CERVICAL CANCER

Cervical cancer - major public health problem in SEAR countries About 10.9% of the Asian women are estimated to harbour cervical HPV infection 190,000 new cervical cancer cases every year in SEAR 35% of the global burden of the disease Two-pronged strategies for prevention - HPV vaccination - population based organized cervical cancer screening.

None of the SEAR countries have effective screening programs due to resource and logistic constraints Develops slowly over 10 to 15 years Human Papillomavirus (HPV) infection, HPV 16 and 18 most common high risk types implicated in 65-80% of cervical cancers

Prevention levels
Primary Prevention HPV Vaccination

Secondary Prevention- Detection and treatment of the disease at the HSIL stage through cervical cancer screening
Tertiary Prevention treatment of invasive cervical cancer and palliative care

Components of cervical cancer control Preventive strategies Treatment of invasive cancer Palliative care Success of the cervical cancer control program depend on pragmatic selection of service delivery models good centralized control system of quality assurance.

Objective
To guide and assist member countries to develop or strengthen their national strategies to improve cervical cancer control activities reduce the burden of morbidity Reduce disability and deaths from cervical cancer promote womens health.

Objectives of Framework
Introduce or scale up delivery of HPV vaccine to girls between 9 to 13 years of age through a coordinated multi-sectoral approach involving national programs of immunization, cancer control, reproductive and adolescent health Implement or scale up organized cervical cancer screening program utilizing evidence based, cost-effective interventions through effective service delivery strategies across the different levels of health care Strengthen health systems to ensure equitable access of all eligible women to cervical cancer screening services, with particular attention to the socio-economically disadvantaged population groups.

Objectives of Framework
Augment management facilities for invasive cancer and introduce palliative care services as part of comprehensive cancer control program Bring convergence of related health programs to ensure a coordinated and operationally feasible approach for cervical cancer control within the health system

Estimated Female Population

Country Estimated Female Population (in thousands) in single age cohorts (9-13 years) 9 year Bangladesh Bhutan DPR Korea India Indonesia Maldives Myanmar Nepal Sri lanka Thailand Timor-Leste
1,529 7 174 11,853 2,174 3 389 360 175 465 16

10 years 1,549 7 178 11,790 2,177 3 392 363 171 473 16

11 years 1,558 7 181 11,752 2,162 3 399 364 166 478 16

12 years 1,559 7 186 11,733 2,135 3 407 362 161 481 16

13 years 1,556 7 190 11,722 2,102 3 416 360 156 484 16

Cervical Cancer Incidence And Mortality

Country Cervical Cancer Incidence Cervical Cancer Mortality Source of Incidence & Mortality Data No. of cases/yr ASR (/100,000) No. of deaths/yr ASR (/100,000) Bangladesh 17686 29.8 10364 17.9 No PBCR; Hospital based data Bhutan 50 DPR Korea India 134420 20.4 942 26.9 13762 6434 32.4 1395 27 6.6 72825 12.7 26.4 1872 11.8 24.5 10.9 518 15.2 7493 3536 17.6 814 5216 No PBCR; Hospital based data 3.3 No PBCR; Hospital based data PBCR in select areas (<5% population covered) 7.0 15.0 No PBCR; Hospital based data No PBCR; No data No PBCR; Hospital based data

Indonesia Maldives Myanmar Nepal 3504 Sri lanka

No PBCR; Hospital based data 6.9 No PBCR; Hospital based data 12.8 PBCR in select areas (~40% No PBCR; No Data

Thailand 9999 population covered) Timor-Leste -

CERVICAL CANCER CONTROL INITIATIVES

Bangladesh
National Cervical Cancer Screening Program launched in 2005. Recommended screening of women aged 30 years or above by VIA at an interval of 3 years. A national Coordinating Center set up at Bangabandhu Seikh Mujib Medical University, Dhaka is responsible for training of all service providers, setting up screening and colposcopy centers across the country, ensuring steady supply of consumables and monitoring and evaluation of the program. VIA services set up Initially in the district hospitalS, subsequently expanded to the subdistrict and rural health centers Currently screening offered at 57 district hospitals, 61 maternity clinics, 70 sub-district hospitals and 50 rural health centers across the country. Nurses and gynaecologists trained to perform VIA.

