LAUSR

We read with great interest the work of Gong et al. [1], which addressed the differences in clinical outcomes in women with HER2-positive metastatic breast cancer (MBC) conducted in clinical trials and in real life. In the population-based cohort, the overall survival observed in populations treated with trastuzumab/pertuzumab (39.2 months) and T-DM1 (15.4 months) was lower than that observed in the respective pivotal clinical trials (56.4 and 30.9 months, respectively). In lowand middle-income countries, the difference between real life and clinical trials is even greater. In these countries, there are additional problems, such as limited access to health services, causing late diagnosis and in more advanced stages. In addition, we highlight the use of treatments below the standard already established, especially among users of the public health service [2]. However, these countries are not usually included in clinical studies and have a few population-based data, which further prejudice the comparison between the two scenarios. In the Brazilian public healthcare system, which provides care to around 70% of the country’s population, trastuzumab became available for the treatment of HER2-positive MBC in 2017, almost 20 years after the US Food and Drug Administration approved the drug for use in the USA [2]. Even in 2020, the use of pertuzumab or T-DM1 only occurs in the public service after a long procedural analysis and judicial release. To assess the scenario of MBC in Brazil and the treatment of HER2-positive disease, we conducted an ecological, population-based clinical study in the city of Goiânia, Brazil. Between 1995 and 2011, 5289 cases of breast cancer were registered in Goiânia and 277 (5.2%) were diagnosed as de novo metastatic disease. Mean age was 54.7 ± 14.5 years. Of the 24 women with HER2-positive breast cancer for whom data were available on the treatment received, 3 (12.5%) had received trastuzumab as first-line treatment and two as second-line treatment. Two patients received lapatinib in subsequent lines. For HER2-positive disease, the mean survival was 29.1 months (95% CI 21.8–36.3) and the overall survival at 60 months was 11.7%. In the multivariate analysis, HER2 status was not statistically significant in predicting overall survival. In this context, the small number of patients who received anti-HER2 therapy is noteworthy. Similarly, several studies conducted between 2000 and 2015 reported that almost 15% of patients in the USA, up to 54% in Europe and almost 50% in China did not receive Trastuzumab or any other anti-HER2 therapy to treat MBC [3]. With the subsequent introduction of the CDK4/6 inhibitors and other anti-HER2 therapies in high-income countries, this difference in oncological outcome may have increased even further. In Canada, Gong et al. demonstrated the difference between real life and the controlled world of clinical trials. However, in lowand middle-income countries, this gap is even greater, considering that the majority of the population does not even have access to anti-HER2 therapy. As expected, there is not a single generalizable solution. Clinical research initiatives, consolidation of biosimilar trastuzumab and public policies for facilitated release of costeffective drugs are some points that must be analyzed and discussed in this context. * Ruffo Freitas-Junior [email protected]