Optimizing Chemotherapy for Frail and/or Elderly Patients With Advanced Gastroesophageal Cancer (Agoac): the Go2 Phase Iii Trial

Daniel Swinson, Peter S Hall, Simon R. Lord, Helen Marshall, Sharon Ruddock, Christine Allmark, D. Cairns, Justin S. Waters, Jonathan Wadsley, Stephen Falk, Rajarshi Roy, Mano Jospeh, Jonathan Nicoll, Konstantinos Kamposioras, Tania Tillett, Sebastian Cummings, Simon Aird Grumett, Z Stokes, Tom Waddell, Anirban ChatterjeeAngel Garcia-Alonso, M Khan, Russell Petty, Matthew T. Seymour

Research output: Contribution to journalMeeting abstract

Abstract

Introduction: aGOAC patients are frequently elderly and/ or frail.

Objectives: (i) find the optimum dose of oxaliplatin capecitabine (OCap) for this population; (ii) explore the use of an objective geriatric assessment to individualize dose for maximum overall treatment utility (OTU), a composite of clinical benefit, tolerability, quality of life (QL) and patient value.

Methods: Patients with aGOAC were eligible if there was uncertainty of the appropriate dose of chemotherapy. Baseline assessment included global QL; symptoms; functional scales; comorbidity; frailty. Randomization was 1:1:1 to dose Level A (Ox 130 mg/m2 d1, Cap 625 mg/m2 bd d1–21, q21d), B (80% Level A) or C (60% Level A). At 9 weeks, patients were scored for OTU. Non-inferiority (vs A) was assessed using PFS, censored at 12 months, with upper boundary HR 1.34 (based on patients’ and clinicians’ discussions), needing 284 PFS events per two-way comparison. In a separate sub-study, when there was uncertainty regarding the use of chemotherapy, patients were randomized between level C and supportive care alone (SCA).

Results and Conclusions: 512 patients were randomized, 2014–2017, at 61 UK centers. Age, performance status and frailty were similar in all arms. 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 patients had the least toxicity and best OTU outcomes. When analyzed by baseline age, frailty and PS no group was identified who benefit more from higher treatment doses. A further 46 patients were randomized between chemotherapy and SCA. A non-significant trend to improved survival was observed (HR=0.69, CI 0.32- 1.48) and QL deteriorated less with chemotherapy. This is the largest RCT specifically investigating frail and/ or elderly aGOAC patients, and should guide future treatment. The lowest dose tested was non-inferior in terms of PFS, produced less toxicity and better overall treatment utility.
Original languageEnglish
Article numberKO2
Pages (from-to)S8
Number of pages1
JournalJournal of Geriatric Oncology
Volume10
Issue number6 Supp. 1
DOIs
Publication statusPublished - Nov 2019

Keywords

  • Gastro-oesophageal cancer
  • frailty
  • comprehensive geriatric assessment
  • chemotherapy
  • quality of life
  • overall treatment utility

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    Swinson, D., Hall, P. S., Lord, S. R., Marshall, H., Ruddock, S., Allmark, C., Cairns, D., Waters, J. S., Wadsley, J., Falk, S., Roy, R., Jospeh, M., Nicoll, J., Kamposioras, K., Tillett, T., Cummings, S., Grumett, S. A., Stokes, Z., Waddell, T., ... Seymour, M. T. (2019). Optimizing Chemotherapy for Frail and/or Elderly Patients With Advanced Gastroesophageal Cancer (Agoac): the Go2 Phase Iii Trial. Journal of Geriatric Oncology, 10(6 Supp. 1), S8. [KO2]. https://doi.org/10.1016/S1879-4068(19)31133-6