FOLFIRINOX vs gemcitabine/nab-paclitaxel for treatment of metastatic pancreatic cancer: Single-center cohort study

Table 1 Baseline characteristics of all patients, n (%)

Characteristics	FOLFIRINOX (n = 86)	Gem + Nab-paclitaxel (n = 81)	P value
Age (yr)	54 (30-78)	65 (42-79)	< 0.001
Male sex	49 (57.0)	37 (45.7)	0.144
ECOG-PS			0.040
0	72 (83.7)	57 (70.4)
1	14 (16.3)	24 (29.6)
Body mass index	22.13 (16.49-31.63)	21.97 (16.11-29.59)	0.432
Tumor location1			0.398
Head and neck	40 (46.5)	32 (39.5)
Body and tail	46 (53.5)	48 (49.3)
Metastasis site
Liver	57 (66.3)	40 (49.4)	0.027
Lung	9 (10.5)	12 (14.8)	0.397
Bone	4 (4.7)	6 (7.4)	0.5262
Peritoneum (carcinomatosis)	35 (40.7)	42 (51.9)	0.148
Distant LN	33 (38.4)	28 (34.6)	0.610
Othersite (e.g. adrenal gland)	14 (16.3)	20 (24.7)	0.177
No. of metastasis site			0.726
1 site	39 (45.3)	38 (46.9)
2 sites	30 (34.9)	24 (29.6)
3 or more	17 (19.8)	19 (23.5)
Laboratory data (at diagnosis)
WBC count (cells/μL)	6765 (2830-21880)	6240 (2580-12240)	0.068
Neutrophil count (cells/μL)	4660 (1610-18930)	4045 (1410-8540)	0.035
Prothrombin time (INR)	1.01 (0.80-1.28)	1.00 (0.83-1.16)	0.176
Total bilirubin (mg/dL)	0.7 (0.2-13.5)	0.6 (0.2-23.4)	0.200
AST (IU/L)	24 (9-204)	22 (9-765)	0.286
ALT (IU/L)	27 (5-192)	17 (5-717)	0.117
Alkaline phosphatase (IU/L)	116 (43-957)	92 (37-2080)	0.798
CA 19-9 at diagnosis (U/mL)	585.3 (3.4-20000)	305.2 (0.6-20000)	0.678

¹Except for one case that originated from an ectopic pancreas;

²Fisher's exact test. Gem + nabPTX: Gemcitabine plus nab-paclitaxel; ECOG-PS: Eastern Cooperative Oncology Group performance status; LN: Lymph node; WBC: White blood cell; AST: Aspartate aminotransferase; ALT: Alanine aminotransferase; CA: Carbohydrate antigen.

Table 2 Treatment data and efficacy of FOLFIRINOX and gemcitabine plus nab-paclitaxel, n (%)

	FOLFIRINOX (n = 86)	Gem + nabPTX (n = 81)	P value
Duration of chemotherapy
Cycles	8 (2-24)	5 (2-16)
Duration, days	138 (19-551)	154 (32-554)	0.249
Accumulation dose, mg/m2
Gemcitabine		14000 (4000-40000)
Nab-paclitaxel		1562.5 (375-4875)
5-Fluorouracil	16800 (5600-53200)
Oxaliplatin	510 (170-1445)
Irinotecan	1080 (360-3060)
Relative dose intensity, %
Gemcitabine		93.3 (54.3-100)
Nab-paclitaxel		86.2 (22.7-100)
5-Fluorouracil	80.0 (52.5-100.0)
Oxaliplatin	75.0 (52.5-100.0)
Irinotecan	75.0 (52.5-100.0)
Best response of chemotherapy			0.067
Complete response	0 (0)	0 (0)
Partial response	29 (33.7)	38 (46.9)
Stable disease	31 (36.0)	30 (37.0)
Progression of disease	26 (30.2)	13 (16.0)
Response rates
Objective response rate	29 (33.7)	38 (46.9)	0.082
Disease control rate	60 (69.8)	68 (84.0)	0.03

Gem + nabPTX: Gemcitabine plus nab-paclitaxel.

Table 3 Treatment-related adverse events due to the chemotherapy regimen, n (%)

	FOLFIRINOX (n = 86)	Gem + nabPTX (n = 81)	P value
Hematologic adverse event
Grade ≥ 3 Anemia	17 (19.8)	12 (14.8)	0.398
Grade ≥ 3 Thrombocytopenia	7 (8.1)	5 (6.2)	0.623
Grade ≥ 3 Neutropenia	64 (74.4)	38 (46.9)	< 0.001
Febrile neutropenia	22 (25.6)	13 (16.0)	0.130
Administration of G-CSF	66 (76.7)	15 (18.5)	< 0.001
Neurologic adverse event
Peripheral neuropathy	16 (18.6)	46 (56.8)	< 0.001
Grade ≥ 3 neuropathy	3 (3.5)	15 (18.5)	0.002
Median time to onset-days (range)	120 (15-278)	73.5 (17-284)	0.051
Gastrointestinal adverse event
Nausea/Vomiting	43 (50.0)	17 (21.0)	< 0.001
Diarrhea	15 (17.4)	12 (14.8)	0.645
Grade ≥ 3 adverse events	39 (45.3)	16 (19.8)	< 0.001
General weakness	30 (34.9)	40 (49.4)	0.058
Dermatologic adverse event	12 (14.0)	34 (42.0)	< 0.001

G-CSF, granulocyte-colony stimulating factor; Gem + nabPTX: Gemcitabine plus nab-paclitaxel.

Table 4 Dose modification, treatment delay and cessation, n (%)

Variables	FOLFIRINOX (n = 86)	Gem + nabPTX (n = 81)	P value
Dose reduction	76 (88.4)	49 (60.5)	< 0.001
At beginning	43 (50)	7 (8.6)
Before 1st RE	25 (29.1)	12 (14.8)
1st RE-2nd RE	5 (5.8)	15 (18.5)
After 2nd RE	3 (3.5)	15 (18.5)
Delay of administration due to AE	47 (54.7)	51 (63.0)	0.346
Neurologic AE	2 (2.4)	14 (17.3)
Hematologic AE	30 (34.9)	22 (27.2)
Gastrointestinal AE	3 (3.5)	4 (4.9)
General weakness	8 (9.3)	20 (24.7)
Others	6 (7.0)	2 (2.5)
Cessation of administration due to AE	12 (14.0)	17 (21.0)	0.307
Neurologic AE	2 (2.4)	3 (3.7)
Hematologic AE	1 (1.2)	0 (0)
Gastrointestinal AE	1 (1.2)	2 (2.5)
General weakness	8 (9.3)	11 (13.6)
Death	0 (0)	1 (1.2)

RE: Response evaluation; AE: Adverse event; Gem + nabPTX: Gemcitabine plus nab-paclitaxel.