comparison of hpv primary screening algorithms with
TRANSCRIPT
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Comparison of HPV Primary Screening Algorithms with Cytology-Based Strategies
GISCI Workshop June 11, 2014 Catherine Behrens, MD, PhD, FACOG Director Clinical Research, Roche Molecular Systems
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FDA approved Primary Screening Algorithm
The ATHENA Trial Design
Justification for Beginning Primary Screening at 25 years
ATHENA Longitudinal Data
3 year Performance of Strategies
Conclusions
Agenda
2
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FDA approved Primary Screening Algorithm
The ATHENA Trial Design
Justification for Beginning Primary Screening at 25 years
ATHENA Longitudinal Data
3 year Performance of Strategies
Conclusions
Agenda
3
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Indicazione Approvata per lo Screening con HPV test
4
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Algoritmo di Screening HPV con genotipizzazione 16/18 e Citologia Reflex
hrHPV=high risk HPV
Routine screening HPV−
COLPOSCOPY
HPV16/18+
Follow-up in 12 months
NILM
≥ASC-US
COLPOSCOPY
Cytology 12 other hrHPV+
hrHPV
45
31 33
39
35
51
52 56 58
59 66 68
16 18
cobas® HPV Test
5
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FDA approved Primary Screening Algorithm
The ATHENA Trial Design
Justification for Beginning Primary Screening at 25 years
ATHENA Longitudinal Data
3 year Performance of Strategies
Conclusions
Agenda
6
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Colposcopy (n = 8,067)
NILM and hrHPV (-)
Women >25 yrs visiting for routine exam (n = 42,209)
>ASC-US or hrHPV (+)
Randomized (n = 895)
Exit study
<CIN2 ≥CIN2 Not Randomized
Year 3 Colposcopy
(n = 4,063)
Year 2 Visit
Year 1 Visit
ATHENA Study Design
7
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cobas® HPV Test Technology Overview Approvato per ASC-US Triage, Cotesting e Screening primario
4 canali di lettura permettono di ottenere risultati per hrHPV, e contemporaneamente per HPV 16/18 nella stessa seduta
Wright TC Jr, et al. Am J ObstetGynecol2012; 206:46.e1-.e11
16 Detects HPV16 Channel 2
18 Detects HPV18 Channel 3
45 31 33 39 35 51 52 56 58 59 66 68
12 hrHPV genotypes as a pooled result Channel 1
Detects β-globin (internal control) Channel 4
8
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FDA approved Primary Screening Algorithm
The ATHENA Trial Design
Justification for Beginning Primary Screening at 25 years
ATHENA Longitudinal Data
3 year Performance of Strategies
Conclusions
Agenda
9
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Le attuali linee guida americane non raccomandano il cotesting per le donne di 25-29 anni
Le infezioni da HPV transienti sono comuni a questa età e gli autori delle linee guida non raccomandano esami di follow-up e colposcopie non necessarie
Esiste un’alta incidenza di lesioni CIN3 nelle donne 25-29 anni e la citologia è poco performante come mostrato negli audits dello screening UK
Nel 2013 Kaiser Permanente, N. California hanno rianalizzato I loro dati di registro ed hanno deciso di avviare il cotesting all’età di 25 anni
A quale età avviare lo screening?
10
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Cervicocarcinoma invasivo negli U.S.A SEER Tumor Registry (1975-2010)
Cer
vica
l Can
cer I
ncid
ence
per
100
,000
Age Group
http://seer.cancer.gov/csr/1975_2010/
0
2
4
6
8
10
12
14
16
11
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Percentage of ≥CIN3
ATHENA data on file
Più di 1/3 di lesioni ≥CIN3 è stato rilevato nelle donne di 25-29 anni
25%
N=6647 N=22,006
Age Group
40%
30%
20%
10%
0% 25-29 40-49 30-39 >50
34.3%
16.4
40.3
8.9
(N=6647) (N=22,006)
40.3%
12
ATHENA data
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57,3 46,7 38,3
27,8
0%
20%
40%
60%
80%
100%
25-29 30-39 40-49 ≥50
42.7 53.3
61.7 72.2
ATHENA trial: Percentuale di donne con lesione ≥CIN3 e Citologia Negative (NILM)
Percentages shown are for hrHPV+ women with ≥CIN3, N=252 Huh W, et al. 27th International Papillomavirus Conference, Berlin, Germany, September 17–22, 2011, OP-229.
Prop
ortio
n of
≥C
IN3
(%)
Age
≥ASC-US NILM
13
ATHENA data
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La genotipizzazione HPV 16/18 invia meno donne alla Colposcopia che Citologia ≥ASCUS ATHENA
0%
2%
4%
6%
8%
10%
12%
14%
21-24 25-29 30-39 40-49 >50
5.3
1.6
9.5
HPV 18 HPV 16 Abnormal Pap
Wright et al. Am J ObstGynecol, 2011.
