VOLUME 42  •  NUMBER 6 April 30, 2022

TOPICS IN
OBSTETRICS & GYNECOLOGY Practical CE Newsletter for Clinicians

Vaginal Intraepithelial Neoplasia (VaIN): Diagnosis and

Management
Julia Dexter, MD, and Elizabeth Lokich, MD
Learning Objectives: After participating in this continuing professional development activity, the provider should be
better able to:
1. Identify patients to screen for vaginal intraepithelial neoplasia.
2. Explain treatment options and their adverse effects for patients with vaginal intraepithelial neoplasia.
3. Describe appropriate patient surveillance for patients with vaginal intraepithelial neoplasia.
Key Words: Human papilloma virus (HPV), Vaginal intraepithelial neoplasia (VaIN)

Vaginal intraepithelial neoplasia (VaIN) is an uncommon
lower genital tract dysplasia with malignant potential. Due
to its rarity, there is a paucity of high-quality clinical
research guiding management. Observational studies have
demonstrated that there is a long latency period between the
diagnosis of VaIN and the development of invasive carci-
noma. Thus, the lengthy burden of surveillance is tasked to
women’s health providers including gynecologists and pri-
mary care physicians.
We review much of the available research on VaIN to help
guide clinicians with surveillance and management deci-
sions and provide some of the clinical reasoning behind this
guidance. We also discuss special populations and give
recommendations on when to refer to subspecialty care. As
VaIN is a relatively uncommon condition, large-scale data
are limited, and recommendations presented here are based
Dr. Dexter is a Resident, and Dr. Lokich is Assistant Professor, Division of
Gynecologic Oncology, Women and Infant’s Hospital of Rhode Island, 90 Plain
St, 2nd Floor, Providence, RI 02903; E-mail: elokich@wihri.org.
The authors, faculty, and staff in a position to control the content of this CME/
NCPD activity have disclosed that they have no financial relationships with, or
financial interests in, any commercial organizations relevant to this educational
activity.
primarily on the results of retrospective studies and expert
opinion.
Background and Epidemiology
VaIN is rare, affecting 0.2 per 100,000 women and repre-
senting just 0.4% of all lower genital tract dysplasia in
women.1 However, several recent studies indicate that the
frequency of diagnosis is increasing, although it is difficult
to determine whether this is due to enhanced screening or
increasing incidence.2 Most patients with VaIN either have
or have had other lower genital tract dysplasia or carcinoma
of the cervix, vulva, or anus.3
Similar to other lower genital tract dysplasia, VaIN is
classified according to the depth of epithelial involvement.
VaIN 1 involves the lower one-third of the epithelium, VaIN
2 involves the lower two-thirds of the epithelium, and VaIN
3 involves more than two-thirds of the epithelium but does
not have any evidence of invasion.
The median age of diagnosis ranges from 43 to 50 years
in the general population. However, in special populations,
age of diagnosis can be older or younger based on clinical
history and risk factors. For example, a case-control study
by Liao et al4 demonstrated a median age of diagnosis of

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evaluation on the enclosed answer form, answering at least seven of the 10 quiz questions correctly. This CME activity expires on April 29, 2024.
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ANCC contact hours are included on the test page of the newsletter. This NCPD activity expires on March 7, 2025.
