An observational study in Metastatic Renal Cell Carcinoma, sponsored by Pfizer. Terminated at 8 sites in 4 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-05-10.
Sponsored by Pfizer · Observational
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.
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
2,037 studies on the registry are indexed under Carcinoma, Renal Cell; 395 are open to participants now.
This study's enrollment of 77 is below the median of 151 across 337 observational studies indexed under Carcinoma, Renal Cell.
Browse Carcinoma, Renal Cell studies →Pfizer is the lead sponsor of 3,334 studies on the registry; 149 are open to participants now.
Of its 601 completed or terminated interventional studies of FDA-regulated products, 391 (65%) have results posted.
Counted across the registry records on this site, refreshed daily.
Adult patients with metastatic renal cell carcinoma being treated with Sunitinib as the first line therapy.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Patients being treated with SU as treatment according to the approved therapeutic indication.
Exclusion Criteria:
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Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Line of therapy
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Measurable disease
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
RECIST
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Sunitinib is an FDA approved targeted therapy for use as first line therapy for patients with metastatic renal cell carcinoma.
Also known as: Sutent
Progression Free Survival (PFS)
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 frame: 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)
Time to Treatment Failure (TTF)
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.
Time frame: From date of first dose of sunitinib until the date of discontinuation or censored date (up to maximum of 36 months)
Objective Response Rate (ORR) at 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.
Time frame: Months 3, 6, 9 and 12
Number of Participants With Recommended Starting Dose of Sunitinib
The recommended starting dose of sunitinib was 50 milligrams (mg) per day, 4 weeks on treatment followed by 2 weeks off.
Time frame: At initiation of sunitinib (Day 0)
Number of Participants With Other Starting Doses
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.
Time frame: At initiation of sunitinib (Day 0)
Number of Participants With Moderate Chronic Liver Failure, With 2 Milligrams (mg) Twice Daily (BID) as Starting Dose
Time frame: At initiation of sunitinib (Day 0)
Average Dose Received Over the Sunitinib Treatment Period
Time frame: During treatment period (up to 12 months)
Dose Intensity of Sunitinib
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).
Time frame: During treatment period (up to 12 months)
Number of Participants With Change in Dose or Schedule of Sunitinib
Number of participants with change in dose or schedule of sunitinib at the specified time points were reported in this outcome measure.
Time frame: Month 3, 6, 9 and 12
Number of Participants With Dose Increase
Time frame: During treatment period (up to 12 months)
Number of Participants With Temporary Interruption During the Sunitinib Treatment Period
Time frame: During treatment period (up to 12 months)
Time to First Interruption
Time frame: During treatment period (up to 12 months)
Time to All Interruptions
Time frame: During treatment period (up to 12 months)
Number of Participants According to Reasons for Temporary Interruption
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.
Time frame: Months 3, 6, 9 and 12
Number of Participants With Sunitinib Discontinuation
Number of participants with sunitinib discontinuation at specified time points is presented in this outcome measure.
Time frame: Months 3, 6, 9 and 12
Number of Participants According to Reasons for Sunitinib Discontinuation
Number of participants according to reasons for sunitinib discontinuation (death, intolerability, progression) at specified time points is presented in this outcome measure.
Time frame: Months 3, 6, 9 and 12
Median Duration of Sunitinib Treatment
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.
Time frame: From date of first dose of sunitinib until discontinuation or last follow-up date with sunitinib treatment (up to maximum of 36 months)
Combined Progression Free Survival
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.
Time frame: 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 TTF for the Sunitinib-2nd Line Sequence
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).
Time frame: From date of first dose of sunitinib until discontinuation of second line treatment (up to maximum of 36 months)
Combined PFS According to Type of Second Line 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 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.
Time frame: From date of first dose of sunitinib until progression or death whichever occurred first during second line treatment (up to maximum of 36 months)
Overall Survival
Overall survival was defined as the time from date of first sunitinib dose to the date of death of any cause.
Time frame: From date of first dose of sunitinib to the date of death of any cause (up to maximum of 36 months)
Number of Participants Experiencing At Least One Adverse Event (AE) of Any Grade
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.
Time frame: From date of sunitinib first dose until end of follow-up (up to maximum of 36 months)
Number of Most Common AEs of Any Grade by Preferred Term
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.
Time frame: 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
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.
