FOLFIRI regimen in metastatic pancreatic adenocarcinoma resistant to gemcitabine and platinum-salts

Table 1 Characteristics of the 63 patients with metastatic pancreatic cancer treated with FOLFIRI after failure of gemcitabine and platinum-salts

Characteristics	Data
Age (yr)
Median	59 (range: 24-81)
Sex (%)
Male	33 (52.4)
Performans status (%)
PS 0	27 (42.9)
PS 1	24 (38.1)
PS 2	12 (19.0)
Liver metastases (%)
Present	51 (81.0)
Number of previous lines before FOLFIRI (%)
1	19 (30.2)
2	39 (61.9)
≥ 3	5 (7.9)

Table 2 Results of univariate and multivariate analysis for time to progression with FOLFIRI

	Progression	Univariate analysis			Multivariate analysis
	Yes/no (57/1)	HR	95% CI	P value	HR	95% CI	P value
Primary tumor location1				0.687
Body or tail	18/0	1
Head	28/1	0.883	(0.483-1.615)
Stage at the diagnosis				0.666			0.652
Resectable	22/0	1			1
Locally advanced	15/1	1.235	(0.631-2.418)		1.394	(0.662-2.939)
Metastatic	20/0	0.905	(0.490-1.674)		1.299	(0.626-2.695)
Previous surgery				0.659
No	37/1	1
Yes	20/0	0.882	(0.506-1.539)
Previous radiotherapy				0.411			0.168
No	44/0	1			1
Yes	13/1	1.305	(0.692-2.459)		1.770	(0.786-3.987)
Number of previous chemotherapy lines				0.284			0.026
1	16/0	1			1
2	36/1	0.649	(0.350-1.204)	0.170	0.385	(0.193-0.770)
3	5/0	1.128	(0.411-3.096)	0.814	0.554	(0.177-1.735)
Liver metastases				0.531			0.564
No	9/0	1			1
Yes	48/1	0.793	(0.383-1.640)		1.298	(0.535-3.151)
WHO performans status				< 0.0001			< 0.0001
0	24/0	1			1
1	22/1	1.325	(0.731-2.399)		1.431	(0.745-2.748)
2	11/0	16.036	(5.926-43.394)		29.255	(9.278-92.248)
Type of FOLFIRI regimen				0.124
FOLFIRI-1	50/0	1
FOLFIRI-3	7/1	0.503	(0.210-1.207)

HR: Hazard ratio; WHO: World Health Organization.

¹Data available in 47 out of 58 cases.

Table 3 Results of univariate and multivariate analysis for overall survival with FOLFIRI

	Death	Univariate analysis			Multivariate analysis
	Yes/no (49/14)	HR	95% CI	P value	HR	95% CI	P value
Primary tumor location1				0.306
Body or tail	16/2	1
Head	25/7	0.717	(0.380-1.355)
Stage at the diagnosis				0.754			0.644
Resectable	20/4	1			1
Locally advanced	13/6	1.012	(0.497-2.058)		0.790	(0.346-1.806)
Metastatic	16/4	1.271	(0.643-2.515)		1.205	(0.577-2.514)
Previous surgery				0.203
No	31/9	1
Yes	18/5	0.676	(0.370-1.236)
Previous radiotherapy				0.916			0.935
No	38/9	1			1
Yes	11/5	0.964	(0.491-1.894)		0.965	(0.412-2.260)
Number of previous chemotherapy lines				0.102			0.171
1	14/5	1			1
2	30/9	1.234	(0.649-2.346)		1.197	(0.564-2.538)
3	5/0	3.188	(1.090-9.326)		2.945	(0.930-9.324)
Liver metastases				0.599			0.957
No	9/3	1			1
Yes	40/11	1.217	(0.586-2.528)		0.978	(0.444-2.159)
WHO performance status				0.004			0.004
0	22/5	1			1
1	18/6	1.360	(0.719-2.573)		1.284	(0.650-2.535)
2	9/3	4.003	(1.770-9.056)		4.702	(1.883-11.741)
Type of FOLFIRI regimen				0.856
FOLFIRI-1	42/13	1
FOLFIRI-3	7/1	1.083	(0.458-2.562)

HR: Hazard ratio; WHO: World Health Organization.

¹Data available in 50 out of 63 cases.

Table 4 PhaseI-II studies of regimens as first and second lines chemotherapy in advanced pancreatic cancer

Regimen	Number of patients	TCR/ORR (%/%)	TTP or PFS (mo)	OS (mo)
Phase I-II studies1
Irinotecan/gemcitabine/5-FU[27]	30	43/7	3.4	8.3
G-FLIP (Irinotecan/gemcitabine/5-FU/cisplatin)[28]	31	68/26	6.1	8.1
FOLFIRI-3 (Irinotecan/5-FU)[20]	40	65/38	5.6	12.1
Irinotecan/S1[29]	16	75/44	4.9	11.3
Phase II studies2
Irinotecan/raltitrexed[32]	19	53/16	4.0	6.5
IROX (Irinotecan/oxaliplatin)[33]	30	33/10	4.1	5.9
IROX (Irinotecan/oxaliplatin)[34]	14	50/21	1.4	4.1
G-FLIP (Irinotecan/gemcitabine/5-FU/cisplatin)[35]	34	44/24	3.9	10.3
Irinotecan/docetaxel[36]	14	21/0	1.2	4.4
MDI (Irinotecan/mitomycin/docetaxel)[37]	15	20/0	1.7	6.1

¹Phases I-II studies of irinotecan and 5-fluorouracil (5-FU)-based regimens as first line chemotherapy;

²Phase II studies of irinotecan-based regimens as second line chemotherapy. TCR: Tumor control rate; ORR: Overall response rate; TTP: Time to progression; PFS: Progression free survival; OS: Overall survival.