Genitourinary Syndrome of Menopause in Breast Cancer Survivors: Current Perspectives on the Role of Laser Therapy

Figures & data

Figure 1 Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) study selection flow diagram.

Table 1 Summary of Included Studies on Fractional Micro Ablative Vaginal Laser in Breast Cancer Survivors (BCSs)

Author	n.	Characteristics of Patients (Pts)/Inclusion Criteria	Age (Yrs)	Age at Menopause and/or Duration	Adjuvant Therapy for BC	Study Design	Therapeutic Protocol	Outcomes	Follow Up	AEs (n.)	Main Results and Conclusions
Pagano et al, 2016^Citation33	26	Women with diagnosis of BC with VVA symptoms	42 (Median, range 20–62)	Not specified (1 woman with spontaneous menopause, 25 women with iatrogenic menopause because of BC treatment)	26 women on ET: TMX + ovarian suppression (25) AIs (1)	Retrospective study	Three sessions every 30–40 days Area treated: not specified Setting: dot power 30 w, scan time 1000 µs, dot spacing 1000 µm, smart stack from 1 to 3	Self-reported measures: VAS score for each VVA symptom and for each procedure-related discomfort symptom Clinician assessment: genital examination	Every application and 30 days after completion of three cycles of treatment	No	After three cycles of laser treatment, the median VAS scores for dyspareunia, dryness, itching/stinging, and sensitivity during sexual intercourse were 78%, 80%, 75% and 86%, respectively, lower than baseline The median VAS score for intensity of discomfort during insertion of the probe, probe movements, and for laser-associated pain was 67%, 50% and 30%, respectively, lower after treatment
Pieralli et al, 2016^Citation34	50	Women with iatrogenic menopause because of current or previous BC Presence of VVA related dyspareunia	53.3 (median, range 41–66)	6.6 (median time of menopause, range 1–17)	22 women on ET: AIs (2) TMX (20)	Single arm prospective study	Three sessions every 30 days with vaginal probe Settings: dot power 30 w, dwell time 1000 µs, dot spacing 1000 µm and smart stack parameter 1	Self-reported measures: dyspareunia, satisfaction (VAS) Clinician assessment: VHI (including vaginal pH)	4 weeks after the last laser application	No	Significant improvement in dyspareunia at follow up 76% satisfied/very satisfied at follow up Significant improvement in VHI, with no differences between AIs, TMX-treated groups and untreated group
Pagano et al, 2018^Citation35	82	Women with a history of BC and VVA symptoms, after failure of vaginal moisturisers or lubricants	44 (median)	Not specified (10 women with spontaneous menopause, 72 with iatrogenic menopause)	61 women received ET: AIs (37) TMX (23)	Retrospective study	Three sessions every 30–40 days Setting: a dot power of 30 W, scan time 1000 µs, dot spacing 1000 µm, smart stack parameter from 1 to 3	Self-reported measures: VAS score for each VVA symptom and for each procedure-related discomfort symptom Clinician assessment: genital examination	30 days after completion of three cycles of treatment	No	Differences in the mean VAS scores were significant for sensitivity during sexual intercourse, vaginal dryness, itching/stinging, dyspareunia, dysuria, bleeding, probe insertion, and movement-related pain Neither age and type of adjuvant systemic anticancer therapy seem to affect treatment outcome
Becorpi et al, 2018^Citation36	20	Menopausal status History of BC VVA diagnosed if any of the following were present: (i) patient reported vaginal dryness; (ii) at least a clinically documented sign of VVA (flattening of the vaginal folds, dryness of the vaginal mucosa, pallor of the vaginal mucosa, fragility of the mucosa, and petechiae); (iii) vaginal pH>5.	58.2 (mean)	8.85±5.54 (mean duration of menopausal status)	16 women used ET in the past	Single arm prospective study	Two sessions with vaginal probe Settings: 30-W power, dwell time of 1000 μs, dot spacing of 1000 μm, smart stack 1	Self-reported measures: clinical symptoms (VRS), treatment satisfaction (Likert scale), FSFI, FSDS Clinician assessment: VHI (including vaginal pH), vaginal microbiome and vaginal inflammatory cytokines pattern	30 days from second laser treatment	No	Significant improvement of VRS for all VVA symptoms, and FSFI; no significant changes in FSDS Significant improvement of VHI No significant changes in vaginal microbiome; significant changes in inflammatory and modulatory cytokines pattern towards a ‘tissue remodeling’ profile
