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Phase II trial of S-1 in combination with gemcitabine for chemo-naïve patients with locally advanced or metastatic pancreatic cancer

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Abstract

Background

We performed a phase II study of combination chemotherapy with S-1 plus gemcitabine for treating chemo-naïve patients with unresectable pancreatic cancer to evaluate the efficacy and toxicity.

Patients and methods

Patients with histologically confirmed unresectable pancreatic cancer were eligible. The treatment consisted of S-1 (40 mg/m2 p.o. b.i.d. from D1 to 14) and gemcitabine (1,250 mg/m2 on D1 and 8), repeated every 3 weeks.

Results

Thirty-two patients were enrolled between March 2005 and December 2007. No complete response was observed and a partial response was observed in 14 patients (44.0%), stable disease in eight patients (25.0%), and progressive disease in eight patients (25.0%). The median time to progression was 4.92 months (95% CI: 4.16–5.67 months), and the median overall survival was 7.89 months (95% CI: 5.96–9.82 months). The survival duration was significantly longer for the patients with a good performance status compared with that of the patients with a poor performance status. The major toxicities were grade 3–4 neutropenia (9, 28.1%), grade 3/4 thrombocytopenia (5, 15.6%), and grade 3 diarrhea (5, 15.6%).

Conclusion

The combination chemotherapy of S-1 and gemcitabine showed promising antitumor activity and manageable toxicities, and especially for the good performance status patients with unresectable pancreatic cancer.

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Acknowledgments

We thank to Jeil Pharmaceutical Co. Ltd Taiho & Jeil Pharmaceutical Co. Ltd generously provided S-1. This study was supported by a 2008 special clinical grant of Gyeongsang National University Hospital.

Conflict of interest statement

None.

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Authors and Affiliations

  1. Division of Hematology-Oncology, Department of Internal Medicine, College of Medicine, Gyeongsang National University, Jinju, 660-702, Korea

    Gyeong-Won Lee, Ji-Hyun Ju, Seok-Hyun Kim, Hoon Gu Kim, Tae Hyo Kim, Hyun Jin Kim & Jung Hun Kang

  2. Gyeongsang Institute of Health Science, Jinju, Korea

    Gyeong-Won Lee, Ji-Hyun Ju, Seok-Hyun Kim, Hoon Gu Kim, Tae Hyo Kim, Hyun Jin Kim, Chi-Young Jeong & Jung Hun Kang

  3. Gyeongnam Regional Cancer Center, Jinju, Korea

    Gyeong-Won Lee, Hye Jung Kim, Ji-Hyun Ju, Seok-Hyun Kim, Hoon Gu Kim, Tae Hyo Kim, Hyun Jin Kim, Chi-Young Jeong & Jung Hun Kang

  4. Department of Pharmacology, School of Medicine, Gyeongsang National University, Jinju, Korea

    Hye Jung Kim

  5. Department of Surgery, School of Medicine, Gyeong-Sang National University, Jinju, Korea

    Chi-Young Jeong

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  1. Gyeong-Won Lee
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Correspondence to Jung Hun Kang.

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Lee, GW., Kim, H.J., Ju, JH. et al. Phase II trial of S-1 in combination with gemcitabine for chemo-naïve patients with locally advanced or metastatic pancreatic cancer. Cancer Chemother Pharmacol 64, 707–713 (2009). https://doi.org/10.1007/s00280-008-0918-0

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  • DOI: https://doi.org/10.1007/s00280-008-0918-0

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