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Treatment of Anal High-Grade Squamous Intraepithelial Lesions to Prevent Anal Cancer.
Palefsky, Joel M; Lee, Jeannette Y; Jay, Naomi; Goldstone, Stephen E; Darragh, Teresa M; Dunlevy, Hillary A; Rosa-Cunha, Isabella; Arons, Abigail; Pugliese, Julia C; Vena, Don; Sparano, Joseph A; Wilkin, Timothy J; Bucher, Gary; Stier, Elizabeth A; Tirado Gomez, Maribel; Flowers, Lisa; Barroso, Luis F; Mitsuyasu, Ronald T; Lensing, Shelly Y; Logan, Jeffrey; Aboulafia, David M; Schouten, Jeffrey T; de la Ossa, Juan; Levine, Rebecca; Korman, Jessica D; Hagensee, Michael; Atkinson, Thomas M; Einstein, Mark H; Cracchiolo, Bernadette M; Wiley, Dorothy; Ellsworth, Grant B; Brickman, Cristina; Berry-Lawhorn, J Michael.
Afiliação
  • Palefsky JM; From the University of California, San Francisco School of Medicine, San Francisco (J.M.P., N.J., T.M.D., A.A., C.B., J.M.B.-L.); University of Arkansas for Medical Sciences, Little Rock (J.Y.L., S.Y.L.); Icahn School of Medicine at Mount Sinai (S.E.G., J.A.S.), Weill Cornell Medicine (T.J.W., G.B.E
  • Lee JY; From the University of California, San Francisco School of Medicine, San Francisco (J.M.P., N.J., T.M.D., A.A., C.B., J.M.B.-L.); University of Arkansas for Medical Sciences, Little Rock (J.Y.L., S.Y.L.); Icahn School of Medicine at Mount Sinai (S.E.G., J.A.S.), Weill Cornell Medicine (T.J.W., G.B.E
  • Jay N; From the University of California, San Francisco School of Medicine, San Francisco (J.M.P., N.J., T.M.D., A.A., C.B., J.M.B.-L.); University of Arkansas for Medical Sciences, Little Rock (J.Y.L., S.Y.L.); Icahn School of Medicine at Mount Sinai (S.E.G., J.A.S.), Weill Cornell Medicine (T.J.W., G.B.E
  • Goldstone SE; From the University of California, San Francisco School of Medicine, San Francisco (J.M.P., N.J., T.M.D., A.A., C.B., J.M.B.-L.); University of Arkansas for Medical Sciences, Little Rock (J.Y.L., S.Y.L.); Icahn School of Medicine at Mount Sinai (S.E.G., J.A.S.), Weill Cornell Medicine (T.J.W., G.B.E
  • Darragh TM; From the University of California, San Francisco School of Medicine, San Francisco (J.M.P., N.J., T.M.D., A.A., C.B., J.M.B.-L.); University of Arkansas for Medical Sciences, Little Rock (J.Y.L., S.Y.L.); Icahn School of Medicine at Mount Sinai (S.E.G., J.A.S.), Weill Cornell Medicine (T.J.W., G.B.E
  • Dunlevy HA; From the University of California, San Francisco School of Medicine, San Francisco (J.M.P., N.J., T.M.D., A.A., C.B., J.M.B.-L.); University of Arkansas for Medical Sciences, Little Rock (J.Y.L., S.Y.L.); Icahn School of Medicine at Mount Sinai (S.E.G., J.A.S.), Weill Cornell Medicine (T.J.W., G.B.E
  • Rosa-Cunha I; From the University of California, San Francisco School of Medicine, San Francisco (J.M.P., N.J., T.M.D., A.A., C.B., J.M.B.-L.); University of Arkansas for Medical Sciences, Little Rock (J.Y.L., S.Y.L.); Icahn School of Medicine at Mount Sinai (S.E.G., J.A.S.), Weill Cornell Medicine (T.J.W., G.B.E
  • Arons A; From the University of California, San Francisco School of Medicine, San Francisco (J.M.P., N.J., T.M.D., A.A., C.B., J.M.B.-L.); University of Arkansas for Medical Sciences, Little Rock (J.Y.L., S.Y.L.); Icahn School of Medicine at Mount Sinai (S.E.G., J.A.S.), Weill Cornell Medicine (T.J.W., G.B.E
  • Pugliese JC; From the University of California, San Francisco School of Medicine, San Francisco (J.M.P., N.J., T.M.D., A.A., C.B., J.M.B.-L.); University of Arkansas for Medical Sciences, Little Rock (J.Y.L., S.Y.L.); Icahn School of Medicine at Mount Sinai (S.E.G., J.A.S.), Weill Cornell Medicine (T.J.W., G.B.E
  • Vena D; From the University of California, San Francisco School of Medicine, San Francisco (J.M.P., N.J., T.M.D., A.A., C.B., J.M.B.-L.); University of Arkansas for Medical Sciences, Little Rock (J.Y.L., S.Y.L.); Icahn School of Medicine at Mount Sinai (S.E.G., J.A.S.), Weill Cornell Medicine (T.J.W., G.B.E
