Τίτλος:
Disease-Free Survival According to Degree of HER2 Amplification for
Patients Treated With Adjuvant Chemotherapy With or Without 1 Year of
Trastuzumab: The HERA Trial
Γλώσσες Τεκμηρίου:
Αγγλικά
Περίληψη:
Purpose
To determine whether (1) immunohistochemical (IHC) HER2 status (ie, 2+
or 3+), (2) degree of fluorescence in situ hybridization (FISH)
amplification according to (2a) HER2/CEP17 ratio or (2b) HER2 gene copy
number, or (3) polysomy significantly influenced clinical outcome for
patients with human epidermal growth factor receptor 2 (HER2) -positive
breast cancer enrolled in the Herceptin Adjuvant trial of trastuzumab
versus no trastuzumab administered after completion of chemotherapy.
Patients and Methods
IHC and/or FISH analyses were performed locally and required central
confirmation as indicating HER2 positivity for trial entry. FISH data
from the central HER2 analysis on patients in the 1-year trastuzumab and
no trastuzumab arms were assessed in relation to disease-free survival
(DFS) after a median 2 years of follow-up.
Results
Central FISH results were available for 2,071 (61%) of the 3,401
patients randomized to the 2 arms. Among patients with FISH-positive
disease, (1) the hazard ratios for trastuzumab versus no trastuzumab
were 0.56 (95% CI, 0.32 to 0.99) for locally IHC2+ cases (n = 340) and
0.80 (95% CI, 0.40 to 1.61) for centrally IHC2+ cases (n = 299). There
was no significant prognostic relationship between (2a) HER2 FISH ratio,
(2b) HER2 copy number, or (3) polysomy and DFS in the control arm or
predictive relationship defining differential benefit from trastuzumab.
Conclusion
There was no evidence for reduced benefit of trastuzumab in HER2 IHC2+
FISH+ cases. The degree of HER2 amplification does not influence
prognosis or benefit from adjuvant trastuzumab in patients treated with
prior adjuvant chemotherapy. J Clin Oncol 27: 2962-2969. (C) 2009 by
American Society of Clinical Oncology
Συγγραφείς:
Dowsett, Mitch
Procter, Marion
McCaskill-Stevens, Worta
de
Azambuja, Evandro
Dafni, Urania
Rueschoff, Josef
Jordan,
Bruce
Dolci, Stella
Abramovitz, Mark
Stoss, Oliver and
Viale, Giuseppe
Gelber, Richard D.
Piccart-Gebhart, Martine and
Leyland-Jones, Brian
Περιοδικό:
World Journal of Clinical Oncology
Εκδότης:
AMER SOC CLINICAL ONCOLOGY 2318 MILL ROAD, STE 800, ALEXANDRIA, VA 22314 USA
DOI:
10.1200/JCO.2008.19.7939
