Table 2.
First-line FOLFIRINOX in pancreatic cancer: treatment regimen, toxicity and efficacy data.
| Study | Regimen | Febrile neutropenia prophylaxis | Population | Grade 3–4 neutropenia; febrile neutropenia | Fatigue | Vomiting | Diarrhea | OS (months) PFS (months) |
|---|---|---|---|---|---|---|---|---|
| Conroy et al.7 | FOLFIRINOX | Filgrastim not recommended as primary prophylaxis | MPA | 75/164 (45.7%) 9/166 (5.4%) |
39/165 (23.6%) | 24/166 (14.5%) | 21/165 (12.7%) | 11.1 6.4 |
| Hosein et al.62 | FOLFIRINOX | Pegfilgrastim 6 mg for 89% of the patients | LAPC, BRPC | 4/18 (22%) 3/18 (17%) |
2/18 (11%) | 0 | 2/18 (11%) | 100% at 1 year 95% at 1 year |
| Faris et al.63 | FOLFIRINOX | Pegfilgrastim 6 mg | LAPC | 4/22 (18%) 0/22 |
NAπ | NAπ | 4/22 (18%) (all grades) | 7% at 3 years 11.7 |
| Gunturu et al.49 | Dose modifications at physician discretion; 6/35 received full doses | Pegfilgrastim 6 mg | MPA, LAPC | 4/35 (11.4%) 1/35 (2.9%) |
2/35 (5.7%) | 1/35 (2.9%) | 1/35 (2.9%) | 11.2 (MPA) 9.9 (MPA) |
| Mahaseth et al.64 | mFOLFIRINOX no bolus 5-FU | Pegfilgrastim 6 mg | MPA, LAPC, BRPC | 2/60 (3.3%) 0/60 |
8/60 (13.3%) | 5/60 (8.3%) | 8/60 (13.3%) | 9.0 8.5 |
| Alessandretti et al.65 | mFOLFIRINOX (no bolus 5-FU and reduced dose of at least one agent since first cycle) | Pegfilgrastim 6 mg | LAPC | 4/19 (21%) 3/19 (15.7%) |
3/19 (15.7%) | 1/19 (5.2%) | 1/19 (5.2%) | NA |
| Umemura et al.40 | 20% dose reduction of FOLFIRINOX, and 3 weeks interval. | NA§ | MPA, LAPC$ | 5/13 (38.5%) 0/13 |
NA | NA | NA | 6 4.7 |
| James et al.66 | mFOLFIRINOX with 25% dose reductions of irinotecan and bolus 5-FU | Pegfilgrastim 6 mg | MPA, LAPC | 10/62 (16.2%) 3/62 (4.8%) |
7/62 (11.3%) | NA | NA | NA |
| Ghorani et al.67 | mFOLFIRINOX irinotecan 135 mg/m2; no bolus 5-FU | Filgrastim for 7 days | LAPC | 0/18 1/18 (5.6%) |
1/18 (5.6%) | 5/18 (27.8%) | 3/18 (16.7%) | 9.3 7.2 |
| Nanda et al.68 | mFOLFIRINOX no bolus 5-FU |
Pegfilgrastim 6 mg | LAPC | NA | NA | NA | NA | 65.5% at 1 year 49.2% at 1 year |
| Blazer et al.55 | mFOLFIRINOX irinotecan 165 mg/m2; no bolus 5-FU | Pegfilgrastim 6 mg | LAPC, BRPC | 0/43 | 4/43 (9.3%) | 0 | 6/43 (14%) | 21.2 18 (resection) 8 (no resection) |
| Stein et al.69 | mFOLFIRINOX irinotecan 135 mg/m2; 300 mg/m2 bolus 5-FU | Pegfilgrastim on day 3 or 4 | MPA, LAPC | 9/74 (12.2%) 3/74 (4.1%) |
9/74 (16.2%) | 2/74 (2.7%) | 12/74 (16.2%) | 10.2 (MPA) 26.6 (LAPC) 6.1 (MPA) 17.8 (LAPC) |
OS, overall survival; PFS, progression-free survival; MPA, metastatic pancreatic cancer; LAPC, locally advanced pancreatic cancer; BRPC, borderline resectable pancreatic cancer; NA, nonavailable; 5-FU, fluorouracil.