1
Postgraduate Obstetrics & Gynecology April 30, 2022
Editors
William Schlaff, MD
Professor and Chair,
Department of Obstetrics
and Gynecology, Thomas
Jefferson Medical College,
Philadelphia, Pennsylvania
Lorraine Dugoff, MD
Professor and Chief, Division of
Reproductive Genetics,
Department of Obstetrics
and Gynecology, University
of Pennsylvania Perelman
School of Medicine,
Philadelphia, Pennsylvania
Founding Editors
Edward E. Wallach, MD
Roger D. Kempers, MD
Associate Editors
Meredith Alston, MD
Denver, Colorado
Amanda French, MD
Boston, MA
Nancy D. Gaba, MD
Washington, DC
Veronica Gomez-Lobo, MD
Washington, DC
Star Hampton, MD
Providence, Rhode Island
Enrique Hernandez, MD
Philadelphia, Pennsylvania
Bradley S. Hurst, MD
Charlotte, North Carolina
Jeffrey A. Kuller, MD
Durham, North Carolina
Peter G. McGovern, MD
New York, New York
Owen Montgomery, MD
Philadelphia, Pennsylvania
Christopher M. Morosky, MD
Farmington, Connecticut
William D. Petok, PhD
Baltimore, Maryland
VaIN after radiation for a prior pelvic malig- be because the metaplastic transformation
nancy to be 55. Conversely, a series on lower zone of the cervix is more susceptible to
genital tract dysplasia in solid organ trans- oncogenic transformation, whereas the more
plant recipients by Thimm et al5 demon- mature vaginal squamous epithelium is less
strated a younger median age of diagnosis. vulnerable. Interestingly, patients who were
Risk factors for the development of VaIN exposed to DES in utero can have squamous
include human papilloma virus (HPV) metaplasia of the vagina, which could explain
infection, immunosuppression or immuno- the increased incidence of VaIN in these
deficiency, history of pelvic radiation ther- patients.14,15
apy, in utero diethylstilbesterol (DES) expo- The largest series exploring the course of
sure, and prior hysterectomy for benign, VaIN was published by Kim et al,16 and
premalignant, and malignant conditions. reviewed 576 cases of VaIN from 2000 to
Risk of persistence is increased by some of 2016 with a median follow-up time of 44.6
these factors such as HPV infection and months. This series demonstrated the rate of
chronic immunosuppression or immunode- persistence and progression to be 18.3% and
ficiency, along with cigarette smoking. This 4.7%, respectively. Additionally, 16.9% of
necessitates long-term surveillance due to those who initially regressed had a recur-
the increased risk of developing invasive rence during the study period. Notably, the
cancer. Fortunately, persistence and pro- grade of dysplasia was not significantly asso-
gression are both relatively infrequent. One ciated with regression and recurrence rates,
of the highest risk groups is patients who although high-grade dysplasia had an
have undergone a hysterectomy for cervical increased risk of progression.16
intraepithelial neoplasia (CIN). This group
has a risk of developing VaIN 2+ that is as Diagnosis
high as 7.4%.6 VaIN is most commonly asymptomatic
The most common risk factor for VaIN is although it can be associated with vaginal
persistent HPV infection, and this is the discharge or postcoital spotting. Diagnosis of
main factor associated with persistence, vaginal dysplasia can be made by cytology
recurrence, and progression. The distribu- alone or by cotesting (cytology plus HPV
tion of HPV subtypes varies, but HPV 16 is testing), then colposcopy with biopsy. The
the subtype implicated in the majority of histologic findings are that of squamous dys-
high-grade dysplasia.3 Additional suggested plasia without invasion. Gunderson et al9
risk factors for progression to carcinoma are found that high-grade cytology is predictive
a history of hysterectomy for cervical dys- of VaIN 2 and Van 3 in 89% of cases; low-
plasia/carcinoma and a history of pelvic grade cytology is not as predictive, but is still
radiation therapy.4,7 Overall, the rate of associated with VaIN 2 and Van 3 in 53% of
progression to invasive cancer has been cases.9 This highlights the need to thor-
found to be somewhere between 2% and oughly follow up all abnormal vaginal Pap
8% in several retrospective studies.8-13 testing including low-grade squamous
The incidence of VaIN is much lower intraepithelial lesion (LSIL), high-grade
than the incidence of CIN in patients with squamous intraepithelial lesion (HSIL), and
HPV infection. It is thought that this could atypical glandular cells of undetermined
The continuing professional development activity in Topics in Obstetrics & Gynecology is intended for obstetricians, gynecologists, advanced
practice nurses, and other health care professionals with an interest in the diagnosis and treatment of obstetric and gynecological conditions.
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2
April 30, 2022 Topics in Obstetrics & Gynecology
significance (AGUS) with vaginoscopy and/or colposcopy.
Nearly all VaIN lesions are located in the epithelial recesses
of the upper third of the vagina; therefore, it is important to
fully visualize this area and biopsy all suspicious lesions. In
contrast to cervical dysplasia, there are no data to support
random biopsies after an abnormal vaginal pap.
Treatment
Treatment of VaIN depends on grade. VaIN 1 is usually
followed by close monitoring without active treatment.
This recommendation is based on the observation that
these lesions are often caused by nononcogenic HPV
strains and will regress without treatment.17 Additionally,
in postmenopausal women, these changes can be due in
part to atrophy and treatment with topical estrogen therapy
can be used.18
Current treatment options for VaIN 2 and VaIN 3 include
topical medications, surgical excision, and laser ablation.