Pearson et al, 2019^Citation37	26	Women with a history of stage I–III BC Presence of at least one of the following VVA symptoms: vaginal dryness, itching, burning, dysuria and dyspareunia	55 (median)	Not reported	25 women received ET: TMX (12) AIs (11) AIs and ovarian suppression (1)	Single arm pilot study	Three sessions every 4 weeks, with vaginal probe Settings: power 40 W, dwell time 1000 μs and spacing of 1000 μm with a smart stack of 2	Self-reported measures: VVA symptoms (VAS), FSFI, QoL (SF-12) and patient reported improvement in symptoms, sexual function, QoL (Likert scale) Clinician assessment: genital examination	4, 8, 12 weeks and 4 weeks after completion of the final treatment	Not reported	Significant improvement in VAS for all VVA symptoms (dryness, itch, burning, dysuria and dyspareunia) at 12 weeks Significant improvement in FSFI (total score and each domain) at 12 weeks 73% of patients reported an improvement of VVA symptoms, 50% in sexual function and 65% in QoL
Gittens et al, 2019^Citation38	25	Women complaining of GSM symptoms with either spontaneous menopause or iatrogenic menopause secondary to ET for BC	55.2±9.5 (mean±SD)	47.3±6.3 (mean age at menopause)	8 women on ET (type not specified)	Retrospective study	Three sessions every 6 weeks with vaginal and vulvar probes Setting: not reported	Self-reported measures: FSFI, FSDS and pain (WBFS9) overall and in each cohort (menopausal versus BCSs) Clinician assessment: genital examination	6 weeks after each treatment	No	Overall significant improvement in FSFI, FSDS, WBFS from baseline after 3 laser sessions Significant improvement in FSFI (total score and each domain), pain, dyspareunia and vaginal dryness domains of WBFS and FSDS in women with BC history after 3 laser sessions
Angioli et al, 2020^Citation39	165 (full cohort, 135 with BC history)	Women with a history of breast, ovarian, cervical, or uterus cancer At least one of the following symptoms of GSM: vaginal dryness, dyspareunia, vaginal pain at introitus, burning, or itching	53 (mean, range 31–73)	45 (mean age at menopause, range 31–54)	Not reported	Retrospective multicentric study	Three sessions every 30 days with vaginal probe Settings: dot power 40 w, dwell time of 1000 μs and dot spacing of 1000 µm	Self-reported measures: vaginal dryness, dyspareunia, vaginal introitus pain, burning, or itching (VAS) Clinician assessment: vaginal pH	4 weeks after the last laser application	No	Significant improvement in vaginal dryness (64%), dyspareunia (59%), vaginal introitus pain (52%), burning (68%), itching (71%) and vaginal pH (11%) in the overall, BCS and gynecological cancer survivors’ cohorts of women
Hersant et al, 2020^Citation40	20	Women with a history of BC VHI<15	56.1±8.8 (mean±SD)	51.25±1.5 (mean age ±SD at menopause)	9 women treated with ET: TMX (2) AIs (4) TAM followed by AIs (3)	Single arm feasibility study	2 sessions one month apart, with vaginal probe Settings: pulse width 0.9 ms, and energy density or fluence 11.5 J/cm^2	Self-reported measures: FSD (FSDS), pain and satisfaction (VAS) Clinician assessment: VHI (including vaginal pH)	1, 3 and 6 months from first session	Two cases of moderate bleeding within 24 hours from procedure	Significant improvement of FSD score by 7% at 1 month, 35% at 3 months and 52% at 6 months compared with baseline Significant improvement of VHI by 21% at 1 month, 30% at 3 months and 34% at 6 months compared with baseline
