3 - NCG - INDIA - Rev - Preventive Oncology - Primary - Care

NATIONAL CANCER GRID (NCG) OF INDIA
TATA MEMORIAL CENTER
Consensus Evidence Based Resource Stratified Guidelines on Secondary

prevention of Cervical , Breast & Oral Cancers
NCG WORKING GROUP
Resource Stratified guidelines for Preventive Oncology and Primary Care.
SUMMARY
RESOURCE-STRATIFIED CLINICAL PRACTICE GUIDELINE SUMMARY
The National Cancer Grid (NCG) formed in 2012 funded by the Government of India through
the Department of Atomic Energy, is amongst the largest cancer networks in the world
formed with the primary mandate of working towards uniform standards of patient care
across India by adopting evidence-based cancer prevention, screening and management
guidelines, which are implementable across the country.
RATIONAL FOR DEVELOPMENT OF RESOURCE STRATIFIED GUIDELINES
WHO Guidelines for screening of Oral, Breast and Cervical cancers for LMIC settings are
currently available. However, there are challenges for their adoption and implementation due
to large disparities and variations in the availability and access to health care resources.
Recently Government of India have also released broad programmatic guidelines, mainly
focused on opportunistic screening within the existing public health systems framework.
These pose unique challenges such as cost of administration, training of manpower, access to
screening facilities, follow up management and adequate linkages for confirmatory diagnosis
and subsequent treatment. The development of public health care systems varies across
different States in the country as health is a State subject. The health resources allocated
towards cancer control also vary between different States in the country.
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National Cancer Grid: Resource Stratified Guidelines_2019/Preventive Oncology & Primary Care
Hence evidence based screening, diagnosis and management protocols for common
cancers need to be developed to suit different levels of health resource settings. This will
enable identifying the most suitable options for adaptation to the local context.
Considering the complexities involved in delivering population based cancer screening

programs and the diversity of health system capabilities with in different regions in India,
the National Cancer Grid (NCG), a consortium of more than 180 cancer institutions in India,
the largest cancer networks in the world, aims to provide evidence based resource stratified
strategies and approaches that are operationally feasible to help adopt best practices in a
wide range of situations stratified by resources, leveraging with existing health system.
The NCG consensus guidelines and algorithms are consistent with existing evidence and
appropriate in the context of health systems of our country, for a sustainable implementation
of population based cancer screening and early detection program.
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TABLE 1: Summary of the Resource-Stratified Clinical Practice Guideline for Secondary
Prevention of Cervical Cancer: NCG INDIA
ESSENTIAL/ OPTIMAL/ OPTIONAL /

LIMITED ENHANCED HIGH RESOURCE
RESOURCE RESOURCE
1 Primary Visual inspection Human papillomavirus Human

Screening with acetic acid (HPV) DNA papillomavirus (HPV)
methods (VIA) DNA
2 Where : Place Health & Wellness Health & Wellness District Hospitals
for screening Centers Centers (DH)
Primary Health Primary Health
Centers (PHC), Centers (PHC), Private Health Care
Community Health Community Health Facilities
Centers (CHC) Centers (CHC)
3 By Whom Trained Primary Trained Nurse Trained Nurse

Care Workers
Physician Physician
Trained Nurse
4 Target 30-65 years 30-65 years 25-65 years
screening ages
5 Frequency of One to three times 10 years 5 years
screening in a lifetime if two consecutive
negative tests at 5-
year intervals,
6 Exiting Resource 65 years of age or 65 years of age or
Screening dependent older with consistently older with
negative results over consistently
the past 15 years. negative results over
the past 15 years.
7 Use of triage VIA : See and Treat Cytology (Quality HPV 16/18
and Diagnostic Assured) Genotyping
steps
VIA Cytology: Quality
Assured
8 After Triage NEGATIVE: NEGATIVE:

Follow-up in 12 Follow-up in 12
months months
ABNORMAL ABNORMAL
/POSITIVE: /POSITIVE:
Colposcopy if available Colposcopy /
3
directed Biopsy
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Visual
assessment for
treatment (VAT) if
colposcopy is not
available.
9 Opportunity Yes Resource dependent NOT Recommended

for
implementing
screen-and-
treat
approaches
10 Treatment of Cryotherapy: Loop electrosurgical Loop electrosurgical
Women With Lesions suitable for excision procedure excision procedure
Precursor cryotherapy (LEEP). (LEEP).
Lesions
Loop
electrosurgical
excision procedure
(LEEP): Lesions not
suitable for
cryotherapy
11 Post- One month & Twelve-month post-treatment follow-up is

treatment recommended for all settings
follow-up
12 Special primary screening
Populations: 6 weeks
Women who postpartum
are HIV
positive or
immunosuppr
essed for
other reasons
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TABLE 2 : Summary of the Resource-Stratified Clinical Practice Guideline for Secondary
Prevention of Breast Cancer: NCG INDIA

RESOURCE RESOURCE
1 Primary Clinical Breast Clinical Breast Clinical Breast

Screening Examination (CBE) Examination (CBE) Examination (CBE)
methods +
Conventional digital
Mammography
2 Where : Place Health & Wellness Health & Wellness Health & Wellness
for screening Centers Centers Centers (if
Mammography
Primary Health Primary Health facilities are available)
Centers (PHC), Centers (PHC),
Community Health
Community Health Community Health Centers (CHC) (if
Centers (CHC) Centers (CHC) Mammography
facilities are available)
District Hospitals (DH)

Tertiary Health care
settings
Private Health Care
Facilities
3 By Whom Trained Primary Trained Nurse Trained Nurse
Care Workers
Physician Physician / Breast
Trained Nurse Surgeon
4 Target 40-65 years 40-65 years Women aged 40-49 :

screening CBE + Mammography
ages depending on Risk
assessment and advise
of the Physician
Women aged >50 -75:

CBE + Conventional
Mammography
5 Frequency of One to three times 2 years 2 years
screening in a lifetime
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6 Exiting 75 years 75 years of age or 75 years of age or older
Screening older
7 Diagnostic IMAGING 1. Mammography Core biopsy
steps 1. Mammography 2. Ultrasonography
2. Ultrasonography 3. Core biopsy
TISSUE DIAGNOSIS As appropriate (as
CYTOLOGY/PATHO per availability
LOGY of infrastructure and
3. FNAC facilities)
4. Core biopsy
8 Treatment of Refer to Tertiary Refer to Tertiary Refer to Tertiary

