title: First-line treatment with FOLFOXIRI for advanced pancreatic cancer in clinical practice: Patients' outcome and analysis of prognostic factors.
abstract: FOLFIRINOX is a standard first-line treatment for advanced pancreatic cancer (aPC). The Gruppo Oncologico Nord Ovest (GONO) FOLFOXIRI regimen demonstrated efficacy in metastatic colorectal cancer. We aimed to evaluate activity and tolerability of FOLFOXIRI regimen in patients with aPC and to explore putative prognostic factors. One hundred thirty-seven consecutive aPC patients were treated with FOLFOXIRI in our institution between 2008 and 2014. Clinical, laboratory and pathological data were collected and their association with activity, progression free survival (PFS) and overall survival (OS) was investigated. After a median follow up of 30 months, median PFS and OS were 8.0 months (95% CI 6.19-9.81) and 12 months (95% CI 9.75-14.25), respectively. Response rate was 38.6%, while disease-control rate 72.2%. At multivariate analysis liver metastases (p = 0.019; Hazard Ratio, HR, 0.59, 95% Confidence Interval, CI, 0.380.96), Eastern Cooperative Oncology Group (ECOG) performance status (PS) 1 (p = 0.001; HR 2.26, 95%CI 1.42-3.59) and neutrophil-lymphocyte ratio (NLR)> 4 (p= 0.002; HR: 2.42; 95% CI 1.38-4.25) were associated with poorer OS. We categorized 119 pts with complete available data as good-risk (0 factors, 38 pts), intermediate-risk (1 factor, 49 pts) and poor-risk (≥2 factors, 32 pts). Median OS for these three groups were 17.6, 11.1 and 7.4 months, respectively (p < 0.001). FOLFOXIRI is active and feasible in aPC. Prognosis of aPC pts treated with FOLFOXIRI is influenced by easily available factors: our analysis revealed ECOG PS, liver metastases and NLR as the most important predictors of survival. These factors could be helpful for treatment decision and clinical trial design.
authors.affiliation: Polo Oncologico, Azienda Ospedaliero-Universitaria Pisana, Pisa, Italy.
authors.forename: Caterina
authors.initials: C
authors.lastname: Vivaldi
authors.affiliation: Polo Oncologico, Azienda Ospedaliero-Universitaria Pisana, Pisa, Italy.
authors.forename: Chiara
authors.initials: C
authors.lastname: Caparello
authors.affiliation: Polo Oncologico, Azienda Ospedaliero-Universitaria Pisana, Pisa, Italy.
authors.forename: Gianna
authors.initials: G
authors.lastname: Musettini
authors.affiliation: Polo Oncologico, Azienda Ospedaliero-Universitaria Pisana, Pisa, Italy.
authors.forename: Giulia
authors.initials: G
authors.lastname: Pasquini
authors.affiliation: Polo Oncologico, Azienda Ospedaliero-Universitaria Pisana, Pisa, Italy.
authors.forename: Silvia
authors.initials: S
authors.lastname: Catanese
authors.affiliation: Polo Oncologico, Azienda Ospedaliero-Universitaria Pisana, Pisa, Italy.
authors.forename: Lorenzo
authors.initials: L
authors.lastname: Fornaro
authors.affiliation: Polo Oncologico, Azienda Ospedaliero-Universitaria Pisana, Pisa, Italy.
authors.forename: Monica
authors.initials: M
authors.lastname: Lencioni
authors.affiliation: Polo Oncologico, Azienda Ospedaliero-Universitaria Pisana, Pisa, Italy.
authors.forename: Alfredo
authors.initials: A
authors.lastname: Falcone
authors.affiliation: Polo Oncologico, Azienda Ospedaliero-Universitaria Pisana, Pisa, Italy.
authors.forename: Enrico
authors.initials: E
authors.lastname: Vasile
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D002166:Camptothecin / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D015331:Cohort Studies; D005260:Female; D005472:Fluorouracil / Q000009:adverse effects / Q000627:therapeutic use; D006801:Humans; D002955:Leucovorin / Q000009:adverse effects / Q000627:therapeutic use; D007958:Leukocyte Count; D008214:Lymphocytes; D008297:Male; D008875:Middle Aged; D060787:Neoplasm Grading; D009362:Neoplasm Metastasis; D009367:Neoplasm Staging; D009504:Neutrophils; D009944:Organoplatinum Compounds / Q000009:adverse effects / Q000627:therapeutic use; D010190:Pancreatic Neoplasms / Q000175:diagnosis* / Q000188:drug therapy* / Q000401:mortality; D011379:Prognosis; D016019:Survival Analysis; D016896:Treatment Outcome
chemical_list: D009944:Organoplatinum Compounds; D002955:Leucovorin; D005472:Fluorouracil; D002166:Camptothecin
keywords: FOLFIRINOX; FOLFOXIRI; first-line chemotherapy; pancreatic cancer; prognostic factors