TY - JOUR
T1 - Ten-year survival of neoadjuvant dual HER2 blockade in patients with HER2-positive breast cancer
AU - Nuciforo, Paolo
AU - Townend, John
AU - Piccart, Martine J.
AU - Fielding, Shona
AU - Gkolfi, Panagiota
AU - El-Abed, Sarra
AU - de Azambuja, Evandro
AU - Werutsky, Gustavo
AU - Bliss, Judith
AU - Moebus, Volker
AU - Colleoni, Marco
AU - Aspitia, Alvaro Moreno
AU - Gomez, Henry
AU - Gombos, Andrea
AU - Coccia-Portugal, Maria A.
AU - Tseng, Ling Ming
AU - Kunz, Georg
AU - Lerzo, Guillermo
AU - Sohn, Joohyuk
AU - Semiglazov, Vladimir
AU - Saura, Cristina
AU - Kroep, Judith
AU - Ferro, Antonella
AU - Cameron, David
AU - Gelber, Richard
AU - Huober, Jens
AU - Di Cosimo, Serena
N1 - Publisher Copyright:
© 2022 Elsevier Ltd
PY - 2023/3
Y1 - 2023/3
N2 - Background: Dual anti-HER2-targeted therapy in breast cancer (BC) significantly increased the rate of pathological complete response (pCR) compared to single blockade when added to chemotherapy. However, limited data exist on the long-term impact on survival of the additional increase in pCR. Methods: Neoadjuvant lapatinib and/or trastuzumab treatment optimisation (NCT00553358) is an international, randomised, open-label, phase III study investigating the addition of lapatinib to chemotherapy plus trastuzumab in HER2-positive early BC. Ten-year event-free survival (EFS), overall survival (OS) and safety were assessed on intention-to-treat population. The association between pCR and EFS or OS was investigated in landmark population. Results: A total of 455 patients were randomised to receive lapatinib (154), trastuzumab (149) or the combination (152). Ten-year EFS estimates were 63% (95% confidence interval [CI], 54%–71%) in the lapatinib group, 64% (95% CI, 55%–72%) in the trastuzumab group and 67% (95% CI, 58%–74%) in the combination group. Ten-year OS rates were 76% (95% CI, 67%–83%), 75% (95% CI, 66%–82%) and 80% (95% CI, 73%–86%) in the lapatinib, trastuzumab and combination groups, respectively. Women who achieved a pCR had improved EFS (hazard ratio 0.48, 95% CI, 0.31–0.73) and OS (hazard ratio 0.37, 95% CI, 0.20–0.63) compared with those who did not. The numerical difference in survival according to pCR status was greater in women treated with the combination and those with hormone-receptor-negative tumours. There were no new or long-term safety concerns. Conclusions: Patients with HER2-positive BC showed a durable survival benefit of neoadjuvant anti-HER2, irrespective of treatment arm. Patients who achieve pCR have significantly better outcomes than patients without pCR.
AB - Background: Dual anti-HER2-targeted therapy in breast cancer (BC) significantly increased the rate of pathological complete response (pCR) compared to single blockade when added to chemotherapy. However, limited data exist on the long-term impact on survival of the additional increase in pCR. Methods: Neoadjuvant lapatinib and/or trastuzumab treatment optimisation (NCT00553358) is an international, randomised, open-label, phase III study investigating the addition of lapatinib to chemotherapy plus trastuzumab in HER2-positive early BC. Ten-year event-free survival (EFS), overall survival (OS) and safety were assessed on intention-to-treat population. The association between pCR and EFS or OS was investigated in landmark population. Results: A total of 455 patients were randomised to receive lapatinib (154), trastuzumab (149) or the combination (152). Ten-year EFS estimates were 63% (95% confidence interval [CI], 54%–71%) in the lapatinib group, 64% (95% CI, 55%–72%) in the trastuzumab group and 67% (95% CI, 58%–74%) in the combination group. Ten-year OS rates were 76% (95% CI, 67%–83%), 75% (95% CI, 66%–82%) and 80% (95% CI, 73%–86%) in the lapatinib, trastuzumab and combination groups, respectively. Women who achieved a pCR had improved EFS (hazard ratio 0.48, 95% CI, 0.31–0.73) and OS (hazard ratio 0.37, 95% CI, 0.20–0.63) compared with those who did not. The numerical difference in survival according to pCR status was greater in women treated with the combination and those with hormone-receptor-negative tumours. There were no new or long-term safety concerns. Conclusions: Patients with HER2-positive BC showed a durable survival benefit of neoadjuvant anti-HER2, irrespective of treatment arm. Patients who achieve pCR have significantly better outcomes than patients without pCR.
KW - Breast cancer
KW - Dual anti-HER2 blockade
KW - HER2-Positive
KW - Long-term survival
KW - Neoadjuvant
KW - Pathological complete response
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U2 - 10.1016/j.ejca.2022.12.020
DO - 10.1016/j.ejca.2022.12.020
M3 - Article
C2 - 36641898
AN - SCOPUS:85146155206
SN - 0959-8049
VL - 181
SP - 92
EP - 101
JO - European Journal of Cancer
JF - European Journal of Cancer
ER -