Time frame: From date of sunitinib first dose until end of follow-up (up to maximum of 36 months)
Number of Participants With Serious Adverse Events and Non-Serious AEs
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.
Time frame: From date of sunitinib first dose until end of follow-up (up to maximum of 36 months)
Number of Adverse Events According to Grade
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.
Time frame: From date of sunitinib first dose until end of follow-up (up to maximum of 36 months)
Number of Participants Who Discontinued Treatment Due to AEs
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.
Time frame: From date of sunitinib first dose until end of follow-up (up to maximum of 36 months)
Duration of Treatment Until Discontinuation for AEs
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.
Time frame: From date of sunitinib first dose until end of follow-up (up to maximum of 36 months)
Number of Participants Who Died Due to Any Cause
Time frame: 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
Time frame: From date of sunitinib first dose until end of follow-up (up to maximum of 36 months)
Functional Assessment of Cancer Therapy Kidney Symptom Index-19 (FKSI-19) Total Scores
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.
Time frame: Day 0, Month 3, 6, 9, 12, 18 and 24
Functional Assessment of Cancer Therapy Kidney Symptom Index-19 (FKSI-19) Sub-scale Scores
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.
Time frame: Day 0, Month 3, 6, 9, 12, 18 and 24
Participants aged 18 years and above diagnosed with advanced metastatic renal cell cancer (mRCC) and treated with sunitinib as first line treatment according to the approved therapeutic indication in real world practice were enrolled in this observational study. Participants were enrolled across Africa and Middle East (AfME) countries.
| Milestone | Sunitinib |
|---|---|
| Started | 74 |
| Completed | 0 |
| Not completed | 74 |
| Withdrew: Reason missing | 23 |
| Withdrew: Death | 33 |
| Withdrew: Disease progression | 1 |
| Withdrew: Physician decision | 1 |
| Withdrew: Withdrawal by subject | 1 |
| Withdrew: Lost to follow-up | 15 |
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.
| Days | Sunitinib |
|---|---|
| Progression Free Survival (PFS) | 321.0 (115.0 to 546.0) |
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.
| Days | Sunitinib |
|---|---|
| Time to Treatment Failure (TTF) | 348.0 (109.0 to 546.0) |
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.
| Percentage of participants | Sunitinib |
|---|---|
| Month 3 | 17.6 |
| Month 6 | 9.5 |
| Month 9 | 8.1 |
| Month 12 | 2.7 |
The recommended starting dose of sunitinib was 50 milligrams (mg) per day, 4 weeks on treatment followed by 2 weeks off.
| Participants | Sunitinib |
|---|---|
| Number of Participants With Recommended Starting Dose of Sunitinib | 29 |
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.
| Participants | Sunitinib |
|---|---|
| 50 mg per day, 2 weeks on, 1 week off | 41 |
| 37.5 mg per day for 2 weeks on and 1 week off | 2 |
| 25 mg per day for 2 weeks on and 1 week off | 1 |
| 37.5 mg per day 4 weeks on and 2 weeks off | 1 |
| Participants | Sunitinib |
|---|---|
| Number of Participants With Moderate Chronic Liver Failure, With 2 Milligrams (mg) Twice Daily (BID) as Starting Dose | 0 |
| Milligrams | Sunitinib |
|---|---|
| Average Dose Received Over the Sunitinib Treatment Period | 7917.1 ± 6834.5 |
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).
| Milligrams per day | Sunitinib |
|---|---|
| Dose Intensity of Sunitinib | 48.5 ± 5.1 |
Number of participants with change in dose or schedule of sunitinib at the specified time points were reported in this outcome measure.
| Participants | Sunitinib |
|---|---|
| Month 3 | 7 |
| Month 6 | 3 |
| Month 9 | 2 |
| Month 12 | 0 |
| Participants | Sunitinib |
|---|---|
| Number of Participants With Dose Increase | 0 |
| Participants | Sunitinib |
|---|---|
| Number of Participants With Temporary Interruption During the Sunitinib Treatment Period | 15 |
| Days | Sunitinib |
|---|---|
| Time to First Interruption | 130.0 (49.0 to 252.0) |
| Days | Sunitinib |
|---|---|
| Time to All Interruptions | 109.0 (49.0 to 253.0) |
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.
