First-line erlotinib and fixed dose-rate gemcitabine for advanced pancreatic cancer

Table 1 Patients’ characteristics n (%)

Characteristics	Categories	Data
Age (yr)	Median (range)	64 (35-81)
Gender	Male	25 (54)
	Female	21 (46)
Stage	Locally advanced	5 (11)
	Metastatic	41 (89)
ECOG PS	0	10 (22)
	1	26 (56)
	2	9 (20)
	3	1 (2)
Basal CA 19-9 (U/mL)	Median (range)	897 (1-49, 483)
Interval between symptoms and treatment (wk)	Median (range)	12 (2-179)
Clinical benefit	Evaluable	33 (75)
	Not evaluable	13 (25)
Follow-up (wk)	Median (range)	21.5 (2-91)
Number of administrations	Median (range)	9 (1-29)

PS: Performance status; ECOG: Eastern Cooperative Oncology Group; CA 19-9: Carbohydrate antigen 19-9.

Table 2 Objective response, clinical benefit response and carbohydrate antigen 19-9 reduction in the overall population n (%)

Parameter	Patients (n = 46)
CR/PR	5 (10.9)
SD	21 (45.7)
PD	20 (43.4)
CB
Pos	15 (42.9)
Neg	20 (57.1)
CA 19-9 reduction > 25%	14 (63.6)1

¹In 23 evaluable patients. CR: Complete response; PR: Partial response; SD: Stable disease; PD: Progressive disease; CB: Clinical benefit; Pos: Positive; Neg: Negative; CA 19-9: Carbohydrate antigen 19-9.

Table 3 Toxicity (maximum toxicity per patient) n (%)

Variables	Grade 0	Grade 1	Grade 2	Grade 3	Grade 4
Haemoglobin	15 (32.6)	17 (37.0)	10 (21.7)	4 (8.7)	-
Leucopenia	29 (63.0)	3 (6.5)	9 (19.6)	5 (10.9)	-
Neutropenia	25 (54.3)	2 (4.3)	9 (19.6)	8 (17.4)	2 (4.3)
Febrile neutropenia	44 (95.7)	-	2 (4.3)	-	-
Platelet	32 (69.6)	6 (13.0)	2 (4.3)	6 (13.0)	-
Fever	35 (76.1)	9 (19.6)	2 (4.3)	-	-
Bleeding	45 (97.8)	-	-	1 (2.2)	-
Alopecia	41 (89.1)	4 (8.7)	1 (2.2)	-	-
Anorexia	38 (82.6)	7 (15.2)	1 (2.2)	-	-
Asthenia	22 (47.8)	12 (26.1)	11 (23.9)	1 (2.2)	-
Cardiac	45 (97.8)	-	1 (2.2)	-	-
Skin	24 (52.2)	15 (32.6)	5 (10.9)	2 (4.3)	-
Diarrhoea	18 (39.1)	16 (34.8)	11 (23.9)	1 (2.2)	-
Constipation	46 (100.0)	-	-	-	-
Stomatitis	42 (91.3)	1 (2.2)	3 (6.5)	-	-
ALT	24 (52.2)	13 (28.3)	6 (13.0)	3 (6.5)	-
AST	19 (41.3)	12 (26.1)	10 (21.7)	4 (8.7)	1 (2.2)
Bilirubine	42 (91.3)	2 (4.3)	2 (4.3)	-	-
Renal	43 (93.5)	3 (6.5)	-	-	-
Neurological	45 (97.8)	1 (2.2)	-	-	-
Nausea	39 (84.8)	3 (6.5)	4 (8.7)	-	-
Vomiting	40 (87.0)	3 (6.5)	3 (6.5)	-	-

ALT: Alanine aminotransferase; AST: Aspartate aminotransferase.

Table 4 Multivariate analysis for progression-free survival and overall survival

Variables	PFS		OS
	HR (95%CI)	P value	HR (95%CI)	P value
PS	NA		8.78 (1.60-48.2)	0.01
Gender	2.99 (1.13-7.90)	0.03	2.66 (0.85-8.35)	0.09
CB	NA		3.07 (0.87-10.8)	0.08
Skin rash1	8.66 (2.65-28.32)	< 0.0001	5.10 (1.41-18.4)	0.01
CA 19-9 decrease2	2.64 (0.93-7.45)	0.07	3.36 (1.05-10.6)	0.04

¹None vs any grade;

²Carbohydrate antigen 19-9 (CA 19-9) decrease of ≥25%. PFS: Progression-free survival; OS: Overall survival; PS: Performance status according to Eastern Cooperative Oncology Group (PS 0-1 vs PS 2-3); CB: Clinical benefit; NA: Not applicable.