The team from the Technology Assessment Center (Nats) at Unicamp's Hospital de Clínicas (HC) participated, together with the Ministry of Health, in updating the Diagnostic and Therapeutic Guidelines (DDT) for Multiple Myeloma. The DDT are documents based on scientific evidence that guide the best conduct to be adopted in the area of Oncology for patients in the Unified Health System (SUS).
The proposal presented to the members of the Plenary of conitec (National Commission for the Incorporation of Technologies in the Unified Health System) in its 107th Ordinary Meeting recommended the incorporation of the cytogenetic test by Fluorescence In Situ Hybridization (Fish) in the detection of high-risk cytogenetic alterations in patients with multiple myeloma. Furthermore, the DDT text contains recommendations on the use of bortezomib, a medication adopted by the SUS in 2020.
The updated version of the DDT was approved by Conitec after public consultation and is awaiting publication. Here the previous version available with the new guidelines for the diagnosis and treatment of multiple myeloma.
Multiple myeloma is cancer of the bone marrow cells that produce antibodies to fight viruses and bacteria, called plasma cells. When plasma cells mutate, they become abnormal and multiply uncontrollably, compromising the production of other blood cells.
According to Cármino Antonio de Souza, hematologist and professor of Hematology and Hemotherapy at the Faculty of Medical Sciences (FCM) at Unicamp, multiple myeloma is one of the most emerging diseases in the area of hematological cancer and has been growing, mainly among elderly people due to the increase in the longevity of the population.
“This growth is on the order of 2% to 3% above population growth per year, and this means that we have an increasing number of people with multiple myeloma”, points out Cármino.
According to the International Agency for Research on Cancer of the World Health Organization (WHO), multiple myeloma was responsible for 176.404 new cases and 117.077 deaths of patients of both sexes in 2020, worldwide. In Brazil, data from the Brazil Oncology Panel show that, between 2013 and 2019, around 2.600 cases of multiple myeloma were diagnosed annually in both sexes, for an estimated total of 1,24 cases/100 thousand inhabitants.
The main risk factors for multiple myeloma are age, sex, race and family history. Regarding age, only 15% of diagnoses are made in people under 55 years of age, while more than 60% of diagnoses occur in adults over 65 years of age. In Brazil, data from the Oncology Observatory indicate a median age of these patients of 63 years, with a range from 18 to 100 years.
“In the past, myeloma was such an aggressive, disabling and deadly disease. One spectacular thing that has been happening, despite multiple myeloma still being an incurable disease, is that we are managing to make patients live much longer and much better, with practically normal activity. This is due to the incorporation of several medications, such as bortezomib”, explains the Unicamp hematologist.
Diagnosis and treatment of patients
Nats' work began to be developed at the beginning of 2021. The multidisciplinary team was coordinated by professor Daniela Fernanda dos Santos Alves, from the Faculty of Nursing (FEnf) at Unicamp. The process of prioritizing the topics and technologies to be evaluated by Nats included the participation of experts on the topic, patients, the technical team from the Ministry of Health and methodologists from Hospital Moinhos de Vento, in Porto Alegre.
“These guidelines guide how the diagnosis and treatment of patients with multiple myeloma should be carried out in the SUS, which tests should be carried out, which treatment and monitoring strategies for patients [to be adopted]”, explains pharmacist Mayra Carvalho Ribeiro, of the Nats of the HC of Unicamp.
During the updating of the guidelines, four technical-scientific opinions were submitted to Conitec for consideration. Of these opinions, three were prepared by the Nats of the HC of Unicamp and one was prepared in partnership with the Nats of the Federal University of Paraná (UFPR).
“The participation of the Unicamp HC Nats in this process was quite challenging. The group was able to select evidence and develop economic evaluations from the perspective of the SUS for the diagnosis and treatment of multiple myeloma”, says Daniela.
According to Cármino de Souza, although it took Brazil almost ten years to incorporate bortezomib into the therapeutic arsenal for the treatment of multiple myeloma in SUS patients, the introduction of the drug associated with other drugs and cytogenetic tests is very auspicious, as patients with multiple myeloma have benefited from innovative, target-specific and smart drugs.
“Bortezomib, associated with other drugs, helps with bone recomposition or stabilization of the disease and the cytogenetic test allows the doctor to approach the patient in a different, unique way. We transformed an unworthy disease into a perfectly treatable disease. I would venture to say that we are moving, in the coming years, towards the possibility of curing multiple myeloma”, confides Cármino.