Cervical Cancer Prevention UPDATE ON H.P.V. vaccination

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Cervical Cancer Prevention
UPDATE
ON H.P.V. vaccination
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NARENDRA MALHOTRA
JAIDEEP MALHOTRA
GLOBAL RAINBOW HEALTH
CARE,INDIA
mnmhagra3@gmail.com

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Why vaccinate girls ?
• Vaccination before during and after
pregnancy helps protect girls from serious
infections .
• It can also help in improving the women’s
health in general .
• It is an important preventable measure which
should be adopted rationally

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Vaccination in women
Prof Girija Wagh
AT BIRTH : AT CHILDHOOD : AT ADOLESCENCE : AT REPRODUCTIVE AGE : AT PERIMENOPAUS :AT MENOPAUSE

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What is Cancer?
• Cancer is the uncontrolled growth of certain
cells in the body, causing tumors or growths.
• Not all growths are cancer.
• Those cells which may spread to other parts of
the body and can interfere with normal
functions are called cancer.
WHO Book - Comprehensive cervical cancer control : a guide to essential practice.

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What is Cervical Cancer?
•It is cancer that begins on the
cervix, which is the mouth of
the uterus.

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What is Cervical Cancer?
Cells on the cervix begin to grow abnormally and sometimes, if they are not treated, they
become cancer.
However, these early changes can disappear on their own, without causing problems.

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Cervical Cancer disease burden in India
1,22,844 New cases annually
2nd Common cause of
female cancer
2nd
Most common female cancer
in women aged 15-44 years
• India has a population of 436.76 million women aged 15
years and older who are at risk of developing cervical cancer.
• India accounts for ~ 1/4th of Cervical cases and deaths
worldwide
Bruni L, Barrionuevo-Rosas L, Albero G, Serrano B, Mena M, Gómez D, Muñoz J, Bosch FX, de Sanjosé S. ICO Information Centre on HPV and Cancer (HPV Information Centre). Human
Papillomavirus and Related Diseases in India. Summary Report 19 April 2017. [Accessed on 18th May 2017]

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Cervical Cancer mortality in India
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67,477
Deaths
Annually
Approx. 185 women die every day
A women is dies every 8 minutes
Approx. 8 women die every hour
2nd Cause in female cancer deaths and 2nd leading cause of
cancer deaths in women aged 15-44 years

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Mortality Rate compared to other
cancers in Indian women

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Cervical Cancer … catches em young
3/28/2019 10
Learning
Point
*US data
Surveillance, Epidemiology and End Results: https://seer.cancer.gov/

11
11
*Ray K et al, Indian J Med Res 2006; 124: 559-56 - done in STD clinic
18.1%
5.8%
11% 10.5%
0
2
4
6
8
10
12
14
16
18
20
1990-93 1994-97 1998-01 2002-04
Study Period
Percentage
Genital Warts – Disease Burden: India*
There is an increasing trend of Genital
warts incidence in India
In approximately
10 years time the
incidence of GW
have increased 3
times

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Diagnosis of GW was strongly related to Anal,
Vulvar, Vaginal, Cervical and Head & Neck cancer
with confirmed HPV association
Standardized Incidence Ratios (SIRs) of Cancer among women (n = 33,422) diagnosed of GW in Denmark during 1978–2009
2.8
1.5
5.9
7.8
14.8
4.7 4.8
0
2
4
6
8
10
12
14
16
All HPV
related
cancers
Cervix
uteri
Vagina Anus Vulva Tonsils HPV
Associate
d HNC
StandardizedIncidence
Ratios(SIRs)
CI: 2.4- 3.1 CI: 5.5- 9.2 CI: 2.2-12.9 CI: 5.4- 11.0 CI: 11.7-18.6 CI: 2.3-8.4 CI: 2.7-8.0
Blomberg, Friis, Munk et al, Genital Warts and Risk of Cancer: A Danish Study of Nearly 50 000 Patients With Genital Warts, JID, 2012

