Publikation
Survival outcomes of the NeoALTTO study (BIG 1-06): updated results of a randomised multicenter phase III neoadjuvant clinical trial in patients with HER2-positive primary breast cancer
Wissenschaftlicher Artikel/Review - 01.08.2019
Huober Jens, Hackman John, Dasappa Lokanatha, Ciruelos Eva, Toral Pena Juan Carlos, Adamchuk Hryhoriy, Hickish Tamas, de la Pena Lorena, Jackisch Christian, Gelber Richard D, Piccart-Gebhart Martine, Jouannaud Christelle, Wildiers Hans, Lecocq Christophe, Holmes Eileen, Baselga José, de Azambuja Evandro, Untch Michael, Fumagalli Debora, Sarp Severine, Láng István, Smith Ian, Boyle Frances, Xu Binghe, Di Cosimo Serena
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BACKGROUND
Lapatinib (L) plus trastuzumab (T) with weekly paclitaxel significantly increased the pathologic complete response (pCR) rate compared with the anti-human epidermal growth factor receptor 2 (HER2) agent alone plus paclitaxel. The event-free survival (EFS) and overall survival (OS) by the treatment arms L + T vs. T and L vs. T and the relationship between pCR and EFS/OS both in the whole study population and according to hormone receptor-negative and hormone receptor-positive cohorts after a median follow-up of 6.7 years were assessed.
PATIENTS AND METHODS
Four hundred fifty-five patients with HER2-positive early breast cancer randomly received L 1500 mg/day (n = 154), T (common dose, n = 149) or L 1000 mg/day plus T (n = 152) for 6 weeks, followed by the assigned anti-HER2 treatment combined with paclitaxel weekly × 12. After surgery, patients received 3 cycles of fluorouracil, epirubicin and cyclophosphamide. The primary end-point was pCR (ypT0/is; for current analysis, it is ypT0/is ypN0), and the secondary end-points were EFS and OS.
RESULTS
Six-year EFS rates were 67%, 67% and 74% with L, T and L + T, respectively (L vs T: hazard ratio [HR], 0.98 [95% confidence interval {CI}, 0.64-1.51; P = .93]; L + T vs T: HR, 0.81 [95% CI, 0.52-1.26; P = .35]). Six-Year OS rates were 82%, 79% and 85% for L, T and L + T, respectively (L vs T: HR, 0.85 [95% CI, 0.49-1.46; P = .56]; L + T vs T: HR, 0.72 [95% CI, 0.41-1.27; P = .26]). In landmark analyses, patients with a pCR had a significantly higher 6-year EFS (77% and 65%) and OS (89% and 77%) compared with those without a pCR for both overall and the hormone receptor-negative cohort.
CONCLUSION
Achieving a pCR is important in HER2-positive disease and translates into better long-term outcome with regard to EFS and OS.