Olga Kantor1,2,3, Harold J Burstein2,3,4, Tari A King1,2,3, Steven Shak5, Christy A Russell5, Armando E Giuliano6, Gabriel N Hortobagyi7, Eric P Winer2,3,4,8, Larissa A Korde9, Joseph A Sparano10,11, Elizabeth A Mittendorf12,13,14. 1. Division of Breast Surgery, Department of Surgery, Brigham and Women's Hospital, Boston, MA, USA. 2. Breast Oncology Program, Dana-Farber Brigham Cancer Center, Boston, MA, USA. 3. Harvard Medical School, Boston, MA, USA. 4. Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA, USA. 5. Exact Sciences Corporation, Redwood City, CA, USA. 6. Department of Surgery, Cedars-Sinai Medical Center, Los Angeles, CA, USA. 7. Department of Breast Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA. 8. Yale Cancer Center, New Haven, CT, USA. 9. Cancer Therapy Evaluation Program, Division of Cancer Treatment and Diagnosis, National Cancer Institute, Bethesda, MD, USA. 10. Montefiore Medical Center, Albert Einstein College of Medicine, Bronx, NY, USA. 11. Icahn School of Medicine at Mount Sinai, Tisch Cancer Institute, New York, NY, USA. 12. Division of Breast Surgery, Department of Surgery, Brigham and Women's Hospital, Boston, MA, USA. emittendorf@bwh.harvard.edu. 13. Breast Oncology Program, Dana-Farber Brigham Cancer Center, Boston, MA, USA. emittendorf@bwh.harvard.edu. 14. Harvard Medical School, Boston, MA, USA. emittendorf@bwh.harvard.edu.
Abstract
BACKGROUND: The American Joint Committee on Cancer (AJCC) 8th edition pathologic prognostic staging (PPS) incorporates anatomic and biologic factors. The OncotypeDX Breast Recurrence Score (RS) was included based on the initial report of the TAILORx trial, with T1-2N0 hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) breast cancer patients who had a RS < 11 staged as PPS 1A. This study examined whether the RS criteria for PPS 1A can be further expanded using patients enrolled in the TAILORx trial. METHODS: The TAILORx trial enrolled 10,273 HR+HER2- T1-2N0 patients. Those with incomplete HR-status/grade and T3 disease were excluded for analysis. The recurrence-free interval (RFI) was compared between the patients who did and those who did not fall into the current PPS 1A category using the Kaplan-Meier method. RESULTS: The study enrolled 9535 patients for analysis. The RS was < 11 in 16.1%, 11-17 in 35.9%, 18-25 in 32.4%, and > 25 in 15.6% of the patients. The majority (91.2%) of the patients (including all the T1N0 patients regardless of RS) were PPS 1A, and 8.8% were not-PPS 1A. The median follow-up time was 95 months. The PPS 1A patients had an 8-year RFI of 94.2%, which was similar to that of the patients with a RS of 11-17 who were not-PPS 1A (91.7%; p = 0.07) and better than that of the patients with a RS ≥ 18 who were not-PPS 1A (85.4% for a RS of 18-25, 76.0% for a RS > 25; both p < 0.01). Similar RFI trends were seen in patients who received endocrine therapy or chemotherapy followed by endocrine therapy. CONCLUSIONS: Patients with T1-2N0 HR+HER2- breast cancer and a RS < 18 have an RFI similar to that of patients staged as PPS 1A by the current AJCC staging system, regardless of treatment, suggesting that the criteria for PPS 1A can be expanded to include a RS < 18.
