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                  <mods:namePart>Staehler, Michael</mods:namePart>
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                  <mods:namePart>Basso, Umberto</mods:namePart>
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                  <mods:namePart>Eymard, Jean-Christophe</mods:namePart>
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                  <mods:namePart>Barthelemy, Philippe</mods:namePart>
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               <mods:name>
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                     <mods:roleTerm type="text">author</mods:roleTerm>
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                  <mods:namePart>Bigot, Pierre</mods:namePart>
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                  <mods:namePart>LARAMAS, Mathieu</mods:namePart>
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                  <mods:namePart>Suárez, Cristina</mods:namePart>
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                  <mods:dateIssued encoding="iso8601">2025-03-11T11:10:12Z2025-03-11T11:10:12Z20242025-02</mods:dateIssued>
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               <mods:abstract>Adverse event; Dose modification; Targeted therapiesEsdeveniment advers; Modificació de la dosi; Teràpies dirigidesEvento adverso; Modificación de dosis; Terapias dirigidasBackground&#xd;
There is a lack of published data on real-world cabozantinib use in patients with advanced renal cell carcinoma after prior vascular endothelial growth factor (VEGF)-targeted therapy.&#xd;
Methods&#xd;
CASSIOPE was a real-world, prospective, multicenter, non-interventional postauthorization safety study of cabozantinib in adult patients with advanced renal cell carcinoma in Europe following prior VEGF-targeted treatment (NCT03419572). Endpoints included cabozantinib utilization (dose modifications due to adverse events [AEs; primary endpoint], dose, dose modifications, and treatment duration), safety, effectiveness (progression-free survival [PFS], overall survival [OS], best overall response [BOR]), and healthcare resource utilization.&#xd;
Findings&#xd;
Full analysis set (FAS)/safety population comprised 679 patients; 433 of these initiated cabozantinib at 60 mg/day (recommended dose) (primary safety population). Median age (FAS) was 67 (range, 29-93) years; most were male (73·0%), had clear-cell histology (85·7%), metastatic disease at cabozantinib initiation (97·8%), and prior nephrectomy (80·3%). In the primary safety population, 77·1% experienced dose modification owing to an AE. In the safety population, the median daily dose was 40·0 (range, 7·8-60·0) mg/day and the median treatment duration was 7·8 (&lt; 0·1-15·2) months. Treatment-emergent and treatment-related AEs were experienced by 95·9% and 90·4% of patients, respectively. Median PFS (FAS) assessed by the local investigator using any method was 8·3 months, and 1-year OS rate was 74%. Approximately one-third of all patients had a BOR of partial response and 6 had a complete response.&#xd;
Interpretation&#xd;
Second- or later-line cabozantinib was effective and manageable in a real-world setting and had a safety profile consistent with previous studies.This study, manuscript development, and open-access fee were funded by Ipsen.</mods:abstract>
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               <mods:accessCondition type="useAndReproduction">Attribution 4.0 International http://creativecommons.org/licenses/by/4.0/ info:eu-repo/semantics/openAccess</mods:accessCondition>
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                  <mods:topic>Ronyons - Càncer - Tractament</mods:topic>
               </mods:subject>
               <mods:subject>
                  <mods:topic>Proteïnes quinases - Inhibidors - Ús terapèutic - Efectes secundaris</mods:topic>
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                  <mods:topic>DISEASES::Neoplasms::Neoplasms::Neoplasms by Site::Urogenital Neoplasms::Urologic Neoplasms::Kidney Neoplasms::Carcinoma, Renal Cell</mods:topic>
               </mods:subject>
               <mods:subject>
                  <mods:topic>Other subheadings::Other subheadings::Other subheadings::/drug therapy</mods:topic>
               </mods:subject>
               <mods:subject>
                  <mods:topic>DISEASES::Neoplasms::Neoplasms by Site::Urogenital Neoplasms::Urologic Neoplasms::Kidney Neoplasms</mods:topic>
               </mods:subject>
               <mods:subject>
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                  <mods:topic>CHEMICALS AND DRUGS::Amino Acids, Peptides, and Proteins::Peptides::Intercellular Signaling Peptides and Proteins::Angiogenic Proteins::Vascular Endothelial Growth Factors::Vascular Endothelial Growth Factor A</mods:topic>
               </mods:subject>
               <mods:subject>
                  <mods:topic>ENFERMEDADES::neoplasias::neoplasias::neoplasias por localización::neoplasias urogenitales::neoplasias urológicas::neoplasias renales::carcinoma de células renales</mods:topic>
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               <mods:subject>
                  <mods:topic>Otros calificadores::Otros calificadores::Otros calificadores::/farmacoterapia</mods:topic>
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               <mods:subject>
                  <mods:topic>ENFERMEDADES::neoplasias::neoplasias por localización::neoplasias urogenitales::neoplasias urológicas::neoplasias renales</mods:topic>
               </mods:subject>
               <mods:subject>
                  <mods:topic>COMPUESTOS QUÍMICOS Y DROGAS::acciones y usos químicos::acciones farmacológicas::mecanismos moleculares de acción farmacológica::inhibidores enzimáticos::inhibidores de proteínas cinasas</mods:topic>
               </mods:subject>
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               <mods:subject>
                  <mods:topic>TÉCNICAS Y EQUIPOS ANALÍTICOS, DIAGNÓSTICOS Y TERAPÉUTICOS::terapéutica::farmacoterapia::terapia molecular selectiva</mods:topic>
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               <mods:subject>
                  <mods:topic>COMPUESTOS QUÍMICOS Y DROGAS::aminoácidos, péptidos y proteínas::péptidos::péptidos y proteínas de señalización intercelular::proteínas angiogénicas::factores de crecimiento endotelial vascular::factor A de crecimiento endotelial vascular</mods:topic>
               </mods:subject>
               <mods:titleInfo>
                  <mods:title>A Prospective Non-interventional Real-World Study of cabozantinib in Pretreated Patients With Advanced Renal Cell Carcinoma Refractory to Vascular Endothelial Growth Factor-Targeted Therapy (CASSIOPE)</mods:title>
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