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.