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A Prospective Non-interventional Real-World Study of cabozantinib in Pretreated Patients With Advanced Renal Cell
Michael Staehler1, Umberto Basso2, Jean-Christophe Eymard3
1Ludwig Maximilian Universität München, Klinikum Grosshadern, Munich, Germany.
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.
Insights
Cabozantinib is effective and manageable for advanced renal cell carcinoma patients post-VEGF therapy in real-world settings. This study confirms its safety profile aligns with prior research, offering valuable insights for treatment decisions.
Area of Science:
- Oncology
- Pharmacology
- Clinical Research
Background:
- Limited real-world data exists for cabozantinib in advanced renal cell carcinoma (RCC) following vascular endothelial growth factor (VEGF)-targeted therapy.
- This study addresses the need for evidence on cabozantinib's utilization, safety, and effectiveness in this specific patient population.
Purpose of the Study:
- To evaluate cabozantinib utilization, safety, and effectiveness in adult patients with advanced RCC in Europe after prior VEGF-targeted treatment.
- To assess dose modifications due to adverse events (AEs), treatment duration, progression-free survival (PFS), overall survival (OS), and best overall response (BOR).
Main Methods:
- The CASSIOPE study was a prospective, multicenter, non-interventional postauthorization safety study.
- Included 679 patients with advanced RCC who received cabozantinib after prior VEGF-targeted therapy.
- Endpoints focused on cabozantinib use, safety (AEs), and effectiveness (PFS, OS, BOR).
Main Results:
- 77.1% of patients required dose modification due to AEs.
- Median PFS was 8.3 months, and the 1-year OS rate was 74%.
- Approximately one-third achieved partial response, with 6 complete responses.
Conclusions:
- Second- or later-line cabozantinib demonstrated effectiveness and manageability in a real-world setting for advanced RCC.
- The safety profile observed was consistent with findings from previous clinical studies.
- Cabozantinib is a viable treatment option for advanced RCC patients post-VEGF therapy.
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