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)
Abstract 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 no...
| Main Authors: | , , , , , , , , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
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BMC
2022-12-01
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| Series: | BMC Cancer |
| Subjects: | |
| Online Access: | https://doi.org/10.1186/s12885-022-10407-8 |
| _version_ | 1797980300853116928 |
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| author | Fiona Day Swetha Sridharan James Lynam Craig Gedye Catherine Johnson Allison Fraser Stephen R. Thompson Michael Michael Trevor Leong Amitesh Roy Mahesh Kumar Andre van der Westhuizen Gaik T. Quah Hiren Mandaliya Girish Mallesara Joshua Sappiatzer Christopher Oldmeadow Jarad Martin |
| author_facet | Fiona Day Swetha Sridharan James Lynam Craig Gedye Catherine Johnson Allison Fraser Stephen R. Thompson Michael Michael Trevor Leong Amitesh Roy Mahesh Kumar Andre van der Westhuizen Gaik T. Quah Hiren Mandaliya Girish Mallesara Joshua Sappiatzer Christopher Oldmeadow Jarad Martin |
| author_sort | Fiona Day |
| collection | DOAJ |
| description | Abstract 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/m2 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. |
| first_indexed | 2024-04-11T05:53:23Z |
| format | Article |
| id | doaj.art-b27cfdc539b34f84ba338f1a0fa88340 |
| institution | Directory Open Access Journal |
| issn | 1471-2407 |
| language | English |
| last_indexed | 2024-04-11T05:53:23Z |
| publishDate | 2022-12-01 |
| publisher | BMC |
| record_format | Article |
| series | BMC Cancer |
| spelling | doaj.art-b27cfdc539b34f84ba338f1a0fa883402022-12-22T04:42:00ZengBMCBMC Cancer1471-24072022-12-0122111010.1186/s12885-022-10407-8Chemoradiotherapy 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)Fiona Day0Swetha Sridharan1James Lynam2Craig Gedye3Catherine Johnson4Allison Fraser5Stephen R. Thompson6Michael Michael7Trevor Leong8Amitesh Roy9Mahesh Kumar10Andre van der Westhuizen11Gaik T. Quah12Hiren Mandaliya13Girish Mallesara14Joshua Sappiatzer15Christopher Oldmeadow16Jarad Martin17Department of Medical Oncology, Calvary Mater NewcastleSchool of Medicine and Public Health, University of NewcastleDepartment of Medical Oncology, Calvary Mater NewcastleDepartment of Medical Oncology, Calvary Mater NewcastleDepartment of Medical Oncology, Calvary Mater NewcastleDepartment of Medical Oncology, Calvary Mater NewcastlePrince of Wales Clinical School, Faculty of Medicine, University of New South WalesSir Peter MacCallum Department of Oncology, Peter MacCallum Cancer Centre, University of MelbourneSir Peter MacCallum Department of Oncology, Peter MacCallum Cancer Centre, University of MelbourneFlinders Medical CentreSchool of Medicine and Public Health, University of NewcastleDepartment of Medical Oncology, Calvary Mater NewcastleDepartment of Medical Oncology, Calvary Mater NewcastleDepartment of Medical Oncology, Calvary Mater NewcastleDepartment of Medical Oncology, Calvary Mater NewcastleGenesisCare, Flinders Private HospitalSchool of Medicine and Public Health, University of NewcastleSchool of Medicine and Public Health, University of NewcastleAbstract 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/m2 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.https://doi.org/10.1186/s12885-022-10407-8OesophagealGastro-oesophageal (GOS)DysphagiaOligometastaticChemoradiotherapyCheckpoint inhibition |
| spellingShingle | Fiona Day Swetha Sridharan James Lynam Craig Gedye Catherine Johnson Allison Fraser Stephen R. Thompson Michael Michael Trevor Leong Amitesh Roy Mahesh Kumar Andre van der Westhuizen Gaik T. Quah Hiren Mandaliya Girish Mallesara Joshua Sappiatzer Christopher Oldmeadow Jarad Martin 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) BMC Cancer Oesophageal Gastro-oesophageal (GOS) Dysphagia Oligometastatic Chemoradiotherapy Checkpoint inhibition |
| title | 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) |
| title_full | 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) |
| title_fullStr | 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) |
| title_full_unstemmed | 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) |
| title_short | 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) |
| title_sort | 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 |
| topic | Oesophageal Gastro-oesophageal (GOS) Dysphagia Oligometastatic Chemoradiotherapy Checkpoint inhibition |
| url | https://doi.org/10.1186/s12885-022-10407-8 |
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