Abstract
Purpose
To compare sexual/vaginal functioning between early cervical cancer (ECC) and locally advanced cervical cancer (LACC) survivors.
Methods
VAMOS was a multicenter, cross-sectional, questionnaire, noninferiority study including ECC patients treated with surgery and, if clinically indicated, adjuvant (chemo)radiotherapy and LACC patients treated with neoadjuvant (chemo)radiotherapy followed by surgery. Patient-reported outcomes (PROs) were assessed using the EORTC QLQ-C30, EORTC QLQ-CX24, and Female Sexual Functioning Index (FSFI) questionnaires. Clinical reported outcomes (ClinROs) consisted of vaginal morbidity scored according to the CTCAE v4.0 scoring system.
Results
One hundred forty-three patients were included. Compared to ECC patients (n = 97), LACC patients (n = 46) were significantly less sexually active in the 4 weeks prior to completion of the questionnaires (65% vs. 41%; p = .005). The primary endpoint was not met: LACC patients reported a higher mean score (more problems) for sexual/vaginal functioning than ECC patients, with a non-clinically relevant mean difference of 6.38 ([95% CI: − 6.41, 19.17]; p = .570 for noninferiority). Regarding the secondary endpoints, the prevalence of sexual dysfunction between the two groups did not differ significantly (p = 0.124). Compared to ECC patients, LACC patients did not have significantly more vaginal morbidity (adjusted odds ratio [OR] 1.51 [95% CI: 0.22, 10.29]; p = .674). Moreover, there was poor agreement between any vaginal morbidity and sexual dysfunction (Cohen’s kappa of 0.17).
Conclusion
Compared to ECC survivors, LACC survivors were significantly less sexually active and reported equivalent or worse sexual/vaginal functioning, although the proportion of patients with sexual dysfunction was similar. Clinical assessment of vaginal morbidity was poorly correlated with sexual dysfunction.
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Data availability
The data that support the findings of this study are available on request from the corresponding author, E.N. The data are not publicly available due to information that could compromise the privacy of research participants.
References
Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, Bray F (2021) Global Cancer Statistics 2020: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin 71(3):209–49
Belgian Cancer Registry (2019). https://kankerregister.org/media/docs/CancerFactSheets/2019/Cancer_Fact_Sheet_CervicalCancer_2019.pdf. Accessed 18 Jan 2022
Cibula D, Potter R, Planchamp F, Avall-Lundqvist E, Fischerova D, HaieMeder C et al (2018) The European Society of Gynaecological Oncology/European Society for Radiotherapy and Oncology/European Society of Pathology Guidelines for the Management of Patients with Cervical Cancer. Int J Gynecol Cancer 28(4):641–655
Tummers P, Makar A, Vandecasteele K, De Meerleer G, Denys H, De Visschere P et al (2013) Completion surgery after intensity-modulated arc therapy in the treatment of locally advanced cervical cancer: Feasibility, surgical outcome, and oncologic results. Int J Gynecol Cancer 23(5):877–883
Vandecasteele K, Makar A, Van den Broecke R, Delrue L, Denys H, Lambein K et al (2012) Intensity-modulated arc therapy with cisplatin as neo-adjuvant treatment for primary irresectable cervical cancer. Toxicity, tumour response and outcome. Strahlenther Onkol: Organ der Deutschen Rontgengesellschaft [et al] 188(7):576–81
Van Damme A, Rombaut J, Makar A, De Jaeghere E, Naert E, Denys H et al (2023) Completion surgery after intensity-modulated arc therapy for locally advanced cervical cancer: Long-term follow-up and update on surgical outcome and oncologic results of a unique tertiary care single-center retrospective cohort. World J Surg Oncol 21(1):84
Pieterse QD, Kenter GG, Maas CP, de Kroon CD, Creutzberg CL, Trimbos JB, Ter Kuile MM (2013) Self-reported sexual, bowel and bladder function in cervical cancer patients following different treatment modalities: Longitudinal prospective cohort study. Int J Gynecol Cancer 23(9):1717–1725
Donovan KA, Taliaferro LA, Alvarez EM, Jacobsen PB, Roetzheim RG, Wenham RM (2007) Sexual health in women treated for cervical cancer: Characteristics and correlates. Gynecol Oncol 104(2):428–434
Aerts L, Enzlin P, Verhaeghe J, Poppe W, Vergote I, Amant F (2014) Long-term sexual functioning in women after surgical treatment of cervical cancer stages IA to IB: A prospective controlled study. Int J Gynecol Cancer 24(8):1527–1534
