Biomedical Engineering Reference
In-Depth Information
24
the two monotherapy arms.
RS was significantly associated with
distant recurrence when adjusted for tumor size, grade, age and
treatment in the 872 patients with negative axillary nodes (HR 5.25,
p
< 0.001) and the 359 patients with positive axillary nodes (HR
3.47,
< 0.002). The rates of disease distant recurrence at 9 years
for patients with a low, intermediate, and high RS were 4%, 12% and
25%, respectively for patients with negative nodes, and 17%, 28%,
and 49%, respectively, for those with positive axillary nodes. Overall
survival rates at 9 years were 88%, 84% and 73% for patients with
negative nodes and 74%, 69% and 54% for patients with positive
nodes. The prognostic value of RS was similar in anastrozole- and
tamoxifen-treated patients, thereby providing information about
the performance of RS in an AI-treated population. In addition, the
prognostic information from RS was independent of the prognostic
effect of Adjuvant! and vice versa; Adjuvant! is Web-based tool that
provided accurate prognostic information by integrating clinical
and treatment information using a validated algorithm.
p
25
In a model
adjusted for treatment, RS and Adjuvant!, each provided a comparable
degree of mutually independent prognostic information, indicating
that RS and Adjuvant! provide complementary information.
A fourth study evaluated prognostic utility of RS in the context
of adjuvant chemotherapy and endocrine therapy. The study
included patients enrolled in ECOG trial E2197, which included
2885 patients with stage I-III operable breast cancer (and up to 3
positive axillary nodes) who were randomly assigned to receive four
3 week cycles of doxorubicin and cyclophosphamide or docetaxel
plus endocrine therapy.
26
Tamoxifen was initially recommended to
all patients after completion of chemotherapy, but 40% of patients
eventually took and AI after the protocol when amended to allow AI
therapy in postmenopausal women based upon emerging data. Of
the 465 patients with hormone receptor positive disease included
in the analysis, continuous RS was a highly significant predictor of
recurrence (including distant and local) in both the node-negative
and the node-positive patients (
27
Forty-six percent of
patients had low RS tumors, indicating that node-positive disease
was associated with similar rates of low RS as node negative disease.
RS also predicted recurrence more accurately than clinical variables
when integrated by an algorithm modeled after Adjuvant! that was
adjusted to 5-year outcomes.
p
< 0.001).