Age Group
% H
avin
g H
PV b
y co
bas®
HPV
Ass
ay
14
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FDA approved Primary Screening Algorithm
The ATHENA Trial Design
Justification for Beginning Primary Screening at 25 years
ATHENA Longitudinal Data
3 year Performance of Strategies
Conclusions
Agenda
15
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Più del 90% delle donne ≥25 anni sono HPV(-)
0,34
0,78
0
0,1
0,2
0,3
0,4
0,5
0,6
0,7
0,8
0,9
Baseline Year 1 Year 2 Year 3
HPV Negative Pap Negative
CIR
≥C
IN3
(%)
Il minor rischio di lesione di una donna hrHPV negativa alla Baseline conferma la sicurezza di un risultato hrHPV negativo sui 3 anni
16
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Il beneficio del cotesting rispetto ad HPV nel ridurre il rischio di ≥CIN3 su 3 anni è minimo
0,34
0.30*
0
0,1
0,2
0,3
0,4
0,5
0,6
0,7
0,8
0,9
Baseline Year 1 Year 2 Year 3
HPV Negative PAP and HPV Negative
CIR
≥C
IN3
(%)
un Pap test negativo insieme ad un hrHPV test negativo alla Baseline aggiunge pochi benefici ed aumenta le colposcopie da 4.6% a 5.4%
* Statistically significant difference 17
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Rischio Cumulativo per ≥CIN3 a 3 anni Popolazione Screening (≥25 anni)
0
5
10
15
20
25
30
0 1 2 3
Years of Follow-up
CIR
≥C
IN3
(%)
HPV 16+
HPV 18+
Other 12 hrHPV+
HPV-
HPV+
VBA estimates 18
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Rischio Cumulativo a 3 anni (corretto) per ≥CIN3 stratificato secondo il risultato citologico e HPV
N (% of 40,901) Screening Test CIR (95% CI)
38284 (93.6) Normal cytology 0.78 (0.53, 1.09) 2617 (6.4) Abnormal cytology 9.21 (7.91, 10.48)
35118 (85.9) Normal cytology & HPV– 0.30 (0.06, 0.64)
5783 (14.1) Abnormal cytology and/or HPV+ 9.68 (8.58, 10.73)
36626 (89.5) HPV– 0.34 (0.10, 0.65) 4275 (10.5) HPV+ 9.68 (8.58, 10.73)
3108 (7.6) HPV 12 other 5.37 (4.45, 6.35)
1167 (2.9) HPV 16/18 21.16 (18.39, 24.01)
3166 (7.7) Normal cytology & HPV+ 6.35 (5.30, 7.33) 1109 (2.7) Abnormal cytology & HPV+ 19.92 (17.06, 22.70)
2388 (5.8) Normal cytology & HPV 12 other 3.82 (2.88, 4.74)
778 (1.9) Normal cytology & HPV 16/18 14.12 (10.98, 17.21)
CIR ≥CIN3 19
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0,1 1 10 100
N (% of 40,901) Screening Test CIR (95% CI)
38284 (93.6) Normal cytology 0.78 (0.53, 1.09) 2617 (6.4) Abnormal cytology 9.21 (7.91, 10.48)
35118 (85.9) Normal cytology & HPV– 0.30 (0.06, 0.64)
5783 (14.1) Abnormal cytology and/or HPV+ 9.68 (8.58, 10.73)
36626 (89.5) HPV– 0.34 (0.10, 0.65) 4275 (10.5) HPV+ 9.68 (8.58, 10.73)
3108 (7.6) HPV 12 other 5.37 (4.45, 6.35)
1167 (2.9) HPV 16/18 21.16 (18.39, 24.01)
3166 (7.7) Normal cytology & HPV+ 6.35 (5.30, 7.33) 1109 (2.7) Abnormal cytology & HPV+ 19.92 (17.06, 22.70)
2388 (5.8) Normal cytology & HPV12 other+ 3.82 (2.88, 4.74)
720 (1.8) Abnormal cytology & HPV12 other+ 11.1 (8.4, 13.9)
CIR ≥CIN3 20
Rischio Cumulativo a 3 anni (corretto) per ≥CIN3 stratificato secondo il risultato citologico e HPV
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FDA approved Primary Screening Algorithm
The ATHENA Trial Design
Justification for Beginning Primary Screening at 25 years
The Comparator Strategies
ATHENA Longitudinal Data
3 year Performance of Strategies
Conclusions
Agenda
21
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Secondo il disegno dello studio ATHENA, tutte le donne sono uscite se ≥CIN2. Pertanto, sono state fatte ipotesi sul modello:
– Tutte le ≥CIN2 presenti alla Baseline sono persistenti fino all’anno 1
– Lesioni HPV+ all’enrollment sarebbero rimaste HPV+ all’anno 1
– Tutte le <CIN2 sono state seguite per 12 mesi con cotesting
Persistenza HPV, resultati della ripetizione della citologia e perdita dei casi in follow-up sono stati considerati nel modello
Performance degli Algoritmi sui 3 anni: ipotesi per I modelli delle strategie
