Patients with low-risk, early-stage cervical cancer who undergo simple hysterectomy experience significantly better sexual health and quality of life compared to those undergoing radical hysterectomy, according to results from the phase III SHAPE trial. The study, involving 700 patients across 12 countries, demonstrated noninferiority in oncologic outcomes while showing a reduced risk of sexual dysfunction with the less aggressive surgical approach.
The findings, published in the Journal of Clinical Oncology, highlight the benefits of surgical de-escalation in this patient population. Researchers, led by Sarah E. Ferguson, MD, of the Princess Margaret Cancer Centre, University Health Network, Toronto, randomly assigned patients to either simple hysterectomy (n = 350) or radical hysterectomy (n = 350) between December 2012 and November 2019.
Impact on Sexual Function
Sexual health and quality-of-life outcomes were assessed for up to 36 months post-surgery using 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). The FSFI total score in the radical hysterectomy group met the cutoff for dysfunction at 6 months (P = .02). Simple hysterectomy was associated with better outcomes on the FSFI subscales of desire and arousal at 3 months (P ≤ .001) and pain and lubrication at 12 months (P ≤ .018).
Sexual Distress and Quality of Life
Both groups met the cutoff for sexual distress on the FSDS-R. However, 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 reported better symptom experience up to 24 months (P = .031), better body image at 3, 24, and 36 months (P ≤ .01), improved sexual-vaginal functioning up to 24 months (P ≤ .022), and increased sexual activity 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).
Clinical Implications
"Simple hysterectomy was associated with lower rates of sexual dysfunction than radical hysterectomy, with a lower proportion of women having sustained sexual-vaginal dysfunction," the investigators concluded. "These results further support the benefit of surgical de-escalation for low-risk cervical cancer."