Adjuvant Chemotherapy Guided by a 21-Gene Expression Assay in Breast Cancer

Joseph A Sparano ¹, Robert J Gray ¹, Della F Makower ¹, Kathleen I Pritchard ¹, Kathy S Albain ¹, Daniel F Hayes ¹, Charles E Geyer ¹, Elizabeth C Dees ¹, Matthew P Goetz ¹, John A Olson ¹, Tracy Lively ¹, Sunil S Badve ¹, Thomas J Saphner ¹, Lynne I Wagner ¹, Timothy J Whelan ¹, Matthew J Ellis ¹, Soonmyung Paik ¹, William C Wood ¹, Peter M Ravdin ¹, Maccon M Keane ¹, Henry L Gomez Moreno ¹, Pavan S Reddy ¹, Timothy F Goggins ¹, Ingrid A Mayer ¹, Adam M Brufsky ¹, Deborah L Toppmeyer ¹, Virginia G Kaklamani ¹, Jeffrey L Berenberg ¹, Jeffrey Abrams ¹, George W Sledge ¹

Affiliations

¹ From Montefiore Medical Center, Albert Einstein College of Medicine, Bronx, NY (J.A.S., D.F.M.); Dana-Farber Cancer Institute, Boston (R.J.G.); Sunnybrook Research Institute, Toronto (K.I.P.), and McMaster University, Hamilton, ON (T.J.W.) - both in Canada; Loyola University Chicago Stritch School of Medicine, Maywood (K.S.A.), and Northwestern University, Chicago (L.I.W., V.G.K.) - both in Illinois; University of Michigan, Ann Arbor (D.F.H.); Virginia Commonwealth University School of Medicine and the Massey Cancer Center, Richmond (C.E.G.); University of North Carolina, Chapel Hill (E.C.D.), and Duke University Medical Center, Durham (J.A.O.) - both in North Carolina; Mayo Clinic, Jacksonville, FL (M.P.G.); National Institutes of Health, National Cancer Institute, Bethesda, MD (T.L., J.A.); Indiana University School of Medicine (S.S.B.) and Indiana University Hospital (G.W.S.), Indianapolis; Vince Lombardi Cancer Clinic, Two Rivers (T.J.S.), and Fox Valley Hematology and Oncology, Appleton (T.F.G.) - both in Wisconsin; Washington University, St. Louis (M.J.E.); National Surgical Adjuvant Breast and Bowel Project Pathology Office (S.P.) and University of Pittsburgh (A.M.B.), Pittsburgh; Emory University, Atlanta (W.C.W.); University of Texas, San Antonio (P.M.R.); Cancer Trials Ireland, Dublin (M.M.K.); Instituto Nacional de Enfermedades Neoplasicas, Lima, Peru (H.L.G.M.); Cancer Center of Kansas, Wichita (P.S.R.); Vanderbilt University, Nashville (I.A.M.); Rutgers Cancer Institute of New Jersey, New Brunswick (D.L.T.); and University of Hawaii Cancer Center, Honolulu (J.L.B.).

PMID: 29860917
33 References
304 citations

Abstract

Background: The recurrence score based on the 21-gene breast cancer assay predicts chemotherapy benefit if it is high and a low risk of recurrence in the absence of chemotherapy if it is low; however, there is uncertainty about the benefit of chemotherapy for most patients, who have a midrange score.

Methods: We performed a prospective trial involving 10,273 women with hormone-receptor-positive, human epidermal growth factor receptor 2 (HER2)-negative, axillary node-negative breast cancer. Of the 9719 eligible patients with follow-up information, 6711 (69%) had a midrange recurrence score of 11 to 25 and were randomly assigned to receive either chemoendocrine therapy or endocrine therapy alone. The trial was designed to show noninferiority of endocrine therapy alone for invasive disease-free survival (defined as freedom from invasive disease recurrence, second primary cancer, or death).

