Optimizing Chemotherapy for Frail and Elderly Patients with Advanced Gastroesophageal Cancer (aGOAC): the GO2 Phase III Trial.


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Peter Hall1,Daniel Swinson2,Simon Lord3,Helen Marshall4,David Cairns4,Sharon Ruddock4,Emma Batman4,Galina Velikova4,Russell Petty5,Justin Waters6,Jonathan Wadsley7,Stephen Falk8,Catherine Handforth9,Rajarshi Roy10,Mano Joseph11,Konstantinos Kamposioras12,Jonathan Nicoll13,Tania Tillett14,Sebastian Cummins15,Simon Grumett16,Zuzana Stokes17,Tom Waddell18,Anirban Chatterjee19,Angel Garcia20,Christine Allmark21,Matthew Seymour22
1University of Edinburgh, Edinburgh, UK,2Leeds Teaching Hospitals NHS Trust, Leeds, UK,3University of Oxford, Oxford, UK,4University of Leeds, Leeds, UK,5University of Dundee, Dundee, UK,6Kent Oncology Centre, Maidstone, UK,7Western Park Hospital, Sheffield, UK,8Bristol Haematology and Oncology Centre, Bristol, UK,9University of Sheffield, Sheffield, UK,10Castle Hill Hospital, Hull, UK,11The Royal Wolverhampton NHS Trust, Wolverhampton, UK,12Mid Yorkshire Hospitals NHS Trust, Wakefield, UK,13North Cumbria University Hospitals NHS Trust, Carlisle, UK,14Royal United Hospital Bath NHS Trust, Bath, UK,15Royal Surrey County Hospital NHS Foundation Trust, Guilford, UK,16The Dudley Group NHS Foundation Trust, Dudley, UK,17United Lincolnshire Hospitals NHS Trust, Lincoln, UK,18The Christie NHS Foundation Trust, Manchester, UK,19The Shrewsbury and Telford Hospital NHS Trust, Shrewsbury, UK,20The Shrewsbury and Telford Hospital NHS Trust,21NCRI Consumer Forum, London, UK,22University of Leeds

Abstract

Background

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.

Method

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.

Results

512 pts were randomised, 2014-17, 61 UK centres.

Level A

Level B

Level C

Pts (PFS events)

170 (142)

171 (147)

173 (149)

Median age

76

76

77

% PS ≥2

31

32

31

% Severely Frail

61

56

58

% any Gr ≥3 non-haem AE

56

56

49

Median PFS mo

4.9

4.1

4.3

OTU wk 9: % Good/mod./poor

35/34/31

36/26/38

43/27/29

Median OS mo

7.5

6.7

7.6

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.

Conclusion

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.