Table 3.

TAX 324: efficacy and safety results

Results	PF	TPF
Efficacy	n = 246	n = 255
OS
Median, months	30	71a
2-year, %	55	67
3-year, %	48	62
PFS
Median, months	13	36b
2-year, %	42	53
3-year, %	37	49
Response rate, %
ORR, post-chemotherapy	64	72c
CR, post-chemotherapy	15	17d
Major safety	n = 243	n = 251
Grade 3/4 hematologic toxicity, % patients
Neutropenia	56	83
Febrile neutropenia	7	12
Neutropenic infection	8	12
Grade 3/4 non-hematologic toxicity, % patients
Stomatitis	27	21
Lethargy	10	5
Vomiting	10	8
Diarrhea	3	7
Nausea	14	14

^ap = 0.006 vs PF;

^bp = 0.004 vs PF;

^cp = 0.07 vs PF;

^dp = 0.66 vs PF.

Abbreviations: CR, complete response; ORR, overall response rate; OS, overall survival; PF, cisplatin–5-fluorouracil; PFS, progression-free survival; TPF, docetaxel + cisplatin + 5-fluorouracil.