Primary objective: to increase knowledge about safety, tolerability, quality of life and efficacy under conditions of routine use of SUTENT®. Secondary objectives: treatment response, hypothyroidism prevalence.The efficacy will be assessed using the Objective Response Rate, Time to Progression based on the RECIST criteria and the ECOG performance data.
180 patients will be enrolled at 20 key oncological centres, the sample size is sufficient for exploratory analysis.
Study Type
OBSERVATIONAL
Enrollment
186
SUTENT® hard gelatin capsules containing 12.5 mg, 25 mg or 50 mg equivalent of sunitinib malate; daily dosage of 50 mg for 4 consecutive weeks followed by a 2-week rest period. Sutent is administered until disease progression or occurrence of unacceptable toxicity.
Pfizer Investigational Site
Brno, Czechia
Pfizer Investigational Site
Brno, Czechia
Percentage of Participants With Objective Response
Percentage of participants with objective response based assessment of confirmed complete response (CR) or confirmed partial response (PR). CR is defined as the disappearance of all target lesions. PR is defined as at least 30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.
Time frame: 12 months
Progression-free Survival (PFS)
The period from study entry until disease progression, death, or date of last contact.
Time frame: Baseline to measured progressive disease (up to 12 months)
Overall Survival (OS)
OS is the duration from enrollment to death.
Time frame: Baseline to date of death (up to 12 months)
Percentage of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status at Week 6
Following are ECOG grades. 0: Fully active, perform all pre-disease activities without restriction. 1: Restricted in physically strenuous activity but ambulatory, carry out work of a light or sedentary nature. 2: Ambulatory, capable of selfcare, unable to carry out any work activities, up and about more than (\>) 50% of waking hours. 3: Capable of limited selfcare, confined to bed or chair \>50% of waking hours. 4: Completely disabled, not capable of any selfcare, totally confined to bed or chair. 5: Dead. Participants in "Not reported" category were on study, had no data for this time point.
Time frame: Week 6
Percentage of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status at Month 3
Following are ECOG grades. 0: Fully active, perform all pre-disease activities without restriction. 1: Restricted in physically strenuous activity but ambulatory, carry out work of a light or sedentary nature. 2: Ambulatory, capable of selfcare, unable to carry out any work activities, up and about more than (\>) 50% of waking hours. 3: Capable of limited selfcare, confined to bed or chair \>50% of waking hours. 4: Completely disabled, not capable of any selfcare, totally confined to bed or chair. 5: Dead. Participants in "Not reported" category were on study, had no data for this time point.
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Pfizer Investigational Site
Brno, Czechia
Pfizer Investigational Site
Chomutov, Czechia
Pfizer Investigational Site
České Budějovice, Czechia
Pfizer Investigational Site
Fryštát, Czechia
Pfizer Investigational Site
Hradec Králové, Czechia
Pfizer Investigational Site
Jihlava, Czechia
Pfizer Investigational Site
Liberec, Czechia
Pfizer Investigational Site
Nová Ves pod Pleší, Czechia
...and 10 more locations
Time frame: Month 3
Percentage of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status at Month 6
Following are ECOG grades. 0: Fully active, perform all pre-disease activities without restriction. 1: Restricted in physically strenuous activity but ambulatory, carry out work of a light or sedentary nature. 2: Ambulatory, capable of selfcare, unable to carry out any work activities, up and about more than (\>) 50% of waking hours. 3: Capable of limited selfcare, confined to bed or chair \>50% of waking hours. 4: Completely disabled, not capable of any selfcare, totally confined to bed or chair. 5: Dead. Participants in "Not reported" category were on study, had no data for this time point.
Time frame: Month 6
Percentage of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status at Month 9
Following are ECOG grades. 0: Fully active, perform all pre-disease activities without restriction. 1: Restricted in physically strenuous activity but ambulatory, carry out work of a light or sedentary nature. 2: Ambulatory, capable of selfcare, unable to carry out any work activities, up and about more than (\>) 50% of waking hours. 3: Capable of limited selfcare, confined to bed or chair \>50% of waking hours. 4: Completely disabled, not capable of any selfcare, totally confined to bed or chair. 5: Dead. Participants in "Not reported" category were on study, had no data for this time point.
Time frame: Month 9
Percentage of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status at Month 12
Following are ECOG grades. 0: Fully active, perform all pre-disease activities without restriction. 1: Restricted in physically strenuous activity but ambulatory, carry out work of a light or sedentary nature. 2: Ambulatory, capable of selfcare, unable to carry out any work activities, up and about more than (\>) 50% of waking hours. 3: Capable of limited selfcare, confined to bed or chair \>50% of waking hours. 4: Completely disabled, not capable of any selfcare, totally confined to bed or chair. 5: Dead. Participants in "Not reported" category were on study, had no data for this time point.
Time frame: Month 12
Correlation Between Sunitinib-induced Hypertension and Tumor Response to Treatment (PFS)
Sunitinib-induced hypertension was determined using blood pressure recorded at each postbaseline visit. Once participants were identified as having sunitinib-induced hypertension, they retained that status at subsequent visits. PFS is the time from start of study treatment to first documentation of tumor response to treatment. Hazard ratio represents the relationship between sunitinib-induced hypertension and PFS (presence/absence of hypertension).
Time frame: Baseline to date of first documentation of response to treatment (up to 12 months)
Correlation Between Sunitinib-induced Hypertension and Tumor Response to Treatment (OS)
Sunitinib-induced hypertension was determined using blood pressure recorded at each postbaseline visit. Once participants were identified as having sunitinib-induced hypertension, they retained that status at subsequent visits. OS is the time from start of study treatment to death. Hazard ratio represents the relationship between sunitinib-induced hypertension and OS.
Time frame: Baseline to date of death (up to 12 months)
Percentage of Participants With Hypothyroidism
TSH and FT4 levels were measured and hypothyroidism was defined as a TSH level \>5.0 mIU/L at that time point.
Time frame: Baseline, Months 3, 6, 9, 12
Percentage of Participants With Hypertension
Hypertension was defined as follows. Grade 1: Asymptomatic, transient (less than \[\<\]24 hours) increase by \>20mm Hg (diastolic) or to \>150/100 mm Hg if previously within normal limits (WNL). Grade 2: Recurrent or persistent (24 hours or more) or symptomatic increase by \>20 mm Hg (diastolic) or to \>150/100 mm Hg if previously WNL. Grade 3: Requiring \>1 drug or more intensive therapy than previously. Grade 4: Life-threatening. Grade 5: Death.
Time frame: Baseline, Week 6, Months 3, 6, 9, 12