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artículo

Triple-Negative PAM50 Non-Basal Breast Cancer Subtype Predicts Benefit from Extended Adjuvant Capecitabine

Publicado por
Asleh, K, Lluch, A, Goytain, A, Barrios, C, Wang, XQ, Torrecillas, L, Gao, D, Ruiz-Borrego, M, Leung, S, Bines, J, Guerrero-Zotano, A, Garcia-Saenz, JA, Cejalvo, JM, Herranz, J, Torres, R, de-la-Haba-Rodriguez, J, Ayala, F, Gomez, H, Rojo, F, Nielsen, TO, Martin, M

Publicado 2023

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Purpose: Predictive biomarkers for capecitabine benefit in triple-negative breast cancer (TNBC) have been recently proposed using samples from phase III clinical trials, including non-basal phenotype and biomarkers related to angiogenesis, stroma, and capecitabine activation genes. We aimed to validate these findings on the larger phase III GEICAM/CIBOMA clinical trial. Experimental Design: Tumor tissues from patients with TNBC randomized to standard (neo)adjuvant chemotherapy followed by capecitabine versus observation were analyzed using a 164-gene NanoString custom nCounter codeset measuring mRNA expression. A prespecified statistical plan sought to verify the predictive capacity of PAM50 non-basal molecular subtype and tested the hypotheses that breast tumors with increased expression of (meta) genes for cytotoxic cells, mast cells, endothelial cells, PDL2, and 38 individual genes be...

artículo

Adjuvant Pertuzumab and Trastuzumab in Early Human Epidermal Growth Factor Receptor 2-Positive Breast Cancer in the APHINITY Trial: Third Interim Overall Survival Analysis With Eff...

Publicado por
Loibl, S, Jassem, J, Sonnenblick, A, Parlier, D, Winer, E, Bergh, J, Gelber, RD, Restuccia, E, Im, Y-H, Huang, C-S, Dalenc, F, Calvo, I, Procter, M, Caballero, C, Clark, E, Raimbault, A, Mcconnell, R, Monturus, E, De, Azambuja, E, Gomez, HL, Bliss, J, Viale, G, Bines, J, Piccart, M, Aebi, S, Andersson, M, Bonnefoi, H, Cameron, D, Cardoso, F, de, Haas, S, Dent, S, Fein, L, Frank, E, Gnant, M, Gomez, Moreno, H, Im, S-A, Jackisch, C, Janni, W, Krop, I, Kummel, S, Liu, T-W, Loi, S, Masuda, N, Nili, Gam-Yal, E, Nyawira, B, Pascual, T, Pienkowski, T, Rodríguez-Lescure, A, Suter, T, Thomssen, C, Tjan-Heijnen, V, Tomasello, G, Torres, Ulloa, MR, Twelves, C, Walshe, J, Wilcken, N

Publicado 2024

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Clinical trials frequently include multiple end points that mature at different times. The initial report, typically based on the primary end point, may be published when key planned co-primary or secondary analyses are not yet available. Clinical Trial Updates provide an opportunity to disseminate additional results from studies, published in JCO or elsewhere, for which the primary end point has already been reported. The APHINITY trial (ClinicalTrials.gov identifier: NCT01358877) previously demonstrated that pertuzumab added to adjuvant trastuzumab and chemotherapy improved invasive disease-free survival (iDFS) for patients with early human epidermal growth factor receptor 2-positive (HER2+) breast cancer (BC). Here, we report the preplanned third interim analysis of overall survival (OS) and a descriptive updated iDFS analysis with 8.4 years of median follow-up of 4,804 patients in th...