National Cancer Institute - NCI Division of Cancer Treatment and ...

Trastuzumab Combined with
Chemotherapy Improves Disease-
Free Survival for Patients with
Early-Stage Breast Cancer
The combination of the targeted agent
trastuzumab (Herceptin®) and standard
chemotherapy cuts the risk of Her2positive
breast cancer recurrence by more
than half compared with chemotherapy
alone. The result comes from two large,
CTEP-sponsored, randomized trials testing,
as adjuvant therapy, a trastuzumab/
chemotherapy combination against
chemotherapy alone in women with
invasive, early stage, Her2-positive
breast cancer.
Trastuzumab, manufactured by Genentech,
Inc., specifically targets the HER2
protein, which is overexpressed in
approximately 20 to 30 percent of breast
cancers. Her2-positive tumors are not
only more aggressive than tumors that
do not overproduce HER2 protein, but
also they are more likely to recur. Trastuzumab
is approved by FDA for use in
women with Her2-positive metastatic
breast cancer. These are the first trials
to show a benefit for trastuzumab as
breast cancer adjuvant therapy.
Additional analyses will allow the trial
leaders to perform a more thorough risk/
benefit analysis. In the interim analysis,
the likelihood of congestive heart failure
(CHF) in women receiving the trastuzumab/chemotherapy
combination was
increased by 3 to 4 percent, compared
with a less than 1 percent CHF rate in
those treated with chemotherapy alone.
S C I E N T I F I C A D V A N C E S
Romond EH, Perez EA, Bryant J, Suman V, Geyer
CE, Davidson N, Tan-Chiu E, Martino S, Swain SM,
Kaufman P, Fehrenbacher L, Pisansky T, Vogel V,
Kutteh LA, Yothers G, Visscher D, Brown AM, Jenkins
R, Seay TE, Mamounas E, Abrams J, Wolmark
N. Joint analysis of NSABP-B-31 and NCCTG-
N9831. Presented at: Advances in Monoclonal
Antibody Therapy for Breast Cancer Scientific
Symposium, ASCO Annual Meeting. May 13–17,
2005. Orlando, FL.
Oncotype DX® Test Predicts
Breast Cancer Recurrence Risk
and Chemotherapy Benefit
Results from several studies validate
that a new test can predict the risk of
breast cancer recurrence in a sizable
group of patients; the studies also appear
to identify which of those patients will
benefit most from chemotherapy. The
studies were heralded by researchers
as an important moment in the move
toward individualized cancer care. Central
to the investigations is a test, Oncotype
DX®, which analyzes the expression of a
21-gene panel in biopsy samples from
women with estrogen-dependent,
lymph-node negative breast cancer,
which accounts for more than 50,000
breast cancer cases in the United States
each year.
Confirmation of earlier data on the
ability of the assay—developed by
Genomic Health, Inc., which, along with
CTEP and the DCTD Cancer Diagnosis
Program, funded some of the studies—
to accurately predict recurrence risk was
C A N C E R T H E R A P Y E V A L U A T I O N P R O G R A M ■ 79