Commonly used topical medications include imiquimod or
5-fluorouracil (5-FU) and topical chemotherapeutic agents,
which act locally on rapidly proliferating cells. Surgical
treatments include local excision or upper vaginectomy.
Ablative therapy is typically done via carbon dioxide laser
ablation, which requires specialized training and equip-
ment. Treatment must be individualized to each patient.
Excision is recommended for patients in whom a larger
specimen is needed for further evaluation or who have a
lesion that is concerning for invasive disease. Wide local
excision is the most frequently used surgical approach and
can be performed transvaginally. This is very useful, par-
ticularly for patients with a single site of disease.
Alternatively, for disease that is anatomically difficult to
resect due to location in the upper vaginal folds or for more
extensive disease distribution, upper vaginectomy or even
total vaginectomy can be performed. These procedures are
typically accomplished transabdominally either by a mini-
mally invasive or open approach. Vaginal shortening and
stenosis are the most common complications of surgery and
vaginal dilator use after healing can help to minimize this.
Ablative procedures can be performed as long as the
lesion is fully visualized and the possibility of invasion has
been excluded. Kim et al16 demonstrated that laser ablation
was significantly more effective in reducing persistence/
recurrence/progression of multifocal lesions as compared
with excision. Other authors have proposed primary laser
treatment as a preferred treatment for multifocal disease.1
Other benefits to ablative therapy are that it preserves
anatomy and vaginal length. Carbon dioxide laser and ultra-
sonic surgical aspiration are the 2 modalities used.
Postoperative pain, bleeding, and the need for retreatment
are the most common complications.
Nonsurgical management can be accomplished with the
application of topical chemotherapeutic agents. Again,
invasive disease must be excluded for topical treatments to
be a safe option. Use of 5% imiquimod is overall well toler-
ated. It is commonly used 3 times a week for 8 weeks, and
complete response rates can be as high as 77%.19 Fluorouracil
3
can also be used; dosing is typically once a week for 10
weeks and then 2 weeks of daily vaginal estrogen to reduce
irritation. This has been found to have similar success rates
to imiquimod.20 Both topical methods have the advantage
of being able to treat the entire vagina. Complications
include pain and vaginal irritation or burning. Rates of
recurrence and durability of response have not been well
reported.
In rare patients who are unable to undergo surgery or do
not respond to any other treatments, intracavitary radiation
therapy has been used with good success. However, this can
be associated with significant complications including ste-
nosis, vaginal shortening, sexual dysfunction, poor wound
healing, and inability to adequately assess the vaginal epi-
thelium in the future. Therefore, this option should be
reserved for very difficult or refractory cases.
Posttreatment Surveillance
Due to the risk of progression of VaIN 2 and VaIN 3 to
invasive squamous cell carcinoma, long-term follow up is
required. Risk of recurrence of VaIN can be as high as
18%.8,21 Grade 3 histology and prior hysterectomy for
HPV-related disease are independent risk factors for pro-
gression. Most recurrences occur in the first 1 to 2 years.
Therefore, clinical examination every 6 months for 2 years
and annually thereafter with annual cotesting (cytology and
HPV) is a reasonable surveillance strategy. Vaginal colpos-
copy should be performed for any HPV-positive test or
cytologic abnormality.
Referral to a gynecologic oncologist is appropriate in
several clinical scenarios. These include patients with a
Practice Pearls
• Include HPV testing with genotyping if available on
vaginal Pap smears.
• Positive cytology on vaginal Pap smears should be fol-
lowed up with thorough vaginoscopy with colposcopy
and with careful attention paid to visualizing the
recesses of the vaginal apex/cuff. Any suspicious
lesion should be biopsied.
• High-risk patients combined with high-grade dysplasia
necessitate treatment of VaIN, with excision being the
preferred treatment modality.
• Provided that invasive disease has been ruled out, abla-
tion or topical treatment with imiquimod or 5-FU can
be considered for patients with high-grade dysplasia in
certain circumstances, including multifocal or exten-
sive distribution of disease in whom the maintenance
of vaginal length and function is important.
• Surveillance every 6 months is ideal in the first 2 years
after treatment for VaIN 2 and VaIN 3, then annual
surveillance thereafter. Annual cytology and HPV test-
ing with genotyping is an important strategy to guide
more intensive surveillance with colposcopy when
cytology is abnormal or HPV testing result is positive.
