Abstract
This cohort study examines the prevalence of vulvar lichen sclerosus and subsequent incidence of vulvar cutaneous squamous cell carcinoma or vulvar cutaneous squamous cell carcinoma in situ among Medicare beneficiaries 65 years or older.
Vulvar lichen sclerosus (VLS) is understudied and increases vulvar cutaneous squamous cell carcinoma or in situ (VcSCC or VcSCCis) risk.1 Epidemiologic VLS data are limited. Studies suggest a 0.05% prevalence in women younger than 65 years,1 but prevalence in older women is unclear. We aimed to identify VLS prevalence, VcSCC or VcSCCis development, and treatment patterns in female Medicare beneficiaries 65 years or older.
Methods
The MD Anderson Institutional Review Board approved this study and waived informed consent because deidentified data were used. We followed the STROBE reporting guideline.
Inclusion criteria were female; 65 years or older; and continuous Parts A, B, and D fee-for-service Medicare enrollment from October 2015 through December 2021. Exclusion criterion was VcSCC or VcSCCis history before start of follow-up time (eTable 1 in Supplement 1). Patients with VLS had at least 2 VLS International Statistical Classification of Diseases and Related Health Problems, Tenth Revision, (ICD-10) codes (L90.0). Patients without VLS had no VLS ICD codes and at least 2 non-VLS ICD codes. Outcomes included VLS prevalence and treatment patterns and subsequent VcSCC or VcSCCis treatments. Sensitivity analysis excluded patients with lichen planus or lichen simplex.
Follow-up time began with the second ICD code and ended at enrollment end or death. National Drug Codes identified medical VLS treatments (eTable 2 in Supplement 1). ICD-10 codes identified VcSCC or VcSCCis (eTable 1 in Supplement 1). Current Procedural Treatment (CPT) codes identified procedural treatments: wide local excision (WLE), Mohs micrographic surgery (MMS), destructive methods, labial adhesion lysis, and vulvectomy (eTable 3 in Supplement 1). Matched Fine-Gray competing risk analysis (competing risk of death) evaluated VcSCC or VcSCCis in patients with vs without VLS. The eMethods in Supplement 1 provides more details.
Two-sided P < .05 indicated statistical significance. Analyses were performed from August 2023 to April 2025 using SAS 9.4 (SAS Institute).
Results
Among 2 525 340 female Medicare beneficiaries (mean [SD] age, 73.0 [8.3] years) included, VLS prevalence was 0.7% (17 987); prevalence in sensitivity analysis was 0.6%. Of patients with VLS, 13 058 (72.6%) filled topical corticosteroid or calcineurin inhibitor prescriptions. Of 47 499 VLS encounters, obstetrician-gynecologists managed 26 638 (56.1%) and dermatologists managed 9271 (19.5%) (Table 1).
Table 1. Characteristics of Patients With vs Without VLS From 2015 to 2021.
| Characteristic | Patients, No. (%) | |
|---|---|---|
| With VLS | Without VLS | |
| Demographics | ||
| All patients, No. | 17 987 | 2 507 353 |
| Age, mean (SD), ya | 73.5 (7.1) | 73 (8.9) |
| Follow-up time, mean (SD), ya | 3 (1.7) | 4.8 (2.3) |
| Race and ethnicitya,b | ||
| Asian or Pacific Islander | 133 (0.7) | 64 677 (2.6) |
| Black or African American | 263 (1.5) | 157 679 (6.3) |
| Hispanic | 376 (2.1) | 114 265 (4.6) |
| Native American | 36 (0.2) | 9958 (0.4) |
| Non-Hispanic White | 16 810 (93.5) | 2 117 030 (84.4) |
| Otherc | 57 (0.3) | 14 363 (0.6) |
| Unknown | 312 (1.7) | 29 381 (1.2) |
| VcSCC or VcSCCisd | 209 (1.2) | 7312 (0.3) |
| VLS encounters managed by specialties | ||
| All specialties | 47 499 | NA |
| Obstetrics and gynecology | 26 638 (56.1) | NA |
| Gynecologic oncology | 634 (1.3) | NA |
| Dermatology | 9271 (19.5) | NA |
| Advanced practice practitionere | 5608 (11.8) | NA |
| Family practice | 2566 (5.4) | NA |
| Internal medicine | 1683 (3.5) | NA |
| Undefined physician type | 1311 (2.8) | NA |
| Urology | 422 (0.9) | NA |
Abbreviations: NA, not applicable; VcSCC, vulvar cutaneous squamous cell carcinoma; VcSCCis, vulvar cutaneous squamous cell carcinoma in situ; VLS, vulvar lichen sclerosus.
Using χ2 analysis, significant at P < .001, indicating the racial distribution of the VLS cohort is different from the Medicare population.
Race and ethnicity data were defined by the RTI (Research Triangle Institute) race code in the Medicare Master Beneficiary Summary File. These data were included because prevalence of VLS and VcSCC or VcSCCis incidence may vary by race and ethnicity.
