Best supportive care (BSC) with or without low-dose chemotherapy (chemo) in frail elderly patients with advanced gastroesophageal cancer (aGOAC): The uncertain randomization of the GO2 phase III trial
| Autor: | Mohan Hingorani, Helen Howard, Simon Lord, Helen Marshall, Zuzana Stokes, Christine Allmark, J. T. Dent, Matthew T. Seymour, Kamalnayan Guptal, Sharon Ruddock, Konstantinos Kamposioras, Eszter Katona, Daniel Swinson, Peter Hall, Galina Velikova, Mohammad Saud Khan, Anirban Chatterjee, Simon Aird Grumett |
|---|---|
| Rok vydání: | 2019 |
| Předmět: |
Oncology
Cancer Research medicine.medical_specialty Randomization business.industry stomatognathic diseases 03 medical and health sciences 0302 clinical medicine Gastroesophageal cancer Low-dose chemotherapy 030220 oncology & carcinogenesis Internal medicine medicine Overall survival Frail elderly business 030215 immunology |
| Zdroj: | Journal of Clinical Oncology. 37:4051-4051 |
| ISSN: | 1527-7755 0732-183X 4468-7907 |
| Popis: | 4051 Background: Before 2000, trials comparing BSC +/- chemo for aGOAC showed overall survival (OS) benefit, but in predominantly fit patients (pts). We have revisited this question in a modern context, using low-dose chemo in a frail population, with comprehensive baseline health and frailty assessment. Methods: In the GO2 trial, elderly and/or frail aGOAC pts with a “certain” indication for chemo were randomised between 3 chemo doses. In this GO2 substudy, pts with an “uncertain” indication for chemo were instead randomised to BSC ± the lowest dose chemo. Pts were eligible if clinician and pt agreed the indication for chemo was uncertain. There was no PS threshold, but eGFR ≥30 and bili < 2xULN were required. Baseline assessment included global QL, symptom & functional scales, frailty and comorbidity. Randomisation was 1:1 to BSC alone, or with oxaliplatin 78 mg/m2 d1, capecitabine 375 mg/m2 bd d1-21 (modified if eGFR 30-50 ml/min or bili 1.5-2.0 xULN), q21d. QL was reassessed after 9 and 18 wks. The primary endpoint analysis was OS, adjusted for baseline factors. The sample size for this exploratory sub-study was not pre-set, but around 60 pts were anticipated. Results: 558 pts entered GO2 at 61 centres 2014-17, of whom only 45 pts (8%) at 21 centres entered this uncertain randomisation. This would provide 80% power at p = 0.05 (2-tailed) to detect an OS HR of 0.3. OS was shorter in pts with worse baseline PS (p0.32. QL deteriorated less with BSC+chemo than with BSC alone. Conclusions: In this frail, poor PS population, we observed a small survival benefit with chemo but this did not reach statistical significance. Clinicians should carefully consider BSC alone as a valid treatment option for aGOAC pts with poor PS and/or frailty. Clinical trial information: 44687907. [Table: see text] |
| Databáze: | OpenAIRE |
| Externí odkaz: |
|