In patients with advanced esophageal cancer, radiation therapy (RT) alone is as effective as RT combined with chemotherapy in decreasing swallowing complications, thus allowing patients to forgo chemotherapy, according to research presented at the American Society for Radiation Oncology (ASTRO) annual meeting in San Francisco.
The international study included sites in Australia, New Zealand, Canada, and the U.K. and assessed the use of palliative chemotherapy combined with RT, or chemoradiotherapy (CRT), to provide relief from dysphagia, according to an ASTRO press release.
"This study was the largest, randomized, phase three trial of advanced esophageal cancer and was a significant undertaking for a 'palliative care' trial, namely where the emphasis was on the best, yet simplest and least toxic, treatment to alleviate pain," stated lead author Michael Penniment, MBBS, MBA, director of radiation oncology at the Royal Adelaide Hospital in South Australia and director of radiation oncology at Alan Walker Cancer Care Centre in Darwin, Australia, in the release.
Dysphagia is a common complication of advanced esophageal cancer and has been shown to be relieved with radiation therapy. The trial evaluated the effectiveness of RT alone versus CRT through patient-reported questionnaires that measured swallowing ability and quality of life, and also through clinician-reported questionnaires that measured potential side effects and adverse events that affected the entire body.
Some 220 patients were randomized to receive a course of palliative RT: 115 patients in Australia and New Zealand received 35 Gy in 15 fractions, and 105 patients in Canada and the U.K. received 30 Gy in 10 fractions. Of those patients, 109 received only RT, and 111 received concomitant CRT, including cisplatin and fluorouracil.
Dysphagia was measured using the Mellow scoring system, which measures swallowing on a scale of 0 to 5 based on the patient's ability to swallow liquids or solids. Side effects were measured by clinicians using the Common Terminology Criteria for Adverse Events (CTCAE) v2, and quality of life was evaluated using two patient questionnaires: EORTC QLQ30 and oesophagus module (OES-18). The primary end point was the proportion of patients with improved dysphagia as measured at week nine and maintained until week 13.
Of the patients who received RT alone, 67.89% of patients reported a more favorable dysphagia response (meaning decreased pain at any point) compared with73.87% of patients who received CRT and showed a positive dysphagia response.
Gastrointestinal side effects were reported in the CRT patients, including nausea and vomiting. The median survival was 203 days for patients who received RT alone and 210 days for patients who had CRT, demonstrating comparable survival prognosis for both groups.
The study results allow treatment to be simplified for these patients, according to Dr. Penniment.
"It is common for chemotherapy to be prescribed for patients with advanced esophageal cancer, and this is based on the standard use of CRT in people with less advanced disease," he stated. "However, some clinicians believe no treatment should be offered, assuming treatment is futile and potentially toxic. These results will allow us to simplify the treatment for patients who cannot be cured but who can expect an improvement in swallowing and quality of life as a result of RT alone; and these patients can be spared the extra toxicity and cost of chemotherapy."