Table 1. Patient characteristics.

	Docetaxel		Docetaxel–Irinotecan
	No.	%	No.	%	P
Patients entered	56		52		NS
Age (years)					NS
Median	59		58
Range	36–78		42–76
Sex					NS
Male	44	79	32	62
Female	12	21	20	38
Stage					NS
IIIb	14	25	11	21
IV	42	75	41	79
Performance status					NS
0	10	18	13	25
1	39	70	37	71
2	7	13	2	4
Histology					NS
Squamous cell carinoma	17	30	10	19
Adenocarcinoma	25	45	22	42
Large cell carcinoma	11	20	19	37
Other	3	5	1	2
Previous radiotherapy
To primary tumour	16	29	14	27	NS
To metastases	10	18	4	8	NS
First-line chemotherapy					NS
Platinum-based	40	71	39	75
Nonplatinum-based	16	29	13	25
RR to first-line chemotherapy					NS
%	54		48
95% CI	41–67		34–62
Treatment interval (weeks) a					NS
Median	35		29
Range	2–167		1–147

NS=not significant, RR=response rate, CI=confidence interval.

^aInterval between completion of previous chemotherapy and the date of randomisation.