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Randomized Controlled Trial
. 2025 Oct;21(10):1475-1482.
doi: 10.1200/OP-24-00830. Epub 2025 Mar 6.

Health-Related Quality of Life for Persons Treated or Monitored for Anal High-Grade Squamous Intraepithelial Lesions (AMC-A01)

Thomas M Atkinson  1 , Madhu Mazumdar  2 , Grace Van Hyfte  2 , Jeannette Y Lee  3 , Yuelin Li  1 , Kathleen A Lynch  1   4 , Andrew Webb  1 , Susan M Holland  1 , Erica I Lubetkin  5 , Stephen Goldstone  6 , Mark H Einstein  7 , Elizabeth A Stier  8 , Dorothy J Wiley  9 , Ronald Mitsuyasu  10 , Isabella Rosa-Cunha  11 , David M Aboulafia  12 , Shireesha Dhanireddy  13 , Jeffrey T Schouten  12   13 , Rebecca Levine  7 , Edward M Gardner  14   15 , Hillary Dunlevy  15 , Luis F Barroso  16 , Gary Bucher  17 , Jessica Korman  18 , Benjamin Stearn  19 , Timothy J Wilkin  20 , Grant Ellsworth  21 , Julia C Pugliese  22 , David Cella  23 , J Michael Berry-Lawhorn  22 , Joel M Palefsky  22
Affiliations
Randomized Controlled Trial

Health-Related Quality of Life for Persons Treated or Monitored for Anal High-Grade Squamous Intraepithelial Lesions (AMC-A01)

Thomas M Atkinson et al. JCO Oncol Pract. 2025 Oct.

Abstract

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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Conflict of interest statement

AUTHORS’ DISCLOSURES OF POTENTIAL CONFLICTS OF INTEREST

Disclosures provided by the authors are available with this article at DOI https://doi.org/10.1200/OP-24-00830.

AUTHORS’ DISCLOSURES OF POTENTIAL CONFLICTS OF INTEREST

The following represents disclosure information provided by authors of this manuscript. All relationships are considered compensated unless otherwise noted. Relationships are self-held unless noted. I = Immediate Family Member, Inst = My Institution. Relationships may not relate to the subject matter of this manuscript. For more information about ASCO’s conflict of interest policy, please refer to www.asco.org/rwc or ascopubs.org/op/authors/author-center.

Open Payments is a public database containing information reported by companies about payments made to US-licensed physicians (Open Payments).

Susan M. Holland

Employment: Memorial Sloan-Kettering Cancer Center

Stephen Goldstone

Consulting or Advisory Role: THDAmerica, Merck, LinKinVax

Speakers’ Bureau: Merck

Research Funding: Merck

Travel, Accommodations, Expenses: Merck, THD America

Mark H. Einstein

Consulting or Advisory Role: Merck (Inst), Antiva Biosciences (Inst), Aseris Pharmaceuticals (Inst)

Research Funding: Johnson and Johnson (Inst), Merck (Inst), PapiVax Biotech, Inc (Inst)

Dorothy J. Wiley

Consulting or Advisory Role: Merck

Travel, Accommodations, Expenses: Merck

Ronald Mitsuyasu

Stock and Other Ownership Interests: Amgen

Edward M. Gardner

Research Funding: Gilead Sciences (Inst), ViiV Healthcare (Inst)

Luis F. Barroso

Employment: Atrium Wake Forest Baptist Health, UpToDate

Uncompensated Relationships: International Anal Neoplasia Society

Gary Bucher

Consulting or Advisory Role: THD America

Research Funding: Frantz Viral Therapeutics, LLC

Jessica Korman

Consulting or Advisory Role: Bristol Myers Squibb/Medarex, Janssen

Speakers’ Bureau: Nestle USA, AbbVie, Takeda

Timothy J. Wilkin

Employment: Bayer (I)

Honoraria: Merck, ViiV Healthcare

Research Funding: Merck (Inst), ViiV Healthcare (Inst)

Travel, Accommodations, Expenses: Merck

David Cella

Stock and Other Ownership Interests: FACIT.org

Consulting or Advisory Role: AbbVie, Pfizer, Novartis, Bristol Myers Squibb, Ipsen, Merck Serono, Black Diamond Therapeutics, Dompé Farmaceutici, Exact Sciences

Research Funding: Novartis (Inst), Ipsen (Inst), Pfizer (Inst), Bristol Myers Squibb (Inst), AbbVie (Inst), Merck Serono (Inst)

Joel M. Palefsky

Stock and Other Ownership Interests: Virion Therapeutics

Consulting or Advisory Role: Vir Biotechnology, Abbott Laboratories, Asieris Pharmaceuticals, Spotlight Therapeutics, Merck

Research Funding: Atila Biosystems (Inst), Roche Diagnostics Solutions (Inst)

Travel, Accommodations, Expenses: Roche Molecular Diagnostics

No other potential conflicts of interest were reported.

Figures

FIG 1.
FIG 1.
CONSORT diagram. QoL, quality of life.
FIG 2.
FIG 2.
Mean response by arm and subscale measure (n = 124). SEM, standard error of the mean.
See this image and copyright information in PMC

References

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