Results: Endocrine therapy was noninferior to chemoendocrine therapy in the analysis of invasive disease-free survival (hazard ratio for invasive disease recurrence, second primary cancer, or death [endocrine vs. chemoendocrine therapy], 1.08; 95% confidence interval, 0.94 to 1.24; P=0.26). At 9 years, the two treatment groups had similar rates of invasive disease-free survival (83.3% in the endocrine-therapy group and 84.3% in the chemoendocrine-therapy group), freedom from disease recurrence at a distant site (94.5% and 95.0%) or at a distant or local-regional site (92.2% and 92.9%), and overall survival (93.9% and 93.8%). The chemotherapy benefit for invasive disease-free survival varied with the combination of recurrence score and age (P=0.004), with some benefit of chemotherapy found in women 50 years of age or younger with a recurrence score of 16 to 25.

Conclusions: Adjuvant endocrine therapy and chemoendocrine therapy had similar efficacy in women with hormone-receptor-positive, HER2-negative, axillary node-negative breast cancer who had a midrange 21-gene recurrence score, although some benefit of chemotherapy was found in some women 50 years of age or younger. (Funded by the National Cancer Institute and others; TAILORx ClinicalTrials.gov number, NCT00310180 .).

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Does the Sequence of Anthracycline and Taxane Matter? The NeoSAMBA Trial. José Bines, Isabele A Small, +9 authors, Martin Bonamino. less Oncologist, 2020 Jun 02; 25(9). PMID: 32476183 Free PMC article.
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Luminal Breast Cancer: The Head of Janus in Breast Oncology. Oleg Gluz. Breast Care (Basel), 2020 Sep 29; 15(4). PMID: 32982641 Free PMC article.
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Should we target "intermediate expression" of HER2 in older estrogen receptor positive patients? Yoshihisa Tokumaru, Lan Le, +4 authors, Kazuaki Takabe. less Transl Cancer Res, 2020 Oct 27; 9(7). PMID: 33102162 Free PMC article.
Integrated Multiparametric Radiomics and Informatics System for Characterizing Breast Tumor Characteristics with the OncotypeDX Gene Assay. Michael A Jacobs, Christopher B Umbricht, +5 authors, Antonio C Wolff. less Cancers (Basel), 2020 Oct 01; 12(10). PMID: 32992569 Free PMC article.
Cost-effectiveness analyses demonstrate that observation is superior to sentinel lymph node biopsy for postmenopausal women with HR + breast cancer and negative axillary ultrasound. Aubriana M McEvoy, Steven Poplack, +7 authors, William E Gillanders. less Breast Cancer Res Treat, 2020 Jul 12; 183(2). PMID: 32651755 Free PMC article. Review.
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Ten Thousand Consecutive Gastrectomies for Gastric Cancer: Perspectives of a Master Surgeon. Yoon Young Choi, Minah Cho, +5 authors, Woo Jin Hyung. less Yonsei Med J, 2019 Feb 26; 60(3). PMID: 30799586 Free PMC article. Review.
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A Prognostic Gene-Expression Signature and Risk Score for Meningioma Recurrence After Resection. William C Chen, Harish N Vasudevan, +16 authors, David R Raleigh. less Neurosurgery, 2020 Aug 30; 88(1). PMID: 32860417 Free PMC article.
Blood molecular markers associated with COVID-19 immunopathology and multi-organ damage. Yan-Mei Chen, Yuanting Zheng, +24 authors, Yong-Zhen Zhang. less EMBO J, 2020 Nov 04; 39(24). PMID: 33140861 Free PMC article.
Predictability of 21-Gene Recurrence Score Assay by Using Pathological and Immunohistochemical Parameters in Breast Cancer. Abdulmohsen Alkushi, Ahmad Omair, +2 authors, Haitham Arabi, Emad Masuadi, Omalkhair Abualkhair. less Breast Cancer (Auckl), 2020 Dec 22; 14. PMID: 33343196 Free PMC article.
