About 70% of Early-stage Breast Cancer Patients May Avoid Agony of Chemotherapy: Study
by Shrutee K/DNS
Mumbai, 2nd August 2018:
Breakthrough finding by the landmark Trial Assigning Individualized Options for
Treatment (TAILORx) demonstrates the
Oncotype DX Breast Recurrence Score® Test definitively identifies
the 70% of women with early-stage breast cancer who receive no
benefit from chemotherapy, and the 30% of women for whom chemotherapy benefit
can be life-saving. “This
study will have a practice changing impact on the medical community related to
prescribing chemotherapy to breast cancer patients. The Oncotype Dx test, can
help oncologist identify low risk patients who may safely avoid chemotherapy as
well as the high risk patient who will benefit by chemotherapy. By limiting the
use of chemotherapy only to those likely to benefit such personalised treatment
has the potential to decrease the overall use of chemotherapy in breast
cancer.,” remarked Dr. Vinay Deshmane, Surgical oncologist at P D Hinduja
Hospital and Breach Candy Hospital, Mumbai.
The TAILORx study, the largest ever breast cancer treatment
trial, was published in the New England Journal of Medicine in June. It was supported by the United States
National Cancer Institute (NCI), part of the National Institutes of Health, and
designed and led by the ECOG-ACRIN Cancer Research Group. Breast cancer is
the most common cancer in women in India and accounts for 27% of all cancers in
women. At
an incidence rate of 25.8 per 100,000 it is lower than in some developed countries,
but the mortality rate (12.7 per 100,000) is comparable to that in western
countries. Data on incidence rates of breast cancer from six major cancer
registries of India show that the annual percentage increase in the incidence
of breast cancer has been in the 0.46 to 2.56% range.
The majority of breast cancer
patients diagnosed worldwide have hormone-positive, HER2-negative,
node-negative cancer. The TAILORx study
definitively established that chemotherapy may be spared in about 70 percent of
these patients, including all women older than 50 with Breast Recurrence Score®
results of 0 to 25 and all women age 50 or younger with Breast Recurrence Score
results of 0 to 15. Importantly, 30 percent of
early-stage breast cancer patients will derive benefit from chemotherapy,
including women of any age with Breast Recurrence Score results of 26 to 100,
and in women younger than 50, where a modest (2 percent) benefit from
chemotherapy was observed with Breast Recurrence Score results of 16 to 20,
which gradually grew as scores increased up to and above 25. This important
finding reveals a new level of precision of chemotherapy benefit for younger
patients that only the Oncotype DX® test can provide.
"The
TAILORx findings can spare thousands
of women from getting toxic chemotherapy treatment that really wouldn’t benefit
them. By identifying the
right patients who can benefit from chemotherapy, and sparing chemotherapy and
its toxic side effects in those who will not benefit from its treatment, the
personalized treatment approach is a breakthrough advancement in the medical
fraternity. As the sole commercial
representative in India for Genomic Health, we hope to bring changes in the
standard of care in India," said Mr. Prasad Vaidya, CEO, Medilinks
Inc.
The trial
enrolled 10,273 women with breast cancer from 6 countries across the globe. It
used the Oncotype DX Breast Recurrence Score® test that
assesses the expression of 21 genes associated with breast cancer recurrence to
assign women with early-stage, HR- positive, HER2-negative, axillary lymph
node–negative breast cancer to the most appropriate and effective
post-operative treatment.
TAILORx
participants with Breast Recurrence Score results from 0 to 10 were treated
with endocrine therapy alone based on the prior results from the NSABP B-20
study, which showed no opportunity for chemotherapy benefit. TAILORx
participants with Breast Recurrence Score results from 26 to 100 were treated
with chemotherapy plus endocrine therapy based on the prior results from the
NSABP B-20 study, which showed an absolute benefit of chemotherapy greater than
20 percent. To more
precisely define the effect of chemotherapy for women considered to be at
intermediate risk for recurrence, 6,711 women with Oncotype DX Breast
Recurrence Score results of 11 to 25, the primary study group in TAILORx, were
randomized to receive endocrine therapy with or without chemotherapy. These
randomized patients comprised two-thirds of all patients enrolled in TAILORx
and were followed by the investigators for approximately nine years on average. Dr. Mandar
Nadkarni, Oncosurgeon at Kokilaben Dhirubhai Ambani Hospital,Mumbai, commented,
“This is a landmark study in the field of breast cancer management. Results of
the study will have a major impact on practicing physicians and breast cancer
patients. Previously, majority of breast cancer patients all over the world
were recommended to receive chemotherapy after surgery with lots of side
effects affecting quality of life of patients. But we were not sure how far
chemotherapy is helping in improving survival.” Dr. Suresh Advani - Renowned
Oncologist and Padma Bhushan recipient- concluded, “Today, personalized
medicine has allowed us to avoid chemotherapy for certain group of patients. We
can select the people who don’t need chemo and administer it to only those who
need it.”
ABOUT GENOMIC HEALTH: Genomic
Health, Inc. (NASDAQ: GHDX) is the world's leading provider of
genomic-based diagnostic tests that help optimize cancer care, including
addressing the overtreatment of the disease, one of the greatest issues in
healthcare today. With its Oncotype IQ® Genomic Intelligence
Platform, the company is applying its world-class scientific and commercial
expertise and infrastructure to lead the translation of clinical and genomic
big data into actionable results for treatment planning throughout the cancer
patient journey, from diagnosis to treatment selection and monitoring. The
Oncotype IQ portfolio of genomic tests and services currently consists of the
company's flagship line of Oncotype DX® gene expression tests
that have been used to guide treatment decisions for more than 900,000 cancer
patients worldwide. The company is based in Redwood
City, California, with international headquarters
in Geneva, Switzerland. For more information, please visit, www.GenomicHealth.com
ABOUT MEDILINKS: Medilinks
Inc is involved in marketing specialized Oncology Genomics, Genetics & CTC
testing for Breast, Colon, Prostate & Thyroid cancer for various
multinational companies in India for the last 9 years. Medilinks
Inc is the sole representative in India of Genomic Health Inc., USA for the
Oncotype DX Breast Recurrence Score®
Test (the 21 Gene Expression Assay used in the TAILORx trial).
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