BACKGROUND: The American Joint Committee on Cancer (AJCC) 8th edition pathologic prognostic staging (PPS) incorporates anatomic and biologic factors. The OncotypeDX Breast Recurrence Score (RS) was included based on the initial report of the TAILORx trial, with T1-2N0 hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) breast cancer patients who had a RS < 11 staged as PPS 1A. This study examined whether the RS criteria for PPS 1A can be further expanded using patients enrolled in the TAILORx trial. METHODS: The TAILORx trial enrolled 10,273 HR+HER2- T1-2N0 patients. Those with incomplete HR-status/grade and T3 disease were excluded for analysis. The recurrence-free interval (RFI) was compared between the patients who did and those who did not fall into the current PPS 1A category using the Kaplan-Meier method. RESULTS: The study enrolled 9535 patients for analysis. The RS was < 11 in 16.1%, 11-17 in 35.9%, 18-25 in 32.4%, and > 25 in 15.6% of the patients. The majority (91.2%) of the patients (including all the T1N0 patients regardless of RS) were PPS 1A, and 8.8% were not-PPS 1A. The median follow-up time was 95 months. The PPS 1A patients had an 8-year RFI of 94.2%, which was similar to that of the patients with a RS of 11-17 who were not-PPS 1A (91.7%; p = 0.07) and better than that of the patients with a RS ≥ 18 who were not-PPS 1A (85.4% for a RS of 18-25, 76.0% for a RS > 25; both p < 0.01). Similar RFI trends were seen in patients who received endocrine therapy or chemotherapy followed by endocrine therapy. CONCLUSIONS: Patients with T1-2N0 HR+HER2- breast cancer and a RS < 18 have an RFI similar to that of patients staged as PPS 1A by the current AJCC staging system, regardless of treatment, suggesting that the criteria for PPS 1A can be expanded to include a RS < 18.
Authors: Kevin Kalinsky; William E Barlow; Julie R Gralow; Funda Meric-Bernstam; Kathy S Albain; Daniel F Hayes; Nancy U Lin; Edith A Perez; Lori J Goldstein; Stephen K L Chia; Sukhbinder Dhesy-Thind; Priya Rastogi; Emilio Alba; Suzette Delaloge; Miguel Martin; Catherine M Kelly; Manuel Ruiz-Borrego; Miguel Gil-Gil; Claudia H Arce-Salinas; Etienne G C Brain; Eun-Sook Lee; Jean-Yves Pierga; Begoña Bermejo; Manuel Ramos-Vazquez; Kyung-Hae Jung; Jean-Marc Ferrero; Anne F Schott; Steven Shak; Priyanka Sharma; Danika L Lew; Jieling Miao; Debasish Tripathy; Lajos Pusztai; Gabriel N Hortobagyi Journal: N Engl J Med Date: 2021-12-01 Impact factor: 91.245
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Authors: Joseph A Sparano; Robert J Gray; Della F Makower; Kathleen I Pritchard; Kathy S Albain; Daniel F Hayes; Charles E Geyer; Elizabeth C Dees; Matthew P Goetz; John A Olson; Tracy Lively; Sunil S Badve; Thomas J Saphner; Lynne I Wagner; Timothy J Whelan; Matthew J Ellis; Soonmyung Paik; William C Wood; Peter M Ravdin; Maccon M Keane; Henry L Gomez Moreno; Pavan S Reddy; Timothy F Goggins; Ingrid A Mayer; Adam M Brufsky; Deborah L Toppmeyer; Virginia G Kaklamani; Jeffrey L Berenberg; Jeffrey Abrams; George W Sledge Journal: N Engl J Med Date: 2018-06-03 Impact factor: 91.245
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Authors: Ulrike Nitz; Oleg Gluz; Matthias Christgen; Ronald E Kates; Michael Clemens; Wolfram Malter; Benno Nuding; Bahriye Aktas; Sherko Kuemmel; Toralf Reimer; Andrea Stefek; Fatemeh Lorenz-Salehi; Petra Krabisch; Marianne Just; Doris Augustin; Cornelia Liedtke; Calvin Chao; Steven Shak; Rachel Wuerstlein; Hans H Kreipe; Nadia Harbeck Journal: Breast Cancer Res Treat Date: 2017-06-29 Impact factor: 4.872
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