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.
L to R: Dr. Suresh Advani, Dr. Vinay Deshmane & Dr. Mandar Nadkarni, Prasad Vaidya
“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.
L to R: Dr. Suresh Advani, Dr. Vinay Deshmane & Dr. Mandar Nadkarni
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.
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).