Chemotherapy unnecessary for a specific group of patients

Chemotherapy after unnecessary surgery for group of patients evaluated with genetic test

The result of a phase III study, TailorX, presented at the plenary session on June 3rd, at the ASCO congress, which analyzed more than 10,000 women with hormone-positive breast cancer positive at the initial stage and without infiltration of the axillary lymph node.

A genetic test that tests 21 genes related to breast cancer and predicts the risk of recurrence of the disease, called Oncotype DX® Breast Recurrence Score, was used in the patients and approximately 6,700 women showed a low risk, with a score in the test of 11 25.

Low-risk women were randomly separated into two groups, one receiving isolated hormone therapy and another one treated with hormone therapy and standard chemotherapy. The researchers wanted to investigate what would be the best treatment for each risk range identified by the test.

After monitoring these patients for 7.5 years, the researchers observed that women without chemotherapy did not have a worse outcome than the others. Recurrence in both groups was very similar (94.5% vs. 95%), as well as overall survival (93.9% vs. 93.8%) and progression-free survival (83.3% vs. 84.3%).

"Half of all breast cancers are of this type, hormone positive and HER2 and negative axilal lymph node. Our study shows that 70% of these women can avoid chemotherapy when we use the genetic test, limiting the most aggressive treatment to only 30% who actually benefit from this regimen, "Albert Einstein, study leader Joseph Sparano, told a news conference. Cancer Center (USA).

Until the disclosure of these data, the standard treatment was chemotherapy associated with hormone therapy after surgery. Chemotherapy, however, in addition to having no effect for all patients, generates many side effects that decrease the quality of life of women. Among the most common are nausea, vomiting, fatigue, hair loss, infections, infertility and neuropathy.

Dr. Gilberto Amorim, Oncologist at Rede D'or and scientific advisor at Laço Rosa commented on the study presented:

"TaylorX is one of those studies that changes practice immediately in the US and Europe. Oncotype DX, a genomic test used in the postoperative period of the initial breast cancer, receives a negative axilia informs the "recurrence score" and the chance of a recurrence of the disease notably in the first 5 years and whether or not there is benefit in performing adjuvant chemotherapy.

Until today, the possible results were low-high risk-intermediate. We already knew that at "low risk" chemotherapy is not necessary. But in the real world, 40% fall in the middle group and in this way the decision is often frustrating.

With the result of more than 6,000 women evaluated in TaylorX between performing only an anti-hormonal treatment and / or starting chemo and supplementing with the tablets, it was very clear that in these "intermediate" patients chemotherapy is not necessary, with Oncotype DX being a binary examination, low or high risk. Scientific information is robust and definitive. Oncotype DX joins MamaPrint in data consistency to assess whether there is a greater or lesser risk of recurrence. A pity that for the Brazilian reality is an exception of cost. There is how to send to the US to carry out the test but the cost is high, about $ 13,500.00. Unfortunately it is an exam for Brazilian upper class and it has coverage in Europe, Israel, USA and Japan. There are preliminary discussions / initiatives of Brazilian operators to pay the cost of the exam, since it can be cost effective in our reality. In a simple account, if out of every 10 patients 7 do chemotherapy and if now after the study, out of 10 only 3 will chemo, if we add the cost of 3 chemo + 10 tests the value may be lower than the cost of 10 without the genetic test.

Out of every 10 patients evaluated, 70% will fall into the new "low risk" so we will be able to save 7 out of 10 patients from the physical, psychological and social impact of chemotherapy with potential cost reduction for public health.

See the study published by ASCO here: https://bit.ly/2kL6unn

Access the Onco & News Magazine article here: https://bit.ly/2JdM3tR

Source: Onco & News / ASCO Magazine