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
Published online Nov 15, 2018. doi: 10.4251/wjgo.v10.i11.421
sFOLFIRINOX | mFOLFIRINOX | P value | |
(n = 88) | (n = 42) | ||
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) | |
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) | |
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) | |
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 |
sFOLFIRINOX | mFOLFIRINOX | P 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) | |||
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 |
Event | sFOLFIRINOX | mFOLFIRINOX | P value |
(n = 88) | (n = 42) | ||
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 |
- 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