TY - JOUR
T1 - S-1 monotherapy as first-line treatment in patients with advanced biliary tract cancer
T2 - A multicenter phase II study
AU - Furuse, Junji
AU - Okusaka, Takuji
AU - Boku, Narikazu
AU - Ohkawa, Shinichi
AU - Sawaki, Akira
AU - Masumoto, Toshikazu
AU - Funakoshi, Akihiro
N1 - Funding Information:
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.
Funding Information:
ConXict of interest The study was supported by Taiho Pharmaceutical Co., Ltd. (Tokyo). For all authors, there is no potential conXict of interest, relevant to this article.
PY - 2008/10
Y1 - 2008/10
N2 - 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.
AB - 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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U2 - 10.1007/s00280-007-0673-7
DO - 10.1007/s00280-007-0673-7
M3 - Article
C2 - 18214482
AN - SCOPUS:49749136654
SN - 0344-5704
VL - 62
SP - 849
EP - 855
JO - Cancer Chemotherapy and Pharmacology
JF - Cancer Chemotherapy and Pharmacology
IS - 5
ER -