  • Sparano JA; From the University of California, San Francisco School of Medicine, San Francisco (J.M.P., N.J., T.M.D., A.A., C.B., J.M.B.-L.); University of Arkansas for Medical Sciences, Little Rock (J.Y.L., S.Y.L.); Icahn School of Medicine at Mount Sinai (S.E.G., J.A.S.), Weill Cornell Medicine (T.J.W., G.B.E
  • Wilkin TJ; From the University of California, San Francisco School of Medicine, San Francisco (J.M.P., N.J., T.M.D., A.A., C.B., J.M.B.-L.); University of Arkansas for Medical Sciences, Little Rock (J.Y.L., S.Y.L.); Icahn School of Medicine at Mount Sinai (S.E.G., J.A.S.), Weill Cornell Medicine (T.J.W., G.B.E
  • Bucher G; From the University of California, San Francisco School of Medicine, San Francisco (J.M.P., N.J., T.M.D., A.A., C.B., J.M.B.-L.); University of Arkansas for Medical Sciences, Little Rock (J.Y.L., S.Y.L.); Icahn School of Medicine at Mount Sinai (S.E.G., J.A.S.), Weill Cornell Medicine (T.J.W., G.B.E
  • Stier EA; From the University of California, San Francisco School of Medicine, San Francisco (J.M.P., N.J., T.M.D., A.A., C.B., J.M.B.-L.); University of Arkansas for Medical Sciences, Little Rock (J.Y.L., S.Y.L.); Icahn School of Medicine at Mount Sinai (S.E.G., J.A.S.), Weill Cornell Medicine (T.J.W., G.B.E
  • Tirado Gomez M; From the University of California, San Francisco School of Medicine, San Francisco (J.M.P., N.J., T.M.D., A.A., C.B., J.M.B.-L.); University of Arkansas for Medical Sciences, Little Rock (J.Y.L., S.Y.L.); Icahn School of Medicine at Mount Sinai (S.E.G., J.A.S.), Weill Cornell Medicine (T.J.W., G.B.E
  • Flowers L; From the University of California, San Francisco School of Medicine, San Francisco (J.M.P., N.J., T.M.D., A.A., C.B., J.M.B.-L.); University of Arkansas for Medical Sciences, Little Rock (J.Y.L., S.Y.L.); Icahn School of Medicine at Mount Sinai (S.E.G., J.A.S.), Weill Cornell Medicine (T.J.W., G.B.E
  • Barroso LF; From the University of California, San Francisco School of Medicine, San Francisco (J.M.P., N.J., T.M.D., A.A., C.B., J.M.B.-L.); University of Arkansas for Medical Sciences, Little Rock (J.Y.L., S.Y.L.); Icahn School of Medicine at Mount Sinai (S.E.G., J.A.S.), Weill Cornell Medicine (T.J.W., G.B.E
  • Mitsuyasu RT; From the University of California, San Francisco School of Medicine, San Francisco (J.M.P., N.J., T.M.D., A.A., C.B., J.M.B.-L.); University of Arkansas for Medical Sciences, Little Rock (J.Y.L., S.Y.L.); Icahn School of Medicine at Mount Sinai (S.E.G., J.A.S.), Weill Cornell Medicine (T.J.W., G.B.E
  • Lensing SY; From the University of California, San Francisco School of Medicine, San Francisco (J.M.P., N.J., T.M.D., A.A., C.B., J.M.B.-L.); University of Arkansas for Medical Sciences, Little Rock (J.Y.L., S.Y.L.); Icahn School of Medicine at Mount Sinai (S.E.G., J.A.S.), Weill Cornell Medicine (T.J.W., G.B.E
  • Logan J; From the University of California, San Francisco School of Medicine, San Francisco (J.M.P., N.J., T.M.D., A.A., C.B., J.M.B.-L.); University of Arkansas for Medical Sciences, Little Rock (J.Y.L., S.Y.L.); Icahn School of Medicine at Mount Sinai (S.E.G., J.A.S.), Weill Cornell Medicine (T.J.W., G.B.E
  • Aboulafia DM; From the University of California, San Francisco School of Medicine, San Francisco (J.M.P., N.J., T.M.D., A.A., C.B., J.M.B.-L.); University of Arkansas for Medical Sciences, Little Rock (J.Y.L., S.Y.L.); Icahn School of Medicine at Mount Sinai (S.E.G., J.A.S.), Weill Cornell Medicine (T.J.W., G.B.E
  • Schouten JT; From the University of California, San Francisco School of Medicine, San Francisco (J.M.P., N.J., T.M.D., A.A., C.B., J.M.B.-L.); University of Arkansas for Medical Sciences, Little Rock (J.Y.L., S.Y.L.); Icahn School of Medicine at Mount Sinai (S.E.G., J.A.S.), Weill Cornell Medicine (T.J.W., G.B.E
  • de la Ossa J; From the University of California, San Francisco School of Medicine, San Francisco (J.M.P., N.J., T.M.D., A.A., C.B., J.M.B.-L.); University of Arkansas for Medical Sciences, Little Rock (J.Y.L., S.Y.L.); Icahn School of Medicine at Mount Sinai (S.E.G., J.A.S.), Weill Cornell Medicine (T.J.W., G.B.E
