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78strategiesn in ksa 78strategiesn in ksa Presentation Transcript

  • Dr.Nisrin  Anfinan   Consultant  Gynecology  Oncology     King  Abdulaziz  University  Hospital    
  • 64,928 Europe 67,078 Africa 49,025 South America 14,845 United States/ Canada 1,077 Australia/ New Zealand 39,648 Southeast Asia 51,266 Eastern Asia 21,596 Central America 151,297 Southcentral Asia Cervical  Cancer:  Worldwide  Prevalence,  Incidence,  and     Mortality  Es8mates   Prevalence:  2,274,000  women  have  cervical  cancer1   Incidence:  510,000  new  cases  each  year1   Mortality:  Second  leading  cause  of  female  cancer-­‐related  deaths  (288,000  annually)1     1.  World  Health  Organization.  Geneva,  Switzerland:  World  Health  Organization;  2003:1–74.  2.  Bosch  FX,  de  Sanjosé  S.     J  Natl  Cancer  Inst  Monogr.  2003;31:3–13.       2000 estimated incidence of invasive cervical cancer ! by selected region2:
  • Saudi Arabia Cervical  Cancer:  In  Saudi  Arabia  ,  Incidence,    and  Mortality  Es8mates   1.9  cases  per  100,000  women,  accounting  for  2.6%  of  diagnosed  cancer  cases  in   women         Every  year,  152  women  are  diagnosed  with  cervical   cancer  and  55  die  from  the  disease.      new  cervical  cancer  cases  and  deaths  in  2025  are  309     Cancer  Incidence  Report  Saudi  Arabia  2007.  Available  at  www.scr.org.sa/reports/SCR2007.pdf  Accessed  on   June  26,  2011  
  • Cervical  Cancer:  Global  Stats   Age  Standardized   Incidence  rate/ 100000  women   Total  Cases     Deaths   World   15.3   530232   275008   Saudi   Arabia   1.9   152   55   Western   Asia   39.18   4.5   2.1   Canada   6.6   1419   544   Globocan  2008  IARC  
  • Cervical  Cancer:  Saudi  Arabia   —  Very  low  incidence,  1.9/100,000  women   —  ?  Any  demographic  data  on  “high  risk  groups”?   —  Very  little  known  about  HPV  incidence  and   transmission   —  Data  on  conventional  pap  triage  is  poor   —  Hospital  based   —  No  population  based  data  
  • Foreseeable  Challenges:    —  To  understand  the  prevalence  of  high-­‐risk  (HR)-­‐HPV  infections     and  the  prevalence  of  abnormal  cytology  findings  in  general   population.   To  understand  the  sexual  practices  of  the  population.   By  region  and  population  group.   Implementation  of  any  screening  program,  either  primary  or   secondary,  will  be  difficult  in  patients  with  a  sexually   transmitted  infection.   Vaccination  –  is  it  cost-­‐effective  given  the  low  rates  of  cervical   cancer?   Introduction  of  quality  assurance  in  screening  and  colposcopy.   Which  screening  method  should  be  used  and  how  does  one  triage   the  patients?  
  • Foreseeable  Challenges:    —  To  understand  the  prevalence  of  high-­‐risk  (HR)-­‐HPV  infections     and  the  prevalence  of  abnormal  cytology  findings  in  general   population.   —  To  understand  the  sexual  practices  of  the  population.   —  By  region  and  population  group.   Implementation  of  any  screening  program,  either  primary  or   secondary,  will  be  difficult  in  patients  with  a  sexually   transmitted  infection.   Vaccination  –  is  it  cost-­‐effective  given  the  low  rates  of  cervical   cancer?   Introduction  of  quality  assurance  in  screening  and  colposcopy.   Which  screening  method  should  be  used  and  how  does  one  triage   the  patients?  
