The purpose of this study is to describe the real-life use of Cabometyx® in monotherapy or in combination with nivolumab in Belgium in patients with advanced or metastatic Renal Cell Carcinoma (1st, 2nd and later lines of treatment)
Study Type
OBSERVATIONAL
Enrollment
150
Onze-Lieve-vrouw Ziekenhuis Aalst
Aalst, Belgium
Imeldaziekenhuis
Bonheiden, Belgium
Treatment line
Treatment line will be assessed at baseline. It is a percentage of patients receiving cabozantinib as 1st, 2nd or later lines of treatment or cabozantinib in monotherapy or in combination with nivolumab as 1st line of treatment.
Time frame: Baseline
Dose reductions and reasons
Number of dose reductions and reason
Time frame: From baseline up to 6 to 8 weeks after cabozantinib initiation and within 10 days of cabozantinib stop
Treatment interruptions and reason
Number of treatment interruptions and reason
Time frame: From baseline up to 6 to 8 weeks after cabozantinib initiation and within 10 days of cabozantinib stop
Treatment discontinuations and reason
Number of patients with permanent discontinuation and reason
Time frame: From baseline up to 6 to 8 weeks after cabozantinib initiation and within 10 days of cabozantinib stop
Alternative dose schedule
Number of patients with schedules other than 1 pill at fixed dose/day for the total treatment period
Time frame: From baseline until the end of study up to 9 months
Mean number of any dose modification
Time frame: From baseline up to 6 to 8 weeks after cabozantinib initiation and within 10 days of cabozantinib stop
Median number of any dose modification
Time frame: From baseline up to 6 to 8 weeks after cabozantinib initiation and within 10 days of cabozantinib stop
Median time to any first dose modification
Time frame: From baseline up to 6 to 8 weeks after cabozantinib initiation and within 10 days of cabozantinib stop
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Clinique Saint-Luc Bouge
Bouge, Belgium
AZ Sint-Jan Brugge
Bruges, Belgium
AZ Sint-Lucas
Bruges, Belgium
UZ Brussel
Brussels, Belgium
Ziekenhuis Oost-Limburg Genk
Genk, Belgium
Universitair Ziekenhuis Gent
Ghent, Belgium
Hôpital de Jolimont
La Louvière, Belgium
CHC MontLegia
Liège, Belgium
...and 10 more locations
Median time to end of treatment
Time frame: From baseline until the end of study up to 9 months
Duration of treatment exposure
Time frame: From baseline until the end of study up to 9 months
Dose prescribed at initiation
Number of patients with dose of 60 mg/day, 40 mg/day or 20 mg/day at baseline
Time frame: Baseline
Average daily dose
Estimation of average daily dose received by subject during the treatment exposure
Time frame: From baseline until the end of study up to 9 months
Change in Quality of Life score
Changes in quality of life data by comparing changes in scores on Using the National Comprehensive Cancer Network/Functional Assessment of Cancer Therapy Kidney Symptom Index-19 (NFKSI-19). It describes the severity, interference, and frequency rates.
Time frame: From baseline up to 6 to 8 weeks after cabozantinib initiation and within 10 days of cabozantinib stop
Progression Free Survival (PFS)
Radiological progression using RECIST 1.1 or investigator assessed or according to local standard of care or death; PFS evaluated at least every 12 weeks under treatment with cabozantinib
Time frame: From baseline until the end of study up to 9 months
Objective Response Rate
Percent of patients with partial and complete response during the treatment with cabozantinib
Time frame: From baseline until the end of study up to 9 months
Disease Control Rate
Percent of patients with stable disease, partial and complete response during the treatment with cabozantinib
Time frame: From baseline until the end of study up to 9 months