Background: Anal cancer is a rare disease that only accounts for 2.7% of gastrointestinal malignant tumors in Europe. However, during the last decades its prevalence and incidence recorded a steady increase, particularly in women living with HIV, who are mostly affected by several clinical risk factors and face many socio-cultural barriers to access both screening and care. Despite representing an increasing share among non-AIDS defining cancers, knowledge and risk perception toward anal cancer are still limited in this population. In addition to the awareness problem and increasing incidence, it must be noted that the possibility of early diagnosis for anal cancer is hampered by the lack of unanimous agreement on screening programs, among all the available international guidelines. Aims of the study: This study was created with the aim of investigating the uptake and acceptability of anal cancer screening in a cohort of women with HIV and the prevalence of HPV-related anal cancer, according to the hypothesis that a screening program extended to this entire population is justified by the high incidence rates and the coexistence of multiple risk factors. Methods: In this prospective single-center study, which began in November 2023 as part of the implementation of a clinical service, all HIV-infected women attending the clinics of the Infectious Diseases Clinic of the Padua Hospital were included. They were asked to undergo screening for anal cancer by taking 2 anal swabs (one for the search for HPV-DNA and a brush for cytological examination). Women who presented cytological alterations and/or oncogenic HPV genotypes were referred to the proctological surgery service for clinical examination and performance of high-resolution anoscopy. The number of women who refused, with the simultaneous reason for refusal, was recorded. The demographic and clinical data collected were analyzed with descriptive and inferential statistical methods. Results: The screening program we proposed achieved an uptake rate of 54.7%. The main reasons for refusal included a lack of interest in prevention, fear of pain, and, in some cases, purely cultural aspects. Of the 181 women who adhered to the screening, 51.9% were found to carry high risk anal HPV and 4.4% tested positive for high-grade intraepithelial lesions (HSIL). At the end of a preliminary analysis conducted on the outcomes of the second-level investigations, 8 cases of anal squamous cell carcinoma were diagnosed. More than 80% of cancer cases and high-grade lesions were observed in patients older than 40 years. Conclusions: The prevention of anal cancer in this high-risk population is still limited by suboptimal adherence to the screening program and insufficient vaccination coverage. The implementation of this program is justified by the relatively high prevalence of the disease, non-negligible mortality of anal cancer, and the efficacy and benefits of early treatment. Lastly, to improve cost- effectiveness of the screening, we consider it acceptable to narrow the target population to women older than 40 years of age.
Background: Il cancro dell’ano è una patologia rara, che in Europa rappresenta soltanto il 2,7% dei tumori maligni del tratto gastrointestinale. Tuttavia, nell’ultimo decennio si è assistito ad un lento ma costante incremento dell’incidenza di questa patologia, in particolare nella popolazione femminile con infezione da HIV, la quale risulta tutt’oggi maggiormente colpita da una serie di fattori di rischio clinico e barriere di natura socio-culturale nell’accesso alla prevenzione e alle cure. Nonostante il cancro dell’ano rappresenti una quota sempre più rilevante tra i tumori non-AIDS defining, la conoscenza e la percezione del rischio verso di esso sono ancora limitate in questa popolazione. Oltre al problema riguardante la consapevolezza e la diffusione della malattia, è necessario osservare come la possibilità di diagnosi precoce del cancro dell’ano sia ostacolata dalla mancanza di un accordo unanime in merito ai programmi di screening, i quali risultano fortemente eterogenei se si pongono a confronto le diverse linee guida prodotte dalle società scientifiche internazionali. Scopo dello studio: Il presente studio nasce con lo scopo di valutare la prevalenza delle neoplasie anali HPV-correlate nelle donne con infezione da HIV, secondo l’ipotesi che un programma di screening esteso a tutta questa popolazione sia giustificato dagli elevati tassi di incidenza e dalla coesistenza di multipli fattori di rischio. Contestualmente, un altro obiettivo è stato quello di determinare il livello di adesione allo screening da parte delle pazienti e di identificare i fattori demografici e clinici associati all’eventuale rifiuto. Materiali e metodi: In questo studio, di tipo prospettico monocentrico, iniziato a novembre 2023 nell’ambito dell’implementazione di un servizio clinico, sono state incluse tutte le donne con infezione da HIV afferenti agli ambulatori della Unità di Malattie Infettive dell’Azienda Ospedale-Università di Padova. Ad esse è stato proposto di sottoporsi ad un protocollo di screening per il cancro dell’ano da noi ideato, che prevedeva due test di primo