In Brazil we have some new information in the last years about even the screening to the treatment of these patients and their outcomes. What brings more attention in Brazil is that around 30% only of the patients perform the screening with mammography so this is very low compared to the data that we have, for example, in the US that’s around 80%. So the impact of that is that there is a high proportion of patients in Brazil that are diagnosed with a locally advanced stage, so stage 2 and 3, especially in the public health system. So this is what we described in some studies and this is something that needs to be improved because, of course, we know that the prognosis of the patients depends on the stage.
After that we have the treatment, they assessed the treatments. In general the patients have access to hydrotherapy but especially in the public health system we have a lack of some new drugs for the treatment of the patients, for example pertuzumab in the adjuvant setting. In the metastatic disease, especially also in HER2 positive patients, we don’t have access until now to pertuzumab and T-DM1. So it makes the public and the private health systems very different in terms of patient outcomes. So this is something that is important that we are describing in some studies because we would like the health authorities to take a look on that because we need to change that for the patients.
Can you outline the AMAZONA III study?
Today we presented the AMAZONA III study was an observational prospective study that included around 3,000 patients from around 24 institutions in Brazil. These patients were recruited from 2016 until 2018. What we presented today here a poster just evaluating how many patients from Amazonia would fill the criteria for genomic tests for BRCA mutation. So we saw that around 35% of these patients would be recommended to perform the BRCA test but unfortunately the majority of patients don’t have access to this test in Brazil. As we know, the BRCA mutation has many impacts in the patient’s life because even if you treat breast cancer these patients have a high risk of a new breast cancer in the future and even ovarian carcinoma. So the idea here was to highlight the need to have more access for these tests.
The other information that we have from AMAZONA is about the low rate of screening of these patients, the high proportion of locally advanced disease. Something that is really important is that we saw that around 42% of the patients diagnosed with breast cancer in Brazil were less than 50 years old. It means that at least one-third of the patients have breast cancer with less than 50 years and these patients in the actual recommendations for screening are not covered because in Brazil the recommendation for mammography starts at 50 years old. So we are losing 30% or more of these patients unfortunately in Brazil. So this is something that these kinds of studies of real data are important to describe because we need to discuss if the screening in Brazil would need to start at 40 years old.
Is there anything you’ve seen from the meeting this year that will have impact in Brazil?
Here in San Antonio we had two presented abstracts that were published in The New England Journal of Medicine so these are important abstracts. Especially these two studies were in HER2 positive metastatic disease. The first one was with tucatinib, this is a TKI that was combined with capecitabine and trastuzumab, and this study in patients treated already without the regime is that we have with anti-HER2 a better PFS and also overall response rate. So this study probably shows a new drug that has a high potential to be approved in the next year, for example. It will be an important treatment for the patients.
The other one is a phase II study with trastuzumab deruxtecan that was tested in patients highly treated so they had a median of six treatments before. This study, the data is very impressive because these patients had around 60% response. This is an IDC drug and they had around 60 month of median PFS. So this is very high for patients already pre-treated with many regimens. So these are the most important studies presented today in HER2 positive.
We have also updated information for the APHINITY trial that is adjuvant pertuzumab for the patients. Here we have the confirmation of benefit in the invasive disease free survival, especially in node positive disease and hormone receptor negative. The data presented here showed that there was no difference in overall survival until now.
The last one that will probably be a practice changing trial, it’s not approved yet, was an update from KEYNOTE-522. This is a neoadjuvant study that incorporated for the first time the first study with immunotherapy. In this case it was pembrolizumab. What was showed here was a sub-analysis of pCR and what was very interesting to see is that as high is the stage of the disease, so stage 3, the higher is the difference between the immunotherapy plus chemo versus chemotherapy. So this was very interesting to see and this is very good because these patients with locally advanced disease they normally have also a higher chance of relapse.
The other data showed from the presenter is that it’s related to PD-L1 expression and we have also a trend for higher response when the patients have PD-L1 expression more than 20, for example. This was amazing because this was around 80% of pCR that is very high.
What other studies are you currently working on?
In Brazil we have the offices from the Latin American Cooperative Oncology Group. This is a group that helps investigators in Latin America to develop studies. What we are doing now that will be very interesting is starting the biggest registry of breast cancer in Latin America. The name of this study is LATINA. This is real world data that you recruit prospectively 4,500 patients in around ten countries in Latin America. So we probably are going to have the first patients included at the beginning of next year and we hope to recruit all the patients until the end of next year.
The idea here is that we are going to describe also a lot of sociodemographic characteristics of these patients. For example, if the patients are working; if these patients are working one year after their diagnosis, for example. If the patients are married, for example, in one year what is happening. And, of course, how the information from the clinic or pathological and treatment and outcomes. So this is the first big study in Latin American breast cancer and we are leading that in LACOG.
We also have another project that are academic studies that you test a short time of trastuzumab in patients with a pCR after neoadjuvant treatment, six months treatment. And another one that you compare the combination of metronomic chemotherapy with hormone therapy in the metastatic setting versus hormone therapy. So yesterday we saw a very interesting study here, the name is PEARL. The study was led by GEICAM, the Spanish group, and they showed in the second line metastatic disease, hormone receptor positive, that palbociclib and hormone therapy had the same benefit in terms of PFS than capecitabine. So this highlights a possibility that maybe some types of chemotherapy combined with hormone therapy would have a similar benefit as CDKs. Because CDK4/6 we have the data, the data is amazing, it’s very good, but in countries like Brazil and Latin American countries these drugs take a lot of time to be approved in the public health system. So we need to find a way, and this is why we are doing this study, to try to have an opportunity for them to have a benefit also.
Is there anything else you’d like to add?
No, I think this is a good event. San Antonio is a good event to be for the Latin Americans. I think everybody that has the possibility and are dedicated to breast cancer should be here. It’s a good event to see new information but also to have a network with investigators and projects to perform in our countries.
