BACKGROUND: The SINODAR-ONE trial is a prospective noninferiority multicenter randomized study aimed at assessing the role of axillary lymph node dissection (ALND) in patients undergoing either breast-conserving surgery or mastectomy for T1-2 breast cancer (BC) and presenting one or two macrometastatic sentinel lymph nodes (SLNs). The endpoints were to evaluate whether SLN biopsy (SLNB) only was associated with worsening of the prognosis compared with ALND in terms of overall survival (OS) and relapse. METHODS: Patients were randomly assigned (1:1 ratio) to either removal of ≥ 10 axillary level I/II non-SLNs followed by adjuvant therapy (standard arm) or no further axillary treatment (experimental arm). RESULTS: The trial started in April 2015 and ceased in April 2020, involving 889 patients. Median follow-up was 34.0 months. There were eight deaths (ALND, 4; SNLB only, 4), with 5-year cumulative mortality of 5.8% and 2.1% in the standard and experimental arm, respectively (p = 0.984). There were 26 recurrences (ALND 11; SNLB only, 15), with 5-year cumulative incidence of recurrence of 6.9% and 3.3% in the standard and experimental arm, respectively (p = 0.444). Only one axillary lymph node recurrence was observed in each arm. The 5-year OS rates were 98.9% and 98.8%, in the ALND and SNLB-only arm, respectively (p = 0.936). CONCLUSIONS: The 3-year survival and relapse rates of T1-2 BC patients with one or two macrometastatic SLNs treated with SLNB only, and adjuvant therapy, were not inferior to those of patients treated with ALND. These results do not support the use of routine ALND.
BACKGROUND: The SINODAR-ONE trial is a prospective noninferiority multicenter randomized study aimed at assessing the role of axillary lymph node dissection (ALND) in patients undergoing either breast-conserving surgery or mastectomy for T1-2 breast cancer (BC) and presenting one or two macrometastatic sentinel lymph nodes (SLNs). The endpoints were to evaluate whether SLN biopsy (SLNB) only was associated with worsening of the prognosis compared with ALND in terms of overall survival (OS) and relapse. METHODS: Patients were randomly assigned (1:1 ratio) to either removal of ≥ 10 axillary level I/II non-SLNs followed by adjuvant therapy (standard arm) or no further axillary treatment (experimental arm). RESULTS: The trial started in April 2015 and ceased in April 2020, involving 889 patients. Median follow-up was 34.0 months. There were eight deaths (ALND, 4; SNLB only, 4), with 5-year cumulative mortality of 5.8% and 2.1% in the standard and experimental arm, respectively (p = 0.984). There were 26 recurrences (ALND 11; SNLB only, 15), with 5-year cumulative incidence of recurrence of 6.9% and 3.3% in the standard and experimental arm, respectively (p = 0.444). Only one axillary lymph node recurrence was observed in each arm. The 5-year OS rates were 98.9% and 98.8%, in the ALND and SNLB-only arm, respectively (p = 0.936). CONCLUSIONS: The 3-year survival and relapse rates of T1-2 BC patients with one or two macrometastatic SLNs treated with SLNB only, and adjuvant therapy, were not inferior to those of patients treated with ALND. These results do not support the use of routine ALND.
Authors: David N Krag; Stewart J Anderson; Thomas B Julian; Ann M Brown; Seth P Harlow; Joseph P Costantino; Takamaru Ashikaga; Donald L Weaver; Eleftherios P Mamounas; Lynne M Jalovec; Thomas G Frazier; R Dirk Noyes; André Robidoux; Hugh Mc Scarth; Norman Wolmark Journal: Lancet Oncol Date: 2010-10 Impact factor: 41.316
Authors: Umberto Veronesi; Giuseppe Viale; Giovanni Paganelli; Stefano Zurrida; Alberto Luini; Viviana Galimberti; Paolo Veronesi; Mattia Intra; Patrick Maisonneuve; Francesca Zucca; Giovanna Gatti; Giovanni Mazzarol; Concetta De Cicco; Dario Vezzoli Journal: Ann Surg Date: 2010-04 Impact factor: 12.969
Authors: Robert E Mansel; Lesley Fallowfield; Mark Kissin; Amit Goyal; Robert G Newcombe; J Michael Dixon; Constantinos Yiangou; Kieran Horgan; Nigel Bundred; Ian Monypenny; David England; Mark Sibbering; Tholkifl I Abdullah; Lester Barr; Utheshtra Chetty; Dudley H Sinnett; Anne Fleissig; Dayalan Clarke; Peter J Ell Journal: J Natl Cancer Inst Date: 2006-05-03 Impact factor: 13.506
Authors: Anthony Lucci; Linda Mackie McCall; Peter D Beitsch; Patrick W Whitworth; Douglas S Reintgen; Peter W Blumencranz; A Marilyn Leitch; Sukumal Saha; Kelly K Hunt; Armando E Giuliano Journal: J Clin Oncol Date: 2007-05-07 Impact factor: 44.544
Authors: David N Krag; Stewart J Anderson; Thomas B Julian; Ann M Brown; Seth P Harlow; Takamaru Ashikaga; Donald L Weaver; Barbara J Miller; Lynne M Jalovec; Thomas G Frazier; R Dirk Noyes; André Robidoux; Hugh M C Scarth; Denise M Mammolito; David R McCready; Eleftherios P Mamounas; Joseph P Costantino; Norman Wolmark Journal: Lancet Oncol Date: 2007-10 Impact factor: 41.316
Authors: Umberto Veronesi; Giovanni Paganelli; Giuseppe Viale; Alberto Luini; Stefano Zurrida; Viviana Galimberti; Mattia Intra; Paolo Veronesi; Chris Robertson; Patrick Maisonneuve; Giuseppe Renne; Concetta De Cicco; Francesca De Lucia; Roberto Gennari Journal: N Engl J Med Date: 2003-08-07 Impact factor: 91.245
Authors: Massimiliano De Bortoli; Robert C Castellino; Xin-Yan Lu; Jeffrey Deyo; Lisa Marie Sturla; Adekunle M Adesina; Laszlo Perlaky; Scott L Pomeroy; Ching C Lau; Tsz-Kwong Man; Pulivarthi H Rao; John Y H Kim Journal: BMC Cancer Date: 2006-09-12 Impact factor: 4.430