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UCINKOVITOST POSAMEZNIH METOD ZDRAVLJENJA PREDRAKAVIH SPREMEMB MATERNICNEGA VRATU
Avtor: Nina Jancar, Igor Muževic
Mentor: doc. dr. Eda Vrtacnik Bokal
Somentor: prof. dr. Mario Poljak
IZHODIŠCE: Rak maternicnega vratu (RMV) je drugi najpogostejši rak, ki prizadene ženske po vsem svetu. Razvije se preko vec stopenj intraepitelijskih sprememb. Incidenca RMV je v Sloveniji višja kot v razvitih državah. RMV šteje za eno redkih oblik raka, ki jo je mogoce prepreciti in pozdraviti, ce odkrijemo zgodnje predrakave spremembe. Nujen etiološki dejavnik za nastanek RMV je dolgotrajna okužba z visokorizicnimi genotipi humanih virusov papiloma (HPV). Presejalni test za odkrivanje predrakavih sprememb maternicnega vratu (MV) je citološki bris po Papanicolaou (PAP). Kot dodatni test ponekod uporabljajo test za odkrivanje okužbe s HPV. Za zdravljenje predrakavih sprememb MV najpogosteje uporabljamo lasersko vaporizacijo (LV), ekscizijo transformacijske cone z elektricno zanko (LETZ) in konizacijo. NAMEN: Namen naše raziskave je bil ugotoviti uspešnost posameznih metod zdravljenja (LV, LETZ, konizacija) predrakavih sprememb MV. Glede na to, da je v Sloveniji veliko žensk s citološkim izvidom PAP II, ki potrebujejo nadaljnjo opredelitev resnosti lezije, smo poskušali ugotoviti, ce bi dodatno testiranje teh bolnic v smeri odkrivanja okužbe s HPV pripomoglo k lažjemu odlocanju za nadaljnje ukrepanje. HIPOTEZA: Preiskovanke, okužene s HPV, smo po opravljenem operativnem posegu ponovno testirali za prisotnost okužbe s HPV, da bi preverili naslednjo hipotezo: Pri ženskah, okuženih z visokorizicnimi genotipi HPV, po opravljeni metodi LETZ ali konizaciji, izzveni okužba s temi virusi. METODE: V prospektivno raziskavo smo vkljucili 151 preiskovank, ki smo jih glede na citološki izvid razdelili v dve skupini: preiskovanke s PAP II izvidom in preiskovanke s PAP III izvidom. Vsem preiskovankam smo odvzeli bris MV in ga analizirali z metodo Hybrid Capture 2™ (HC 2) za dokaz okužbe z visokorizicnimi genotipi HPV. Preiskovanke smo zdravili z LV, LETZ ali konizacijo. Pri vseh preiskovankah smo med posegom pridobili material za histološki pregled. HPV pozitivnim preiskovankam smo 9 mesecev po posegu ponovno odvzeli bris za dokaz okužbe s HPV. Za statisticno obdelavo podatkov smo uporabili dvosmerne statisticne metode. Uporabili smo Mann-Whitneyjev test, Pearsonov hi-kvadrat test ter McNemarjev test. REZULTATI: Okužba s HPV je izzvenela pri 66,7% (95% interval zaupanja [IZ] = 46,7 do 82,0%) (n=16) preiskovank zdravljenih z LV, pri 91,3% (95% IZ = 73,2 do 97,6%) (n=21) preiskovank zdravljenih z LETZ ter pri 100,0% (95% IZ = 72,3 do 100,0%) (n=10) preiskovank zdravljenih s konizacijo. Uspešnost LV v primerjavi z LETZ in konizacijo je bila statisticno znacilno nižja (p<0,05). Prekuženost s HPV pri preiskovankah s citološkim izvidom PAP II je bila 25,0% (95% IZ = 16,6 do 35,8%) (n=19), pri preiskovankah s PAP III izvidom je bila prekuženost 72,0% (95% IZ = 61,0 do 80,9%) (n=54) (p<0,001). Preiskovanke z izvidom PAP II so imele v 72,6% (95% IZ = 61,8 do 81,9%) (n=53) histološki izvid manj kot CIN II, preiskovanke z izvidom PAP III so imele v 26,0% (95% IZ = 17,0 do 36,7%) (n=19) histološki izvid manj kot CIN II (p<0,001). Obcutljivost PAP testa v kombinaciji s HC 2 testom za odkrivanje intraepitelijskih lezij visoke stopnje (CIN II ali vec) je bila 82,3% (95% IZ = 74,0 do 89,6%), specificnost je bila 61,4% (95% IZ = 53,2 do 68,6%). Od vseh preiskovank jih je imelo 30,1% (95% IZ = 23,3 do 38,0%) (n=44) PAP II izvid in hkrati HPV negativen izvid ob histološkem izvidu manj kot CIN II. ZAKLJUCKI: Rezultati raziskave so potrdili našo hipotezo. Po opravljeni metodi LETZ v visokem odstotku izzveni okužba s HPV. Po konizaciji okužba s HPV vedno izzveni. Za odpravljanje okužbe s HPV sta operativni metodi LETZ in konizacija ucinkovitejši od LV. Citološki izvid PAP III predstavlja zadostno indikacijo za poseg. Citološki izvid PAP II v kombinaciji s kolposkopijo ni zadostna indikacija za poseg. Obcutljivost za odkrivanje intraepitelijskih lezij visoke stopnje je dobra, ce uporabimo PAP citološki test v kombinaciji s HC 2 testom. Z omenjeno kombinacijo bi zmanjšali število prekomerno zdravljenih žensk s citološkim izvidom PAP II.
