Chemoradiotherapy with concurrent durvalumab for the palliative treatment of oligometastatic oesophageal and gastrooesophageal carcinoma with dysphagia: a single arm phase II clinical trial (PALEO, sponsored by the Australasian Gastro-Intestinal Trials Group).

Autor: Day F; Department of Medical Oncology, Calvary Mater Newcastle, Waratah, NSW, Australia. fiona.day@calvarymater.org.au.; School of Medicine and Public Health, University of Newcastle, Callaghan, NSW, Australia. fiona.day@calvarymater.org.au.; Hunter Medical Research Institute, New Lambton Heights, NSW, Australia. fiona.day@calvarymater.org.au., Sridharan S; School of Medicine and Public Health, University of Newcastle, Callaghan, NSW, Australia.; Department of Radiation Oncology, Calvary Mater Newcastle, Waratah, NSW, Australia., Lynam J; Department of Medical Oncology, Calvary Mater Newcastle, Waratah, NSW, Australia.; School of Medicine and Public Health, University of Newcastle, Callaghan, NSW, Australia., Gedye C; Department of Medical Oncology, Calvary Mater Newcastle, Waratah, NSW, Australia.; School of Medicine and Public Health, University of Newcastle, Callaghan, NSW, Australia., Johnson C; Department of Medical Oncology, Calvary Mater Newcastle, Waratah, NSW, Australia.; Hunter Medical Research Institute, New Lambton Heights, NSW, Australia., Fraser A; Department of Medical Oncology, Calvary Mater Newcastle, Waratah, NSW, Australia.; Department of Radiation Oncology, Calvary Mater Newcastle, Waratah, NSW, Australia., Thompson SR; Prince of Wales Clinical School, Faculty of Medicine, University of New South Wales, Sydney, NSW, Australia., Michael M; Sir Peter MacCallum Department of Oncology, Peter MacCallum Cancer Centre, University of Melbourne, Melbourne, VIC, Australia., Leong T; Sir Peter MacCallum Department of Oncology, Peter MacCallum Cancer Centre, University of Melbourne, Melbourne, VIC, Australia., Roy A; Flinders Medical Centre, Bedford Park, Adelaide, SA, Australia., Kumar M; School of Medicine and Public Health, University of Newcastle, Callaghan, NSW, Australia.; Department of Radiation Oncology, Calvary Mater Newcastle, Waratah, NSW, Australia., van der Westhuizen A; Department of Medical Oncology, Calvary Mater Newcastle, Waratah, NSW, Australia.; School of Medicine and Public Health, University of Newcastle, Callaghan, NSW, Australia., Quah GT; Department of Medical Oncology, Calvary Mater Newcastle, Waratah, NSW, Australia.; School of Medicine and Public Health, University of Newcastle, Callaghan, NSW, Australia., Mandaliya H; Department of Medical Oncology, Calvary Mater Newcastle, Waratah, NSW, Australia.; School of Medicine and Public Health, University of Newcastle, Callaghan, NSW, Australia., Mallesara G; Department of Medical Oncology, Calvary Mater Newcastle, Waratah, NSW, Australia.; School of Medicine and Public Health, University of Newcastle, Callaghan, NSW, Australia., Sappiatzer J; GenesisCare, Flinders Private Hospital, Bedford Park, Adelaide, SA, Australia., Oldmeadow C; School of Medicine and Public Health, University of Newcastle, Callaghan, NSW, Australia.; Hunter Medical Research Institute, New Lambton Heights, NSW, Australia., Martin J; School of Medicine and Public Health, University of Newcastle, Callaghan, NSW, Australia.; Department of Radiation Oncology, Calvary Mater Newcastle, Waratah, NSW, Australia.
Jazyk: angličtina
Zdroj: BMC cancer [BMC Cancer] 2022 Dec 17; Vol. 22 (1), pp. 1324. Date of Electronic Publication: 2022 Dec 17.
DOI: 10.1186/s12885-022-10407-8
Abstrakt: Background: Oesophageal and gastrooesophageal junction (GOJ) carcinoma frequently present with dysphagia and de novo metastatic disease. There is scope to improve treatment paradigms to both address symptoms and improve survival. One method is integrating immune checkpoint inhibition with novel treatment combinations.
Methods: PALEO is a single arm, phase II clinical trial in patients with previously untreated, oligometastatic or locoregionally advanced oesophageal or GOJ carcinoma and dysphagia. PALEO is sponsored by the Australasian Gastro-Intestinal Trials Group (AGITG). Participants receive 2 weeks of therapy with concurrent hypofractionated radiotherapy of 30Gy in 10 fractions to the primary tumour, weekly carboplatin AUC2, weekly paclitaxel 50 mg/m 2 and durvalumab 1500 mg q4 weekly, followed by durvalumab monotherapy continuing at 1500 mg q4weekly until disease progression, unacceptable toxicity or 24 months of therapy. A single metastasis is treated with stereotactic radiotherapy of 24Gy in 3 fractions in week 7. The trial primary endpoint is the progression free survival rate at 6 months. Secondary endpoints include duration of dysphagia relief, nutritional status change, quality of life, response rate, toxicity, progression free survival and overall survival. The tertiary endpoint is prediction of outcome based on biomarkers identified from patient serial blood samples collected pre- and post-radiotherapy.
Discussion: This unique investigator-initiated clinical trial is designed to simultaneously address the clinically relevant problems of dysphagia and distant disease control. The overarching aims are to improve patient nutrition, quality of life and survival with low toxicity therapy. AGITG PALEO is a multidisciplinary collaboration and will add to the understanding of the relationship between radiotherapy and the anti-tumour immune response.
Trial Registration: Australian and New Zealand Clinical Trials Registry: ACTRN12619001371189 , registered 8 October 2019.
(© 2022. The Author(s).)
Databáze: MEDLINE
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