LAUSR

Abstract Background Many pts with aGOAC are elderly and/or frail. GO2 [ASCO 2019 #4006] found that lower dose OxaliplatinCapecitabine (OCap) led to non-inferior progression free survival, less toxicity and better patient-centred outcomes using a novel composite endpoint ‘Overall Treatment Utility’. QoL endpoints were chosen to reflect the balance between benefits and harms of the three dose levels and to help patients understand likely implications of treatment for shared decision making. Methods Eligible pts unsuitable for full-dose 3-drug chemotherapy due to frailty, but fit for OCap. Baseline assessment included QoL; symptoms; functional scales; comorbidity; frailty. Randomization was 1:1:1 to dose Level (Lvl) A (Ox 130 mg/m2d1, Cap 625 mg/m2bd d1-21, q21d), B (80% Lvl A doses) or C (60% Lvl A doses) until progression or decision to stop. An alternative randomisation option where chemo benefit was considered uncertain (‘uc’) was between OCap Lvl C and Best Supportive Care (BSC). QoL (EQ-VAS) was measured weekly during chemotherapy. QoL (EQ-5D), Fatigue (EORTC QLQ-C30 Fatigue scale) were measured 9-weekly for 1 year. QoL endpoints were analysed descriptively as pre-defined in the statistical analysis plan. Results 558 pts were enrolled, 2014-17, 61 UK centres, of which 45 pts were in the uc randomisation. Table . LBA46 Lvl A Lvl B Lvl C Lvl C (‘uc’) BSC (‘uc’) Pts 170 171 173 23 22 Median Age 76 76 77 79 79 % PS ≥ 2 31 32 31 57 68 % Severely Frail 61 56 58 70 68 9 wk Δ QLQ QoLa +0.4 +5.3 +4.9 na na 9 wk Δ EQ-5D QoLa -0.01 +0.06 +0.8 -0.19 -0.35 9 wk Δ EQ-VAS QoLa +8.6 +3.4 +5.4 +2.7 +0.2 9 wk Δ Fatigueb +8.6 +3.4 -0.6 +4.0 +15.1 Median TDFc (mths) 7.1 5.4 6.5 na na a. higher=better; b. higher=worse; c. TDF=Time to deterioration in fatigue Longitudinal QoL and Fatigue over the one year follow-up period were very similar between arms. Cancer symptoms also improved to a similar extend in each arm. Conclusions GO2 is the largest RCT to date investigating frail and/or elderly aGOAC pts, and should guide future treatment. Lower doses led to more rapid improvements in QoL and fatigue without compromising disease control or survival. Clinical trial identification EudraCT: 2013-000009-21; ISRCTN44687907 Rec No: 13/YH/0229. Legal entity responsible for the study University of Leeds. Funding Cancer Research UK. Disclosure All authors have declared no conflicts of interest.