Women Centre. Centre. Centre.
Management of Management of
treatment as per treatment as per Management of
standard standard guidelines. treatment as per
guidelines. standard guidelines.
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TABLE 2 : Summary of the Resource-Stratified Clinical Practice Guideline for Secondary
Prevention of Oral Cancer: NCG INDIA

RESOURCE RESOURCE
1 Primary Oral Visual Oral Visual Oral Visual

Screening Inspection (OVI) Inspection (OVI Inspection (OVI
methods
2 Where : Place for Health & Wellness Health & Wellness District Hospitals
screening Centers Centers (DH)
Primary Health Primary Health
Centers (PHC), Centers (PHC), Secondary / Tertiary
Community Health Community Health Health care settings
Centers (CHC) Centers (CHC)
Private Health Care
Facilities
3 By Whom Trained Primary Trained Nurse Physician/Surgeons/
Care Workers Dentist
Dentists, General
Trained Nurse practitioners
4 Target Group At Risk population: At Risk population: At Risk population:

Use of Tobacco / Use of Tobacco / Use of Tobacco /
Alcohol / Areca Alcohol / Areca nut / Alcohol / Areca nut /
nut / Mixed use Mixed use Mixed use
5 Target screening All age groups All age groups All age groups
ages 15 years and older 15 years and older
6 Frequency of One to three times 5-year intervals 2 years

screening in a lifetime
7 Counselling on Tobacco cessation Tobacco cessation Tobacco cessation

tobacco Counselling by Counselling by Counselling by
cessation Trained Primary Trained Medical Trained Medical
Care Workers Social Workers Social Workers /
Physician
8 Triage steps OVI Positive OVI Positive OVI Positive
Evaluation by Evaluation Primary Evaluation by

Doctor at care dental and General Surgeon/
PHC/CHC/DH General ENT Surgeon
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(including Dentist) practitioners including Dentist

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Evaluation by
General Surgeon/
ENT Surgeon
including Dentist at
DH.
9 Diagnostic NEGATIVE: NEGATIVE: NEGATIVE:
Confirmation Follow-up in 12 Follow-up in 12 Follow-up in 12
months months months
ABNORMAL ABNORMAL ABNORMAL

/POSITIVE: /POSITIVE: /POSITIVE:
Diagnosis by Oral Diagnosis by
Diagnosis by punch / Excision Oral punch /
Oral punch at PHC Biopsy at CHC /DH Excision Biopsy at
Tertiary center
Excision Biopsy at
CHC /DH
10 Treatment of Surgical Excision at Surgical Excision at Surgical Excision /

Precursor DH DH Laser Excision at
Lesions Tertiary center
11 Post-treatment Twelve-month post-treatment follow-up is recommended for all

follow-up settings
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CERVICAL CANCER SCREENING:
CERVICAL CANCER INCIDENCE AND MORTALITY:
Cervical cancer is the fourth most common cancer affecting women worldwide, after breast,
colorectal, and lung cancers, with 570,000 cases and the fourth leading cause of cancer death
in women with 311,000 deaths in 2018 worldwide. India accounted for 25% of global cervical
cancer mortality burden in 2018. (GLOBOCAN) Cervical cancer incidence rates varied across
population based cancer registries (PBCR) in India with a mean Age Standardised Rate (ASR)
of 22.0 per 100,000.
Considering the evidence generated till date for cervix cancer screening modalities for early
detection of cervical cancers, we present in this document, the current evidence based
recommendations that can be adopted for India for implementing cervical cancer screening
and pre cancer management strategies that will help address the gaps in uniform
implementation at different resource settings in India.
I. CHOICE OF THE SCREENING TEST: OPTIMAL RESOURCE SETTING
a. High Risk HPV (hrHPV) testing in primary screening
In the past 20 years, large cross sectional studies designed to evaluate the performance of
high-risk human papillomavirus (hrHPV) testing have demonstrated the sensitivity of hrHPV
testing at 66–95%, with specificity between 76% and 95%. HPV test is the most sensitive
among all the screening tests available till date. A large randomized study in India
demonstrated that even a single round of HPV test followed by appropriate management of
the screen positive women could reduce the cervical cancer mortality by 50%. The other
advantages of the test are – the test is objective and highly reproducible, training needs are
not very stringent, point of care tests are now available. The high negative predictive value of
the test can allow prolongation of screening interval up to 10 years in the screen negative
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women.
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RECOMMENDATIONS: HPV DNA testing as primary screening test has been adopted in many
national programs globally in High and Middle Income resource settings. HPV testing can
replace cytology as a primary screening tool in setups which can afford HPV Screening.
In women who test negative on an HPV test, rescreening should be done after a minimum
interval of five years.
b. Conventional Cytology:
Organised cytology-based cervical screening in the Europe, North America and Australia led
to a substantial reduction of the incidence of cervical cancer in these regions in the past five
decades. Successes of the cytology based screening programs were mainly due to repeated
testing at frequent intervals, high population coverage, and quality-control procedures
adopted in these regions.
The test has several limitations particularly for resource constrained settings – need for highly
skilled cytotechnicians and pathologists, high infrastructural requirements, need for stringent
quality control at each step.
RECOMMENDATIONS: Can be recommended in Opportunistic Health settings with Quality

