Early Interdisciplinary Palliative Care in Patients with Previously Untreated Metastatic Oesophagogastric Cancer: A Phase 3 Randomised Controlled Trial

Abstract

Background: Effective interventions to improve prognosis in metastatic oesophagogastric cancer (EGC) is urgently needed. Since EGC had the highest presence of malnutrition and psychological stress, which are closely related to the OS in cancer patients, we assessed the effect of early integration of interdisciplinary palliative care in patients with metastatic EGC on overall survival. Methods: A single-centre, open-label, phase 3, randomised, controlled trial was conducted in Peking University Cancer Hospital & Institute. Patients with previously untreated metastatic oesophageal or gastric cancer were enrolled. Patients were randomly assigned (2:1) to either early interdisciplinary palliative care (EPC) integrated with standard oncologic care group, or standard care (SC) group. We used an interactive web response system for randomisation and stratified according to the primary tumour site (oesophageal cancer and gastric cancer). Patients were offered EPC by the interdisciplinary palliative care team, which included gastrointestinal medical oncologist, nurse, dietitian and psychologist; while patients in SC group received standard oncologic care alone. The primary endpoint was overall survival in the intention-to-treat population. This trial is registered with ClinicalTrials.gov, number NCT02375997. Findings: Between April 16, 2015 and December 29, 2017, 328 patients were enrolled: 214 to EPC group, 114 to SC group. At the time of data cutoff on Jan 26, 2019, 15 (5%) patients were lost to follow up. The median number of cycles of first-line chemotherapy received was 5 (IQR 4-7) in EPC group and 4 (IQR 2-6) in SC group. Median overall survival was significantly improved in EPC group compared with SC group (14.8 months, 95% CI: 13∙3–16∙3 vs 11.9 months, 95% CI: 9∙6–13∙6; hazard ratio for death 0∙68, 95% CI 0∙51–0∙9; p=0∙021). Interpretation: The early interdisciplinary palliative care is an effective intervention for survival benefit in patients with metastatic oesophagogastric cancer. Further optimization, standardization and multi-centre investigations are warranted. Trial Registration: This trial is registered with ClinicalTrials.gov, number NCT02375997. Funding Statement: This study was supported by the National Key Research and Development Program of China (2017YFC1308900), Z141107002514013 from Beijing Municipal Science and Technology Commission Program, the National Key Research and Development Program of China (2018YFC1313303). Declaration of Interests: None of the authors declare any conflict of interest. Ethics Approval Statement: This study was approved by the Ethics Committee of Peking University Cancer Hospital and was performed in accordance with the study protocol and Good Clinical Practice guidelines as defined by the International Conference on Harmonization. All patients provided written informed consent before study participation.