{"id":6525,"date":"2021-06-04T12:10:05","date_gmt":"2021-06-04T11:10:05","guid":{"rendered":"https:\/\/www.library.sath.nhs.uk\/research\/?p=6525"},"modified":"2021-07-02T12:48:18","modified_gmt":"2021-07-02T11:48:18","slug":"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","status":"publish","type":"post","link":"https:\/\/www.library.sath.nhs.uk\/research\/2021\/06\/04\/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\/","title":{"rendered":"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 (2021)"},"content":{"rendered":"

Type of publication:<\/strong>
\nRandomised controlled trial<\/p>\n

Author(s):<\/strong>
\nHall, Peter S; Swinson, Daniel; Cairns, David A; Waters, Justin S; Petty, Russell; Allmark, Christine; Ruddock, Sharon; Falk, Stephen; Wadsley, Jonathan; Roy, Rajarshi; Tillett, Tania; Nicoll, Jonathan; Cummins, Sebastian; Mano, Joseph; Grumett, Simon; Stokes, Zuzana; Konstantinos-Velios, Kamposioras; *Chatterjee, Anirban; Garcia, Angel; Waddell, Tom; Guptal, Kamalnayan; Maisey, Nick; Khan, Mohammed; Dent, Jo; Lord, Simon; Crossley, Ann; Katona, Eszter; Marshall, Helen; Grabsch, Heike I; Velikova, Galina; Ow, Pei Loo; Handforth, Catherine; Howard, Helen; Seymour, Matthew T; GO2 Trial Investigators<\/p>\n

Citation:<\/strong>
\nJAMA oncology; May 2021; 7(6):869-877<\/p>\n

Abstract:<\/strong>
\nImportance Older and\/or frail patients are underrepresented in landmark cancer trials. Tailored research is needed to address this evidence gap. ObjectiveThe 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.InterventionsThere 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 MeasuresFirst, 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 benefited from higher doses: Level C produced better OTU even in younger or less frail patients. A total of 45 patients entered the CHEMO-BSC randomization: overall survival was nonsignificantly longer with chemotherapy: median 6.1 vs 3.0 months (HR = 0.69 [95% CI, 0.32-1.48], P = .34). In multivariate analysis in 522 patients with all variables available, baseline frailty, quality of life, and neutrophil to lymphocyte ratio were independently associated with OTU, and can be combined in a model to estimate the probability of different outcomes. Conclusions and Relevance This phase 3 randomized clinical trial found that reduced-intensity chemotherapy provided a better patient experience without significantly compromising cancer control and should be considered for older and\/or frail patients. Baseline geriatric assessment can help predict the utility of chemotherapy but did not identify a group benefiting from higher-dose treatment. Trial Registrationisrctn.org Identifier: ISRCTN44687907.<\/p>\n

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