Assured program.
c. Co testing
Co-testing is no longer recommended for cervical cancer screening.(European QA

guidelines)
RECOMMENDATIONS: If resources permit, HPV testing should be the test of first choice.
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II. CHOICE OF THE SCREENING METHOD: RESOURCE CONSTRAINED SETTING
1. Appropriate screening technologies for LMIC:
a. Visual Inspection with Acetic Acid (VIA)
Visual inspection with acetic acid (VIA) is simple, non invasive and inexpensive visual test,
has easy to learn approach, does not require laboratory involvement, is a real time test with
results available immediately and even non-physicians can be trained to perform the
procedure. The efficiency and cost-effectiveness of Visual inspection with acetic acid
(VIA) has been evaluated in two Randomized Control Trials (RCT) showing a significant
mortality benefit following VIA cervical screening. [35% South India ,31% Mumbai]. The
advantages of VIA are higher sensitivity than cytology, immediate availability of results
allowing management decisions to be taken at the same visit, feasibility of the test being
performed by trained nurses of health workers and low cost. More recently, Sauvaget and
colleagues, after pooling 26 studies from low- and middle income provided summary
estimate of VIA accuracy for sensitivity of 80% (range, 79%–82%), specificity of 92% (range,
91%–92%), PPV of 10% (range, 9%–10%), and NPV of 99%. Effects of factors such as
region, capacity of screener (health worker, nurse, or physician), place of screening, study
period, and size of study population had no effects on VIA accuracy demonstrating the
overall reliability of VIA screening
RECOMMENDATIONS: Visual inspection using acetic acid (VIA) can be adopted as the
screening modality of choice in settings where resources are not adequate to provide HPV
testing.
2. Appropriate Age For Screening & Screening Frequency.
RECOMMENDATIONS: Twice in a life time Screening between Age of 30 and 49 can be highly
protective and cost-effective which can be considered in Indian context where screening
coverage is extremely low.
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III. MANAGEMENT & TREATMENT FOR PRE-INVASIVE DISEASE
A screening program will be effective only when there is a mechanism to ensure high
compliance of the screen positive women for further diagnosis and treatment.
3 A. Treatment for Pre-Invasive disease
RECOMMENDATIONS:
1. For all screen-and-treat recommendations, cryotherapy or thermo-coagulation is

the first-choice treatment for women who have screened positive and are eligible for
ablative treatment.
2. Cryotherapy or thermo-coagulation can be safely administred at the primary care
facility if staff are appropriately trained .
3. When women have been assessed as not eligible for ablative therapy, LEEP is the
alternative treatment or cold knife conization (CKC).
4. Hysterectomy is not the treatment for CIN and should only be reserved for the
women with recurrent lesion in whom fertility preservation is not required. Even in
these women invasive cancer should be carefully ruled out after colposcopy directed
biopsies or LEEP.
3 B. Adopting Single visit and See- Treat approaches.
WHO has recommended VIA based Screen and Treat programs for better compliance to
cervical pre cancer treatment especially in regions with poor access to health care facilities.
RECOMMENDATIONS: Primary screening by VIA gives immediate results, which when linked
to cryotherapy facilities to permit a single-visit Screen & Treat strategy. [ Algorithm for
Primary Screening by VIA. CHART 1]
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IV. SCREENING AND DIAGNOSIS : WHERE AND BY WHOM?
RECOMMENDATIONS:
1. Para Medical workers like ANMs can be trained to perform VIA at Subcentre level and
above.
2. Screen positives should be evaluated for confirmation of the diagnosis at Primary
Health Centers (PHC), Community Health Centers (CHC) and District Hospitals (DH) by
available modalities like cytology, Colposcopy guided biopsy.
3. Biopsies to be performed at PHC, CHC and DH.
4. See and treat approach can be practiced at PHC and above levels.
5. Colposcopy, biopsy and treatment of precancerous lesion at District hospitals.
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CHART 1 : Cervical Cancer Screening _Primary Screening by VIA & management
of VIA positive Women
Screening and Management Algorithm for Cervical Cancer
Visual inspection using 5% acetic acid (VIA)
VIA Negative VIA Positive

acetic acid (VIA)
Return to routine screening at 3-5 Preferably see & If not, Refer to Skilled
years interval treat Health care provider for
assessment & further
management
Lesions suitable for Cryotherapy Lesions not suitable for

(PHC / CHC) Cryotherapy
()
Cryotherapy Referral to CHC / SDH / DH for:

1. Colposcopy guided biopsy
Or
2. Per speculum naked eye biopsy
Follow up after 1 year with VIA
Indications of Cryotherapy:
1. Entire lesion visible on
ectocervix Low grade High grade Invasive
2. Lesion not extending to (CIN 1) (CIN 2&3) cancer
endo cervical canal or
vagina
3. No evidence of
suspicious cancer Treatment by Treatment by Refer to tertiary
4. Non Pregnant Cryotherapy LEEP or care centre for
5. No evidence of pelvic PHC/ CHC Conization treatment of
inflammatory disease at DH / SDH Invasive cancer
time of treatment
6. Not menstruating at
time of treatment
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Post treatment follow up at one year

with VIA
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CHART 2: Cervical Cancer Screening _Primary Screening by HPV DNA Test & Management of
women after a positive HPV primary screening test.
Primary Screening
HPV DNA test
HPV Test Negative HPV – DNA Positive
Cytology Direct Colposcopy VIA
Negative ASCUS or Negative Positive VIA VIA

worse Negative Positive
Guided Biopsy Repeat HPV Colposcopy

Repeat HPV Colposcopy Repeat HPV
& treatment Testing after or
Testing after Testing/
based on HP 12 months. assessment
12 months.
colposcopy report or Colposcopy for
Colposcopy if
after 12 immediate if still immediate
still positive
months treatment of positive treatment
suspected
high grade CIN
Repeat screening after 5 – 10

years
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CHART 3: Cervical Cancer Screening _ Abnormal Pap Cytology Investigation and Follow Up
Cytology
Normal Positive
Rescreen every 3-5

years ASCUS or greater
Colposcopy Colposcopy Suspicious for

positive negative cancer
Biopsy No biopsy Rescreen within 3 Refer to

years appropriate
diagnosis and
treatment
Eligible for Not eligible for

cryotherapy, treat cryotherapy, treat with
with cryotherapy LEEP
If CIN2+, treat with Post-treatment

cryotherapy or LEEP follow-up at 1 year
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If CIN1 or less, rescreen within 3 years

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REFERENCES:
1. Ferlay J, Colombet M, Soerjomataram I, Mathers C, Parkin DM, Piñeros M, Znaor A,

