| 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, T.; 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. |
| Source: |
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, T, 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 & GO2 Trial Investigators 2021, 'Efficacy of Reduced-Intensity Chemotherapy With Oxaliplatin and Capecitabine on Quality of Life and Cancer Control Among Older and Frail Patients .... |
| Publication Year: |
2021 |
| Collection: |
Maastricht University Research Publications |
| Subject Terms: |
1ST-LINE THERAPY; ADENOCARCINOMA; ADVANCED GASTRIC-CANCER; ELDERLY-PATIENTS; ESOPHAGOGASTRIC JUNCTION; EUROPEAN-ORGANIZATION; FLUOROURACIL; II TRIAL; METASTATIC COLORECTAL-CANCER; REGRESSION-MODELS |
| 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/m 2 on day 1, capecitabine 625 mg/m 2 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 |
| ISSN: |
2374-2437; 2374-2445 |
| Relation: |
info:eu-repo/semantics/altIdentifier/pmid/33983395; info:eu-repo/semantics/altIdentifier/wos/000650217900006; info:eu-repo/semantics/altIdentifier/pissn/2374-2437; info:eu-repo/semantics/altIdentifier/eissn/2374-2445 |
| DOI: |
10.1001/jamaoncol.2021.0848 |
| Availability: |
https://cris.maastrichtuniversity.nl/en/publications/4a5dd86c-27dd-4bc9-95e8-f740d5d97829; https://doi.org/10.1001/jamaoncol.2021.0848 |
| Rights: |
info:eu-repo/semantics/openAccess ; http://creativecommons.org/licenses/by/4.0/ |
| Accession Number: |
edsbas.1181137 |
| Database: |
BASE |