Radical hysterectomy for operable early cervical cancer in <scp>HIV</scp>‐positive and <scp>HIV</scp>‐negative women in western Kenya

Peter, Itsura M.; Deraney, Rachel N.; Orang’o, Omenge; Tonui, Philip; Rosen, Barry P.; Cu‐Uvin, Susan

doi:10.1002/ijgo.13004

Cited by 3 publications

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References 4 publications

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“…Women living with HIV (WLWH), the majority of whom live in LMICs, have increased incidence and persistence of human papillomavirus (HPV) infection, 3 and a six to eightfold increased risk of developing invasive cancer compared to HIV-negative women. 4,5 Cervical precancer is categorized into low grade disease – cervical intraepithelial neoplasia grade 1 (CIN1) – and high-grade disease, cervical intraepithelial neoplasia grade 2 and 3. 6 Both cervical precancer and cancer diagnoses are established through pathology evaluation of cells from the cervix obtained through a biopsy.…”

Section: Introductionmentioning

confidence: 99%

Intravaginal artesunate pessaries for treatment of cervical intraepithelial neoplasia 2/3 among HIV-positive and HIV-negative women in Kenya: Study protocol for a pilot trial

Mungo,

Sorgi,

Hoch

et al. 2024

Preprint

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BackgroundCervical cancer disproportionately affects women in low- and middle-income countries (LMICs), which bear 90% of deaths. Current precancer treatments rely on healthcare workers who may be out of reach for many women. Development of a patient-controlled cervical precancer treatment can significantly improve access in remote areas and promote secondary prevention of cervical cancer.MethodsThis is a phase I trial among 18 HIV-positive and HIV-negative women in Kenya, investigating use of artesunate vaginal pessaries as treatment for cervical precancer among women screening positive for cervical precancer who need excisional treatment. The primary objective will be the safety of self-administered artesunate pessaries. Participants will self-administer 200mg of artesunate vaginally daily for 5 days, followed by a drug-free week, repeated for a total of 4 cycles (artesunate self-administration on weeks 1, 3, 5, 7). The total study duration, including participant follow-up is 48 weeks. Safety and adherence will be assessed through review of symptom diaries and biweekly follow-ups during the treatment phase. Data analysis will include quantitative and qualitative methods.DiscussionConsidering the challenges associated with excisional treatments for cervical precancer in LMICs where access to care is limited, this study proposes an alternative approach using intravaginal Artesunate. This clinical trial will provide important safety and efficacy data on using artesunate as a topical therapy for both HIV-positive and HIV-negative women.Trial RegistrationClinicalTrials.govidentifier:NCT06165614

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Section: Introductionmentioning

confidence: 99%

Intravaginal artesunate pessaries for treatment of cervical intraepithelial neoplasia 2/3 among HIV-positive and HIV-negative women in Kenya: Study protocol for a pilot trial

Mungo,

Sorgi,

Hoch

et al. 2024

Preprint

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“…1 Cervical cancer is an AIDS-defining malignancy and women living with HIV (WLWH), the majority of whom reside in LMICs, are at significantly increased risk. 2 Compared to HIV-negative women, WLWH have increased incidence and persistence of human papillomavirus (HPV), 3 have a shorter time from HPV infection to development of precancerous lesions, 4 and have a six to eightfold increased risk of developing invasive cancer, 5,6 making prevention efforts among them an urgent priority. With increasing access to antiretroviral therapy (ART), WLWH in LMICs have prolonged life expectancy, increasing their vulnerability to death from cervical cancer.…”

Section: Introductionmentioning

confidence: 99%

Feasibility of adjuvant self-administered intravaginal 5-fluorouracil cream following primary treatment of cervical intraepithelial neoplasia grade 2 or 3 among women living with HIV in Kenya: study protocol for a pilot trial

