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01.04.2012 | Original Article

Phase I/II study of gemcitabine as a fixed dose rate infusion and S-1 combination therapy (FGS) in gemcitabine-refractory pancreatic cancer patients

verfasst von: Chigusa Morizane, Takuji Okusaka, Hideki Ueno, Shunsuke Kondo, Masafumi Ikeda, Junji Furuse, Ohkawa Shinichi, Kohei Nakachi, Shuichi Mitsunaga, Yasushi Kojima, Eiichiro Suzuki, Makoto Ueno, Tomohiro Yamaguchi

Erschienen in: Cancer Chemotherapy and Pharmacology | Ausgabe 4/2012

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Abstract

Purpose

There is no standard regimen for gemcitabine (Gem)-refractory pancreatic cancer (PC) patients. In a previous phase II trial, S-1 was found to exhibit marginal efficacy. Gem administration by fixed dose rate infusion of 10 mg/m²/min (FDR-Gem) should maximize the rate of intracellular accumulation of gemcitabine triphosphate and might improve clinical efficacy. We conducted the phase I/II of FDR-Gem and S-1 (FGS) in patients with Gem-refractory PC.

Methods

The patients received FDR-Gem on day 1 and S-1 orally twice daily on days 1–7. Cycles were repeated every 14 days. Patients were scheduled to receive Gem (mg/m²/week) and S-1 (mg/m²/day) at four dose levels in the phase I: 800/80 (level 1), 1,000/80 (level 2), 1,200/80 (level 3) and 1,200/100 (level 4). Forty patients were enrolled in the phase II study at recommended dose.

Results

The recommended dose was the level 3. In the phase II, a partial response has been confirmed in seven patients (18%). The median overall survival time and median progression-free survival time are 7.0 and 2.8 months, respectively. The common adverse reactions were anorexia, leukocytopenia and neutropenia.

Conclusion

This combination regimen of FGS is active and well tolerated in patients with Gem-refractory PC.

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Titel: Phase I/II study of gemcitabine as a fixed dose rate infusion and S-1 combination therapy (FGS) in gemcitabine-refractory pancreatic cancer patients
verfasst von: Chigusa Morizane
Takuji Okusaka
Hideki Ueno
Shunsuke Kondo
Masafumi Ikeda
Junji Furuse
Ohkawa Shinichi
Kohei Nakachi
Shuichi Mitsunaga
Yasushi Kojima
Eiichiro Suzuki
Makoto Ueno
Tomohiro Yamaguchi
Publikationsdatum: 01.04.2012
Verlag: Springer-Verlag
Erschienen in: Cancer Chemotherapy and Pharmacology / Ausgabe 4/2012
Print ISSN: 0344-5704
Elektronische ISSN: 1432-0843
DOI: https://doi.org/10.1007/s00280-011-1786-6

Springer Medizin

Phase I/II study of gemcitabine as a fixed dose rate infusion and S-1 combination therapy (FGS) in gemcitabine-refractory pancreatic cancer patients