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      Adjuvant chemotherapy with gemcitabine and cisplatin compared to observation after curative intent resection of cholangiocarcinoma and muscle invasive gallbladder carcinoma (ACTICCA-1 trial) - a randomized, multidisciplinary, multinational phase III trial.

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          Abstract

          Despite complete resection, disease-free survival (DFS) of patients with cholangiocarcinoma (CCA) is less than 65 % after one year and not more than 35 % after three years. For muscle invasive gallbladder carcinoma (GBCA), prognosis is even worse, with an overall survival (OS) of only 30 % after three years. Thus, evaluation of adjuvant chemotherapy in biliary tract cancer in a large randomized trial is warranted.

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          Estimates of worldwide burden of cancer in 2008: GLOBOCAN 2008.

          Jacques Ferlay, Hai-Rim Shin, Freddie Bray … (2010)
          Estimates of the worldwide incidence and mortality from 27 cancers in 2008 have been prepared for 182 countries as part of the GLOBOCAN series published by the International Agency for Research on Cancer. In this article, we present the results for 20 world regions, summarizing the global patterns for the eight most common cancers. Overall, an estimated 12.7 million new cancer cases and 7.6 million cancer deaths occur in 2008, with 56% of new cancer cases and 63% of the cancer deaths occurring in the less developed regions of the world. The most commonly diagnosed cancers worldwide are lung (1.61 million, 12.7% of the total), breast (1.38 million, 10.9%) and colorectal cancers (1.23 million, 9.7%). The most common causes of cancer death are lung cancer (1.38 million, 18.2% of the total), stomach cancer (738,000 deaths, 9.7%) and liver cancer (696,000 deaths, 9.2%). Cancer is neither rare anywhere in the world, nor mainly confined to high-resource countries. Striking differences in the patterns of cancer from region to region are observed. Copyright © 2010 UICC.
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            Cisplatin plus gemcitabine versus gemcitabine for biliary tract cancer.

            Juan Ignacio Valle, Harpreet Singh Wasan, Daniel H Palmer … (2010)
            There is no established standard chemotherapy for patients with locally advanced or metastatic biliary tract cancer. We initially conducted a randomized, phase 2 study involving 86 patients to compare cisplatin plus gemcitabine with gemcitabine alone. After we found an improvement in progression-free survival, the trial was extended to the phase 3 trial reported here. We randomly assigned 410 patients with locally advanced or metastatic cholangiocarcinoma, gallbladder cancer, or ampullary cancer to receive either cisplatin (25 mg per square meter of body-surface area) followed by gemcitabine (1000 mg per square meter on days 1 and 8, every 3 weeks for eight cycles) or gemcitabine alone (1000 mg per square meter on days 1, 8, and 15, every 4 weeks for six cycles) for up to 24 weeks. The primary end point was overall survival. After a median follow-up of 8.2 months and 327 deaths, the median overall survival was 11.7 months among the 204 patients in the cisplatin-gemcitabine group and 8.1 months among the 206 patients in the gemcitabine group (hazard ratio, 0.64; 95% confidence interval, 0.52 to 0.80; P<0.001). The median progression-free survival was 8.0 months in the cisplatin-gemcitabine group and 5.0 months in the gemcitabine-only group (P<0.001). In addition, the rate of tumor control among patients in the cisplatin-gemcitabine group was significantly increased (81.4% vs. 71.8%, P=0.049). Adverse events were similar in the two groups, with the exception of more neutropenia in the cisplatin-gemcitabine group; the number of neutropenia-associated infections was similar in the two groups. As compared with gemcitabine alone, cisplatin plus gemcitabine was associated with a significant survival advantage without the addition of substantial toxicity. Cisplatin plus gemcitabine is an appropriate option for the treatment of patients with advanced biliary cancer. (ClinicalTrials.gov number, NCT00262769.) 2010 Massachusetts Medical Society
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              Cholangiocarcinoma.

              Nataliya Razumilava, Gregory J. Gores (2014)
              Cholangiocarcinoma represents a diverse group of epithelial cancers united by late diagnosis and poor outcomes. Specific diagnostic and therapeutic approaches are undertaken for cholangiocarcinomas of different anatomical locations (intrahepatic, perihilar, and distal). Mixed hepatocellular cholangiocarcinomas have emerged as a distinct subtype of primary liver cancer. Clinicians need to be aware of intrahepatic cholangiocarcinomas arising in cirrhosis and properly assess liver masses in this setting for cholangiocarcinoma. Management of biliary obstruction is obligatory in perihilar cholangiocarcinoma, and advanced cytological tests such as fluorescence in-situ hybridisation for aneusomy are helpful in the diagnosis. Liver transplantation is a curative option for selected patients with perihilar but not with intrahepatic or distal cholangiocarcinoma. International efforts of clinicians and scientists are helping to identify the genetic drivers of cholangiocarcinoma progression, which will unveil early diagnostic markers and direct development of individualised therapies. Copyright © 2014 Elsevier Ltd. All rights reserved.
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                Author and article information

                Journal
                Journal ID (iso-abbrev): BMC Cancer
                Title: BMC cancer
                Publisher: Springer Science and Business Media LLC
                ISSN (Electronic): 1471-2407
                ISSN (Print): 1471-2407
                Publication date (Electronic): Jul 31 2015
                Volume: 15
                Affiliations
                [1 ] University Medical Center Hamburg-Eppendorf, and University Cancer Center Hamburg, Hamburg, Germany. a.stein@uke.de.
                [2 ] Tumor Biology Center, Clinic for Medical Oncology, Freiburg im Breisgau, Germany. arnold@tumorbio.uni-freiburg.de.
                [3 ] University College London Cancer Institute, London, UK. j.bridgewater@ucl.ac.uk.
                [4 ] University of New South Wales, Sydney, Australia. d.goldstein@unsw.edu.au.
                [5 ] Vejle Hospital, Vejle, Denmark. lars.henrik.jensen@rsyd.dk.
                [6 ] Academic Medical Center, Amsterdam, The Netherlands. h.klumpen@amc.uva.nl.
                [7 ] University Medical Center Hamburg-Eppendorf, and University Cancer Center Hamburg, Hamburg, Germany. a.lohse@uke.de.
                [8 ] University Medical Center Hamburg-Eppendorf, and University Cancer Center Hamburg, Hamburg, Germany. nashan@uke.de.
                [9 ] Southampton General Hospital, Southampton, United Kingdom. j.n.primrose@soton.ac.uk.
                [10 ] CTC North GmbH & Co. KG at the University Medical Center Hamburg-Eppendorf, Hamburg, Germany. s.schrum@ctc-north.com.
                [11 ] University of Sydney, Sydney, Australia. jenny.shannon@swahs.health.nsw.gov.au.
                [12 ] University Medical Center Hamburg-Eppendorf, and University Cancer Center Hamburg, Hamburg, Germany. e.vettorazzi@uke.de.
                [13 ] University Medical Center Hamburg-Eppendorf, and University Cancer Center Hamburg, Hamburg, Germany. hwege@uke.de.
                Article
                Publisher Item ID: 10.1186/s12885-015-1498-0
                DOI: 10.1186/s12885-015-1498-0
                PMC ID: 4520064
                PubMed ID: 26228433
                SO-VID: 0405648e-980c-4ce1-ac4b-606efb6b0482
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