| Participants | Sunitinib |
|---|---|
| Month 3 — Adverse events | 5 |
| Month 3 — Logistical | 1 |
| Month 3 — Personal | 1 |
| Month 3 — Intolerant to Sunitinib | 1 |
| Month 6 — Adverse events | 3 |
| Month 6 — Logistical | 0 |
| Month 6 — Personal | 0 |
| Month 6 — Intolerant to Sunitinib | 0 |
| Month 9 — Adverse events | 1 |
| Month 9 — Logistical | 0 |
| Month 9 — Personal | 0 |
| Month 9 — Intolerant to Sunitinib | 0 |
| Month 12 — Adverse events | 3 |
| Month 12 — Logistical | 0 |
| Month 12 — Personal | 0 |
| Month 12 — Intolerant to Sunitinib | 0 |
Number of participants with sunitinib discontinuation at specified time points is presented in this outcome measure.
| Participants | Sunitinib |
|---|---|
| Month 3 | 15 |
| Month 6 | 4 |
| Month 9 | 4 |
| Month 12 | 6 |
Number of participants according to reasons for sunitinib discontinuation (death, intolerability, progression) at specified time points is presented in this outcome measure.
| Participants | Sunitinib |
|---|---|
| Month 3 — Death | 1 |
| Month 3 — Intolerability | 4 |
| Month 3 — Progression | 10 |
| Month 3 — Unknown/Missing | 0 |
| Month 6 — Death | 0 |
| Month 6 — Intolerability | 1 |
| Month 6 — Progression | 3 |
| Month 6 — Unknown/Missing | 0 |
| Month 9 — Death | 0 |
| Month 9 — Intolerability | 1 |
| Month 9 — Progression | 2 |
| Month 9 — Unknown/Missing | 1 |
| Month 12 — Death | 0 |
| Month 12 — Intolerability | 1 |
| Month 12 — Progression | 5 |
| Month 12 — Unknown/Missing | 0 |
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.
| Days | Sunitinib |
|---|---|
| Median Duration of Sunitinib Treatment | 169.5 (87.0 to 362.0) |
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.
| Days | Sunitinib |
|---|---|
| Combined Progression Free Survival | 502.0 (215.0 to 660.0) |
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).
| Days | Sunitinib |
|---|---|
| Combined TTF for the Sunitinib-2nd Line Sequence | 378.0 (146.0 to 793.0) |
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.
| Days | Sunitinib |
|---|---|
| BSC | 169.0 (144.0 to 539.0) |
| TKI | 948.0 (435.0 to 1095.0) |
| mTOR | 399.0 (215.0 to 399.0) |
Overall survival was defined as the time from date of first sunitinib dose to the date of death of any cause.
| Days | Sunitinib |
|---|---|
| Overall Survival | 544.0 (146.0 to 794.0) |
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.
| Participants | Sunitinib |
|---|---|
| Number of Participants Experiencing At Least One Adverse Event (AE) of Any Grade | 51 |
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.
| Events | Sunitinib |
|---|---|
| Death | 19 |
| Anemia | 8 |
| Diarrhea | 8 |
| Mucosal inflammation | 8 |
| Vomiting | 8 |
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.
| Events | Sunitinib |
|---|---|
| Diarrhea | 8 |
| Hypertension | 2 |
| Fatigue | 4 |
| Asthenia | 4 |
| Palmar-plantar erythrodysesthesia syndrome | 6 |
| Nausea | 2 |
| Stomatitis | 3 |
| Neutropenia | 1 |
| Lymphopenia | 0 |
| Elevated lipase | 0 |
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.
| Participants | Sunitinib |
|---|---|
| Serious adverse events | 35 |
| Non-serious AEs | 35 |
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.
| Events | Sunitinib |
|---|---|
| Grade 1 | 35 |
| Grade 2 | 38 |
| Grade 3 | 32 |
| Grade 4 | 23 |
| Grade 5 | 22 |
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.
| Participants | Sunitinib |
|---|---|
| Number of Participants Who Discontinued Treatment Due to AEs | 20 |
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.
| Days | Sunitinib |
|---|---|
| Duration of Treatment Until Discontinuation for AEs | 572 (201 to 1079) |
| Participants | Sunitinib |
|---|---|
| Number of Participants Who Died Due to Any Cause | 33 |
| Participants | Sunitinib |
|---|---|
| Other cause | 11 |
| Tumor-related | 22 |
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.
