The purpose of the protocol is to assess the Overall Survival (OS) at 1 year in patients after cabozantinib initiation.
Study Type
OBSERVATIONAL
Overall survival (OS) rate at 1 year after cabozantinib initiation
OS is the time between treatment initiation and the date of death from any cause. For participants who are alive, their survival time will be censored at the last date that they were known to be alive if before 1 year.
Time frame: up to 12 months
Objective Response Rate (ORR) at 1 year
ORR is defined as the proportion of participants who achieve partial or complete response from the start of the study treatment. The ORR will be assessed by tumour response evaluation according to investigator assessment. Tumour response will be evaluated per routine clinical practice by the physician.
Time frame: Day 15, 1 month, 3, 6 and 12 months
Best Overall Response (BOR) at 1 year
BOR is the best response recorded from the start of the study treatment until the disease progression/recurrence. The BOR will be assessed by tumour response evaluation according to investigator assessment. Tumour response will be evaluated per routine clinical practice by the physician.
Time frame: Day 15, 1 month, 3, 6 and 12 months
Progression Free Survival (PFS) at 1 year
PFS is defined as the time elapsed from the date of first treatment intake to the date of documented progression reported by the investigator or death due to any cause, whichever occurs first. Disease progression will be assessed by tumour response evaluation according to investigator assessment. Tumour response will be evaluated per routine clinical practice as Progressive / not progressive disease by the physician.
Time frame: Day 15, 1 month, 3, 6 and 12 months
Previous systemic neoadjuvant and adjuvant therapies for RCC prior cabozantinib initiation in terms of nature of the therapy, duration, and reason for discontinuation.
Time frame: Baseline
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First-line therapy for RCC prior cabozantinib initiation in terms of nature of the therapy, duration, and reason for discontinuation.
Time frame: Baseline
Pattern of use of cabozantinib
Dose modification, reason of modification and treatment duration of cabozantinib will be described from cabozantinib initiation until participants' end of study treatment or study withdrawal.
Time frame: Baseline, day 15, 1 month, 3, 6 and 12 months
Quality of life (QoL) change according to Functional Assessment of Cancer Therapy (FKSI-19) questionnaire
QoL change from baseline. The score will be evaluated with FKSI 19 questionnaires at the planned visits and at treatment discontinuation. The FKSI-19 is a disease-specific instrument that measures disease and treatment-related symptoms in 4 domains by using a 5-point scale (0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, 4=very much). Higher scores represent better health. A negative change from Baseline represents a worsening of condition.
Time frame: Baseline, day 15, 1 month, 3, 6 and 12 months
Pain assessment
To assess pain according to the Brief Pain Inventory-Short Form (BPI-SF) questionnaire and analgesic consumption/duration and the time for improvement of symptomatology. BPI-SF has a scale of 0 to 10 with 0 indicating "No pain" and 10 indicating "Pain as bad as you can imagine".
Time frame: Baseline, day 15, 1 month, 3, 6 and 12 months
Subsequent systemic treatment for RCC after cabozantinib discontinuation in terms of the description of the nature of the therapy, starting date.
Time frame: End of Study visit (12 months if the patient didn't discontinue earlier)
Safety of cabozantinib in the real-world setting
Incidence of Adverse Events (AEs),Serious Adverse Events (SAEs) assessed overall and by intensity and causality.
Time frame: Day 15, 1 month, 3, 6 and 12 months