Partha Basu M.D. Screening Group/ Early Detection & Prevention Section

Transcription

1 Current Status of Quality Assured Colposcopy Practice in South Asia Partha Basu M.D. Screening Group/ Early Detection & Prevention Section

2 Disclosures No financial disclosure NO conflict of interest to disclose

3 Bangladesh: VIA Based Screening Program STAKEHOLDER S MEETING 2003 EVALUATION OF PILOT 2005 NATIONAL PROGRAM LAUNCHED 2006 SCALE UP TO PRIMARY CARE 2010 Program Milestones PILOT PROGRAM LAUNCHED 2004 NATIONAL SCREENING PROTOCOL 2006 PROGRAM EVALUATION 2008 GUIDELINES REVISED Colposcopists trained for 23 Colpo facilities Basu et al. J Fam Plann Reprod Health Care 2010; 36(3): Ashrafunnessa. High-level Convening on Cervical Cancer Prevention and Control in India and Beyond. New Delhi 2016

4 Sri Lanka Cytology Based Screening Program Unit of Primary Prevention, Screening & Early Detection of Cancers National Cancer Control Programme, Ministry of Health, 2014

5 India: Breast & Cervical Cancer Screening Program in Tamilnadu Target Women screened for Cervical Cancer (VIA/VILI) and Breast cancer (CBE) Primary health clinics, district hospitals, municipal dispensaries & hospitals Secondary evaluation using Colposcopy /Mammography / FNAC, Biopsy/ Treatment of cervical precancer District hospitals, Medical colleges, Municipal hospitals Microscopic confirmation through Histopathological examination Govt. Medical College Hospital Staging and treatment Govt. Medical College Hospital

6 Thailand: Cervical Cancer Screening- Program Organization General Hospital - 94 TERTIARY HEALTH CARE Cancer Treatment; Registry; Research Community Hospitals SECONDARY HEALTH CARE Screening; Colpo & treatment; Surgery Primary Care Unit 12,000 PRIMARY HEALTH CARE Primary prevention; Screening Village Health Volunteers >10,000 COMMUNITY Health Education, Mobilization Suleeporn S. High-level Convening on Cervical Cancer Prevention and Control in India and Beyond. New Delhi October 2016

7 China: National Cervical Cancer Screening Program in Rural Areas Ministry of Health Provincial MCH Centers Country Level Hospitals Township Level Hospitals Provincial MCH Supervision Institutions Country Level Institutions Management guidelines Program monitoring Technical support Quality Assurance Technical support Screening &/or Diagnostic services Supervision & technical support Screening Data collection Women & Children Health Plan: 70% of the target 270 million women (35-64 yrs) to be screened once in 5 yrs by cyto or VIA Health education & invitation by All China Women s Federation Jiangli Di. Asian Pac J Cancer Prev, 2016 (17), Wang S. Jpn J Clin Oncol, 2015, Vol. 45, No. 1

8 Indications for Colposcopy Follow up Triage + HPV + (+triage) Cytology + Colposcopy VIA +

9 Traditional Role of Colposcopy Exclude the normal cervix Identify the most suitable area to direct biopsy Detect invasive cancers Identify the type of TZ Make management decisions Guide treatment Estimate the severity of the underlying disease

10 Diagnostic Test Accuracy of Colposcopy (pooled analysis) Test Results No. of results /1000 women tested Number of Participants (Studies) Quality of Evidence (GRADE) True Positives 190/1000 (95%CI: ) False Negatives 10/1000 (95%CI: 4-28) True Negatives 336/1000 (95%CI: ) False Positives 464/1000 (95%CI: ) Pooled Sensitivity 95% (95% CI: 86-98) Pooled Specificity 42% (95% CI: 26-61) 6370 (11 studies) High Moderate Assumed 20% prevalence of CIN 2+ in test positives Mustafa et al. Int J Gynecol Obstet 132 (2016)

11 In other words, for every 1000 women screened positive and then sent to colposcopy, 464 would be falsely diagnosed as CIN grade 2 3 positive and subsequently treated Mustafa et al. Int J Gynecol Obstet 132 (2016)

12 Analysis of 84,244 Colposcopies from British Columbia Screening Program Directed Biopsy Colposcopic Impression Normal CIN 1 CIN 2/3 Cancer Total Normal (47.5%) 7910 (30.3%) 5764 (22.1%) 38 (0.1%) 26,112 CIN (13.3%) 9723 (49.3%) 7354 (37.3%) 14 (0.1%) 19,703 CIN 2/ (3.7%) 5868 (15.4%) (80.7%) 103 (0.3%) 38,214 Cancer 10 (4.6%) 5 (2.3%) 39 (18.1%) 161 (74.9%) 215 Total (19.5%) (27.9%) (52.2%) 330 (0.4%) 84,244 Prevalence of CIN 2+: 52.6% False +ve to detect CIN 2/3: 29.7% Benedet et al. Gynecologic Oncology 92 (2004)

