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
Adult patients with metastatic renal cell carcinoma being treated with Sunitinib as the first line therapy.
Patients being treated with SU as 1st line treatment according to the approved therapeutic indication.
Exclusion Criteria:
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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 |
Documents are hosted by the registry — open the source record to download them.
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.
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