Adjuvant chemotherapy for luminal breast cancer in elderly women: Feasibility of the ongoing ASTER 70S gerico UNICANCER phase III trial

Introduction: Advanced gastric and oesophageal cancer typically affects the elderly. Palliative chemotherapy may relieve cancer symptoms and may also extend life-expectancy, but it may also cause side-effects. Establishing the correct balance of benefits and harms in this vulnerable population is critical. Evidence-based chemotherapy consists of intensive multi-drug combinations developed in young fit patients. There is only limited evidence for its use in patients not fit enough to tolerate such regimens. Drug manufacturers and researchers have historically excluded such patients from clinical trials in this type of cancer. There is therefore an urgent need to conduct research that tells us which less-fit people can benefit from, or are harmed by, less intense chemotherapy. Objectives: The GO2 trial aims to provide evidence supporting or refuting the use of combination palliative chemotherapy in the frail or elderly with a diagnosis of advanced gastric or oesophageal cancer. Methods: Following on froma successful feasibility study called 321GO, GO2 is a trial that will offer chemotherapy to patients who are not fit enough for full-dose 3-drug chemotherapy. Patients will be randomly assigned to one of three different intensities of chemotherapy consisting of only two drugs: oxaliplatin and capecitabine. The objective of the trial is to identify which patients benefit fromdifferent intensities in terms of the balance of symptom control, side-effects and quality of life. A baseline Comprehensive Geriatric Assessment will be key to identifying predictors benefits and harms. Endpoints will include traditional trial endpoints of progression-free survival, overall survival and toxicity, but will also include more contemporary endpoints including quality-adjusted survival, time to deterioration in fatigue and ‘overall treatment utility’ which between them attempt to convey the balance between benefits and harms of treatment. Results: Funded by Cancer Research UK, GO2 opens to recruitment in the UK in the autumn of 2013. The trial will recruit patients over 3 years in 56 NHS cancer centres in the UK, aiming for a sample size of 500-750 patients. Conclusion: GO2 is the first phase three randomised controlled trial designed specifically to identify the optimal combination chemotherapy intensity in patients not fit enough to receive standard fulldose chemotherapy as palliative treatment for advanced gastric and oesophageal cancer.