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, JW
AU - Wasan, H
AU - Johnson, Philip
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
PY - 2009/8/1
Y1 - 2009/8/1
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, n = 44/42) 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 n = 31 vs B n = 36): no CRs; PR 22.6 vs 27.8%; SD 35.5 vs 47.1% for a tumour control rate (CR + PR + SD) 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. British Journal of Cancer (2009) 101, 621-627. doi: 10.1038/sj.bjc.6605211 www.bjcancer.com (C) 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, n = 44/42) 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 n = 31 vs B n = 36): no CRs; PR 22.6 vs 27.8%; SD 35.5 vs 47.1% for a tumour control rate (CR + PR + SD) 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. British Journal of Cancer (2009) 101, 621-627. doi: 10.1038/sj.bjc.6605211 www.bjcancer.com (C) 2009 Cancer Research UK
KW - biliary tract
KW - cholangiocarcinoma
KW - gemcitabine
KW - gallbladder cancer
KW - cisplatin
KW - chemotherapy
U2 - 10.1038/sj.bjc.6605211
DO - 10.1038/sj.bjc.6605211
M3 - Article
C2 - 19672264
VL - 101
SP - 621
EP - 627
JO - British Journal of Cancer
JF - British Journal of Cancer
IS - 4
ER -
