人类免疫缺陷病毒 (HIV) 感染者的肛门癌发病率远高于一般人群。与宫颈癌相似，肛门癌之前有高度鳞状上皮内病变 (HSIL)。宫颈 HSIL 的治疗可减少进展为宫颈癌；然而，缺乏治疗肛门 HSIL 以预防肛门癌的前瞻性研究数据。

在美国 25 个地点进行了 3 期试验。年龄在 35 岁或以上且患有经活检证实的肛门 HSIL 的 HIV 感染者被随机分配，以 1:1 的比例接受 HSIL 治疗或不进行治疗的主动监测。治疗包括门诊消融手术、麻醉下消融或切除，或外用氟尿嘧啶或咪喹莫特。主要结果是在事件发生时间分析中进展为肛门癌。治疗组的参与者接受治疗直至 HSIL 完全消退。所有参与者至少每 6 个月接受一次高分辨率肛门镜检查；还对治疗组中疑似正在进行的 HSIL 进行了活检，在主动监测组中每年进行一次活检，或者在任何有癌症担忧的时候进行活检。

在接受随机分组的 4459 名参与者中，4446 名 (99.7%) 被纳入至进展为癌症的时间分析中。中位随访 25.8 个月，治疗组诊断出 9 例（每 100,000 人年 173 例；95% 置信区间 [CI]，90 至 332），主动监测组诊断出 21 例（每 100,000 人年 402 例） 100,000 人年；95% CI，262 至 616）。治疗组的肛门癌进展率比主动监测组低 57%（95% CI，6 至 80；时序检验 P = 0.03）。在接受随机分组的 4459 名参与者中，4446 名 (99.7%) 被纳入至进展为癌症的时间分析中。中位随访 25.8 个月，治疗组诊断出 9 例（每 100,000 人年 173 例；95% 置信区间 [CI]，90 至 332），主动监测组诊断出 21 例（每 100,000 人年 402 例） 100,000 人年；95% CI，262 至 616）。治疗组的肛门癌进展率比主动监测组低 57%（95% CI，6 至 80；时序检验 P = 0.03）。

Abstract

Background: 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.

Methods: 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.

Results: 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).

Conclusions: 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.).

原文链接

pubmed.ncbi.nlm.nih.gov/35704479/

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