TY - JOUR
T1 - Gemcitabine alone or in combination with cisplatin in patients with advanced or metastatic cholangiocarcinomas or other biliary tract tumours: A multicentre randomised phase II study- the UK ABC-01 Study
AU - Valle, J. W.
AU - Wasan, H.
AU - Johnson, P.
AU - Jones, E.
AU - Dixon, L.
AU - Swindell, R.
AU - Baka, S.
AU - Maraveyas, A.
AU - Corrie, P.
AU - Falk, S.
AU - Gollins, S.
AU - Lofts, F.
AU - Evans, L.
AU - Meyer, T.
AU - Anthoney, A.
AU - Iveson, T.
AU - Highley, M.
AU - Osborne, R.
AU - Bridgewater, J.
N1 - GeneGenie is a two-tiered web application, developed with the Google Web Toolkit (GWT) and written in Java 7, CSS and HTML. The web interface is accessible through web browser that support GWT (Firefox, Internet Explorer 6 and above, Safari 5 and above, Chromium and Google Chrome, and Opera latest version) and provides the facility for submitting jobs and viewing results. The web server provides an implementation of a novel simulated annealing algorithm for optimising gene design. Source code is freely available at http://svn.code.sf.net/p/mcisb/code/mcisb-mercedes/.
PY - 2009/8/18
Y1 - 2009/8/18
N2 - Background:We assessed the activity of gemcitabine (G) and cisplatin/gemcitabine (C/G) in patients with locally advanced (LA) or metastatic (M) (advanced) biliary cancers (ABC) for whom there is no standard chemotherapy.Methods:Patients, aged 18 years, with pathologically confirmed ABC, Karnofsky performance (KP) 60, and adequate haematological, hepatic and renal function were randomised to G 1000 mg m 2 on D1, 8, 15 q28d (Arm A) or C 25 mg m 2 followed by G 1000 mg m 2 D1, 8 q21d (Arm B) for up to 6 months or disease progression.Results:In total, 86 patients (A/B, n44/42) were randomised between February 2002 and May 2004. Median age (64/62.5 years), KP, primary tumour site, earlier surgery, indwelling biliary stent and disease stage (LA: 25/38%) are comparable between treatment arms. Grade 3-4 toxicity included (A/B, % patients) anaemia (4.5/2.4), leukopenia (6.8/4.8), neutropenia (13.6/14.3), thrombocytopenia (9.1/11.9), lethargy (9.1/28.6), nausea/vomiting (0/7.1) and anorexia (2.3/4.8). Responses (WHO criteria, % of evaluable patients: A n31 vs B n36): no CRs; PR 22.6 vs 27.8%; SD 35.5 vs 47.1% for a tumour control rate (CRPRSD) of 58.0 vs 75.0%. The median TTP and 6-month progression-free survival (PFS) (the primary end point) were greater in the C/G arm (4.0 vs 8.0 months and 45.5 vs 57.1% in arms A and B, respectively).Conclusion:Both regimens seem active in ABC. C/G is associated with an improved tumour control rate, TTP and 6-month PFS. The study has been extended (ABC-02 study) and powered to determine the effect on overall survival and the quality of life. © 2009 Cancer Research UK.
AB - Background:We assessed the activity of gemcitabine (G) and cisplatin/gemcitabine (C/G) in patients with locally advanced (LA) or metastatic (M) (advanced) biliary cancers (ABC) for whom there is no standard chemotherapy.Methods:Patients, aged 18 years, with pathologically confirmed ABC, Karnofsky performance (KP) 60, and adequate haematological, hepatic and renal function were randomised to G 1000 mg m 2 on D1, 8, 15 q28d (Arm A) or C 25 mg m 2 followed by G 1000 mg m 2 D1, 8 q21d (Arm B) for up to 6 months or disease progression.Results:In total, 86 patients (A/B, n44/42) were randomised between February 2002 and May 2004. Median age (64/62.5 years), KP, primary tumour site, earlier surgery, indwelling biliary stent and disease stage (LA: 25/38%) are comparable between treatment arms. Grade 3-4 toxicity included (A/B, % patients) anaemia (4.5/2.4), leukopenia (6.8/4.8), neutropenia (13.6/14.3), thrombocytopenia (9.1/11.9), lethargy (9.1/28.6), nausea/vomiting (0/7.1) and anorexia (2.3/4.8). Responses (WHO criteria, % of evaluable patients: A n31 vs B n36): no CRs; PR 22.6 vs 27.8%; SD 35.5 vs 47.1% for a tumour control rate (CRPRSD) of 58.0 vs 75.0%. The median TTP and 6-month progression-free survival (PFS) (the primary end point) were greater in the C/G arm (4.0 vs 8.0 months and 45.5 vs 57.1% in arms A and B, respectively).Conclusion:Both regimens seem active in ABC. C/G is associated with an improved tumour control rate, TTP and 6-month PFS. The study has been extended (ABC-02 study) and powered to determine the effect on overall survival and the quality of life. © 2009 Cancer Research UK.
KW - Biliary tract
KW - Chemotherapy
KW - Cholangiocarcinoma
KW - Cisplatin
KW - Gallbladder cancer
KW - Gemcitabine
U2 - 10.1038/sj.bjc.6605211
DO - 10.1038/sj.bjc.6605211
M3 - Article
VL - 101
SP - 621
EP - 627
JO - BJC
JF - BJC
SN - 0007-0920
IS - 4
ER -