  • Foreseeable  Challenges:    —  To  understand  the  prevalence  of  high-­‐risk  (HR)-­‐HPV  infections     and  the  prevalence  of  abnormal  cytology  findings  in  general   population.   —  To  understand  the  sexual  practices  of  the  population.   —  By  region  and  population  group.   —  Implementation  of  any  screening  program,  either  primary  or   secondary,  will  be  difficult  in  patients  with  a  sexually   transmitted  infection.   Vaccination  –  is  it  cost-­‐effective  given  the  low  rates  of  cervical   cancer?   Introduction  of  quality  assurance  in  screening  and  colposcopy.   Which  screening  method  should  be  used  and  how  does  one  triage   the  patients  
  • Foreseeable  Challenges:    —  To  understand  the  prevalence  of  high-­‐risk  (HR)-­‐HPV  infections     and  the  prevalence  of  abnormal  cytology  findings  in  general   population.   —  To  understand  the  sexual  practices  of  the  population.   —  By  region  and  population  group.   —  Implementation  of  any  screening  program,  either  primary  or   secondary,  will  be  difficult  in  patients  with  a  sexually   transmitted  infection.   —  Vaccination  –  is  it  cost-­‐effective  given  the  low  rates  of  cervical   cancer?   Introduction  of  quality  assurance  in  screening  and  colposcopy.   Which  screening  method  should  be  used  and  how  does  one  triage   the  patients?  
  • Foreseeable  Challenges:    —  To  understand  the  prevalence  of  high-­‐risk  (HR)-­‐HPV   infections    and  the  prevalence  of  abnormal  cytology   findings  in  general  population.   —  To  understand  the  sexual  practices  of  the  population.   —  By  region  and  population  group.   —  Implementation  of  any  screening  program,  either  primary   or  secondary,  will  be  difficult  in  patients  with  a  sexually   transmitted  infection.   —  Vaccination  –  is  it  cost-­‐effective  given  the  low  rates  of   cervical  cancer?   —  Introduction  of  quality  assurance  in  screening  and   colposcopy.    
  • Foreseeable  Challenges:    —  To  understand  the  prevalence  of  high-­‐risk  (HR)-­‐HPV  infections     and  the  prevalence  of  abnormal  cytology  findings  in  general   population.   —  To  understand  the  sexual  practices  of  the  population.   —  By  region  and  population  group.   —  Implementation  of  any  screening  program,  either  primary  or   secondary,  will  be  difficult  in  patients  with  a  sexually   transmitted  infection.   —  Vaccination  –  is  it  cost-­‐effective  given  the  low  rates  of  cervical   cancer?   —  Introduction  of  quality  assurance  in  screening  and  colposcopy.   —  Which  screening  method  should  be  used  and  how  does  one   triage  the  patients?  
  • Cervical  Cancer  Preven8on   Normal   Cervix   HPV   Infection   Cervical   Dysplasia   Cervical   Cancer   Primary   Prevention:   Vaccination   Secondary   Prevention:   Screening  
  • PRIMERY  PREVENSION    
  • Transmission  of  HPV   — Prevalence  in  asymptomatic  North  American   women  is  2-­‐40  %  mean  10.41%   —  Highest  in  young  women   — Sexual  contact  primary  route  of  transit,   important  factors   —  Earlier  age  at  sexual  debut   —  Increased  number  of  partners     — More  transmissible  than  any  virus  but  less  than   bacterial  infections   Burchell  et  al  Vaccine  24S3  (2006)  
  • Ac8ve  protec8on  via  vaccina8on  is  mediated  by   neutralizing  an8bodies  at  the  cervix   HPV   Cervical  canal   Neutralizing  an8bodies   Blood  vessel   Epithelial  tear   Basement  membrane   Cervical   epithelium   1.  Stanley  M.  Vaccine  2006;  24:S16–S22;     2.  Giannini  S,  et  al.  Vaccine  2006;  24:5937–5949;     3.  Nardelli-­‐Haefliger  D,  et  al.  J  Natl  Cancer  Inst  2003;  95:1128–1137;     4.  Poncelet  S,  et  al.  IPC  2007(poster).  
