Letter to the Editor
Considerations about document of Spanish consensus for the management of patients with advanced radioactive iodine refractory differentiated thyroid cancer (CDT-RAI)
Consideraciones con relación al documento de consenso español sobre el manejo del cáncer diferenciado de tiroides en fase avanzada y resistente al tratamiento con radioyodo (CDT-RAI)
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(B) Scan after initial treatment with <span class="elsevierStyleSup">131</span>I in the second patient. (C) Scan after the second treatment with <span class="elsevierStyleSup">131</span>I in the second patient.</p>" ] ] ] "autores" => array:1 [ 0 => array:2 [ "autoresLista" => "Ander Ernaga Lorea, Maria Cecília Hernández Morhain, Emma Anda Apiñániz, Sonia Lapeña Calavia, Nerea Eguílaz Esparza" "autores" => array:5 [ 0 => array:2 [ "nombre" => "Ander" "apellidos" => "Ernaga Lorea" ] 1 => array:2 [ "nombre" => "Maria Cecília" "apellidos" => "Hernández Morhain" ] 2 => array:2 [ "nombre" => "Emma" "apellidos" => "Anda Apiñániz" ] 3 => array:2 [ "nombre" => "Sonia" "apellidos" => "Lapeña Calavia" ] 4 => array:2 [ "nombre" => "Nerea" "apellidos" => "Eguílaz Esparza" ] ] ] ] ] "idiomaDefecto" => "en" "Traduccion" => array:1 [ "es" => array:9 [ "pii" => "S2530016416300155" "doi" => "10.1016/j.endinu.2016.09.008" "estado" => "S300" "subdocumento" => "" "abierto" => array:3 [ "ES" => false "ES2" => false "LATM" => false ] "gratuito" => false "lecturas" => array:1 [ "total" => 0 ] "idiomaDefecto" => "es" "EPUB" => "https://multimedia.elsevier.es/PublicationsMultimediaV1/item/epub/S2530016416300155?idApp=UINPBA00004N" ] ] "EPUB" => "https://multimedia.elsevier.es/PublicationsMultimediaV1/item/epub/S2530018017300252?idApp=UINPBA00004N" "url" => "/25300180/0000006400000002/v1_201704211147/S2530018017300252/v1_201704211147/en/main.assets" ] "en" => array:13 [ "idiomaDefecto" => true "cabecera" => "<span class="elsevierStyleTextfn">Letter to the Editor</span>" "titulo" => "Considerations about document of Spanish consensus for the management of patients with advanced radioactive iodine refractory differentiated thyroid cancer (CDT-RAI)" "tieneTextoCompleto" => true "saludo" => "Dear Editor," "paginas" => array:1 [ 0 => array:2 [ "paginaInicial" => "123" "paginaFinal" => "124" ] ] "autores" => array:1 [ 0 => array:4 [ "autoresLista" => "Ana Albero Tamarit, Alberto Torres Cuadro, Tomás Martín Hernández" "autores" => array:3 [ 0 => array:3 [ "nombre" => "Ana" "apellidos" => "Albero Tamarit" "referencia" => array:1 [ 0 => array:2 [ "etiqueta" => "<span class="elsevierStyleSup">a</span>" "identificador" => "aff0005" ] ] ] 1 => array:4 [ "nombre" => "Alberto" "apellidos" => "Torres Cuadro" "email" => array:1 [ 0 => "casablanca37@terra.com" ] "referencia" => array:2 [ 0 => array:2 [ "etiqueta" => "<span class="elsevierStyleSup">b</span>" "identificador" => "aff0010" ] 1 => array:2 [ "etiqueta" => "<span class="elsevierStyleSup">*</span>" "identificador" => "cor0005" ] ] ] 2 => array:3 [ "nombre" => "Tomás" "apellidos" => "Martín Hernández" "referencia" => array:1 [ 0 => array:2 [ "etiqueta" => "<span class="elsevierStyleSup">b</span>" "identificador" => "aff0010" ] ] ] ] "afiliaciones" => array:2 [ 0 => array:3 [ "entidad" => "Unidad de Gestión Clínica de Oncología, Hospital Universitario Virgen Macarena, Sevilla, Spain" "etiqueta" => "a" "identificador" => "aff0005" ] 1 => array:3 [ "entidad" => "Unidad de Gestión Clínica de Endocrinología y Nutrición, Hospital Universitario Virgen Macarena, Sevilla, Spain" "etiqueta" => "b" "identificador" => "aff0010" ] ] "correspondencia" => array:1 [ 0 => array:3 [ "identificador" => "cor0005" "etiqueta" => "⁎" "correspondencia" => "Corresponding author." ] ] ] ] "titulosAlternativos" => array:1 [ "es" => array:1 [ "titulo" => "Consideraciones con relación al documento de consenso español sobre el manejo del cáncer diferenciado de tiroides en fase avanzada y resistente al tratamiento con radioyodo (CDT-RAI)" ] ] "textoCompleto" => "<span class="elsevierStyleSections"><p id="par0005" class="elsevierStylePara elsevierViewall">We congratulate the authors of the Spanish consensus on the management of patients with advanced radioactive iodine-refractory differentiated thyroid cancer (RAI-DTC)<a class="elsevierStyleCrossRef" href="#bib0055"><span class="elsevierStyleSup">1</span></a> for their efforts to focus attention on this type of cancer that compromises patient survival and poses so many questions for medical teams. However, we would like to point to some pending issues that may seem confusing in the document, referring mainly to systemic treatments.