Summary of findings for the main comparison. Single‐fraction radiotherapy (8 Gy) compared to short‐course radiotherapy (16 Gy in two fractions) for adults with metastatic extradural spinal cord compression.
| Single‐fraction radiotherapy (8 Gy) compared to short‐course radiotherapy (8 Gy ‐ two fractions over one week) for adults with metastatic extradural spinal cord compression | ||||||
| Patient or population: adults with metastatic extradural spinal cord compression (poor prognosis with visceral metastasis, and no spinal instability or bony impingement of cord) Intervention: single‐fraction (8 Gy) radiotherapy Comparison: short‐course (8 Gy ‐ two fractions over one week) radiotherapy | ||||||
| Outcomes | Illustrative comparative risks* (95% CI) | Relative effect (95% CI) | No of Participants (studies) | Quality of the evidence (GRADE) | Comments | |
| Assumed risk | Corresponding risk | |||||
| Short‐course radiotherapy | Single‐fraction radiotherapy | |||||
|
Ambulation One month after radiation |
693 per 1000 | 645 per 1000 (569 to 721) | RR 0.93 (0.82 to 1.04) | 303 (1 study1) | ⊕⊕⊕⊝
moderate2,3 (serious indirectness) |
Single‐fraction and short‐course radiotherapy are probably equally effective in enhancing ambulation (maintaining and regaining ambulation) in the short term. |
| Survival Follow‐up: mean 36 months | See comment | See comment | Not estimable | 0 (1 study) | ⊕⊕⊕⊝
moderate2,3 (serious indirectness) |
Median survival was similar with both radiotherapy schedules (four months). |
|
Reduction in analgesic and narcotic use One month after radiation |
403 per 1000 | 343 per 1000 (250 to 467) | RR 0.85 (0.62 to 1.16) | 271 (1 study) | ⊕⊕⊕⊝
moderate2,3 (serious indirectness) |
Single‐fraction and short‐course radiotherapy are probably equally effective in reducing analgesic and narcotic use in the short term. |
|
Urinary continence One month after radiation |
873 per 1000 | 900 per 1000 (838 to 961) | RR 1.03 (0.96 to 1.1) | 303 (1 study) | ⊕⊕⊕⊝
moderate2,3 (serious indirectness) |
Single‐fraction and short‐course radiotherapy are probably equally effective in enhancing urinary continence overall, and in the proportions maintaining or regaining continence one month after treatment. |
| Local recurrence MRI: follow‐up: median 36 months | 27 per 1000 | 59 per 1000 (18 to 187) | RR 2.21 (0.69 to 7.01) | 303 (1 study) | ⊕⊕⊝⊝
low2,4 (serious indirectness, serious imprecision) |
Short‐course radiotherapy may result in fewer local recurrences than single fraction radiotherapy, but the numbers with local recurrences were too few for the difference to be statistically significant. |
| Adverse events Grade 3 oesophagitis, diarrhoea and nausea | 20 per 1000 | 3 per 1000 (0 to 54) | RR 0.14 (0.01 to 2.69) | 303 (1 study) | ⊕⊕⊕⊝
moderate4 (serious indirectness) |
Single‐fraction and short‐course radiotherapy probably do not differ significantly in the incidence of gastrointestinal adverse effects. Serious adverse events or post‐radiotherapy myelopathy were not noted with either treatment schedule. |
| Quality of life | See comment | See comment | Not estimable | ‐ | ‐ | Not assessed. |
| *The basis for the assumed risk is the risk in the control group. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CI: confidence interval; RR: risk ratio; | ||||||
| GRADE Working Group grades of evidence High quality: further research is very unlikely to change our confidence in the estimate of effect. Moderate quality: further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate. Low quality: further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate. Very low quality: we are very uncertain about the estimate. | ||||||
1Maranzano 2009 was conducted in multiple sites in Italy and used an equivalence design with the sample size powered to demonstrate equivalence in response rates separately evaluated for ambulatory status (maintaining or regaining ambulation), urinary continence (not requiring a catheter), and reduction in back pain (not requiring a narcotic) one month after treatment. Parenteral dexamethasone (8 mg twice daily) was administered from the first day of clinical‐radiologic diagnosis for 4–5 days. 2 Serious indirectness: the trial included those usually given short‐course radiotherapy (those with poor prognosis, with visceral metastasis, and not suitable for surgery). However the evidence for the equivalence of single dose and short‐course radiotherapy is from only one trial from a high‐income country, where early diagnosis and early institution of radiotherapy (within 24 to 48 hours after diagnosis) was possible; these may not be possible in many resource constrained settings. Downgraded 1 level. 3 No imprecision: the trial was powered to demonstrate equivalence in response rates post‐treatment and the difference in response rates with the two radiotherapy schedules was within the pre‐set precision limits. Not downgraded. 4 Serious imprecision: the trial was not powered to detect equivalence for this outcome; the 95% CI of the effect estimate includes no difference. The number of events were few and the sample size was smaller than the optimal sample size. Downgraded 1 level.