Maire J Amlicke1, Jihye Park2, Chris B Agala1, Dana L Casey3,4, Emily M Ray4,5, Stephanie M Downs-Canner6, Philip M Spanheimer7,8. 1. Department of Surgery, University of North Carolina, Chapel Hill, NC, USA. 2. Department of Epidemiology, University of North Carolina, Chapel Hill, NC, USA. 3. Department of Radiation Oncology, University of North Carolina, Chapel Hill, NC, USA. 4. Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill, NC, USA. 5. Department of Medicine, Division of Oncology, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA. 6. Breast Service, Department of Surgery, Memorial Sloan Kettering Cancer Center, New York, NY, USA. 7. Department of Surgery, University of North Carolina, Chapel Hill, NC, USA. Philip_Spanheimer@med.unc.edu. 8. Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill, NC, USA. Philip_Spanheimer@med.unc.edu.
Abstract
BACKGROUND: The RxPONDER trial demonstrated that the 21-gene recurrence score can be used to guide adjuvant systemic therapy decisions in postmenopausal women with pN1 ER+/HER2- breast cancer. As such, a sentinel lymph node biopsy (SLNB) may not provide systemic treatment-altering information for many patients, and omission of SLNB in patients with low probability of pN2/N3 disease could be considered. METHODS: Postmenopausal women (aged ≥ 50 years) diagnosed with cN0cM0, ER+/HER- breast cancer from 2013 to 2017 were identified in the National Cancer Database. The primary outcome was the prevalence of pN2/N3 disease. RESULTS: Of 325,692 postmenopausal women with cN0 ER+/HER2- breast cancer, 7106 (2.2%) were pN2/N3. In total, 81.7% had cT1 tumors, 16.8% T2, 1.3% T3, and 0.2% T4. In patients with T1 tumors, the prevalence of pN2/N3 disease was 1.2% compared with 17.2% in patients with T3/T4 tumors. In multivariable models, cT stage was the strongest predictor of pN2/N3 disease (adjusted odds ratio [aOR] 14.9 [12.1-18.4]). Lobular histology (aOR 2.4 [2.3-2.6]), higher grade (aOR 2.9 [2.6-3.1]), and young age (aOR 1.5 [1.3-1.7]) were also associated with increased prevalence of pN2/N3. We created a model using histology, grade, and T stage that stratifies patients with low prevalence of pN2/3 disease (< 1%) and those at high risk (> 20%). CONCLUSIONS: In postmenopausal women with cN0 ER+/HER2- breast cancer, the prevalence of pN2/N3 disease is low, indicating a potential opportunity to use the results of RxPONDER to extend criteria to omit SLNB. Prospective study is needed to determine safety, including risk of nodal recurrence, of omission of SLNB in carefully selected patients.
BACKGROUND: The RxPONDER trial demonstrated that the 21-gene recurrence score can be used to guide adjuvant systemic therapy decisions in postmenopausal women with pN1 ER+/HER2- breast cancer. As such, a sentinel lymph node biopsy (SLNB) may not provide systemic treatment-altering information for many patients, and omission of SLNB in patients with low probability of pN2/N3 disease could be considered. METHODS: Postmenopausal women (aged ≥ 50 years) diagnosed with cN0cM0, ER+/HER- breast cancer from 2013 to 2017 were identified in the National Cancer Database. The primary outcome was the prevalence of pN2/N3 disease. RESULTS: Of 325,692 postmenopausal women with cN0 ER+/HER2- breast cancer, 7106 (2.2%) were pN2/N3. In total, 81.7% had cT1 tumors, 16.8% T2, 1.3% T3, and 0.2% T4. In patients with T1 tumors, the prevalence of pN2/N3 disease was 1.2% compared with 17.2% in patients with T3/T4 tumors. In multivariable models, cT stage was the strongest predictor of pN2/N3 disease (adjusted odds ratio [aOR] 14.9 [12.1-18.4]). Lobular histology (aOR 2.4 [2.3-2.6]), higher grade (aOR 2.9 [2.6-3.1]), and young age (aOR 1.5 [1.3-1.7]) were also associated with increased prevalence of pN2/N3. We created a model using histology, grade, and T stage that stratifies patients with low prevalence of pN2/3 disease (< 1%) and those at high risk (> 20%). CONCLUSIONS: In postmenopausal women with cN0 ER+/HER2- breast cancer, the prevalence of pN2/N3 disease is low, indicating a potential opportunity to use the results of RxPONDER to extend criteria to omit SLNB. Prospective study is needed to determine safety, including risk of nodal recurrence, of omission of SLNB in carefully selected patients.
Authors: Soonmyung Paik; Gong Tang; Steven Shak; Chungyeul Kim; Joffre Baker; Wanseop Kim; Maureen Cronin; Frederick L Baehner; Drew Watson; John Bryant; Joseph P Costantino; Charles E Geyer; D Lawrence Wickerham; Norman Wolmark Journal: J Clin Oncol Date: 2006-05-23 Impact factor: 44.544
Authors: Soonmyung Paik; Steven Shak; Gong Tang; Chungyeul Kim; Joffre Baker; Maureen Cronin; Frederick L Baehner; Michael G Walker; Drew Watson; Taesung Park; William Hiller; Edwin R Fisher; D Lawrence Wickerham; John Bryant; Norman Wolmark Journal: N Engl J Med Date: 2004-12-10 Impact factor: 91.245
Authors: Reshma Jagsi; Manjeet Chadha; Janaki Moni; Karla Ballman; Fran Laurie; Thomas A Buchholz; Armando Giuliano; Bruce G Haffty Journal: J Clin Oncol Date: 2014-08-18 Impact factor: 44.544
Authors: Mila Donker; Geertjan van Tienhoven; Marieke E Straver; Philip Meijnen; Cornelis J H van de Velde; Robert E Mansel; Luigi Cataliotti; A Helen Westenberg; Jean H G Klinkenbijl; Lorenzo Orzalesi; Willem H Bouma; Huub C J van der Mijle; Grard A P Nieuwenhuijzen; Sanne C Veltkamp; Leen Slaets; Nicole J Duez; Peter W de Graaf; Thijs van Dalen; Andreas Marinelli; Herman Rijna; Marko Snoj; Nigel J Bundred; Jos W S Merkus; Yazid Belkacemi; Patrick Petignat; Dominic A X Schinagl; Corneel Coens; Carlo G M Messina; Jan Bogaerts; Emiel J T Rutgers Journal: Lancet Oncol Date: 2014-10-15 Impact factor: 41.316
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
Authors: José Luiz B Bevilacqua; Michael W Kattan; Jane V Fey; Hiram S Cody; Patrick I Borgen; Kimberly J Van Zee Journal: J Clin Oncol Date: 2007-07-30 Impact factor: 44.544
Authors: Armando E Giuliano; Karla V Ballman; Linda McCall; Peter D Beitsch; Meghan B Brennan; Pond R Kelemen; David W Ollila; Nora M Hansen; Pat W Whitworth; Peter W Blumencranz; A Marilyn Leitch; Sukamal Saha; Kelly K Hunt; Monica Morrow Journal: JAMA Date: 2017-09-12 Impact factor: 56.272
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
Authors: Armando E Giuliano; Karla Ballman; Linda McCall; Peter Beitsch; Pat W Whitworth; Peter Blumencranz; A Marilyn Leitch; Sukamal Saha; Monica Morrow; Kelly K Hunt Journal: Ann Surg Date: 2016-09 Impact factor: 12.969