[Abstract / English version]
UCINKOVITOST POSAMEZNIH METOD ZDRAVLJENJA PREDRAKAVIH SPREMEMB MATERNICNEGA VRATU
Author: Nina Jancar, Igor Muževic
Mentor: doc. dr. Eda Vrtacnik Bokal
Co-mentor: prof. dr. Mario Poljak
BACKGROUND: Cervical cancer ranks as the second leading cancer among women worldwide. It evolves through several stages of preinvasive intraepithelial changes. The incidence of cervical cancer is higher in Slovenia than in most developed countries. Cervical cancer is regarded as the most preventable and treatable form of major cancer through early diagnosis of preinvasive and invasive disease. Persistent infection with high-risk types of human papillomavirus (HPV) is necessary for the development of cervical cancer. The Papanicolaou (PAP) smear is the screening test for detecting cervical cytological abnormalities. Testing for HPV DNA is used as adjunct to cytological testing in some countries. Treatment modalities for cervical intraepithelial lesions most widely used are: laser vaporization (LV), large loop excision of transformation zone (LLETZ) and cold-knife conization. AIM: Our study was undertaken to compare different treatment modalities (LV, LLETZ, conization) for cervical intraepithelial neoplasia. In Slovenia there are a lot of women with PAP smears classified as PAP II and, therefore they need further evaluation. We tried to find out whether adding the HPV DNA testing to cytology would increase the ability to identify women who are truly at risk for cervical cancer and enable us to more efficiently plan further diagnostic evaluation. HYPOTHESIS: Participants who were initially found to be HPV positive were tested for the presence of high-risk HPV DNA after the therapeutic procedure in order to confirm our hypothesis: High-risk HPV infection is eliminated after LLETZ and cold-knife conization. METHODS: Our prospective study included 151 participants who were divided into two groups, according to cytology result: PAP II or PAP III. Cervical swabs were obtained before the procedure and tested with Hybrid Capture 2™ (HC 2) assay for detection of high-risk HPV DNA. The participants were treated with LV, LLETZ or cold-knife conization. All participants had subsequent histological analysis of material provided during the procedure. We tested HPV positive participants for the presence of HPV infection again 9 months after the procedure. All statistical tests were two-sided. We used Mann-Whitney's test, Pearson's chi-square test and McNemar's test. RESULTS: Infection with high-risk HPV was cured in 66,7% (95% confidence interval [CI] = 46,7 to 82,0%) (n=16) of participants treated with LV, in 91,3% (95% CI = 73,2 to 97,6%) (n=21) of participants treated with LLETZ and in 100,0% (95% CI = 72,3% to 100,0%) (n=10) of participants treated with cold-knife conization. Success rate of LV compared to LLETZ and cold-knife conization was found to be significantly lower (p<0.05). Prevalence of HPV infection in participants diagnosed with PAP II was 25,0% (95% CI = 16,6 to 35,8%) (n=19) and 72,0% (95% CI = 61,0 to 80,9%) (n=54) in participants diagnosed with PAP III (p<0.001). Participants with PAP II cytological result had in 72,6% (95% CI = 61,4 to 81,5%) (n=53) histological result less than CIN II, participants with PAP III had in 26,0% (95% CI = 17,3 to 37,1%) (n=19) histological result less than CIN II (p<0,001).Sensitivity of PAP test in combination with HC 2 test for the detection of high-grade intraepithelial lesions (CIN II or more) was 82,3% (95% CI = 74,0 to 89,6%). Specificity of the above combination was 61,4% (95% CI = 53,2 to 68,6%). Out of all participants 30,1% (95% CI = 23,3 to 38,0% ) (n=44) were diagnosed with PAP II cytological result and simultaneously with HPV negative result while having histological diagnosis less than CIN II. CONCLUSIONS: Our results prove the postulated hypothesis. Namely, HPV infection is eliminated in a high percentage of participants after LLETZ. HPV infection is eliminated in all the participants after cold-knife conization. LLETZ and cold-knife conization are more efficient than LV in eliminating the HPV infection. PAP III cytological result is by itself a sufficient indication for the therapeutic procedure. PAP II cytological result in combination with colposcopy is not a sufficient indication for operative treatment. Sensitivity of cytological testing combined with HC 2 test for detection of high-grade CIN is very good. Combination of cytological testing and HC 2 testing results in lowering the percentage of over-treated women with PAP II cytological result.