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

Joseph A. Sparano, Robert J. Gray, Della F. Makower, Kathy S. Albain, Thomas J. Saphner, Sunil S. Badve, Lynne I. Wagner, Virginia G. Kaklamani, MacCon M. Keane, Henry L. Gomez, Pavan S. Reddy, Timothy F. Goggins, Ingrid A. Mayer, Deborah L. Toppmeyer, Adam M. Brufsky, Matthew P. Goetz, Jeffrey L. Berenberg, Catalin Mahalcioiu, Christine Desbiens, Daniel F. HayesElizabeth C. Dees, Charles E. Geyer, John A. Olson, William C. Wood, Tracy Lively, Soonmyung Paik, Matthew J. Ellis, Jeffrey Abrams, George W. Sledge

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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 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 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.

Original languageEnglish (US)
JournalJAMA Oncology
DOIs
StateAccepted/In press - Jan 1 2019

Fingerprint

Adjuvant Chemotherapy
Randomized Controlled Trials
Breast Neoplasms
Recurrence
Genes
Therapeutics
Anthracyclines
docetaxel
Drug Therapy
Cyclophosphamide
Disease-Free Survival
Second Primary Neoplasms
Methotrexate
Fluorouracil
Population

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

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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. / Sparano, Joseph A.; Gray, Robert J.; Makower, Della F.; Albain, Kathy S.; Saphner, Thomas J.; Badve, Sunil S.; Wagner, Lynne I.; Kaklamani, Virginia G.; Keane, MacCon M.; Gomez, Henry L.; Reddy, Pavan S.; Goggins, Timothy F.; Mayer, Ingrid A.; Toppmeyer, Deborah L.; Brufsky, Adam M.; Goetz, Matthew P.; Berenberg, Jeffrey L.; Mahalcioiu, Catalin; Desbiens, Christine; Hayes, Daniel F.; Dees, Elizabeth C.; Geyer, Charles E.; Olson, John A.; Wood, William C.; Lively, Tracy; Paik, Soonmyung; Ellis, Matthew J.; Abrams, Jeffrey; Sledge, George W.

In: JAMA Oncology, 01.01.2019.

Research output: Contribution to journalArticle

Sparano, JA, Gray, RJ, Makower, DF, Albain, KS, Saphner, TJ, Badve, SS, Wagner, LI, Kaklamani, VG, Keane, MM, Gomez, HL, Reddy, PS, Goggins, TF, Mayer, IA, Toppmeyer, DL, Brufsky, AM, Goetz, MP, Berenberg, JL, Mahalcioiu, C, Desbiens, C, Hayes, DF, Dees, EC, Geyer, CE, Olson, JA, Wood, WC, Lively, T, Paik, S, Ellis, MJ, Abrams, J & Sledge, GW 2019, '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', JAMA Oncology. https://doi.org/10.1001/jamaoncol.2019.4794
Sparano, Joseph A. ; Gray, Robert J. ; Makower, Della F. ; Albain, Kathy S. ; Saphner, Thomas J. ; Badve, Sunil S. ; Wagner, Lynne I. ; Kaklamani, Virginia G. ; Keane, MacCon M. ; Gomez, Henry L. ; Reddy, Pavan S. ; Goggins, Timothy F. ; Mayer, Ingrid A. ; Toppmeyer, Deborah L. ; Brufsky, Adam M. ; Goetz, Matthew P. ; Berenberg, Jeffrey L. ; Mahalcioiu, Catalin ; Desbiens, Christine ; Hayes, Daniel F. ; Dees, Elizabeth C. ; Geyer, Charles E. ; Olson, John A. ; Wood, William C. ; Lively, Tracy ; Paik, Soonmyung ; Ellis, Matthew J. ; Abrams, Jeffrey ; Sledge, George W. / 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. In: JAMA Oncology. 2019.
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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 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 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.",
author = "Sparano, {Joseph A.} and Gray, {Robert J.} and Makower, {Della F.} and Albain, {Kathy S.} and Saphner, {Thomas J.} and Badve, {Sunil S.} and Wagner, {Lynne I.} and Kaklamani, {Virginia G.} and Keane, {MacCon M.} and Gomez, {Henry L.} and Reddy, {Pavan S.} and Goggins, {Timothy F.} and Mayer, {Ingrid A.} and Toppmeyer, {Deborah L.} and Brufsky, {Adam M.} and Goetz, {Matthew P.} and Berenberg, {Jeffrey L.} and Catalin Mahalcioiu and Christine Desbiens and Hayes, {Daniel F.} and Dees, {Elizabeth C.} and Geyer, {Charles E.} and Olson, {John A.} and Wood, {William C.} and Tracy Lively and Soonmyung Paik and Ellis, {Matthew J.} and Jeffrey Abrams and Sledge, {George W.}",
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TY - JOUR

T1 - Clinical Outcomes in Early Breast Cancer with a High 21-Gene Recurrence Score of 26 to 100 Assigned to Adjuvant Chemotherapy plus Endocrine Therapy

T2 - A Secondary Analysis of the TAILORx Randomized Clinical Trial

AU - Sparano, Joseph A.

AU - Gray, Robert J.

AU - Makower, Della F.

AU - Albain, Kathy S.

AU - Saphner, Thomas J.

AU - Badve, Sunil S.

AU - Wagner, Lynne I.

AU - Kaklamani, Virginia G.

AU - Keane, MacCon M.

AU - Gomez, Henry L.

AU - Reddy, Pavan S.

AU - Goggins, Timothy F.

AU - Mayer, Ingrid A.

AU - Toppmeyer, Deborah L.

AU - Brufsky, Adam M.

AU - Goetz, Matthew P.

AU - Berenberg, Jeffrey L.

AU - Mahalcioiu, Catalin

AU - Desbiens, Christine

AU - Hayes, Daniel F.

AU - Dees, Elizabeth C.

AU - Geyer, Charles E.

AU - Olson, John A.

AU - Wood, William C.

AU - Lively, Tracy

AU - Paik, Soonmyung

AU - Ellis, Matthew J.

AU - Abrams, Jeffrey

AU - Sledge, George W.

PY - 2019/1/1

Y1 - 2019/1/1

N2 - 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 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.

AB - 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 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.

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