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What causes Cervical Cancer?
• Cervical cancer is caused by infection with a virus
called human papillomavirus or HPV.
– Approximately 15 to 20 high-risk types are associated
with cancer
– Approximately 10 to 15 low-risk types associated with
genital warts and other benign lesions.
• Most of the time, HPV infection disappears
without treatment; sometimes, however, HPV
stays in the cells for years and, in some women,
eventually causes cervical cancer.
Centers for Disease Control and Prevention.[Quadrivalent Human Papillomavirus Vaccine Recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR 2007;56[Early Release]:[1-24]

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HPV 16
HPV 18
HPV 6
HPV 11
Cancer causing Types1,2,4 Non-cancer causing types1,2
• >75% of Cervical Cancer5,6
• >50% of Vaginal & Vulvar Cancer5
90% of Anogenital warts5
HPV is a necessary cause of cervical cancer – 99.7%4
HPV
1.Schiffman M, Castle PE. Arch Pathol Lab Med. 2003;127:930–934. 2. Wiley DJ, Douglas J, Beutner K, et al. Clin Infect Dis. 2002;35(suppl 2):S210–S224. 3. Muñoz N, Bosch FX, Castellsagué X, et al. Int J Cancer.
2004;111:278–285. Reprinted from J Virol. 1994;68:4503–4505 with permission from the American Society for Microbiology Journals Department. 4. Walboomers JM, Jacobs MV, Manos MM, et al. J
Pathol. 1999;189:12–19. 5. X. Castellsagué, S. de Sanjose, T. Aguado, K. S. Louie, L. Bruni, J.Muñoz, M. Diaz, K. Irwin, M. Gacic, O. Beauvais, G. Albero, E. Ferrer, S. Byrne,F. X. Bosch. HPV and Cervical
Cancer in the World. 2007 Report. WHO/ICO Information Centre on HPV and Cervical Cancer (HPV Information Centre). Available at: www.who.int/hpvcentre6. Bhatla N et al.Vaccine (2008;26; 2811-17
What causes Cervical Cancer?

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Cervical cancer and HPV infection
• Human papillomavirus (HPV) infection is now a well-
established cause of cervical cancer. HPV causes
virtually 100% of cervical cancer cases
• There is growing evidence of HPV being a relevant
factor in other anogenital cancers (anus, vulva,
vagina and penis) and head and neck cancers.
• HPV is also responsible for other diseases such as
recurrent juvenile respiratory papillomatosis and
genital warts
Bruni L, Barrionuevo-Rosas L, Albero G, Aldea M, Serrano B, Valencia S, Brotons M, Mena M, Cosano R, Muñoz J, Bosch FX, de Sanjosé S, Castellsagué X. ICO Information Centre on HPV and Cancer (HPV
Information Centre). Human Papillomavirus and Related Diseases in India. Summary Report 2015-12-23. [Accessed on 2016-04-20 from http://hpvcentre.net/statistics/reports/IND.pdf]

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Cervical cancer and HPV types
• HPV types 16 and 18 are responsible for about 70% of all
cervical cancer cases worldwide. After HPV16/18, the six
most common cervical cancer causing HPV types are 31,
33, 35, 45, 52 and 58
• In India 82.7% of invasive cervical cancers are attributed
to HPVs 16 or 18.
• In India about 5.0% of women in the general population
are estimated to harbor cervical HPV-16/18 infection at a
given time
• HPV types 6 and 11 are responsible for over 90% of all
anogenital warts
Bruni L, Barrionuevo-Rosas L, Albero G, Aldea M, Serrano B, Valencia S, Brotons M, Mena M, Cosano R, Muñoz J, Bosch FX, de Sanjosé S, Castellsagué X. ICO Information Centre on HPV and Cancer (HPV
Information Centre). Human Papillomavirus and Related Diseases in India. Summary Report 2015-12-23. [Accessed on 2016-04-20 from http://hpvcentre.net/statistics/reports/IND.pdf]