  •  Product  characteristics  –  prophylactic      HPV   vaccines   CervarixTM1 Gardasil®2 Antigen VLPs of HPV 16 & 18 VLPs of HPV 16, 18, 6 & 11 Administration 0, 1 & 6 months by intramuscular injection 0, 2 & 6 months by intramuscular injection 1.  CervarixTM.  European  Summary  of  Product  Characteris8cs,  2007;   2.  Gardasil®.  European  Summary  of  Product  Characteris8cs,  2008.  
  • HPV  Vaccines:  Cross  Protec8on   Gardasil(Merck) Quadrivalent Cervarix (GSK) Bivalent HPV 45 (related to 18) V/P 3/2 V/P 1/17 Reduction 94% HPV 31 (related to 16) V/P 5/21 Reduction 76% V/P 14/30 Reduction 54%
  • HPV  Vaccines:  Published  data   Gardasil(Merck) Cervarix (GSK) Dose and administration 0.5 ml IM 0.5 ml IM Schedule 0,2,6 months 0,1,6 months Trial size 17622 18644 comparator Placebo with alum Hepatitis A Site Up to 16 countries 14 countries Age range 16-24; 15-26 15-25 eligibility < 4 sexual partners ( median 2) < 6 sexual partners exclusion Hx of abnormal pap smears; pregnancy Hx of colposcopy, immunocompromised or pregnant duration 48 month study, 3 year data Mean 14.8 months
  • HPV  Vaccina8on  Efficacy    Harper  D;  Expert  Review  Vaccines  2009  
  • Vaccine  efficacy   —  Safe  effective  vaccines     —  Trials  show  a  reduction  in  CIN  and  treatment     —  Other  trials  have  shown  safety  and  immunogenicity  in   women  9-­‐15  years  old  
  •        Safety/Adverse  Events       GARDASIL Quadravalent CERVARIX Bivalent 14 days after injection Gardasil (14 days after injection) (n=5088)% Alum Placebo (n=3470)% Saline Placebo (n=320)% Cervarix (7 days after injection) (n=22806)% Alum Placebo (n=4485)% HAV 720 (n=8750)% Injection site Pain 83.9 75.4 48.6 78 52.5 58.9 Swelling 25.4 15.8 7.3 25.8 8.2 10.1 Erythema 24.6 18.4 12.1 29.6 10.6 16.1 Puritis 3.1 2.8 0.6 Not noted Not noted Not noted Systemic Fever (>37.8oC) 10.3 8.6 5.1 5.2 4.6 Nausea 4.2 4.1 12.9 11.6 14.0Diarrhea 1.2 1.5 Dizziness 2.8 2.6 Data  taken  from  product  monograph  Canada  and  Australia  
  • When  to  vaccinate?   —  Should  vaccinate  before  sexual  activity     —  Works  best  in  a  school  based  program   —  High  rates  of  vaccination  in  UK,  Canada  Australia  etc;   where  school  based  programs  are  used      
  • Dura8on  and  Safety   —  Both  vaccines  have  demonstrated  efficacy  beyond  7   years     —  Antibody  levels  vary,  but  there  has  been  no  evidence   of  breakthrough  infections  thus  far     —  All  evidence  from  the  millions  of  doses  given  confirms   that  they  are  very  safe  vaccines  
  • HPV  vaccine  in  Saudi  Arabia                                          Statement  
  • Saudi  Gynecology  Oncology  Group(  SGOG)  statement       —  Health  care  providers  should  be  encouraged  to  discuss  HPV   vaccine  for  women  who  wish  to  be  vaccinated  and  help  them  in   the  decision  making.   Primary  Vaccination  with  three  doses  of  cancer  cervix  vaccine   should  be  given  for  females  15  to  26  years  of  age  to  decrease  the   risk  of  HPV  infection  and  subsequently  prevent  cervical  cancer.   In  addition  catch-­‐up  immunization  for  women  above  age  26   years  could  be  done  .     Women  who  received  the  HPV  vaccine  should  continue  to  follow   the  existing  cervical  cancer  screening  programs.        