Bray F. Estimating the global cancer incidence and mortality in 2018: GLOBOCAN
sources and methods. Int J Cancer. 2018 Oct 23. doi: 10.1002/ijc.31937.
2. Bray F, Ferlay J, Soerjomataram I, Siegel RL, Torre LA, Jemal A. Global Cancer
Statistics 2018: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36
Cancers in 185 Countries. CA Cancer J Clin. 2018 Nov;68(6):394-424. doi:
10.3322/caac.21492.
Epub 2018 Sep 12.
3. Incidence and Distribution of Cancer, Three year report of Population Based Cancer
Registries 2009-2011, National Cancer Registry Program, Indian Council for Medical
Research, National Centre for Disease Informatics and Research.
4. Rajendra A. Badwe, Rajesh Dikshit, M. Laversanne et al. Cancer Incidence Trends in
India. Jpn J Clin Oncol 2014;44:401–407
5. World Health Organization, Comprehensive Cervical Cancer Control: A Guide to
Essential Practice, second ed., World Health Organization, Geneva, 2014
6. Operational Guidelines for Common Non–Communicable Diseases. Report of the
Task Force on Comprehensive Primary Health Care Rollout, Ministry of Health

and Family Welfare, Government of India, 2015. Available
from:http://www.nicpr.res.in/images/pdf/guidelines_for_population_level_screening
_of_co mmon_NCDs.pdf
7. Operational Framework: Management of Common Cancers. Ministry of Health and
Family Welfare Government of India.
Available from: http://cancerindia.org.in/wp-
content/uploads/2017/11/Operational_Framework_Management_of_Common_Canc
ers.pdf
8. Pramesh CS, Badwe RA, Sinha RK: The National Cancer Grid of India. Indian J Med
Paediatr Oncol 35:226-227, 2014
9. Madlensky L, Goel V, Polzer J, Ashbury FD. Assessing the evidence for organised
17
cancer screening programmes. Eur J Cancer 2003;39:1648–53

Page
National Cancer Grid: Resource Stratified Guidelines_2019/Preventive Oncology

10. IARC. IARC Handbooks of Cancer Prevention. Vol. 10. Cervix Cancer Screening. Lyon,
France:
IARC; 2005
11. Arbyn M, Sankaranarayanan R, Muwonge R, et al. Pooled analysis of the accuracy

of five cervical cancer screening tests assessed in eleven studies in Africa and India. Int
J Cancer 2008; 123: 153–60.
12. Sankaranarayanan R, Nene BM, Shastri SS et al. HPV screening for cervical cancer in
rural India.
N Engl J Med 2009; 360: 1385–1394.
13. Ronco G, Giorgi-Rossi P, Carozzi F et al. Results at recruitment from a randomized
controlled trial comparing human papillomavirus testing alone with conventional
cytology as the primary cervical cancer screening test. J Natl Cancer Inst 2008;100:
492 – 501
14. Lawrence von Karsa , Marc Arbyn , Hugo De Vuyst , Joakim Dillner , Lena Dillner ,
Silvia Franceschi et al. European guidelines for quality assurance in cervical
cancer screening. Summary of the supplements on HPV screening and vaccination
Papillomavirus Research 1 (2015) 22–31
15. Tota JE, Bentley J, Blake J, Coutlée F, Duggan MA, Ferenczy A et al. Introduction
of molecular HPV testing as the primary technology in cervical cancer screening:
Acting on evidence to change the current paradigm. Preventive Medicine 98
(2017) 5–14
16. Strategic framework for the Comprehensive Control of Cancer Cervix. ISBN 978-92-
9022-472- 3 World Health Organization, Regional Office for South-East Asia. 2015
17. G. Dijkstra, P. J. F. Snijders, M. Arbyn et al. Cervical cancer screening: on the way to
a shift from cytology to full molecular screening. Annals of Oncology 25: 927–935,
2014
18. Surendra S Shastri, Ketayun Dinshaw, Geetanjali Amin et al. Concurrent evaluation of
visual,
cytological and HPV testing as screening methods for the early detection of cervical
neoplasia in Mumbai, India. Bulletin of the World Health Organization 2005;83:186-
18
194.
Page

19. Sankaranarayanan R, Basu P, Wesley R S. et al. Accuracy of visual screening for
cervical neoplasia: Results from an IARC multicentre study in India and Africa. Int. J.
Cancer 2004;110: 907–913.
20. Sankaranarayanan R, Esmy PO, Rajkumar R, et al. Effect of visual screening on
cervical cancer incidence and mortality in Tamil Nadu, India: a cluster-randomised
trial. Lancet 2007;370:398e406.
21. Shastri SS, Mittra I, Mishra GA, et al. Effect of VIA screening by primary health
workers: randomized controlled study in Mumbai, India. J Natl Cancer Inst
2014;106:dju009.
22. Sankaranarayanan R, Rajkumar R, Esmy PO et al. Effectiveness, safety and
acceptability of 'see and treat' with cryotherapy by nurses in a cervical screening
study in India. Br J Cancer. 2007; 96:738–743.
23. Castro W, Gage J, Gaffikin L, et al. Effectiveness, Safety and Acceptability of

