Sistema de Salut de Catalunya
Institut Català de la Salut
[Staehler M] Ludwig Maximilian Universität München, Klinikum Grosshadern, Munich, Germany. [Basso U] Oncology 1 Unit, Istituto Oncologico Veneto IOV IRCCS, Padova, Italy. [Eymard JC] Institut Jean Godinot, Reims, France. [Barthelemy P] Institut de Cancérologie Strasbourg Europe, Strasbourg, France. [Bigot P] Centre Hospitalier Universitaire d'Angers, Angers, France. [Laramas M] Grenoble Alpes University Hospital, Grenoble, France. [Suarez C] Vall d’Hebron Institute of Oncology (VHIO), Barcelona, Spain. Vall d’Hebron Hospital Universitari, Barcelona, Spain
Vall d'Hebron Barcelona Hospital Campus
2025-03-11T11:10:12Z
2025-03-11T11:10:12Z
2024
2025-02
Adverse event; Dose modification; Targeted therapies
Esdeveniment advers; Modificació de la dosi; Teràpies dirigides
Evento adverso; Modificación de dosis; Terapias dirigidas
Background 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. Methods 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. Findings 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 (< 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. Interpretation 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.
Article
Published version
English
Ronyons - Càncer - Tractament; Proteïnes quinases - Inhibidors - Ús terapèutic - Efectes secundaris; Factors de creixement; DISEASES::Neoplasms::Neoplasms::Neoplasms by Site::Urogenital Neoplasms::Urologic Neoplasms::Kidney Neoplasms::Carcinoma, Renal Cell; Other subheadings::Other subheadings::Other subheadings::/drug therapy; DISEASES::Neoplasms::Neoplasms by Site::Urogenital Neoplasms::Urologic Neoplasms::Kidney Neoplasms; CHEMICALS AND DRUGS::Chemical Actions and Uses::Pharmacologic Actions::Molecular Mechanisms of Pharmacological Action::Enzyme Inhibitors::Protein Kinase Inhibitors; Other subheadings::Other subheadings::/therapeutic use; ANALYTICAL, DIAGNOSTIC AND THERAPEUTIC TECHNIQUES, AND EQUIPMENT::Therapeutics::Drug Therapy::Molecular Targeted Therapy; 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; ENFERMEDADES::neoplasias::neoplasias::neoplasias por localización::neoplasias urogenitales::neoplasias urológicas::neoplasias renales::carcinoma de células renales; Otros calificadores::Otros calificadores::Otros calificadores::/farmacoterapia; ENFERMEDADES::neoplasias::neoplasias por localización::neoplasias urogenitales::neoplasias urológicas::neoplasias renales; COMPUESTOS QUÍMICOS Y DROGAS::acciones y usos químicos::acciones farmacológicas::mecanismos moleculares de acción farmacológica::inhibidores enzimáticos::inhibidores de proteínas cinasas; Otros calificadores::Otros calificadores::/uso terapéutico; TÉCNICAS Y EQUIPOS ANALÍTICOS, DIAGNÓSTICOS Y TERAPÉUTICOS::terapéutica::farmacoterapia::terapia molecular selectiva; 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
Elsevier
Clinical Genitourinary Cancer;23(1)
https://doi.org/10.1016/j.clgc.2024.102285
Attribution 4.0 International
http://creativecommons.org/licenses/by/4.0/
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