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Harbeck, N.; Rastogi, P.; Martin, M.; Tolaney, S.M.; Shao, Z.M.; Fasching, P.A.; Huang, C.S.; Jaliffe, G.G.; Tryakin, A.; Goetz, M.P.; Rugo, H.S.; Senkus, E.; Testa, L.; Andersson, M.; Tamura, K.; Del Mastro, L.; Steger, G.G.; Kreipe, H.; Hegg, R.; Sohn, J.; Guarneri, V.; Cortés, J.; Hamilton, E.; André, V.; Wei, R.; Barriga, S.; Sherwood, S.; Forrester, T.; Munoz, M.; Shahir, A.; San Antonio, B.; Nabinger, S.C.; Toi, M.; Johnston, S.R.D.; O’Shaughnessy, J.; Jimenez, M.M.; Johnston, S.; Boyle, F.; Steger, G.G.; Neven, P.; Jiang, Z.; Campone, M.; Huober, J.; Shimizu, C.; Cicin, I.; Wardley, A.; Tolaney, S.M.; Abuin, G.G.; Zarba, J.; Lim, E.; Sant, P.; Liao, N.; Christiansen, B.; Eigeliene, N.; Martin-Babau, J.; Ettl, J.; Mavroudis, D.; Chiu, J.; Boer, K.; Nagarkar, R.; Paluch-Shimon, S.; Moscetti, L.; Sagara, Y.; Kim, S.-B.; Maciel, M.M.; Tjan-Heijnen, V.; Broom, R.; Lacko, A.; Schenker, M.; Volkov, N.; Sim Yap, Y.; Coccia-Portugal, M.; Ángel García Sáenz, J.; Andersson, A.; Chao, T.-Y.; Gokmen, E.; Harputluoglu, H.; Berzoy, O.; Patt, D.; McArthur, H.; Chew, H.; Chalasani, P.; Kaufman, P.; Tedesco, K.; Graff, S.L.
Annals of oncology, December 2021, 2021-12-00, Volume: 32, Issue: 12Journal Article
Adjuvant abemaciclib combined with endocrine therapy (ET) previously demonstrated clinically meaningful improvement in invasive disease-free survival (IDFS) and distant relapse-free survival (DRFS) in hormone receptor-positive, human epidermal growth factor receptor 2-negative, node-positive, high-risk early breast cancer at the second interim analysis, however follow-up was limited. Here, we present results of the prespecified primary outcome analysis and an additional follow-up analysis. This global, phase III, open-label trial randomized (1 : 1) 5637 patients to adjuvant ET for ≥5 years ± abemaciclib for 2 years. Cohort 1 enrolled patients with ≥4 positive axillary lymph nodes (ALNs), or 1-3 positive ALNs and either grade 3 disease or tumor ≥5 cm. Cohort 2 enrolled patients with 1-3 positive ALNs and centrally determined high Ki-67 index (≥20%). The primary endpoint was IDFS in the intent-to-treat population (cohorts 1 and 2). Secondary endpoints were IDFS in patients with high Ki-67, DRFS, overall survival, and safety. At the primary outcome analysis, with 19 months median follow-up time, abemaciclib + ET resulted in a 29% reduction in the risk of developing an IDFS event hazard ratio (HR) = 0.71, 95% confidence interval (CI) 0.58-0.87; nominal P = 0.0009. At the additional follow-up analysis, with 27 months median follow-up and 90% of patients off treatment, IDFS (HR = 0.70, 95% CI 0.59-0.82; nominal P < 0.0001) and DRFS (HR = 0.69, 95% CI 0.57-0.83; nominal P < 0.0001) benefit was maintained. The absolute improvements in 3-year IDFS and DRFS rates were 5.4% and 4.2%, respectively. Whereas Ki-67 index was prognostic, abemaciclib benefit was consistent regardless of Ki-67 index. Safety data were consistent with the known abemaciclib risk profile. Abemaciclib + ET significantly improved IDFS in patients with hormone receptor-positive, human epidermal growth factor receptor 2-negative, node-positive, high-risk early breast cancer, with an acceptable safety profile. Ki-67 index was prognostic, but abemaciclib benefit was observed regardless of Ki-67 index. Overall, the robust treatment benefit of abemaciclib extended beyond the 2-year treatment period. •Adjuvant abemaciclib combined with ET improved IDFS in patients with hormone receptor-positive, human epidermal growth factor receptor 2-negative, high-risk early breast cancer.•Abemaciclib benefit extended beyond the 2-year treatment period.•Ki-67 ≥20% was prognostic and may be used with clinicopathological features to identify patients at high risk of recurrence.•Adjuvant abemaciclib + ET benefited patients with high-risk clinicopathologic features regardless of Ki-67 index.•Safety data were consistent with the known abemaciclib risk profile.
