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Letter to the Editor
Treatment of colorectal liver metastases with y-90: the problem is the toxicity
Tratamiento de las metástasis hepáticas de cáncer colorrectal con y-90: el problema es la toxicidad
Ana Ruiz-Casado
Corresponding author
arcasado@salud.madrid.org

Corresponding author.
, Lourdes Gutiérrez Sanz, Fernando Franco Pérez, Antonio C. Sánchez Ruiz
Servicio de Oncología Médica, Hospital Puerta de Hierro-Majadahonda, Spain
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    "textoCompleto" => "<span class="elsevierStyleSections"><p id="par0005" class="elsevierStylePara elsevierViewall">The results of the phase III EPOCH trial evaluating the addition of selective internal radiotherapy &#40;SIR&#41; to second-line chemotherapy in metastatic colorectal cancer were recently reported<a class="elsevierStyleCrossRef" href="#bib0005"><span class="elsevierStyleSup">1</span></a>&#46; This was a positive trial&#44; the publication of which was accompanied by a very critical editorial clearly positioned against modifying the second-line standard of care<a class="elsevierStyleCrossRef" href="#bib0010"><span class="elsevierStyleSup">2</span></a>&#46;</p><p id="par0010" class="elsevierStylePara elsevierViewall">The trial was oriented at a clearly defined question&#58; Does the addition of Y-90 glass beads improve progression-free survival &#40;PFS&#41; in the scenario of second-line metastatic colorectal cancer&#63; On the other hand&#44; patients were randomly assigned to the treatment&#44; were followed according to the study&#44; and were analyzed by intention to treat&#46; Due to the complexity of the technique and for unavoidable ethical imperatives&#44; the intervention was mot masked and the patients were treated equally independently of the study arm assigned&#46; The authors reported that the hazard ratio &#40;HR&#41; for PFS was 0&#46;69 &#40;95&#37; CI&#44; 0&#46;54 to 0&#46;88 p&#8201;&#61;&#8201;0&#46;0013&#41; and HR for PFS at a hepatic level was 0&#46;59 &#40;95&#37; CI&#44; 0&#46;46 to 0&#46;77 p&#8201;&#61;&#8201;0&#46;0001&#41;&#44; although there was no advantage in overall survival &#40;OS&#41; in either of the analyses &#40;for intention to treat or per protocol&#41;&#46;</p><p id="par0015" class="elsevierStylePara elsevierViewall">In 2017&#44; the results of three first-line randomized trials which added resin beads with Y-90 to treatment with FOLFOX were published together&#46;<span class="elsevierStyleSup">3</span> In this global study including 1103 patients&#44; the primary objective&#44; which was a better OS&#44; was not achieved&#44; and neither was PFS &#40;secondary objective&#41; improved&#46; So&#44; what led the authors of the editorial to be so critical of a methodologically correct trial with positive results&#63;</p><p id="par0020" class="elsevierStylePara elsevierViewall">Lentz and Messersmith criticize the fact that the principal variable was PFS versus OS or quality of life as well as the additional cost and toxicity&#46; In our opinion&#44; more than being a question of the use of surrogate variable&#44; which is a usual&#44; justified discussion in trials on oncological treatments&#44; it is a problem of toxicity&#46; While PFS is certainly not an objective that is as robust as OS&#44; it is a valid surrogate objective for metastatic colon cancer<a class="elsevierStyleCrossRef" href="#bib0020"><span class="elsevierStyleSup">4</span></a>&#46; Unfortunately&#44; what this trial&#44; confirms is that intraarterial treatment with Y-90 combined with chemotherapy is not as innocuous as initially intended and has consequences which may lead to death&#46; Or at least&#44; it confirms that adding SIR to chemotherapy treatment as we have done up to now in the trials &#40;one dose for everyone&#44; a single procedure&#44; non-selective treatment&#41; induces an unacceptable increase of the risks&#46;</p><p id="par0025" class="elsevierStylePara elsevierViewall">Among the adverse events that were mortal in the EPOCH trial and were considered to be related to the treatment&#44; it is of note that three were considered to be related to SIR versus only one was related to chemotherapy&#46; Hepatic toxicity was attributable to the technique&#58; radio-induced liver disease&#44; hepatic insufficiency&#44; and portal hypertension&#46; The latter has also been described with resin beads<a class="elsevierStyleCrossRef" href="#bib0025"><span class="elsevierStyleSup">5</span></a> and is exceptional with chemotherapy treatment &#40;although it has been described with oxaliplatin&#41;<a class="elsevierStyleCrossRef" href="#bib0030"><span class="elsevierStyleSup">6</span></a>&#46; In the article that analyzes first-line SIR&#44; eight deaths were also related in the experimental arm versus three in the control arm&#46; In addition&#44; two additional deaths due to &#8220;hepatic events&#8221; were mentioned &#40;hepatic insufficient or ascites&#41; in the SIR arm&#46; It is very notable that neither of the two articles