1. 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. 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
3. 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
4. The Nobel Prize in Physiology or Medicine 2008
Harald Zur Hausen for his discovery of human Papilloma
viruses causing cervical cancer
8. 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
11. 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.
12. 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
13. 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
18. 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.
19. 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.
20.
21. 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
22. 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
24. 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
25. 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
26.
27. 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).
31. 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
32.
33. Proposal
HPV testing HC2 (high risk)
Data base with recalling system
Quality assurance and frequent monitoring
34. 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
35. Age 30-65 year.
Married for three years.
Saudi & non Saudi.
39. 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
47. 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 forYear 2012-2013 Saudi vs. Non-Saudi
Saudi Non-Saudi
50. Guideline meeting for cervical cancer
screening
المركزالسعوديللرعايهالصحيهالمبنيهعلىالبراهين.
Agreed among panel members that HPV testing will be
used as primary screening for cervical cancer in Saudi
Arabia.