 Postgraduate Obstetrics & Gynecology April 30, 2022
history of in utero DES exposure, immunosuppression due
to solid organ transplant, or HIV/AIDS and history of per-
sistent high-risk HPV infection. Additionally, patients who
have had a hysterectomy for high-grade cervical dysplasia
or cervical cancer and patients who have been treated for
vulvar or anal cancer with surgery and/or radiation should
be referred to a gynecologic oncologist for management.
REFERENCES
1. Bogani G, Ditto A, Ferla S, et al. Treatment modalities for recurrent high-
grade vaginal intraepithelial neoplasia. J Gynecol Oncol. 2019;30(2):e20.
doi:10.3802/jgo.2019.30.e20.
2. Zhang J, Chang X, Qi Y, et al. A retrospective study of 152 women with
vaginal intraepithelial neoplasia. Int J Gynaecol Obstet. 2016;133(1):80-83.
doi:10.1016/j.ijgo.2015.08.014.
3. Yu D, Qu P, Liu M. Clinical presentation, treatment, and outcomes associ-
ated with vaginal intraepithelial neoplasia: a retrospective study of 118
patients. J Obstet Gynaecol Res. 2021;47(5):1624-1630. doi:10.1111/
jog.14733.
4. Liao JB, Jean S, Wilkinson-Ryan I, et al. Vaginal intraepithelial neoplasia
(VAIN) after radiation therapy for gynecologic malignancies: a clinically
recalcitrant entity. Gynecol Oncol. 2011;120(1):108-112. doi:10.1016/j.
ygyno.2010.09.005.
5. Thimm MA, Rositch AF, VandenBussche C, et al. Lower genital tract dys-
plasia in female solid organ transplant recipients. Obstet Gynecol.
2019;134(2):385-394. doi:10.1097/AOG.0000000000003378.
6. Curtin JP, Twiggs LB, Julian TM. Treatment of vaginal intraepithelial neo-
plasia with the CO2 laser. J Reprod Med. 1985;30(12):942-944.
7. Schockaert S, Poppe W, Arbyn M, et al. Incidence of vaginal intraepithelial
neoplasia after hysterectomy for cervical intraepithelial neoplasia: a retro-
spective study. Am J Obstet Gynecol. 2008;199(2):113.e1-e5. doi:10.1016/j.
ajog.2008.02.026.
8. Sillman FH, Fruchter RG, Chen YS, et al. Vaginal intraepithelial neoplasia: risk
factors for persistence, recurrence, and invasion and its management. Am J
Obstet Gynecol. 1997;176(1, pt 1):93-99. doi:10.1016/s0002-9378(97)80018-x.
4
9. Gunderson CC, Nugent EK, Elfrink SH, et al. A contemporary analysis of
epidemiology and management of vaginal intraepithelial neoplasia. Am J
Obstet Gynecol. 2013;208(5):410.e1-e6. doi:10.1016/j.ajog.2013.01.047.
10. Hoffman MS, DeCesare SL, Roberts WS, et al. Upper vaginectomy for in
situ and occult, superficially invasive carcinoma of the vagina. Am J Obstet
Gynecol. 1992;166(1, pt 1):30-33. doi:10.1016/0002-9378(92)91823-s.
11. Wharton JT, Tortolero-Luna G, Linares AC, et al. Vaginal intraepithelial
neoplasia and vaginal cancer. Obstet Gynecol Clin North Am. 1996;23(2):
325-345.
12. Dodge JA, Eltabbakh GH, Mount SL, et al. Clinical features and risk of
recurrence among patients with vaginal intraepithelial neoplasia. Gynecol
Oncol. 2001;83(2):363-369. doi:10.1006/gyno.2001.6401.
13. Jentschke M, Hoffmeister V, Soergel P, et al. Clinical presentation, treatment
and outcome of vaginal intraepithelial neoplasia. Arch Gynecol Obstet.
2016;293(2):415-419. doi:10.1007/s00404-015-3835-6.
14. Bornstein J, Adam E, Adler-Storthz K, et al. Development of cervical and
vaginal squamous cell neoplasia as a late consequence of in utero exposure
to diethylstilbestrol. Obstet Gynecol Surv. 1988;43(1):15-21.
