世界卫生组织建议在低收入和中等收入国家（LMICs）的“筛查治疗”宫颈癌计划中，将热消融（TA）作为与冷冻疗法的替代方法，包括人类免疫缺陷病毒（HIV）感染的女性（WLWH）。然而，关于WLWH中TA疗效的数据有限。我们进行了一项临床试验，以评估TA在肯尼亚WLWH中治疗活检确诊的宫颈上皮内瘤变2级和3级（CIN2/3）的疗效。25至65岁、非孕的HPV阳性WLWH进行宫颈镜引导活检，并在可行的情况下当日进行TA治疗。基线时活检确诊为CIN2/3的妇女在12个月时进行宫颈镜引导活检以确定治愈情况。在研究期间共有376名参与者接受了TA。基线时，238人（63.3%）具有正常组织学、39人（10.4%）具有CIN1、15人（4.0%）具有CIN2、55人（14.6%）具有CIN3、7人（1.9%）具有微浸润性癌症和22人（5.6%）结果不确定。对于基线时CIN2/3的70人中的59人（84.3%），我们可获得12个月后的随访病理结果。其中，39人（66.1%，95% CI 0.54-0.99）治疗成功，定义为活检确诊为CIN1或正常结果，而20人（33.9%，95% CI 0.22-0.46）治疗失败，定义为持续的活检确诊为CIN2或更严重病变。治疗失败率在基线时CIN2和CIN3的妇女中分别为23.1%（95% CI 0.17-0.46）和39.9%（95% CI 0.23-0.51）。CIN2/3的HIV阳性妇女在热消融后1年内治疗失败率较高。这突显了当前WHO宫颈癌二级预防策略的显著局限，并呼吁优化此人群宫颈癌前病变治疗的策略。© 2023 UICC.

The World Health Organization recommends thermal ablation (TA) as an alternative to cryotherapy within "screen-and-treat" cervical cancer programs in low- and middle-income countries (LMICs), including among women living with HIV (WLWH). Data on TA efficacy among WLWH are limited, however. We conducted a clinical trial to evaluate efficacy of TA for treatment of biopsy-confirmed cervical intraepithelial neoplasia grades 2 and 3 (CIN2/3) among WLWH in Kenya. Nonpregnant HPV-positive WLWH age 25 to 65 years underwent colposcopy-directed biopsy, and same-day treatment with TA, if eligible. Women with biopsy-confirmed CIN2/3 at baseline had colposcopy-directed biopsies at 12 months to determine cure. A total of 376 participants underwent TA during the study period. At baseline, 238 (63.3%) had normal histology, 39 (10.4%) had CIN1, 15 (4.0%) had CIN2, 55 (14.6%) had CIN3, 7 (1.9%) had microinvasive cancer and 22 (5.6%) had indeterminate results. Twelve-month follow-up pathology results are available for 59 of 70 (84.3%) participants with CIN2/3 at baseline. Of these, 39 (66.1%, 95% CI 0.54-0.99) had successful treatment, defined as biopsy-confirmed CIN1 or normal findings, while 20 (33.9%, 95% CI 0.22-0.46) had treatment failure, defined as persistent biopsy-confirmed CIN2 or worse. Treatment failure was 23.1% (95% CI 0.17-0.46) and 39.9% (95% CI 0.23-0.51) among women with CIN2 and CIN3 at baseline, respectively. HIV-positive women with CIN2/3 have high rates of treatment failure at 1-year following thermal ablation. This highlights a significant limitation in the current WHO cervical cancer secondary-prevention strategy and calls for strategies to optimize cervical precancer treatment in this population.© 2023 UICC.