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

68 Pages Posted: 7 Aug 2020

See all articles by Zhihao Lu

Zhihao Lu

Peking University - Key Laboratory of Carcinogenesis and Translational Research

Yu Fang

Peking University - Department of Clinical Nutrition

Chang Liu

Peking University - Department of Gastrointestinal Oncology

Xiaotian Zhang

Peking University - Key Laboratory of Carcinogenesis and Translational Research

Xiaowei Xin

Peking University - Department of Clinical Nutrition

Yi He

Peking University - Department of Psycho-Oncology

Yanshuo Cao

Peking University - Department of Gastrointestinal Oncology

Xi Jiao

Peking University - Department of Gastrointestinal Oncology

Tianqi Sun

Precision Scientific (Beijing) Co., Ltd.

Ying Pang

Peking University - Department of Psycho-Oncology

Yanli Wang

Peking University - Department of Clinical Nutrition

Jun Zhou

Peking University - Key Laboratory of Carcinogenesis and Translational Research

Changsong Qi

Peking University - Department of Gastrointestinal Oncology

Jifang Gong

Peking University - Key Laboratory of Carcinogenesis and Translational Research

Xicheng Wang

Peking University - Key Laboratory of Carcinogenesis and Translational Research

Jian Li

Peking University - Key Laboratory of Carcinogenesis and Translational Research

Lili Tang

Peking University - Department of Psycho-Oncology

Lin Shen

Peking University - Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing)

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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.

Keywords: Early interdisciplinary palliative care; oesophagogastric cancer; survival; randomised controlled trial

Suggested Citation

Lu, Zhihao and Fang, Yu and Liu, Chang and Zhang, Xiaotian and Xin, Xiaowei and He, Yi and Cao, Yanshuo and Jiao, Xi and Sun, Tianqi and Pang, Ying and Wang, Yanli and Zhou, Jun and Qi, Changsong and Gong, Jifang and Wang, Xicheng and Li, Jian and Tang, Lili and Shen, Lin, Early Interdisciplinary Palliative Care in Patients with Previously Untreated Metastatic Oesophagogastric Cancer: A Phase 3 Randomised Controlled Trial (4/21/2020). Available at SSRN: https://ssrn.com/abstract=3582831 or http://dx.doi.org/10.2139/ssrn.3582831

Zhihao Lu

Peking University - Key Laboratory of Carcinogenesis and Translational Research

Beijing, 100142
China

Yu Fang

Peking University - Department of Clinical Nutrition

Beijing
China

Chang Liu

Peking University - Department of Gastrointestinal Oncology

Beijing
China

Xiaotian Zhang

Peking University - Key Laboratory of Carcinogenesis and Translational Research

Beijing, 100142
China

Xiaowei Xin

Peking University - Department of Clinical Nutrition

Beijing
China

Yi He

Peking University - Department of Psycho-Oncology

Beijing
China

Yanshuo Cao

Peking University - Department of Gastrointestinal Oncology

Beijing
China

Xi Jiao

Peking University - Department of Gastrointestinal Oncology

Beijing
China

Tianqi Sun

Precision Scientific (Beijing) Co., Ltd.

C707 Jiahua Building
No. 9 Shangdi 3rd Street
Beijing
China

Ying Pang

Peking University - Department of Psycho-Oncology

Beijing
China

Yanli Wang

Peking University - Department of Clinical Nutrition

Beijing
China

Jun Zhou

Peking University - Key Laboratory of Carcinogenesis and Translational Research

Beijing, 100142
China

Changsong Qi

Peking University - Department of Gastrointestinal Oncology

Beijing
China

Jifang Gong

Peking University - Key Laboratory of Carcinogenesis and Translational Research

Beijing, 100142
China

Xicheng Wang

Peking University - Key Laboratory of Carcinogenesis and Translational Research

Beijing, 100142
China

Jian Li

Peking University - Key Laboratory of Carcinogenesis and Translational Research

Beijing, 100142
China

Lili Tang

Peking University - Department of Psycho-Oncology ( email )

Beijing
China

Lin Shen (Contact Author)

Peking University - Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing) ( email )

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