University of British Columbia, Vancouver, Canada.
BC Cancer, Vancouver, Canada.
J Gynecol Oncol. 2024 Nov;35(6):e117. doi: 10.3802/jgo.2024.35.e117. Epub 2024 Oct 18.
SHAPE (Simple Hysterectomy And PElvic node assessment) was an international phase III trial demonstrating that simple hysterectomy was non-inferior to radical hysterectomy for pelvic recurrence risk, but superior for quality of life and sexual health. The objective was to conduct a cost-effectiveness analysis comparing simple vs. radical hysterectomy for low-risk early-stage cervical cancer.
Markov model compared the costs and benefits of simple vs. radical hysterectomy for early cervical cancer over a 5-year time horizon. Quality-adjusted life years (QALYs) were estimated from health utilities derived from EQ-5D-3L surveys. Sensitivity analyses accounted for uncertainty around key parameters. Monte Carlo simulation estimated complication numbers according to surgical procedure.
Simple hysterectomy was more effective and less costly than radical hysterectomy. Average overall costs were $11,022 and $12,533, and average gains were 3.56 and 3.54 QALYs for simple and radical hysterectomy, respectively. Baseline health utility scores were 0.81 and 0.83 for simple and radical hysterectomy, respectively. By year 3, these scores improved for simple hysterectomy (0.82) but not for radical hysterectomy (0.82). Assuming 800 early cervical cancer patients annually in Canada, the model estimated 3 vs. 82 patients with urinary retention, and 49 vs. 86 patients with urinary incontinence persisting 4 weeks after simple vs. radical hysterectomy, respectively. Results were most sensitive to variability in health utilities after surgery, but stable through wide ranges of costs and recurrence estimates.
Simple hysterectomy is less costly and more effective in terms of quality-adjusted life expectancy compared to radical hysterectomy for early cervical cancer.
ClinicalTrials.gov Identifier: NCT01658930.
SHAPE(简单子宫切除术和盆腔淋巴结评估)是一项国际 III 期试验,证明简单子宫切除术在盆腔复发风险方面不劣于根治性子宫切除术,但在生活质量和性健康方面更优。目的是进行成本效益分析,比较低危早期宫颈癌的简单子宫切除术与根治性子宫切除术。
Markov 模型比较了简单子宫切除术与根治性子宫切除术治疗早期宫颈癌的成本效益,时间范围为 5 年。使用来自 EQ-5D-3L 调查的健康效用来估计质量调整生命年(QALY)。敏感性分析考虑了关键参数的不确定性。蒙特卡罗模拟根据手术程序估计并发症数量。
简单子宫切除术比根治性子宫切除术更有效且成本更低。总的平均成本分别为 11022 美元和 12533 美元,简单子宫切除术和根治性子宫切除术的平均收益分别为 3.56 和 3.54 QALY。简单子宫切除术和根治性子宫切除术的基线健康效用评分分别为 0.81 和 0.83。到第 3 年,简单子宫切除术的评分提高(0.82),而根治性子宫切除术的评分则没有提高(0.82)。假设加拿大每年有 800 例早期宫颈癌患者,模型估计简单子宫切除术后有 3 例和 82 例患者发生尿潴留,49 例和 86 例患者发生尿失禁持续 4 周,分别为简单子宫切除术和根治性子宫切除术。结果对手术后健康效用的变异性最敏感,但在成本和复发估计的广泛范围内是稳定的。
与根治性子宫切除术相比,简单子宫切除术在早期宫颈癌的成本效益方面更具成本效益,在质量调整预期寿命方面更优。
ClinicalTrials.gov 标识符:NCT01658930。