| 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, P. S.; Swinson, D.; Cairns, D. A.; Waters, J. S.; 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, Thomas; Guptal, K.; Maisey, N.; Khan, M.; Dent, J.; Lord, S.; Crossley, A.; Katona, E.; Marshall, H.; Grabsch, H. I.; Velikova, G.; Ow, P. L.; Handforth, C.; Howard, H; Seymour, M. T. |
| Contributors: |
University of Leeds, Leeds, United Kingdom. |
| Publication Year: |
2021 |
| Collection: |
The Christie School of Oncology: Christie Research Publications Repository |
| 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 ... |
| Document Type: |
article in journal/newspaper |
| Language: |
English |
| Relation: |
https://dx.doi.org/10.1001/jamaoncol.2021.0848; http://hdl.handle.net/10541/624085; JAMA Oncology |
| DOI: |
10.1001/jamaoncol.2021.0848 |
| Availability: |
http://hdl.handle.net/10541/624085; https://doi.org/10.1001/jamaoncol.2021.0848 |
| Accession Number: |
edsbas.D264BD45 |
| Database: |
BASE |