54MO - Quality of life (QoL) and value of health (V-He) in advanced biliary cancers (ABC) treated with second-line active-symptom-control (ASC) alone or ASC with oxaliplatin/5-FU chemotherapy (ASC+FOLFOX) in the randomised phase III, multi-centre, open-label ABC-06 trial

Background

The ABC-06 clinical trial stablished ASC+mFOLFOX as the standard of care treatment after Cisplatin and Gemcitabine (CisGem) for ABC but its impact on QoL has not been reported.

Methods

Within the ABC-06 study, patients (pts) diagnosed with ABC with progression after CisGem were randomised (1:1) to ASC+mFOLFOX or ASC. QoL (European Organisation for Research and Treatment of Cancer [EORTC] QLQ-30, QLQ-BIL21) and V-He (Euroqol EQ5D) questionnaires were completed at baseline and 12-weekly thereafter. Pateints who completed all or part of the EORTC or EQ-5D measure at baseline (BSL) were elegible. Follow-up data is reported for month 4 (M4) (follow-up visit that occurred up to 120 days post screening). Descriptive analyses,of the QoL measures by study arm are reported here; T-test was used for comparison between time-points (two-tailed p-value <0.05 was considered statistically significant).

Results

Out of 162 pts randomised, 138 were eligible for this available case analysis (65 ASC arm, 73 ASC+FOLFOX arm). Baseline characteristics and time from BSL to M4 visit were well balanced between both study arms. Addition of FOLFOX to ASC did not appear to induce worsening of the QOL parameters assessed (Table). In contrast, pts in the ASC-alone arm appeared to experience worsening of the EQ-5D utility values, and most of the QLQ-30 scales (including global, physical, social and role scales). There also appeared to be worsening of nausea and pain which remained stable in the ASC+FOLFOX arm. Table: 54MO

Conclusions

For ABC patients, treatment with second-line ASC+mFOLFOX may allow stabilisation of QoL scales and avoid worsening of nausea and pain at 4 months after baseline assessment. Full analyses of QoL to explore this potentially positive impact of FOLFOX is ongoing, along with an assessment of whether FOLFOX may be cost-effective.

Clinical trial identification

NCT01926236.

Editorial acknowledgement

Legal entity responsible for the study

The Christie NHS Foundation Trust.

Funding

Cancer Research UK, StandUpToCancer, AMMF (The UK Cholangiocarcinoma Charity), and The Christie Charity, with additional funding from The Cholangiocarcinoma Foundation and the Conquer Cancer Foundation Young Investigator Award for translational research.

Disclosure

A. Lamarca: Financial Interests, Personal, Invited Speaker: Merck, Pfizer, Ipsen, Incyte, AAA, QED, QED, AstraZeneca, EISAI, Servier, Incyte; Financial Interests, Personal, Advisory Board: EISAI, Nutricia, Ipsen, QED, Roche, Servier, Boston Scientific, Albireo Pharma, AstraZeneca; Financial Interests, Institutional, Other, Access to FM molecular profiling: Roche; Non-Financial Interests, Principal Investigator, PI of trial: QED, Merck; Other, Other, Travel and educational support: Ipsen, Pfizer, Bayer, AAA, SIrTex, Novartis, Mylan, Delcath. All other authors have declared no conflicts of interest.