Bangladesh
Referral centers for colposcopy and treatment set up at the Medical College hospitals maintaining a linkage with screening centers. Colposcopy and treatment are performed by trained gynaecologists and nonspecialist clinicians.

If high grade lesions are suspected on colposcopy, immediate treatment offered (see and treat) without waiting for histology confirmation.
Nearly 100,000 women screened every year and the VIA positivity is consistently around 5%. HPV vaccines are licensed in the country for opportunistic vaccination. No population based cancer registry in the country.

BHUTAN
Pilot project on cervical cancer screening was initiated in 2002. Recommended screening of 20 to 60 year old women using Pap smear cytology and referral of all positives to one designated colposcopy center.

DRAWBACKS
Pap smear was of suboptimal quality (high rate of unsatisfactory smears) long reporting time for pap smears. loss to follow up was high with very few cytology positive women attending the colposcopy center. The program scaled up in 2005 by establishing new cytology laboratories and recruiting more trained cytotechnicians and pathologists & centers with colposcopy and treatment facilities program remained ineffective due to lack of sustained motivation of the staff, irregular supply of the consumables and low participation rates. Recently VIA by nurses mobile outreach approach introduced. The screening program is still opportunistic with low uptake and reaching the women in geographically remote areas is a major challenge.

BHUTAN
February 2011- quadrivalent vaccine introduced in the national immunization program.

Every year all the girls reaching the age of 12 years are being vaccinated

There is no population based cancer registry in the country.

DPR KOREA
Pilot project has been launched to screen women between 30-55 years by VIA The Family Health Doctors during their home visits counsel and motivate eligible women to undergo screening. VIA will be done in the rural Hospitals and district/county hospitals by the nurses and gynecologists. Colposcopy and biopsy will be arranged at the Provincial Hospitals where the specialist gynecologists will be trained to do the procedures. The HPV vaccines are not available

There is no population based cancer registry.

INDIA
No organized cervical cancer screening program . Pap smear cytology facilities available in select laboratories National guideline for cervical cancer screening drafed in 2005. Recommendations were to screen women between 30 to 59 years using VIA and to set up a two-tier system to perform screening at the primary health centers and colposcopy at the district hospitals The need of the hour is drafting of a pragmatic operational guideline to integrate screening in the health facilities, augment capacity of health system to make screening and colposcopy services accessible to women train a critical number of health care providers to deliver the services. - Both bivalent and quadrivalent vaccines are licensed in India but administered only to those who pay from their own pocket - Well-organized population based cancer registries in several provinces under the National Cancer Registry Program but still population covered is less than 5%

INDONESIA
National Cervical Cancer Screening Program launched in 2007 Objective - To screen 30 to 50 year old women every 5 years. The Cervical and Breast Cancer Prevention (CECAP) Project. Single visit approach by VIA followed by cryotherapy of the VIA positive women was evaluated.

Services are grossly inadequate for the large target population and lot of investment is required.
Both the HPV vaccines are available in the private market and are considered too costly to be considered for the national immunization program. School based vaccine delivery services - very successful in achieving high coverage of other childhood vaccines. The existing health promoting schools (UKS) and adolescent friendly health services (PKPR) program targeted towards boys and girls aged between 6 to 19 years of age provide great opportunities for introduction of the HPV vaccines. There is no population based cancer registry, only hospital based cancer registries exist in 23 teaching hospitals.

MALDIVES
There is no radiation therapy facility

Currently only one tertiary care hospital in the capital city of Male has a laboratory equipped to process and read pap smear cytology.
Pap smears are advised only to women suspected to have cervical cancer and is rarely followed up with colposcopy.

A pilot cervical cancer screening project is being planned to be implemented in Male and another province.
Women between 30 to 50 years of age will be screened by VIA to be performed by the trained nurses. VIA positive will be referred to the tertiary hospitals where colposcopy units will be set up.

