Gemcitabine alone or in combination with cisplatin in patients with biliary tract cancer: a comparative multicentre study in Japan
By T. Okusaka, K. Nakachi, A. Fukutomi, N. Mizuno, S. Ohkawa, A. Funakoshi, M. Nagino, S. Kondo, S. Nagaoka, J. Funai and 5 more. British Journal of Cancer, 2010
718 citations recorded by the source corpus.
Background:A British randomised study of gemcitabine plus cisplatin (GC) combination showed promising results in biliary tract cancer (BTC) patients. In our study, we evaluated the efficacy and safety of this combination compared with gemcitabine alone (G) in Japanese BTC patients.Methods:Overall, 84 advanced BTC patients were randomised to either cisplatin 25 mg m−2 plus gemcitabine 1000 mg m−2 on days 1, 8 of a 21-day cycle (GC-arm), or single-agent gemcitabine 1000 mg m−2 on days 1, 8 and 15 of a 28-day cycle (G-arm). Treatments were repeated for at least 12 weeks until disease progression or unacceptable toxicity occurred, up to a maximum of 48 weeks.Results:A total of 83 patients were included in the analysis. For the GC and G-arms, respectively, the 1-year survival rate was 39.0 vs 31.0%, median survival time 11.2 vs 7.7 months, median progression-free survival time 5.8 vs 3.7 months and overall response rate 19.5 vs 11.9%. The most common grade 3 or 4 toxicities (GC-arm/G-arm) were neutropenia (56.1%/38.1%), thrombocytopenia (39.0%/7.1%), leukopenia (29.3%/19.0%), haemoglobin decrease (36.6%/16.7%) and γ-GTP increase (29.3%/35.7%).Conclusions:Gemcitabine plus cisplatin combination therapy was found to be effective and well tolerated, suggesting that it could also be a standard regimen for Japanese patients.
Subfields: Oncology, Pulmonary and Respiratory Medicine, Surgery
View Paper: https://www.semanticscholar.org/paper/cc187695d1b2c13c677b4348aea4c88b78bfe89a
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Citations in the corpus
- Cholangiocarcinoma — evolving concepts and therapeutic strategies (2017, neutral): “A subsequent metaanalysis 71 , which incorporated data from the UK study 11 and a Japanese study 72 , among others, reported similar results for the gemcitabine and cisplatin regimen, with a median over all survival of 11.7 months — and 11.1 months in the UK and Japanese study cohorts…”
- Guidelines for the diagnosis and management of intrahepatic cholangiocarcinoma. (2014, methodology): “These data are supported by a randomized phase 2 study of 83 patients using the same protocol [218].”
- Primary sclerosing cholangitis - a comprehensive review. (2017, background): “III], and BT22 [(phase II]), provides supportive evidence for use of gemcitabine combined with cisplatin as first-line treatment (219-221).”