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First-line treatment of pancreatic cancer patients with the combination of 5-fluorouracil/folinic acid plus gemcitabine: a multicenter phase II trial by the CONKO-study group

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Abstract

Purpose

This open-label, multi-center phase II study investigated the efficacy and safety of the combination of 5-fluorouracil (5-FU)/folinic acid (FA) plus gemcitabine (GFF) in patients with advanced pancreatic cancer. The study is based on our completed dose finding phase I trial.

Methods

A total of 90 patients (pts) were recruited between 02/2000 and 04/2002 to receive 5-FU 750 mg/m2 (24 h, i.v.), FA 500 mg/m2 (2 h, i.v.) and gemcitabine 1,000 mg/m2 (30 min, i.v.) on days 1, 8, 15, and 22. Treatment was repeated on day 43 until disease progression. The primary objective was the 1-year survival rate. The trial was conducted in compliance with the Declaration of Helsinki.

Results

The 1-year survival rate was 25% [95% CI: 16–34], median overall survival was 6.8 months [95% CI: 5.13–8.45], 9 patients showed partial responses (PR) so that the overall response rate was 10.3%. Overall control rate (PR + stable disease for at least 6 months) was 56%. Median time to progression was 4.6 months [95% CI: 3.68–5.52]. In 402 GFF cycles, we observed adverse events grade 3 in up to 10% of patients and grade 4 below 5% of patients.

Conclusions

The GFF combination appears to be effective and well tolerated. This intravenous regimen represents an intensified therapy with low frequency of toxicities and seems to be convenient for patients who are unable to get oral anti-neoplastic medication. After these encouraging results, the German CONKO-002 trial investigated the GFF regimen versus single-agent gemcitabine.

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Acknowledgments

This study was supported by “Deutsche Krebsgesellschaft e.V.”, the German AIO-Group and by a grand from Lilly Deutschland GmbH to the CONKO-study group.

Conflict of interest

The authors declare that they have no competing interest or financial disclosures.

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Authors and Affiliations

  1. Charité Centrum für Tumormedizin, Universitätsmedizin Berlin, Augustenburger Platz 1, 13353, Berlin, Germany

    Uwe Pelzer, Jens Stieler, Bernd Dörken, Hanno Riess & Helmut Oettle

  2. Department of Internal Medicine, Universitätsklinikum Halle, Ernst-Gruber-Str. 40, Halle, Germany

    Dirk Arnold

  3. Department of Internal Medicine, Sana Klinikum Berlin, Fanningerstraße 32, Berlin, Germany

    Peter Reitzig

  4. Outpatient Department, Hematology/Oncology, Clayalle 225, Berlin, Germany

    Julia Herrenberger

  5. Department of Internal Medicine, Hospital St. Elisabeth, Von-Werth-Straße 5, Grevenbroich, Germany

    Friedrich Wilhelm Korsten

  6. Outpatient Department, Hematology/Oncology, Landsberger Allee 277, Berlin, Germany

    Manfred Kindler

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  1. Uwe Pelzer
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  2. Dirk Arnold
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  4. Julia Herrenberger
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  10. Helmut Oettle
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Correspondence to Uwe Pelzer.

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Pelzer, U., Arnold, D., Reitzig, P. et al. First-line treatment of pancreatic cancer patients with the combination of 5-fluorouracil/folinic acid plus gemcitabine: a multicenter phase II trial by the CONKO-study group. Cancer Chemother Pharmacol 68, 1173–1178 (2011). https://doi.org/10.1007/s00280-011-1602-3

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  • DOI: https://doi.org/10.1007/s00280-011-1602-3

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