There is no plan to introduce the HPV vaccines in the national immunization program in the near future.
There are no population based or hospital based cancer registries

MYANMAR
High burden of cervical cancer lack of any organized screening program. National Cancer Control Program was launched in 2008 HPV vaccines are available in the private sector. A policy of introduction of new vaccines in the National Immunization Program drafted in 2012 and accepted by the Ministry of Health advocated HPV vaccine, though as a second priority. financing and ensuring the logistics for a three dose vaccine are challenges for the future HPV vaccination program. There are no population based cancer registries.

NEPAL
The National Guideline for Cervical Cancer Screening and Prevention drafted in 2010 recommendation - VIA as the screening test and single visit approach (VIA followed by cryotherapy of the VIA positive women in the same sitting To screen women between 30 to 60 years at least once in the next 5 years screening services presently are more community oriented and additional midwives and nurses have been trained to do VIA. A group of medical officers and gynecologists have been trained in colposcopy and management of cervical precancers. A linkage between the screening centers and hospitals offering colposcopy services have been created and efforts are on to connect the cervical cancer screening database to the Medical Information System. Nepal Network for Cancer Treatment and Research (NNCTR) initiated vaccination of small cohorts of 12 to 14 year old girls every year starting from 2008 with funding support from Australian Cervical Cancer Foundation. Lack of regular power supply makes maintenance of cold chain a challenging task. There is no population based cancer registry in the country.

SRILANKA

Screening program is predominantly opportunistic with certain components of organized screening program A Guideline for Cervical Cytology Screening and Reporting in Sri Lanka was formulated in 2010 Recommendation - once in a life time screening using conventional Pap smear cytology for the women of 35 years of age more than 800 Well Woman Clinics (WWC) Every year more than 100,000 women have pap smear. There is a 6-8 weeks of lag period between smear taking and delivery of reports. 20 colposcopy centers at the provincial hospitals or tertiary Institutes. Drawbacks - No linkage between the WWCs with the Colposcopy centers Lack of system of proper monitoring and quality assurance Both bivalent and quadrivalent vaccines are available, no immediate plan to introduce the vaccine the national immunization program. Hospital based cancer registries present, no population based cancer registry.

THAILAND
National Cervical Cancer Screening Program was launched in 2005 Target age for screening is 30 to 60 years. The Department of Health is responsible for screening of women using VIA in select districts and the Department of Medical Services is responsible for screening women with pap smears linkage between screening and colposcopy services and developing a mechanism of identifying the non-compliant women Records entered in a computerized screening registry

Single visit approach (cryotherapy for VIA positive women) is followed in places where women are screened by VIA.
Population based cancer registries present

TIMOR LESTE
No population based cervical cancer screening program.

Pap smear cytology is performed only on symptomatic patients and is of uncertain quality.
There is no facility for colposcopy and management of cervical cancer precursors by cryotherapy or LEEP. Pap smear abnormalities are managed by hysterectomy. No radiation therapy facility

No population or hospital based cancer registry.

PRIMARY PREVENTION
The vaccination is most effective if administered prior to sexual debut and exposure to HPV infection. Recommended age - 9 to 13 year old girls Vaccinating a single age cohort within the target age range - a cost-effective approach key factors for the success of the program. High coverage of the target population Adherence to the three dose schedule - Cost of the vaccines is a major limitation - Eligible to procure the vaccines through Global Alliance for Vaccine & Immunization (GAVI Alliance) at a much subsidized cost

School Based Vaccination- Involve the parents and obtain their explicit consent Health Centre Based Vaccination Procurement and Logistics - program managers are expected to regulate the vaccine procurement, supply chain, temperature monitoring, storage and transport capacities, and report regularly on progress against targets, stock levels and wastage rates. Capacity Building - Orientation training and supervision of the existing staff are critical components of a delivery strategy. Specified funds for preparation of manuals and training materials. The vaccinated population will also need screening in future, since nearly 30% of all cervical cancers are caused by HPV types not targeted by the currently available vaccines

