FOLFOXIRI vs FOLFIRINOX as first-line chemotherapy in patients with advanced pancreatic cancer: A population-based cohort study

Table 1 Patient characteristics of the overall population according to first-line chemotherapy, n (%)

Characteristics	FOLFIRINOX (n = 124)	FOLFOXIRI (n = 165)	P value
Demographic parameters
Age, median [IQR], yr	60.2 [53.0-65.9]	62.5 [54.6-67.5]	0.174
Missing	1	0
Gender			0.989
Male	73 (58.9)	97 (58.8)
Female	51 (41.1)	68 (41.2)
Familial history of cancer			0.195
No	32 (45.1)	89 (54.3)
Yes	39 (54.9)	75 (45.7)
Missing	53	1
Personal history of cancer			0.219
No	110 (90.2)	139 (85.3)
Yes	12 (9.8)	24 (14.7)
Missing	2	2
Pathological parameters
Stage at diagnosis			< 0.001
Localized	20 (16.1)	13 (7.9)
Locally advanced	18 (14.5)	60 (36.3)
Metastatic	86 (69.4)	92 (55.8)
Primary tumor site			0.022
Head	53 (43.1)	93 (56.7)
Body and/or tail	70 (56.9)	71 (43.3)
Missing	1	1
Histological grade			0.014
Well or moderately differentiated	45 (83.3)	39 (62.9)
Poorly differentiated or undifferentiated	9 (16.7)	23 (37.1)
Missing	70	103
Tumor extension
Stage at chemotherapy initiation			< 0.001
Locally advanced	14 (11.3)	60 (36.4)
Metastatic	110 (88.7)	105 (63.6)
Number of metastatic sites			< 0.001
0	14 (11.3)	60 (36.6)
1	69 (55.7)	74 (44.9)
≥ 2	41 (33.0)	31 (18.8)
Lymph node metastases			< 0.001
No	95 (76.6)	153 (92.7)
Yes	29 (23.4)	12 (7.3)
Liver metastases			< 0.001
No	37 (29.8)	84 (50.9)
Yes	87 (70.2)	81 (49.1)
Peritoneal metastases			0.124
No	109 (87.9)	134 (81.2)
Yes	15 (12.1)	31 (18.8)
Lung metastases			0.133
No	102 (82.3)	146 (88.5)
Yes	22 (17.7)	19 (11.5)
Other metastases			0.060
No	116 (93.6)	162 (98.2)
Yes	8 (6.4)	3 (1.8)
Clinical parameters
Performance status (WHO)			0.185
0	42 (35.0)	54 (32.7)
1	66 (55.0)	103 (62.4)
≥ 2	12 (10.0)	8 (4.9)
Missing	4	0
Body mass index, kg/m2	23.9 [20.8-27.4]	23.0 [20.8-25.6]	0.114
Missing	9	0
Pain			< 0.001
No	90 (73.8)	83 (50.9)
Yes	32 (26.2)	80 (49.1)
Missing	2	2
Jaundice			0.266
No	114 (93.4)	148 (89.7)
Yes	8 (6.6)	17 (10.3)
Missing	2	0
Ascites			1.000
No	117 (95.9)	157 (96.3)
Yes	5 (4.1)	6 (3.7)
Missing	2	2
Biological parameters
Albumin, median [IQR], g/L	39.1 [37.0-43.0]	35.0 [29.0-39.0]	< 0.001
Missing	48	80
Lymphocytes, median [IQR], mm3			0.408
< 1000	10 (15.9)	12 (11.4)
≥ 1000	53 (84.1)	93 (88.6)
Missing	19	102
Neutrophil-to-lymphocyte ratio, median [IQR]			0.103
< 5	82 (78.1)	42 (66.7)
≥ 5	23 (21.9)	21 (33.3)
Missing	19	102
CA19-9, median [IQR], UI/mL	885.0 [79.0-4756.0]	650.0 [138.0-5300.0]	0.669
Missing	3	34
Previous treatment
Primary tumor resection			0.277
Yes	18 (14.5)	17 (10.3)
No	106 (85.5)	148 (89.7)
Adjuvant chemotherapy			0.865
Yes	12 (9.7)	15 (9.1)
No	112 (90.3)	150 (90.9)
Median follow-up time (95%CI), mo	30.8 [23.0-NA]	61.4 [43.2-87.9]

χ² tests or Fisher’s exact tests were used to compare proportions, and Wilcoxon tests were used to compare continuous variables between the FOLFIRINOX and FOLFOXIRI groups. All statistical tests were two-sided. CA19-9: Carbohydrate Antigen 19-9; IQR: Interquartile range; WHO: World Health Organization.

Table 2 Outcomes in the overall population and propensity score-matched population according to first-line chemotherapy, n (%)