Cryotherapy: A Systematic Literature Review. Seattle: PATH; 2003. Cervical Cancer
Prevention Issues in Depth, No.1.
24. Denny L, Kuhn L, De Souza M, Pollack AE, Dupree W, Wright TC Jr. Screen-and-treat
approaches for cervical cancer prevention in low-resource settings: a randomized
controlled trial. JAMA. 2005;294:2173–2181.
25. Nene BM, Hiremath PS, Kane S, Fayette JM, Shastri SS, Sankaranarayanan R.
Effectiveness, safety, and acceptability of cryotherapy by midwives for cervical
intraepithelial neoplasia in Maharashtra, India. Int J Gynaecol Obstet. 2008
Dec;103:232-6.
26. Sauvaget C, Muwonge R, Sankaranarayanan R. Meta-analysis of the
effectiveness of cryotherapy in the treatment of cervical intraepithelial neoplasia.
Int J Gynaecol Obstet. 2013 Mar;120:218-23.
27. L Dolman, C Sauvaget, R Muwonge, R Sankaranarayanan. Meta-analysis of the
efficacy of cold coagulation as a treatment method for cervical intraepithelial
neoplasia: A systematic review.. BJOG. 2014 Jul;121(8):929-42
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BREAST CANCER SCREENING
Breast cancer is the most common cancer and most common cause of cancer related death
among women globally and also in India. An estimated 208,8849 new breast cancer cases
were diagnosed globally in 2018, accounting for 24.2% of all female cancers and the fourth
leading cause of death due to cancers in females with nearly 626,679 women deaths due to
breast cancer. In India the Age Standardised Incidence rate for breast cancer was reported
at 24.7 per 100,000 with 162,468 new cases.
Methods of Screening for Breast Cancer:
Mammography is the most widely used screening modality, with evidence of benefit for
women aged 40 to 74 years. Clinical breast examination and breast self-exam have also been
evaluated but are of uncertain benefit. Technologies such as ultrasound, magnetic resonance
imaging, tomosynthesis, and molecular breast imaging are being evaluated, usually as
adjuncts to mammography.
Mammography:
Mammography screening has been shown to be associated with a reduction in breast cancer
mortality across a range of study designs, including RCTs and observational studies (trend
analyses, cohort studies, and case-control studies), with most studies demonstrating a
significant benefit. Evidence suggests that mammography screening performed every 12 to
33 months is effective in decreasing breast cancer mortality. Large proportion of the benefit
of screening mammography is maintained by biennial screening.
Screening for breast cancer is associated with false-positive findings leading to recall for
additional imaging or biopsy in women without cancer. The estimates of over diagnosis vary
widely, from less than 5% to more than 50%.
A mammography screening program is complex multidisciplinary undertaking. Accuracy of

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screening mammography is dependent on factors related to requirement of high-quality

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instrumentation and trained radiologists and involves substantial resources and

infrastructure, which are not within the reach of most LMICs and hence mammography
screening is considered not cost-effective for a lower-middle income country.
Clinical Breast Examination (CBE):
The Canadian National Breast Screening Study- 2, that compared CBE with CBE +
Mammography, did not show any added benefit of adding mammography to CBE. (1,2) The
intermediate analysis of the Trivandrum RCT initiated in 2006 showed early stage detection
of breast cancers with CBE. (3) The Mumbai RCT with CBE, which is one of the largest and
oldest trial with biennial CBE offered four times in one arm versus no screening in the other
arm has shown downstaging with CBE for all age groups (4) and breast cancer mortality
reduction among women more than 50 years. (personal communication, in process of
publishing)
CBE screening in India may be valuable, practical and cost effective option in LMICs. Training
health workers in CBE and using these trained personnel to implement early detection
programmes for breast cancer may provide the only opportunity for women in LMICs to
undergo regular breast examination for early detection of breast cancer.
Breast Self-Examination
Breast self-examination (BSE) has been compared with usual care (no screening activity) and
has not been shown to reduce breast cancer mortality.
Ultrasonography
The primary role of ultrasound is in the diagnostic evaluation of palpable or

mammographically identified masses, rather than a primary screening modality. A consensus
statement by the European Group for Breast Cancer Screening on screening of breast cancer
using ultrasound examination concluded that ultrasound is an important adjunct to
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mammography and clinical examination in the further assessment of both palpable and
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impalpable breast abnormalities.

RECOMMENDATIONS : OPTIMAL -RESOURCED SETTINGS
A. Women Aged 50−69 Years: Asymptomatic and at Average Risk For Breast Cancer
WHO recommends organized, population based mammography screening programmes for

women aged 50−69 years if the conditions for implementing an organized programme
specified are complied by the health-care system. Screening interval of two years.
B. Women Aged 40−49 Years: Asymptomatic and at Average Risk For Breast Cancer
WHO suggests an organized, population-based screening programme for women aged 40−49
years only if such programme is conducted in the context of rigorous research and monitoring
and evaluation
C. Women Aged 70−75 Years: Asymptomatic and at Average Risk For Breast Cancer
WHO suggests Conditional recommendation based on low quality evidence
RECOMMENDATIONS : LIMITED RESOURCE SETTINGS :
A. Women Aged 50−69 Years: Asymptomatic and at Average Risk For Breast Cancer
Clinical Breast Examination, a low-cost screening method, seems to be a promising approach

for these settings and could be implemented when the necessary evidence from ongoing
studies becomes available.
B. Women Aged 40−49 Years: Asymptomatic and at Average Risk For Breast Cancer
Clinical Breast Examination in population-based screening programmes for women aged

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40−49 years.
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C. Women Aged 70−75 Years: Asymptomatic and at Average Risk For Breast Cancer
WHO recommends against the implementation of population-based screening programmes
BREAST HEALTH / BREAST AWARENESS:
Need to address the value of increasing breast awareness and in improving accessibility for
early clinical diagnosis and prompt treatment in health services
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CHART 1: Breast Cancer Screening _Low Resource Settings
Breast Cancer Screening (40 – 65)
Sub Centre / Health

Clinical Breast Examination (CBE) Wellness Centre
Positive Criteria:
CBE Negative CBE Positive 1. Change in size and shape of
breast
2. Change in position of nipple
Self Breast Health Awareness & 3. Nipple discharge
Breast Self Examination (BSE) 4. Nipple retraction
5. New Lumps
6. Skin changes (Dimpling of
skin,Peau D’orange)
2.
Clinical Evaluation by Medical Officer at
PHC/ CHC, Surgeon at CHC
CBE negative CBE Probably Benign CBE Suspicious for Malignancy

Normal findings
Abnormal CBE referral to Triple

Assessment
Age <50 Age >50 1. Mammography
2. Ultrasonography
3. FNAC or core biopsy
Ultrasonography Mammography As appropriate (as per availability of
FNAC FNAC / Core Biopsy infrastructure and facilities)
Normal findings Benign findings Suspect/ confirmed

malignancy
1. Follow up as per the

Return to routine Refer to Tertiary Centre.
discretion of Surgeon
screening schedule Management of treatment as
2. Return to Routine
2 – 3 years
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Screening per standard guidelines.

