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Randomized Controlled Trial
. 2023 Mar:181:92-101.
doi: 10.1016/j.ejca.2022.12.020. Epub 2022 Dec 27.

Ten-year survival of neoadjuvant dual HER2 blockade in patients with HER2-positive breast cancer

Paolo Nuciforo  1 , John Townend  2 , Martine J Piccart  3 , Shona Fielding  2 , Panagiota Gkolfi  4 , Sarra El-Abed  5 , Evandro de Azambuja  3 , Gustavo Werutsky  6 , Judith Bliss  7 , Volker Moebus  8 , Marco Colleoni  9 , Alvaro Moreno Aspitia  10 , Henry Gomez  11 , Andrea Gombos  3 , Maria A Coccia-Portugal  12 , Ling-Ming Tseng  13 , Georg Kunz  14 , Guillermo Lerzo  15 , Joohyuk Sohn  16 , Vladimir Semiglazov  17 , Cristina Saura  18 , Judith Kroep  19 , Antonella Ferro  20 , David Cameron  21 , Richard Gelber  22 , Jens Huober  23 , Serena Di Cosimo  24
Affiliations
Randomized Controlled Trial

Ten-year survival of neoadjuvant dual HER2 blockade in patients with HER2-positive breast cancer

Paolo Nuciforo et al. Eur J Cancer. 2023 Mar.

Abstract

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.

Keywords: Breast cancer; Dual anti-HER2 blockade; HER2-Positive; Long-term survival; Neoadjuvant; Pathological complete response.

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