September 15, 2014 — Radiation therapy (RT) alone is as effective in decreasing swallowing complications experienced by advanced esophageal cancer patients as RT combined with chemotherapy, thus allowing patients to forgo chemotherapy, according to research presented at the American Society for Radiation Oncology’s (ASTRO’s) 56th Annual Meeting.
In this international study that included sites in Australia, New Zealand, Canada and the United Kingdom, researchers assessed the use of palliative chemotherapy combined with RT, or chemoradiotherapy (CRT), to provide relief from dysphagia. Dysphagia, or difficulty swallowing, is a common complication of advanced esophageal cancer and has been shown to be relieved with RT. The trial evaluated the effectiveness of RT alone versus CRT through patient-reported questionnaires that measured swallowing ability and quality of life, and through clinician-reported questionnaires that measured potential side effects and adverse events that affected the entire body.
A total of 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 United Kingdom received 30 Gy in 10 fractions. Of those patients, 109 received only RT, and 111 received concomitant CRT including Cisplatin and 5FU.
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 percent of patients reported a more favorable dysphagia response (meaning decreased pain at any point) compared to 73.87 percent of patients who received CRT and showed a positive dysphagia response (p=0.343).
Gastrointestinal side effects were reported in the CRT patients, including nausea (p=0.0019) and vomiting (p=0.0072). 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.
“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,” said lead author Michael Penniment, MBBS, MBA, FRANZCR, director of radiation oncology at Royal Adelaide Hospital in South Australia and the director of radiation oncology at Alan Walker Cancer Care Centre in Darwin, Australia. “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. 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.”
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