726P - Neoadjuvant modified FOLFOXIRI in locally advanced pancreatic cancer

Date 30 September 2012
Event ESMO Congress 2012
Session Poster presentation II
Topics Anti-Cancer Agents & Biologic Therapy
Pancreatic Cancer
Presenter Enrico Vasile
Authors E. Vasile1, N. De Lio2, C. Cappelli3, L. Ginocchi4, S. Caponi5, A. Sainato6, C. Greco6, F. Mosca7, A. Falcone8, U. Boggi2
  • 1Oncology, Polo Oncologico - Azienda Ospedaliero-Universitaria Pisana - Istituto Toscano Tumori, 56126 - Pisa/IT
  • 2Dipartimento Di Oncologia, Dei Trapianti E Delle Nuove Tecnologie In Medicina, U.O. Chirurgia Generale e Trapianti - Azienda Ospedaliero-Universitaria Pisana, Pisa/IT
  • 3Dipartimento Di Radiodiagnostica E Radiologia Interventistica, Azienda Ospedaliero-Universitaria Pisana, Pisa/IT
  • 4Oncologia, Trapianti E Nuove Tecnologie In Medicina, Polo Oncologico - Azienda Ospedaliero-Universitaria Pisana - Istituto Toscano Tumori, 56126 - Pisa/IT
  • 5Polo Oncologico - Azienda Ospedaliero-Universitaria Pisana - Istituto Toscano Tumori, 56126 - Pisa/IT
  • 6Dipartimento Di Oncologia, Dei Trapianti E Delle Nuove Tecnologie In Medicina, U.O. Radioterapia - Azienda Ospedaliero-Universitaria Pisana, Pisa/IT
  • 7Dipartimento Di Oncologia, Dei Trapianti E Delle Nuove Tecnologie In Medicina, U.O. Chirurgia Generale 1 Universitaria - Azienda Ospedaliero-Universitaria Pisana, Pisa/IT
  • 8Dept. Of Oncology-presidio Ospedaliero, Polo Oncologico - Azienda Ospedaliero-Universitaria Pisana - Istituto Toscano Tumori, 56126 - Pisa/IT

Abstract

Background

FOLFIRINOX has shown high activity in metastatic pancreatic cancer patients. Considering its activity, the regimen could be of interest also for patients with inoperable locally advanced disease. 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 with good tolerance and activity.

Methods

We have performed a phase II trial in order to prospectively evaluate the activity of a modified (m)FOLFOXIRI regimen in locally advanced pancreatic cancer. mFOLFOXIRI consisted of: oxaliplatin 85 mg/sqm, irinotecan 150 mg/sqm and folinic acid 200 mg/sqm on day 1, plus infusional 5-fluorouracil 2800 mg/sqm administered in 48 hours on days 1 to 3, with cycle repeated every 14 days.

The study enrolled patients with cytological or histological diagnosis of pancreatic adenocarcinoma, stage III locally advanced disease without evidence of metastatic disease, ECOG performance status (PS) 0 or 1, age 18-75. The primary end-point of the study was the percent of patients who can achieve radical surgical resection after chemotherapy; the trial was designed with a percentage of low activity of 30% and a percentage of interest of 50% with an α and � error of 0.05 and 0.20.

Results

Twenty-two patients have been so far enrolled; 8 men and 14 women; PS was 0 in 10 patients. Median age was 60 years (range 44-75). Celiac axis was involved in 7 patients, superior mesenteric artery in 10 cases, both arteries in 5 patients.

Among the 15 patients so far evaluated, 6 partial responses (40%) and 9 stable disease (60%) have been observed. A local treatment after chemotherapy was received by 9 patients until now: 5 (55.5%) underwent to radical surgery; 1 underwent an explorative laparotomy with evidence of liver metastases; 3 received concomitant chemo-radiotherapy with gemcitabine.

Median progression-free survival was 24.5 months and median overall survival was 30.1 months.

Conclusions

Chemotherapy with mFOLFOXIRI seems active in locally advanced pancreatic cancer patients and may allow to obtain a downstaging of disease leading some patient to achieve a curative surgical resection. Longer follow up is needed to better evaluate long-term outcome of this strategy.

Disclosure

All authors have declared no conflicts of interest.