13 HPV/VIA Demo Project Kolkata, India Colpo-Histo Correlation Directed Biopsy Colposcopic Impression Normal CIN 1 CIN 2/3 Cancer Total Normal 296 (30.0%) CIN (19.6%) CIN 2/3 28 (12.2%) Cancer 2 (3.9%) Total 694 (22.0%) 647 (65.5%) 1348 (71.7%) 91 (39.6%) 3 (5.9%) 40 (4.0%) 156 (8.3%) 102 (44.3%) 9 (17.6%) 4 (0.4%) 8 (0.4%) 9 (3.9%) 37 (72.5%) 2089 (66.4%) 307 (9.7%) 58 (1.8%) Prevalence of CIN % False positive rate to detect CIN 2/3: 63.8% Basu et al. In J Cancer

14 Risk of CIN 2+ in HPV +ve Women with Normal/CIN 1 Histology at Baseline A cohort of HPV +ve women with <CIN 2 histopathology were followed up yearly Mean follow up 2.1 PYO Histopathology proved CIN 2+ detected in Normal colposcopy at baseline 5% Low grade lesion at baseline colpo 7.7% High grade lesion at baseline colpo 26.4% Mittal S et al. Int J Cancer 2017

15 Unresolved Issues Random biopsies from normal areas on colposcopy in HPV positive women Management of HPV positive women with normal colpo & type 3 TZ

16 High Grade Lesions Missed on Colposcopy - Thin CIN? Yang et al. Gynecol Oncol. 2008;110:32 6.

17 Histology Mean average thickness (micron) of epithelium as functions of histology & colposcopy diagnoses Colposcopy Diagnosis Normal Condyloma Low Grade High Grade Normal (N=28) ( ) ( ) ( ) CIN (N=94) ( ) ( ) ( ) ( ) CIN (N=50) ( ) ( ) ( ) CIN (N=37) ( ) ( ) ( ) Ghosh et al. Int J Gynecol Pathol 2015

18

19

20

21 RCT to Evaluate VIA, HPV Test & Cytology in India (Barshi) Women aged yrs in 52 clusters HPV 13 clusters (N = ) Cytology 13 clusters (N = ) VIA 13 clusters (N = ) Control 13 clusters (N = ) Diagnosis and treatment of screen-positive women Diagnosis and treatment of screen-positive women Diagnosis and treatment of screen-positive women Health education, routine existing care Follow-up for cervical cancer incidence and mortality (passive and active) Follow-up for cervical cancer incidence and mortality (passive and active) Follow-up for cervical cancer incidence and mortality (passive and active) Follow-up for cervical cancer incidence and mortality (passive and active) Sankaranarayanan et al., N Engl J Med 2009;360:

22 Cyto Abnormal; Type 3 TZ; Colpo Normal HP Report of LLETZ Specimens Cytology Diagnosis Histopathology Diagnosis Normal CIN 1 CIN 2/3 Cancer Total ASCUS 34 (58.6%) 21 (36.2%) 3 (5.1%) 0 (0%) 58 LSIL 17 (54.8%) 11 (35.5%) 3 (9.7%) 0 (0%) 31 HSIL 9 (29.0%) 8 (25.8%) 13 (41.9%) 1 (3.2%) 31 Cancer 2 (18.2%) 2 (18.2%) 7 (63.6%) 0 (0%) 11 Total 62 (47.3%) 42 (32.1%) 26 (19.8%) 1 (0.8%) 131 Sankaranarayanan R. Unpublished data

23 HPV +ve; Type 3 TZ; Colpo Normal HP Report of LLETZ Specimens RLU/CO on HC2 Histopathology Diagnosis Normal CIN 1 CIN 2/3 Cancer Total (77.9%) 20 (14.7%) 9 (6.6%) 1 (0.7%) 136 > (68.8%) 13 (16.9%) 11 (14.3%) 0 (0%) (45.6%) 18 (20.0%) 29 (32.2%) 2 (2.2%) 90 Total 200 (66.0%) 51 (16.8%) 49 (16.2%) 3 (1.0%) 303 Sankaranarayanan R. Unpublished data

24 Challenges of Colposcopy in South Asia Screening tests (VIA/HPV) have low specificity & PPV Screening tests do not provide any indication about the expected morphological abnormality Being implemented in settings with little experience/training in colposcopy/guided treatment Colposcopy training opportunities very limited

25