Lammerink EA, de Bock GH, Pras E, Reyners AK, Mourits MJ (2012) Sexual functioning of cervical cancer survivors: A review with a female perspective. Maturitas 72(4):296–304
Pieterse QD, Maas CP, ter Kuile MM, Lowik M, van Eijkeren MA, Trimbos JB, Kenter GG (2006) An observational longitudinal study to evaluate miction, defecation, and sexual function after radical hysterectomy with pelvic lymphadenectomy for early-stage cervical cancer. Int J Gynecol Cancer 16(3):1119–1129
Jensen PT, Groenvold M, Klee MC, Thranov I, Petersen MA, Machin D (2003) Longitudinal study of sexual function and vaginal changes after radiotherapy for cervical cancer. Int J Radiat Oncol Biol Phys 56(4):937–949
Kirchheiner K, Smet S, Jurgenliemk-Schulz IM, Haie-Meder C, Chargari C, Lindegaard JC et al (2022) Impact of vaginal symptoms and hormonal replacement therapy on sexual outcomes after definitive chemoradiotherapy in patients with locally advanced cervical cancer: results from the EMBRACE-I study. Int J Radiat Oncol Biol Phys 112(2):400–413
Zhou W, Yang X, Dai Y, Wu Q, He G, Yin G (2016) Survey of cervical cancer survivors regarding quality of life and sexual function. J Cancer Res Ther 12(2):938–944
Correa CS, Leite IC, Andrade AP, de Souza Sergio Ferreira A, Carvalho SM, Guerra MR (2016) Sexual function of women surviving cervical cancer. Arch Gynecol Obstet 293(5):1053–63
Bakker RM, Kenter GG, Creutzberg CL, Stiggelbout AM, Derks M, Mingelen W et al (2017) Sexual distress and associated factors among cervical cancer survivors: A cross-sectional multicenter observational study. Psychooncology 26(10):1470–1477
Tsai TY, Chen SY, Tsai MH, Su YL, Ho CM, Su HF (2011) Prevalence and associated factors of sexual dysfunction in cervical cancer patients. J Sex Med 8(6):1789–1796
Harding Y, Ooyama T, Nakamoto T, Wakayama A, Kudaka W, Inamine M et al (2014) Radiotherapy- or radical surgery-induced female sexual morbidity in stages IB and II cervical cancer. Int J Gynecol Cancer 24(4):800–805
Tsatsou I, Parpa E, Tsilika E, Katsaragakis S, Batistaki C, Dimitriadou E, Mystakidou K (2019) A systematic review of sexuality and depression of cervical cancer patients. J Sex Marital Ther 45(8):739–754
Bae H, Park H (2016) Sexual function, depression, and quality of life in patients with cervical cancer. Support Care Cancer 24(3):1277–1283
Juraskova I, Bonner C, Bell ML, Sharpe L, Robertson R, Butow P (2012) Quantity vs. quality: An exploration of the predictors of posttreatment sexual adjustment for women affected by early stage cervical and endometrial cancer. J Sex Med 9(11):2952–60
Derks M, van Lonkhuijzen LR, Bakker RM, Stiggelbout AM, de Kroon CD, Westerveld H et al (2017) Long-term morbidity and quality of life in cervical cancer survivors: A multicenter comparison between surgery and radiotherapy as primary treatment. Int J Gynecol Cancer 27(2):350–356
Vandenbroucke JP, von Elm E, Altman DG, Gotzsche PC, Mulrow CD, Pocock SJ et al (2007) Strengthening the reporting of observational studies in epidemiology (STROBE): Explanation and elaboration. PLoS Med 4(10):e297
ter Kuile MMB, M., Laan, E (2009) De Female Sexual Function Index (FSFI) en de Female Sexual Distress Scale (FSDS): Psychometrische eigenschappen in een Nederlandse populatie. Tijdschr Seksuol 33–3:207–22
Aaronson NK, Ahmedzai S, Bergman B, Bullinger M, Cull A, Duez NJ et al (1993) The European organization for research and treatment of cancer QLQ-C30: A quality-of-life instrument for use in international clinical trials in oncology. J Natl Cancer Inst 85(5):365–376
Greimel ER, Kuljanic Vlasic K, Waldenstrom AC, Duric VM, Jensen PT, Singer S et al (2006) The European organization for research and treatment of cancer (EORTC) quality-of-life questionnaire cervical cancer module: EORTC QLQ-CX24. Cancer 107(8):1812–1822
White ID, Sangha A, Lucas G, Wiseman T (2016) Assessment of sexual difficulties associated with multi-modal treatment for cervical or endometrial cancer: A systematic review of measurement instruments. Gynecol Oncol 143(3):664–673
Fayers PM (2001) Interpreting quality of life data: population-based reference data for the EORTC QLQ-C30. Eur J Cancer (Oxford, England: 1990) 37(11):1331–4
Rosen R, Brown C, Heiman J, Leiblum S, Meston C, Shabsigh R et al (2000) The Female Sexual Function Index (FSFI): A multidimensional self-report instrument for the assessment of female sexual function. J Sex Marital Ther 26(2):191–208
Wiegel M, Meston C, Rosen R (2005) The female sexual function index (FSFI): Cross-validation and development of clinical cutoff scores. J Sex Marital Ther 31(1):1–20