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CHART 1: Breast Cancer Screening _Medium to High Resource Settings
PRIMARY Screening for Breast Cancer with CONVENTIONAL / DIGITAL MAMMOGRAPHY
Women aged Women aged

40 to 49 years 50 – 75 years
Clinical Breast
Examination (CBE) Mammography Mammography
Negative Positive
Screen
CBE Positive every 2 years
Diagnostic Sonography Clinical Evaluation by Surgeon

+/- at Secondary / Tertiary Health Facility
Diagnostic Mammography
USG Core biopsy / Image – guided

Mammography biopsy
Positive
Normal Findings Benign Suspect / confirmed

Findings Malignancy
25
Return to Routine Follow up as per the Refer to Tertiary Centre.

Page
Screening schedule discretion of the surgeon Management of

Return to Routine treatment as per
screening standard guidelines.
REFERENCES: BREAST CANCER SCREENING
1. Nelson HD, Tyne K, Naik A, et al.: Screening for breast cancer: an update for the U.S.
Preventive Services Task Force. Ann Intern Med 2009;151,10:727-37,W237-42.
2. Moss SM, Cuckle H, Evans A, et al.: Effect of mammographic screening from age 40
years on breast cancer mortality at 10 years' follow-up: a randomised controlled
trial. Lancet 2006;368,9552:2053-60.
3. Broeders M, Moss S, Nyström L, et al; EUROSCREEN Working Group. The impact of

mammographic screening on breast cancer mortality in Europe: a review of
observational studies. J Med Screen. 2012;19(suppl 1):14-25.
4. Independent UK Panel on Breast Cancer Screening. The benefits and harms of breast
cancer screening: an independent review. Lancet.2012;380(9855):1778-1786.
5. Tonelli M, Connor Gorber S, Joffres M, et al; Canadian Task Force on Preventive

Health Care. Recommendations on screening for breast cancer in average-risk women
aged 40-74 years. CMAJ.2011;183(17):1991-2001.
6. Gøtzsche PC, Jørgensen KJ. Screening for breast cancer with mammography.
Cochrane Database Syst Rev. 2013;6:CD001877.
7. Welch HG, Black WC: Overdiagnosis in cancer. J Natl Cancer Inst 2010;102,9:605-13.
8. Bleyer A, Welch HG: Effect of three decades of screening mammography on breast-

cancer incidence. N Engl J Med 2012;367,21:1998-2005.
9. Kalager M, Zelen M, Langmark F, et al.: Effect of screening mammography on breast-

cancer mortality in Norway. N Engl J Med 2010;363,13:1203-10.
10.Final Update Summary: Breast Cancer: Screening. U.S. Preventive Services Task
Force. July
2015.http://www.uspreventiveservicestaskforce.org/Page/Document/UpdateSummary
Final/brea st-cancer-screening.
26
Page
11.WHO Position Paper on Mammography Screening , 2014

12.Sankaranarayanan R, Ramadas K, Thara S, Muwonge R, Prabhakar J, Augustine P,
Venugopal M, Anju G, Mathew BS. Clinical breast examination: preliminary results
from a cluster randomized controlled trial in India. J Natl Cancer Inst.
2011;103,19:1476-80.
13. Mittra I, Mishra GA, Singh S, Aranke S, Notani P, Badwe R, Miller AB, Daniel EE, Gupta
S, Uplap P, Thakur MH, Ramani S, Kerkar R, Ganesh B, Shastri SS. A cluster

randomized, controlled trial of breast and cervix cancer screening in Mumbai, India:
methodology and interim results after three rounds of screening. Int J Cancer.
2010;126,4:976-84.
14. Miller AB, Wall C, Baines CJ, et al.: Twenty five year follow-up for breast cancer
incidence and mortality of the Canadian National Breast Screening Study:
randomised screening trial. BMJ 2014;348:g366.
15. Fenton JJ, Rolnick SJ, Harris EL, et al.: Specificity of clinical breast examination in
community practice. J Gen Intern Med 2007;22,3:332-7.
16. Thomas DB, Gao DL, Ray RM, et al.: Randomized trial of breast self-examination in
Shanghai: final results. J Natl Cancer Inst 2002;94,19:1445-57.
17. Semiglazov VF, Manikhas AG, Moiseenko VM, et al.: [Results of a prospective
randomized investigation [Russia (St.Petersburg)/WHO] to evaluate the significance
of self-examination for the early detection of breast cancer]. Vopr Onkol
2003;49,4:434-41.
18. Teh W, Wilson AR. The role of ultrasound in breast cancer screening. A consensus
statement by the European Group for Breast Cancer Screening. Eur J Cancer.
1998;34,4:449-50.
19. Lord SJ, Lei W, Craft P, et al. A systematic review of the effectiveness of magnetic
resonance imaging (MRI) as an addition to mammography and ultrasound in
screening young women at high risk of breast cancer. Eur J Cancer 2007;43,13:1905-
27
17.
Page

ORAL CANCER SCREENING
Oral cancer is an important public health problem with increasing incidence and late-stage
presentation. Cancers of the mouth , pharynx and larynx taken together are the seventh most
commonly occurring type of cancer worldwide. India reported Lip, oral cavity cancer at ASIR
of 9.1 for both sexes combine a n d 1 3 . 9 for men. Oral cancer thus accounts as the
highest incidence of malignancy in males and the second highest in females in India.
Smoking, alcohol use, smokeless tobacco use, and HPV infection are the major risk factors for
oral cavity cancer. Smokeless tobacco products and betel quid with or without tobacco are
the major risk factors for oral cavity cancer in India and other neighbouring countries. Human
papillomavirus (HPV) has been shown to be another independent risk factor for oral
squamous cell carcinomas ( OSCC) of the base of the tongue, tonsils, pharynx, and larynx.
Despite the general accessibility of the oral cavity during physical examination, many
malignancies are not diagnosed until late stages of disease. Early detection of oral cancer and
their precursors is the key to reducing the high mortality rate attributable to oral cancer.
Oral Cancer screening
The screening tests or diagnostic aids used to improve early detection and diagnosis of oral
precancers and cancers which are available for oral cancer, some of which have been
practiced and studied for many years while others have recently become commercially
available include Oral Visual examination, exfoliative cytology, vital tissue staining (toluidine
blue, Methylene blue), visualization adjuncts (ViziLite Plus with TBlue, ViziLite, Microlux DL,
Orascoptic DK, VELscope), and OralCDx brush biopsy.
Oral Visual Inspection (0VI)

