FOLFIRI as second-line chemotherapy for advanced pancreatic cancer: a GISCAD multicenter phase II study

Cancer Chemotherapy and Pharmacology, 05/14/2012

Zaniboni A et al. – The FOLFIRI regimen showed a modest clinical activity in this quite heavily pretreated patients’ population with locally advanced or metastatic pancreatic cancer with a manageable toxicity profile.


  • Patients with locally advanced/metastatic disease who received a first-line chemotherapy (one line only) with gemcitabine±platinoid (cisplatin, oxaliplatin) and who had measurable disease conform with the RECIST criteria were eligible for the study.
  • FOLFIRI consists of irinotecan 180mg/m2 iv on day 1, leucovorin (l-form) 200mg/m2 iv on day 1 and 2, 5-FU 400mg/m2 iv bolus on days 1 and 2, and 5-FU 600mg/m2 iv by ci for 22h on days 1 and 2, repeated every 2weeks.
  • The primary end point was the response rate.


  • Among the 50 enrolled patients, 4 partial responses (PR) (8 %) and 14 stable diseases were observed, for a disease control rate of 18/50 (36 %).
  • Forty-one patients (82 %) have been pretreated with cisplatin/oxaliplatin+gemcitabine as first-line chemotherapy.
  • The median progression-free and overall survivals were 3.2 and 5months, respectively.
  • The 6-month survival rate was 32 %.
  • Grade 3–4 neutropenia and diarrhea occurred in 10 (20 %) and 6 (12 %) patients, respectively.

Print Article Summary Cat 2 CME Report