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Results of Sentinel Sites Study

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Presentation on theme: "Results of Sentinel Sites Study"— Presentation transcript:

1 Results of Sentinel Sites Study
Dr Karin Denton

2 HPV testing as a triage for women with low grade cytological abnormalities: results from the sentinel sites studies. Kelly R, Patnick J, Kitchener HC, Moss SM Br J Cancer Sep 27;105(7):983-8.

3 North Bristol NHS Trust/Avon Cervical screening programme
Results Study took place between 1 Jan 2008 and 1 April 2009 Data collected until September 2009 Analysis conducted independently at Cancer Screening Evaluation Unit, Institute of Cancer Research Over 90% of women attended colposcopy North Bristol NHS Trust/Avon Cervical screening programme

4 HPV positive rates by age group and initial cytology result
Borderline Mild Total Age Grp No of women HPV + n (%) 25-34 3121 2144 (68.7) 2203 1964 (89.2) 5324 4108 (77.2) 35-49 2783 1165 (41.9) 1129 869 (77.0) 3912 2034 (52.0) 50-64 603 187 (31.0) 212 141 (66.5) 815 328 (40.2) 6507 3496 (53.7) 3544 2974 (83.9) 10051 6470 (64.4) North Bristol NHS Trust/Avon Cervical screening programme

5 North Bristol NHS Trust/Avon Cervical screening programme
SSS Results from different centres HPV positive rate by site and initial cytology 1 Site Borderline Mild Total n HPV +ve (%) A B C D E F 1263 643 2557 789 663 592 866 (68.6) 224 (34.8) (43.4) (57.7) 406 (61.2) 434 (73.3) 404 523 1507 420 557 133 370 (91.6) (73.4) (81.8) 372 (88.6) 500 (89.8) 116 (87.2) 1667 1116 4064 1209 1220 7255 (74.1) 608 (52.1) (57.7) 827 (68.4) 906 (74.3) 550 (75.9) North Bristol NHS Trust/Avon Cervical screening programme

6 North Bristol NHS Trust/Avon Cervical screening programme
SSS Results from different centres HPV positive rate by site and initial cytology 2 Site Borderline Mild Total n HPV +ve (%) Centre C (Thinprep® LBC) 1188 543 (47.7) 798 669 (83.8) 1986 (61.0) (BD SurepathTM LBC) 426 216 (50.7) 241 204 (84.6) 667 420 (63.0) 3903 (58.2) 2179 (87.7) 6082 (68.7) 1661 874 (52.6) 897 704 (78.5) 2558 (61.7) North Bristol NHS Trust/Avon Cervical screening programme

7 Sentinel Site Study Results at colposcopy
CIN 1 CIN2 CIN3+ n (%) BL 25-34 35-49 50-64 (20.4) (16.3) (15.8) (10.0) (8.3) (2.3) 142* (7.4) (6.1) (2.9) Total (18.8) (9.0) (6.7) Mild (26.7) (29.6) (23.8) (12.4) (10.9) (6.2) (6.3) (3.8) (2.3) (27.5) (11.7) (5.4) (22.8) (10.2) (6.1) *Includes 3 invasive cancers North Bristol NHS Trust/Avon Cervical screening programme

8 Sentinel Site Study PPV of colposcopy by site 1
Borderline Mild No attending colposcopy PPV CIN2+ CIN3+ A B C D E F 803 178 978 430 355 417 21.5 11.2 11.6 16.5 9.3 20.9 7.8 6.2 5.0 7.4 2.5 11.5 350 317 1104 354 440 112 25.4 9.1 15.9 21.8 10.9 30.0 7.1 3.5 4.8 7.6 15.2 North Bristol NHS Trust/Avon Cervical screening programme

9 North Bristol NHS Trust/Avon Cervical screening programme
Sentinel Sites Study Rate of disease at 1, 2 3 and >3 years after negative colposcopy in 956 women with long term follow-up Time since negative colposcopy Abnormal cytology CIN1 CIN2 CIN3 No. % %. 1 year 2 years 3 years >3 years 10 19 25 30 1.0 2.0 2.6 3.1 18 33 38 49 1.9 3.5 4.0 5.1 6 16 23 0.6 1.7 2.4 28 2.9 North Bristol NHS Trust/Avon Cervical screening programme

