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

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Abstract

Purpose

The purpose of the present study was to evaluate the activity and the tolerability of the FOLFIRI regimen, administered as second-line chemotherapy in patients with locally advanced or metastatic pancreatic cancer after the failure of a gemcitabine-based regimen.

Methods

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 180 mg/m2 iv on day 1, leucovorin (l-form) 200 mg/m2 iv on day 1 and 2, 5-FU 400 mg/m2 iv bolus on days 1 and 2, and 5-FU 600 mg/m2 iv by ci for 22 h on days 1 and 2, repeated every 2 weeks. The primary end point was the response rate.

Results

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 5 months, respectively. The 6-month survival rate was 32 %. Grade 3–4 neutropenia and diarrhea occurred in 10 (20 %) and 6 (12 %) patients, respectively.

Conclusion

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.

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Acknowledgments

The authors thank the staff of the Giscad Foundation Executive Office, Silvia Rota and Luciano Frontini, for data management and secretarial activities. The study is sponsored by Fondazione GISCAD who provided the economical support for insurance and costs related to data management, statistical analysis, and the other activities of central and group coordinating centres. Hospira-Italia srl supports the study providing and managing the drug (Irinotecan) required for the treatment.

Conflict of interest

None.

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Authors and Affiliations

  1. Medical Oncology Unit, Fondazione Poliambulanza, Via Bissolati 57, 25124, Brescia, Italy

    Alberto Zaniboni

  2. Medical Oncology Unit, C. Poma Hospital, Mantua, Italy

    Enrico Aitini

  3. Medical Oncology Unit, Treviglio-Caravaggio Hospital, Treviglio, Italy

    Sandro Barni

  4. Medical Oncology Unit, S. Paolo Hospital, Milan, Italy

    Daris Ferrari

  5. Medical Oncology Unit, Università Politecnica delle Marche, Ospedali Riuniti di Ancona, Ancona, Italy

    Stefano Cascinu

  6. Medical Oncology Unit, Ospedali Riuniti Marche Nord, Presidio San Salvatore, Pesaro, Italy

    Vincenzo Catalano

  7. Medical Oncology DH, Ospedale di Sondalo, Sondalo, Italy

    Giuseppe Valmadre

  8. Medical Oncology Unit, Ospedale San Carlo, Potenza, Italy

    Domenica Ferrara

  9. Medical Oncology Unit, Ospedale Don Luigi di Liegro, Gaeta, Italy

    Enzo Veltri

  10. Department of Surgery, Fondazione Poliambulanza, Brescia, Italy

    Claudio Codignola

  11. Medical Oncology Unit, Ospedali Riuniti, Bergamo, Italy

    Roberto Labianca

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  1. Alberto Zaniboni
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  2. Enrico Aitini
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  3. Sandro Barni
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  4. Daris Ferrari
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  5. Stefano Cascinu
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  6. Vincenzo Catalano
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  9. Enzo Veltri
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  10. Claudio Codignola
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  11. Roberto Labianca
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Corresponding author

Correspondence to Alberto Zaniboni.

Additional information

This research is conducted for the GISCAD (Italian Group for the Study of Gastrointestinal Cancer).

EUDRACT code 2008-004637-16.

Clinicaltrials.gov Identifier: NCT01543412.

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Zaniboni, A., Aitini, E., Barni, S. et al. FOLFIRI as second-line chemotherapy for advanced pancreatic cancer: a GISCAD multicenter phase II study. Cancer Chemother Pharmacol 69, 1641–1645 (2012). https://doi.org/10.1007/s00280-012-1875-1

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  • DOI: https://doi.org/10.1007/s00280-012-1875-1

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