Retrospective Study
Copyright ©The Author(s) 2018.
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
sFOLFIRINOXmFOLFIRINOXP value
(n = 88)(n = 42)
Sex, n (%)0.0041
Male61 (69.3)18 (42.9)
Female27 (30.7)24 (57.1)
Age, yr0.0181
Median (range)57 (31-79)63.5 (41-77)
ECOG-PS, n (%)0.426
068 (77.3)35 (83.3)
120 (22.7)7 (16.7)
Laboratory test results, median (range)
Absolute neutrophil count, /μL4200 (1610-11170)4525 (2080-18930)0.317
Hemoglobin, g/dL12.3 (7.1-17.1)12.1 (8.5-14.9)0.36
Platelet count, × 103/μL218 (76-439)245 (107-764)0.247
Total bilirubin, mg/dL0.7 (0.2-4.8)0.5 (0.2-2.7)0.144
Albumin, g/dL3.9 (2.8-5.0)3.9 (2.4-4.8)0.797
Creatinine, mg/dL0.67 (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
Presence29 (33.0)11 (26.2)
Tumor location in pancreas, n (%)0.657
Head40 (45.5)16 (38.1)
Body and tail44 (50.0)23 (54.8)
Recurrent4 (4.5)3 (7.1)
Tumor size, cm0.313
Median (range)3.6 (1.3-7.7)4.0 (1.3-8.0)
Disease extent, n (%)0.243
Borderline resectable17 (19.3)6 (14.3)
Locally advanced26 (29.5)8 (19.0)
Metastatic45 (51.1)28 (66.7)
Stage, n (%)0.248
II24 (27.3)8 (19.0)
III19 (21.6)6 (14.3)
IV45 (51.1)28 (66.7)
Prior treatment, n (%)
Naïve75 (85.2)33 (85.7)0.941
Curative resection4 (4.5)4 (9.5)0.272
CCRT9 (10.2)4 (9.5)1.000
Table 2 Treatment characteristics
sFOLFIRINOXmFOLFIRINOXP value
(n = 88)(n = 42)
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)
Oxaliplatin85.3 (56.3-100)75.0 (51.1-75.0)< 0.0011
Irinotecan85.0 (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 (%)
Neutropenia53 (60.2)9 (21.4)< 0.0011
Febrile neutropenia10 (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 (%)
Neutropenia16 (18.2)5 (11.9)0.363
Febrile neutropenia16 (18.2)5 (11.9)0.363
Fatigue7 (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
Table 3 Response evaluation n (%)
sFOLFIRINOXmFOLFIRINOXP value
(n = 88)(n = 42)
CR1 (1.1)1 (2.4)
PR34 (38.6)14 (33.3)
SD36 (40.9)20 (47.6)
PD17 (19.3)7 (16.7)
Objective responsea35 (39.8)15 (35.7)0.656
Disease controlb71 (80.7)35 (83.3)0.716
Table 4 Adverse events (≥ Grade 3) n (%)
EventsFOLFIRINOXmFOLFIRINOXP value
(n = 88)(n = 42)
Hematologic
Neutropenia73 (83.0)28 (66.7)0.0441
Febrile neutropenia24 (27.3)9 (21.4)0.474
Anemia19 (21.6)11 (26.2)0.561
Thrombocytopenia8 (9.1)2 (4.8)0.499
Non-hematologic
Fatigue33 (37.5)14 (33.3)0.644
Anorexia43 (48.9)12 (28.6)0.0291
Nausea/Vomiting53 (60.2)19 (45.2)0.108
Diarrhea12 (13.6)0 (0.0)0.0091
Peripheral sensory neuropathy12 (13.6)2 (4.8)0.224
Sepsis5 (5.7)0 (0.0)0.174
Lung infection3 (3.4)4 (9.5)0.212
Biliary tract infection6 (6.8)0 (0.0)0.176