Preliminary Analyses of QOL Data from the ABC-06 Clinical Trial

Active symptom control (ASC) in conjunction with a modified L-folinic acid plus oxaliplatin plus 5-fluorouracil (mFOLFOX) regimen has emerged as a standard of care for advanced and metastatic biliary tract cancers (BTCs) following treatment with gemcitabine/cisplatin (GemCis). However, patient outcomes regarding quality of life (QOL) and value of health (V-He) have not been examined. This analysis of data collected as part of the randomized, phase 3, open-label, multicenter ABC-06 trial sought to determine the effect of ASC and mFOLFOX on QOL and V-He. Results were shared at the 2022 ESMO congress.

A total of 162 patients in the ABC-06 study who were diagnosed with advanced BTC that progressed following GemCis treatment were randomly assigned (1:1) to 1 of 2 treatment arms. Arm A received ASC alone, consisting primarily of supportive treatment, including biliary drainage, antibiotics, analgesia, steroids, antiemetics, and other palliative treatments to mitigate symptoms. Arm B received ASC interventions plus mFOLFOX. Patients’ perceptions of QOL and V-He were collected via questionnaires at baseline and every 12 weeks thereafter. Descriptive analyses of the QOL and V-He measures by study arm were reported, and patients who completed all or part of the QOL and V-He questionnaires were included in the interim analysis.

Data from 138 participating patients were eligible for analysis, with 65 in arm A (ASC alone) and 73 in arm B (ASC plus mFOLFOX). Baseline characteristics were well matched across both study arms. Patients receiving mFOLFOX plus ASC generally reported stable responses to questions assessing QOL, including metrics such as global health, physical health, and social function as well as symptoms of nausea, pain, and fatigue. Patients who received ASC alone reported worsening V-He perceptions and a decline in QOL for most indicators. These patients also reported an increase in nausea and pain. Additional analysis showed that adding mFOLFOX to ASC did not have a significant impact on the time to Global Health Scale deterioration.

Preliminary data from this study indicate that second-line treatment in patients with advanced BTCs with ASC plus mFOLFOX improved self-reported QOL and V-He scales versus ASC alone. In addition, patients receiving ASC plus mFOLFOX did not report an increase in nausea or pain from baseline to 4 months of follow-up. A fuller analysis of QOL and V-He data is ongoing.

Sources: Lamarca A, Palmer D, Wasan HS, et al. 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. Ann Oncol. 2022;33(suppl 7):S564-S565.

Lamarca A, Palmer D, Wasan HS, et al. 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. European Society for Medical Oncology Congress 2022. Abstract 54MO.