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How HPV is transmitted?
• Sexually Transmitted
– Genital skin to skin contact
• Non Sexually Transmitted
– Mother to Child
– Fomites

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Who is at risk of cervical cancer?
• Young age at first sexual intercourse
• Greater number of lifetime and recent sex
partners
• Sex with a new partner
• Male partner sexual history
• In addition to sexual behavior, other potential
risk factors include
– smoking,
– oral contraceptive (OC) use
– nutritional factors

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What are the signs of cervical cancer?
• Early cervical cancer usually has no signs, which is why
screening is so important.
• Signs of cancer are:
– vaginal spotting or bleeding after sexual intercourse,
between menstruations, or after menopause, and
– foul-smelling discharge that does not go away even
with treatment

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How is Cervical Cancer diagnosed?
Screening
• It is a test done on people who are healthy and without
symptoms,
– to identify those with a higher chance of getting a particular
disease.
• A cervical cancer screening test can determine if a cervix is
normal or not.
• It can detect early signs of disease before a woman has
symptoms, when treatment can prevent the disease from
developing.

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What exactly is done during
screening?
• The most common screening test is
the Papanicolaou (Pap) smear.
– Physician will do a genital
examination to look at the
cervix, collect a sample of cells
from your cervix, and send it to
the laboratory to be examined.
• Other tests are sometimes used to
screen for cervical cancer,
– such as looking at the cervix
after putting Vinegar/Lugol’s
Iodine on it (VIA or VILI)

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DIAGNOSIS
1.Colposcopy and acetic
acid test
2.Biopsy
3.DNA test (PCR, Southern
Blot Hybridization, In Situ
Hybridization)
4.Pap smear (LBC)(DIRECT
TO SLIDE)

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Can Cervical Cancer be treated?
• Most cervical cancer can be successfully
treated if it is found early.
• In middle aged women who have never been
screened,
– cancer may be discovered late, when it has
already spread beyond the cervix and is more
difficult to treat.

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Treatment Options
Treatment
Options
Surgery Radiation Chemotherapy
Ablative
1. Cryosurgery
2. CO2 Laser Beam
Excisional Procedure
1. LEEP
2. Conization
3. Hysterectomy
4. Exenteration

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Can Cervical Cancer be prevented?
• Yes, cervical cancer can be prevented by
– Education
– Screening
– Vaccination

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Cervical Cancer - Prevention

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• The definitive cause of cervical cancer is primarily due to high risk HPV infection.
• The disease takes a long time to develop after initial infection.
• Unlike most other types of cancer, it is preventable when precursor lesions are
detected early and treated.
• Therefore, screening can reduce both the incidence and mortality of cervical
cancer.
Preventable?- YES
Educating and
empowering women
to prioritise their
health
Informing and educating
their families on
importance of proactive
screening

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2 Prevention strategies
Screening:
• Well-organised cervical screening programmes or
widespread good quality cytology can reduce cervical
cancer incidence and mortality.
• However, competing health care priorities, insufficient
financial resources, weak health systems, and limited
numbers of trained providers have made high coverage
for cervical cancer screening in most low- and middle-
income countries difficult to achieve.
Vaccination:
• The introduction of HPV vaccination has considerably
reduced the burden of Cervical cancer.
1. Bruni L, Barrionuevo-Rosas L, Albero G, Aldea M, Serrano B, Valencia S, Brotons M, Mena M, Cosano R, Muñoz J, Bosch FX, de Sanjosé S, Castellsagué X. ICO Information Centre on HPV and Cancer (HPV Information Centre). Human
Papillomavirus and Related Diseases in India. Summary Report 2015-12-23. [Accessed on 2016-04-20 from http://hpvcentre.net/statistics/reports/IND.pdf]; 2. WHO guidance note: comprehensive cervical cancer prevention and control: a

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ONLY SYMPTOMATIC
WOMEN ATTEND
LIMITED ACCESS TO
SERVICES DUE TO
GEOGRAPHIC LOCATION
LACK OF INSURANCE
PSYCHOLOGICAL AND
SOCIAL BARRIERS
LACK OF AWARENESS
LACK OF FOLLOW UP

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HPV Vaccination – Let’s Talk Right

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That’s why we are here to learn
3/28/2019 31
What to talk ?
How to talk ?
Whom to talk ?

