Phase II study of irinotecan and amrubicin in patients with relapsed non-small cell lung cancer: Okayama Lung Cancer Study Group Trial 0402

Figures & data

Table I. Patient characteristics.

Number of patients		31
Age (years)	Median (range)	66 (29–75)
Gender	Male	21
	Female	10
Smoking status	Current/former/never	3/18/10
Performance status	0/1	19/12
Histology	Adenocarcinoma	21
	Squamous cell carcinoma	5
	Unclassified	5
Stage	IIIB	6
	IV	21
	Post-operative recurrence	4
No. of prior chemotherapy regimens	1/2	13/18
Prior regimens
First-line regimens	CDDP-based chemoradiotherapy	9
	CDDP-based chemotherapy	16
	CBDCA-based chemotherapy	4
	Non-platinum based chemotherapy	1
	EGFR-TKI	1
Second-line regimens	EGFR-TKI	11
	CBDCA based chemotherapy	4
	Single new agent	3

CBDCA, carboplatin; CDDP, cisplatin; EGFR-TKI, epidermal growth factor receptor-tyrosine kinase inhibitor.

Figure 1. Survival curves: Bold and thin lines indicate progression-free and overall survival, respectively. The median survival time and 1-year survival rate were 14.2 months and 64.5%, respectively, while the median progression-free survival time and 6-month progression-free survival rate were 4.0 months and 22.6%, respectively.

Table II. Adverse events in the 31 patients with 101 courses.

	Grades
	Number of patients		Number of cycles
	3	4	3	4
Leucopenia	14 (45%)	6 (19%)	27 (27%)	9 (9%)
Neutropenia	10 (32%)	14 (45%)	32 (32%)	20 (20%)
Hemoglobin	5 (16%)	2 (7%)	9 (9%)	3 (3%)
Thrombocytopenia	4 (13%)	1 (3%)	4 (4%)	1 (1%)
Febrile neutropenia	4 (13%)	3 (10%)	6 (6%)	3 (3%)
Infection	1 (3%)	1 (3%)	2 (2%)	3 (3%)
Nausea/vomiting	2 (7%)	0	3 (3%)	0
Diarrhea	2 (7%)	2 (7%)	2 (2%)	2 (2%)
Hepatotoxicity	1 (3%)	1 (3%)	1 (1%)	1 (1%)
Pneumonitis	1 (3%)	0	1 (1%)	0
Cardiac ischemia	1 (3%)	0	1 (1%)	0