Browsing by Author "Huang, C-S"

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    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 Efficacy Update
    (Lippincott Williams and Wilkins, 2024) 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
    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 the intent-to-treat population. The 8-year OS was 92.7% in the pertuzumab versus 92.0% in the placebo group (hazard ratio [HR], 0.83 [95% CI, 0.68 to 1.02]; P =.078, above the 0.006 significance threshold). The HR was 0.80 [95% CI 0.63 to 1.00] in the node-positive cohort and 0.99 [95% CI, 0.64 to 1.55] in the node-negative cohort. Updated results of 8-year iDFS in the node-positive cohort showed an absolute improvement of 4.9% favoring pertuzumab (86.1% v 81.2%; HR, 0.72 [95% CI, 0.60 to 0.87]). The node-negative cohort did well without adding pertuzumab (8-year iDFS and OS in the placebo group were 93.3% and 96.4%, respectively). The iDFS benefit was seen in the hormone receptor-negative (HR, 0.82 [95% CI, 0.64 to 1.06]) and HR+ cohorts (HR of 0.75 [95% CI, 0.61 to 0.92]). Despite improvement in overall iDFS, the addition of pertuzumab did not improve OS at this third interim analysis.
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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 (Alliance)]
    (Elsevier B.V., 2024) 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
    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 balanced between groups. At a median follow-up of 9.8 years, the addition of lapatinib to trastuzumab and chemotherapy did not significantly improve DFS nor OS. The 10-year DFS was 77% in T, 79% in L + T and 79% in T→L, and the 10-year OS was 87%, 89% and 89%, respectively. The incidence of any cardiac event was low and similar in the three treatment groups. Conclusions: With a longer follow-up, no significant improvement was observed in DFS in patients treated with dual anti-HER2 blockade with lapatinib + trastuzumab compared to trastuzumab alone. The 10-year survival rates for the combination group are consistent with other studies that have explored dual anti-HER2 therapy.