Oops, you're using an old version of your browser so some of the features on this page may not be displaying properly.

MINIMAL Requirements: Google Chrome 24+Mozilla Firefox 20+Internet Explorer 11Opera 15–18Apple Safari 7SeaMonkey 2.15-2.23

Poster Discussion – Gastrointestinal tumours, non-colorectal

5708 - Chemotherapy for Frail and Elderly Patients (pts) with Advanced Gastroesophageal Cancer (aGOAC): Quality of Life (QoL) results from the GO2 Phase III Trial

Date

28 Sep 2019

Session

Poster Discussion – Gastrointestinal tumours, non-colorectal

Presenters

Peter Hall

Citation

Annals of Oncology (2019) 30 (suppl_5): v851-v934. 10.1093/annonc/mdz394

Authors

P. Hall1, D. Swinson2, S. Lord3, C. Handforth4, D. Cairns5, H. Marshall6, R. Petty7, M. Bennett2, G. Velikova2, M.T. Seymour2

Author affiliations

  • 1 Oncology, Edinburgh Cancer Research UK Centre, EH4 2XR - Edinburgh/GB
  • 2 Medical Oncology, St. James's University Hospital Leeds, LS9 7TF - Leeds/GB
  • 3 Oxford Cancer Centre, University of Oxford, OX3 7LE - Oxford/GB
  • 4 Clinical Oncology, Weston Park Hospital Cancer Research Centre, S10 2SJ - Sheffield/GB
  • 5 Ctru, Univ Leeds, LS2 9JT - Leeds/GB
  • 6 Leeds Clinical Trials Unit, University of Leeds, LS2 - JT/GB
  • 7 Department Of Oncology, Ninewells Hospitals and Medical School Biomedical Research Centre, DD1 9SY - Dundee/GB

Resources

Login to access the resources on OncologyPRO.

If you do not have an ESMO account, please create one for free.

Abstract 5708

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 ALvl BLvl CLvl C (‘uc’)BSC (‘uc’)
Pts1701711732322
Median Age7676777979
% PS ≥ 23132315768
% Severely Frail6156587068
9 wk Δ QLQ QoLa+0.4+5.3+4.9nana
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)7.15.46.5nana

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.

Editorial acknowledgement

Legal entity responsible for the study

University of Leeds.

Funding

Cancer Research UK.

Disclosure

All authors have declared no conflicts of interest.

This site uses cookies. Some of these cookies are essential, while others help us improve your experience by providing insights into how the site is being used.

For more detailed information on the cookies we use, please check our Privacy Policy.

Customise settings
  • Necessary cookies enable core functionality. The website cannot function properly without these cookies, and you can only disable them by changing your browser preferences.