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Results of Sentinel Sites Study Dr Karin Denton. HPV testing as a triage for women with low grade cytological abnormalities: results from the sentinel.

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Presentation on theme: "Results of Sentinel Sites Study Dr Karin Denton. HPV testing as a triage for women with low grade cytological abnormalities: results from the sentinel."— 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.Br J Cancer Sep 27;105(7):983-8.

3 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 BorderlineMildTotal Age Grp No of women HPV + n (%) No of women HPV + n (%) No of women HPV + n (%) (68.7) (89.2) (77.2) (41.9) (77.0) (52.0) (31.0) (66.5) (40.2) Total (53.7) (83.9) (64.4) North Bristol NHS Trust/Avon Cervical screening programme

5 SSS Results from different centres HPV positive rate by site and initial cytology 1 SiteBorderlineMildTotal nHPV +ve (%) nHPV +ve (%) nHPV +ve (%) ABCDEFABCDEF (68.6) 224 (34.8) 1111 (43.4) 455 (57.7) 406 (61.2) 434 (73.3) (91.6) 384 (73.4) 1232 (81.8) 372 (88.6) 500 (89.8) 116 (87.2) (74.1) 608 (52.1) 2343 (57.7) 827 (68.4) 906 (74.3) 550 (75.9) North Bristol NHS Trust/Avon Cervical screening programme

6 SSS Results from different centres HPV positive rate by site and initial cytology 2 SiteBorderlineMildTotal nHPV +ve (%) nHPV +ve (%) nHPV +ve (%) Centre C (Thinprep® LBC) (47.7) (83.8) (61.0) Centre C (BD Surepath TM LBC) (50.7) (84.6) (63.0) Total (Thinprep® LBC) (58.2) (87.7) (68.7) Total (BD Surepath TM LBC) (52.6) (78.5) (61.7) North Bristol NHS Trust/Avon Cervical screening programme

7 Sentinel Site Study Results at colposcopy CIN 1CIN2CIN3+ n (%) BL (20.4) 173 (16.3) 27 (15.8) 193 (10.0) 88 (8.3) 4 (2.3) 142* (7.4) 65 (6.1) 5 (2.9) Total594 (18.8)285 (9.0)212 (6.7) Mild (26.7) 236 (29.6) 31 (23.8) 217 (12.4) 87 (10.9) 8 (6.2) 111 (6.3) 30 (3.8) 3 (2.3) Total735 (27.5)312 (11.7)144 (5.4) Total 1239 (22.8)597 (10.2)356 (6.1) North Bristol NHS Trust/Avon Cervical screening programme *Includes 3 invasive cancers

8 Sentinel Site Study PPV of colposcopy by site 1 SiteBorderlineMild No attending colposcopy PPV CIN2+ PPV CIN3+ No attending colposcopy PPV CIN2+ PPV CIN3+ ABCDEFABCDEF North Bristol NHS Trust/Avon Cervical screening programme

9 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 cytologyCIN1CIN2CIN3 No.% % %.No.% 1 year 2 years 3 years >3 years North Bristol NHS Trust/Avon Cervical screening programme

10 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(%) Histol Smear\ NilHPV/ inflam CIN1CIN2CIN3Micro Bline HPV Mild HPV

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 Smear + hpv test 6 months after treatment Cytology negative HPV negative 3 year recall Cytology negative and HPV positive – recall colp (12%) Colp satisfactory 3 year recallColp unsatisfactory Colp abnormal Biopsy and retreat (4.8%) Cytology positive Recall colp (6%) Biopsy/treat

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 Michaels = 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? Dont panic, no change to data collection or categories

23 Longer term impact on KC61 data BC rate will fall (due to loss of 2 nd and 3 rd 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 Aroutine recall Rmearly repeat in 'm' months Ssuspend from recall PROVISIONAL Result codes Ø *?glandular neoplasia (non cervical) G *?glandular neoplasia (non cervical) (HPV tested) 1inadequate 2negative (not HPV tested) Nnegative (HPV tested) 3low grade dyskaryosis (not HPV tested) Mlow grade dyskaryosis (HPV tested) 4high grade dyskaryosis (severe) 5high grade dyskaryosis ?invasive squamous carcinoma 6?glandular neoplasia of endocervical type 7high grade dyskaryosis (moderate) 8borderline change in squamous cells (not HPV tested) Bborderline change in squamous cells (HPV tested) 9borderline change in endocervical cells Eborderline 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 UHPV result inadequate/unreliable Miscellaneous NTDDNext 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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