Common Terminology Criteria for Adverse Events v.4.0 (CTCAE). National Cancer Institute. http://ctep.cancer.gov/protocolDevelopment/electronic_applications/ctc.htm. Accessed 17 Jan 2022
Harris PA, Taylor R, Thielke R, Payne J, Gonzalez N, Conde JG (2009) Research electronic data capture (REDCap) – a metadata-driven methodology and workflow process for providing translational research informatics support. J Biomed Inform 42(2):377–381
Harris PA, Taylor R, Minor BL, Elliott V, Fernandez M, O’Neal L et al (2019) The REDCap consortium: building an international community of software platform partners. J Biomed Inform 95:103208
R Core Team (2016) R: a language and environment for statistical computing. Vienna, Austria. https://www.R-project.org/. Accessed 20 Dec 2022
White ID, Allan H, Faithfull S (2011) Assessment of treatment-induced female sexual morbidity in oncology: Is this a part of routine medical follow-up after radical pelvic radiotherapy? Br J Cancer 105(7):903–910
Kirchheiner K, Smet S, Jurgenliemk-Schulz IM, Haie-Meder C, Chargari C, Lindegaard JC et al (2021) Impact of vaginal symptoms and hormonal replacement therapy on sexual outcomes in locally advanced cervical cancer patients after definitive chemoradiotherapy – results from the EMBRACE-I study. Int J Radiat Oncol Biol Phys 112(2):400–413
Correia RA, Bonfim CVD, Feitosa KMA, Furtado B, Ferreira D, Santos SLD (2020) Sexual dysfunction after cervical cancer treatment. Rev Escola Enfermagem da U S P 54:e03636
Oveisi N, Khan Z, Brotto LA (2023) A qualitative study of sexual health and function of females with pelvic cancer. Sex Med 11(2):qfac002
Osei Appiah E, Amertil NP, Oti-Boadi Ezekiel E, Lavoe H, Siedu DJ (2021) Impact of cervical cancer on the sexual and physical health of women diagnosed with cervical cancer in Ghana: A qualitative phenomenological study. Womens Health (Lond Engl) 17:17455065211066076
Levkovich I, Hamama-Raz Y, Shinan-Altman S (2022) “A kaleidoscope of relationships” – cervical cancer survivors’ perspectives on their intimate relationships: A qualitative study. Palliat Support Care 1–10
Wiltink LM, King M, Muller F, Sousa MS, Tang M, Pendlebury A et al (2020) A systematic review of the impact of contemporary treatment modalities for cervical cancer on women’s self-reported health-related quality of life. Support Care Cancer 28(10):4627–4644
Hamidou Z, Dabakuyo TS, Bonnetain F (2011) Impact of response shift on longitudinal quality-of-life assessment in cancer clinical trials. Expert Rev Pharmacoecon Outcomes Res 11(5):549–559
Palaia I, Santangelo G, Caruso G, Perniola G, Tibaldi V, Muzii L et al (2022) Long-term quality of life and sexual function after neoadjuvant chemotherapy and radical surgery for locally advanced cervical cancer. J Sex Med 19(4):613–619
Acknowledgements
We thank all the women, their families, and their caregivers for participating in this study. E.N. is a clinical PhD Fellow of the Research Foundation-Flanders (FWO) (Grant Number: 1703020N). E.N. is supported by a grant from the Fund of Innovation and Research of Ghent University Hospital. E.A.D. is an “aspirant” (PhD Fellow) of the FWO (Grant Number: 1195919N) (https://www.fwo.be/en/). This work was supported by a grant from Fundamental Scientific Research/Fight Against Cancer Belgium (G0F9319N) in the name of K.V.
Funding
This work was supported by a grant from the Fundamental Scientific Research/Fight Against Cancer Belgium (G0F9319N) in the name of K.V.
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Conceptualization: E.N., H.V., P.T., H.D., and K.V.; Methodology: E.N., H.V., P.T., H.D., and K.V.; Investigation: E.N., R.S., P.T., H.D., and K.V.; Data Curation: E.N., A.D., R.B., and K.V.; Formal analysis: A.D.; Writing – Original Draft: E.N.; Writing – Review & Editing: all authors; Funding: K.V.; Resources: all authors; Supervision: H.V., P.T., H.D., and K.V.
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Approval was obtained from the ethics committee of Ghent University Hospital, Belgium (B.U.N.: B670201939288). The procedures used in this study adhere to the tenets of the Declaration of Helsinki.
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Naert, E., Decruyenaere, A., Bultijnck, R. et al. Vaginal morbidity, sexual functioning, and health-related quality of life in cervical cancer survivors: a cross-sectional multicenter study (VAMOS). Support Care Cancer 31, 703 (2023). https://doi.org/10.1007/s00520-023-08155-x
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DOI: https://doi.org/10.1007/s00520-023-08155-x