10 North Bristol NHS Trust/Avon Cervical screening programme
Test of Cure Preliminary data only in un-triaged women 3203 women had test of cure Failed test of cure by 18.3% 6.2% by abnormal cytology 12.1% by HPV +ve with normal cytology Increased ‘failure’ rates with lower CIN grade Persistent CIN2+ in 7% 3% in HPV +ve 13% in cytology +ve North Bristol NHS Trust/Avon Cervical screening programme

11 Bristol experience

12 Bristol Outcome Lletz histology for mild and borderline HPV positive smears with CIN 2/3 on PB(%)
Nil HPV/ inflam CIN1 CIN2 CIN3 Micro B’line HPV 3 13 10 35 38 1 Mild 8 12 29 41 2

13 National outcomes 90% attendance Half had PB (47% negative histology)
2.4% had LLETZ ( 28% neg histology) 1/3 of identified CIN1 were not treated Apparent overall cytological progression was 3.4% at 12 months

14 Role for HPV testing Test of cure

15 Management outcome in women referred to Colposcopy following HPV Test of Cure (TOC)
Mohini Vachhani, Mary Brett*, Anne Vaughton, Vikki Finch, John Murdoch Colposopy Clinic and *Cellular Pathology Dept, Southmead Hospital Presented 22/06/2011 (Also, poster at BSCCP meeting /2011)

16 Results No of samples with HPV TOC test = 2369
HPV negative = 2017 (85%)  routine recall HPV positive = 352 (15% - National rate 18%)  colposcopy Referred to Southmead = 141 Referred to St Michael’s = 211

17 Outcome TZ seen; NAD –> Cytology follow up in Community (n = 66)
TZ seen; abnormality seen (n = 22): 2 LLETZ (CIN 1, CIN2) 16 biopsy (3 CIN1, 13 neg) 4 rpt cytology (all negative)

18 Outcome Colposcopy was unsatisfactory in 30% of cases (i.e.TZ not seen): n = 38 6 had further LLETZ (all negative) 13 had Bx (1 CIN 1, 12 neg)

19 Outcome Total no with repeat LLETZ = 8 cases
7 had involved margins in index LLETZ 2/8 with satisfactory colp and abnormality seen (Histo: CIN1, CIN2) 6/8 with unsatisfactory colp (Histo: all negative)

20 Conclusion Women with positive TOC are at minimal risk of residual CIN (6/126 =4.8%) 5/126 (4%) = CIN1 1/126 (0.8%) = CIN2 Nationally PPV for CIN2 or worse = 2.9% and for CIN3 or worse = 0.4%

21 Other studies H Kitchener et al. BJOG 2008, 15(8): Of cyto neg/HPV pos referrals to colp, 9/75 had CIN (at 6, 12 or 24 months follow up post-LLETZ; 4 CIN1, 4 CIN2, 1 CIN3) = 12% treatment failure rate. (Compared with Southmead data: 6/126 had residual CIN = 4.8%)

22 Changes to KC61? Don’t panic, no change to data collection or categories

23 Longer term impact on KC61 data
BC rate will fall (due to loss of 2nd and 3rd bc) Mild rate will also fall depending on previous policy Will be visible effect from year 1 High grade rate will also fall slightly because women will be referred on a prior low grade result

24 PPV should remain unaffected

25 Caution You must decide on a diagnosis and stick to it regardless of HPV result Do not use BC?HG in order to get an HPV test Follow the management protocol

26 ABC3 ? Launch date Will abolish BC?HG

27

28 KEY TO CODES & ABBREVIATIONS
 Action codes A routine recall Rm early repeat in 'm' months S suspend from recall PROVISIONAL Result codes Ø * ?glandular neoplasia (non cervical) G * ?glandular neoplasia (non cervical) (HPV tested) 1 inadequate 2 negative (not HPV tested) N negative (HPV tested) 3 low grade dyskaryosis (not HPV tested) M low grade dyskaryosis (HPV tested) 4 high grade dyskaryosis (severe) 5 high grade dyskaryosis ?invasive squamous carcinoma 6 ?glandular neoplasia of endocervical type 7 high grade dyskaryosis (moderate) 8 borderline change in squamous cells (not HPV tested) B borderline change in squamous cells (HPV tested) 9 borderline change in endocervical cells E borderline change in endocervical cells (HPV tested)

29 * non-cervical neoplasia treated as negative for CSP management
Infection codes Ø (zero) HPV negative 9 (nine) HPV positive U HPV result inadequate/unreliable Miscellaneous NTDD Next Test Due Date BLUE indicates codes used on NHAIS in format Cytology result – HPV infection code – Action code RED indicates manual action required to reset NTDD

30 Questions?


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