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S-1 monotherapy as first-line treatment in patients with advanced biliary tract cancer: a multicenter phase II study

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Abstract

A pilot phase II study showed S-1 monotherapy to be safe and active against biliary tract cancer (BTC). We, therefore, conducted a multicenter phase II study to evaluate the antitumor effect and safety of S-1 in previously untreated patients with advanced BTC. Eligible patients had pathologically proven, unresectable adenocarcinoma with no prior chemotherapy or radiotherapy. Patients received S-1 orally at 80 mg/m2 total daily dose divided b.i.d. for 28 days followed by 14 days of rest. Of the 41 enrolled patients, 40 were assessable. The primary tumor sites were as follows: gallbladder (n = 20), extrahepatic bile duct (n = 15), and the ampulla of Vater (n = 5). One patient (2.5%) achieved a complete response, 13 patients (32.5%) had partial responses, 17 patients (42.5%) had no change, 7 patients (17.5%) had progressive disease, and 2 patients (5.0%) were not evaluable. The overall objective response rate was 35.0%. The median overall survival (median OS) was 9.4 months, and the median time to progression was 3.7 months. Grade 3 or 4 toxicities included fatigue (7.5%), anorexia (7.5%) and T-Bil elevation (7.5%). Significant antitumor activity combined with a mild toxicity profile was observed. This monotherapy warrants further evaluation in a randomized study.

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Acknowledgments

We thank Drs. M. Kurihara, S. Matsuno, O. Ishikawa, C. Hamada and T. Taguchi for their kind advice, and Drs. H. Saisho, N. Moriyama and W. Koizumi for this extramural review. The authors are indebted to Professor J. Patrick Barron of the International Medical Communications Center of Tokyo Medical University for his review of this manuscript. This study was supported by Taiho Pharmaceutical Co. Ltd.

Conflict of interest

The study was supported by Taiho Pharmaceutical Co., Ltd. (Tokyo). For all authors, there is no potential conflict of interest, relevant to this article.

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Authors and Affiliations

  1. Division of Hepatobiliary and Pancreatic Oncology, National Cancer Center Hospital East, 6-5-1 Kashiwanoha, Kashiwa-shi, Chiba, 277-8577, Japan

    Junji Furuse

  2. Division of Hepatobiliary and Pancreatic Oncology, National Cancer Center Hospital, Tokyo, Japan

    Takuji Okusaka

  3. Division of Gastrointestinal Oncology, Shizuoka Cancer Center, Suntou-gun Shizuoka, Japan

    Narikazu Boku

  4. Division of Hepatobiliary and Pancreatic Medical Oncology, Kanagawa Cancer Center, Yokohama, Japan

    Shinichi Ohkawa

  5. Department of Gastroenterology, Aichi Cancer Center Hospital, Nagoya, Japan

    Akira Sawaki

  6. Department of Internal Medicine, National Shikoku Cancer Center, Matsuyama, Japan

    Toshikazu Masumoto

  7. Department of Gastroenterology, National Kyushu Cancer Center, Fukuoka, Japan

    Akihiro Funakoshi

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  1. Junji Furuse
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  2. Takuji Okusaka
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  3. Narikazu Boku
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  4. Shinichi Ohkawa
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  5. Akira Sawaki
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  6. Toshikazu Masumoto
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  7. Akihiro Funakoshi
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Correspondence to Junji Furuse.

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Furuse, J., Okusaka, T., Boku, N. et al. S-1 monotherapy as first-line treatment in patients with advanced biliary tract cancer: a multicenter phase II study. Cancer Chemother Pharmacol 62, 849–855 (2008). https://doi.org/10.1007/s00280-007-0673-7

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  • DOI: https://doi.org/10.1007/s00280-007-0673-7

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