Mungo,

Bukusi,

Kirkland

et al. 2023

Preprint

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BackgroundWomen living with HIV (WLWH), the majority of whom live in low- and middle-income countries (LMICs), are at higher risk of cervical precancer, known as cervical intraepithelial neoplasia (CIN), and are up to six times more likely to get cervical cancer. Current CIN treatment methods, primarily ablation or excision, have high treatment failure rates among WLWH, up to 30% for CIN grade 2 or 3 (CIN2/3) at 24 months following ablation. Without strong follow-up many WLWH with treatment failure are at risk of developing invasive cervical cancer, highlighting the urgent need for improved CIN treatment methods. Prior studies in high-income countries (HICs) have demonstrated that 5-Fluorouracil (5-FU) cream, an antimetabolite drug that is easily accessible in LMICs, can be used intravaginally as adjuvant therapy following primary CIN2/3 treatment in WLWH to reduce CIN2/3 recurrence. While the safety, acceptability, and efficacy of self-administered 5-FU for cervical precancer treatment has been demonstrated in HICs, it has not been studied among WLWH in LMICs who bear the greatest burden of cervical cancer.MethodsWe are conducting a Phase I pilot study investigating the feasibility of using 5-FU cream as an adjuvant, self-administered intravaginal therapy following cervical intraepithelial neoplasia grade 2/3 (CIN2/3) treatment among WLWH in Kenya (ClinicalTrials.govNCT05362955). Twelve participants will be enrolled in this single-arm study. Participants will self-administer 2g of 5% 5-FU cream intravaginally every other week for eight applications. The primary objective is to determine safety, defined as the type, frequency, and severity of adverse events (AEs) using a standardized grading scale. The secondary objectives are uptake, tolerability, adherence, and acceptability.ResultsThere are no results at this time as this is an ongoing study.DiscussionTo achieve the World Health Organization (WHO) 90/70/90 global cervical cancer elimination goals, which include 90% of women with cervical precancer adequately treated by 2030, it is essential to employ innovative and resource-appropriate strategies to improve cervical precancer treatment among WLWH. The use of 5-FU as adjuvant therapy following current screen & treat programs may be a feasible and scalable strategy to optimize outcomes in this high-risk group. This clinical trial will provide important feasibility data to inform future randomized efficacy trials in LMICs.Trial registrationClinicalTrials.govidentifier:NCT05362955Key messages regarding feasibilityWhat uncertainties existed regarding feasibility?There are no uncertainties to report yet as the study is ongoing.What are the key feasibility findings?There are no key feasibility findings as the study is ongoing.What are the implications of the feasibility findings for the design of the main study?Feasibility findings from this trial that will inform the design of the future study include safety findings - frequency and severity of adverse events, which may necessitate a different dosing schedule for the main study, adherence findings - if low levels of adherence to self-administered therapies are established, the authors will work on designing strategies to improve adherence prior to moving to a larger study. Finally, acceptability findings including the levels of male partner support of the treatment will inform future study efforts.

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“…Women living with Human Immunodeficiency Virus (WLWH), the majority of whom reside in LMICs, are at increased risk of cervical cancer due to higher prevalence and persistence of human papillomavirus (HPV), the causative agent [3]. Compared to human immunodeficiency virus (HIV)-negative women, WLWH have a shorter time from HPV infection to development of precancerous lesions [4], and have a six to eightfold increased risk of developing invasive cervical cancer [5,6], making prevention efforts an urgent priority among WLWH.…”

Section: Introductionmentioning

confidence: 99%

Integration of cervical cancer screening into HIV/AIDS care in low income countries: a moral imperative

Mungo¹,

Barker²,

Randa³

et al. 2021

ecancer

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Although cervical cancer is preventable, in 2018, approximately 570,000 new cases occurred globally. Cervical cancer disproportionately affects low-and middle-income countries (LMICs), which accounted for 90% of deaths in 2018. Women living with the Human Immunodeficiency Virus (WLWH) are at increased risk of cervical cancer and are in urgent need of prevention. Despite evidence-based guidelines for screening and prevention of cervical cancer, the majority of WLWH in LMICs lack access to cervical cancer screening. Despite tremendous gains made in access to life prolonging antiretroviral therapy for WLWH, most are served by vertical human immunodeficiency virus (HIV) programmes which do not integrate these two crucial services. We present a case of a WLWH, in HIV care for a decade, who was recently diagnosed with preventable, advanced stage cervical cancer.

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Radical hysterectomy for operable early cervical cancer in HIV‐positive and HIV‐negative women in western Kenya

Abstract: Radical hysterectomy is well tolerated with no increase in complications in HIV‐infected women and is an appropriate form of treatment for early‐stage cervical cancer in HIV‐infected women.

Cited by 3 publications

References 4 publications

Intravaginal artesunate pessaries for treatment of cervical intraepithelial neoplasia 2/3 among HIV-positive and HIV-negative women in Kenya: Study protocol for a pilot trial

Intravaginal artesunate pessaries for treatment of cervical intraepithelial neoplasia 2/3 among HIV-positive and HIV-negative women in Kenya: Study protocol for a pilot trial

Feasibility of adjuvant self-administered intravaginal 5-fluorouracil cream following primary treatment of cervical intraepithelial neoplasia grade 2 or 3 among women living with HIV in Kenya: study protocol for a pilot trial

Integration of cervical cancer screening into HIV/AIDS care in low income countries: a moral imperative

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