</p><p id="par0010" class="elsevierStylePara elsevierViewall">Although there is no complete agreement on the definition of iodine refractoriness/non-avidity, we think that the main problem is to ascertain whether this group shows homogeneous behavior. In the Durante et al. study,<a class="elsevierStyleCrossRef" href="#bib0060"><span class="elsevierStyleSup">2</span></a> on which the DECISION and SELECT<a class="elsevierStyleCrossRefs" href="#bib0065"><span class="elsevierStyleSup">3,4</span></a> studies are based, the independent variables for survival considered included advanced age, male sex, poorly differentiated histology, the extent of the disease, and the presence or absence of initial iodine uptake. The latter is one of the most statistically significant factors, and introduces a “new” factor: the presence or absence of “primary iodine resistance”. However, DECISION and SELECT<a class="elsevierStyleCrossRefs" href="#bib0065"><span class="elsevierStyleSup">3,4</span></a> do not consider the absence of iodine uptake at diagnosis, and one may therefore wonder if the arms were well balanced with regard to this apparently important variable. In fact, it is unknown whether uptake itself may indicate a more benign behavior of the tumor, rather than a benefit of treatment in patients who take up iodine but do not achieve a complete response (CR) to <span class="elsevierStyleSup">131</span>I.</p><p id="par0015" class="elsevierStylePara elsevierViewall">The document does not specify, although it seems important, when progression should be considered slow or rapid. In the DECISION and SELECT studies, progression in approximately one year was considered rapid. However, in the placebo arms of both studies there was a substantial proportion (one third) of patients with stable disease for more than six months, but we do not know for how much longer. Therefore, where do we draw the line regarding time to progression in asymptomatic patients?</p><p id="par0020" class="elsevierStylePara elsevierViewall">Both studies left many issues unresolved, and there are variables that need to be analyzed. One of the most immediate questions concerns the very different behavior of their control groups, despite theoretically meeting very similar selection criteria and having similar baseline characteristics.<ul class="elsevierStyleList" id="lis0005"><li class="elsevierStyleListItem" id="lsti0005"><span class="elsevierStyleLabel">1.</span><p id="par0025" class="elsevierStylePara elsevierViewall">In DECISION and SELECT, respectively, 74% and 54% of patients achieved stable disease. In addition, one third of both groups achieved long-term stable disease (longer than 6 months) without active treatment. Thus, patients who achieved stable disease with treatment coexist with those with stable disease without treatment, a fact which has not been analyzed.</p></li><li class="elsevierStyleListItem" id="lsti0010"><span class="elsevierStyleLabel">2.</span><p id="par0030" class="elsevierStylePara elsevierViewall">One-year progression-free survival (PFS) in the placebo group of both studies was over 30% in the DECISION study, and about 10% in the SELECT study, and decreased at two years to slightly over 10% and 5% respectively. These differences may be partially explained by the inclusion of patients receiving second-line treatment in the SELECT study. On the other hand, in the DECISION study some patient subgroups showed some questionable advantages in PFS as compared to the placebo group: male sex, small metastases (<71<span class="elsevierStyleHsp" style=""></span>mm), and few lesions (<5 lesions), patients receiving more than 600<span class="elsevierStyleHsp" style=""></span>mCi.