Original Title: Eficacia, seguridad y eficiencia de las técnicas de localización magnética del ganglio centinela en cáncer de mama

Authors' objectives: To analyse the efficacy/effectiveness, safety, efficiency and patient preferences regarding the use of sentinel lymph node magnetic localisation systems in breast cancer and to draw evidence-based conclusions for its use in clinical practice.

Authors' results and conclusions: The efficacy/effectiveness results obtained with the SPIO-guided localisation technique can be considered similar or non-inferior to those of conventional radiotracer-guided technology alone or in combination with blue dye. Meta-analyses developed for detection rate, concordance and non-localised positive lymph nodes resulted in risk difference estimates that were not statistically significant at 95% confidence. The available articles conclude that the magnetic localisation technique appears to be generally safe. The main safety issue observed with SPIO was breast discoloration or hyperpigmentation after the procedure. Only one article documented lymphoedema in 7.5% of patients after SLNB in combination with other surgical procedures of tumour excision or mastectomy. No studies reporting on efficiency or cost-effectiveness of the technologies analysed were identified. The budget impact analysis favours the progressive incorporation of magnetic localisation devices, implying a cost reduction compared to the baseline scenario. Results obtained regarding patient values and preferences come from a single study and are not very informative. Iron oxide nanoparticle-guided sentinel node localisation may be a non-inferior alternative to conventional radiopharmaceutical-guided localisation technology, with or without blue dye. These results should be taken with caution, as the evidence identified has been considered to be of low quality. No key adverse effects were found for the SPIO-guided localisation technique, compared to conventional techniques. Information on adverse effects should be analysed in more detail in future studies. The progressive incorporation of sentinel node magnetic localisation technology in hospitals without a Nuclear Medicine department could be a favourable budgetary impact strategy.

Authors' methods: First, outcome variables were identified through a prioritisation process based on their relative importance. Three systematic literature reviews were conducted on clinical effectiveness and safety, on efficiency and on patient preferences and values of sentinel lymph node magnetic localisation techniques in breast cancer. In addition, a budget impact analysis was carried out to determine the consequences of incorporating magnetic localisation systems for sentinel lymph node in hospitals without Nuclear Medicine department. Population parameters were taken to determine the number of SLNB candidates, who would be users of magnetic localisation technology per million inhabitants. For this volume of patients, two hypothetical scenarios were defined, a baseline scenario with no changes and a second where the new technology was incorporated in centres without a Nuclear Medicine department. Cost data for the conventional technique (lymphoscintigraphy and lymph node localisation), transport costs and potential costs of the lymph node magnetic localisation technique (iron oxide nanoparticle dose and magnetic probe device) were used. A deterministic sensitivity analysis was employed to examine the robustness of the different scenarios.

Project Status: Completed

Year Published: 2022

URL for published report: https://www.iacs.es/wp-content/uploads/2022/07/01_IACS_Sentimag_DEF.pdf

English language abstract: An English language summary is available

Publication Type: Mini HTA

Country: Spain

Organisation Name: Health Sciences Institute in Aragon (IACS)

Contact Address: Avda, San Juan Bosco, 13, planta 2

Contact Name: María Pilar Calvo Pérez

Contact Email: direccion.iacs@aragon.es