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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| Year/Month | Html | Total | |
|---|---|---|---|
| 2024 November | 15 | 13 | 28 |
| 2024 October | 67 | 48 | 115 |
| 2024 September | 57 | 39 | 96 |
| 2024 August | 88 | 59 | 147 |
| 2024 July | 70 | 40 | 110 |
| 2024 June | 71 | 28 | 99 |
| 2024 May | 70 | 36 | 106 |
| 2024 April | 65 | 22 | 87 |
| 2024 March | 67 | 26 | 93 |
| 2024 February | 56 | 25 | 81 |
| 2024 January | 48 | 30 | 78 |
| 2023 December | 55 | 23 | 78 |
| 2023 November | 56 | 22 | 78 |
| 2023 October | 48 | 18 | 66 |
| 2023 September | 68 | 28 | 96 |
| 2023 August | 45 | 19 | 64 |
| 2023 July | 45 | 35 | 80 |
| 2023 June | 38 | 30 | 68 |
| 2023 May | 41 | 26 | 67 |
| 2023 April | 37 | 22 | 59 |
| 2023 March | 37 | 18 | 55 |
| 2023 February | 27 | 21 | 48 |
| 2023 January | 29 | 37 | 66 |
| 2022 December | 45 | 34 | 79 |
| 2022 November | 24 | 17 | 41 |
| 2022 October | 18 | 22 | 40 |
| 2022 September | 20 | 26 | 46 |
| 2022 August | 13 | 36 | 49 |
| 2022 July | 22 | 31 | 53 |
| 2022 June | 23 | 29 | 52 |
| 2022 May | 24 | 31 | 55 |
| 2022 April | 31 | 32 | 63 |
| 2022 March | 37 | 44 | 81 |
| 2022 February | 32 | 23 | 55 |
| 2022 January | 28 | 32 | 60 |
| 2021 December | 21 | 33 | 54 |
| 2021 November | 33 | 42 | 75 |
| 2021 October | 24 | 47 | 71 |
| 2021 September | 22 | 45 | 67 |
| 2021 August | 29 | 33 | 62 |
| 2021 July | 15 | 24 | 39 |
| 2021 June | 26 | 33 | 59 |
| 2021 May | 25 | 26 | 51 |
| 2021 April | 60 | 57 | 117 |
| 2021 March | 38 | 31 | 69 |
| 2021 February | 41 | 16 | 57 |
| 2021 January | 24 | 15 | 39 |
| 2020 December | 24 | 13 | 37 |
| 2020 November | 16 | 13 | 29 |
| 2020 October | 15 | 13 | 28 |
| 2020 September | 21 | 7 | 28 |
| 2020 August | 19 | 19 | 38 |
| 2020 July | 51 | 14 | 65 |
| 2020 June | 45 | 27 | 72 |
| 2020 May | 18 | 18 | 36 |
| 2020 April | 27 | 19 | 46 |
| 2020 March | 31 | 19 | 50 |
| 2020 February | 5 | 7 | 12 |
| 2020 January | 4 | 3 | 7 |
| 2019 December | 4 | 2 | 6 |
| 2019 November | 4 | 0 | 4 |
| 2019 August | 4 | 1 | 5 |
| 2019 July | 4 | 8 | 12 |
| 2019 June | 4 | 0 | 4 |
| 2019 May | 4 | 6 | 10 |
| 2019 April | 2 | 4 | 6 |
| 2019 March | 2 | 5 | 7 |
| 2019 January | 2 | 3 | 5 |
| 2018 December | 3 | 0 | 3 |
| 2018 November | 1 | 0 | 1 |
| 2018 October | 3 | 0 | 3 |
| 2018 September | 5 | 0 | 5 |
| 2018 February | 20 | 1 | 21 |
| 2018 January | 35 | 5 | 40 |
| 2017 December | 30 | 8 | 38 |
| 2017 November | 18 | 3 | 21 |
| 2017 October | 30 | 3 | 33 |
| 2017 September | 28 | 5 | 33 |
| 2017 August | 37 | 8 | 45 |
| 2017 July | 30 | 6 | 36 |
| 2017 June | 48 | 11 | 59 |
| 2017 May | 39 | 4 | 43 |
| 2017 April | 42 | 8 | 50 |
| 2017 March | 32 | 9 | 41 |
| 2017 February | 21 | 8 | 29 |
| 2017 January | 19 | 9 | 28 |
| 2016 December | 34 | 4 | 38 |
| 2016 November | 41 | 10 | 51 |
| 2016 October | 29 | 15 | 44 |
| 2016 September | 42 | 8 | 50 |
| 2016 August | 59 | 9 | 68 |
| 2016 July | 41 | 16 | 57 |
| 2016 June | 12 | 14 | 26 |
| 2016 May | 7 | 13 | 20 |
| 2016 April | 3 | 1 | 4 |
| 2016 March | 6 | 0 | 6 |
| 2016 February | 13 | 3 | 16 |
| 2016 January | 4 | 1 | 5 |
| 2015 December | 13 | 0 | 13 |
| 2015 November | 17 | 6 | 23 |
| 2015 October | 10 | 3 | 13 |
| 2015 September | 7 | 4 | 11 |
| 2015 August | 11 | 7 | 18 |
| 2015 July | 31 | 9 | 40 |
| 2015 June | 46 | 6 | 52 |
| 2015 May | 53 | 9 | 62 |
| 2015 April | 38 | 10 | 48 |
| 2015 March | 37 | 7 | 44 |
| 2015 February | 43 | 8 | 51 |
| 2015 January | 29 | 11 | 40 |
| 2014 December | 31 | 8 | 39 |
| 2014 November | 34 | 10 | 44 |
| 2014 October | 50 | 26 | 76 |
| 2014 September | 8 | 5 | 13 |
| 2014 August | 16 | 8 | 24 |
| 2014 July | 14 | 6 | 20 |
| 2014 June | 22 | 5 | 27 |
| 2014 May | 30 | 5 | 35 |
| 2014 April | 27 | 3 | 30 |
| 2014 March | 38 | 9 | 47 |
| 2014 February | 19 | 3 | 22 |
| 2014 January | 27 | 11 | 38 |
| 2013 December | 31 | 8 | 39 |
| 2013 November | 26 | 8 | 34 |
| 2013 October | 13 | 6 | 19 |
| 2013 September | 13 | 19 | 32 |
| 2013 August | 11 | 14 | 25 |
| 2013 July | 14 | 21 | 35 |
| 2013 June | 11 | 22 | 33 |
| 2013 May | 14 | 31 | 45 |
| 2013 April | 16 | 14 | 30 |
| 2013 March | 15 | 5 | 20 |
| 2013 February | 28 | 2 | 30 |
| 2013 January | 16 | 11 | 27 |
| 2012 December | 19 | 5 | 24 |
| 2012 November | 6 | 1 | 7 |
| 2012 October | 1 | 0 | 1 |
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