Quality of life, long-term survivors and long-term outcome from the ABC-02 study.
The ABC-02 (Advanced Biliary Tract Cancer) study established cisplatin and gemcitabine (CisGem) as the standard first-line chemotherapy for patients with locally advanced or metastatic biliary tract cancer (BTC). We examine quality of life (QoL), describe the long-term survivors and provide a long-term outcome.



A total of 410 BTC patients were randomised to receive either CisGem or gemcitabine alone (Gem); 324 patients consented to complete EORTC QLQ-C30 and EORTC QLQ-PAN26 QoL questionnaires; 268 (83%) patients returned at least one QoL questionnaire (134 in each arm). Long-term survivors were defined as those surviving over 2 years and we performed a final analysis of the primary outcome; overall survival (OS).



Most QoL scales showed a trend favouring the combined CisGem arm, including functional and symptomatic scales, although the differences were not statistically significant. Forty-five (11%)) patients survived at least 2 years (34 received CisGem and 11 Gem) and 21 (5%) 3 years or more (14 received CisGem and 7 Gem). After a median follow-up of 9.2 months and 398 deaths, the median OS was 11.7 months for CisGem and 8.1 months for Gem (hazard ratio (HR)=0.65, 95% CI: 0.53-0.79, P<0.001).



The survival advantage of CisGem compared to Gem was not associated with an improvement or deterioration of QoL. Long-term survivors were more likely to have received CisGem and the long-term OS is identical to that previously described.
UCL Cancer Institute, UCL, London WC1E 6DD, UK.
John
J
Bridgewater
UCL and CRUK Clinical Trials Centre, UCL, London W1T 4TJ, UK.
Andre
A
Lopes
Institute of Translational Medicine, University of Liverpool, Liverpool L69 3BX, UK.
Daniel
D
Palmer
Department of Medicine, Royal Marsden Hospital, Sutton SM2 5PT, UK.
David
D
Cunningham
Department of Oncology, St. James's Hospital, Leeds LS9 7TF, UK.
Alan
A
Anthoney
Department of Oncology, Castle Hill Hospital, Hull HU16 5JQ, UK.
Anthony
A
Maraveyas
Department of Oncology, Nottingham University Hospitals, Nottingham NG7 2UH, UK.
Srinivasan
S
Madhusudan
Department of Oncology, Southampton University Hospitals, Southampton SO16 6YD, UK.
Tim
T
Iveson
The University of Manchester, Manchester M20 4BX, UK.
Juan
J
Valle
Hammersmith Hospital, London W12 0HS, UK.
Harpreet
H
Wasan
D001661:Biliary Tract Neoplasms / Q000188:drug therapy / Q000401:mortality*; D005260:Female; D006801:Humans; D008297:Male; D011788:Quality of Life; D017741:Survivors; D016896:Treatment Outcome