Case and Research Letter
Lack of High-Quality Evidence On the Value of Sentinel Node Biopsy in Melanoma
Falta de evidencia de calidad sobre el valor de la biopsia del ganglio centinela en melanoma
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Romero Aguilera, J.L. Santiago Sánchez-Mateos, P. Cortina de la Calle, A. Leon Martín" "autores" => array:4 [ 0 => array:4 [ "nombre" => "G." "apellidos" => "Romero Aguilera" "email" => array:1 [ 0 => "guillermor@sescam.jccm.es" ] "referencia" => array:2 [ 0 => array:2 [ "etiqueta" => "<span class="elsevierStyleSup">a</span>" "identificador" => "aff0005" ] 1 => array:2 [ "etiqueta" => "<span class="elsevierStyleSup">¿</span>" "identificador" => "cor0005" ] ] ] 1 => array:3 [ "nombre" => "J.L." "apellidos" => "Santiago Sánchez-Mateos" "referencia" => array:1 [ 0 => array:2 [ "etiqueta" => "<span class="elsevierStyleSup">a</span>" "identificador" => "aff0005" ] ] ] 2 => array:3 [ "nombre" => "P." "apellidos" => "Cortina de la Calle" "referencia" => array:1 [ 0 => array:2 [ "etiqueta" => "<span class="elsevierStyleSup">a</span>" "identificador" => "aff0005" ] ] ] 3 => array:3 [ "nombre" => "A." "apellidos" => "Leon Martín" "referencia" => array:1 [ 0 => array:2 [ "etiqueta" => "<span class="elsevierStyleSup">b</span>" "identificador" => "aff0010" ] ] ] ] "afiliaciones" => array:2 [ 0 => array:3 [ "entidad" => "Servicio de Dermatología, Hospital General Universitario de Ciudad Real, España" "etiqueta" => "<span class="elsevierStyleSup">a</span>" "identificador" => "aff0005" ] 1 => array:3 [ "entidad" => "Unidad de Apoyo a la Investigación, Hospital General Universitario de Ciudad Real, España" "etiqueta" => "<span class="elsevierStyleSup">b</span>" "identificador" => "aff0010" ] ] "correspondencia" => array:1 [ 0 => array:3 [ "identificador" => "cor0005" "etiqueta" => "⁎" "correspondencia" => "Corresponding author." ] ] ] ] "titulosAlternativos" => array:1 [ "es" => array:1 [ "titulo" => "Falta de evidencia de calidad sobre el valor de la biopsia del ganglio centinela en melanoma" ] ] "textoCompleto" => "<span class="elsevierStyleSections"><p id="par0005" class="elsevierStylePara elsevierViewall">It was with great interest that we read the very sound and relevant opinion article published in a recent issue of <span class="elsevierStyleItalic">Actas Dermo-Sifiliográficas</span> on sentinel node biopsy (SNB) in malignant melanoma.<a class="elsevierStyleCrossRef" href="#bib0005"><span class="elsevierStyleSup">1</span></a> We believe that SNB may have a minor impact on overall survival, but that such an impact has yet to be demonstrated. Currently, however, there is no high-quality evidence to determine whether this is indeed the case.</p><p id="par0010" class="elsevierStylePara elsevierViewall">The results of the only randomized clinical trial to analyze the therapeutic value of SNB in malignant melanoma, the Multicenter Selective Lymphadenectomy Trial (MSLT-I),<a class="elsevierStyleCrossRef" href="#bib0010"><span class="elsevierStyleSup">2</span></a> were clear: there were no differences in overall survival between the SNB group and the observation group (<span class="elsevierStyleItalic">P</span><span class="elsevierStyleHsp" style=""></span>=<span class="elsevierStyleHsp" style=""></span>.59). Since the randomization of patients is what minimized the differences between the 2 groups and allowed them to be compared, the postrandomization analysis through which the authors attempt to reach the statistical significance that their study lacks introduces a classification bias that invalidates its conclusions. All patients with clinical and radiologic evidence of disease recurrence in the observation group had evident