  • Saudi  Gynecology  Oncology  Group(  SGOG)  statement       —  Health  care  providers  should  be  encouraged  to  discuss  HPV   vaccine  for  women  who  wish  to  be  vaccinated  and  help  them  in   the  decision  making.   —  Primary  Vaccination  with  three  doses  of  cancer  cervix  vaccine   should  be  given  for  females  15  to  26  years  of  age  to  decrease  the   risk  of  HPV  infection  and  subsequently  prevent  cervical  cancer.   In  addition  catch-­‐up  immunization  for  women  above  age  26   years  could  be  done  .     —  Women  who  received  the  HPV  vaccine  should  continue  to   follow  the  existing  cervical  cancer  screening  programs.        
  • Saudi  Gynecology  Oncology  Group(  SGOG)  statement       —  Health  care  providers  should  be  encouraged  to  discuss  HPV   vaccine  for  women  who  wish  to  be  vaccinated  and  help  them  in   the  decision  making.   —  Primary  Vaccination  with  three  doses  of  cancer  cervix  vaccine   should  be  given  for  females  15  to  26  years  of  age  to  decrease  the   risk  of  HPV  infection  and  subsequently  prevent  cervical  cancer.   In  addition  catch-­‐up  immunization  for  women  above  age  26   years  could  be  done  .     —  Women  who  received  the  HPV  vaccine  should  continue  to   follow  the  existing  cervical  cancer  screening  programs.        
  •        Cervical  Cancer  Preven8on   Normal   Cervix   HPV   Infection   Cervical   Dysplasia   Cervical   Cancer   Primary   Prevention:   Vaccination   Secondary   Prevention:   Screening  
  • Op8ons    in  screening       —  PAP  smear       —  VIA       —  HPV  testing      
  • Collec8on  methods   Physician  /  nurse  collection     Patient  self  collection    
  • Cervical  cancer  decrease  with  PAP  smear  
  • Cervical  Screening:  Status  and  Challenges   —  Well  established  system  of  cytology  screening  with   colposcopy  follow-­‐up   —  Successful  in  reducing  the  incidence  and  mortality   from  cervical  cancer   However:   —  Realistically  in  Canada  ,  they  have  been  unable  to   screen  more  than  70%  of  the  population  well   —  How  would  a  cytology  based  program  work  in  Saudi   Arabia?   —   What  effect  will  vaccination  have?  
  • Limita8ons  of  Cytology   —  Sensitivity  of  pap  test  to  detect  CIN3+:  55%   —  Should  be  done  in  the  context  of  an  organized  screening   program   —  Quality  assurance  of  cytology  needs  to  be  very  good   —  system  of  communication  to  the  women  screened  so  that   they  may  receive  sufficient  treatment.   —  Requires  colposcopy  and  biopsy  to  confirm  dysplasia   —  The  necessity  for  multiple  visits  with  cytology  based            screening  results  in  significant  loss  to  follow-­‐up  
  • Limita8ons  of  Cytology   —  Sensitivity  of  pap  test  to  detect  CIN3+:  55%   —  Should  be  done  in  the  context  of  an  organized  screening   program   —  Quality  assurance  of  cytology  needs  to  be  very  good   —  system  of  communication  to  the  women  screened  so  that   they  may  receive  sufficient  treatment.   —  Requires  colposcopy  and  biopsy  to  confirm  dysplasia   —  The  necessity  for  multiple  visits  with  cytology  based            screening  results  in  significant  loss  to  follow-­‐up  
