Estrogen receptor-positive (ER+) and
HER2-negative (HER2-) breast cancer with no spread to the lymph nodes accounts
for about one-half of all new breast cancers in the United States each year.
Long-term recurrence and survival data are now
available from the groundbreaking Trial Assigning Individualized Options for
Treatment (Rx) or TAILORx trial. With 12 years of follow-up, the updated
analysis confirms the original findings that chemotherapy has no benefit for a
large proportion of women with early-stage breast cancer. In addition, the
longer follow-up reveals unexpected information about late recurrences. There
was also a higher risk of early recurrence in Black women.
The landmark TAILORx trial gave an
evidence-based answer to the question of which women with this type of breast
cancer may benefit from chemotherapy as a potentially life-saving treatment-and
which may effectively pursue endocrine therapy (ET) alone and avoid the
unnecessary side effects of chemotherapy.
Joseph A. Sparano, MD, presented the updated
analysis today during the 2022 San Antonio Breast Cancer Symposium. Abstract
GS1-05 Trial Assigning Individualized Options for Treatment (TAILORx): An
update including 12-year event rates occurred during General Session #1.
“The immediate clinical impact is that
with longer follow-up, the main TAILORx study findings remain unchanged.
Therefore, physicians can continue to use the 21-gene recurrence score results
to guide decisions about the use of chemotherapy,” said Dr. Sparano,
deputy director of The Tisch Cancer Center at Mount Sinai Health System and
leader of TAILORx for the ECOG-ACRIN Cancer Research Group.
Estrogen receptor-positive (ER+) and
HER2-negative (HER2-) breast cancer with no spread to the lymph nodes accounts
for about one-half of all new breast cancers in the United States each year.
The landmark TAILORx trial gave an evidence-based answer to the question of
which women with this type of breast cancer may benefit from chemotherapy as a
potentially life-saving treatment—and which may effectively pursue endocrine
therapy (ET) alone and avoid the unnecessary side effects of chemotherapy.
The study used a molecular test that assesses
the expression of 21 genes associated with breast cancer recurrence (on a scale
of 0-100).
After following 10,273 women for at least 5
years (median of 7.5 years), TAILORx established that chemotherapy may safely
be spared in women with ER+, HER2-, and lymph node-negative breast cancer with
a 21-gene recurrence score of 0-25 who were postmenopausal or older than 50 at
diagnosis. It may also be spared in most women with this type of breast cancer
who were younger than 50 or premenopausal (Sparano JA, N Engl J Med, 2018 and
here).
12-Year Results
In this updated analysis, trial volunteers
were followed for an additional 3.5 years, now for an average of 11 years. The
main study findings remain unchanged: chemotherapy use may be spared in many
women with ER+, HER2-, and lymph node-negative breast cancer when guided by the
21-gene recurrence score result. As in the original analysis, the subgroup of
women aged 50 and younger with a score of 21-25 or 16-25 and high clinical risk
derived some chemotherapy benefit that persists out to 12 years. This cohort
accounted for 7% of the trial population.
New information:
For women with a score of 0-25 treated with ET
alone, recurrence rates were very low on average, at less than 1% per year over
the 12 years. However, more late recurrences occurred beyond 5 years after
breast cancer diagnosis than in the first 5 years.
The rates of cancer that came back in another
part of the body other than the breast (distant recurrence) remained low, and
overall survival rates remained high for women with a score of 0-25 when
treated with ET alone. However, there was an increasing divergence between
rates of distant recurrence and invasive disease-free survival, a measure that
includes recurrence, death, and second primary cancers. This finding shows that
the new development of second primary cancers dominated this cohort.
“There is a higher risk of developing a
new breast cancer or other cancer than having a recurrence of the original
cancer, pointing out the need for vigilance in cancer screening after a breast
cancer diagnosis,” said Dr. Sparano.
Distant recurrence rates remained high for
those with a score of 26-100 despite adding chemotherapy to ET.
“More research is needed to develop more
effective therapies for women with a very high recurrence score who have
unacceptably high recurrence risk despite the use of chemotherapy,” said Dr.
Sparano.
Black women were at higher risk of recurrence
in the first 5 years after diagnosis, but not later.
“Racial disparities were noted that were
not explained by inequities in social determinants of health or by stopping anti-hormonal
endocrine therapy early,” said Dr. Sparano. “This finding adds to a
growing body of evidence suggesting biological factors may contribute to the
body developing resistance to endocrine therapy.”
Reference:
Joseph A. Sparano, et al,The TAILORx trial
in over 10,000 women with early breast cancer reaches 12 years of recurrence
and survival outcomes
ECOG-ACRIN CANCER RESEARCH GROUP