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25 MN
adolescent female population
awaiting for your attention
3/28/2019 32
Census 2011 (https://www.census2011.co.in...as accessed on 25/05/2018)
Definition for healthcare expenditure clusters as per Mckinsey & Company; India
Healthcare: Inspiring Possibilities , challenging journey report; Dec 2012

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Why is it important that we talk about
adolescent* HPV immunization?
3/28/2019 33
*https://www.britannica.com/science/adolescence…as accessed on 22/6/2018
Age group referred as adolescent : 10-19 years

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We counsel, persist
immunization for him/her
We are happy to help them
with flu shots
3/28/2019 34

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Total Population: 1210
MN1
Total Male Population: 623 MN Total Female Population: 586 MN
51.5% 48.4%
Female Adolescent Population: 120 MN
20 %
Let us quantify now…
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Urban Female Adolescent Population: 25 MN
16 %
Census 2011 (https://www.census2011.co.in...as accessed on 25/05/2018)
Definition for healthcare expenditure clusters as per Mckinsey & Company; India
Healthcare: Inspiring Possibilities , challenging journey report; Dec 2012

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IAP supports adolescent vaccination as well
Routine:
– Tdap
– HPV
High risk group:
– Influenza
– Pneumococcal
– Meningococcal
– Cholera
– Japanese encephalitis
– Rabies
VM Vashishtha etal - Indian Academy of Pediatrics (IAP) Recommended Immunization Schedule for Children Aged 0 through 18 years — India, 2016 and
Updates on Immunization3/28/2019 36

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3/28/2019 37
Let us peep into the
Future Of
Immunization

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Make a Vaccine Wish List
3/28/2019 38
• HIV
• HSV
• GC
• RSV
• Chlamydia
• Group B Strep.
• Group A Strep.
• Staph. aureus
• Tuberculosis
• HCV
• Malaria
• Prostate cancer
• Breast cancer
Dr Kenneth Alexander – Meet the experts session in Delhi, 28th March 2018. Data on file MSD.

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How many of these are
related to sexual
behavior?
3/28/2019 39
Which of these
vaccines would have
been for teenagers?
• HIV
• HSV
• GC
• RSV
• Chlamydia
• Group B Strep.
• Group A Strep.
• Staph. aureus
• Tuberculosis
• HCV
• Malaria
• Prostate cancer
• Breast cancer
• HIV
• HSV
• GC
• RSV
• Chlamydia
• Group B Strep.
• Group A Strep.
• Staph. aureus
• Tuberculosis
• HCV
• Malaria
• Prostate cancer
• Breast cancer
Probably all Some of them

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Cervical Cancer … catches em young
3/28/2019 40
Learning Point
*US data
Surveillance, Epidemiology and End Results: https://seer.cancer.gov/

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Why is vaccinating the younger better?
3/28/2019 41

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Why is it best to immunize
adolescents at age 11-12 years?
3/28/2019 42

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Immunizing before exposure can give
per-protocol efficacy
1. HPV vaccines are preventive
Dr Kenneth Alexander – Meet the experts session in Delhi, 28th March 2018. Data on file MSD.3/28/2019 44

45
3/28/2019 45
2. A dose delayed is a dose
that may not get given

46
.
9 10 11 12 13 14 15 16 17 18 19 20 21 22 23
Age at Enrollment (Years)
500
700
900
1100
1300
1500
1600
SerumcLIAGMTWith
95%CI,mMU/mL
Adolescent Females Young Adult Females
Serum anti-HPV 6 responses 1 month after completion of
vaccination regimen
Per-protocol immunogenicity population (ages 9–26)a
aInclusive of protocols 007, 013, 015, 016 and 018; all GMTs measured using competitive Luminex® immunoassay;
women 24–26 years of age were omitted in the figure because of small numbers. Similar results were observed for HPV 11, 16, and 18.
GMT = geometric mean titer. (Ref in the slide note)3/28/2019
46
3. Higher immune response in
Adolescents vs Young adults

