The first immunotherapy for breast cancer

 The US Food and Drug Administration (FDA) has urgently approved the use of the drug Atezolizumab that contains the active ingredient (Tecentriq, Genentech / Roche) along with the chemotherapy nab-paclitaxel of the active ingredient (Abraxane - Celgene) as an option The first treatment for non-operative triple-negative breast cancer, whether local or relapsing, that contains a gene (link) for the apoptotic protein (PD-L1-positive triple-negative breast cancer TNBC).

The disease has been called triple-negative breast cancer because the tumor cells lack the receptors of estrogen and progesterone and the epidermal growth factor Her2, and thus do not respond to hormonal treatment, but the tumor cells that contain ligands can bind to the apoptotic protein PD-1, and the tumor has been described as PD-L1 positive. 

Atizolizumab was the first immunotherapy drug approved for treating breast cancer.

This approval was based on the results of the elapsed time since the start of treatment and then cessation of it without deterioration in health status (Progression-free survival results). The continuation of approval may be conditional on the results of other confirmatory trials.

The new approval for the combination of Atizolizumab and paclitaxel was based on safe and effective results obtained from experimental research, called the IMpassion130 trial, and was conducted in more than one research center. These results were presented in the Congress of European Society of Oncology (ESMO) 2018, and have also been published in the New England Journal of Medicine.

The trial included 451 random people with localized or metastatic triple-negative breast cancer (relapsing), and this group got the drug Atizolizumab, and on the other hand, another group of 451 people also got a placebo (without knowing that they were taking a placebo) and got Both groups received NAB-paclitaxel.

After a period of using the treatment, the research participants underwent an analysis of their response to the treatment. 

It was observed that Atizolizumab significantly reduced the chances of disease progression or death in the group that received it compared to the other group that received the placebo with an average rate of no worsening and remaining the same during the treatment. He took 7.2 months after stopping treatment for Atizolizumab, versus only 5.5 months in the placebo group
(Median PFS = 7.2 Vs 5.5 months).

Atizolizumab also improved the overall median survival (survival), reaching 21.3 months versus 17.6 months for those who received placebo (Median OS = 21.3 Vs. 17.6), but this statistical result did not represent a value during the interim analysis of the research results. The average follow-up of improvement or worsening was 12.9 months.

The authors analyzed the two groups to detect patients who possessed the programmed cell death protein gene (PD-L1 + patients). The Atisolizumab group included 185 of these patients, while the placebo group included 184 people.

In these patients, Atizolizumab significantly reduced the risk of disease development or death (Median PFS = 7.5 Vs. 5 months), and improved survival and overall survival (Median OS = 25.0 Vs. 15.5 months).

While presenting the results of the research last year, Peter Schmid - the research team leader with a doctorate in medicine and philosophy who works at the St. Bartholomew's Breast Cancer Center and has the secretariat of the National Health Service (NHS) in London, UK, said: "These groups whose patients contain the PD-L1 genes have approximately 10 months of difference in survival rate, which I think is encouraging to consider this drug as a first choice (standard drug) for treating these conditions."

Kathy Miller, MD, of the Simon Cancer Center at Indiana University, was unsure of the results of the research; As the overall survival - OS was not final, and in her comment to Medscape about this experiment, she said:

 “The researchers responsible for this research (Impassion 130) state that the use of Atisolizumab in combination with Nap-paclitaxel is a standard treatment for groups of patients who are pregnant. For PD-L1 leagues. But I object to that; As the results of the statistical research on the extent to which the disease does not deteriorate (PFS) are very modest, and we do not know whether there is an improvement in the overall survival rate (OS) or not.

In this core trial, Atisolizumab was administered at a fixed dose - 840 mg - by intravenous injection on the first and fifteenth days of every 28 days until disease progression or unacceptable therapeutic intoxication (severe side effects). NAB-paclitaxel was given an initial dose of 100 mg per square meter of the body by intravenous injection on the first, eighth, and fifteenth days of every 28 days.

The average duration of the two treatments in the group of patients exposed to Atizolizumab was 24.1 weeks for Atizolizumab and 22.1 weeks for nape-paclitaxel, and in the group that received a placebo, on the other hand, they received a placebo for 22.1 weeks, and on the drug nape-paclitaxel for 21.8 weeks.

During the study period, 358 patients (79.4%) from the Atisolizumab group and 378 patients (83.8%) from the placebo group experienced either a deterioration of disease or death. The researchers stated that the adverse effects of the two new treatments are in line with the safety rules and within the permissible limits.

It should be noted that severe side effects appeared in 23% of patients in the Atisolizumab group and 18% of patients in the placebo group. And the reverse symptoms appeared of the third degree
The second and fourth in 49% of the patients in the Atisolizumab group versus 42% of the patients in the placebo group, and the most common of these symptoms were: lack of white blood cells, especially neutrophils (8%), peripheral neuropathy (6%), fatigue (4) %), Anemia (3%)