Quick et al, 2020^Citation41	67 (59 completed follow-up)	Women with BC stage I–III Self-reported dyspareunia and/or vaginal dryness of any severity	57.4±95 years (mean±SD)	Not reported	59 women treated with ET: AIs (44) TMX (13) TMX and ovarian suppression (2)	Single arm feasibility study	3 sessions every 30–45 days with vaginal and vulvar probe Setting: dot power 30 w, dwell time 1000 μs, spacing 1000 μm and smart stack parameter 1	Self-reported measures: FSFI, UDI-6, PGI-I Clinician assessment: VAS and VuAS scores + VHA (including vaginal pH)	At each session and after completion of the final treatment	No	59 women (88.1%) were able to complete the study Significant improvement in FSFI and UDI-6 at 4 weeks 39% of participants reported that their symptoms were a little better, 28.8% reported they were much better, and 22.0% reported they were very much better Significant improvement in total VAS and VuAS VHA improved from baseline to follow up (no level of significance reported)
Veron et al, 2021^Citation42	46	Menopausal women with BC history and GSM symptoms	56 (median, range 45–59)	Not reported	36 current users of ET: 24 AIs 6 AIs and ovarian suppression 6 TMX	Single arm prospective study	3 sessions every month, with vaginal probe Setting: dot power 26 to 40 w, dwell time of 1000 μs, dot spacing of 1000 μm, with increasing stack at each session (1–3)	Self-reported measures: FSFI, Ditrovie score and SF-12 for urinary and general QoL, respectively Clinician assessment: vaginal pH and vaginal epithelial maturation pattern	Last laser session, 6 and 18 months	Low grade (2) and high grade (1) HPV-linked cervical lesions	Significant improvement of all FSFI domains score at 6 months, followed by a decrease in all domains which remained significantly higher than baseline at 18 months, with the exception of pain and desire Significant improvement of Ditrovie score at 6 months, return to baseline scores at 18 months Global QoL remained unchanged Vaginal pH slightly decreased (Δ= −0.3), whereas maturation pattern did not show significant changes at follow up
Siliquini et al, 2021^Citation43	135	45 menopausal women with BC history 90 age and BMI matched menopausal women without history of BC, with GSM symptoms	60.6±8.18 (mean±SD, BC) 58.3±8.40 (mean±SD, controls)	Not reported	18 past users (10 TMX, 6 TMX and ovarian suppression, 2 AIs) 17 current users (5 TMX, 11 AIs, 1 AIs and ovarian suppression)	Retrospective cohort study	3 sessions every 30 days with vaginal and vulvar probes Setting: dot power 40 watts with smart stack 3 at vaginal level, 25–35 watts with smart stack 1 at introital level and 20–30 watts with smart stack 1 at vulvar level	Self-reported measures: dyspareunia, vaginal dryness severity, pain with the procedure (VAS) Clinician assessment: VHI (including vaginal pH), VVHI	30 days after each session, 3, 6 and 12 months after last session	No	Significant improvement in vaginal dryness and dyspareunia severity from 3 months follow up in both groups, persisting at 12 months follow up; improvement was slower in BCS compared with controls. Significant improvement in VHI and VVHI at any session and maintained through the 12-month follow up; VHI reached scores of normal trophism after 2 sessions in BCS and one session in control group.
Salvatore et al, 2021^Citation44	40	Women with a history of BC Past or current treatment with ET Symptoms of VVA (vaginal dryness, vaginal burning, vaginal itching, dyspareunia, and dysuria)	57.6±7.2 (mean±SD)	49.5±4.6 years (mean age at menopause±SD)	25 past ET users (Group 1) 15 current ET users (Group 2) Type of ET not reported	Prospective cohort study	5 sessions every 4 weeks with vaginal probe Settings: dot power 30 watts, dwell time 1000 μs, dot spacing 1000 μm, and smart stack parameter from 1 to 3	Self-reported measures: satisfaction (Likert scale), VVA symptoms severity (VAS), FSFI, QoL (SF12) Clinician assessment: VHI (including vaginal pH)	30, 60, 90, 120, 150 days	No	Six (15.0%) women were very satisfied, 25 (62.5%) were satisfied, 6 (15.0%) were uncertain, and 3 (7.5%) were dissatisfied at 20-week follow up Significant improvement in VVA symptoms severity, VHI, all FSFI domains, physical and mental domains of SF12, with no significant differences between study groups at 20-week follow up