Cervical cancer control activities

Countries Cervical Cancer Screening HPV Vaccination Nature of Program Screening test used Recommended target Population Coverage achieved Link between screening & treatment Nature of program Target age Funding source Bangladesh Opportunistic with good central coordination VIA 30 yr and above Low Good, through see and treat approach Only opportunistic vaccination NA NA Bhutan Opportunistic Pap, VIA 20 -60 yrs Insignificant Poor Part of National Immunization 12 yrs External donation DPR Korea NIL. Pilot planned VIA for pilot 30-55 yrs NA Vaccine not available NA NA India Opportunistic. Few pilot studies Pap, VIA, HPV 30-59 yrs Insignificant NA Only opportunistic vaccination NA NA Indonesia Opportunistic. Few pilot studies VIA 30-50 YRS Insignificant Good in places where screen & treat approach followed Only opportunistic vaccination NA NA Maldives Opportunistic Pap Not defined Insignificant NA Vaccine not available NA NA Myanmar Opportunistic Pap Not defined Insignificant NA Only opportunistic vaccination NA NA Nepal Opportunistic VIA, Pap 30-60 yrs Insignificant NA Small number vaccinated each year 12-14 Yrs External donation Sri lanka Opportunistic with good central coordination Pap 35 yrs High Poor Only opportunistic vaccination NA NA Thailand Opportunistic with good central coordination Pap, VIA 30-60 yrs High Good in places where screen & treat approach followed Only opportunistic vaccination NA NA Timor-Leste NA Opportunistic Pap NA Not defined Insignificant NA Vaccine not available

Monitoring & Surveillance

Two key indicators for performance monitoring : Vaccination coverage - in terms of proportion of girls in the target age group vaccinated and proportion of vaccinated girls received all three doses of the vaccine. Disease surveillance data (data on reduction of the disease burden targeted by the vaccines Linking up the vaccine database to a cancer registry will provide information on the vaccine efficacy in prevention of cervical cancer in the long run. Continued surveillance to detect and report side effects and complications of the new vaccine is most crucial.

Key Strategic Directions to Introduce HPV Vaccine in National Immunization Program

Strategic Direction 1: Define the target population The vaccine should be given to girls only until there is a new recommendation for vaccinating the boys The countries can decide to vaccinate initially all girls in the age group of 9 to 13 years and then fix one specific age at which girls will be vaccinated every year Vaccinating a single age cohort considered most accessible to the school-based health program or the health facilities is also acceptable Strategic Direction 2: Arrange for Sustainable Financing Sustainability should be ensured prior to launch of nationwide program The member countries eligible for donations from GAVI Alliance may approach the Alliance for initial support to the program The startup cost for introduction of new vaccine for the first year (estimated to be 3$ per girl) and the operational cost of vaccine delivery (estimated to be 4.20$ for delivering 3 doses) every year should be considered while budgeting for the HPV vaccination program . Countries having appropriate capabilities should promote research for the indigenous production of the vaccine

ContinuedStrategic Direction 3: Select Appropriate Delivery and Coverage Strategy Appropriate delivery strategy should be selected to ensure highest coverage of the target age group A school based vaccination program may be considered if a good proportion of the girls attend middle and high schools in the country Vaccination can be done in the health facilities at the primary and the secondary levels Combination of both delivery strategies along with out-reach or campaign approach to vaccinate the socio-economically disadvantaged population will ensure high coverage Whatever delivery strategy is selected, maintenance of cold chain, uninterrupted supply of consumables and high coverage with all three doses of the vaccine should be ensured

Continued Strategic Direction 4: Integrate immunization, surveillance and other related health interventions The health system should be strengthened to reduce the barriers to immunization and improve post-vaccination surveillance for adverse events A program officer at national/regional level should be responsible for planning and execution of the services, coordination between various levels and quality assurance The opportunity of getting access to the adolescent girls through the vaccination program should be utilized to deliver other health services targeted to the same population Regular programme evaluations should be conducted at local, district and national levels and should be linked with routine coverage evaluation surveys of immunization