Comparison of efficacy and safety between standard-dose and modified-dose FOLFIRINOX as a first-line treatment of pancreatic cancer

doi:10.4251/wjgo.v10.i11.421

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World Journal of Gastrointestinal Oncology

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Baishideng Publishing Group Inc, 7041 Koll Center Parkway, Suite 160, Pleasanton, CA 94566, USA

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Retrospective Study

World J Gastrointest Oncol. Nov 15, 2018; 10(11): 421-430
Published online Nov 15, 2018. doi: 10.4251/wjgo.v10.i11.421

Table 1 Pretreatment characteristics

	sFOLFIRINOX	mFOLFIRINOX	P value
	(n = 88)	(n = 42)	P value
Sex, n (%)			0.004¹
Male	61 (69.3)	18 (42.9)
Female	27 (30.7)	24 (57.1)
Age, yr			0.018¹
Median (range)	57 (31-79)	63.5 (41-77)	0.018¹
ECOG-PS, n (%)			0.426
0	68 (77.3)	35 (83.3)
1	20 (22.7)	7 (16.7)
Laboratory test results, median (range)
Absolute neutrophil count, /μL	4200 (1610-11170)	4525 (2080-18930)	0.317
Hemoglobin, g/dL	12.3 (7.1-17.1)	12.1 (8.5-14.9)	0.36
Platelet count, × 10³/μL	218 (76-439)	245 (107-764)	0.247
Total bilirubin, mg/dL	0.7 (0.2-4.8)	0.5 (0.2-2.7)	0.144
Albumin, g/dL	3.9 (2.8-5.0)	3.9 (2.4-4.8)	0.797
Creatinine, mg/dL	0.67 (0.37-1.02)	0.70 (0.37-1.04)	0.516
Level of CA 19-9
U/mL, median (range)	172.2 (0.6-20000.0)	455.5 (0.7-20000.0)	0.709
Normal, n (%)	17 (19.3)	11 (21.5)	0.274
Elevated, < 59 × ULN, n (%)	53 (60.2)	19 (45.2)
Elevated, ≥ 59 × ULN, n (%)	18 (20.5)	12 (28.6)
Biliary drainage, n (%)			0.435
Presence	29 (33.0)	11 (26.2)	0.435
Tumor location in pancreas, n (%)			0.657
Head	40 (45.5)	16 (38.1)
Body and tail	44 (50.0)	23 (54.8)
Recurrent	4 (4.5)	3 (7.1)
Tumor size, cm			0.313
Median (range)	3.6 (1.3-7.7)	4.0 (1.3-8.0)	0.313
Disease extent, n (%)			0.243
Borderline resectable	17 (19.3)	6 (14.3)
Locally advanced	26 (29.5)	8 (19.0)
Metastatic	45 (51.1)	28 (66.7)
Stage, n (%)			0.248
II	24 (27.3)	8 (19.0)
III	19 (21.6)	6 (14.3)
IV	45 (51.1)	28 (66.7)
Prior treatment, n (%)
Naïve	75 (85.2)	33 (85.7)	0.941
Curative resection	4 (4.5)	4 (9.5)	0.272
CCRT	9 (10.2)	4 (9.5)	1.000

¹Values indicate statistical significance. mFOLFIRINOX: Modified FOLFIRINOX; sFOLFIRINOX: Standard FOLFIRINOX; ECOG-PS: Eastern Cooperative Oncology Group performance status; ULN: Upper limit of normal range; CA: Carbohydrate antigen; CCRT: Concurrent chemoradiotherapy.