Quick et al, 2021^Citation45	67 (59 completed 4 weeks ad 39 completed 1 year follow ups)	Women with BC stage I–III Self-reported dyspareunia and/or vaginal dryness of any severity	574±10.5 (mean±SD)	Not reported	37 women on ET: AIs (26) TMX (9) TMX and ovarian suppression (2)	Single arm prospective study	3 sessions every 30–45 days with vaginal and vulvar probe Setting: dot power 30 w, dwell time 1000 μs, spacing 1000 μm and smart stack parameter 1	Self-reported measures: FSFI, FSDS Clinician assessment: genital examination	4 weeks after last session and 1 year	No	Significant improvement of FSFI and FSDS from baseline to 4-week follow up At 12 months, FSFI was significantly reduced compared with 4-week follow up, but higher compared with baseline No significant changes of FSDS observed at 12 months compared with 4-week follow up
Gardner et al, 2021^Citation46	139 (full cohort, 38 with BC history)	Women who completed 2 sessions of fractional micro ablative CO2 laser for bothersome symptoms of VVA	62±10 (mean±SD, full cohort)	12.6±9.45 (mean±SD duration of menopause)	19 of BC women on ET: AI (15) TMX (4)	Retrospective study	3 sessions every 6 weeks with vaginal and vulvar probe Settings: dot power 30 watts, dwell time 1000 μs, dot spacing 1000 μm, smart stack from 1 to 3	Self-reported measures VVA symptoms (VSQ), pain with VVA symptoms (VAS), FSFI Clinician assessment: genital examination	About 13 weeks from baseline	No	In BCSs group, significant improvement in 18 of the VSQ questions and in VAS for 5 symptoms (vaginal pain, itching, burning, dryness, painful intercourse, but not painful urination), and in FSFI (total score and all six domains), similar to general cohort
Quick et al, 2022^Citation47	67 (64 started, 39 completed 1 year, 33 completed 2 years)	Women with history of BC stage I–III Self-reported dyspareunia and/or vaginal dryness of any severity	59.3±10.8 (mean±SD)	Not reported	32 women on ET: AIs (23) TMX (7) TMX and ovarian suppression (2)	Single arm prospective study	3 sessions every 30–45 days with vaginal and vulvar probe Setting: dot power 30 w, dwell time 1000 μs, spacing 1000 μm and smart stack parameter 1	Self-reported measures: VAS and VuAS score, FSFI, FSDS, UDI-6 Clinician assessment: genital examination	4 weeks, 1 and 2 years	No	No significant difference in VAS and VuAS score and sexual function compared with the improvement at 4-week follow up. No significant changes in FSFI and FSDS compared with the improvement at 4-week follow up and values at 12-month follow up UDI-6 approached baseline scores
Mension et al, 2023^Citation48	72	Women with a history of BC currently treated with AIs Menopausal status, with signs or symptoms of GSM, including dyspareunia and vaginal pH>5 Self-reported willingness of being sexually active	51.3 years (laser-treated group); 53.7 years (sham-treated group)	44.7 years (laser-treated group); 45.6 years (sham-treated group)	Aromatase inhibitor therapy ongoing for at least 6 months	Prospective, randomized, double-blind, sham-controlled trial	Two arms randomly assigned: 35 women: 5 monthly sessions of intravaginal CO2 laser. Setting: dot power 40 w, dwell time 1000 μs, dot spacing 1000 μm. 37 women: 5 monthly sessions with intravaginal sham probe. Setting: dot power 0 w, dwell time 100 μs, dot spacing 2000 μm. All patients instructed to use daily external moisturizer, intravaginal moisturizer pessaries every 3 days and vaginal vibrator twice/week	Self-reported measures: FSFI (primary outcome), VAS for dyspareunia, SF-12, Spanish body image scale, Likert scale for tolerance Clinician assessment: VHI Objective outcomes: vaginal pH, VMI, VEE (Pascal), VET (mm), circulating E2	6 months	13 women in laser group and 10 women in sham group, intensity rated mild (45%, spotting, vaginal itching) to moderate (10%, urinary tract infection)	Improvement in most of subjective and objective outcomes in both groups, with the exception of quality of life and vaginal epithelial thickness, without any significant difference between laser-treated and sham-treated groups Laser treatment significantly less tolerated than sham treatment