  • Limita8ons  of  Cytology   —  Sensitivity  of  pap  test  to  detect  CIN3+:  55%   —  Should  be  done  in  the  context  of  an  organized  screening   program   —  Quality  assurance  of  cytology  needs  to  be  very  good   —  system  of  communication  to  the  women  screened  so  that   they  may  receive  sufficient  treatment.   —  Requires  colposcopy  and  biopsy  to  confirm  dysplasia   —  The  necessity  for  multiple  visits  with  cytology  based            screening  results  in  significant  loss  to  follow-­‐up  
  • Authora   Duration   Total no   Abnormal PAP smear   ASC-US   ASC-H   LSIL   HSIL   AGUS   INVASIVE   CANCER   Al-Jaroudi (8)   2008-2009   241   7   (2.9%)   3   (1.2%)   1   (0.4%)   2   (0.83%)   NR   1   (0.4%)   NR   Jamal   1984-2000   22089   368   (1.66%)   88   (0.4%)   NR   81   (0.37%)   72   (0.32%)   36   (0.16%)   26   (0.1%)   Altaf   2001   3088   97   (3.14%)   14   (0.45%)   NR   29   (0.93%)   17   (0.55%)   4   (0.13%)   5   (0.16%)   Abdullah L (1)   1998 – 2005   5590   261   (4.7%)   103   (1.84%)   6   (0.10%)   5   (0.09%)   31   (0.55%)   30   (0.53%)   2   (0.04%)   Altaf   2000-2004   5132   241   (4.7%)   124   (2.4%)   NR   31   (0.6%)   22   (0.4%)   58   (1.1%)   6   (0.1%)   Summary  of  reported  data  on  Pap  smear  abnormalities  in  Saudi  Arabia  
  • Visual  Inspec8on  with  Ace8c  Acid  (VIA)  
  • Op8ons  in  Screening   —  VIA:  Visual  inspection  with  acetic  acid     —  VILI:  Visual  inspection  with  Lugols  iodine   —  Both  Low  tech  can  be  done  by  nurses   —  May  need  to  utilize  colposcopy  to  triage  post  positive   test  to  rule  out  cancer  
  • Test  Quali8es  of  VIA  in  Primary  Healthcare  Sefng   (Phase  2)   TEST SENSITIVITY (%) SPECIFICITY (%)* POSITIVE PREDICTIVE VALUE (%)* NEGATIVE PREDICTIVE VALUE (%)* VIA (n = 2,130) 77 (70–82) 64 (62–66) 19 96 Pap smear (n = 2,092) 44 (35–51) 91 (37–51) 33 94 95%  Confidence  Interval   University  of  Zimbabwe/JHPIEGO  Cervical  Cancer  Project  1999.  
  • HPV  tes8ng  in  cervical  cancer  screening   Approaches  already  implemented  or  being  examined:     Ø  Serial:  Cytology  screening  followed  by  HPV  testing  to   triage  ASC-­‐US  (USA,  Nfld)     Ø  Parallel:  Cytology  and  HPV  cotesting  (approved  in  USA,   implemented  in  California(Kaiser),Quebec)     Ø  Serial:  HPV  testing  followed  by  cytologic  triage  (being   examined  in  the  Finnish  trial,  BC  RCT,  a.k.a.,  HPV   FOCAL  Study)  
  • HPV  Tes8ng   ADVANTAGES   —  Very  sensitive     —  Better  quality  control     —  Decreases  the  number  of   cytologists  needed     —  Increase  screening  interval   which  decreases  cost  and   improves  convenience   DISADVANTAGES     —  Need  a  second  test  due   to  lower  specificity  
  • Role  of  HPV  tes8ng   •  Triage  equivocal  or  low  grade  cytology  smears          (ALTS  trial)   •  FUP  of  women  with  abnormal  cytology  but  normal            colposcopy   •  Predict  outcome  after  treatment  of  high  grade  disease   •  Primary  Screening     Cuzick  J.  Vaccine  2008  
  • CCCAST  trial   PAP  HPV   55.6%  94.6%  Sensitivity     96.8%  94.1%  Specificity              Mayrand  et  al.;   Ø compare  the  relative  efficacy  of  HPV  DNA  testing  and  Pap  cytology         in  primary  screening  for  cervical  cancer  and  its  high-­‐grade  precursors     NEJM  2007   Ø Pap  screening  followed  by  HPV  (hc  2)  vs  hc2    testing   followed  by  HPV  in  women  30-­‐69   Ø   9,667    women     HPV  testing  is  significantly  more  sensitive  to  detect  CIN  2+  
