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

Terminated

Conditions: Metastatic Renal Cell Carcinoma

Registration Number: NCT03140176

Lead Sponsor: Pfizer

Brief Summary: OPTIMISE is designed to provide knowledge regarding the use of Sunitinib as 1st line treatment and 2nd line treatment selected (Sunitinib-different sequence) with respect to efficacy outcomes, adverse events, and health related QoL in the real life setting.

Detailed Description: OPTIMISE study objectives are dual and aim primarily to increase the knowledge regarding the outcomes from Sunitinib use on one hand; and outcomes from the combined Sunitinib-2nd line sequence on the other hand in real life clinical practice.

This will be addressed in many countries across AfME and in individual country cohorts to understand specificities and differences in use and outcomes

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 77

Inclusion Criteria

Patients being treated with SU as 1st line treatment according to the approved therapeutic indication.
Histologically confirmed diagnosis of mRCC (clear cell RCC as well as nonclear cell RCC) with measurable disease according to RECIST 1.1
Evidence of a personally signed and dated informed consent document indicating that the patient (or a legally acceptable representative) has been informed of all pertinent aspects of the study.

Exclusion Criteria

Patients being treated with cytokines or any other treatment other than SU in 1st line setting
Patients presenting with a known hypersensitivity to SU or its metabolites will not be included in the study per the label.

Study & Design

Study Type: OBSERVATIONAL

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Progression Free Survival (PFS)	From date of first dose of sunitinib to date of progression or death or censored date, whichever occurred first (up to maximum of 36 months)	PFS was defined as the time from when the participant received the first dose of sunitinib to the time of progression or death due to any cause, which occurred first. The time of progression was the date of the first tumor assessment where the progression was notified as response to therapy, over the sunitinib treatment. Participants who discontinued the study for any reason, including unacceptable toxicity during the treatment period, who remained alive and without disease progression, were censored at the last disease assessment that verified lack of disease progression. As per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, disease progression was defined as at least a 20% increase (including an absolute increase of at least 5 millimeters \[mm\]) 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.
Time to Treatment Failure (TTF)	From date of first dose of sunitinib until the date of discontinuation or censored date (up to maximum of 36 months)	TTF was defined as the time from when the participant received the first dose of sunitinib to the time of sunitinib discontinuation (date completed by the physician). In case of death when the participant was still treated with sunitinib, date of death was considered as date of discontinuation. If no sunitinib discontinuation was reported during the follow-up visits, participants were censored to the last follow-up visit.

Secondary Outcome Measures

Name	Time	Method
Objective Response Rate (ORR) at Months 3, 6, 9 and 12	Months 3, 6, 9 and 12	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.
Number of Participants With Recommended Starting Dose of Sunitinib	At initiation of sunitinib (Day 0)	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	At initiation of sunitinib (Day 0)	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.
Number of Participants With Moderate Chronic Liver Failure, With 2 Milligrams (mg) Twice Daily (BID) as Starting Dose	At initiation of sunitinib (Day 0)
Average Dose Received Over the Sunitinib Treatment Period	During treatment period (up to 12 months)
Dose Intensity of Sunitinib	During treatment period (up to 12 months)	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	Month 3, 6, 9 and 12	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 With Dose Increase	During treatment period (up to 12 months)
Number of Participants With Temporary Interruption During the Sunitinib Treatment Period	During treatment period (up to 12 months)
Time to First Interruption	During treatment period (up to 12 months)
Time to All Interruptions	During treatment period (up to 12 months)
Combined Progression Free Survival	From date of first dose of sunitinib until progression or death whichever occurred first during second line treatment (up to maximum of 36 months)	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.
Number of Participants Who Died Due to Any Cause	From date of sunitinib first dose until end of follow-up (up to maximum of 36 months)
Number of Participants According to the Cause of Death	From date of sunitinib first dose until end of follow-up (up to maximum of 36 months)
Number of Participants According to Reasons for Temporary Interruption	Months 3, 6, 9 and 12	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	Months 3, 6, 9 and 12	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	Months 3, 6, 9 and 12	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 Sunitinib Treatment	From date of first dose of sunitinib until discontinuation or last follow-up date with sunitinib treatment (up to maximum of 36 months)	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 TTF for the Sunitinib-2nd Line Sequence	From date of first dose of sunitinib until discontinuation of second line treatment (up to maximum of 36 months)	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 According to Type of Second Line Treatment	From date of first dose of sunitinib until progression or death whichever occurred first during second line treatment (up to maximum of 36 months)	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	From date of first dose of sunitinib to the date of death of any cause (up to maximum of 36 months)	Overall survival was defined as the time from date of first sunitinib dose to the date of death of any cause.
Number of Participants Experiencing At Least One Adverse Event (AE) of Any Grade	From date of sunitinib first dose until end of follow-up (up to maximum of 36 months)	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.
Number of Most Common AEs of Any Grade by Preferred Term	From date of sunitinib first dose until end of follow-up (up to maximum of 36 months)	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	From date of sunitinib first dose until end of follow-up (up to maximum of 36 months)	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.
Number of Participants With Serious Adverse Events and Non-Serious AEs	From date of sunitinib first dose until end of follow-up (up to maximum of 36 months)	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.
Number of Participants Who Discontinued Treatment Due to AEs	From date of sunitinib first dose until end of follow-up (up to maximum of 36 months)	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.
Duration of Treatment Until Discontinuation for AEs	From date of sunitinib first dose until end of follow-up (up to maximum of 36 months)	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.
Number of Adverse Events According to Grade	From date of sunitinib first dose until end of follow-up (up to maximum of 36 months)	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.
Functional Assessment of Cancer Therapy Kidney Symptom Index-19 (FKSI-19) Total Scores	Day 0, Month 3, 6, 9, 12, 18 and 24	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.
Functional Assessment of Cancer Therapy Kidney Symptom Index-19 (FKSI-19) Sub-scale Scores	Day 0, Month 3, 6, 9, 12, 18 and 24	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.

Trial Locations

Locations (8): Pierre Et Marie Curie Center
🇩🇿
Algers, Algeria
Hanene Djedi
🇩🇿
Annaba, Algeria
Demerdash Hospital
🇪🇬
Cairo, Egypt
CAC Annaba
🇩🇿
Annaba, Algeria
Kasr Al Aini
🇪🇬
Cairo, Egypt
National Cancer Institute
🇪🇬
Cairo, Egypt
Kuwait Cancer Control Center
🇰🇼
Kuwait City, Kuwait
Institut National D'Oncologie
🇲🇦
Rabat, Morocco