HannaH phase III randomised study: Association of total pathological complete response with event-free survival in HER2-positive early breast cancer treated with neoadjuvant-adjuvant trastuzumab after 2 years of treatment-free follow-up.

Date publication

juillet 2016

Journal

European journal of cancer (Oxford, England : 1990)

Auteurs

Membres identifiés du Cancéropôle Est :
Pr PIVOT Xavier

Tous les auteurs :
Jackisch C, Hegg R, Stroyakovskiy D, Ahn JS, Melichar B, Chen SC, Kim SB, Lichinitser M, Starosławska E, Kunz G, Falcon S, Chen ST, Crepelle-Fléchais A, Heinzmann D, Shing M, Pivot X

Lien Pubmed

https://www.ncbi.nlm.nih.gov/pubmed/27208905

Résumé

In the phase III, open-label, randomised HannaH study, fixed-dose neoadjuvant-adjuvant subcutaneous trastuzumab for human epidermal growth factor receptor 2 (HER2)-positive early breast cancer was non-inferior to standard weight-based intravenous infusion in terms of serum trough concentration and pathological complete response (pCR). Evidence suggests that pCR, particularly total pCR (tpCR), is likely to predict clinical benefit. We report associations between tpCR and event-free survival (EFS) from HannaH (the largest population from a single study of patients presenting with newly diagnosed HER2-positive breast cancer treated with neoadjuvant-adjuvant trastuzumab to date) plus long-term efficacy and safety.

Mots clés

Herceptin, Neoadjuvant chemotherapy, Pathological complete response, Subcutaneous, Trastuzumab

Référence

Eur. J. Cancer. 2016 Jul;62:62-75