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Final analysis of the ALTTO trial: adjuvant trastuzumab in sequence or in combination with lapatinib in patients with HER2-positive early breast cancer [BIG 2-06/NCCTG N063D (Allia...

Publicado por
de, Azambuja, E, Piccart-Gebhart, M, Fielding, S, Townend, J, Hillman, DW, Colleoni, M, Roylance, R, Kelly, CM, Lombard, J, El-Abed, S, Choudhury, A, Korde, L, Vicente, M, Chumsri, S, Rodeheffer, R, Ellard, SL, Wolff, AC, Holtschmidt, J, Lang, I, Untch, M, Boyle, F, Xu, B, Werutsky, G, Tujakowski, J, Huang, C-S, Baruch, NB, Bliss, J, Ferro, A, Gralow, J, Kim, S-B, Kroep, JR, Krop, I, Kuemmel, S, McConnell, R, Moscetti, L, Knop, AS, van, Duijnhoven, F, Gomez, H, Cameron, D, Di, Cosimo, S, Gelber, RD, Moreno-Aspitia, A

Publicado 2024

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Background: Dual anti-human epidermal growth factor receptor 2 (HER2) blockade has improved the outcomes of patients with early and metastatic HER2-positive breast cancer. Here we present the final 10-year analysis of the ALTTO trial. Patients and methods: The ALTTO trial (NCT00490139) is a prospective randomized, phase III, open-label, multicenter study that investigated the role of adjuvant chemotherapy and trastuzumab alone, in combination or sequentially with lapatinib. The primary endpoint was disease-free survival (DFS) and secondary endpoints included overall survival (OS), time to distant recurrence and safety. Results: Overall, 6281 patients with HER2-positive early breast cancer were included in the final efficacy analysis in three treatment groups: trastuzumab (T), lapatinib + trastuzumab (L + T) and trastuzumab followed by lapatinib (T→L). Baseline characteristics were well...

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...