Abbreviations: AEs, adverse events; AIs, aromatase inhibitors; BC, breast cancer; E2, estradiol; ET, endocrine therapy; FSFI, female sexual function index; FSD, female sexual dysfunction; FSDS, female sexual distress scale; PGI-I, patient global impression of improvement; QoL, quality of life; SF-12, short form 12; TMX, tamoxifen; UDI-6, urinary distress inventory, short form; VHA, vaginal health assessment; VAS, visual analogue scale; VAS and VuAS, Vaginal and Vulvar Assessment Scales; VEE, vaginal epithelial elasticity; VET, vaginal epithelial thickness; VRS, verbal rating scale; VHI, vaginal health index; VMI, vaginal maturation index; VSQ, vaginal symptoms questionnaire; VVA, vulvovaginal atrophy, VVHI, vulvovaginal health index; WBFS, Wong-Baker FACES scale.

Table 2 Summary of Included Studies on Non-Ablative Vaginal Erbium Laser in Breast Cancer Survivors (BCSs)

Author	n.	Characteristics of Patients (Pts)/Inclusion Criteria	Age (Yrs)	Age at Menopause and/or Duration	Adjuvant Therapy for BC	Study Design	Therapeutic Protocol	Outcomes	Follow Up	AEs (n.)	Main Results and Conclusions
Gambacciani et al, 2017^Citation49	43	Postmenopausal women with BC history reporting symptoms of GSM	50.8±8.1 (mean±SD)	43.2±5.0 years (mean)	Not reported	Pilot, prospective, longitudinal study	3 sessions every 30 days with vaginal probe Settings: frequency 1.6 Hz, fluence 6.0 J/cm^2	Self-reported measures: dryness and dyspareunia (VAS) Clinician assessment: VHI score (including vaginal pH)	Following each session and after 1, 3, 6, 12 and 18 months	No	Significant decrease in VAS for dryness, dyspareunia and increase in VHI up to 12 months compared to baseline
Mothes et al, 2017^Citation50	16	BCSs complaining symptoms of VVA after surgery for pelvic organ prolapse	71±7 (mean±SD)	Not reported	Not reported	Retrospective study	Single 10-min course vaginal erbium laser Setting: fluence between 15 and 35 J/m^2 (phase I) and 3 and 9 J/m^2 (phase II)	Self-reported measures: Overall satisfaction Clinician assessment: VHI, vaginal pH	8.3 ±2 weeks (mean±SD)	Not reported	94% of patient satisfied with the procedure Significant improvement of VHI
Arêas et al, 2019^Citation51	24	Menopausal women with history of BC Presence of vaginal dryness and/or dyspareunia	53.7±9.66 (mean±SD)	7.92±5.94 years (mean±SD, duration of menopause)	60% currently treated with TMX	Open prospective intervention study	Three sessions every 30 days, with vaginal probe Settings: fluence 2.0 J/cm^2, frequency 0.5 Hz, pulses using the smooth-mode technique (eight pulse trains of 50 ms totaling 400 ms)	Self-reported measures: SPEQ Clinician assessment: VHI (including vaginal pH)	Before laser session and after 1 month following the last	Vaginal candidiasis (1) and acute cystitis (1)	Significant improvement of SPEQ, with significant effect size for total score and dyspareunia, and of VHI
Gold et al, 2022^Citation52	43	Women with a history of BC with at least one of the following symptoms: vaginal dryness, burning or irritation; lack of lubrication during sexual intercourse/ sexual discomfort or pain; symptoms of urgency and dysuria; recurrent urinary tract infection	54 (median, range 49–58)	Not reported (9 women premenopausal, 34 women postmenopausal)	32 women on current ET: AIs (25) TMX (7)	Single centre, randomized, controlled trial	Two arms randomly assigned: 22 women: intravaginal non-ablative erbium laser (2 sessions within one month; intravaginal application; fluence 20 J/cm2) 21 women: hyaluronic acid suppositories (3 time/week for 3 months)	Self-reported measures: Subjective bother of urogenital atrophy and degree of discomfort or pain during laser therapy (NRS), PGI-I e PGI-S, EORTC-QLQ-BR45, EORTC SHQ–C22, Australian pelvic floor questionnaire Clinician assessment: VHI (including vaginal pH)	3 months	No	Significant improvement of urogenital atrophy associated bother in both groups without significant differences between laser and suppositories; dyspareunia and OAB associated bother decreased in both groups, SUI associated bother decreased in laser group only PGI-I improved slightly in both groups; PGI-S decreased only in the laser group Several domains of EORTC-QLQ-BR45 improved in both groups. Only sexual pain multi-domains item decreased in the laser group, whereas sexual satisfaction and other single domains did not change in any of the two groups Significant improvement of VHI

Abbreviations: AEs, adverse events; AIs, aromatase inhibitors; BC, breast cancer; BCSs, breast cancer survivors; ET, endocrine therapy; EORTC-QLQ-BR45, European organization for research and treatment of cancer-quality of life questionnaire; EORTC-SHQ–C22, European Organization for Research and Treatment of Cancer-Sexual Health Questionnaire; GSM, genitourinary syndrome of menopause; NRS, numerical rating scale; OAB, overactive bladder; PGI-I, patient global impression of improvement; PGI-S, patient global impression of severity; SPEQ, Short Personal Experiences Questionnaire; SUI, stress urinary incontinence; TMX, tamoxifen; VAS, visual analogue scale; VHI, vaginal health index; VVA, vulvovaginal atrophy.

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