In an analysis from the phase III SHAPE trial reported in the Journal of Clinical Oncology, Ferguson et al found that simple hysterectomy was associated with a reduced risk of sexual dysfunction vs radical hysterectomy in patients with low-risk, early-stage cervical cancer. The trial showed noninferiority in oncologic outcomes for simple vs radical hysterectomy.
Study Details
In the trial, 700 patients from sites in 12 countries were randomly assigned between December 2012 and November 2019 to simple hysterectomy (n = 350) or radical hysterectomy (n = 350). Sexual health and quality-of-life (QOL) outcomes were assessed up to 36 months after surgery with the Female Sexual Function Index (FSFI), Female Sexual Distress Scale–Revised (FSDS-R), EORTC QOL Questionnaire Core 30 (QLQ-C30), and Cervical Cancer–Specific Module (QLQ-CX24).
Key Findings
The FSFI total score met the cutoff for dysfunction at 6 months (P = .02) in the radical hysterectomy group. Compared with the radical hysterectomy group, outcomes in the simple hysterectomy group were better on the FSFI subscales of desire and arousal at 3 months (P ≤ .001) and pain and lubrication at 12 months (P ≤ .018).
Both groups met the cutoff for sexual distress on the FSDS-R. At 3 months, the level of distress was significantly greater in the radical hysterectomy group (P = .018).
On the QLQ-CX24, the simple hysterectomy group had better symptom experience at up to 24 months (P =.031), better body image at 3, 24, and 36 months (P ≤ .01), better sexual-vaginal functioning at up to 24 months (P ≤ .022), and increased sexual activity at up to 36 months (P = .024). Global health status on the QLQ-C30 was significantly better at 36 months in the simple hysterectomy group (P = .025).
The investigators concluded: “Simple hysterectomy was associated with lower rates of sexual dysfunction than radical hysterectomy, with a lower proportion of women having sustained sexual-vaginal dysfunction. These results further support the benefit of surgical de-escalation for low-risk cervical cancer.”
Sarah E. Ferguson, MD, of the Princess Margaret Cancer Centre, University Health Network, Toronto, is the corresponding author for the Journal of Clinical Oncology article.
Disclosure: The study was supported by the Canadian Institutes of Health Research and Canadian Cancer Society. For full disclosures of all study authors, visit ascopubs.org.
