. Author manuscript; available in PMC: 2015 Jul 31.

Published in final edited form as: Clin Cancer Res. 2011 Oct 25;17(24):7743–7753. doi: 10.1158/1078-0432.CCR-11-1540

Table 2. Number of patients with grade 3 or 4 nonhematologic toxicities per topotecan dose level.

	Dose level

	1	2	3	4	5	6	7	8	Expanded MTD cohort
	10 mg/m²	15 mg/m²	20 mg/m²	27 mg/m²	36 mg/m²	48 mg/m²	64 mg/m²	85 mg/m²
	n = 4	n = 6	n = 4	n = 5	n = 9	n = 5	n = 7	n = 5	N = 16
Mucositis (grade 4)	1 (25%)	2 (33%)	2 (50%)	4 (80%)	5 (56%)	5 (100%)	7 (100%)	4 (80%)	15 (94%)
Number of days with grade 4 mucositis. median (range)	0 (0-1)	0 (0-10)	2.5 (0-6)	2 (0-7)	1 (0-20)	5 (1-9)	6 (4-11)	8 (0-12)	6 (0-20)
Enteritis	0	1 (17%)	3 (75%)	3 (60%)	4 (44%)	2 (40%)	4 (57%)	3 (60%)	5 (31 %)
Hematuria	0	1 (17%)	1 (25%)	0	0	0	1 (14%)	1 (20%)	0
Cortical function	0	1 (17%)	0	1 (20%)	1 (11 %)	0	0	0	2 (13%)
Peripheral nerve function	0	1 (17%)	0	0	0	0	1 (14%)	0	0
Reduction in ejection fraction	0	0	0	1 (20%)	0	0	0	1 (20%)	1 (6%)
Pulmonary clinical status	1 (25%)	1 (17%)	0	1 (20%)	0	0	0	0	1 (6%)
Nonrelapse deaths	0	0	0	0	0	0	1 (14%)	1 (20%)	2 (13%)
							Fungal infection	Septic shock	Arrhythmia (1) and bacterial sepsis (1)