lymph node disease. This was not the case in the group with tumor-positive sentinel nodes (SNs), in which perhaps as many as 25% of patients may have been false positives. The existence of this 25% of false positives can be demonstrated through simple mathematical analysis<a class="elsevierStyleCrossRef" href="#bib0015"><span class="elsevierStyleSup">3</span></a>: there was a higher incidence of lymph node disease in the SNB group than in the observation group. It has been argued that there were cases of late recurrence in the observation group,<a class="elsevierStyleCrossRef" href="#bib0020"><span class="elsevierStyleSup">4</span></a> but this was the case in the SNB group as well (20% were false negatives). Furthermore, the fourth interim analysis of the MSLT-I indicated that the rate of late recurrence had slowed down and that it was practically impossible for the rate of nodal recurrence in the observation group to equal that of the SNB group.<a class="elsevierStyleCrossRef" href="#bib0015"><span class="elsevierStyleSup">3</span></a></p><p id="par0015" class="elsevierStylePara elsevierViewall">It was also been rightly pointed out that the impact of SNB on overall survival decreases over time.<a class="elsevierStyleCrossRef" href="#bib0020"><span class="elsevierStyleSup">4</span></a> A 20% survival benefit for the SNB group with respect to the proportion of patients with lymph node disease (16%) would mean an increase in overall survival for the entire cohort of only 3.2% (20% of 16%). Calculation of the sample size needed to detect such a difference with a power of 80% and randomization in a 40:60 ratio (as in MSLT-I) using Ene software v. 2.0 (Glaxo-Smith-Kline, Madrid, Spain) for the comparison of independent proportions in a bilateral contrast test shows that nearly 4000 patients would be needed: 1575 in the control group and 2364 in the intervention group. The power of the study of Morton et al,<a class="elsevierStyleCrossRef" href="#bib0010"><span class="elsevierStyleSup">2</span></a> with 2001 patients, was less than 40%.</p><p id="par0020" class="elsevierStylePara elsevierViewall">Additionally, the Australian authors who recruited 946 of the 2001 patients for MSLT-I performed lymphoscintigraphy in the observation group outside the protocol,<a class="elsevierStyleCrossRef" href="#bib0025"><span class="elsevierStyleSup">5</span></a> thus introducing a further bias. They located the SN and without removing it tattooed the skin to permit close clinical and ultrasound monitoring. While they did observe recurrence in the SNs they had detected, they undermined the main objective of the study through early diagnosis and treatment, reducing the overall survival advantage of the SNB group.</p><p id="par0025" class="elsevierStylePara elsevierViewall">In short, not only are there “certain doubts” about the therapeutic value of SNB in melanoma, as Dr. Botella<a class="elsevierStyleCrossRef" href="#bib0005"><span class="elsevierStyleSup">1</span></a> maintains, but there is also a complete lack of quality evidence. The only randomized clinical trial to date that has attempted to analyze its value was clearly underpowered and had proven biases. In view of this lack of evidence, almost all guidelines (National Comprehensive Cancer Network, European Organisation for Research and Treatment of Cancer [EORTC], Australian, etc) recommend discussing SNB with patients and offering it as an option rather than simply indicating the need for the procedure. The point made concerning the extension of the indications for selective lymphadenectomy<a class="elsevierStyleCrossRef" href="#bib0005"><span class="elsevierStyleSup">1</span></a> thus seems pertinent and its use in tumors with a thickness of at least 0.75<span class="elsevierStyleHsp" style=""></span>mm in the presence of mitosis is prudent.