Real-world Clinical Patterns Of Care And Outcomes Among AfME mRCC Patients Receiving Sunitinib as First Line Therapy.

ORR was defined as the percentage of participants with confirmed complete response (CR) or confirmed partial response (PR) according to RECIST version 1.1. As per RECIST 1.1 criteria: CR = disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (<)10 mm. Disappearance of all non-target lesions and normalization of tumor marker level. All lymph nodes must be non-pathological in size (<10 mm short axis); PR = at least 30% decrease in sum of diameters of target lesions taking as reference baseline sum diameters.

The recommended starting dose of sunitinib was 50 milligrams (mg) per day, 4 weeks on treatment followed by 2 weeks off.

Number of participants with other starting doses of sunitinib (50 mg per day, 2 weeks on, 1 week off; 37.5 mg per day for 2 weeks on and 1 week off; 25 mg per day for 2 weeks on and 1 week off; 37.5 mg per day 4 weeks on and 2 weeks off) were reported in this outcome measure.

Dose intensity was defined as defined as the sum of sunitinib daily doses divided by the duration of sunitinib treatment in days (delay between the first sunitinib dose and the last dose, including temporary interruption).

Number of participants with change in dose or schedule of sunitinib at the specified time points were reported in this outcome measure.

Number of participants according to reasons for temporary interruption (adverse events, logistical, personal and intolerant to sunitinib) at specified time points is presented in this outcome measure.

Number of participants with sunitinib discontinuation at specified time points is presented in this outcome measure.

Number of participants according to reasons for sunitinib discontinuation (death, intolerability, progression) at specified time points is presented in this outcome measure.

Median duration of treatment was defined as the time between the sunitinib initiation and the sunitinib discontinuation date or the last follow-up date with sunitinib treatment.

Combined PFS was defined as the time from when the participants received the first dose of sunitinib as first line, until progression or death due to any cause while on the 2nd line treatment, whichever occurred first during the 2nd line sequence treatment. As per RECIST version 1.1, disease progression was defined as at least a 20% increase (including an absolute increase of at least 5 mm) in the sum of the longest dimensions of the target lesions taking as a reference smallest sum of the longest dimensions recorded since the treatment started, or the appearance of 1 or more new lesions.

Combined TTF was defined as the time from when the participant received the first dose with sunitinib as first line, to the time of 2nd line sequence discontinuation (date completed by the physician).

Combined PFS was defined as the time from when the participants received the first dose of sunitinib as first line, until progression or death due to any cause while on the 2nd line treatment, whichever occurred first during the 2nd line sequence treatment. As per RECIST version 1.1, disease progression was defined as at least a 20% increase (including an absolute increase of at least 5 mm) in the sum of the longest dimensions of the target lesions taking as a reference smallest sum of the longest dimensions recorded since the treatment started, or the appearance of 1 or more new lesions. Combined PFS according to the type of second line treatment (best supportive care [BSC], tyrosine kinase inhibitors [TKI] including pazopanib and mammalian target of rapamycin [mTOR] inhibitors including everolimus) were reported in this outcome measure.

Overall survival was defined as the time from date of first sunitinib dose to the date of death of any cause.

An AE was any untoward medical occurrence in a participant administered a medicinal product. The event need not necessarily have a causal relationship with the product treatment or usage. AEs were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) as follows: Grade 1: mild AE, Grade 2: moderate AE, Grade 3: severe AE, Grade 4: life-threatening consequences and urgent intervention indicated, Grade 5: death related to AE. In this outcome measure, number of participants with at least one AE of any grade is reported.

An AE was any untoward medical occurrence in a participant administered a medicinal product. The event need not necessarily have a causal relationship with the product treatment or usage. AEs were graded according to NCI-CTCAE as follows: Grade 1: mild AE, Grade 2: moderate AE, Grade 3: severe AE, Grade 4: life-threatening consequences and urgent intervention indicated, Grade 5: death related to AE. In this outcome measure, number of most common AEs of any grade is presented. Only events captured as deaths (preferred term) are reported as deaths in the data table.

Number of events of diarrhea, hypertension, fatigue, asthenia, palmar-plantar erythrodysesthesia syndrome, nausea, stomatitis, neutropenia, lymphopenia and elevated lipase were reported in this outcome measure.

A serious adverse event was any untoward medical occurrence in a participant administered a medicinal or nutritional product (including pediatric formulas) at any dose that: resulted in death; was life-threatening; required inpatient hospitalization or prolongation of hospitalization; resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions); resulted in congenital anomaly/birth defect. In this outcome measure, number of participants with serious adverse events and non-serious adverse events are reported.

An AE was any untoward medical occurrence in a participant administered a medicinal product. The event need not necessarily have a causal relationship with the product treatment or usage. AEs were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) as follows: Grade 1: mild AE, Grade 2: moderate AE, Grade 3: severe AE, Grade 4: life-threatening consequences and urgent intervention indicated, Grade 5: death related to AE.

An AE was any untoward medical occurrence in a participant administered a medicinal product. The event need not necessarily have a causal relationship with the product treatment or usage. In this outcome measure, number of participants who discontinued treatment due to AEs are reported.

An AE was any untoward medical occurrence in a participant administered a medicinal product. The event need not necessarily have a causal relationship with the product treatment or usage.

The FKSI-19 is a disease-specific instrument that assessed symptoms of importance in renal cancer participants. It consisted of 4 subscales (FKSI-Disease Related Symptoms [DRS]-Physical [P]-12 items, FKSI-DRS-Emotional [E]-1 item, treatment side effects [TSE]-3 items, functional wellbeing [FWB]-3 items). Participants were required to respond to a total of 19 questions regarding symptoms, side effects and wellbeing on a 5-point scale (0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, 4=very much). The total FKSI scores were calculated as the sum of the item responses divided by the number of items completed multiplied by the total number of items in the scale and ranged from 0 (severely symptomatic) to 76 (asymptomatic), where higher scores indicated better health.

The FKSI-19 is a disease-specific instrument that assessed symptoms of importance in renal cancer participants. It consisted of 4 subscales (FKSI-DRS-P: 12 items, FKSI-DRS-E: 1 item, TSE: 3 items, FWB: 3 items). Participants were required to respond to the items in each subscale on a 5-point scale (0=not at all, 1=a little bit, 2=somewhat, 3=quite a bit, 4=very much). The FKSI subscale scores were calculated as the sum of item responses divided by the number of items completed multiplied by the total number of items in the subscale and ranged from 0 (severely symptomatic) to 48 (asymptomatic) for FKSI-DRS-P, 0 (severely symptomatic) to 4 (asymptomatic) for FKSI-DRS-E and 0 (severely symptomatic) to 12 (asymptomatic) for TSE and FWB; higher scores indicated better health.