Clinical Outcomes in Early Breast Cancer With a High 21-Gene Recurrence Score of 26 to 100 Assigned to Adjuvant Chemotherapy Plus Endocrine Therapy: A Secondary Analysis of the TAILORx Randomized Clinical Trial.

Autor:	Sparano JA; Montefiore Medical Center, Albert Einstein College of Medicine, Bronx, New York., Gray RJ; Dana Farber Cancer Institute, Boston, Massachusetts., Makower DF; Montefiore Medical Center, Albert Einstein College of Medicine, Bronx, New York., Albain KS; Loyola University Medical Center, Maywood, Illinois., Saphner TJ; Aurora Cancer Center (formerly Vince Lombardi Cancer Clinic), Two Rivers, Wisconsin., Badve SS; Indiana University School of Medicine, Indianapolis., Wagner LI; Northwestern University, Chicago, Illinois.; (now at) Wake Forest University Health Service, Winston Salem, North Carolina., Kaklamani VG; Northwestern University, Chicago, Illinois.; (now at) University of Texas Health Science Center, San Antonio., Keane MM; Cancer Trials Ireland, Dublin, Ireland., Gomez HL; Instituto Nacional de Enfermedades Neoplasicas, Lima, Peru., Reddy PS; Cancer Center of Kansas, Wichita, Kansas., Goggins TF; Fox Valley Hematology and Oncology, Appleton, Wisconsin., Mayer IA; Vanderbilt University, Nashville, Tennessee., Toppmeyer DL; Rutgers Cancer Institute of New Jersey, New Brunswick, New Jersey., Brufsky AM; University of Pittsburgh, Pittsburgh, Pennsylvania., Goetz MP; Mayo Clinic, Jacksonville, Florida., Berenberg JL; University of Hawaii Cancer Center, Honolulu, Hawaii., Mahalcioiu C; McGill University, Montreal, Canada., Desbiens C; Universite Laval, Quebec, Canada., Hayes DF; University of Michigan, Ann Arbor., Dees EC; University of North Carolina, Chapel Hill., Geyer CE Jr; the Massey Cancer Center, Virginia Commonwealth University School of Medicine, Richmond., Olson JA Jr; Duke University Medical Center, Durham, North Carolina.; (now at) University of Maryland School of Medicine, Baltimore., Wood WC; Emory University, Atlanta, Georgia., Lively T; National Institutes of Health, National Cancer Institute, Bethesda, Maryland., Paik S; NSABP Pathology Office, Pittsburgh, Pennsylvania.; (now at) Yonsei University College of Medicine, Seoul, South Korea., Ellis MJ; Washington University, St Louis, Missouri.; (now at) Baylor College of Medicine, Houston, Texas., Abrams J; National Institutes of Health, National Cancer Institute, Bethesda, Maryland., Sledge GW Jr; Indiana University Hospital, Indianapolis.; (now at) Stanford University, Stanford, California.
Jazyk:	angličtina
Zdroj:	JAMA oncology [JAMA Oncol] 2020 Mar 01; Vol. 6 (3), pp. 367-374.
DOI:	10.1001/jamaoncol.2019.4794
Abstrakt:	Importance: A high 21-gene recurrence score (RS) by breast cancer assay is prognostic for distant recurrence of early breast cancer after local therapy and endocrine therapy alone, and for chemotherapy benefit. Objective: To describe clinical outcomes for women with a high RS who received adjuvant chemotherapy plus endocrine therapy in the TAILORx trial, a population expected to have a high distant recurrence rate with endocrine therapy alone. Design, Setting, and Participants: In this secondary analysis of data from a multicenter randomized clinical trial, 1389 women with hormone receptor-positive, ERBB2-negative, axillary node-negative breast cancer, and a high RS of 26 to 100 were prospectively assigned to receive adjuvant chemotherapy in addition to endocrine therapy. The analysis was conducted on May 12, 2019. Interventions: The adjuvant chemotherapy regimen was selected by the treating physician. Main Outcomes and Measures: Freedom from recurrence of breast cancer at a distant site, and freedom from recurrence, second primary cancer, and death (also known as invasive disease-free survival [IDFS]). Results: Among the 9719 eligible women, with a mean age of 56 years (range 23-75 years), 1389 (14%) had a recurrence score of 26 to 100, of whom 598 (42%) had an RS of 26 to 30 and 791 (58%) had an RS of 31 to 100. The most common chemotherapy regimens included docetaxel/cyclophosphamide in 589 (42%), an anthracycline without a taxane in 334 (24%), an anthracycline and taxane in 244 (18%), cyclophosphamide/methotrexate/5-fluorouracil in 52 (4%), other regimens in 81 (6%), and no chemotherapy in 89 (6%). At 5 years, the estimated rate of freedom from recurrence of breast cancer at a distant site was 93.0% (standard error [SE], 0.8%), freedom of recurrence of breast cancer at a distant and/or local regional site 91.0% (SE, 0.8%), IDFS 87.6% (SE, 1.0%), and overall survival 95.9% (SE, 0.6%). Conclusions and Relevance: The estimated rate of freedom from recurrence of breast cancer at a distant site in women with an RS of 26 to 100 treated largely with taxane and/or anthracycline-containing adjuvant chemotherapy regimens plus endocrine therapy in the prospective TAILORx trial was 93% at 5 years, an outcome better than expected with endocrine therapy alone in this population. Trial Registration: ClinicalTrials.gov identifier: NCT00310180.
Databáze:	MEDLINE
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