livello: un pap-test anale e un tampone molecolare. Le donne che presentavano alterazioni citologiche e/o genotipi di HPV high risk sono state riferite al servizio di chirurgia proctologica per esame clinico ed esecuzione di anoscopia ad alta risoluzione. Contestualmente, tra le donne che rifiutavano lo screening, è stato registrato il motivo del rifiuto. I dati demografici e clinici raccolti sono stati analizzati con metodiche di statistica descrittiva ed inferenziale. Risultati: Il programma di screening da noi sviluppato ha raggiunto un livello di uptake pari al 54,7%, su un totale di 331 pazienti. Le principali motivazioni del rifiuto riguardavano il disinteresse verso la prevenzione, la paura del dolore e in qualche caso aspetti puramente socio-culturali. Delle 181 pazienti che hanno aderito allo screening, il 51,9% risultava portatrice a livello anale di un genotipo HPV high risk e il 4,4% presentava lesioni intraepiteliali di alto grado (HSIL). Al termine di un’analisi preliminare condotta sugli esiti delle indagini di secondo livello, sono stati riscontrati 8 casi di carcinoma squamoso dell’ano. Oltre l’80% dei casi di cancro e di lesioni di alto grado sono stati osservati in pazienti con età superiore ai 40 anni. Conclusioni: La prevenzione del cancro dell’ano in questa popolazione ad elevato rischio è tuttora limitata da un’adesione non ottimale allo screening e da una copertura vaccinale del tutto insufficiente. L’implementazione di questo programma risulta giustificato dalla prevalenza relativamente elevata della malattia, da una mortalità non trascurabile, dall’efficacia e dai benefici di un trattamento precoce. Al fine di migliorare la cost-effectiveness, in base ai nostri risultati riteniamo che lo screening possa essere indirizzato ad una popolazione target di età superiore ai 40 anni.
Uptake e outcome di un programma di screening per il cancro anale in una coorte di donne con infezione da HIV
CAMPAGNOLO, EGIDIO
2023/2024
Abstract
Background: Anal cancer is a rare disease that only accounts for 2.7% of gastrointestinal malignant tumors in Europe. However, during the last decades its prevalence and incidence recorded a steady increase, particularly in women living with HIV, who are mostly affected by several clinical risk factors and face many socio-cultural barriers to access both screening and care. Despite representing an increasing share among non-AIDS defining cancers, knowledge and risk perception toward anal cancer are still limited in this population. In addition to the awareness problem and increasing incidence, it must be noted that the possibility of early diagnosis for anal cancer is hampered by the lack of unanimous agreement on screening programs, among all the available international guidelines. Aims of the study: This study was created with the aim of investigating the uptake and acceptability of anal cancer screening in a cohort of women with HIV and the prevalence of HPV-related anal cancer, according to the hypothesis that a screening program extended to this entire population is justified by the high incidence rates and the coexistence of multiple risk factors. Methods: In this prospective single-center study, which began in November 2023 as part of the implementation of a clinical service, all HIV-infected women attending the clinics of the Infectious Diseases Clinic of the Padua Hospital were included. They were asked to undergo screening for anal cancer by taking 2 anal swabs (one for the search for HPV-DNA and a brush for cytological examination). Women who presented cytological alterations and/or oncogenic HPV genotypes were referred to the proctological surgery service for clinical examination and performance of high-resolution anoscopy. The number of women who refused, with the simultaneous reason for refusal, was recorded. The demographic and clinical data collected were analyzed with descriptive and inferential statistical methods. Results: The screening program we proposed achieved an uptake rate of 54.7%. The main reasons for refusal included a lack of interest in prevention, fear of pain, and, in some cases, purely cultural aspects. Of the 181 women who adhered to the screening, 51.9% were found to carry high risk anal HPV and 4.4% tested positive for high-grade intraepithelial lesions (HSIL). At the end of a preliminary analysis conducted on the outcomes of the second-level investigations, 8 cases of anal squamous cell carcinoma were diagnosed. More than 80% of cancer cases and high-grade lesions were observed in patients older than 40 years. Conclusions: The prevention of anal cancer in this high-risk population is still limited by suboptimal adherence to the screening program and insufficient vaccination coverage. The implementation of this program is justified by the relatively high prevalence of the disease, non-negligible mortality of anal cancer, and the efficacy and benefits of early treatment. Lastly, to improve cost- effectiveness of the screening, we consider it acceptable to narrow the target population to women older than 40 years of age.File | Dimensione | Formato | |
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https://hdl.handle.net/20.500.12608/67035