</p><p id="par0030" class="elsevierStylePara elsevierViewall">Our group has been performing SNB in cases of malignant melanoma since 1999 and we continue to offer it because it allows early treatment of lymph node disease and better risk classification. Unfortunately, a positive SN is indicative of a poor prognosis and no treatment has been shown to improve it. The Sunbelt Melanoma Trial found no benefit in interferon treatment in patients with a positive SN.<a class="elsevierStyleCrossRef" href="#bib0030"><span class="elsevierStyleSup">6</span></a> The benefits of early lymphadenectomy after detection of a positive SN compared to waiting for clinical or radiologic recurrence has yet to be determined (MINITUB and MSLT-II). Many patients prefer watchful waiting following detection of a positive SN,<a class="elsevierStyleCrossRef" href="#bib0035"><span class="elsevierStyleSup">7</span></a> given that in more than 80% of cases no other affected nodes will be found at lymphadenectomy and that the significant morbidity associated with the procedure can thus be avoided.</p><p id="par0035" class="elsevierStylePara elsevierViewall">This conservative attitude on the part of patients stands in contrast to the position taken by authors whose standard of care is complete lymphadenectomy for micrometastases of a single lymph node,<a class="elsevierStyleCrossRef" href="#bib0040"><span class="elsevierStyleSup">8</span></a> especially now that the new American Joint Committee on Cancer staging criteria set no lower limit for considering a SN to be positive, thus giving rise to the new concept of “submicrometastasis”. A review carried out in 2011 by authors of the same group<a class="elsevierStyleCrossRef" href="#bib0045"><span class="elsevierStyleSup">9</span></a> minimizes the importance of the false negatives and does not even discuss the false positives, providing an idealized view of SNB. Since the 1990s the management of nodal involvement in malignant melanoma has been more aggressive in the United States than in Europe.<a class="elsevierStyleCrossRef" href="#bib0050"><span class="elsevierStyleSup">10</span></a> The EORTC group are currently investigating less invasive techniques. They evaluate nodal tumor burden as part of their decision-making process and consider ultrasound as an alternative or complement to SNB.<a class="elsevierStyleCrossRef" href="#bib0055"><span class="elsevierStyleSup">11</span></a> This approach should guide our clinical practice until we have more evidence from MINITUB and MSLT-II, the 2 clinical trials currently underway.</p></span>" "pdfFichero" => "main.pdf" "tienePdf" => true "NotaPie" => array:1 [ 0 => array:2 [ "etiqueta" => "☆" "nota" => "<p class="elsevierStyleNotepara">Please cite this article as: Romero Aguilera G, Santiago Sánchez-Mateos G, Cortina de la Calle P, León Martín A. Falta de evidencia de calidad sobre el valor de la biopsia del ganglio centinela en melanoma. 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| año/Mes | Html | Total | |
|---|---|---|---|
| 2024 Noviembre | 14 | 13 | 27 |
| 2024 Octubre | 67 | 48 | 115 |
| 2024 Septiembre | 57 | 39 | 96 |
| 2024 Agosto | 88 | 59 | 147 |
| 2024 Julio | 70 | 40 | 110 |
| 2024 Junio | 71 | 28 | 99 |
| 2024 Mayo | 70 | 36 | 106 |
| 2024 Abril | 65 | 22 | 87 |
| 2024 Marzo | 67 | 26 | 93 |
| 2024 Febrero | 56 | 25 | 81 |
| 2024 Enero | 48 | 30 | 78 |
| 2023 Diciembre | 55 | 23 | 78 |
| 2023 Noviembre | 56 | 22 | 78 |
| 2023 Octubre | 48 | 18 | 66 |
| 2023 Septiembre | 68 | 28 | 96 |
| 2023 Agosto | 45 | 19 | 64 |
| 2023 Julio | 45 | 35 | 80 |