15. Townsend DE. Gynecologic Oncology: Fundamental Principles and
Clinical Practice. Edinburgh, Scotland: Churchill Livingstone; 1992:493.
16. Kim MK, Lee IH, Lee KH. Clinical outcomes and risk of recurrence among
patients with vaginal intraepithelial neoplasia: a comprehensive analysis of
576 cases. J Gynecol Oncol. 2018;29(1):e6. doi:10.3802/jgo.2018.29.e6.
17. Smith JS, Backes DM, Hoots BE, et al. Human papillomavirus type-distri-
bution in vulvar and vaginal cancers and their associated precursors. Obstet
Gynecol. 2009;113(4):917-924. doi:10.1097/AOG.0b013e31819bd6e0.
18. Rhodes HE, Chenevert L, Munsell M. Vaginal intraepithelial neoplasia
(VaIN 2/3): comparing clinical outcomes of treatment with intravaginal
estrogen. J Low Genit Tract Dis. 2014;18(2):115-121. doi:10.1097/
LGT.0b013e31829f52f4.
19. Tranoulis A, Laios A, Mitsopoulos V, et al. Efficacy of 5% imiquimod for
the treatment of vaginal intraepithelial neoplasia—a systematic review of
the literature and a meta-analysis. Eur J Obstet Gynecol Reprod Biol.
2017;218:129-136. doi:10.1016/j.ejogrb.2017.09.020.
20. Fiascone S, Vitonis AF, Feldman S. Topical 5-fluorouracil for women with
high-grade vaginal intraepithelial neoplasia. Obstet Gynecol. 2017;130(6):
1237-1243. doi:10.1097/AOG.0000000000002311.
21. Cheng D, Ng TY, Ngan HY, et al. Wide local excision (WLE) for vaginal
intraepithelial neoplasia (VAIN). Acta Obstet Gynecol Scand. 1999;78(7):
648-652.
April 30, 2022 Topics in Obstetrics & Gynecology

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 Postgraduate Obstetrics & Gynecology April 30, 2022

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1. The incidence of VaIN is 7. Which of the following is/are appropriate treatment for a
A. 2 in 10,000. patient with VaIN 1?
B. 0.5 in 100,000. A. upper vaginectomy
C. 5 in 10,000. B. topical 5-FU
D. 0.2 in 100,000. C. topical estrogen
D. all of the above
2. Average patient age at diagnosis of VaIN is
A. 30s. 8. Which of the following is/are appropriate treatment for a
B. 40s. patient with VaIN 2 and VaIN3?
C. 50s. A. laser ablation
D. 60s. B. topical imiquimod
C. surgical excision
3. Risk factors for VaIN include all of the following, except
D. all of the above
A. history of CIN.
B. cigarette smoking. 9. All of the following patients should be referred to a gyneco-
C. history of liver transplantation and subsequent immu- logic oncologist for management, except a
nosuppression. A. 50-year-old woman with a history of adenocarcinoma
D. history of IV drug use. of the cervix who is status post hysterectomy.
B. 60-year-old woman with a history of a hysterectomy for
4. Which one of the following high-risk HPV types is implicat-
fibroids in her 40s and colon cancer treated with sur-
ed in most cases of VaIN?
gery and radiation.
A. HPV 18
C. 60-year-old woman with a history of anal cancer.
B. HPV 31
D. 75-year-old woman with a history of vulvar cancer
C. HPV 16
treated with wide local excision.
D. HPV 45
10. Which one of the following is appropriate surveillance for
5. A 47-year-old woman with a history of cervical dysplasia is
women with a history of VaIN?
diagnosed with VaIN after biopsy. Her risk of progression
A. Pap smear with HPV testing every 3 months for
to invasive cancer is approximately
2 years, then every 6 months for 3 years and annually
A. <1%.
thereafter
B. 2%–8%.
B. Pap smear with cytology alone every 6 months for
C. 10%–18%.
2 years, then annually thereafter
D. 16%–25%.
C. clinical examination every 6 months for 2 years, then
6. A 55-year-old patient has a history of anal cancer and hys- annually thereafter with annual cotesting (cytology and
terectomy for fibroids. Vaginal colposcopy is indicated if a HPV)
vaginal Pap smear demonstrates D. annual HPV testing
A. LSIL, HPV+.
B. HSIL, HPV unknown.
C. AGUS.
D. all of the above.