Outcomes	Overall population			Propensity score-matched population
	FOLFIRINOX (n = 124)	FOLFOXIRI (n = 165)	P value	FOLFIRINOX (n = 96)	FOLFOXIRI (n = 96)	P value
Number of cycles, median [IQR]	11.0 [6.0-13.0]	7.0 [4.0-13.0]	0.027	11.0 [6.0-14.0]	7.0 [4.0-14.5]	0.164
Missing	1	0		1	0
RECIST best response			0.187			0.079
Complete or partial response	53 (47.8)	49 (37.1)		41 (47.7)	25 (32.5)
Stability	31 (27.9)	39 (29.6)		24 (27.9)	22 (28.5)
Progression	27 (24.3)	44 (33.3)		21 (24.4)	30 (39.0)
Missing	13	33		108	19
Toxicity of grade 3 or 4			0.079			0.148
No	95 (80.5)	117 (71.3)		72 (80.0)	68 (70.8)
Yes	23 (19.5)	47 (28.7)		18 (20.0)	28 (29.2)
Digestive	5 (4.2)	21 (12.8)		5 (5.6)	9 (9.4)
Hematology	1 (0.9)	5 (3.1)		1 (1.0)	4 (4.2)
Neurology	9 (7.6)	14 (8.5)		6 (6.7)	9 (9.4)
Other	8 (6.8)	7 (4.3)		6 (6.7)	6 (6.2)
Missing	6	1		6	0
Reason for discontinuation			0.291			0.441
Progression	83 (68.0)	108 (65.5)		63 (67.0)	67 (69.8)
Toxicity	12 (9.9)	10 (6.0)		12 (12.8)	7 (7.3)
Other	27 (22.1)	47 (28.5)		19 (20.2)	22 (22.9)
Missing	2	0		2	0
Maintenance			0.194			0.553
Yes	56 (45.2)	62 (37.6)		39 (40.6)	35 (36.5)
No	68 (54.8)	103 (64.4)		57 (59.4)	61 (63.5)
Second-line chemotherapy administration			0.643			0.636
Yes	91 (73.4)	117 (70.9)		69 (71.9)	66 (68.8)
No	33 (26.6)	48 (29.1)		27 (28.1)	30 (31.2)

χ² tests or Fisher’s exact tests were used to compare proportions, and Wilcoxon tests were used to compare continuous variables between the FOLFIRINOX and FOLFOXIRI groups. All statistical tests were two-sided. IQR: Interquartile range.

Table 3 Patient characteristics in the propensity score-matched population according to first-line chemotherapy, n (%)

Characteristics	FOLFIRINOX (n = 96)	FOLFOXIRI (n = 96)	P value
Demographic parameters
Age, median [IQR], years	59.9 [53.0-66.9]	63.1 [55.2-67.1]	0.221
Missing	1	0
Gender			0.661
Male	54 (56.3)	57 (59.4)
Female	42 (43.7)	39 (40.6)
Familial history of cancer			0.806
No	31 (51.7)	51 (53.7)
Yes	29 (48.3)	44 (46.3)
Missing	36	1
Personal history of cancer			0.824
No	83 (88.3)	82 (87.2)
Yes	11 (11.7)	12 (12.8)
Missing	2	2
Pathologic parameters
Stage at diagnosis			0.598
Localized	14 (14.6)	12 (12.5)
Locally advanced	13 (13.5)	18 (18.87
Metastatic	69 (71.9)	66 (68.8)
Primary tumor site			0.385
Head	41 (42.7)	47 (49.0)
Body and/or tail	55 (57.3)	49 (51.0)
Histological grade			0.011
Well or moderately differentiated	36 (83.7)	24 (58.5)
Poorly differentiated or undifferentiated	7 (16.3)	17 (41.5)
Missing
Tumor extension
Stage at chemotherapy initiation			0.439
Locally advanced	14 (14.6)	18 (18.2)
Metastatic	82 (85.4)	78 (81.3)
Number of metastatic sites			0.724
0	14 (14.6)	18 (18.8)
1	57 (59.4)	53 (55.2)
≥ 2	25 (26.0)	25 (26.0)
Lymph node metastases			0.817
No	86 (89.6)	85 (88.5)
Yes	10 (10.4)	11 (11.5)
Liver metastases			0.274
No	26 (27.1)	33 (34.4)
Yes	70 (72.9)	63 (65.6)
Peritoneal metastases			0.059
No	84 (87.5)	74 (77.1)
Yes	12 (12.5)	22 (22.9)
Lung metastases			0.845
No	81 (84.4)	80 (83.3)
Yes	15 (15.6)	16 (16.7)
Other metastases			0.279
No	90 (93.8)	94 (97.9)
Yes	6 (6.2)	2 (2.1)
Clinical parameters
Performance status (WHO)			0.165
0	36 (39.1)	35 (36.5)
1	49 (53.3)	59 (61.5)
≥ 2	7 (7.6)	2 (2.0)
Missing	4	0
Body mass index, kg/m2	23.9 [20.7-27.1]	23.0 [21.2-25.0]	0.285
Missing	5	0
Pain			0.877
No	65 (67.7)	66 (68.8)
Yes	31 (32.3)	30 (31.2)
Jaundice			0.637
No	87 (91.6)	86 (89.6)
Yes	8 (8.4)	10 (10.4)
Missing	1	0
Ascites			1.000
No	92 (96.8)	92 (95.8)
Yes	3 (3.2)	4 (4.2)
Missing	1	0
Biological parameters
Albumin, median [IQR], g/L	39.6 [37.0-43.0]	34.6 [29.0-40.0]	0.001
Missing	40	51
Lymphocytes, median [IQR], mm3			0.157
< 1000	9 (11.2)	8 (21.0)
≥ 1000	71 (88.8)	30 (79.0)
Missing	16	58
Neutrophil-to-lymphocyte ratio, median [IQR]			0.072
< 5	63 (78.8)	24 (63.2)
≥ 5	17 (21.2)	14 (36.8)
Missing	16	58
CA19-9, median [IQR], UI/mL	857.5 [69.0-6210.0]	726.5 [152.0-5507.0]	0.500
Missing	2	20
Previous treatment
Primary tumor resection			0.284
Yes	10 (10.4)	15 (15.6)
No	86 (89.6)	81 (84.4)
Adjuvant chemotherapy			0.091
Yes	6 (6.2)	13 (13.5)
No	90 (93.8)	83 (86.5)

χ² tests or Fisher’s exact tests were used to compare proportions, and Wilcoxon tests were used to compare continuous variables between the FOLFIRINOX and FOLFOXIRI groups. All statistical tests were two-sided. CA19-9: Carbohydrate Antigen 19-9; IQR: Interquartile range; WHO: World Health Organization.