28
A conventional oral visual inspection (0VI) of the oral cavity, using normal (incandescent)
light, has long been the standard method for oral cancer screening. The UK working group on
Page
20
screening for oral cancer and precancer in 1990's had concluded that the most suitable
screening for oral cancer and precancer is a thorough and methodical examination in good
lighting of the mucosal surfaces of the oral cavity. A meta-analysis of four studies of OVI
conducted in developing countries using health care auxiliaries as screeners showed an
overall sensitivity of 0.85 (95% CI 0.73, 0.92) and specificity of 0.97 (95% CI 0.93, 0.98)
indicating a satisfactory test performance for an oral examination.
Results of community-based cluster randomized controlled intervention trial in Trivandrum

district, Kerala, South India, showed significant 34% reduction in oral cancer mortality among
users of tobacco or alcohol, or both and a much higher reduction in those complying with all
rounds of screening in a randomized trial in India. Although OVI could be considered as an
effective as a screening test, there are still many problems with this approach since , the vast
majority of the precancer lesions detected are benign and only a small percentage of
leukoplakias are progressive or become malignant thus OVI cannot discriminate between
potentially premalignant lesions and non-progressive lesions.
Mouth Self Examination (MSE)
As an alternative Mouth Self Examination (MSE) was evaluated in a study involving 34,766
subjects in India and was found to have low sensitivity of 18% while the specificity was 99.9%.
Overall awareness about oral cancer and its risk factors after introduction of MSE program
was over 80%; but the compliance to seek treatment was reported to be very poor at 32%.
The authors concluded that role of health education in sustained practice of MSE needs to be
evaluated.
Adjunctive Technologies: There is currently no evidence to support the use of like , vital
tissue staining (toluidine blue, Methylene blue), visualization adjuncts (ViziLite Plus with
TBlue, ViziLite, Microlux DL, Orascoptic DK, VELscope), as a screening tool to reduce oral
cancer mortality.
21
Page
21
CONCLUSION
There has been a dramatic increase in the development of tools and devices for oral cancer
screening in the last few decades. However no technology to date has provided definitive
evidence to suggest that it improves the sensitivity or specificity of oral cancer screening
beyond OVI alone. Most studies conducted for these newer devices have been performed
in a setting used to aid in the diagnosis of a lesion that has already been identified by the
naked eye, rather than as true screening tools.
Effective early detection technologies that are easy to perform clinically in primary care
settings combined with an increased public awareness of oral cancer in general will help attain
the goal of decreasing the burden of oral cancer.
DIAGNOSTIC EVALUATION
Oral Brush Cytology: Standard exfoliative oral cytology from the mucosal surface and has
been existence for a long time but has proven unreliable so far.
Oral Brush Biopsy: Brush Biopsy was designed for evaluating clinical lesions that would not
be subjected to standard biopsy due to lack of facilities. Several studies have shown
encouraging results with oral brush cytology for evaluation of oral precancerous lesions. This
may have application in resource challenged areas and could be a risk free method of
evaluating oral lesions.
22
Page
22
CHART : Oral Cancer Screening
High risk population based screening

Screen Positive
criteria :
1.Leucoplakia
At Risk population: Use of Tobacco / Alcohol / 2.Erythroplakia
Areca nut / Mixed use (All age groups) 3.Oral Submucous
Fibrosis
4. Non healing
ulcers
Oral Cancer screening by Oral Visual Inspection 5. Suspicious
(OVI) at SC / PHC cancerous Growth
in oral cavity
OVI Negative OVI Positive Counselling

for Tobacco
Cessation
Evaluation by Doctor at PHC/CHC (including Dentist)
OVI Negative Normal Findings Potentially Malignant Lesion/Malignant lesion
Return to Routine Counselling for Tobacco / Alcohol Diagnosis by Oral punch

screening at 3 – 5 cessation by primary healthcare worker / Excision Biopsy at CHC
years / NCD Nurse /DH
Histopathology: Negative Histopatholoy :

Moderate /Severe Dysplasia / Malignancy
6-12 months follow up for lesion

status/confirm tobacco cessation Referral to a Tertiary care
centre for further management
23
Regression No change /
Page
Progression
23
REFERENCES: ORAL CANCER SCREENING
1. Ferlay J, Colombet M, Soerjomataram I, Mathers C, Parkin DM, Piñeros M, Znaor A,

Bray F. Estimating the global cancer incidence and mortality in 2018: GLOBOCAN
sources and methods. Int J Cancer. 2018 Oct 23. doi: 10.1002/ijc.31937
2. Hashibe M, Brennan P, Chuang SC, et al. Interaction between tobacco and alcohol
use and the risk of head and neck cancer: pooled analysis in the International Head
and Neck Cancer Epidemiology Consortium. Cancer Epidemiol Biomarkers
Prev.2009;18:541-550.
3. Wen CP, Tsai MK, Chung WS, et al. Cancer risks from betel quid chewing beyond oral
cancer: a multiple-site carcinogen when acting with smoking. Cancer Causes Control.
2010;21:1427-1435.
4. Kreimer AR, Clifford GM, Boyle P, Franceschi S. Human papillomavirus types in head
and neck squamous cell carcinomas worldwide: a systematic review. Cancer Epidemiol
Biomarkers Prev 2005;14:467–475.
5. R. Sankaranarayanan. Screening for Cancer in Low- and Middle-Income Countries.
Annals of Global Health 2014;80:412-417
6. Screening for Oral Cancer and Precancer. A report of the UK Working Group on
Screening for Oral Cancer and Precancer. Community Dental Health 1993;10:1-89
7. Warnakulasuriya S, Pindborg JJ. Reliability of oral precancer screening by primary
health care workers in Sri Lanka. Community Dent Health 1990;7(1):73–9. [PubMed:
2357611]
8. Mathew B, Sankaranarayanan R, Sunilkumar KB, Kuruvila B, Pisani P, Nair MK.
Reproducibility and validity of oral visual inspection by trained health workers in the
detection of oral precancer and cancer. Br J Cancer 1997;76(3):390–4. [PubMed:
9252209]
9. Sankaranarayanan R, Ramadas K, Thara S, et al. Long term effect of visual screening
on oral cancer incidence and mortality in a randomized trial in Kerala, India. Oral Oncol
2013;49:314e21.
10. Ramadas K, Sankaranarayanan R, Jacob BJ, Thomas G, Somanathan T, Mahe C, et al.
Interim results from a cluster randomized controlled oral cancer screening trial in
Kerala, India. Oral Oncol 2003;39:580–8.
11. Sankaranarayanan R, Mathew B, Jacob BJ, Thomas G, Somanathan T, Pisani P, et al.
Early findings from a community-based, cluster-randomized, controlled oral cancer
screening trial in Kerala, India. The Trivandrum Oral Cancer Screening Study Group.
Cancer 2000;88:664–73
12. Sankaranarayanan R, Ramadas K, Thomas G, et al. Effect of screening on oral cancer
mortality in Kerala, India: a clusterrandomised controlled trial. Lancet
2005;365:1927e33.
13. Subramanian S, Sankaranarayanan R, Bapat B, et al. Cost-effectiveness of oral cancer
screening: results from a cluster randomized controlled trial in India. Bull World Health
Organ 2009;87:200e6.
14. Eisen D, Frist S. The relevance of the high positive predictive value of the oral brush
24
biopsy. Oral Oncol 2005;41:753–5.

