714P - Modified FOLFOXIRI in advanced pancreatic cancer

Date 30 September 2012
Event ESMO Congress 2012
Session Poster presentation II
Topics Anti-Cancer Agents & Biologic Therapy
Pancreatic Cancer
Presenter Laura Ginocchi
Authors L. Ginocchi1, E. Vasile2, S. Caponi3, M. Lucchesi3, C. Caparello1, V. Da Prat1, M. Baretti1, M. Lencioni1, S. Ricci1, A. Falcone1
  • 1Oncologia, Trapianti E Nuove Tecnologie In Medicina, Polo Oncologico - Azienda Ospedaliero-Universitaria Pisana - Istituto Toscano Tumori, 56126 - Pisa/IT
  • 2Oncology, Polo Oncologico - Azienda Ospedaliero-Universitaria Pisana - Istituto Toscano Tumori, 56126 - Pisa/IT
  • 3Polo Oncologico - Azienda Ospedaliero-Universitaria Pisana - Istituto Toscano Tumori, 56126 - Pisa/IT

Abstract

Background

The combination regimen of 5-fluorouracil/folinic acid, oxaliplatin and irinotecan named FOLFIRINOX has been proposed as a new standard of care for metastatic pancreatic cancer patients. However, FOLFIRINOX was associated with high incidence of grade 3 and 4 toxicities (neutropenia in 45.7% of patients with G-CSF use in 42.5% of patients; febrile neutropenia in 5.4%; diarrhea in 12.7%). Our group had developed a very similar schedule in colorectal cancer named FOLFOXIRI which contains no bolus 5-fluorouracil and a slight lower dose of irinotecan.

Methods

The objective of this study was to prospectively evaluate the tolerability and activity of a modified (m) FOLFOXIRI regimen in metastatic or locally advanced pancreatic cancer patients. The regimen included a lower dose of irinotecan (administered at 150 mg/sqm on day 1 every 14 days) and of infusional 5-fluorouracil (2800 mg/sqm administered as a 48-hour continuous infusion on days 1 to 3 every 14 days). Folinic acid and oxaliplatin remained unchanged.

Results

Thirty-nine patients with cytological or histological diagnosis of pancreatic adenocarcinoma have been treated with mFOLFOXIRI from august 2010 onwards; 17 had metastatic disease while 22 had locally advanced disease. A total of 260 cycles have been administered so far. The grade 3-4 toxicities reported are: neutropenia in 35.9% of patients; thrombocytopenia 2.6%; diarrhea 5.1%; stomatitis 7.7%; nausea/vomiting 5.1%; fatigue 2.6%; liver toxicity 5.1%; sensory neuropathy 5.1%. No toxic deaths and no febrile neutropenia have been occurred. G-CSF has been used in seven patients (18%). A delay in the administration of chemotherapy was required in 12 patients (31%) and a reduction of doses in 7 cases (18%). Among 30 evaluable patients 11 partial responses (36.7%) and 14 stable disease (46.7%) have been observed. Median progression-free survival (PFS) was 11.5 months and median overall survival (OS) 25.5 months. For metastatic patients only, response rate resulted 33% with a PFS and OS of 8.4 and 14.8 months, respectively.

Conclusions

The mFOLFOXIRI regimen as we used resulted feasible and quite well tolerated and it maintained its good activity in metastatic pancreatic cancer.

Disclosure

All authors have declared no conflicts of interest.