Original Title: Alternativas a las técnicas isotópicas en la detección del ganglio linfático centinela en el cáncer de mama

Authors' objectives: The objectives of the study were: - To evaluate and synthesize the available scientific evidence on the effectiveness and cost-effectiveness of radioactive tracers compared with non- radioactive tracers for identification of the sentinel lymph node in early-stage breast cancer. - To report on the effectiveness of potential organizational models of care services for the SLNB implementation in general hospitals without Nuclear Medicine Service.

Authors' results and conclusions: RESULTS: The search yielded 759 initial references and 10 studies (N= 3449) were finally eligible for inclusion, all of them were studies of test accuracy with a cross-sectional design. Overall, their methodological quality was assessed as moderate. The selected studies are very heterogeneous in terms of type of radiotracer and dye used, doses, and the time and place of injection. The most used dyes were methylene blue followed by vital blue and most studies used human serum albumin labeled with 99mTc as radiocolloid. In general, studies obtain lower rates of sentinel node identification for dye than for radiotracer. In the meta-analysis, a sensitivity of 96% (95% CI: 89-99) for the combined identification technique (radiotracer + dye) was obtained and of 72% for the exclusive use of dye (95% CI: 60-83). Although an overall estimate of effect for sensitivity could not be obtained for the exclusive use of radiotracer due to lack of data, the available studies also point to a higher sensitivity compared to the exclusive use of dye. Regarding specificity, an overall effect size of 90% for the exclusive use of dye (95% CI 0.85 to 0.94) and 84% for the combined use of dye and radiotracer (IC 95%: 0.79 to 0.89) were obtained. Selected studies did not include information on safety strategies sentinel node identification and possible adverse events associated with the use of radiotracer and dye. Safety of strategies for the identification of sentinel node and potential adverse events associated with the use of radiotracer and/or dye were not reported. No studies that evaluated any new technique (not dye) for SLNB not dependent on the use of radiotracers were identified. No economic evaluations meeting the pre-specified selection criteria were found. A single study that describes and evaluates the implementation of the SLNB with radiotracer in hospitals without Nuclear Medicine was identified, providing only diagnostic accuracy measures. Regarding to possible organizational variations in healthcare to locate this diagnostic technology in non-specialized centers or general hospitals, a single study conducted in Spain that describes and evaluates the implementation of SLNB with radiotracer in hospitals without Nuclear Medicine was identified, providing only diagnostic accuracy measures. CONCLUSIONS: There is great heterogeneity in terms of the radiotracer, dye and doses used as well as the time and place of injection which makes comparison between studies very difficult. Currently available scientific evidence suggests that the use of radiotracer, alone or in combination with dye, provides a higher rate of sentinel node detection compared with the exclusive use of dye. The combined technic (radiotracer + dye) provides a much higher sensitivity (96%; 95% CI, 89-99) than obtained by the dye (72%; 95% CI: 60-83). (GRADE ⨁⨁⨀⨀) Selected studies did not report on safety of strategies for the identification of sentinel node and potential adverse events associated with the use of radiotracer and/or dye. No economic evaluations on the use of radiotracer compared to dye or the combined use (radiotracer + dye) for the identification of sentinel node in breast cancer were found. There is not yet enough evidence to assess the real value of performing SLNB at general hospitals without Nuclear Medicine service.

Authors' methods: Systematic review of published literature until February 2015. MEDLINE Y PREMEDLINE, EMBASE, SCI, CENTRAL and CRD EED were searched. A comprehensive search strategy that included controlled vocabulary and free text terms was used. In addition, a manual search was performed with the references of articles included. Original studies published in English or Spanish that compared an isotopic technique against non-isotopic for identification of the sentinel lymph node in early-stage breast cancer were selected. Diagnostic cohort studies with at least two arms, randomized and non-randomized controlled trials, and full economic evaluation were included in the review. Considered outcome measures were: the identification rate, sensitivity, specificity, false negative rate, false positive rate, positive predictive value and negative predictive value, mortality, morbidity, symptoms, safety, health-related quality of life and costs. Studies describing and assessing experiences of SLNB implementation in breast cancer using radiotracer in hospitals without Nuclear Medicine were also searched. The assessment of methodological limitations of the included clinical trials was planned according to the criteria of Scottish Intercollegiate Guidelines Network (SIGN), the diagnostic accuracy studies by mean of QUADAS-2 scale and the economic evaluations using the criteria of Drummond et al. Data are presented through narrative synthesis and tables. Pooled estimates of sensitivity and specificity were obtained for studies with methodological homogeneity using random effects meta-analysis (MetaDISC software). Results were weighted means and confidence intervals (CI) at 95% were analyzed by the Mantel-Haenszel method. The methodology of the international working group Grading of Recommendations Assessment, Development and Evaluation (GRADE) was follow to assess the quality of evidence and to grade the strength of the recommendations.

Project Status: Completed

Year Published: 2015

URL for published report: https://sescs.es/alternativas-a-tecnicas-isotopicas-en-la-deteccion-del-ganglio-linfatico-centinela-en-cancer-de-mama/

English language abstract: An English language summary is available

Publication Type: Full HTA

Country: Spain

Organisation Name: Canary Health Service

Contact Address: Dirección del Servicio. Servicio Canario de la Salud, Camino Candelaria 44, 1ª planta, 38109 El Rosario, Santa Cruz de Tenerife

Contact Name: sescs@sescs.es

Contact Email: sescs@sescs.es