The National Commission for the Incorporation of Technologies in the United Health System (Conitec) recommended the incorporation in the SUS of a photodynamic therapy that could be another alternative for the diagnosis and non-invasive treatment of patients with basal cell carcinoma, the skin type of cancer more frequent in Brazil and in the world.
The low-cost, easy-to-produce device and the application technique were developed by researchers attached to the Optics and Photonics Research Center (CEPOF) – one of the Research, Innovation and Dissemination Centers (CEPIDs) funded by FAPESP (Fundação de Support) for research in the State of São Paulo), headquartered at the São Carlos Institute of Physics at the University of São Paulo (IFSC-USP).
“The indication of incorporation into the SUS is a great achievement for the IFSC-USP. If implemented, Brazil will be, as far as we know, the first country to offer photodynamic therapy in the public health system. This result demonstrates the importance of funding basic and applied research, like that carried out in the CEPIDs, which contribute to the development and implementation of new technologies for health”, assesses 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 distinction between skin cancer and increasing the contrast of the visualization of the margins of the damage.
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 protoporphyrin is formed inside the mitochondria of the tumor cells – 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 that generate reactive oxygen species capable of eliminating lesions. Healthy tissue is 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, where the same procedure is repeated, one week apart.
Through a project supported by the National Bank for Economic and Social Development (BNDES) and Finep, clinical trials were conducted 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 from patients treated by the institution were treated with the new method, and 40 groups of doctors were trained to use the technique. In addition to hospitals, clinics and clinics in Brazil, clinical studies were conducted in nine other Latin American countries.
The results of clinical trials showed that the treatment was able to eliminate about 85% of the tumors without side effects, causing only mild redness at the site and without scarring. 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 have 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 using photodynamic therapy, which is an outpatient procedure, becomes a relevant therapeutic option, which is safe and effective”, assesses Kurachi.
promising results
According to a note from Conitec, this is the first requirement by a university to incorporate a technology into SUS and a successful case of technological innovation in the country.
“Brazilian universities play a central role in innovation, recognizing the needs of SUS, driving research, development and innovation, producing clinical documentation, training health services and participating in the process of incorporating and offering a new technology in SUS”, he said. the director of the Department of Management and Incorporation of Health Technologies (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 the Health Technology Assessment Nucleus (NATS) collaborator in the Ministry of Health in the demand analysis.
The members of Conitec, upon their return from the public hearing on the subject presented on June 28, observed 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 has been shown to be a safe and effective alternative for cases where 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 commission also noted that in the case of patients who cannot undergo surgery or who have been diagnosed with low-risk tumors, the procedure has advantages over surgery because it is an outpatient procedure and does not require much time. infrastructure. In addition, the final recommendation in favor of incorporation into SUS assessed 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 of 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 Minister for Science, Technology, Innovation and the Health Complex in the Ministry of Health (SECTICS/MS) and published in the Official Gazette (DOU).