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. 2022 Aug 22;2022(8):CD010260. doi: 10.1002/14651858.CD010260.pub3

Summary of findings 3. Hysterectomy (simple or radical) with radiotherapy versus radiotherapy alone.

Hysterectomy (simple or radical) with radiotherapy versus radiotherapy alone
Patient or population: women with locally advanced cervical cancer
Settings: outpatient
Intervention: radiotherapy + hysterectomy (simple or radical)
Comparison: radiotherapy alone
Outcomes Relative effect (95% CI) No of participants Certainty of the evidence (GRADE) Comments
Overall survival
Median follow‐up 9.6 years
HR 0.89 (0.61 to 1.29) 256
(1 RCT)
⊕⊕⊖⊖
Lowa,b
12 participants in each regimen (10% with radiotherapy + hysterectomy vs 9% with radiotherapy) were lost to follow‐up by 5 years.
Progression‐free survival
Median follow‐up 9.6 years
HR 0.77
(0.54 to 1.10)
256
(1 RCT)
⊕⊕⊖⊖
Lowa,b
12 participants in each regimen (10% with radiotherapy + hysterectomy vs 9% with radiotherapy) were lost to follow‐up by 5 years.
Tumour‐free actuarial survival at 5 years 5‐year, tumour‐free actuarial survival for women with Stage IB was 80% in the preoperative radiotherapy + hysterectomy group and 89% in the radiotherapy group. In Stage IIA, these rates were 79% in the preoperative radiotherapy + hysterectomy group and 56% in the radiotherapy group. 118
(1 RCT)
⊕⊖⊖⊖
Very lowa,b,c
Quality of life Not reported.
Severe/serious adverse events 1 trial stated that both treatment programmes were well tolerated and there were no differences between groups in adverse effects. There were 18/129 women with a grade 3 or 4 adverse effect in the radiotherapy + hysterectomy group and 19 cases in 18/121 women of severe adverse effects in the radiotherapy group.
In another trial, only 1/48 (2%) women with Stage IB disease experienced a severe complication (grade 3) in the radiotherapy + hysterectomy group (ureteral stricture) whereas 5/40 experienced severe complications in the radiotherapy group (including rectovaginal fistula, vesicovaginal fistula, ureteral stricture and pelvic infection) (P > 0.05). Similarly in women with Stage IIA disease, 5/14 (40%) women experienced a severe complication in the radiotherapy + hysterectomy group (including proctitis, rectal stricture, small bowel stricture and ureteral stricture) whereas only 1/16 women experienced a severe complication in the radiotherapy group (rectal stricture) (P > 0.05).
374
(2 RCTs)
⊕⊕⊖⊖
Lowa,b
Relative effect measures were not presented due to the crude combining of adverse events or sparse data, or both.
CI: confidence interval; HR: hazard ratio; RCT: randomised controlled trial.
GRADE Working Group grades of evidence
High certainty: further research is very unlikely to change our confidence in the estimate of effect.
Moderate certainty: further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate.
Low certainty: 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 certainty: we are very uncertain about the estimate.

aDowngraded one level due to sparse data leading to imprecision.
bDowngraded one level due to small number of trials and a lack of representation.
cDowngraded one level due to inadequate reporting of results.