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SEOUL, South Korea -- Women with low-risk, early-stage cervical cancer who underwent radical hysterectomy experienced more toxicities associated with sexual health compared with those who underwent a simple hysterectomy, according to a quality-of-life analysis from the phase III SHAPE trial.

Using the Female Sexual Function Index (FSFI), patients who underwent a radical hysterectomy versus a simple hysterectomy experienced worse desire (P=0.001) and arousal (P<0.0001) at 3 months, reported Sarah Ferguson, MD, of the Princess Margaret Cancer Centre and the University of Toronto, at the International Gynecologic Cancer Society annual meeting.

The radical hysterectomy group also had worse lubrication (P=0.003 to 0.18) and sexual pain (P<0.001 to 0.01) for up to 12 months. However, there were no differences in the orgasm and satisfaction subscales between the groups.

Since previously reported results from the SHAPE trial -- which included 700 women with low-risk, early-stage cervical cancer defined as stage IA2 or IB1 disease -- showed that simple hysterectomy was noninferior to radical hysterectomy for oncologic outcomes, the procedure "should be the new standard for this population."

While most patients recovered with time, the findings "allow us to offer early sexual health interventions for those patients who still need a radical hysterectomy," Ferguson said.

The quality-of-life assessment using the EORTC QLQ-C30 cervical cancer module showed that patients who underwent radical hysterectomy versus simple hysterectomy had worse symptom experience and sexual vaginal functioning for up to 24 months; worse body image at 3, 24, and 36 months; and worse sexual worry and enjoyment at 3 months. They also reported less sexual activity for up to 36 months.

In the primary analysis, the incidence of pelvic recurrence at 3 years -- the primary endpoint -- was 2.52% among women who underwent simple hysterectomy compared with 2.17% for those who underwent radical hysterectomy, a difference of 0.35% that met the prespecified criteria for noninferiority for the less extensive procedure.

For the current analysis, Ferguson and team used the FSFI to assess sexual health and the EORTC QLQ-C30 with a cervical cancer module to assess quality of life.

Survey compliance was high, at 85% at baseline and 65% at 36 months for the sexual health assessment, and 73% and 56%, respectively, for the quality-of-life assessment. The study population was young, with a median age of 42 among the 485 patients who had a sexual health assessment, and 44 among the 663 who had the quality-of-life assessment, and the vast majority (80%) of patients were under the age of 50.

There were no differences in mean baseline scores for sexual health or quality of life between the two cohorts. The baseline scores were high for all EORTC QLQ-C30 functional scales, except for the emotional subscale, which Ferguson called "understandable," considering that these women were dealing with the trauma of a cervical cancer diagnosis.

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