15. Scully C, Bagan JV, Hopper C, Epstein JB. Oral cancer: current and future diagnostic
Page
techniques. Am J Dent. 2008;21:199–209.

24
16. Mehrotra R, Singh MK, Pandya S, Singh M. The use of an oral brush biopsy without
computer-assisted analysis in the evaluation of oral lesions: A study of 94 patients.
Oral Surg Oral Med Oral Pathol Oral Radiol Endod 2008;106:246-53.
17. Elango KJ, Anandkrishnan N, Suresh A et al. Mouth self-examination to improve oral
cancer awareness and early detection in a high-risk population. Oral
Oncol. 2011;47:620-4.
18. Epstein JB, Güneri P. The adjunctive role of toluidine
blue in detection of oral premalignant and malignant lesions. Curr Opin Otolaryngol
Head Neck Surg. 2009;17:79-87.
19. Chen, Y.W., J.S. Lin, J.H.J. Fong et al. Use of methylene blue as a diagnostic aid in early
detection of oral cancer and precancerous lesions. Br J Oral Maxillofac Surg
2007;45:590-591.
20. Mark W. Lingen, John R. Kalmar, Theodore Karrison et al. Critical Evaluation of
Diagnostic Aids for the Detection of Oral Cancer. Oral Oncol. 2008; 44: 10–22.
21. Brocklehurst P, Kujan O, O'Malley LA et al. Screening programmes for
the early detection and prevention of oral cancer. Cochrane Database Syst Rev. 2013
25
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NATIONAL CANCER GRID (NCG) OF INDIA

TATA MEMORIAL CENTER

Consensus Evidence Based Resource Stratified Guidelines on Secondary

NCG WORKING GROUP

Resource Stratified guidelines for Preventive Oncology and Primary Care.

RATIONAL FOR DEVELOPMENT OF RESOURCE STRATIFIED GUIDELINES

Considering the complexities involved in delivering population based cancer screening

ESSENTIAL/ OPTIMAL/ OPTIONAL /

1 Primary Visual inspection Human papillomavirus Human

3 By Whom Trained Primary Trained Nurse Trained Nurse

8 After Triage NEGATIVE: NEGATIVE:

9 Opportunity Yes Resource dependent NOT Recommended

11 Post- One month & Twelve-month post-treatment follow-up is

ESSENTIAL/ OPTIMAL/ OPTIONAL /

1 Primary Clinical Breast Clinical Breast Clinical Breast

District Hospitals (DH)

4 Target 40-65 years 40-65 years Women aged 40-49 :

Women aged >50 -75:

8 Treatment of Refer to Tertiary Refer to Tertiary Refer to Tertiary

ESSENTIAL/ OPTIMAL/ OPTIONAL /

1 Primary Oral Visual Oral Visual Oral Visual

4 Target Group At Risk population: At Risk population: At Risk population:

6 Frequency of One to three times 5-year intervals 2 years

7 Counselling on Tobacco cessation Tobacco cessation Tobacco cessation

8 Triage steps OVI Positive OVI Positive OVI Positive

Evaluation by Evaluation Primary Evaluation by

(including Dentist) practitioners including Dentist

ABNORMAL ABNORMAL ABNORMAL

10 Treatment of Surgical Excision at Surgical Excision at Surgical Excision /

11 Post-treatment Twelve-month post-treatment follow-up is recommended for all

CERVICAL CANCER INCIDENCE AND MORTALITY:

I. CHOICE OF THE SCREENING TEST: OPTIMAL RESOURCE SETTING

a. High Risk HPV (hrHPV) testing in primary screening

RECOMMENDATIONS: Can be recommended in Opportunistic Health settings with Quality

Co-testing is no longer recommended for cervical cancer screening.(European QA

1. Appropriate screening technologies for LMIC:

a. Visual Inspection with Acetic Acid (VIA)

2. Appropriate Age For Screening & Screening Frequency.

3 A. Treatment for Pre-Invasive disease

1. For all screen-and-treat recommendations, cryotherapy or thermo-coagulation is

3 B. Adopting Single visit and See- Treat approaches.

Screening and Management Algorithm for Cervical Cancer

Visual inspection using 5% acetic acid (VIA)

VIA Negative VIA Positive

Lesions suitable for Cryotherapy Lesions not suitable for

Cryotherapy Referral to CHC / SDH / DH for:

Post treatment follow up at one year

HPV Test Negative HPV – DNA Positive

Cytology Direct Colposcopy VIA

Negative ASCUS or Negative Positive VIA VIA

Guided Biopsy Repeat HPV Colposcopy

Repeat screening after 5 – 10

Rescreen every 3-5

Colposcopy Colposcopy Suspicious for

Biopsy No biopsy Rescreen within 3 Refer to

Eligible for Not eligible for

If CIN2+, treat with Post-treatment

If CIN1 or less, rescreen within 3 years