Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Clinical Trial
. 2010 Aug 10;103(4):469-74.
doi: 10.1038/sj.bjc.6605779. Epub 2010 Jul 13.

Gemcitabine alone or in combination with cisplatin in patients with biliary tract cancer: a comparative multicentre study in Japan

T Okusaka  1 , K Nakachi, A Fukutomi, N Mizuno, S Ohkawa, A Funakoshi, M Nagino, S Kondo, S Nagaoka, J Funai, M Koshiji, Y Nambu, J Furuse, M Miyazaki, Y Nimura
Affiliations
Clinical Trial

Gemcitabine alone or in combination with cisplatin in patients with biliary tract cancer: a comparative multicentre study in Japan

T Okusaka et al. Br J Cancer. .

Abstract

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 gamma-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.

PubMed Disclaimer

Conflict of interest statement

TO, KN, NM, SO, SK and JF have received honoraria, and YN, MK, JF and SN are employed by Eli Lilly Japan.

Figures

Figure 1
Figure 1
CONSORT diagram. Disposition of patients. GC=gemcitabine–cisplatin combination; GEM=gemcitabine alone.
Figure 2
Figure 2
Kaplan–Meier curve of overall survival and progression-free survival. (A) Overall survival. (B) Progression-free survival. GC=gemcitabine–cisplatin combination; GEM=gemcitabine alone; CI=confidence interval.
See this image and copyright information in PMC

References

    1. Aljiffry M, Walsh MJ, Molinari M (2009) Advances in diagnosis, treatment and palliation of cholangiocarcinoma: 1990-2009. World J Gastroenterol 15: 4240–4262 - PMC - PubMed
    1. Bergman AM, Ruiz van Haperen VW, Veerman G, Kuiper CM, Peters GJ (1996) Synergistic interaction between cisplatin and gemcitabine in vitro. Clin Cancer Res 2: 521–530 - PubMed
    1. Charoentum C, Thongprasert S, Chewaskulyong B, Munprakan S (2007) Experience with gemcitabine and cisplatin in the therapy of inoperable and metastatic cholangiocarcinoma. World J Gastroenterol 13: 2852–2854 - PMC - PubMed
    1. Doval DC, Sekhon JS, Gupta SK, Fuloria J, Shukla VK, Gupta S, Awasthy BS (2004) A phase II study of gemcitabine and cisplatin in chemotherapy-naive, unresectable gall bladder cancer. Br J Cancer 90: 1516–1520 - PMC - PubMed
    1. Eckel F, Schmid RM (2007) Chemotherapy in advanced biliary tract carcinoma: a pooled analysis of clinical trials. Br J Cancer 96: 896–902 - PMC - PubMed

Publication types