Indian doctors endorse TAILORx finding on breast cancer vs chemoSeptember 12, 2018
Senior oncologists in India have strongly endorsed the breakthrough finding of the Trial Assigning Individualized Options for Treatment (TAILORx) conducted by United States National Cancer Institute (NCI) and ECOG-ACRIN Cancer Research Group.
The findings of the study, which were published in the New England Journal of Medicine in June, demonstrated that the ‘Oncotype DX Breast Recurrence Score’ test definitively identified zero benefit from chemotherapy in 70% of women with early-stage breast cancer. It also found that among the 30% who benefited, chemotherapy could be life-saving.
“The study will have a practice-changing impact on the medical community with regard to prescribing chemotherapy to breast cancer patients. The Oncotype Dx test can identify low-risk patients who may safely avoid chemotherapy as well as the high-risk patient who will benefit by chemotherapy. Such personalized 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 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 among women in India and accounts for 27% of all cancers in women. The incidence rate of 25.8 per 100,000 is lower in India 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 in 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.
Dr Vinay Deshmane Surgical oncologist at Breach Candy Hospital, Mumbai
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 it, 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 Prasad Vaidya, CEO, Medilinks Inc.
However, there are oncology experts who do not fully support the generalisation of the study finding and its impact, especially in countries like India.
Prasad Vaidya CEO, Medilinks Inc
“Although the findings of TAILORx trial gives an insight for judging low risk patients and help avoid the pain and toxicity of chemo for them, the situation in India is not exactly comparable with the West, where very early testing (mammography etc.) for breast.cancer is quite common. But, that is not the case in India, where majority of patients come for treatment at an advanced stage and if a situation arises like the patient needs chemotherapy even after doing a costly Oncotype DX test (as it’s not available here) it is a double whammy,” said Dr Narayanankutty Warrier, Medical Director at MVR Cancer Centre and Research Institute, Kozhikode.
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. The score is used 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 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 practising physicians and breast cancer patients. Previously, the majority of breast cancer patients all over the world were recommended to receive chemotherapy after surgery with lots of side effects, affecting the quality of life of patients. For long, doctors and patients both have wished to have a reliable tool that will help identify patients who need chemotherapy and spare the others who would not benefit much by this treatment, thereby individualizing patient therapy instead of generalising it.’’
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.”
Currently, MammaTyper is the only test performed for measuring breast cancer gene expression in order to predict Oncotype DX-type results within India. This test offered by Mumbai-based diagnostics lab Metropolis Healthcare at its Global Reference Laboratory in Mumbai. Since other players in this space get the test conducted abroad (Europe or the US) by sending out the samples, it often adds to the cost and time consumed for the results.
Dr Narayanankutty Warrier Medical Director, MVR Cancer Centre and Research Institute, Kozhikode
Dr Kirti Chadha Vice President, Oncomet
According to Dr Kirti Chadha, Vice President, Oncomet – the Integrated Oncopathology division of Metropolis Healthcare, MammaTyper, which is a CE-IVD marked assay, does subtyping for prognosis of breast cancer suggesting that endocrine therapy may be adequate for patients with a low risk of relapse. “Thus, it is a cost-effective method to identify low-risk patients
at the current set-up in India,”
MammaTyper, which is offered by Metropolis in India through a technology collaboration with BioNTech Diagnostics GmbH, Germany, allows precise, quantitative measurement of the mRNA expression of the ERBB2 (HER2), ESR1 (ER), PGR (PR) and MKI67 (proliferation marker Ki-67) biomarkers, which in turn facilitates molecular subtyping of tumor tissue according to St. Gallen guidelines, according to leading oncologists.
They agree that this test provides molecular stratification of breast cancer, information which is required for the selection of effective therapy tailored to each patient. Since quantitative measurement of the expression levels of the four St. Gallen biomarkers is a much better predictor of Oncotype DX Recurrence Score (RS) results than using traditional IHC or FISH methods. It also helps physicians avoid over treating certain patient groups, thus sparing patients from additional rounds of debilitating chemotherapy, says Dr N K Warrier, Medical Director at MVR Cancer Centre & Research Institute, Kozhikode.
According to the Union health ministry, breast cancer ranks as the number one cancer among Indian females with rate as high as 25.8 per 100,000 women and mortality of 12.7 per 100,000 women. For women diagnosed during 2010-14, five-year survival for breast cancer is now 89.5% in Australia and 90.2% in the USA, but international differences remain very wide, with levels as low as 66.1% in India according to the study titled Global surveillance of trends in cancer survival CONCORD-3.