TABLE I.

Clinical trial data for supportive care treatments in acute promyelocytic leukemia (apl)

Reference	Complication and treatment	Pts (n)	Median age (years)	Efficacy results and safety
Barreto et al., 201219 (apl patients at the Mayo Clinic during 2000–2011)
	atra plus chemotherapy plus voriconazole	31	56	Only body mass index differed between study arms
	atra plus chemotherapy (no fungal prophylaxis)	15	(range: 18–80)	[higher in patients receiving voriconazole (hr: 1.04; 95% ci: 1.001 to 1.078; p=0.0427)].
				The overall incidence of ds was 35% (n=16), with patients receiving voriconazole being more likely to experience ds (hr: 2.31; 95% ci: 0.78 to 6.874; p=0.1308). After adjusting for body mass index, patients receiving voriconazole had a higher tendency to experience ds [especially severe ds (13 of 16 cases, 81%)]; however, because of small numbers, the trend was not statistically significant (hr: 1.96; 95% ci: 0.65 to 5.94; p=0.23). Admission to the intensive care unit was needed for management of severe ds in 7 patients (44%), 5 of whom had received voriconazole. Mean length of those stays was 4 days (range: 1–7 days), with no patients requiring intubation, but 29% receiving vasopressor support. No deaths were attributable to ds.
Chang et al., 201220
	Correlation of clinical bleeding events with lab coagulation profiles in apl	116	—	Overt dic occurred in 77.6% of patients.
				In patients with bleeding, wbc count was higher (p=0.026): 26.73±6.18/μL vs. 13.03±3.03/μL. prothrombin time was prolonged (p=0.002): 4.85±0.70 s vs. 2.59±0.28 s. (Patients with a prothrombin time of 5 s or greater had a relative risk of 6.14 for bleeding.) activated partial thromboplastin time was prolonged (p=0.017): 3.98±1.68 s vs. 0.96±0.93 s.
				Fibrinogen levels, platelet counts, and leukemia cell percentages were nonsignificantly different between bleeding and non-bleeding patients.
				Before initiation of atra, 7 patients experienced severe bleeding.
Ikezoe et al., 201221
	dic caused by apl; treated with rtm plus atra plus chemotherapy versus historical controls	9 8	— —	Intracranial vascular incidents developed in 2 control patients. No bleeding-related mortality was noted in patients treated with rtm. Rescue from dic occurred earlier in patients treated with rtm than in historical controls (log-rank p=0.019).

Pts = patients; atra = all-trans-retinoic acid; hr = hazard ratio; ci = confidence interval; ds = differentiation syndrome; dic = disseminated intravascular coagulation; wbc = white blood cell; rtm = recombinant human thrombomodulin.