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Saudi – Belgian Collaboration in Health:
Improving Quality of Care: Methodology and Prevention Tuesday, March 18, 2014
Cervical Cancer Prevention in Saudi Arabia
Prof. Khalid Sait
Chairman of Scientific Chair of Prof. Abdullah Hussain Basalamah for
Gynecological Cancer
2 FerlayJ, et al.GLOBOCAN 2008, Cancer Incidence and Mortality Worldwide. IARC CancerBaseNo.10. Lyon, France. 2010
Every 2 minutes a woman dies of cervical cancer.1
Every minute a woman is diagnosed with cervical cancer.1
New cases per year: ~ 530,000
Deaths per year: ~ 275,000
NA + Europe
Africa
Asia
Latina
29,000
53,000
31,000
159,000
77,000
80,000
68,000
312,000
80% in developing countries = 2nd cause of cancer
death in women
Incidence of cervical cancer is low in Saudi Arabia
(2:100,000)
Every year, 152 women are diagnosed with cervical cancer
and 55 die from the disease.
SCR Report 2009
The Nobel Prize in Physiology or Medicine 2008
Harald Zur Hausen for his discovery of human Papilloma
viruses causing cervical cancer
HPV18- Related
45, 39, 59, 51, 56 HPV16- Related
31, 33, 35, 52, 58
Nature Volume: 2012
Author No of patients HPV prevalence
Gazzaz 2007 100 5 (5%)
Bondoggi 2013 485 27 (5.6 %)
1-Ann Saudi Med. 2007 Jan-Feb;27(1):1-5.
2- Saudi Med J. 2007 Dec;28(12)
3-Ann Saudi Med. 2013 Jan-Feb;33
Secondary
Prevention:
Screening
Primary
Prevention:
Vaccination
Normal Cervix
HPV Infection
Cervical Dysplasia
Cervical Cancer
HPV
Cervical canal
Neutralizing antibodies
Blood vessel
Epithelial tear
Basement membrane
Cervical
epithelium
Stanley M. Vaccine 2006; 24:S16–S22;
Giannini S, et al. Vaccine 2006; 24:5937–5949;
Nardelli-Haefliger D, et al. J Natl Cancer Inst 2003; 95:1128–1137;
Poncelet S, et al. IPvC 2007; Abstract.
Cervarix is a registered trade mark of the GlaxoSmithKline group of companies.
Cervarix ®
Antigen Specificity of the immune response
Adjuvant Substances that potentiate the immune
response to antigen
Through MPL, AS04 Adjuvant System utilizes
natural ‘danger’ signals
AS04 Adjuvant System
Aluminium salt + MPL (Al(OH)3)
Giannini SL, et al. Vaccine 2006; 24:5937–5949.
20 µg
L1 HPV 16
20 µg
L1 HPV 18
+
Manufactured in insect vector
Gardasil ® Merck
Gardasil ®
Adjuvant Substances that potentiate the immune
response to antigen
(Al(OH)3)
Manufactured in recombinant Saccharomyces Cerevisiae (yeast)
40 µg
L1 HPV 16
+ 20 µg
L1 HPV 6
40 µg
L1 HPV 11
20 µg
L1 HPV 18
Antigen Specificity of the immune response
Sustained high Antibodies for up to
9.7 years.
Reducing the leep procedure from CIN2+.
Long term is reduction in cancer cervix incidence.
Harper D; Expert Review Vaccines 2009
Gardasil(Merck)
Quadrivalent
Cervarix (GSK)
Bivalent
HPV 45
(related to 18)
V/P 3/2
V/P 1/17
Reduction 94%
HPV 31
(related to 16)
V/P 5/21
Reduction 76%
V/P 14/30
Reduction 54%
No head-head efficacy studies were carried out – those
comparisons are only informative
Gardasil®
Combined protocols Future I, FutureII
R-MITT-2 cohort (EOS* data)1
Lesion Gardasil® Control %Efficacy
(95% CI) N n N n
CIN2+, irrespective of causal HPV type
4616 77 4680 136 42.7
(23.7;57.3)
CIN3+, irrespective of causal HPV type
4616 36 4680 64 43.0
(13.0;63.2)*
Cervarix®
Protocol 008 TVC-naïve cohort (48 months of FU)2
Cervarix® Control %Efficacy
(95% CI) N n N n
5466 61 5452 172 64.9
(52.7;74.2)
5466 3 5452 44 93.2
(78.9;98.7)
* for Gardasil® the endpoint was CIN3 N = number of evaluable women in each group; n = number of evaluable women reporting at least one event in each group; - : not available; Bold = statistically significant.
* The median duration of follow-up for the combined protocols (005, 007, 013, and 015) was 3.6 years after receipt of dose
1 and maximum of 4.9 years.
