Table 3.

Response to Treatment

Response to Treatment	Treatment				Total
	BEP		T-BEP
	No. of Patients	%	No. of Patients	%	No. of Patients	%
Intent-to-treat analysis
No. of patients	169		168		337
Response to treatment
CR to chemotherapy only	84	49.7	100	59.5	184	54.6
NED, CR after chemotherapy and surgery	11	6.5	8	4.8	19	5.6
Treatment failure	17	10.1	7	4.2	24	7.1
Not evaluable	56	33.1	47	28.0	103	30.6
Early death as a result of disease	1	0.6	2	1.2	3	0.9
Early death as a result of toxicity	0	0.0	2	1.2	2	0.6
Early death as a result of other reason	0	0.0	2	1.2	2	0.6
Response, CR/NED	95	56.2	108	64.3	203	60.2
95% CI, %	48.4 to 63.8		56.5 to 71.5		P = .1482
All eligible patients
No. of patients	153		152		305
Response to treatment
CR to chemotherapy only	80	52.3	99	65.1	179	58.7
NED, CR after chemotherapy and surgery)	11	7.2	8	5.3	19	6.2
Treatment failure	15	9.8	5	3.3	20	6.6
Not evaluable	46	30.1	36	23.7	82	26.9
Early death as a result of disease	1	0.7	1	0.7	2	0.7
Early death as a result of toxicity	0	0.0	2	1.3	2	0.7
Early death as a result of other	0	0.0	1	0.7	1	0.3
Response, CR/NED	91	59.5	107	70.4	198	64.9
95% CI, %	51.2 to 67.3		62.4 to 77.5		P = .0549
Per-protocol analysis
No. of patients	152		148		300
Response to treatment
CR to chemotherapy only	80	52.6	98	66.2	178	59.3
NED, CR after chemotherapy and surgery	11	7.2	8	5.4	19	6.3
Treatment failure	15	9.9	5	3.4	20	6.7
Not evaluable	45	29.6	34	23.0	79	26.3
Early death as a result of disease	1	0.7	1	0.7	2	0.7
Early death as a result of toxicity	0	0.0	2	1.4	2	0.7
Response, CR/NED	91	59.9	106	71.6	197	65.7
95% CI, %	51.6 to 67.7		63.6 to 78.7		P = .0384

Abbreviations: BEP, bleomycin, etoposide, and cisplatin; CR, complete response; NED, no evidence of disease; T-BEP, paclitaxel–bleomycin, etoposide, and cisplatin.