Second-line therapy for gemcitabine-pretreated advanced or metastatic pancreatic cancer

Table 1 Baseline patient characteristics in second line therapy

Clinical features	80 patients
Sex
Male	38
Female	42
Median age (yr)	61.0
Histological diagnosis	67 (83.8)
OMS
0	31 (38.7%)
1	40 (50.0%)
2	7 (8.8%)
3	2 (2.5%)
Presence of primary tumor	55 (68.8%)
Gemcitabine
Median number of cycle	3.0 (1.0-12.0)
Median duration (mo)	3.3 (0.5-18.9)
Duration ≥ 4 mo	29 (36.2%)
Metastatic disease	77 (96.3%)
Hepatic	70.1%
Peritoneal	29.9%
Nodal	23.4%
Pulmonary	16.9%
Carbohydrate antigen 19-9
Initial median concentration (IU/mL)	741 (2.0-> 2000)
Elevated (> 60 IU/mL)	57 (89.1%)

Data are expressed as median values (range).

Table 2 Treatment regimens in second line n (%)

Groups of chemotherapy	Patients
Cisplatin group	23 (28.8)
LV5FU2-CDDP	23 (28.8)
Irinotecan group	22 (27.5)
FOLFIRI	12 (15.0)
XELIRI	10 (12.5)
Oxaliplatin group	21 (26.2)
GEMOX	13 (16.2)
FOLFOX	8 (10.0)
Other group	14 (17.5)
5-FU alone	3 (3.7)
Gemcitabine + erlotinib	4 (5.0)
Gemcitabine + capecitabine	3 (3.7)
Capecitabine	1 (1.2)
5-FU + CDDP + RT	3 (3.7)

LV5FU2-CDDP: Folinic acid 400 mg/m², 5-FU bolus 400 mg/m², 5-FU 2400 mg/m² over 46 h and cisplatin 50 mg/m² on day 2, every 2 wk; FOLFIRI: Irinotecan 180 mg/m², folinic acid 400 mg/m², 5-FU bolus 400 mg/m², 5-FU 2400 mg/m² over 46 h, every 2 wk; XELIRI: Irinotecan 240 mg/m² and capecitabine po 2000 mg/m² J2-J15 every 3 wk; GEMOX: Gemcitabine 1000 mg/m² J1 and oxaliplatine 100 mg/m² J2, every two weeks; FOLFOX: Oxaliplatine 85 mg/m², folinic acid 400 mg/m², 5-FU bolus 400 mg/m², 5-FU 2400 mg/m² over 46 h, every 2 wk; 5-FU alone: 5-FU 250 mg/m² every day as continuous infusion; Gemcitabine + erlotinib: Gemcitabine 1000 mg/m² weekly X 7 for 8 wk then weekly X 3 out of 4 wk plus either erlotinib 100 mg po daily; Gemcitabine + capecitabine: Gemcitabine 1000 mg/m² weekly X 3 for 4 wk and capecitabine 1600 mg/m² J1-J21; Gapecitabine: 2500 mg/m² weekly X 2 for 3 wk; 5-FU + CDDP + RT: 60 Gy in 6 wk, 2 Gy/fraction, concomitant with 5-FU 300 mg/m² per 24 h as a continuous infusion, day 1-5 every week and cisplatin 20 mg/m² per day, day 1-5 at week 1 and 5.

Table 3 Chemotherapy regimens in second line

	Cisplatin group	Irinotecan group	Oxaliplatin group	Other group	P value
Number of patient	23 (28.8%)	22 (27.5%)	21 (26.3%)	14 (17.5%)	NS
Median number of cycle	5.0 (1.0-10.0)	5.0 (1.0-12.0)	4.0 (1.0-12.0)	2.0 (1.0-5.0)	NS
Median duration of treatment (mo)	2.7 (0.5-6.9)	3.2 (0.3-7.4)	2.3 (0.6-7.1)	2.3 (0.3-7.4)	NS
Disease control rate	10 (43.5%)	9 (40.9%)	9 (42.9%)	4 (28.6%)	NS
OS (mo)	6.7 (3.2-9.3)	4.5 (3.2-6.4)	4.5 (2.6-9.6)	5.2 (3.8-15.8)	NS
PFS (mo)	4.1 (1.9-6.7)	3.0 (2.0-6.1)	2.6 (1.8-5.4)	2.4 (2.1-10.1)	NS

OS: Overall survival; PFS: Progression-free survival; NS: Not significant.

Table 4 Toxicity, dosage modifications and chemotherapy discontinuation n (%)

	Patients
Clinical toxicity grade 3-4
Nausea	3 (3.7)
Vomiting	5 (6.2)
Diarrhea	2 (2.4)
Stomatitis	1 (1.2)
Fever	6 (7.5)
Infection	6 (7.5)
Haematological toxicity grade 3-4
Anemia	2 (2.4)
Neutropenia	14 (17.1)
Thrombocytopenia	1 (1.2)
Dosage modifications	41 (51.3)
Type
Treatment suppression	7 (17.1)
Dose reduction	17 (41.5)
Delay of cycle	33 (80.5)
Discontinuation before evaluation	31 (41.3)
Progressive disease	23 (74.2)
Toxicity	3 (9.7)
Chemotherapy-related deaths	5 (16.1)

Table 5 Toxicity for chemotherapy groups n (%)

	Cisplatin group	Irinotecan group	Oxaliplatin group	Other group	P value
Clinical toxicity grade 3-4
Nausea	0	0	3 (14.3)	0	NS
Vomiting	2 (9.1)	0	2 (9.5)	1 (5.3)	NS
Diarrhea	1 (4.5)	1 (5.6)	0	0	NS
Fever	0	4 (22.3)	1 (4.8)	1 (5.3)	NS
Infection	0	3 (16.7)	3 (14.3)	0	NS
Haematological toxicity grade 3-4
Anemia	0	1 (5.6)	1 (4.8)	0	NS
Neutropenia	6 (27.3)	6 (33.4)	2 (9.5)	0	NS
Thrombocytopenia	1 (4.5)	0	0	0	NS

NS: Not significant.

Table 6 Dose reduction n (%)

Dose reduction	Patients
Neutropenia grade 2 or 3-4	5 (6.2)
Thrombocytopenia grade 2	4 (5.0)
Hand-foot skin reaction grade 2	5 (6.2)
Neuropathy grade 2	2 (2.4)
Diarrhea grade 3-4	1 (1.2)