The addition of chemotherapy to radiation therapy increased gastrointestinal toxicity but did not confer significant improvement in dysphagia or survival among patients with advanced esophageal cancer, according to results of a multinational, randomized phase 3 trial presented at the ASTRO Annual Meeting.
The findings suggest radiation therapy alone remains an effective strategy for palliation and should remain the standard of care for these patients, researchers wrote.
About 75% of patients in the study had metastatic disease. The others had advanced disease in the esophagus, poor performance status or other factors that made them unsuitable for curative treatment.
“A lot of advances have bene made in methods of curing patients with several types of cancer, including esophageal cancer, for which chemoradiotherapy is now the established gold standard,” Michael Penniment, MBBS, MBA, FRANZCR, director of radiation oncology at Royal Adelaide Hospital and director of radiation oncology at Alan Walker Cancer Care Centre in Australia, said during a press conference. “In terms of palliation of patients [with advanced esophageal cancer], there isn’t really a gold standard … We knew we needed to give them better information about the chances that the treatment we offered them would actually help them.”
Penniment and colleagues conducted the study to identify the most effective, least toxic treatment that provided dysphagia symptom relief to patients with advanced esophageal cancer. They also hoped to assess how treatments affected quality of life and end-of-life care.
The analysis included 220 patients, all of whom received palliative radiotherapy. Patients in Australia and New Zealand (n=115) received 35 Gy in 15 fractions, whereas patients in the United Kingdom and Canada (n=105) received 30 Gy in 10 fractions.
About half of study participants (n=111; 50.4%) also received concomitant chemoradiotherapy, including cisplatin and fluorouracil. Baseline parameters between those assigned chemotherapy plus radiation therapy and those assigned radiation therapy alone were balanced.
Penniment and colleagues used the Mellow score to measure dysphagia, of difficulty swallowing. They used the EORTC QLQ30 questionnaire — as well as the esophageal-specific OES-18 module — to assess quality of life. They used Common Toxicity Criteria for Adverse Events version 2.0 to measure toxicity.
The proportion of patients who demonstrated improved dysphagia at week 9 and maintained that improvement until week 13 served as the primary endpoint.
Researchers reported a higher dysphagia response rate (73.8% vs. 67.8%; P=.343) and longer median survival (210 days vs. 203 days) among patients assigned chemotherapy plus radiation therapy, but the differences were not statistically significant.
However, researchers observed significantly increased gastrointestinal toxicities — including nausea (P=.0019) and vomiting (P=.0072) — among patients who received chemotherapy.
“This … 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,” Penniment said in a press release. “It is common for chemotherapy to be prescribed for patients with advanced esophageal cancer, and this is based on the standard use of chemoradiotherapy 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 radiotherapy alone, and these patients can be spared the extra toxicity and cost of chemotherapy.”
For more information:
Penniment MG. Abstract #CT-03. Presented at: ASTRO Annual Meeting; Sept. 14-17, 2014; San Francisco.
Disclosure: The researchers report no relevant financial disclosures.