2083 - PALAESTRA - A phase II trial with short-course radiotherapy followed by chemotherapy as palliative treatment in esophageal adenocarcinoma

Background

Patients with esophageal cancer commonly suffer from dysphagia, leading to nutritional problems and impaired quality of life. Self-expanding metallic stents (SEMS) is frequently used in the palliative setting providing a rapid but short-term relief. In this phase II study we assessed a novel first-line treatment schedule with short-course radiotherapy followed by chemotherapy with the primary aim to achieve a long-term improvement of dysphagia.

Methods

Patients with dysphagia due to adenocarcinoma of the esophagus or esophagogastric junction, not eligible for curative treatment, were recruited. Treatment consisted of radiotherapy (5 x 4 Gy) followed by 4 cycles of chemotherapy (FOLFOX regimen). Dysphagia was assessed using a 5-grade scale and a response was defined as an improvement from baseline with at least one step in dysphagia score during the study treatment period or within 4 weeks after end of study treatment. Response of the primary tumour was assessed using endoscopy and PET imaging.

Results

From October 2014 to May 2018 a total of 29 patients were enrolled. Median age was 68 years. WHO PS (0/1/2); 10/12/7, female/male; 6/23, stage III/IV; 3/26, dysphagia score (0/1/2/3/4); 0/15/6/7/1. In the per-protocol (PP) population of 23 patients (treated with at least 4 fractions of radiotherapy and 2 cycles of chemotherapy) the rate of dysphagia improvement was 91%, the median time to improvement was 2.0 months (95% CI: 1.5, 2.5) and the median duration of improvement was 12.2 months (95% CI: 6.2, 18.2). 5 patients received SEMS during follow-up. In the PP population the endoscopic response rate was 78% with 22% complete responders, the metabolic response rate of the primary tumor was 61% with 30% complete responders. Median overall survival was 16.0 months (95% CI: 9.6, 22.5). In the safety population (28 patients who started treatment) the most frequent grade 3-4 adverse events were neutropenia (32%), infection (25%), pain (14%), esophagitis (11%) and anorexia (11%).

Conclusions

Palliative short-course radiotherapy followed by chemotherapy is a promising treatment strategy that can provide long-lasting relief of dysphagia in patients with esophageal adenocarcinoma.

Clinical trial identification

2014-002362-74.

Editorial acknowledgement

Legal entity responsible for the study

Skåne University Hospital, Department of Oncology.

Funding

Lund University Faculty of Medicine and Skåne University Hospital Funds and Donations.

Disclosure

All authors have declared no conflicts of interest.