Table 2.

Tumor response

Efficacy measurement	Lipo-MIT	MIT	P-value
Best overall response (%)			0.14
CR	0.0 (0/30)	0.0 (0/30)
PR	13.3 (4/30)	6.7 (2/30)
SD	36.7 (11/30)	23.3 (7/30)
PD	50.0 (15/30)	63.3 (19/30)
NE	0.0 (0/30)	6.7 (2/30)
ORR (%)	13.3 (4/30), CI: 3.8–30.7	6.7 (2/30), CI: 0.8–22.1	0.67
DCR (%)	50.0 (15/30), CI: 31.3–68.7	30.0 (9/30), CI: 14.7–49.4	0.11

Data are expressed as percentage (counts) unless otherwise specified. DCR: defined as the percentage of patients with CR or PR or SD. DCR is described by percentage (number of CRs + PRs + SDs / number of patients) and its CI. ORR: defined as the percentage of patients with CR or PR. ORR is described by percentage (number of CRs + PRs / number of patients) and its CI

CI 95% confidence interval, CR complete response, DCR disease control rate, Lipo-MIT mitoxantrone hydrochloride liposome injection, MIT mitoxantrone hydrochloride injection, NE Not evaluable, ORR overall response rate, PD progress disease, PR partial response, SD stable disease