Download High-Grade Cervical Intraepithelial Neoplasia in the United States

High-Grade Cervical Intraepithelial Neoplasia
in the United States and Europe
High Grade Cervical
Intraepithelial Neoplasia (CIN 2/3)
FACT SHEET
Annual Incidencea
Annual incidencea
400,000
350,000
300,000
US
389,000
EU31
340,000
Value
250,000
233,000
200,000
195,000
150,000
100,000
50,000
0
CIN2/3 irrespective
of HPV genotype
HPV 16/18
caused CIN2/3
CIN2/3, cervical intraepithelial neoplasia grade 2/3; EU31, European Union 31 countries;
CIN2/3, cervical intraepithelial neoplasia grade 2/3; EU31,
HPV, human papillomavirus.
European Union 31 countries; HPV, human papillomavirus.
a
a
Approximate numbers
per various
estimates.
Approximate
numbers
per various estimates.
Treatment
The standard of care for women identified with cervical intraepithelial neoplasia
grade 2 or 3 (CIN2/3) is surgical excision, the most common form being loop
electrosurgical excision procedure (LEEP):
•
•
•
Risks of LEEP
LEEP involves the use of a heated wire loop to cut abnormal cells from the surface of the cervix
LEEP is initially effective at removing precancerous lesions but does not treat the causative human
papillomavirus (HPV) infection, leading to recurrence of lesions in 10% to 16% of women
No treatments are currently available for women diagnosed with CIN1 or the underlying HPV infection
– Patients with CIN1 undergo “watchful waiting” to monitor the status of their lesions
•
•
Unmet need
Recurrence
Preterm birth
•
•
Infertility
Menstruation problems
•
•
Heavy bleeding
Cramping
•
Black discharge
Inovio Pharmaceuticals’ goal is to provide women with a non-surgical option for CIN2/3 treatment.
We want to give women the option to choose a less invasive procedure that not only treats their
cervical dysplasia but also clears the underlying HPV infection. We strive to provide women with
a treatment option that does not cause risk to their reproductive health.
© 2016 Inovio Pharmaceuticals, Inc., All Rights Reserved.
High-Grade Cervical Intraepithelial Neoplasia
FACT SHEET
20% to 40%
spontaneous regression of CIN2/3 to CIN1
or normal at 9 to 12 months post-diagnosis
43%
progression from HPV 16/18 CIN3 to cervical
carcinoma in situ at 1 year if left untreated
CIN, cervical intraepithelial neoplasia.
About cervical
dysplasia
CIN, also known as cervical dysplasia, is classified as premalignant changes in cervical cells that,
if left untreated, can advance to cervical cancer. CIN most often occurs in younger women (aged
25 to 35 years) and is divided into three progressive stages (ie, CIN1, CIN2, and CIN3). CIN2/3 is
considered high grade, as these lesions have the highest risk of becoming cancerous.
The cause of cervical dysplasia is persistent infection with one or more high-risk genotypes of HPV.
HPV, a sexually transmitted infection, infects approximately 12% of women who do not yet have CIN
worldwide. High-risk HPV genotypes are those types with high potential to cause cancer. HPV 16
and HPV 18 are the two genotypes most likely to cause high-grade CIN. These two genotypes are
estimated to cause approximately 70% of all cervical cancers in the United States and worldwide.
Although effective prophylactic vaccines for HPV have been available for several years, only 40% of
eligible adolescent females (aged 13 to 17 years) in the United States received all three doses of the
regimen in 2014. Furthermore, despite well-known HPV preventive measures (eg, use of condoms
during sexual relations, limiting the number of sexual partners), these behavioral measures are not
practiced universally. Therefore, it is expected that high-risk HPV infections, the resulting high-grade
CIN incidence, and the burden of cervical cancer will continue to be a substantial public health problem
in the United States and worldwide for years to come.
References
1. CIN progression to CIS: Insinga RP, Dasbach EJ, Elbasha EH. Epidemiologic natural history and clinical management of human papillomavirus (HPV) disease: a critical and systematic review of the literature in
the development of an HPV dynamic transmission model. BMC Infect Dis. 2009;9:119. 2. CIN recurrence: a. Xi LF, Kiviat NB, Wheeler CM, Kreimer A, Ho J, Koutsky LA. Risk of cervical intraepithelial neoplasia
grade 2 or 3 after loop electrosurgical excision procedure associated with human papillomavirus type 16 variants. J Infect Dis. 2007;195(9):1340-1344. b. Nobbenhuis MA, Meijer CJ, van den Brule AJ, et al. Addition
of high-risk HPV testing improves the current guidelines on follow-up after treatment for cervical intraepithelial neoplasia. Br J Cancer. 2001;84(6):796-801. 3. CIN incidence, US & high grade-CIN spontaneous
regression: Inovio, unpublished data of CIN incidence, 2015. 4. CIN incidence, US: Henk HJ, Insinga RP, Singhal PK, Darkow T. Incidence and costs of cervical intraepithelial neoplasia in a US commercially insured
population. J Low Genit Tract Dis. 2010;14(1):29-36. 5. CIN incidence, US: Insinga RP, Glass AG, Rush BB. Diagnoses and outcomes in cervical cancer screening: a population-based study. Am J Obs Gyn.
2004;191(1):105-113. 6. HPV types attribution in CIN, EU: Guan P, Howell-Jones R, Li N, et al. Human papillomavirus types in 115,789 HPV-positive women: a meta-analysis from cervical infection to cancer.
Intl J Cancer. 2012;131(10):2349-2359. 7. CIN incidence, EU: Hartwig S, Baldauf J-J, Dominiak-Felden G, et al. Estimation of the epidemiological burden of HPV-related anogenital cancers, precancerous lesions,
and genital warts in women and men in Europe: potential added benefit of a nine-valent second generation HPV vaccine compared to first generation HPV vaccines. Papillomavir Res. 2015;1:90-100. 8. LEEP risks:
https://www.acog.org/~/media/For%20Patients/faq110.pdf. Accessed March 16, 2006. 9. HPV 16/18 caused CIN: Bruni L, Barrionuevo-Rosas L, Albero G, et al; ICO Information Centre on HPV and Cancer
(HPV Information Centre). Human Papillomavirus and Related Diseases in United States of America. Summary Report 2015-12-23. http://www.hpvcentre.net/statistics/reports/XWX.pdf. Accessed March 16, 2016.
10. Cervical cancer caused by HPV: US National Cancer Institute. Cervical Cancer Treatment-Patient Version (PDQ®). http://www.cancer.gov/types/cervical/patient/cervical-treatment-pdq. Accessed March 16,
2016. 11. Prophylactic vaccine uptake: http://www.cdc.gov/mmwr/preview/mmwrhtml/mm6429a3.htm. Accessed March 16, 2016.
© 2016 Inovio Pharmaceuticals, Inc., All Rights Reserved.