1. Munoz et al. J Natl Cancer Inst 2010; 102:1–15; 2. HPV-008 Month 48 analysis.
The vaccines do not contain any living virus.
More than 79 million doses of the quadrivalent
vaccine have been distributed globally, with no
serious adverse events found to be associated with
the vaccine and with no greater risk of adverse
events than with placebo.
Approximately 7 million doses of the bivalent
vaccine have been distributed worldwide.
GARDASIL Product Monograph. Merck Canada Inc. August 2011.
CERVARIX Product Monograph. GlaxoSmithKline Inc. August 2011.
Data on file, Merck Canada Inc.
Phase I/II study
2-dose schedules of the Cervarix and Gardasil were
immunogenic and generally well-tolerated in girls aged 9–25
A 2-dose schedule may be more convenient for physicians
and vaccinees, could facilitate implementation of HPV
vaccination and may help optimise compliance in school-
based immunisation programmes
Joura et al. Eurogin Nov 2013
Nonavalent vaccine (Merck)
(HPV6/11/16/18/31/33/45/52/58)
Followed for 4.5 years
Similar immunological responses
Implementation
After given them an education material
about HPV and vaccination , 381/500
(76.2%) were happy with the introduction
of HPV vaccine to our community
Sait , Saudi Med J. 2009
A total of 85/200 (42.2%) will take the vaccine them
selves
A total of 100/200 (50%) physicians will recommend
the vaccine to their patients.
94 /200 (47%) will recommend HPV vaccine to there
daughter
Sait , Saudi Med J. 2011
Education and Awareness
If HPV vaccine will be implemented in Saudi Arabia , it should be as part of the MOH routine vaccination program for all risk group
Currently HPV vaccine in KSA is been given mostly for educated people and those whom can afforded it. (may be low risk group).
Secondary
Prevention:
Screening
Primary
Prevention:
Vaccination
Normal Cervix
HPV Infection
Cervical Dysplasia
Cervical Cancer
PAP smear
HPV testing
Very sensitive
Hybrid Capture (HC2)
No national Screening
If no action taken: The estimated number of
new cervical cancer cases and deaths in 2025
triple (309 and 117, respectively)
http://www.nationmaster.com/country/
sa-saudi-arabia/Age- _distribution
Proposal
HPV testing HC2 (high risk)
Data base with recalling system
Quality assurance and frequent monitoring
Dr. Nisrin Anfinan
Early Detective Unit and
JCSP Coordinator
Rowaida Al Mehy
GOU Secretary
Maribi Marqueses
GOU Office Assistant
Dr. Faten Gazzaz
Director of
Virology Laboratory
Eman Tayba
JCSP Laboratory Team
Aseel Alsobehi
JCSP Laboratory Team
Soheel Melebari
JCSP Laboratory Team
Prof. Jim Bentley
International Advisor
Prof. Khalid Sait
Director of Scientific Chair of
Professor Abdullah Hussain Basalamah
Prof. Abdullah Hussain Basalamah
General Advisor
Amal Al Montasheri
Nurse JCSP
Reem Qubaidi
Health Educator
Age 30-65 year.
Married for three years.
Saudi & non Saudi.
HR-HPV DNA in women 30 + years old
Negative
Pap test
Negative Positive
Positive
Colposcopy
Positive
Repeat HR-DNA
testing @ 5 year
intervals till
age 65
Repeat HR-
HPV testing at
12 months
Negative
Campaign (Malls)
School
(approval from ministry of education)
Media and news papers
BasalamaSCGC Channel
http://www.youtube.com/user/BasalamaSCGC
Collecting sample at PHC
Collecting sample in our hospital
START DATE: January 2012
Total Number: 4000
Our aim to achieve : 10,000 in four years
0
50
100
150
200
250
300
350
400
Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec
138
210
260
344
294
144
38
78
254
292
390 364
New Registration for Year 2012-2013
0
50
100
150
200
250
300
Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec
102
138 134
264
224
112
18 30
108
216
254 254
36
72
126
80 62
32 20
48
146
76
136 148
New Registration for Year 2012-2013 Saudi vs. Non-Saudi
Saudi Non-Saudi
0
100
200
300
400
500
600
30-34 35-39 40-44 45-49 50-54 55-59 60-64 ≥65
302
416
522
576
512
322
122
34
Per Age Group Year 2012-2013
National
Cervical
Screening
Program
Guideline meeting for cervical cancer
screening
.البراهين على المبنيه الصحيه للرعايه السعودي المركز
Agreed among panel members that HPV testing will be
used as primary screening for cervical cancer in Saudi
Arabia.
Official opening of the JCSP program January
2014
Affects young
women and their
families Al though not common
in KSA, incidence will
rise as it has done in
other areas
Screening
Program