</p></li><li class="elsevierStyleListItem" id="lsti0015"><span class="elsevierStyleLabel">3.</span><p id="par0035" class="elsevierStylePara elsevierViewall">As regards survival, it might be expected that lenvatinib, which achieves a high response rate and greatly improves PFS, would change the course of the disease to a greater extent than sorafenib. However, patients treated with lenvatinib have a lower chance of survival at one and two years than patients treated with sorafenib, despite having received a subsequent line of treatment more frequently.</p></li></ul></p><p id="par0040" class="elsevierStylePara elsevierViewall">The prevalence of some adverse events of this treatment, such as asthenia, anorexia, and weight loss, increases over time, and the prevalence of other controlled events (with medication) is very high.<a class="elsevierStyleCrossRef" href="#bib0075"><span class="elsevierStyleSup">5</span></a> The quality of life analysis performed in the DECISION study<a class="elsevierStyleCrossRef" href="#bib0080"><span class="elsevierStyleSup">6</span></a> showed its impairment with treatment. The SELECT study<a class="elsevierStyleCrossRef" href="#bib0070"><span class="elsevierStyleSup">4</span></a> reported frequent and severe toxicities associated with toxic death, and a quality of life improvement is therefore hardly to be expected (especially in asymptomatic patients, not quantified in this study). We conclude that the results reported in both studies at least raise some doubts regarding the treatment of certain patients.</p><p id="par0045" class="elsevierStylePara elsevierViewall">Finally, chemotherapy has been evaluated infrequently and often inadequately, as studies have included patients with all histological types. Four studies<a class="elsevierStyleCrossRefs" href="#bib0085"><span class="elsevierStyleSup">7–10</span></a> on RAI-DTC alone have been reported, and their results may be as promising as those achieved with other currently tested drugs. A phase II study<a class="elsevierStyleCrossRef" href="#bib0085"><span class="elsevierStyleSup">7</span></a> where a regimen consisting of carboplatinum-4epiADM and TSH hyperstimulation was administered reported a response rate (RR) of 43% (7% of CR) and a clinical benefit (CB) of 93%. Another study<a class="elsevierStyleCrossRef" href="#bib0090"><span class="elsevierStyleSup">8</span></a> using a combination of gemcitabine and oxaliplatin reported a RR of 57% (7% CR) and a CB of 86%. It should be noted that two studies<a class="elsevierStyleCrossRefs" href="#bib0085"><span class="elsevierStyleSup">7,10</span></a> assessed response at 10–40 weeks and at 40–49 weeks respectively, which indicates durable responses. Response durations varied between 6 and 12 months,<a class="elsevierStyleCrossRef" href="#bib0095"><span class="elsevierStyleSup">9</span></a> 15.6 months,<a class="elsevierStyleCrossRef" href="#bib0090"><span class="elsevierStyleSup">8</span></a> and 22 months,<a class="elsevierStyleCrossRef" href="#bib0100"><span class="elsevierStyleSup">10</span></a> which is hardly short. Only Spano et al.<a class="elsevierStyleCrossRef" href="#bib0090"><span class="elsevierStyleSup">8</span></a> analyzed PFS, and found a median of 10.1 months (1.6–22 months), which is similar to the value found in the DECISION study.<a class="elsevierStyleCrossRef" href="#bib0065"><span class="elsevierStyleSup">3</span></a> In the Spano et al. study,<a class="elsevierStyleCrossRef" href="#bib0090"><span class="elsevierStyleSup">8</span></a> median survival was not achieved after a 19.8-month follow-up (1.6–62.9 months) with 10 of 14 patients still alive (71%), and an estimated two-year survival rate of 80%. Median survival was not reached either in the Santini et al.<a class="elsevierStyleCrossRef" href="#bib0085"><span class="elsevierStyleSup">7</span></a> study 21 months (15–34) after treatment start, with 64% of patients still alive at that time. For these reasons, it cannot be stated that “<span class="elsevierStyleItalic">Several studies have assessed the activity of certain agents with variable results, RRs ranging from 0% to 20%, short-lasting responses, with no complete remissions, and with no impact on overall survival”</span>. We think that the results may be promising, as are those found with other drugs, but additional research is certainly needed.