provides data on albumin values&#44; which is essential to understand hepatic toxicity &#40;<a class="elsevierStyleCrossRef" href="#tbl0005">Table 1</a>&#41;&#46;</p><elsevierMultimedia ident="tbl0005"></elsevierMultimedia><p id="par0030" class="elsevierStylePara elsevierViewall">We cannot rule out that hepatic toxicity could have been prevented with sequential treatment &#40;in the case of bilobar disease&#41; with selective treatment of the lesions or with adequate dosimetry&#46; In any case&#44; a rigorous study of the risk factors for developing this toxicity is needed&#46; In addition&#44; in cases with previous treatment with oxaliplatin or previous hepatectomy&#44; an additional selection to the classical selection could be considered carefully accounting for aspects such as the platelet count&#44; the size of the spleen&#44; and in doubtful cases&#44; gastroscopy should be considered to rule out the presence of varices&#46;</p><p id="par0035" class="elsevierStylePara elsevierViewall">The authors of the editorial have sufficient reasons to argue that the addition of SIR to the second chemotherapy line cannot be standard treatment since the risks presented are not compensated by the scarce advantage to PFS and the increase in costs&#46; However&#44; in the same way it can be argued that it was a well-designed trial with positive results that achieved an increase in PFS&#44; which is a validated surrogate variable for OS&#46; We must take what can be learned from a randomized trial of this size which will undoubtedly serve to help administer this treatment in selected patients accompanying second-line treatment minimizing potential toxicity&#46;</p></span>"
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        "nota" => "<p class="elsevierStyleNotepara" id="npar0010">Please cite this article as&#58; Ruiz-Casado A&#44; Guti&#233;rrez Sanz L&#44; Franco P&#233;rez F&#44; S&#225;nchez Ruiz AC&#46; Tratamiento de las met&#225;stasis hep&#225;ticas de c&#225;ncer colorrectal con y-90&#58; el problema es la toxicidad&#46; Rev Esp Med Nucl Imagen Mol&#46; 2022&#59;41&#58;66&#8211;67&#46;</p>"
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                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">AE&#8201;&#8805;&#8201;g3&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">82&#37;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">67&#37;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">AE g5&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">10 cases&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">11 cases&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n
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                  \t\t\t\t">Related AA g5&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
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                  \t\t\t\t">8 cases&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">3 cases&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t ; entry_with_role_rowhead " colspan="3" align="left" valign="\n
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                  \t\t\t\t"><span class="elsevierStyleBold">EPOCH</span><a class="elsevierStyleCrossRef" href="#bib0005"><span class="elsevierStyleSup">1</span></a></td></tr><tr title="table-row"><td class="td-with-role" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">Thrombopenia &#40;any grade&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
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                  \t\t\t\t">18&#46;7&#37;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
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                  \t\t\t\t">8&#46;7&#37;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n
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                  \t\t\t\t">Hypoalbuminemia&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
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                  \t\t\t\t">NR&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">NR&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">AE&#8201;&#8805;&#8201;g3&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
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                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">68&#46;4&#37;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">49&#46;3&#37;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">AE g5&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">8 cases&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
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                  \t\t\t\t">4 cases&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n
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                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">3 cases&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">1 case&nbsp;\t\t\t\t\t\t\n
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Original language: English
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