22
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Citologia (ASC-US Triage)
Cervical Cytology
COLPOSCOPY
Positive
COLPOSCOPY
Negative
ASC-US HPV Testing
Negative or NILM
LSIL/HSIL
Routine screening
Rescreen in 3 years
23
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Cotesting: Citologia (ASC-US Triage) nella fascia 25-29 e Cotesting per le donne ≥30 anni
Cervical Cytology
COLPOSCOPY
Positive
COLPOSCOPY
Negative
ASC-US HPV Testing
Negative or NILM
LSIL/HSIL
Routine screening
Rescreen in 3 years
Women 25-29 years: ASC-US Triage
24
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Women ≥30 years: Cotesting
Cytology
45
31 33
39
35
51
52 56 58
59 66 68
16 18
HPV Test
NILM / HPV+
Routine screening
COLPOSCOPY
Cotesting 12 months
NILM / HPV- ASC-US / HPV-
ASC-US / HPV+ >ASC-US
cobas® HPV Test, high risk HPV DNA test 25
Cotesting: Citologia (ASC-US Triage) nella fascia 25-29 e Cotesting per le donne ≥30 anni
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Screening con HPV test HPV con genotipizzazione 16/18 inclusa
hrHPV=high risk HPV
Routine screening HPV−
COLPOSCOPY
HPV16/18+
Follow-up in 12 months 12 other hrHPV+
hrHPV
45
31 33
39
35
51
52 56 58
59 66 68
16 18
cobas® HPV Test
26
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Screening con HPV test HPV con Citologia Reflex
hrHPV=high risk HPV
Routine screening HPV−
HPV+
Follow-up in 12 months
NILM
≥ASC-US
COLPOSCOPY
Cytology hrHPV
45
31 33
39
35
51
52 56 58
59 66 68
16 18
cobas® HPV Test
27
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Algoritmo di Screening HPV con genotipizzazione 16/18 e Citologia Reflex
hrHPV=high risk HPV
Routine screening HPV−
COLPOSCOPY
HPV16/18+
Follow-up in 12 months
NILM
≥ASC-US
COLPOSCOPY
Cytology 12 other hrHPV+
hrHPV
45
31 33
39
35
51
52 56 58
59 66 68
16 18
cobas® HPV Test
28
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Performance sui 3 anni delle diverse Strategie: popolazione ≥25
Number of Detected Cases
Outcome Strategy Total Detected
at Baseline
Detected Years 1-3
Total Missed Cases
No. of Screening
Tests
No. of Colposcopies
Colposcopies to Detect 1
Case
CIN3+ Cytology 179 143 36 168 45,152 1,927 10.8
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Number of Detected Cases
Outcome Strategy Total Detected
at Baseline
Detected Years 1-3
Total Missed Cases
No. of Screening
Tests
No. of Colposcopies
Colposcopies to Detect 1
Case
CIN3+ Cytology 179 143 36 168 45,152 1,927 10.8
Hybrid strategy 240 143 97 107 82,989 3,096 12.9
30
Performance sui 3 anni delle diverse Strategie: popolazione ≥25
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Number of Detected Cases
Outcome Strategy Total Detected
at Baseline
Detected Years 1-3
Total Missed Cases
No. of Screening
Tests
No. of Colposcopies
Colposcopies to Detect 1
Case
CIN3+ Cytology 179 143 36 168 45,152 1,927 10.8
Hybrid strategy 240 143 97 107 82,989 3,096 12.9 HPV with 16/18
genotyping 276 150 126 71 49,830 3,218 11.7
31
Performance sui 3 anni delle diverse Strategie: popolazione ≥25
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Number of Detected Cases
Outcome Strategy Total Detected
at Baseline
Detected Years 1-3
Total Missed Cases
No. of Screening
Tests
No. of Colposcopies
Colposcopies to Detect 1
Case
CIN3+ Cytology 179 143 36 168 45,152 1,927 10.8
Hybrid strategy 240 143 97 107 82,989 3,096 12.9 HPV with 16/18
genotyping 276 150 126 71 49,830 3,218 11.7
HPV with reflex cytology
271 133 138 76 54,098 3,191 11.8
32
Performance sui 3 anni delle diverse Strategie: popolazione ≥25
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Number of Detected Cases
Outcome Strategy Total Detected
at Baseline
Detected Years 1-3
Total Missed Cases
No. of Screening
Tests
No. of Colposcopies
Colposcopies to Detect 1
Case
CIN3+ Cytology 179 143 36 168 45,152 1,927 10.8
