University of Manchester| December 2019 | One dose of radiotherapy as effective as five doses for cancer in the spine
A study conducted by a team of researchers from the Universities of Manchester and University College London aimed to test whether administering just one dose (single-fraction) of radiotherapy could be used instead of five doses (multi-fraction) which requires several hospital visits. The findings of the SCORAD randomised clinical trial, now published in JAMA, indicate that one dose of radiotherapy should be used instead of five doses for most patients with spinal canal compression, this finding is supported by all of the other statistical criteria and multiple patient outcomes.
The lead trial investigator, Professor Peter Hoskin (University of Manchester, Mount Vernon Cancer Centre (NHS), said: “In the UK, NICE guidelines do not currently stipulate a standard treatment regimen, though most patients with spinal canal compression or other metastatic bone disease are given several fractions.
“We believe our findings, which show equal clinical effectiveness for single-dose radiotherapy, provide strong evidence for NICE guidelines, and those in other countries, to be changed to stipulate a one-dose one-visit approach, reducing unnecessary discomfort for end of life cancer patients without compromising efficacy” (Source: University of Manchester).
Question Is treatment with a single dose of radiotherapy noninferior to multifraction radiotherapy delivered over 5 days among patients with metastatic cancer who have spinal canal compression?
Findings In a clinical trial of 686 patients, the percentage who were ambulatory at 8 weeks was 69.3% in the single-fraction group vs 72.7% in the multifraction radiotherapy group. The lower CI limit for the risk difference (−11.5%) did not meet the predefined noninferiority margin of −11.0%.
Meaning Treatment with single-fraction radiotherapy did not meet the criterion for noninferiority compared with multifraction radiotherapy for ambulatory response rate at 8 weeks, but consideration should be given to the extent to which the lower bound of the CI overlapped with the noninferiority margin.
University of Manchester One dose of radiotherapy as effective as five doses for cancer in the spine
University College London One dose of radiotherapy as effective as five doses for cancer in the spine
Hoskin, P.J., et al.|2019| Effect of Single-Fraction vs Multifraction Radiotherapy on Ambulatory Status Among Patients With Spinal Canal Compression From Metastatic Cancer: The SCORAD Randomized Clinical Trial | JAMA|322| 21| P. 2084–2094 |doi:https://doi.org/10.1001/jama.2019.17913
The full article is available from JAMA
Importance Malignant spinal canal compression, a major complication of metastatic cancer, is managed with radiotherapy to maintain mobility and relieve pain, although there is no standard radiotherapy regimen.
Objective To evaluate whether single-fraction radiotherapy is noninferior to 5 fractions of radiotherapy.
Design, Setting, and Participants Multicenter noninferiority randomized clinical trial conducted in 42 UK and 5 Australian radiotherapy centers. Eligible patients (n = 686) had metastatic cancer with spinal cord or cauda equina compression, life expectancy greater than 8 weeks, and no previous radiotherapy to the same area. Patients were recruited between February 2008 and April 2016, with final follow-up in September 2017.
Interventions Patients were randomized to receive external beam single-fraction 8-Gy radiotherapy (n = 345) or 20 Gy of radiotherapy in 5 fractions over 5 consecutive days (n = 341).
Main Outcomes and Measures The primary end point was ambulatory status at week 8, based on a 4-point scale and classified as grade 1 (ambulatory without the use of aids and grade 5 of 5 muscle power) or grade 2 (ambulatory using aids or grade 4 of 5 muscle power). The noninferiority margin for the difference in ambulatory status was −11%. Secondary end points included ambulatory status at weeks 1, 4, and 12 and overall survival.
Results Among 686 randomized patients (median [interquartile range] age, 70 [64-77] years; 503 (73%) men; 44% had prostate cancer, 19% had lung cancer, and 12% had breast cancer), 342 (49.8%) were analyzed for the primary end point (255 patients died before the 8-week assessment). Ambulatory status grade 1 or 2 at week 8 was achieved by 115 of 166 (69.3%) patients in the single-fraction group vs 128 of 176 (72.7%) in the multifraction group. The difference in ambulatory status grade 1 or 2 in the single-fraction vs multifraction group was −0.4% at week 1, −0.7%; P value for noninferiority = .01) at week 4, and 4.1%; P value for noninferiority = .002) at week 12. Overall survival rates at 12 weeks were 50% in the single-fraction group vs 55% in the multifraction group. Of the 11 other secondary end points that were analyzed, the between-group differences were not statistically significant or did not meet noninferiority criterion.
Conclusions and Relevance 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 CI overlapped with the noninferiority margin should be considered when interpreting the clinical importance of this finding.
Trial Registration ISRCTN Identifiers: ISRCTN97555949 and ISRCTN97108008
The full paper is available from JAMA