The National Health Surveillance Agency (Anvisa) recently approved a new treatment for bladder cancer with the potential to reduce the risk of death by up to 25%. The approval was made for the management of the muscle-village tumor, which represents one in four cases of bladder cancer in Brazil.
Approved treatment is the combination of durvalumab with neoadjuvant chemotherapy, before radical cystectomy (complete surgical removal of the bladder), followed by adjuvant durvalumab monotherapy after surgery. This is the first combination of immunotherapy and chemotherapy to demonstrate significant improvement in patient survival rates.
Bladder-envasive bladder cancer happens when the tumor develops on the bladder muscle wall without distance metastasis. According to Fernando Maluf, oncologist and founder of the Institute to win cancer, this type of cancer is highly aggressive, with a risk of evolving metastatic disease (ie spread to other organs) in at least 50% of patients.
Most participants with muscle-invasive bladder cancer are treated with neoadjuvant chemotherapy and radical cystectomy. However, it is estimated that about 50% of those who perform surgery have recurrence of the disease.
The new approved treatment can change this scenario. In a study, therapy showed a reduction of up to 32% in the risk of disease events. “This treatment also adds an important slice in terms of healing rate and avoid recurrence, in addition to chemotherapy, in isolation, preoperatively did, and in addition to what the surgery did, or alone, or along with chemotherapy,” explains Maluf.
In other words, the new treatment approved by Anvisa has the potential to increase cancer healing rate and to avoid recurrence of the disease compared to the standard treatment previously done.
“The recent approval by Anvisa represents a significant advance, bringing a new possibility of treatment and the hope of a better prognosis,” said Maluf. “The incorporation of the perioperative regime with Durvalumabe has the potential to redefine the treatment of muscle-envasive bladder cancer, reducing the risk of events and increasing the chances of survival,” he adds.
How does treatment work and how was approval?
Durvalumab is an immunotherapy, that is, a drug that stimulates the immune system, activating lymphocytes – cells responsible for identifying and combating infectious agents and abnormal cells such as carcinogens – to attack the tumor more vehemently, as Maluf explains.
Treatment is indicated for patients who have tumor invasion in the bladder muscle layer and eventually in the fat layer or adjacent organs in patients candidates for cisplatin chemotherapy.
Approval was based on phase 3 study “NIAGARA“Whose results were initially presented during a presidential session of change in clinical practice at random, one of the world’s leading Oncology congresses, and published in the New England Journal of Medicine. Through the research, it was possible to observe that 82.2% of patients who received the regime with Durvalumab were alive in two years, compared to 75.2% treated by neoadjuvant chemotherapy.
“The approval of the first regime of perioperative immunotherapy in the treatment of muscle-envasive bladder cancer considering before, associated with chemotherapy, and after surgery, besides bringing promising results in a pioneering way, also reveals the effectiveness of immunotherapy in the early stages of cancer treatment, in which there is still potential for healing,” says Karina Fontão, the director of the executive director of Astrazeneca in Brazil.
Durvalumabe’s safety profile in combination with neoadjuvant chemotherapy was consistent with the already known drugs in isolation. The addition of Durvalumab did not increase the treatment discontinuation rates due to adverse events and did not compromise the viability of patients to complete surgery compared to neoadjuvant chemotherapy.
“This approval is important because it again improves the gold standard that existed, which was isolated chemotherapy, preceding surgery and then surgery. Therefore, it is an extra slice and hope for patients,” concludes Maluf.
Bladder cancer kills more than 19 thousand in Brazil in 4 years
This content was originally published in bladder cancer: new treatment can reduce death risk by up to 25% on CNN Brazil.
Source: CNN Brasil
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