Quality of life, long-term survivors and long-term outcome from the ABC-02 study.
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Embargo End Date
ICR Authors
Authors
Bridgewater, J
Lopes, A
Palmer, D
Cunningham, D
Anthoney, A
Maraveyas, A
Madhusudan, S
Iveson, T
Valle, J
Wasan, H
Lopes, A
Palmer, D
Cunningham, D
Anthoney, A
Maraveyas, A
Madhusudan, S
Iveson, T
Valle, J
Wasan, H
Document Type
Journal Article
Date
2016-04
Date Accepted
2016-02-16
Abstract
Background 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.Methods 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).Results 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).Conclusions 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.
Citation
British journal of cancer, 2016, 114 (9), pp. 965 - 971
Source Title
Publisher
ISSN
0007-0920
eISSN
1532-1827
Collections
Research Team
Medicine (RMH Smith Cunningham)