Ki67 Immunohistochemistry Quantification in Breast Carcinoma: A Comparison of Visual Estimation, Counting, and ImmunoRatio. Eunice J van den Berg, Raquel Duarte, +2 authors, Caroline Dickens, Maureen Joffe, Reena Mohanlal. less Appl Immunohistochem Mol Morphol, 2020 Jun 27; 29(2). PMID: 32590453 Free PMC article.
The molecular landscape of Asian breast cancers reveals clinically relevant population-specific differences. Jia-Wern Pan, Muhammad Mamduh Ahmad Zabidi, +10 authors, Soo-Hwang Teo. less Nat Commun, 2020 Dec 24; 11(1). PMID: 33353943 Free PMC article.
Update on the most promising biomarkers of response to immune checkpoint inhibitors in clear cell renal cell carcinoma. Ivan Pourmir, Johanna Noel, +2 authors, Audrey Simonaggio, Stéphane Oudard, Yann-Alexandre Vano. less World J Urol, 2021 Jan 03;. PMID: 33386948
Residual risk stratification of Taiwanese breast cancers following curative therapies with the extended concurrent genes signature. Ching-Shui Huang, Tzu-Pin Lu, +5 authors, Chi-Cheng Huang. less Breast Cancer Res Treat, 2021 Jan 05;. PMID: 33392837
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Feasibility of Measuring Preferences for Chemotherapy Among Early-Stage Breast Cancer Survivors Using a Direct Rank Ordering Multicriteria Decision Analysis Versus a Time Trade-Off. Laura Panattoni, Charles E Phelps, +4 authors, Scott D Ramsey. less Patient, 2020 May 25; 13(5). PMID: 32447608
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Factors That Predict Biological Aggressiveness in Estrogen Receptor-Positive / Human Epidermal Growth Factor Receptor 2-Negative / Lymph Node-Negative Breast Cancer. Lauren E Arthur, Ashley H McMann, +4 authors, Ralph L Corsetti. less Ochsner J, 2021 Jan 08; 20(4). PMID: 33408575 Free PMC article.
Tryptophanyl-tRNA Synthetase Sensitizes Hormone Receptor-Positive Breast Cancer to Docetaxel-Based Chemotherapy. Kyung-Min Lee, Eun Hye Hwang, +6 authors, Han Suk Ryu. less J Breast Cancer, 2021 Jan 08; 23(6). PMID: 33408886 Free PMC article.
Predicted Chemotherapy Benefit for Breast Cancer Patients With Germline Pathogenic Variants in Cancer Susceptibility Genes. Allison W Kurian, Kevin C Ward, +2 authors, Paul Abrahamse, Ann S Hamilton, Steven J Katz. less JNCI Cancer Spectr, 2021 Jan 12; 5(1). PMID: 33426465 Free PMC article.
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Oncotype DX testing in node-positive breast cancer strongly impacts chemotherapy use at a comprehensive cancer center. Katya Losk, Rachel A Freedman, +7 authors, Tari A King. less Breast Cancer Res Treat, 2020 Sep 18; 185(1). PMID: 32939592
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In modern times, how important are breast cancer stage, grade and receptor subtype for survival: a population-based cohort study. Anna L V Johansson, Cassia B Trewin, +3 authors, Giske Ursin. less Breast Cancer Res, 2021 Feb 03; 23(1). PMID: 33526044 Free PMC article.
Characterizing patient-oncologist communication in genomic tumor testing: The 21-gene recurrence score as an exemplar. Suzanne C O'Neill, Susan T Vadaparampil, +9 authors, Susan Eggly. less Patient Educ Couns, 2020 Sep 10; 104(2). PMID: 32900604 Free PMC article.
Mucinous carcinoma with micropapillary features is morphologically, clinically and genetically distinct from pure mucinous carcinoma of breast. Peng Sun, Zaixuan Zhong, +6 authors, Jiehua He. less Mod Pathol, 2020 May 03; 33(10). PMID: 32358590
Concordance between results of inexpensive statistical models and multigene signatures in patients with ER+/HER2- early breast cancer. Laurence Slembrouck, Isabelle Vanden Bempt, +12 authors, Giuseppe Floris. less Mod Pathol, 2021 Feb 10;. PMID: 33558657