</p></span>" "pdfFichero" => "main.pdf" "tienePdf" => true "NotaPie" => array:1 [ 0 => array:2 [ "etiqueta" => "☆" "nota" => "<p class="elsevierStyleNotepara" id="npar0005">Please cite this article as: Albero Tamarit A, Torres Cuadro A, Martín Hernández T. Consideraciones con relación al documento de consenso español sobre el manejo del cáncer diferenciado de tiroides en fase avanzada y resistente al tratamiento con radioyodo (CDT-RAI). Endocrinol Diabetes Nutr. 2017;64:123–124.</p>" ] ] "bibliografia" => array:2 [ "titulo" => "References" "seccion" => array:1 [ 0 => array:2 [ "identificador" => "bibs0005" "bibliografiaReferencia" => array:10 [ 0 => array:3 [ "identificador" => "bib0055" "etiqueta" => "1" "referencia" => array:1 [ 0 => array:2 [ "contribucion" => array:1 [ 0 => array:2 [ "titulo" => "Spanish consensus for the management of patients with advanced radioactive iodine refractory differentiated thyroid cancer [Article in English, Spanish]" "autores" => array:1 [ 0 => array:2 [ "etal" => true "autores" => array:6 [ 0 => "G. Riesco-Eizaguirre" 1 => "J.C. Galofré" 2 => "E. Grande" 3 => "C. Zafón Llopis" 4 => "T. Ramón y Cajal Asensio" 5 => "E. 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| Year/Month | Html | Total | |
|---|---|---|---|
| 2024 October | 5 | 2 | 7 |
| 2024 September | 7 | 5 | 12 |
| 2024 August | 12 | 3 | 15 |
| 2024 July | 8 | 1 | 9 |
| 2024 June | 8 | 3 | 11 |
| 2024 May | 12 | 2 | 14 |
| 2024 April | 14 | 8 | 22 |
| 2024 March | 8 | 2 | 10 |
| 2024 February | 11 | 0 | 11 |
| 2024 January | 14 | 4 | 18 |
| 2023 December | 11 | 3 | 14 |
| 2023 November | 14 | 3 | 17 |
| 2023 October | 12 | 3 | 15 |
| 2023 September | 13 | 1 | 14 |
| 2023 August | 13 | 2 | 15 |
| 2023 July | 8 | 6 | 14 |
| 2023 June | 16 | 1 | 17 |
| 2023 May | 17 | 3 | 20 |
| 2023 April | 13 | 0 | 13 |
| 2023 March | 28 | 1 | 29 |
| 2023 February | 15 | 3 | 18 |
| 2023 January | 14 | 19 | 33 |
| 2022 December | 6 | 3 | 9 |
| 2022 November | 9 | 5 | 14 |
| 2022 October | 7 | 5 | 12 |
| 2022 September | 10 | 10 | 20 |
| 2022 August | 10 | 9 | 19 |
| 2022 July | 6 | 8 | 14 |
| 2022 June | 6 | 3 | 9 |
| 2022 May | 12 | 5 | 17 |
| 2022 April | 20 | 10 | 30 |
| 2022 March | 19 | 4 | 23 |
| 2022 February | 22 | 7 | 29 |
| 2022 January | 20 | 4 | 24 |
| 2021 December | 7 | 6 | 13 |
| 2021 November | 9 | 7 | 16 |
| 2021 October | 13 | 11 | 24 |
| 2021 September | 10 | 7 | 17 |
| 2021 August | 10 | 7 | 17 |
| 2021 July | 10 | 8 | 18 |
| 2021 June | 10 | 10 | 20 |
| 2021 May | 17 | 11 | 28 |
| 2021 April | 23 | 16 | 39 |
| 2021 March | 11 | 7 | 18 |
| 2021 February | 11 | 7 | 18 |
| 2021 January | 11 | 8 | 19 |
| 2020 December | 10 | 5 | 15 |
| 2020 November | 12 | 9 | 21 |
| 2020 October | 7 | 2 | 9 |
| 2020 September | 6 | 10 | 16 |
| 2020 August | 5 | 2 | 7 |
| 2020 July | 9 | 1 | 10 |
| 2020 June | 6 | 4 | 10 |
| 2020 May | 8 | 13 | 21 |
| 2020 April | 5 | 3 | 8 |
| 2020 March | 19 | 5 | 24 |
| 2020 February | 20 | 2 | 22 |
| 2020 January | 14 | 7 | 21 |
| 2019 December | 12 | 7 | 19 |
| 2019 November | 6 | 7 | 13 |
| 2019 October | 8 | 0 | 8 |
| 2019 September | 9 | 3 | 12 |
| 2019 August | 5 | 0 | 5 |
| 2019 July | 3 | 13 | 16 |
| 2019 June | 24 | 32 | 56 |
| 2019 May | 55 | 58 | 113 |
| 2019 April | 20 | 22 | 42 |
| 2019 March | 1 | 5 | 6 |
| 2019 February | 2 | 1 | 3 |
| 2019 January | 2 | 6 | 8 |
| 2018 December | 0 | 1 | 1 |
| 2018 November | 4 | 6 | 10 |
| 2018 October | 9 | 12 | 21 |
| 2018 September | 5 | 10 | 15 |
| 2018 August | 1 | 0 | 1 |
| 2018 July | 19 | 4 | 23 |
| 2018 June | 6 | 0 | 6 |
| 2018 May | 5 | 1 | 6 |
| 2018 April | 7 | 0 | 7 |
| 2018 March | 3 | 0 | 3 |
| 2018 February | 6 | 2 | 8 |
| 2018 January | 6 | 0 | 6 |
| 2017 December | 3 | 0 | 3 |
| 2017 November | 13 | 1 | 14 |
| 2017 October | 4 | 0 | 4 |
| 2017 September | 11 | 1 | 12 |
| 2017 August | 12 | 2 | 14 |
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