  • Levine R; From the University of California, San Francisco School of Medicine, San Francisco (J.M.P., N.J., T.M.D., A.A., C.B., J.M.B.-L.); University of Arkansas for Medical Sciences, Little Rock (J.Y.L., S.Y.L.); Icahn School of Medicine at Mount Sinai (S.E.G., J.A.S.), Weill Cornell Medicine (T.J.W., G.B.E
  • Korman JD; From the University of California, San Francisco School of Medicine, San Francisco (J.M.P., N.J., T.M.D., A.A., C.B., J.M.B.-L.); University of Arkansas for Medical Sciences, Little Rock (J.Y.L., S.Y.L.); Icahn School of Medicine at Mount Sinai (S.E.G., J.A.S.), Weill Cornell Medicine (T.J.W., G.B.E
  • Hagensee M; From the University of California, San Francisco School of Medicine, San Francisco (J.M.P., N.J., T.M.D., A.A., C.B., J.M.B.-L.); University of Arkansas for Medical Sciences, Little Rock (J.Y.L., S.Y.L.); Icahn School of Medicine at Mount Sinai (S.E.G., J.A.S.), Weill Cornell Medicine (T.J.W., G.B.E
  • Atkinson TM; From the University of California, San Francisco School of Medicine, San Francisco (J.M.P., N.J., T.M.D., A.A., C.B., J.M.B.-L.); University of Arkansas for Medical Sciences, Little Rock (J.Y.L., S.Y.L.); Icahn School of Medicine at Mount Sinai (S.E.G., J.A.S.), Weill Cornell Medicine (T.J.W., G.B.E
  • Einstein MH; From the University of California, San Francisco School of Medicine, San Francisco (J.M.P., N.J., T.M.D., A.A., C.B., J.M.B.-L.); University of Arkansas for Medical Sciences, Little Rock (J.Y.L., S.Y.L.); Icahn School of Medicine at Mount Sinai (S.E.G., J.A.S.), Weill Cornell Medicine (T.J.W., G.B.E
  • Cracchiolo BM; From the University of California, San Francisco School of Medicine, San Francisco (J.M.P., N.J., T.M.D., A.A., C.B., J.M.B.-L.); University of Arkansas for Medical Sciences, Little Rock (J.Y.L., S.Y.L.); Icahn School of Medicine at Mount Sinai (S.E.G., J.A.S.), Weill Cornell Medicine (T.J.W., G.B.E
  • Wiley D; From the University of California, San Francisco School of Medicine, San Francisco (J.M.P., N.J., T.M.D., A.A., C.B., J.M.B.-L.); University of Arkansas for Medical Sciences, Little Rock (J.Y.L., S.Y.L.); Icahn School of Medicine at Mount Sinai (S.E.G., J.A.S.), Weill Cornell Medicine (T.J.W., G.B.E
  • Ellsworth GB; From the University of California, San Francisco School of Medicine, San Francisco (J.M.P., N.J., T.M.D., A.A., C.B., J.M.B.-L.); University of Arkansas for Medical Sciences, Little Rock (J.Y.L., S.Y.L.); Icahn School of Medicine at Mount Sinai (S.E.G., J.A.S.), Weill Cornell Medicine (T.J.W., G.B.E
  • Brickman C; From the University of California, San Francisco School of Medicine, San Francisco (J.M.P., N.J., T.M.D., A.A., C.B., J.M.B.-L.); University of Arkansas for Medical Sciences, Little Rock (J.Y.L., S.Y.L.); Icahn School of Medicine at Mount Sinai (S.E.G., J.A.S.), Weill Cornell Medicine (T.J.W., G.B.E
  • Berry-Lawhorn JM; From the University of California, San Francisco School of Medicine, San Francisco (J.M.P., N.J., T.M.D., A.A., C.B., J.M.B.-L.); University of Arkansas for Medical Sciences, Little Rock (J.Y.L., S.Y.L.); Icahn School of Medicine at Mount Sinai (S.E.G., J.A.S.), Weill Cornell Medicine (T.J.W., G.B.E
N Engl J Med ; 386(24): 2273-2282, 2022 06 16.
Article em En | MEDLINE | ID: mdl-35704479
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 11 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.).
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Texto completo: 1 Base de dados: MEDLINE Assunto principal: Neoplasias do Ânus / Lesões Pré-Cancerosas / Infecções por HIV / Conduta Expectante / Lesões Intraepiteliais Escamosas Idioma: En Ano de publicação: 2022 Tipo de documento: Article
Texto completo
Imprimir
XML
PubMed Links
Buscar no Google

Texto completo: 1 Base de dados: MEDLINE Assunto principal: Neoplasias do Ânus / Lesões Pré-Cancerosas / Infecções por HIV / Conduta Expectante / Lesões Intraepiteliais Escamosas Idioma: En Ano de publicação: 2022 Tipo de documento: Article