Other was not defined in the Medicare Master Beneficiary Summary File.
Using unpaired, 2-tailed t test, significant at P < .001, indicating a difference in VcSCC or VcSCCis development between the 2 groups.
Includes nurse practitioners and physician assistants.
Of patients with VLS, 209 (1.2%) had subsequent VcSCC or VcSCCis ICD codes (Table 2). Patients with VLS had a hazard ratio of 11.81 (95% CI, 11.62-12.02) for VcSCC or VcSCCis. Among patients with VcSCC or VcSCCis, 162 (77.5%) had same-day procedures, of which 131 (80.9%) were non–tissue sparing (vulvectomy or WLE) and 1 (0.6%) was MMS (Table 2).
Table 2. Procedural Treatments for VcSCC and VcSSCis .
| Procedural treatment | No. (%) | ||
|---|---|---|---|
| Total (N = 162) | VcSCC (n = 64) | VcSCCis (n = 98) | |
| Destructive methods | 30 (18.5) | 5 (7.8) | 25 (25.5) |
| Mohs micrographic surgery | 1 (0.6) | 0 (0) | 1 (100) |
| Non–tissue sparing procedures | 131 (80.9) | 59 (92.2) | 72 (73.5) |
| Vulvectomy | 121 (74.7) | 55 (85.9) | 66 (67.3) |
| Total simplea | 76 (46.9) | 21 (32.8) | 55 (56.1) |
| Partial | 71 (43.8) | 19 (26.8) | 52 (73.2) |
| Complete | 5 (3.1) | 2 (40.0) | 3 (60.0) |
| Total radicala | 45 (27.8) | 34 (53.1) | 11 (11.2) |
| Partial | 42 (25.9) | 32 (76.2) | 10 (23.8) |
| Complete | 3 (1.9) | 2 (66.7) | 1 (33.3) |
| Wide local excision | 10 (6.2) | 4 (6.3) | 6 (6.1) |
Abbreviations: VcSCC, vulvar cutaneous squamous cell carcinoma; VcSCCis, vulvar cutaneous squamous cell carcinoma in situ.
Simple vulvectomy excises vulvar epidermis, dermis, and hypodermis, which includes subcutaneous adipose and loose-connective tissue. Radical vulvectomy additionally excises to the deep fascia, superficial to muscle.2 Partial vs complete defines the vulvectomy excision width or surface area. Partial simple and radical vulvectomies excise less than 80% of the vulvar surface area (labia minora, labia majora, and clitoris), whereas complete vulvectomy removes 80% or more.
Discussion
The 0.7% VLS prevalence in female Medicare beneficiaries is higher than the 0.05% prevalence in younger women1 and likely an underestimation, as VLS’s sensitive nature and health care access issues may prevent diagnosis. Percentages of obstetrician-gynecologists and dermatologists managing VLS encounters are similar to previous reports.1 Most patients with VLS obtained appropriate topical therapy, which decreases VcSCC risk.3
Patients with VLS were over 10 times more likely than patients without VLS to develop VcSCC or VcSCCis. Guidelines on VLS surveillance for VcSCC development remain nebulous. European studies described approximately 2.5% VcSCC or VcSCCis incidence in patients with VLS, which is higher than our 1.2%. However, those studies used less stringent diagnostic requirements.4,5
Most procedural treatment received was non–tissue sparing vulvectomy or WLE; only 1 patient received MMS (Table 2). The National Comprehensive Cancer Network guidelines included MMS for genital squamous cell carcinoma6 and penile carcinoma but not vulvar carcinoma. Studies indicate improved recurrence rates, urinary or excretory function, and dyspareunia after MMS for early-stage VcSCC or VcSCCis vs WLE or vulvectomy.2
Study limitations include limited generalizability from focusing on Medicare beneficiaries 65 years or older; however, VLS may be common in this population. Additionally, analyses of claims data relied on ICD and CPT codes, which can be inaccurate. Thus, we required 2 VLS codes to identify VLS. This study provides essential epidemiologic estimates for VLS in older women.
eMethods
eReferences
eTable 1. Vulvar Cutaneous Squamous Cell Carcinoma (cSCC) International Classification of Disease ICD-9 and ICD-10 Codes
eTable 2. Generic Lichen Sclerosus Topical Treatments
eTable 3. Obstetrics & Gynecology (OBGYN) and Dermatology Vulvar cSCC Current Procedural Treatment (CPT) Codes
Data Sharing Statement
References
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Associated Data
This section collects any data citations, data availability statements, or supplementary materials included in this article.
Supplementary Materials
eMethods
eReferences
eTable 1. Vulvar Cutaneous Squamous Cell Carcinoma (cSCC) International Classification of Disease ICD-9 and ICD-10 Codes
eTable 2. Generic Lichen Sclerosus Topical Treatments
eTable 3. Obstetrics & Gynecology (OBGYN) and Dermatology Vulvar cSCC Current Procedural Treatment (CPT) Codes
Data Sharing Statement