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**Gardasil is approved to be used as a two dose regimen in 9-14 year old girls
Gardasil PI
3/28/2019 47
4. Cost of immunization is
less in most of the adolescents
who just need 2 doses**

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5. Young adolescents
are still in our care

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Why Vaccination?
• HPV vaccines are highly effective at preventing the
infection of susceptible women with the HPV types
covered by the vaccine.
• HPV vaccine should be given to females before they
reach an age when the risk of HPV infection increases
and they are at subsequent risk of cervical cancer.
• HPV vaccine should be ideally given to 10-12 year old
girls as per the IAP recommendation. FOGSI
recommends HPV vaccination at various stages of a
woman's life starting from 9 to 45 years of age
• HPV vaccine is given as 2/3 doses (depending on the
age of recipient) over a period of 6 months.
The ‘Green Book’ chapter on Human papillomavirus (HPV)

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Immunization is just a hook to start communication with
adolescent about many other issues and get them to the
clinic
3/28/2019 50
Learning Point
LetusimmunizeagainstcervicalcancerNOW

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3/28/2019 51
Who should immunize –
ObsGyns or Pediatricians?

52
Obstetricians
Gynecologists
– Understand and own the disease
– See adult women
But,
– Don’t see younger adolescents
– Surgery is a priority, immunization is
not
– Lack infrastructure and
understanding of cold chain mgmt
Pediatricians– No ownership of the disease
But,
– See younger adolescents
– See babies with young
mothers, who can be
immunized too
– Immunization is the priority

53
The Cervical cancer vaccines available
in India
qHPV & bHPV

54
Important differences
Quadrivalent Bivalent
HPV Types
Indicated age and
gender
Female 9-45 years old
Female 10-45 years
old
Indicated for
preventing…
Cervical cancer,
Vulvar cancer,
Vaginal cancer,
Genital warts
Cervical cancer
1. Villa LL, Costa RLR, Petta CA, et al. Lancet Oncol. 2005;6:671–678. 2. Harper DM, Franco EL, Wheeler C, et
al. Lancet. 2004;364:1757–1765.
2. PI of gardasil and Cervarix
6 11 16 18 16 18

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If we vaccinate them early in adolescence
will immunity last long?
3/28/2019 55

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Quadrivalent HPV vaccine
• Offers protection against four HPV types
• Indicated for preventing cervical, vaginal and
vulvar cancers and genital warts
• Can be given to girls as young as 9 years
• Not associated with any serious vaccine
related adverse affects

57
Do these vaccines offer protection against
any non-vaccine HPV types?
Cross-Protection??

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Cross Protection
• Both the vaccines are supposed to protect against the
infection caused by the HPV types included in them
(QHPV against types 6, 11, 16 & 18 and bHPV against
types 16 & 18).(Bivalent againt 16-18)
• Cross protection is when the vaccines offer protection
against any other HPV types which were not included in
the vaccine.
• Both vaccines have shown certain degree of cross
protection against non-vaccine HPV types. But the
clinical significance and longevity of this cross
protection are unclear.
World Health Organization: Weekly epidemiological record - 24 OCTOBER 2014, 89th YEAR / 24 OCTOBRE 2014, 89e ANNÉE
No. 43, 2014, 89, 465–492

59
Potential new vaccines in
development
• To increase the protection conferred by HPV
vaccines, a vaccine has been developed in
which the number of HPV types is increased to
9 by the addition of types 31, 33, 45, 52 and
58 to the quadrivalent vaccine.
• Vaccine based on the HPV L2 viral capsid
protein.

