Treatment of Anal High-Grade Squamous Intraepithelial Lesions to Prevent Anal Cancer.
Treatment of Anal High-Grade Squamous Intraepithelial Lesions to Prevent Anal Cancer.
复制标题
DOI：
10.1056/nejmoa2201048
复制
发表时间：
2022-06-16
期刊：
影响因子：
--
通讯作者：
中科院分区：
文献类型：
--
作者：
携带人类免疫缺陷病毒(艾滋病毒)的人的肛门癌发病率大大高于普通人群。与宫颈癌类似，肛门癌发生在高度鳞状上皮内病变(HSILs)之前。宫颈HSIL的治疗减少了宫颈癌的进展；然而，关于肛门HSIL治疗预防肛门癌的前瞻性研究数据缺乏。我们在美国25个地点进行了第三阶段试验。年龄在35岁或以上且经活检证实为肛门HSIL的HIV感染者被随机分配，按1：1的比例接受HSIL治疗或不接受治疗的积极监测。治疗包括基于办公室的消融程序，在麻醉下消融或切除，或局部应用氟尿嘧啶或咪喹莫特。在事件发生时间分析中，主要结果是进展为肛门癌。治疗组患者接受治疗，直至HSIL完全消失。所有参与者至少每6个月接受一次高分辨率肛门镜检查；治疗组还对疑似正在进行的HSIL进行活检，主动监测组每年进行一次，或在任何有癌症问题的时候进行活检。在接受随机分组的4459名参与者中，4446名(99.7%)被纳入癌症进展时间分析。中位随访25.8个月，治疗组确诊9例(173/10万人年，95%可信区间90~332)，主动监测组21例(402/10万人年，95%可信区间262~616)。治疗组的肛门癌进展率比主动监测组低57%(95%可信区间为6~80；经对数等级检验，P=0.03)。在经活检证实为肛门HSIL的参与者中，接受肛门HSIL治疗的患者患肛门癌的风险显著低于积极监测的患者。(由国家癌症研究所资助；ClinicalTrials.gov编号，NCT02135419。)
The incidence of anal cancer is substantially higher among persons living with the human immunodeficiency virus (HIV) than in the general population. Similar to cervical cancer, anal cancer is preceded by high-grade squamous intraepithelial lesions (HSILs). Treatment for cervical HSIL reduces progression to cervical cancer; however, data from prospective studies of treatment for anal HSIL to prevent anal cancer are lacking. We conducted a phase 3 trial at 25 U.S. sites. Persons living with HIV who were 35 years of age or older and who had biopsy-proven anal HSIL were randomly assigned, in a 1:1 ratio, to receive either HSIL treatment or active monitoring without treatment. Treatment included office-based ablative procedures, ablation or excision under anesthesia, or the administration of topical fluorouracil or imiquimod. The primary outcome was progression to anal cancer in a time-to-event analysis. Participants in the treatment group were treated until HSIL was completely resolved. All the participants underwent high-resolution anoscopy at least every 6 months; biopsy was also performed for suspected ongoing HSIL in the treatment group, annually in the active-monitoring group, or any time there was concern for cancer. Of 4459 participants who underwent randomization, 4446 (99.7%) were included in the analysis of the time to progression to cancer. With a median follow-up of 25.8 months, 9 cases were diagnosed in the treatment group (173 per 100,000 person-years; 95% confidence interval [CI], 90 to 332) and 21 cases in the active-monitoring group (402 per 100,000 person-years; 95% CI, 262 to 616). The rate of progression to anal cancer was lower in the treatment group than in the active-monitoring group by 57% (95% CI, 6 to 80; P = 0.03 by log-rank test). Among participants with biopsy-proven anal HSIL, the risk of anal cancer was significantly lower with treatment for anal HSIL than with active monitoring. (Funded by the National Cancer Institute; ClinicalTrials.gov number, NCT02135419.)
影响因子：
6.4
作者：
Massad LS;Hessol NA;Darragh TM;Minkoff H;Colie C;Wright RL;Cohen M;Seaberg EC
通讯作者：
Seaberg EC