Spinal canal compression is a common complication in patients with cancer if disease metastasizes to the spine—about 3% to 5% of patients with cancer develop it. Radiotherapy is used to control pain and alleviate symptoms. According to results from the SCORAD randomized clinical trial, published by Hoskin et al in JAMA, a single fraction of radiotherapy did not meet the criterion for noninferiority when compared with a multifraction dose for patients with spinal canal compression.
First study author Peter Hoskin, BSc, MBBS, MD, said, “We believe our findings, which show equal clinical effectiveness for single-dose radiotherapy, provide strong evidence for … guidelines … to be changed to stipulate a one-dose, one-visit approach, reducing unnecessary discomfort for … patients without compromising efficacy.”
Coauthor Allan Hackshaw, MSc, said, “Terminally ill … patients with spinal canal compression suffer significant problems such as being unable to walk and pain. Radiotherapy is an effective treatment for these patients. At the moment, with no recommended radiotherapy schedule for these patients, many are given several doses of radiation treatment, and each dose requires a separate visit to the hospital. Patients and their carers have to make multiple journeys, which can be uncomfortable to patients, inconvenient, and expensive.”
“This is the first large study to assess whether giving a single dose of radiation in one visit is as clinically effective as multiple doses. Our trial showed that one dose was just as good as several doses for a range of patient outcomes,” he concluded.
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In total, 686 patients with metastatic cancer and spinal canal compression were recruited from 42 radiotherapy centers in the United Kingdom and 5 in Australia. Half were randomly assigned to be given just one radiotherapy dose; the other half were given five doses, which involved visits to the hospital on 5 consecutive days.
Effectiveness was assessed by whether patients were able to walk with or without aids. This was done at about 1, 4, 8, and 12 weeks after starting radiotherapy.
At week 8, 342 patients were still alive, and among these, 69% who had been given one dose were able to walk compared with 73% who had five doses. At week 4, the corresponding percentages of patients who could walk were 67% (one dose) and 68% (five doses); at week 12, the results were 72% (one dose) and 68% (five doses).
Many other patient outcomes were also similar between patients who had been given either one or five radiotherapy doses. At 12 weeks, 50% of patients were still alive in the group who had been given one dose, close to 55% among patients who had five doses (a difference that was not statistically significant). Having additional cancer treatments, supportive care therapies, quality of life, and pain were all similar between having one or five doses.
Radiation therapy was associated with side effects. Fewer patients who had one dose experienced adverse skin reactions (12% given one dose vs 19% who had five doses), and fewer patients also suffered fatigue (49% given one dose vs 55% who had five doses). A group of patients who had radiation treatment specifically to the lower part of their spinal cord were more likely to have bladder problems, and one radiotherapy dose might not be enough treatment for these particular patients.
The authors concluded, “Among patients with malignant metastatic solid tumors and spinal canal compression, a single radiotherapy dose, compared with a multifraction dose delivered over 5 days, did not meet the criterion for noninferiority for the primary outcome (ambulatory at 8 weeks). However, the extent to which the lower bound of the confidence interval overlapped with the noninferiority margin should be considered when interpreting the clinical importance of this finding.”
Disclosure: The study was funded by Cancer Research UK and the Cancer Council Queensland, with support from the National Institute for Health Research. For full disclosures of the study authors, visit jamanetwork.com.The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.