61
The recommendations
WHO
IAP
FOGSI
CANCER ASSOCIATIONS

62
SAGE = Strategic Advisory Committee of Experts; WHO = World Health Organization.
1. World Health Organization. Wkly Epidemiol Rec. 2009;84:1–16.
Vaccination is most effective when given to females naïve to
infection with vaccine-related HPV types
Primary target population is likely to be girls 9 or 10 through
13 years of age
WHO SAGE Recommendations: Primary
Target Population for Vaccination1

63
The Indian Academy of Pediatrics
recommends early HPV vaccination
VASHISHTHA, Indian Academy of Pediatrics (IAP) Recommended Immunization Schedule for Children Aged 0 through 18 years — India, 2016 and
Updates on Immunization

67
HPV vaccination
• FOGSI recommends HPV vaccination in all adolescents for
protection against cancer cervix.
• 2.2.1 This is best given as early as the age of 9 years or before
commencement of sexual activity .
• 2.2.2 Catch up vaccination is recommended in case of incomplete
vaccination.

68
FOGSI Initiative: Vaccination in women
http://www.fogsi.org/images/stories/pdf/vaccination_women.pdf

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Adolescent vaccination: summary
• Adolescent females may have increased susceptibility
to HPV infection, compared with adults
• Exposure to HPV at a Young Age Increases the Risk of
Cervical Lesions and Cancer
• Studies have shown that early qHPV vaccination is
effective and safe
• Population based/national HPV immunization
programs have shown significant reduction in the HPV
infection and disease burden
• Organization like WHO, FOGSI, IAP recommend early
HPV vaccination

70
Cervical Cancer Awareness Level!
• People may not be aware of the tremendous
burden of disease and magnitude of the problem
caused by cervical cancer.
• People may lack accurate information on its
natural history, detection and treatment.
• Many women and men have not heard of cervical
cancer and do not recognize early signs and
symptoms when they occur.
• Women at risk may not be aware of the need to
be tested, even when they do not have any
symptoms.

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Cervical Cancer Prevention
starts in the adolescence
ADOLESCENT CLINICS
71

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ACE10/10 (Adolescent Care Endeavor)
1. http://health.economictimes.indiatimes.com/news/policy/indian-academy-of-paediatrics-launches-ace-10/10-healthcare-initiative-for-adolescents/50923836

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SPOT CANCER STOP CANCER
INITIATIVE
NEWER SCREENING TECHNOLOGY TO
BE ADOPTED AT THE CANCER CLINICS
V.I.A/CONVENTIONAL PAP/L.B.C.

75
What is FOGSI doing about this ?
2018
AKSHAY JEEVAN INITIATIVE
Launched at VARANASI as a pilot project to screen 50 thousand
women and vaccinate 1000 girls 2 doses of bivalent vaccine
provided by UP GOVT
And supported by ASIAN ECONOMIC FORUM
FOGSI is conducting the programme thru already established
GOVT centres SAMPOORNA CLINICS and practisioners (FOGSI
MEMBERS)
2019
WE FOR STREE INITIATE
WOW INITIATIVE
WALKATHON FOR CANCER PREVENTION
AWARENESS IN SCHOOLS AND COLLEGES
RECOMMENDATION TO GOVT OF INDIA

76
Key Points
• Cervical cancer is one of the leading causes of
cancer death in Indian women.
• The primary underlying cause of cervical
cancer is infection with human papillomavirus
(HPV), a very common virus.
• Most HPV infections resolve spontaneously;
those that persist may lead to the
development of precancer and cancer.

77
Key Points
• It usually takes 10 to 20 years for lesions caused
by HPV to develop into cancer.
• Over 80% of women newly diagnosed with
cervical cancer live in developing countries; most
are diagnosed when they have advanced disease.
• If left untreated, cervical cancer is almost always
fatal.
• HPV vaccines are highly effective at preventing
the infection of susceptible women with the HPV
types covered by the vaccine

Cervical Cancer Prevention UPDATE ON H.P.V. vaccination

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