دورية أكاديمية

Multicenter phase II study of S-1 monotherapy as second-line chemotherapy for advanced biliary tract cancer refractory to gemcitabine.

التفاصيل البيبلوغرافية
العنوان: Multicenter phase II study of S-1 monotherapy as second-line chemotherapy for advanced biliary tract cancer refractory to gemcitabine.
المؤلفون: Sasaki T; Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo, 7-3-1 Hongo, Bunkyo-ku, Tokyo 113-8655, Japan., Isayama H, Nakai Y, Mizuno S, Yamamoto K, Yagioka H, Yashima Y, Kawakubo K, Kogure H, Togawa O, Matsubara S, Ito Y, Sasahira N, Hirano K, Tsujino T, Toda N, Tada M, Omata M, Koike K
المصدر: Investigational new drugs [Invest New Drugs] 2012 Apr; Vol. 30 (2), pp. 708-13. Date of Electronic Publication: 2010 Oct 06.
نوع المنشور: Clinical Trial, Phase II; Journal Article; Multicenter Study
اللغة: English
بيانات الدورية: Publisher: Springer Country of Publication: United States NLM ID: 8309330 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1573-0646 (Electronic) Linking ISSN: 01676997 NLM ISO Abbreviation: Invest New Drugs Subsets: MEDLINE
أسماء مطبوعة: Publication: New York : Springer
Original Publication: Boston : M. Nijhoff, 1983-
مواضيع طبية MeSH: Drug Resistance, Neoplasm*, Antimetabolites, Antineoplastic/*therapeutic use , Biliary Tract Neoplasms/*drug therapy , Deoxycytidine/*analogs & derivatives , Oxonic Acid/*therapeutic use , Tegafur/*therapeutic use, Administration, Oral ; Adult ; Aged ; Aged, 80 and over ; Antimetabolites, Antineoplastic/administration & dosage ; Antimetabolites, Antineoplastic/adverse effects ; Biliary Tract Neoplasms/diagnostic imaging ; Biliary Tract Neoplasms/mortality ; Biliary Tract Neoplasms/pathology ; Deoxycytidine/therapeutic use ; Disease Progression ; Drug Administration Schedule ; Drug Combinations ; Female ; Humans ; Japan ; Kaplan-Meier Estimate ; Male ; Middle Aged ; Oxonic Acid/administration & dosage ; Oxonic Acid/adverse effects ; Tegafur/administration & dosage ; Tegafur/adverse effects ; Time Factors ; Tomography, X-Ray Computed ; Treatment Failure ; Gemcitabine
مستخلص: Gemcitabine is widely used for the treatment of advanced biliary tract cancer (BTC) as first-line chemotherapy. However, there is no standard chemotherapy for patient with advanced BTC refractory to gemcitabine. We conducted a multicenter phase II study of S-1 monotherapy as second-line chemotherapy for patients with advanced BTC that were refractory to gemcitabine. S-1 was administered orally at a dose of 80 mg/m(2) for 28 days, followed by 14 days of rest. This regimen was repeated every 6 weeks. Tumor response was assessed every two cycles using the Response Evaluation Criteria in Solid Tumors version 1.0. Twenty-two patients were enrolled between March 2007 and January 2010, with 14 patients (64%) representing cases of recurrence after surgery. The overall response rate was 22.7%, and the overall disease control rate was 50.0%. The median overall survival time was 13.5 months (95% CI, 7.1-23.1 months) and the median time-to-progression was 5.4 months (95% CI, 2.6-17.2 months). Grade 3/4 toxicities included neutropenia (5%) and anemia (5%). The most common non-hematological toxicities were nausea (27%), anorexia (55%), and pigmentation (32%). In conclusion, S-1 monotherapy is feasible and moderately efficacious second-line chemotherapy for advanced BTC.
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المشرفين على المادة: 0 (Antimetabolites, Antineoplastic)
0 (Drug Combinations)
0W860991D6 (Deoxycytidine)
150863-82-4 (S 1 (combination))
1548R74NSZ (Tegafur)
5VT6420TIG (Oxonic Acid)
0 (Gemcitabine)
تواريخ الأحداث: Date Created: 20101007 Date Completed: 20120611 Latest Revision: 20221207
رمز التحديث: 20221213
DOI: 10.1007/s10637-010-9553-9
PMID: 20924641
قاعدة البيانات: MEDLINE
الوصف
تدمد:1573-0646
DOI:10.1007/s10637-010-9553-9