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).
Checkpoint inhibition
Chemoradioimmunotherapy
Chemoradiotherapy
Durvalumab.
Dysphagia
Gastro-oesophageal (GOS)
Oesophageal
Oligometastatic
PD-1
PD-L1
Journal
BMC cancer
ISSN: 1471-2407
Titre abrégé: BMC Cancer
Pays: England
ID NLM: 100967800
Informations de publication
Date de publication:
17 Dec 2022
17 Dec 2022
Historique:
received:
22
09
2022
accepted:
05
12
2022
entrez:
17
12
2022
pubmed:
18
12
2022
medline:
21
12
2022
Statut:
epublish
Résumé
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. 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 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. Australian and New Zealand Clinical Trials Registry: ACTRN12619001371189 , registered 8 October 2019.
Sections du résumé
BACKGROUND
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
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
DISCUSSION
CONCLUSIONS
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
BACKGROUND
Australian and New Zealand Clinical Trials Registry: ACTRN12619001371189 , registered 8 October 2019.
Identifiants
pubmed: 36528772
doi: 10.1186/s12885-022-10407-8
pii: 10.1186/s12885-022-10407-8
pmc: PMC9758808
doi:
Substances chimiques
durvalumab
28X28X9OKV
Types de publication
Clinical Trial, Phase II
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
1324Informations de copyright
© 2022. The Author(s).
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