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Clinical Trial
. 2025 Jan 10;43(2):167-179.
doi: 10.1200/JCO.24.00440. Epub 2024 Oct 1.

Sexual Health and Quality of Life in Patients With Low-Risk Early-Stage Cervical Cancer: Results From GCIG/CCTG CX.5/SHAPE Trial Comparing Simple Versus Radical Hysterectomy

Sarah E Ferguson  1 , Lori A Brotto  2 , Janice Kwon  2 , Vanessa Samouelian  3 , Gwenael Ferron  4 , Amandine Maulard  5 , Cor de Kroon  6 , Willemien Van Driel  7 , John Tidy  8 , Karin Williamson  9 , Sven Mahner  10 , Stefan Kommoss  11 , Frederic Goffin  12 , Karl Tamussino  13 , Brynhildur Eyjolfsdottir  14 , Jae-Weon Kim  15 , Noreen Gleeson  16 , Dongsheng Tu  17 , Lois Shepherd  17 , Marie Plante  18
Affiliations
Clinical Trial

Sexual Health and Quality of Life in Patients With Low-Risk Early-Stage Cervical Cancer: Results From GCIG/CCTG CX.5/SHAPE Trial Comparing Simple Versus Radical Hysterectomy

Sarah E Ferguson et al. J Clin Oncol. .

Abstract

Purpose: Simple hysterectomy and pelvic node assessment (SHAPE) is a phase III randomized trial (ClinicalTrials.gov identifier: NCT01658930) reporting noninferiority of simple compared with radical hysterectomy for oncologic outcomes in low-risk cervical cancer. This study presents secondary outcomes of sexual health and quality of life (QOL) of the SHAPE trial.

Methods: Participants were randomly assigned to receive either radical or simple hysterectomy. Sexual health was assessed up to 36 months postoperatively using the Female Sexual Function Index (FSFI) and Female Sexual Distress Scale-Revised and QOL using European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 and Cervical Cancer-Specific Module (QLQ-CX24) questionnaires.

Results: Among participants with at least one QOL measure, clinical and pathologic characteristics were balanced and with no differences in preoperative baseline scores for sexual health or QOL between groups. FSFI total score met the cutoff for dysfunction up to 6 months (P = .02) in the radical hysterectomy group. Group differences favored simple hysterectomy for FSFI subscales: desire and arousal at 3 months (P ≤ .001) and pain and lubrication up to 12 months (P ≤ .018). Both groups met the cutoff for sexual distress but was higher in radical hysterectomy at 3 months (P = .018). For QLQ-CX24, symptom experience was significantly better up to 24 months (P = .031) and body image better at 3, 24, and 36 months (P ≤ .01) for simple hysterectomy. Sexual-vaginal functioning was significantly better up to 24 months (P ≤ .022) and more sexual activity up to 36 months (P = .024) in the simple hysterectomy arm. Global health status was significantly higher at 36 months for simple hysterectomy (P = .025).

Conclusion: 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.

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Conflict of interest statement

The following represents disclosure information provided by authors of this manuscript. All relationships are considered compensated unless otherwise noted. Relationships are self-held unless noted. I = Immediate Family Member, Inst = My Institution. Relationships may not relate to the subject matter of this manuscript. For more information about ASCO's conflict of interest policy, please refer to www.asco.org/rwc or ascopubs.org/jco/authors/author-center.

Open Payments is a public database containing information reported by companies about payments made to US-licensed physicians (Open Payments).

Lori A. Brotto

Research Funding: Pacific Blue Cross (Inst)

Janice Kwon

Honoraria: AstraZeneca

Vanessa Samouelian

Honoraria: GlaxoSmithKline, Merck, Eisai, AstraZeneca

Consulting or Advisory Role: Merck, GlaxoSmithKline, AstraZeneca

Gwenael Ferron

Employment: See2Cure

Consulting or Advisory Role: Rand Biotech, AstraZeneca, GlaxoSmithKline/Tesaro, MSD Oncology, Eisai Europe, Olympus Medical Systems

Travel, Accommodations, Expenses: AstraZeneca, Roche Pharma AG, PharmaMar, Eisai/MSD, Rand Italy, GlaxoSmithKline

Sven Mahner

Honoraria: Roche/Genentech, AstraZeneca, PharmaMar, Medac, Jenapharm, Janssen-Cilag, Teva, GlaxoSmithKline, Clovis Oncology, Novartis/Pfizer

Consulting or Advisory Role: Roche, AstraZeneca, Merck Sharp & Dohme, Janssen-Cilag, Tesaro, Medac, Sensor-Kinesis Corp, Clovis Oncology, Immunogen

Research Funding: Roche, AstraZeneca, Boehringer Ingelheim, GlaxoSmithKline, Janssen-Cilag, Medac, PharmaMar, Tesaro, Bayer

Stefan Kommoss

Honoraria: AstraZeneca, GlaxoSmithKline, MSD, Eisai Germany

Consulting or Advisory Role: Roche/Genentech, GlaxoSmithKline, MSD

Research Funding: GlaxoSmithKline (Inst)

Travel, Accommodations, Expenses: Eisai, AstraZeneca

Karl Tamussino

Other Relationship: Medtronic (Inst)

Brynhildur Eyjolfsdottir

Consulting or Advisory Role: MSD (Inst)

Other Relationship: Intuitive Surgical (Inst)

Marie Plante

Patents, Royalties, Other Intellectual Property: UpToDate

No other potential conflicts of interest were reported.

Figures

FIG 1.
FIG 1.
Flow diagram. Have completed at least one questionnaire at any time point. EORTC CX24, European Organization for Research and Treatment of Cancer cervical cancer-specific module; EORTC QLQ-C30, European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30; QOL, quality of life. aQOL questionnaire include EORTC QLQ-C30 and EORTC CX24 cancer-specific module. bSexual health assessment includes Female Sexual Functioning Index and Female Sexual Distress Scale-Revised.
FIG 2.
FIG 2.
Sexual health outcomes between SH and RH. FSFI subscales and total FSFI and Female Sexual Distress Scale-Revised. FSFI, Female Sexual Functioning Index; RH, radical hysterectomy; SH, simple hysterectomy.
FIG 3.
FIG 3.
Sexual health and menopausal outcomes between SH and RH as measured by the EORTC QLQ-CX24. EORTC QLQ-CX24, European Organization for Research and Treatment of Cancer Quality of Life Questionnaire cervical cancer-specific module; RH, radical hysterectomy; SH, simple hysterectomy.
See this image and copyright information in PMC

References

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