Spanish Real-World Evidence Cabozantinib
- Registration Number
- NCT04510688
- Lead Sponsor
- Spanish Oncology Genito-Urinary Group
- Brief Summary
RCC (Renal Cell Carcinoma) is the most common form of kidney cancer, accounting for 2-3% of all adult malignancies and for 90% of all kidney cancers. The incidence of RCC has steadily increased over the past two decades, showing a plateau in recent years. Many patients with RCC remain asymptomatic until late disease stages and other patients have disease at diagnosis (metastatic RCC or mRCC).
Recently, the tyrosine kinase inhibitor (TKI) cabozantinib was approved as a first-line therapy for patients with advanced clear-cell RCC (ccRCC). Cabozantinib was initially approved for patients previously treated with antiangiogenic therapy based on the phase 3 METEOR study, which demonstrated a clinical benefit compared with everolimus.
Immunotherapy has been also developed in ccRCC.
The frontline treatment paradigm for ccRCC has evolved, particularly for intermediate-/poor-risk patients, with the recent addition of cabozantinib and nivolumab/ipilimumab (immunotherapy), but overall survival data are needed to understand their benefit-to-risk profiles compared with established therapies.
In October 2016, the Spanish Agency of medicines (AEMPS) granted the temporary Authorization for special use to Cabometyx® 20/40/60 mg within a Managed Access Program (MAP) for the treatment of advanced RCC in adults following prior VEGF-targeted therapy (Vascular Endothelial Growth Factor targeted therapy). The MAP allows the possibility of using a medicinal product which is not yet commercially available or approved. By the end of the MAP period, on July 2017, 136 patients had been included by 61 centers who received at least one dose of Cabometyx® for the treatment of advanced RCC.
Since then, Cabometyx® 20/40/60 mg was made commercially available for the treatment of advanced RCC in adults following prior VEGF-targeted therapy. After the commercialization of Cabometyx® in July 2017 in Spain, the inclusion of new patients in the MAP was closed but those patients that were already included continued receiving Cabometyx® free of charge until clinical decision. In July 2018, the European Commission approved a new indication for adult patients previously untreated with intermediate or poor risk.
Based on this rationale, the aim of this study is to obtain safety and effectiveness information regarding the use of cabozantinib in a non-selected RCC population, both in patients that received this agent under the MAP or under routine clinical prescription (real-world \[RW\]).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 275
- Male or females, aged 18 years or older.
- Diagnosis of advanced Renal Cell Carcinoma (RCC)
- Alive or dead patients at study initiation who received at least one dose of cabozantinib for the treatment of RCC between October 2016 and 1 st June 2019.
- Alive patients who agree to participate and signed the Informed Consent Form (ICF).
- Patients who decline consent.
- Patients whose hospital medical records are unavailable for review.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Managed Access Program (MAP) patients Cabozantinib Patients with RCC treated with cabozantinib under a Managed Access Program (MAP) prior to Cabometyx® marketing authorization Real World (RW) patients Cabozantinib Patients with RCC treated with cabozantinib as routine clinical prescription (Real World), with treatment started after Cabometyx® marketing authorization
- Primary Outcome Measures
Name Time Method Incidence of Adverse Reactions Through study completion, an average of 2 years Evaluation of the safety of cabozantinib by recording the incidence of adverse reactions in both MAP and RW cohorts.
Incidence of dose reductions Through study completion, an average of 2 years Evaluation of the safety of cabozantinib by recording the incidence of dose reductions in both MAP and RW cohorts.
Incidence of temporary interruptions or discontinuations Through study completion, an average of 2 years Evaluation of the safety of cabozantinib by recording the Incidence of temporary interruptions or discontinuations in both MAP and RW cohorts.
Incidence of use of medications to manage adverse reactions Through study completion, an average of 2 years Evaluation of the safety of cabozantinib by recording the incidence of use of medications to manage adverse reactions in both MAP and RW cohorts.
Effectiveness: Progression-Free Survival Through study completion, an average of 2 years Evaluation of the effectiveness of cabozantinib in terms of investigator-assessed PFS (Progression-Free Survival) based on the Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (32)
Hospital Son Llatzer
🇪🇸Palma De Mallorca, Islas Baleares, Spain
Hospital Universitario Central de Asturias
🇪🇸Oviedo, Asturias, Spain
Hospital Universitario Juan Ramón Jiménez
🇪🇸Huelva, Andalucía, Spain
Hospital Clínic de Barcelona
🇪🇸Barcelona, Spain
Complejo Hospitalario Universitario Ourense
🇪🇸Ourense, Galicia, Spain
Hospital Universitario Lucus Augusti
🇪🇸Lugo, Spain
Hospital Arnau de Vilanova
🇪🇸Valencia, Spain
Hospital Universitario Alvaro Cunqueiro
🇪🇸Vigo, Spain
Fundación Instituto Valenciano de Oncología
🇪🇸Valencia, Spain
Hospital Universitario Reina Sofía
🇪🇸Córdoba, Andalucía, Spain
Complejo Hospitalario de Jaén
🇪🇸Jaén, Andalucía, Spain
Hospital de la Santa Creu i Sant Pau
🇪🇸Barcelona, Catalonia, Spain
Hospital Universitario de León
🇪🇸León, Castilla Y León, Spain
Consorci Corporació Sanitària Parc Taulí de Sabadell
🇪🇸Sabadell, Catalunya, Spain
Hospital Universitari Parc Taulí
🇪🇸Sabadell, Barcelona, Spain
Hospital Universitari Sant Joan de Reus
🇪🇸Reus, Catalunya, Spain
Hospital Clínico Universitario de Valenica
🇪🇸Valencia, Comunitat Valenciana, Spain
Hospital Universitari i Politècnic La Fe
🇪🇸Valencia, Comunidad Valenciana, Spain
Hospital Universitari Dr. Peset
🇪🇸Valencia, Comunitat Valenciana, Spain
Hospital Universitario de Badajoz
🇪🇸Badajoz, Extremadura, Spain
Centro Oncológico de Galicia
🇪🇸A Coruña, Galicia, Spain
Complejo Hospitalario Universitario de Ferrol
🇪🇸Ferrol, Galicia, Spain
Hospital Universitari Son Espases
🇪🇸Palma De Mallorca, Illes Ballears, Spain
Hospital Unviersitario de Gran Canaria Doctor Negrin
🇪🇸Las Palmas De Gran Canaria, Islas Canarias, Spain
Hospital Universitario Nuestra Señora de Candelaria
🇪🇸Santa Cruz De Tenerife, Islas Canarias, Spain
Hospital Universitari Vall D'Hebron
🇪🇸Barcelona, Spain
Hospital Del Mar
🇪🇸Barcelona, Spain
Hospital Universitario de Burgos
🇪🇸Burgos, Spain
Hospital Provincial de Castellón
🇪🇸Castellón De La Plana, Spain
Hospital General de Ciudad Real
🇪🇸Ciudad Real, Spain
Hospital San Pedro de Alcántara
🇪🇸Cáceres, Spain
Hospital Virgen de La Salud
🇪🇸Toledo, Spain