A phase I/II study to evaluate the toxicity and efficacy of accelerated fractionation radiotherapy for the palliation of dysphagia from carcinoma of the oesophagus

Clin Oncol (R Coll Radiol). 2008 Feb;20(1):53-60. doi: 10.1016/j.clon.2007.10.003.

Abstract

Aims: We hypothesised that accelerated fractionated radiotherapy may provide a good palliative approach for dysphagia relief in patients with incurable oesophageal cancer, significantly reducing the overall duration of treatment, while providing symptom response with an acceptable toxicity profile. A phase I/II accelerated fractionation study was conducted to evaluate the efficacy and toxicity of this approach.

Materials and methods: Patients with incurable oesophageal cancer, symptomatic with dysphagia, Eastern Cooperative Oncology Group performance status<or=3, without fistula or oesophageal stent in situ, were eligible. Treatment consisted of 40 Gy in 20 fractions, twice a day (2 Gy per fraction, >or=6 h apart), 5 days a week, over 2 weeks.

Results: Of the 39 evaluable patients, the dysphagia response rate was 69% (27/39) with a median response duration of 5.5 months. The median time to response was 4 weeks. Twenty-eight per cent (11/39) of patients had transient worsening in their dysphagia scores. Acute toxicity (weeks 1-8) occurred in 41% (16/39) of patients. An improvement in global quality of life by week 8 was seen in 42% of patients. There were no late neurological sequelae. The median overall survival was 8 (range 1.7-58+) months.

Conclusion: The ideal palliative regimen should be relatively short, with minimal toxicity, while offering a favourable response profile. Accelerated fractionation fulfils these criteria and is a suitable treatment alternative for the palliation of dysphagia, especially if the goal is to deliver a higher total biological dose within a shorter (2 week) period of time.

Publication types

  • Clinical Trial, Phase I
  • Clinical Trial, Phase II

MeSH terms

  • Aged
  • Aged, 80 and over
  • Deglutition Disorders / etiology
  • Deglutition Disorders / radiotherapy*
  • Dose Fractionation, Radiation*
  • Esophageal Neoplasms / complications*
  • Female
  • Humans
  • Male
  • Middle Aged
  • Palliative Care*
  • Quality of Life
  • Radiation Injuries
  • Relative Biological Effectiveness