daunorubicin,+gemtuzumab		139	81^***	28		6
Daunorubicin, Ara-C or clofarabine	51-84	556	58	Improved	0.05	9	Improved 3yr survival (25 vs. 20%)
Daunorubicin, Ara-C or clofarabine +gemtuzumab [42]		559	65			8

Lower intensity therapy
Supportive care or low-dose Ara-C	64-91	243	8	5	0.2	8	Poor/intermediate risk cytogenetics only
Decitabine [50]		242	18	8		9	ECOG PS 0-2 with minimal comorbid conditions
Low-dose Ara-C ± ATRA [49]	51-90	103	18	Improved	<0.05	26	No specific “fitness” criteria except comorbidity if <70
Hydroxyurea ± ATRA		99	1			26	No specific “fitness” criteria except comorbidity if <70
Azacitidine [51]	64-91	241	20	10.4	0.1	7	In adjusted analyses, survival benefit or azacitidine (p=0.03)
Conventional care (supportive, low-dose cytarabine, intensive chemotherapy)		247	22	6.5		10

Abbreviations: AML= acute myelogenous leukemia; N= number of patients enrolled; CR= complete remission; OS= overall survival; Ara-C= cytarabine; N/A= not applicable; GM-CSF= granulocyte macrophage colony stimulating growth factor, ECOG= Eastern Cooperative Oncology Group; PS= performance status.

One limitation in translating clinical trial data into best practices is both the lack of consistency in patient populations recruited and in drug doses utilized making comparisons of results between trials challenging.

^**

4%≥80 years

^***

rates represent CR with incomplete platelet count recovery