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Despite intriguing survival results, this study was not sufficiently feasible to proceed to a fully powered comparative study. A multi-centre study would be required to exclude a significant difference in outcomes.

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Aim: The routine use of prophylactic percutaneous endoscopic gastrostomy (PEG) tubes for nutrition support during radical chemoradiation for head and neck cancer has been suggested to result in PEG dependency. This research aimed to determine the rates of gastrostomy dependency at the Calvary Mater Newcastle (CMN) where PEGs are routinely used and to identify potentially modifiable risk factors. Methods: All patients with head and neck cancer planned for curative chemoradiation with a prophylactic PEG inserted were included in this review. Medical records of 250 patients treated between 2000 and 2015 were examined. Results: Overall, eight patients (3%) were unable to wean. At 12 months following treatment, 16 patients (6%) still required PEG tubes for feeding. A greater T extent (T4 or synchronous head and neck tumors) and number of days Nil By Mouth (NBM) remained as significant independent risk factors for PEG dependency at 12 months (Textent OR 6.96 P < .001; NBM OR 1.01 P = .004) and overall (Textent OR8.04 P = .02; NBM OR1.01 P = .001). Associations with NBM were investigated, which demonstrated that patients had less NBM days with intensity-modulated radiation therapy (IMRT) (-13.3, P = .007) and seeing a speech pathologist during treatment (-11.9, P = .026). More NBM days were associated with tumors with greater T extent (+22; P < .001). Conclusion: The routine use of prophylactic PEGs has not resulted in significant rates of PEG dependency at the CMN. Seeing a speech pathologist during treatment and IMRT may decrease time NBM, which was identified as a potentially modifiable risk factor for PEG dependency. K E Y W O R D S chemoradiotherapy, enteral nutrition, gastrostomy, head and neck cancer 1 INTRODUCTION Dehydration, malnutrition, and weight loss in head and neck (H+N) cancer patients undergoing chemoradiation can cause treatment interruptions and unplanned hospital admissions. 1 Mick et al identified weight loss as the strongest independent predictor of survival in patients with advanced stage H+N cancer undergoing multimodal therapy. 2 The side effects of chemoradiation for H+N cancer (mucosi-tis, xerostomia, dysguesia, dysphagia, odynophagia, nausea, and vomiting) make it difficult for patients to meet their nutrition requirements orally. 3 Enteral nutrition to supplement oral intake is frequently used; however, the route remains debatable. 4 Enteral nutrition approaches include a prophylactic percutaneous endoscopic gastrostomy (PEG) tube, reactive nasogastric tube (NGT), or reactive PEG placement. The use of prophylactic PEG tubes for chemoradiation has been extensively debated. 5 It has been theorized e198 c

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.