Hybrid strategy 240 143 97 107 82,989 3,096 12.9 HPV with 16/18
genotyping 276 150 126 71 49,830 3,218 11.7
HPV with reflex cytology
271 133 138 76 54,098 3,191 11.8
HPV with 16/18 genotyping and reflex cytology
294 197 97 53 52,651 3,767 12.8
33
Performance sui 3 anni delle diverse Strategie: popolazione ≥25
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Number of Detected Cases
Outcome Strategy Total Detected
at Baseline
Detected Years 1-3
Total Missed Cases
No. of Screening
Tests
No. of Colposcopies
Colposcopies to Detect 1
Case
CIN2+ Cytology 270 215 55 317 45,152 1,927 7.1
Hybrid strategy 384 215 169 203 82,989 3,096 8.1
HPV with 16/18 genotyping
441 197 244 146 49,830 3,218 7.3
HPV with reflex cytology
443 200 243 144 54,098 3,191 7.2
HPV with 16/18 genotyping and reflex cytology
471
283
188
116
52,651
3,767
8.0
34
Performance sui 3 anni delle diverse Strategie: popolazione ≥25
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Conclusioni:
• Lo screening con HPV test con genotipizzazione16/18 e citologia in reflex, solo o in combinazione, è più sensibile della citologia nelle donne ≥25
• L’algoritmo che comprende cobas® HPV Test con genotipizzazione 16/18 e citologia reflex
– individua più lesioni alla baseline ed evita le perdite in follow-up
– offre almeno una sensibilità equivalente al cotesting e richiede ~1/2 diel numero di tests
– nella fascia 25-29 anni: individua più lesioni rispetto alla citologia e invia alla colposcopia solo le donne a più alto rischio
• La sicurezza del test cobas HPV come test primario è confermata dalla dimostrazione che un test negativo alla Baseline predice un rischio minore di lesioni ≥CIN3 a 3 anni rispetto ad un Pap test negativo alla Baseline
35
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Doing now what patients need next
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Backup slides
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3 Year Performance of Various Strategies: Women 25-29 years
Number of Detected Cases
Outcome Strategy Total Detected
at Baseline
Detected Years 1-3
Total Missed Cases
No. of Screening
Tests
No. of Colposcopies
Colposcopies to Detect 1
Case CIN3+ Cytology 51 37 14 68 7,846 634 12.4
Hybrid strategy 51 37 14 68 7,846 634 12.4
HPV with 16/18 genotyping
97 49 48 22 9,413 1,081 11.1
HPV with reflex cytology
92 35 57 27 10,829 1,037 11.3
HPV with 16/18 genotyping and reflex cytology
102 61 41 17 10,227 1,246 12.2
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3 Year Performance of Various Strategies: Women 25-29 years
Number of Detected Cases
Outcome Strategy Total Detected
at Baseline
Detected Years 1-3
Total Missed Cases
No. of Screening
Tests
No. of Colposcopies
Colposcopies to Detect 1
Case CIN2+ Cytology 85 71 14 125 7,846 634 7.5
Hybrid strategy 85 71 14 125 7,846 634 7.5
HPV with 16/18 genotyping
160 75 85 50 9,413 1,081 6.8
HPV with reflex cytology
158 67 91 52 10,829 1,037 6.6
HPV with 16/18 genotyping and reflex cytology
172 105 67 38 10,227 1,246 7.2
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3 Year Performance of Various Strategies: Women ≥30 years
Number of Detected Cases
Outcome Strategy Total Detected
at Baseline
Detected Years 1-3
Total Missed Cases
No. of Screening
Tests
No. of Colposcopies
Colposcopies to Detect 1 Case
CIN2+ Cytology 185 144 41 192 37,306 1,293 7.0
Hybrid strategy 299 144 155 78 75,148 2,462 8.2
HPV with 16/18 genotyping
281 122 159 96 40,417 2,137 7.6
HPV with reflex cytology
285 133 152 92 43,269 2,154 7.6
HPV with 16/18 genotyping and reflex cytology
299 178 121 78 42,424 2521 8.4
CIN3+ Cytology 128 106 22 100 37,306 1293 10.1
Hybrid strategy 189 106 83 39 75,148 2,462 13.0
HPV with 16/18 genotyping
179 101 78 49 40,417 2,137 11.9
HPV with reflex cytology
179 98 81 49 43,269 2,154 12
HPV with 16/18 genotyping and reflex cytology
192 136 56 36 42,424 2,521 13.1