Optimizing Chemotherapy for Frail and Elderly Patients with Advanced Gastroesophageal Cancer (aGOAC): the GO2 Phase III Trial.
Session type: Clinical Trials Showcase
Many patients with aGOAC are elderly and/or frail. We previously compared epirubin/ oxaliplatin/ capecitabine (EOCap) vs OCap vs Cap in a pick-the-winner study and found OCap best. GO2 was designed to find the optimum dose of OCap and to explore the use of baseline geriatric assessment to individualize doses for Overall Treatment Utility (OTU), a composite of clinical benefit, tolerability, QoL and patient value.
Patients with aGOAC were eligible if unsuitable for full-dose EOCap due to age or frailty, but fit for OCap. Baseline assessment included QoL; symptoms; functioning; comorbidity; frailty. Randomization was 1:1:1 to dose Level A (Ox 130 mg/m2d1, Cap 625 mg/m2bd d1-21, q21d), B (80% A doses) or C (60% A doses). At 9 weeks, patients were scored for OTU. Non-inferiority (vs A) was assessed using PFS with boundary HR 1.34 based on discussion with patients and clinicians.
512 pts were randomised, 2014-17, 61 UK centres.
Pts (PFS events)
% PS ≥2
% Severely Frail
% any Gr ≥3 non-haem AE
Median PFS mo
OTU wk 9: % Good/mod./poor
Median OS mo
Non-inferiority of PFS is confirmed for Level B vs A (HR 1.09, CI 0.89-1.32) and for Level C vs A (HR 1.10, CI 0.90-1.33). Level C pts had least toxicity and best OTU. OTU was optimal with Level C even in non-frail and PS0-1 pts; no group benefited more from the higher dose levels.
This is the largest RCT to date investigating frail elderly aGOAC pts, and should guide future treatment. The lowest dose was non-inferior for PFS and achieved better overall treatment utility.
© 2019 American Society of Clinical Oncology, Inc. Reused with permission. This abstract was accepted and previously presented at the 2019 ASCO Annual Meeting. All rights reserved.