Conitec (National Commission for the Incorporation of Technologies in the Unified Health System) recommended the incorporation of a photodynamic therapy into the SUS that could be another alternative for the diagnosis and non-invasive treatment of patients with basal cell carcinoma, the most frequent type of skin cancer in Brazil and worldwide.
The low-cost, easy-to-produce device and application technique were developed by researchers linked to the Research Center for Optics and Photonics (CEPOF) – one of the Research, Innovation and Dissemination Centers (CEPIDs) funded by FAPESP, headquartered at the São Carlos Institute of Physics at the University of São Paulo (IFSC-USP).
“The indication for incorporation into the SUS is a great achievement for the IFSC-USP. If materialized, according to our knowledge, Brazil will be the first country to offer photodynamic therapy in the public health system. This result demonstrates the importance of funding basic and applied research, such as that carried out in CEPIDs, which contribute to the development and implementation of new technologies for health”, evaluates Cristina Kurachi, professor at IFSC-USP and one of the authors of the technique.
The equipment, developed with the support of the Financier of Studies and Projects (Finep) and manufactured by the company MM Optics, in São Carlos, is composed of a device capable of promoting a better visual discrimination of skin cancer, increasing the contrast of visualization of the margins of the lesion.
After identifying the lesion, an ointment based on methylaminolevulinate (MAL) – a derivative of 5-aminolevulinic acid (ALA) – is applied to the site. After three hours of contact with the skin, the compound is absorbed and gives rise, inside the mitochondria of tumor cells, to protoporphyrin – a photosensitizing pigment “cousin” of chlorophyll.
After removing the ointment from the lesion, the region is irradiated for 20 minutes with a device containing a 630-nanometer red LED light source integrated into the equipment. Light activates protoporphyrin and triggers a series of reactions in tumor cells, generating reactive oxygen species capable of eliminating lesions. Healthy tissues are preserved.
After the procedure, fluorescence images are generated – also through the equipment – to verify the response to the treatment.
The treatment takes place in two sessions, repeating the same procedure, with an interval of one week between them.
Through a project supported by the National Bank for Economic and Social Development (BNDES) and Finep, clinical trials were carried out to validate the technique in 72 health centers across the country. The multicenter study was coordinated by Vanderlei Salvador Bagnato, professor at IFSC-USP and CEPOF coordinator.
At the Hospital Amaral Carvalho de Jaú, in the interior of São Paulo, for example, more than 2,000 lesions of patients treated by the institution were treated with the new method and 40 groups of physicians were trained to use the technique. In addition to hospitals, outpatient clinics and clinics in Brazil, clinical studies were carried out in nine other Latin American countries.
The results of clinical trials showed that the treatment was able to eliminate about 85% of tumors, without side effects, causing only mild redness at the site and without scar formation. A new protocol developed by the group, with two applications in a single clinical session, achieves the elimination of 93% of tumors.
“There are a large number of patients who need to travel long distances to access surgical treatment or who live in cities with long waiting lists for surgery. In these cases, the possibility of treatment with photodynamic therapy, which is an outpatient procedure, becomes a relevant, safe and effective therapeutic option”, evaluates Kurachi.
According to a note from Conitec, this is the first demand from a university to incorporate a technology into the SUS and a successful case of technological innovation in the country.
“Brazilian universities play a central role in innovation, recognizing the needs of the SUS, boosting research, development and innovation, producing clinical evidence, training health services and participating in the process of incorporating and offering a new technology in the SUS”, said the director of the Department of Management and Incorporation of Technologies in Health (DGITS), Luciene Bonan.
The applicant for incorporation was USP and the Technology Assessment Nucleus of the Federal University of São Paulo (Unifesp) – a member of the Brazilian Health Technology Assessment Network (Rebrats) – acted as a Health Technology Assessment Nucleus (NATS) collaborating with the Ministry of Health in the demand analysis.
The members of Conitec, in return for the public consultation on the subject, presented on June 28, noted that there are good results from photodynamic therapy for patients with non-melanoma skin cancer of the superficial and nodular basal cell carcinoma type and that it is a safe and effective alternative for cases in which surgical intervention is not recommended.
Basal cell carcinoma is the most common type of malignant cancer diagnosed, and the first line of treatment is surgery to remove the lesions. However, the committee also noted that, in cases of patients who cannot undergo surgery or who have been diagnosed with low-risk tumors, there are advantages of the procedure over surgery because it is an outpatient procedure and does not require large infrastructure.
In addition, the final recommendation in favor of incorporation into the SUS considered that there are already trained professionals and a structure installed with the equipment in dozens of public health services.
The proposal still proved to be a treatment with long-term effectiveness. Samples from clinical trials conducted by Brazilian researchers at reference centers in oncology indicate that the lesions have minimal rates of recurrence after treatment with photodynamic therapy and that the cure rate for the disease remains at 90%.
The incorporation of the technology was recommended by Conitec according to the Use Protocol of the Ministry of Health. The decision will now be made by the Secretary of Science, Technology, Innovation and the Health Complex of the Ministry of Health (SECTICS/MS) and published in the Official Gazette (DOU).
* With information from Conitec.