| Units on a scale | Sunitinib |
|---|---|
| Day 0 | 50.6 ± 12.4 |
| Month 3 | 49.8 ± 13.9 |
| Month 6 | 56.1 ± 11.0 |
| Month 9 | 51.6 ± 14.5 |
| Month 12 | 54.1 ± 15.4 |
| Month 18 | 53.3 ± 9.4 |
| Month 24 | 55.2 ± 9.6 |
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.
| Units on a scale | Sunitinib |
|---|---|
| FKSI-DRS-P; Day 0 | 31.9 ± 8.8 |
| FKSI-DRS-P; Month 3 | 33.2 ± 9.1 |
| FKSI-DRS-P; Month 6 | 37.6 ± 7.1 |
| FKSI-DRS-P; Month 9 | 34.7 ± 8.9 |
| FKSI-DRS-P; Month 12 | 35.6 ± 9.2 |
| FKSI-DRS-P; Month 18 | 34.6 ± 6.3 |
| FKSI-DRS-P; Month 24 | 37 ± 6.6 |
| FKSI-TSE; Day 0 | 10.3 ± 1.6 |
| FKSI-TSE; Month 3 | 9.6 ± 2.1 |
| FKSI-TSE; Month 6 | 9.8 ± 1.4 |
| FKSI-TSE; Month 9 | 8.8 ± 2.7 |
| FKSI-TSE; Month 12 | 9.7 ± 2.7 |
| FKSI-TSE; Month 18 | 10.3 ± 1.4 |
| FKSI-TSE; Month 24 | 11 ± 1.2 |
| FKSI-FWB; Day 0 | 6.3 ± 3.5 |
| FKSI-FWB; Month 3 | 5.0 ± 3.7 |
| FKSI-FWB; Month 6 | 6.3 ± 3.5 |
| FKSI-FWB; Month 9 | 5.8 ± 3.8 |
| FKSI-FWB; Month 12 | 6.4 ± 3.6 |
| FKSI-FWB; Month 18 | 5.9 ± 3.4 |
| FKSI-FWB; Month 24 | 5.2 ± 3.4 |
Collected over From date of sunitinib first dose until end of follow-up (up to maximum of 36 months). Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Sunitinib | 33/74 (44.6%) | 35/74 (47.3%) | 35/74 (47.3%) |
| Event | Sunitinib |
|---|---|
| DeathGeneral disorders | 19/74 |
| ComaNervous system disorders | 4/74 |
| DyspneaRespiratory, thoracic and mediastinal disorders | 3/74 |
| HyponatremiaMetabolism and nutrition disorders | 3/74 |
| Hemorrhage intracranialNervous system disorders | 2/74 |
| DehydrationMetabolism and nutrition disorders | 2/74 |
| Electrolyte imbalanceMetabolism and nutrition disorders | 2/74 |
| AnemiaBlood and lymphatic system disorders | 2/74 |
| VomitingGastrointestinal disorders | 2/74 |
| Hepatic failureHepatobiliary disorders | 2/74 |
| Event | Sunitinib |
|---|---|
| DiarrheaGastrointestinal disorders | 8/74 |
| Mucosal inflammationGeneral disorders | 8/74 |
| VomitingGastrointestinal disorders | 6/74 |
| Palmar-plantar erythrodysesthesia syndromeSkin and subcutaneous tissue disorders | 6/74 |
| AnemiaBlood and lymphatic system disorders | 6/74 |
| Skin ulcerSkin and subcutaneous tissue disorders | 5/74 |
| HypothyroidismEndocrine disorders | 5/74 |
| AstheniaGeneral disorders | 4/74 |
| FatigueGeneral disorders | 4/74 |
| StomatitisGastrointestinal disorders | 3/74 |
Full analysis set included all eligible participants enrolled in the study, whatever the therapeutic strategy used during the observation period.
| Age, Continuous(Years) | Sunitinib |
|---|---|
| Mean | 53.5 ± 13.6 |
| Sex: Female, Male(Participants) | Sunitinib |
|---|---|
| Female | 36 |
| Male | 38 |
| Race/Ethnicity, Customized(Participants) | Sunitinib |
|---|---|
| Asian | 2 |
| Black/ African Descent | 2 |
| Caucasian | 18 |
| Middle Eastern | 45 |
| Unknown | 7 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No — Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
Ran from Aug 2017 to primary completion in Jan 2022, 53 months.
Results were first posted in May 2024, 2 years 3 months after primary completion.
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