Belotecan/cisplatin versus etoposide/cisplatin in previously untreated patients with extensive-stage small cell lung carcinoma: a multi-center randomized phase III trial

Table 2 Best overall response of modified intent-to-treat and per protocol population

Modified intent-to-treat population
Response	BP (n = 71)		EP (n = 76)		Difference	90 % CI	P value by CMH test
Response	No.	%	No.	%	Difference	90 % CI	P value by CMH test
CR	1	1.4	0	0
PR	41	57.7	35	46.1
SD	17	23.9	28	36.8
PD	4	5.6	5	6.6
NE	8	11.3	8	10.5
CR + PR	42	59.2	35	46.1	13.1	−0.3 to 26.5	.214
CR + PR + SD	59	83.1	63	82.9	0.2	−10.0 to 10.4	.826
Per protocol population
Response	BP (n = 57)		EP (n = 63)		Difference	90 % CI	P value by CMH test
Response	No.	%	No.	%	Difference	90 % CI	P value by CMH test
CR	1	1.8	0	0
PR	40	70.2	34	54.0
SD	9	15.8	21	33.3
PD	3	5.3	3	4.8
NE	4	7.0	5	7.9
CR + PR	41	71.9	34	54.0	18.0	3.7 to 32.2	.061
CR + PR + SD	50	87.7	55	87.3	0.4	−0.95 to 10.4	.978

Abbreviation: BP belotecan/cisplatin, EP etoposide/cisplatin, CI Confidence interval, CMH Cochran-Mantel-Haenzel, CR complete response, PR partial response, SD stable disease, PD progressive disease, NE non-evaluable cases

ISSN: 1471-2407