دورية أكاديمية

Phase II study of single-agent gemcitabine in patients with advanced biliary tract cancer.

التفاصيل البيبلوغرافية
العنوان: Phase II study of single-agent gemcitabine in patients with advanced biliary tract cancer.
المؤلفون: Okusaka T; Hepatobiliary and Pancreatic Oncology Division, National Cancer Center Hospital, 5-1-1 Tsukiji, Chuo-ku, Tokyo, 104-0045, Japan. tokusaka@ncc.go.jp, Ishii H, Funakoshi A, Yamao K, Ohkawa S, Saito S, Saito H, Tsuyuguchi T
المصدر: Cancer chemotherapy and pharmacology [Cancer Chemother Pharmacol] 2006 May; Vol. 57 (5), pp. 647-53. Date of Electronic Publication: 2005 Sep 02.
نوع المنشور: Clinical Trial, Phase II; Journal Article; Research Support, Non-U.S. Gov't
اللغة: English
بيانات الدورية: Publisher: Springer Verlag Country of Publication: Germany NLM ID: 7806519 Publication Model: Print-Electronic Cited Medium: Print ISSN: 0344-5704 (Print) Linking ISSN: 03445704 NLM ISO Abbreviation: Cancer Chemother Pharmacol Subsets: MEDLINE
أسماء مطبوعة: Publication: Berlin : Springer Verlag
Original Publication: Berlin, New York, Springer International.
مواضيع طبية MeSH: Adenocarcinoma/*drug therapy , Antimetabolites, Antineoplastic/*therapeutic use , Biliary Tract Neoplasms/*drug therapy , Deoxycytidine/*analogs & derivatives, Adenocarcinoma/mortality ; Adenocarcinoma/secondary ; Adult ; Aged ; Biliary Tract Neoplasms/mortality ; Biliary Tract Neoplasms/pathology ; Deoxycytidine/therapeutic use ; Female ; Humans ; Male ; Maximum Tolerated Dose ; Middle Aged ; Ribonucleotide Reductases/antagonists & inhibitors ; Survival Rate ; Gemcitabine
مستخلص: Purpose: This phase II study was conducted to evaluate the efficacy and toxicity of single-agent gemcitabine in patients with advanced or metastatic biliary tract cancer.
Patients and Methods: Gemcitabine 1,000 mg/m(2) was administered as an intravenous 30-min infusion on days 1, 8, and 15 for every 28 days.
Results: Forty chemonaive patients with a median age of 61 (range 33-73) were enrolled, and all 40 patients were involved in efficacy and safety analyses. Seven (17.5%) achieved partial response; 15 (37.5%) had stable disease; 17 (42.5%) had progressive disease; and 1 (2.5%) was not evaluated. The median survival time was 7.6 months, and the 1-year survival rate was 25.0%. Grade 3/4 neutropenia occurred in 12 patients (30.0%), leukopenia in five patients (12.5%), and anemia in four patients (10.0%). The most common grade 3/4 nonhematologic toxicities were elevated ALT (15.0%) and elevated gamma-GTP (12.5%). One patient had grade 4 hemolytic uremic syndrome and recovered after discontinuation of gemcitabine.
Conclusions: In single-agent therapy, gemcitabine demonstrated moderate efficacy with manageable toxicity in patients with advanced or metastatic biliary tract cancer. Further evaluations are warranted, including the exact impact of gemcitabine on the management of advanced or metastatic biliary tract cancer.
المشرفين على المادة: 0 (Antimetabolites, Antineoplastic)
0W860991D6 (Deoxycytidine)
EC 1.17.4.- (Ribonucleotide Reductases)
0 (Gemcitabine)
تواريخ الأحداث: Date Created: 20050906 Date Completed: 20060411 Latest Revision: 20221207
رمز التحديث: 20231215
DOI: 10.1007/s00280-005-0095-3
PMID: 16142487
قاعدة البيانات: MEDLINE
الوصف
تدمد:0344-5704
DOI:10.1007/s00280-005-0095-3