Otto Metzger Filho1, Anita Giobbie-Hurder2, Elizabeth Mallon2, Barry Gusterson2, Giuseppe Viale2, Eric P Winer2, Beat Thürlimann2, Richard D Gelber2, Marco Colleoni2, Bent Ejlertsen2, Marc Debled2, Karen N Price2, Meredith M Regan2, Alan S Coates2, Aron Goldhirsch2. 1. Otto Metzger Filho, Anita Giobbie-Hurder, and Eric P. Winer, Dana-Farber Cancer Institute; Richard D. Gelber and Meredith M. Regan, Harvard Medical School; Karen N. Price, Frontier Science and Technology Research, Boston, MA; Elizabeth Mallon, Southern General Hospital; Barry Gusterson, Institute of Cancer Sciences, University of Glasgow, Glasgow, United Kingdom; Giuseppe Viale, European Institute of Oncology and University of Milan; Marco Colleoni and Aron Goldhirsch, European Institute of Oncology, Milan, Italy; Beat Thürlimann, Kantonsspital, St. Gallen, and Swiss Group for Clinical Cancer Research, Bern, Switzerland; Bent Ejlertsen, Rigshospitalet, Copenhagen, Denmark; Marc Debled, Institut Bergoniié, Bordeaux, France; and Alan S. Coates, International Breast Cancer Study Group, Bern, Switzerland, and University of Sydney, Sydney, Australia. otto_metzger@dfci.harvard.edu. 2. Otto Metzger Filho, Anita Giobbie-Hurder, and Eric P. Winer, Dana-Farber Cancer Institute; Richard D. Gelber and Meredith M. Regan, Harvard Medical School; Karen N. Price, Frontier Science and Technology Research, Boston, MA; Elizabeth Mallon, Southern General Hospital; Barry Gusterson, Institute of Cancer Sciences, University of Glasgow, Glasgow, United Kingdom; Giuseppe Viale, European Institute of Oncology and University of Milan; Marco Colleoni and Aron Goldhirsch, European Institute of Oncology, Milan, Italy; Beat Thürlimann, Kantonsspital, St. Gallen, and Swiss Group for Clinical Cancer Research, Bern, Switzerland; Bent Ejlertsen, Rigshospitalet, Copenhagen, Denmark; Marc Debled, Institut Bergoniié, Bordeaux, France; and Alan S. Coates, International Breast Cancer Study Group, Bern, Switzerland, and University of Sydney, Sydney, Australia.
Abstract
PURPOSE: To evaluate the relative effectiveness of letrozole compared with tamoxifen for patients with invasive ductal or lobular carcinoma. PATIENTS AND METHODS: Patients diagnosed with early-stage invasive ductal carcinoma (IDC) or classic invasive lobular carcinoma (ILC) who were randomly assigned onto the Breast International Group (BIG) 1-98 trial and who had centrally reviewed pathology data were included (N = 2,923). HER2-negative IDC and ILC were additionally classified as hormone receptor-positive with high (luminal B [LB] -like) or low (luminal A [LA] -like) proliferative activity by Ki-67 labeling index. Survival analyses were performed with weighted Cox models that used inverse probability of censoring weighted modeling. RESULTS: The median follow-up time was 8.1 years. In multivariable models for disease-free survival (DFS), significant interactions between treatment and histology (ILC or IDC; P = .006) and treatment and subgroup (LB like or LA like; P = .01) were observed. In the ILC subset, there was a 66% reduction in the hazard of a DFS event with letrozole for LB (hazard ratio [HR], 0.34; 95% CI, 0.21 to 0.55) and a 50% reduction for LA subtypes (HR, 0.50; 95% CI, 0.32 to 0.78). In the IDC subset, there was a significant 35% reduction in the hazard of a DFS event with letrozole for the LB subtype (HR, 0.65; 95% CI, 0.53 to 0.79), but no difference between treatments was noted for IDC and the LA subtype (HR, 0.95; 95% CI, 0.76 to 1.20). CONCLUSION: The magnitude of benefit of adjuvant letrozole is greater for patients diagnosed with lobular carcinoma versus ductal carcinoma.
RCT Entities:
PURPOSE: To evaluate the relative effectiveness of letrozole compared with tamoxifen for patients with invasive ductal or lobular carcinoma. PATIENTS AND METHODS: Patients diagnosed with early-stage invasive ductal carcinoma (IDC) or classic invasive lobular carcinoma (ILC) who were randomly assigned onto the Breast International Group (BIG) 1-98 trial and who had centrally reviewed pathology data were included (N = 2,923). HER2-negative IDC and ILC were additionally classified as hormone receptor-positive with high (luminal B [LB] -like) or low (luminal A [LA] -like) proliferative activity by Ki-67 labeling index. Survival analyses were performed with weighted Cox models that used inverse probability of censoring weighted modeling. RESULTS: The median follow-up time was 8.1 years. In multivariable models for disease-free survival (DFS), significant interactions between treatment and histology (ILC or IDC; P = .006) and treatment and subgroup (LB like or LA like; P = .01) were observed. In the ILC subset, there was a 66% reduction in the hazard of a DFS event with letrozole for LB (hazard ratio [HR], 0.34; 95% CI, 0.21 to 0.55) and a 50% reduction for LA subtypes (HR, 0.50; 95% CI, 0.32 to 0.78). In the IDC subset, there was a significant 35% reduction in the hazard of a DFS event with letrozole for the LB subtype (HR, 0.65; 95% CI, 0.53 to 0.79), but no difference between treatments was noted for IDC and the LA subtype (HR, 0.95; 95% CI, 0.76 to 1.20). CONCLUSION: The magnitude of benefit of adjuvant letrozole is greater for patients diagnosed with lobular carcinoma versus ductal carcinoma.
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