Joseph A Sparano1, Robert J Gray2, Della F Makower1, Kathy S Albain3, Thomas J Saphner4, Sunil S Badve5, Lynne I Wagner6,7, Virginia G Kaklamani6,8, Maccon M Keane9, Henry L Gomez10, Pavan S Reddy11, Timothy F Goggins12, Ingrid A Mayer13, Deborah L Toppmeyer14, Adam M Brufsky15, Matthew P Goetz16, Jeffrey L Berenberg17, Catalin Mahalcioiu18, Christine Desbiens19, Daniel F Hayes20, Elizabeth C Dees21, Charles E Geyer22, John A Olson23,24, William C Wood25, Tracy Lively26, Soonmyung Paik27,28, Matthew J Ellis29,30, Jeffrey Abrams26, George W Sledge31,32. 1. Montefiore Medical Center, Albert Einstein College of Medicine, Bronx, New York. 2. Dana Farber Cancer Institute, Boston, Massachusetts. 3. Loyola University Medical Center, Maywood, Illinois. 4. Aurora Cancer Center (formerly Vince Lombardi Cancer Clinic), Two Rivers, Wisconsin. 5. Indiana University School of Medicine, Indianapolis. 6. Northwestern University, Chicago, Illinois. 7. (now at) Wake Forest University Health Service, Winston Salem, North Carolina. 8. (now at) University of Texas Health Science Center, San Antonio. 9. Cancer Trials Ireland, Dublin, Ireland. 10. Instituto Nacional de Enfermedades Neoplasicas, Lima, Peru. 11. Cancer Center of Kansas, Wichita, Kansas. 12. Fox Valley Hematology and Oncology, Appleton, Wisconsin. 13. Vanderbilt University, Nashville, Tennessee. 14. Rutgers Cancer Institute of New Jersey, New Brunswick, New Jersey. 15. University of Pittsburgh, Pittsburgh, Pennsylvania. 16. Mayo Clinic, Jacksonville, Florida. 17. University of Hawaii Cancer Center, Honolulu, Hawaii. 18. McGill University, Montreal, Canada. 19. Universite Laval, Quebec, Canada. 20. University of Michigan, Ann Arbor. 21. University of North Carolina, Chapel Hill. 22. the Massey Cancer Center, Virginia Commonwealth University School of Medicine, Richmond. 23. Duke University Medical Center, Durham, North Carolina. 24. (now at) University of Maryland School of Medicine, Baltimore. 25. Emory University, Atlanta, Georgia. 26. National Institutes of Health, National Cancer Institute, Bethesda, Maryland. 27. NSABP Pathology Office, Pittsburgh, Pennsylvania. 28. (now at) Yonsei University College of Medicine, Seoul, South Korea. 29. Washington University, St Louis, Missouri. 30. (now at) Baylor College of Medicine, Houston, Texas. 31. Indiana University Hospital, Indianapolis. 32. (now at) Stanford University, Stanford, California.
Abstract
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 receivedadjuvant 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 withtaxane 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.
RCT Entities:
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.
Authors: Sofia F Garcia; Robert J Gray; Joseph A Sparano; Amye J Tevaarwerk; Ruth C Carlos; Betina Yanez; Ilana F Gareen; Timothy J Whelan; George W Sledge; David Cella; Lynne I Wagner Journal: Cancer Date: 2021-10-06 Impact factor: 6.860
Authors: Rocío Núñez-Torres; Miguel Martín; Jose Ángel García-Sáenz; María Rodrigo-Faus; María Del Monte-Millán; Hugo Tejera-Pérez; Guillermo Pita; Julio C de la Torre-Montero; Karen Pinilla; Belén Herraez; Lorena Peiró-Chova; Begoña Bermejo; Anna Lluch; Anna González-Neira Journal: JAMA Dermatol Date: 2020-09-01 Impact factor: 10.282
Authors: Joseph A Sparano; Michael R Crager; Gong Tang; Robert J Gray; Salomon M Stemmer; Steven Shak Journal: J Clin Oncol Date: 2021-04-01 Impact factor: 50.717