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- Title
Randomized phase II trial of S-1 and cisplatin versus gemcitabine and cisplatin in patients with advanced biliary tract adenocarcinoma.
- Authors
Kang, Myoung Joo; Lee, Jae-Lyun; Kim, Tae Won; Lee, Sung Sook; Ahn, Shin; Park, Do Hyun; Lee, Sang Soo; Seo, Dong Wan; Lee, Sung Koo; Kim, Myung-Hwan
- Abstract
Background. We evaluated the efficacy and safety of a combination of S-1 and cisplatin (SP) versus gemcitabine and cisplatin (GP) as first-line therapy for advanced biliary tract adenocarcinoma (ABTA). Material and methods. Patients were randomized to receive cisplatin (60 mg/m2 intravenously [IV] on Day 1) plus S-1 (40 mg/m2 bid orally on Days 1-14) or gemcitabine (1000 mg/m2 IV at 10 mg/m2/min on Days 1 and 8) every three weeks. The primary end point was six-month progression-free survival (PFS). Results. Of 96 eligible patients, 49 were randomized to GP and 47 to SP. At a median follow-up time of 14.2 months, the six-month PFS rates were 43.8% and 34.7%, respectively [unadjusted HR (GP/SP) =0.85, 95% CI 0.52-1.36]. The median OS values in the GP and SP groups were 10.1 months and 9.9 months, respectively [unadjusted HR (GP/SP) =0.72, 95% CI 0.45-1.17]. Grade 3-4 toxicities in the GP and SP groups included neutropenia (49.0% vs. 31.8%), anemia (22.4% vs. 2.3%), thrombocytopenia (22.4% vs. 4.5%), and asthenia (4.1% vs. 2.1%). Conclusion. Both GP and SP has comparable efficacy with favorable safety profile as first-line treatment for ABTA. (ClinicalTrials.gov number NCT 01375972).
- Subjects
COMBINATION drug therapy; ADENOCARCINOMA; ANTIMETABOLITES; ANTINEOPLASTIC agents; CISPLATIN; CONFIDENCE intervals; RESEARCH funding; STATISTICAL sampling; BILE duct tumors; RANDOMIZED controlled trials; DATA analysis software; DESCRIPTIVE statistics; KAPLAN-Meier estimator; PROGNOSIS
- Publication
Acta Oncologica, 2012, Vol 51, Issue 7, p860
- ISSN
0284-186X
- Publication type
Article
- DOI
10.3109/0284186X.2012.682628