  • HPV  Screening  for  Cervical  Cancer  in  India    Sankaranarayanan,R:     —  RCT  ,4  Arms  of  screening  tool  in  India     —  HPV  test  vs.  Pap  test  vs.  VIA  vs.  Observation   —  Cervical  cancer  as  an  endpoint   —  32000  women  in  each  arm   —  Screen  positive  received  colposcopy  and  treatment   —  Only  significant  screening  method  to  reduce  deaths   from  cervical  cancer  was  HPV  testing     —  Significant  reduction  in  Ca  Cervix    in  the  HPV   negative  compared  to  negative  Pap  and  VIA     NEJM  Apr2009  360(14)1385-­‐94  
  • HPV  tes8ng  RCT    Ronco  etal     —  Trial  in  Italy   —  94000  women  25-­‐60  randomized  in  2  phases     Ø Cytology    vs.  HPV  testing  and  cytology  (phase  1)   Ø     HPV  testing  alone  (phase  2).     —  Same  rate  of  cancer  in  round  one  of  testing   —  Increased  cancer  in  cytology  group  in  round  two   —  HPV  testing  was  more  effective  in  preventing  cancer  by   detecting  high  grade  lesions  earlier.   —  However:  HPV  testing  leads  to  over  diagnosis  of  CIN  2   which  is  likely  to  resolve   Ronco  G;  Lancet  March  2010    
  • Cost  Effec8veness        Several  studies  proved  the  cost  effectiveness  of  HPV  testing     as  screening  test  for  Cervical  cancer       —  In  developing  countries     —  Screening  program  not  well  established     —  Middle  income                                                                                                                                      Br  J  Cancer.2010  Dec  7;103(12):1773-­‐82.                                                                                                                                                                                              Cancer  Causes  Control.2011  Feb;22(2):261-­‐72.                                                                                                                                                                                              Eur  J  Cancer.  2011  Jul;47(11):1633-­‐46  
  • Screening  program  in  Saudi  Arabia    
  • Suggested  Screening  Strategy   —  Use  the  high  sensitivity  of  HPV  test  initially   —  Digene  Hybrid  capture  2  test  is  suitable     —  Positive  HPV  test  has  reflex  pap  testing     —  If  both  positive  colposcopy  is  performed     —  If  HPV  neg  repeat  screen  in  5  years     —  If  HPV  +ve  and  pap  neg,  repeat  HPV  and  pap  in  1  year  
  •              HR-­‐HPV  tes8ng  and  Reflex  PAP   HR-­‐HPV  DNA  in  women  30  +  years  old   Negative   Negative   Negative   Pap  test   Positive   Positive   Colposcopy   Positive   Repeat  HR-­‐DNA   testing  @  5  year   intervals  till  age   65   Repeat  HR-­‐ HPV  testing  at   12  months  
  • Conclusions   —  Introduction  of  a  cervical  cancer  prevention  program   in  Saudi  Arabia  is  possible   —  Vaccination  has  the  promise  to  prevent  cervical   cancer  in  a  large  group  of  women   —  Screening  should  be  done  using  HPV  testing  as  the   initial  method   —  All  aspects,  i.e.  Screening,  colposcopy,  treatment  and   invasive  cancer  surveillance  require  very  careful   quality  assurance  processes.  
  •                    Thank  you