| 2023 Junio | 38 | 30 | 68 |
| 2023 Mayo | 41 | 26 | 67 |
| 2023 Abril | 37 | 22 | 59 |
| 2023 Marzo | 37 | 18 | 55 |
| 2023 Febrero | 27 | 21 | 48 |
| 2023 Enero | 29 | 37 | 66 |
| 2022 Diciembre | 45 | 34 | 79 |
| 2022 Noviembre | 24 | 17 | 41 |
| 2022 Octubre | 18 | 22 | 40 |
| 2022 Septiembre | 20 | 26 | 46 |
| 2022 Agosto | 13 | 36 | 49 |
| 2022 Julio | 22 | 31 | 53 |
| 2022 Junio | 23 | 29 | 52 |
| 2022 Mayo | 24 | 31 | 55 |
| 2022 Abril | 31 | 32 | 63 |
| 2022 Marzo | 37 | 44 | 81 |
| 2022 Febrero | 32 | 23 | 55 |
| 2022 Enero | 28 | 32 | 60 |
| 2021 Diciembre | 21 | 33 | 54 |
| 2021 Noviembre | 33 | 42 | 75 |
| 2021 Octubre | 24 | 47 | 71 |
| 2021 Septiembre | 22 | 45 | 67 |
| 2021 Agosto | 29 | 33 | 62 |
| 2021 Julio | 15 | 24 | 39 |
| 2021 Junio | 26 | 33 | 59 |
| 2021 Mayo | 25 | 26 | 51 |
| 2021 Abril | 60 | 57 | 117 |
| 2021 Marzo | 38 | 31 | 69 |
| 2021 Febrero | 41 | 16 | 57 |
| 2021 Enero | 24 | 15 | 39 |
| 2020 Diciembre | 24 | 13 | 37 |
| 2020 Noviembre | 16 | 13 | 29 |
| 2020 Octubre | 15 | 13 | 28 |
| 2020 Septiembre | 21 | 7 | 28 |
| 2020 Agosto | 19 | 19 | 38 |
| 2020 Julio | 51 | 14 | 65 |
| 2020 Junio | 45 | 27 | 72 |
| 2020 Mayo | 18 | 18 | 36 |
| 2020 Abril | 27 | 19 | 46 |
| 2020 Marzo | 31 | 19 | 50 |
| 2020 Febrero | 5 | 7 | 12 |
| 2020 Enero | 4 | 3 | 7 |
| 2019 Diciembre | 4 | 2 | 6 |
| 2019 Noviembre | 4 | 0 | 4 |
| 2019 Agosto | 4 | 1 | 5 |
| 2019 Julio | 4 | 8 | 12 |
| 2019 Junio | 4 | 0 | 4 |
| 2019 Mayo | 4 | 6 | 10 |
| 2019 Abril | 2 | 4 | 6 |
| 2019 Marzo | 2 | 5 | 7 |
| 2019 Enero | 2 | 3 | 5 |
| 2018 Diciembre | 3 | 0 | 3 |
| 2018 Noviembre | 1 | 0 | 1 |
| 2018 Octubre | 3 | 0 | 3 |
| 2018 Septiembre | 5 | 0 | 5 |
| 2018 Febrero | 20 | 1 | 21 |
| 2018 Enero | 35 | 5 | 40 |
| 2017 Diciembre | 30 | 8 | 38 |
| 2017 Noviembre | 18 | 3 | 21 |
| 2017 Octubre | 30 | 3 | 33 |
| 2017 Septiembre | 28 | 5 | 33 |
| 2017 Agosto | 37 | 8 | 45 |
| 2017 Julio | 30 | 6 | 36 |
| 2017 Junio | 48 | 11 | 59 |
| 2017 Mayo | 39 | 4 | 43 |
| 2017 Abril | 42 | 8 | 50 |
| 2017 Marzo | 32 | 9 | 41 |
| 2017 Febrero | 21 | 8 | 29 |
| 2017 Enero | 19 | 9 | 28 |
| 2016 Diciembre | 34 | 4 | 38 |
| 2016 Noviembre | 41 | 10 | 51 |
| 2016 Octubre | 29 | 15 | 44 |
| 2016 Septiembre | 42 | 8 | 50 |
| 2016 Agosto | 59 | 9 | 68 |
| 2016 Julio | 41 | 16 | 57 |
| 2016 Junio | 12 | 14 | 26 |
| 2016 Mayo | 7 | 13 | 20 |
| 2016 Abril | 3 | 1 | 4 |
| 2016 Marzo | 6 | 0 | 6 |
| 2016 Febrero | 13 | 3 | 16 |
| 2016 Enero | 4 | 1 | 5 |
| 2015 Diciembre | 13 | 0 | 13 |
| 2015 Noviembre | 17 | 6 | 23 |
| 2015 Octubre | 10 | 3 | 13 |
| 2015 Septiembre | 7 | 4 | 11 |
| 2015 Agosto | 11 | 7 | 18 |
| 2015 Julio | 31 | 9 | 40 |
| 2015 Junio | 46 | 6 | 52 |
| 2015 Mayo | 53 | 9 | 62 |
| 2015 Abril | 38 | 10 | 48 |
| 2015 Marzo | 37 | 7 | 44 |
| 2015 Febrero | 43 | 8 | 51 |
| 2015 Enero | 29 | 11 | 40 |
| 2014 Diciembre | 31 | 8 | 39 |
| 2014 Noviembre | 34 | 10 | 44 |
| 2014 Octubre | 50 | 26 | 76 |
| 2014 Septiembre | 8 | 5 | 13 |
| 2014 Agosto | 16 | 8 | 24 |
| 2014 Julio | 14 | 6 | 20 |
| 2014 Junio | 22 | 5 | 27 |
| 2014 Mayo | 30 | 5 | 35 |
| 2014 Abril | 27 | 3 | 30 |
| 2014 Marzo | 38 | 9 | 47 |
| 2014 Febrero | 19 | 3 | 22 |
| 2014 Enero | 27 | 11 | 38 |
| 2013 Diciembre | 31 | 8 | 39 |
| 2013 Noviembre | 26 | 8 | 34 |
| 2013 Octubre | 13 | 6 | 19 |
| 2013 Septiembre | 13 | 19 | 32 |
| 2013 Agosto | 11 | 14 | 25 |
| 2013 Julio | 14 | 21 | 35 |
| 2013 Junio | 11 | 22 | 33 |
| 2013 Mayo | 14 | 31 | 45 |
| 2013 Abril | 16 | 14 | 30 |
| 2013 Marzo | 15 | 5 | 20 |
| 2013 Febrero | 28 | 2 | 30 |
| 2013 Enero | 16 | 11 | 27 |
| 2012 Diciembre | 19 | 5 | 24 |
| 2012 Noviembre | 6 | 1 | 7 |
| 2012 Octubre | 1 | 0 | 1 |
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