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Table 2 Treatment characteristics

	sFOLFIRINOX	mFOLFIRINOX	P value
	(n = 88)	(n = 42)	P value
Number of cycles administered, median (range)	9.5 (4-24)	12 (4-32)	0.421
Treatment duration, d, median (range)	126 (42-322)	154 (42-434)	0.595
RDI to sFOLFIRINOX, %, median (range)
Oxaliplatin	85.3 (56.3-100)	75.0 (51.1-75.0)	< 0.001¹
Irinotecan	85.0 (56.3-100)	75.0 (51.1-75.0)	< 0.001¹
5-FU (bolus)	92.1 (21.4-100)	75.0 (51.1-75.0)	< 0.001¹
5-FU (infusion)	94.1 (56.3-100)	75.0 (51.1-75.0)	< 0.001¹
Patients with ≥ 1 dose reduction, n (%)	62 (70.5)	16 (38.1)	< 0.001¹
Cause of dose reduction (> 5%), n (%)
Neutropenia	53 (60.2)	9 (21.4)	< 0.001¹
Febrile neutropenia	10 (11.4)	4 (9.5)	1.000
Patients with ≥ 1 dose delay, n (%)	55 (62.5)	22 (52.4)	0.272
Cause of dose delay (> 5%), n (%)
Neutropenia	16 (18.2)	5 (11.9)	0.363
Febrile neutropenia	16 (18.2)	5 (11.9)	0.363
Fatigue	7 (8.0)	8 (19.0)	0.081
No. of G-CSF administered, median (range)	3.5 (0-24)	2 (0-12)	0.043¹
Patients received G-CSF, n (%)	72 (81.8)	27 (64.3)	0.028¹

¹Values indicate statistical significance. mFOLFIRINOX: Modified FOLFIRINOX; sFOLFIRINOX: Standard FOLFIRINOX; RDI: Relative dose intensity; 5-FU: 5-Fluorouracil; G-CSF: Granulocyte colony-stimulating factor.

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Table 3 Response evaluation n (%)

	sFOLFIRINOX	mFOLFIRINOX	P value
	(n = 88)	(n = 42)	P value
CR	1 (1.1)	1 (2.4)
PR	34 (38.6)	14 (33.3)
SD	36 (40.9)	20 (47.6)
PD	17 (19.3)	7 (16.7)
Objective response^a	35 (39.8)	15 (35.7)	0.656
Disease control^b	71 (80.7)	35 (83.3)	0.716

^aObjective response includes CR and PR;

^bDisease control includes CR, PR, and SD. mFOLFIRINOX: Modified FOLFIRINOX; sFOLFIRINOX: Standard FOLFIRINOX; CR: Complete response; PR: Partial response; SD: Stable disease; PD: Progressive disease.

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Table 4 Adverse events (≥ Grade 3) n (%)

Event	sFOLFIRINOX	mFOLFIRINOX	P value
Event	(n = 88)	(n = 42)	P value
Hematologic
Neutropenia	73 (83.0)	28 (66.7)	0.044¹
Febrile neutropenia	24 (27.3)	9 (21.4)	0.474
Anemia	19 (21.6)	11 (26.2)	0.561
Thrombocytopenia	8 (9.1)	2 (4.8)	0.499
Non-hematologic
Fatigue	33 (37.5)	14 (33.3)	0.644
Anorexia	43 (48.9)	12 (28.6)	0.029¹
Nausea/Vomiting	53 (60.2)	19 (45.2)	0.108
Diarrhea	12 (13.6)	0 (0.0)	0.009¹
Peripheral sensory neuropathy	12 (13.6)	2 (4.8)	0.224
Sepsis	5 (5.7)	0 (0.0)	0.174
Lung infection	3 (3.4)	4 (9.5)	0.212
Biliary tract infection	6 (6.8)	0 (0.0)	0.176

¹Values indicate statistical significance. mFOLFIRINOX: Modified FOLFIRINOX; sFOLFIRINOX: Standard FOLFIRINOX.

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Citation: Kang H, Jo JH, Lee HS, Chung MJ, Bang S, Park SW, Song SY, Park JY. Comparison of efficacy and safety between standard-dose and modified-dose FOLFIRINOX as a first-line treatment of pancreatic cancer. World J Gastrointest Oncol 2018; 10(11): 421-430
URL: https://www.wjgnet.com/1948-5204/full/v10/i11/421.htm
DOI: https://dx.doi.org/10.4251/wjgo.v10.i11.421