New outcomes data from two large population-based studies
, presented at the 2019 San Antonio
Breast Cancer Symposium (SABCS®). The real-world evidence suggests that use of
the Oncotype DX Breast Recurrence Score® test in clinical practice is
consistent with previous clinical validation studies including TAILORx, the
largest ever breast cancer treatment trial. This landmark study was featured in
the William L. McGuire Memorial Lecture Award, which recognized Joseph A.
Sparano, M.D., TAILORx study chair, for his leadership, collaboration and
practice-changing achievements in breast cancer research.
“Last year, TAILORx established the highest level of
evidence and unprecedented precision supporting the use of the Oncotype DX
Breast Recurrence Score test to guide adjuvant chemotherapy treatment for women
with early-stage breast cancer,” said Dr. Sparano, associate director for
clinical research at the Albert Einstein Cancer Center and Montefiore Health
System in New York, and vice chair of the ECOG-ACRIN Cancer Research Group. “I
am honored to receive this prestigious award and pleased that the TAILORx
results have been incorporated in major clinical practice guidelines and used
to guide patient care around the world.”
Outcomes Data in Patients Age 50 or Younger Reinforce
Ability of Oncotype DX® to Identify Those Who Can Be Treated with Hormone
Therapy Alone
An analysis from the U.S. National Cancer Database in over
4,700 women age 40 or younger with node-negative disease showed a distribution
of Recurrence Score® results consistent with existing clinical evidence, with
as many as 80% of patients having low Recurrence Score results (0-25). Higher
Recurrence Score results were associated with worse five-year overall survival.
Another analysis from the Surveillance, Epidemiology, and
End Results (SEER) registry program of the National Cancer Institute (NCI)
provides real-world evidence of the value of the Oncotype DX® test in patients
age 50 or younger with node-positive disease (up to three positive nodes) Results
from more than 2,500 patients indicated a significant association between Recurrence
Score results and breast cancer-specific mortality (BCSM), with five-year BCSM
of less than 2% in young patients with Recurrence Score results 0-25 and no or
unknown use of chemotherapy reported.
New Publication of Long-term Data from Real-world
Clinical Practice Confirms Major Finding of TAILORx Study
Separately, the first reported 10-year outcomes data,
including distant recurrence risk, from a large cohort of patients using the
Recurrence Score results to guide treatment decisions in clinical practice were
recently published. This analysis from
investigators working with Clalit Health Services, the largest health services
organization in Israel, examined medical records of more than 1,300 patients
with node-negative breast cancer and applied the Recurrence Score cut points
established by the landmark TAILORx study.
The findings showed that use of chemotherapy was
aligned with Recurrence Score results, and that patients with Recurrence Score results
up to 25, the vast majority of whom were treated with hormonal therapy alone,
had excellent outcomes at 10 years, with low rates of distant recurrence. For
the group of patients with Recurrence Score results 11-25, there were no
statistically significant differences in 10-year distant recurrence rates
between patients who received chemotherapy and those treated with hormonal
therapy alone. These results are consistent with the primary findings of the
large TAILORx randomized clinical trial.