Adaptation of international coronavirus disease 2019 and breast cancer guidelines to local context. Guillermo Arturo Valencia, Silvia Neciosup, +6 authors, Rodrigo Auqui. less World J Clin Oncol, 2021 Feb 09; 12(1). PMID: 33552937 Free PMC article.
Zinc distribution within breast cancer tissue of different intrinsic subtypes. Peter Rusch, Alfred V Hirner, +3 authors, Maxim Diel. less Arch Gynecol Obstet, 2020 Sep 16; 303(1). PMID: 32930875 Free PMC article.
Tailoring precision immunotherapy: coming to a clinic soon? Shuting Han, Wai Ho Shuen, +2 authors, Who-Whong Wang, Esdy Nazim, Han Chong Toh. less ESMO Open, 2021 Feb 10; 5 Suppl 1. PMID: 33558033 Free PMC article. Review.
FGFR1 amplification or overexpression and hormonal resistance in luminal breast cancer: rationale for a triple blockade of ER, CDK4/6, and FGFR1. Silvana Mouron, Luis Manso, +6 authors, Maria J Bueno. less Breast Cancer Res, 2021 Feb 14; 23(1). PMID: 33579347 Free PMC article.
Current Achievements and Applications of Transcriptomics in Personalized Cancer Medicine. Stanislaw Supplitt, Pawel Karpinski, Maria Sasiadek, Izabela Laczmanska. Int J Mol Sci, 2021 Feb 13; 22(3). PMID: 33572595 Free PMC article. Review.
Concordance of the molecular subtype classification between core needle biopsy and surgical specimen in primary breast cancer. M Pölcher, M Braun, +6 authors, O Stoetzer. less Arch Gynecol Obstet, 2021 Feb 16;. PMID: 33585986
Deep learning in cancer pathology: a new generation of clinical biomarkers. Amelie Echle, Niklas Timon Rindtorff, +3 authors, Jakob Nikolas Kather. less Br J Cancer, 2020 Nov 19; 124(4). PMID: 33204028 Review.
Targeting transcription of MCL-1 sensitizes HER2-amplified breast cancers to HER2 inhibitors. Konstantinos V Floros, Sheeba Jacob, +8 authors, Anthony C Faber. less Cell Death Dis, 2021 Feb 17; 12(2). PMID: 33589591
Proteomic analysis of circulating extracellular vesicles identifies potential markers of breast cancer progression, recurrence, and response. Yaron Vinik, Francisco Gabriel Ortega, +6 authors, Sima Lev. less Sci Adv, 2020 Oct 04; 6(40). PMID: 33008904 Free PMC article.
The Role of Oncotype DX® Recurrence Score in Predicting Axillary Response After Neoadjuvant Chemotherapy in Breast Cancer. Jaime A Pardo, Betty Fan, +5 authors, Ted A James. less Ann Surg Oncol, 2021 Jan 05; 28(3). PMID: 33393046
Postmenopausal Women with HR+/HER2- Early Breast Cancer, 1-3 Positive Nodes, and a Low Risk of Recurrence Can Safely Forego Chemotherapy. Oncologist, 2021 Jan 06; 26 Suppl 2. PMID: 33399242 Free PMC article.
Recommendations from the European Commission Initiative on Breast Cancer for multigene testing to guide the use of adjuvant chemotherapy in patients with early breast cancer, hormone receptor positive, HER-2 negative. Paolo Giorgi Rossi, Annette Lebeau, +13 authors, ECIBC Contributor Group. less Br J Cancer, 2021 Feb 19;. PMID: 33597715 Review.
Refining breast cancer prognosis by incorporating age at diagnosis into clinical prognostic staging: introduction of a novel online calculator. Helen M Johnson, William Irish, Nasreen A Vohra, Jan H Wong. Breast Cancer Res Treat, 2021 Feb 21;. PMID: 33609208
A nomogram to predict the high-risk RS in HR+/HER2-breast cancer patients older than 50 years of age. Jing Yu, Jiayi Wu, +6 authors, Kunwei Shen. less J Transl Med, 2021 Feb 18; 19(1). PMID: 33593381 Free PMC article.
Background Parenchymal Enhancement on Breast MRI as a Prognostic Surrogate: Correlation With Breast Cancer Oncotype Dx Score. Michelle Zhang, Meredith Sadinski, +5 authors, Elizabeth J Sutton. less Front Oncol, 2021 Feb 23; 10. PMID: 33614481 Free PMC article.

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