肛门高级鳞状上皮内病变(AMC-A01)治疗或监测患者的健康相关生活质量

IF 5.5 3区 医学 Q1 ONCOLOGY JCO oncology practice Pub Date : 2025-10-01 Epub Date: 2025-03-06 DOI:10.1200/OP-24-00830
Thomas M Atkinson, Madhu Mazumdar, Grace Van Hyfte, Jeannette Y Lee, Yuelin Li, Kathleen A Lynch, Andrew Webb, Susan M Holland, Erica I Lubetkin, Stephen Goldstone, Mark H Einstein, Elizabeth A Stier, Dorothy J Wiley, Ronald Mitsuyasu, Isabella Rosa-Cunha, David M Aboulafia, Shireesha Dhanireddy, Jeffrey T Schouten, Rebecca Levine, Edward M Gardner, Hillary Dunlevy, Luis F Barroso, Gary Bucher, Jessica Korman, Benjamin Stearn, Timothy J Wilkin, Grant Ellsworth, Julia C Pugliese, David Cella, J Michael Berry-Lawhorn, Joel M Palefsky
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引用次数: 0

摘要

目的:肛门癌/高级别鳞状上皮内病变结局研究(ANCHOR)试验表明,治疗癌前肛门HSIL可使艾滋病毒感染者的肛门癌发病率降低57%。目前尚不清楚HSIL治疗或不治疗的监测如何影响患者报告的健康相关生活质量(HRQoL)。我们评估了随机分配到主动监测(AM)或治疗肛门HSIL的个体的HRQoL差异。方法:采用专为ANCHOR设计并验证的指标,随机分配前(T1)、随机分配/治疗后2-7天(+3天)、随机分配/治疗后28天(±7天)(T3)评估HRQoL。结果:锚定参与者携带艾滋病毒(N = 124;平均[标准差,SD]年龄,52.6岁[10.3];男性101例[81.5%];n = 65[52.4%]白色;n = 95[76.6%]非西班牙裔;治疗组70例[56.4%];AM = 54[43.6%])。治疗组参与者身体症状从t1到t2的平均恶化显著(平均[SD]差为0.31 [0.51];P = 0.0001)和对心理功能的影响(平均[SD]差,0.25 [0.64];P = 0.022),从T2-T3显著提高到T1水平(即,平均[SD]差为-0.25 [0.52];P = .003;均值[SD]差为-0.07 [0.23];P = 0.039)。AM组参与者在T1-T3阶段对心理功能的影响有显著改善(平均[SD],差异为-0.20 [0.50];P = .017)。在调整T1后,治疗组参与者在T2-T3的身体症状方面的平均改善大于AM组参与者(平均[SD]差异为-0.25 [0.52];P = .024);在生理或心理功能方面没有观察到两组之间的差异。结论:治疗组参与者在T1-T2期间身体症状和心理功能的影响显著恶化,但在T3时恢复到随机化前的水平,表明任何与肛门HSIL治疗相关的即时影响HRQoL是暂时的。需要进一步研究确定肛门HSIL治疗对HRQoL的长期影响。
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Health-Related Quality of Life for Persons Treated or Monitored for Anal High-Grade Squamous Intraepithelial Lesions (AMC-A01).

Purpose: The Anal Cancer/High-grade squamous intraepithelial lesions Outcomes Research (ANCHOR) trial demonstrated that treating precancerous anal HSIL reduces the incidence of anal cancer by 57% in people with HIV. It remains unclear how HSIL treatment or monitoring without treatment affects patient-reported health-related quality of life (HRQoL). We evaluated differences in HRQoL for individuals who were randomly assigned to active monitoring (AM) or treatment for anal HSIL.

Methods: Using an index designed and validated for use in ANCHOR, HRQoL was assessed before random assignment (T1), 2-7 days (+3 days) after random assignment/treatment (T2), and 28 days (±7 days) after random assignment/treatment (T3).

Results: ANCHOR participants living with HIV (N = 124; mean [standard deviation, SD] age, 52.6 years [10.3]; n = 101 [81.5%] men; n = 65 [52.4%] White; n = 95 [76.6%] non-Hispanic; treatment n = 70 [56.4%]; and AM n = 54 [43.6%]) were included. Treatment arm participants had significant mean worsening from T1-T2 in physical symptoms (mean [SD] difference, 0.31 [0.51]; P = .0001) and impact on psychological functioning (mean [SD] difference, 0.25 [0.64]; P = .022) that significantly improved to T1 levels from T2-T3 (ie, mean [SD] difference, -0.25 [0.52]; P = .003; and mean [SD] difference, -0.07 [0.23]; P = .039, respectively). AM arm participants experienced significant mean improvement in impact on psychological functioning from T1-T3 (mean [SD], difference, -0.20 [0.50]; P = .017). After adjusting for T1, treatment arm participants had a larger mean improvement than AM arm participants in physical symptoms from T2-T3 (mean [SD] difference, -0.25 [0.52]; P = .024); no between-arm differences were observed for impact on physical or psychological functioning.

Conclusion: Treatment arm participants experienced significant worsening in physical symptoms and impact on psychological functioning from T1-T2 but returned to prerandomization levels by T3, indicating that any immediate anal HSIL treatment-related impacts to HRQoL are temporary. Further research is needed to determine long-term impacts of anal HSIL treatment on HRQoL.

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