| Title: |
Efficacy of Reduced-Intensity Chemotherapy With Oxaliplatin and Capecitabine on Quality of Life and Cancer Control Among Older and Frail Patients With Advanced Gastroesophageal Cancer: The GO2 Phase 3 Randomized Clinical Trial |
| Authors: |
Hall, PS; Swinson, D; Cairns, DA; Waters, JS; Petty, R; Allmark, C; Ruddock, S; Falk, S; Wadsley, J; Roy, R; Tillett, T; Nicoll, J; Cummins, S; Mano, J; Grumett, S; Stokes, Z; Konstantinos-Velios, K; Chatterjee, A; Garcia, A; Waddell, T; Guptal, K; Maisey, N; Khan, M; Dent, J; Lord, S; Crossley, A; Katona, E; Marshall, H; Grabsch, HI; Velikova, G; Ow, PL; Handforth, C; Howard, H; Seymour, MT; GO2 Trial Investigators |
| Publisher Information: |
American Medical Association |
| Publication Year: |
2021 |
| Collection: |
White Rose Research Online (Universities of Leeds, Sheffield & York) |
| Description: |
Importance Older and/or frail patients are underrepresented in landmark cancer trials. Tailored research is needed to address this evidence gap. Objective The GO2 randomized clinical trial sought to optimize chemotherapy dosing in older and/or frail patients with advanced gastroesophageal cancer, and explored baseline geriatric assessment (GA) as a tool for treatment decision-making. Design, Setting, and Participants This multicenter, noninferiority, open-label randomized trial took place at oncology clinics in the United Kingdom with nurse-led geriatric health assessment. Patients were recruited for whom full-dose combination chemotherapy was considered unsuitable because of advanced age and/or frailty. Interventions There were 2 randomizations that were performed: CHEMO-INTENSITY compared oxaliplatin/capecitabine at Level A (oxaliplatin 130 mg/m2 on day 1, capecitabine 625 mg/m2 twice daily on days 1-21, on a 21-day cycle), Level B (doses 0.8 times A), or Level C (doses 0.6 times A). Alternatively, if the patient and clinician agreed the indication for chemotherapy was uncertain, the patient could instead enter CHEMO-BSC, comparing Level C vs best supportive care. Main Outcomes and Measures First, broad noninferiority of the lower doses vs reference (Level A) was assessed using a permissive boundary of 34 days reduction in progression-free survival (PFS) (hazard ratio, HR = 1.34), selected as acceptable by a forum of patients and clinicians. Then, the patient experience was compared using Overall Treatment Utility (OTU), which combines efficacy, toxic effects, quality of life, and patient value/acceptability. For CHEMO-BSC, the main outcome measure was overall survival. Results A total of 514 patients entered CHEMO-INTENSITY, of whom 385 (75%) were men and 299 (58%) were severely frail, with median age 76 years. Noninferior PFS was confirmed for Levels B vs A (HR = 1.09 [95% CI, 0.89-1.32]) and C vs A (HR = 1.10 [95% CI, 0.90-1.33]). Level C produced less toxic effects and better OTU than A or B. No subgroup ... |
| Document Type: |
article in journal/newspaper |
| File Description: |
text |
| Language: |
English |
| ISSN: |
2374-2437 |
| Relation: |
https://eprints.whiterose.ac.uk/id/eprint/174254/1/jamaoncology_hall_2021_oi_210009_1620740746.18047.pdf; Hall, PS, Swinson, D, Cairns, DA orcid.org/0000-0002-2338-0179 et al. (32 more authors) (2021) Efficacy of Reduced-Intensity Chemotherapy With Oxaliplatin and Capecitabine on Quality of Life and Cancer Control Among Older and Frail Patients With Advanced Gastroesophageal Cancer: The GO2 Phase 3 Randomized Clinical Trial. JAMA oncology, 7 (6). pp. 869-877. ISSN: 2374-2437 |
| Availability: |
https://eprints.whiterose.ac.uk/id/eprint/174254/; https://eprints.whiterose.ac.uk/id/eprint/174254/1/jamaoncology_hall_2021_oi_210009_1620740746.18047.pdf |
| Rights: |
cc_by_4 |
| Accession Number: |
edsbas.60BE3D99 |
| Database: |
BASE |