Trial Outcomes & Findings for Observational Study Evaluating The Efficacy And Effects On Quality Of Life Of Targeted Treatments Following TKIs In mRCC (NCT NCT02315755)
NCT ID: NCT02315755
Last Updated: 2019-07-26
Results Overview
PFS was defined as the time duration (in months) during and after the treatment of disease that a participant lived with the disease but it did not get worse or progressed. Progressive disease as per response evaluation criteria in solid tumors (RECIST) version 1.1 defined as at least a 20 percent (%) increase in the sum of longest dimensions of target lesions, reference to the smallest sum of the longest dimensions recorded since the treatment started, or the appearance of one or more new lesions or increase of at least 5 millimeter (mm) in addition to the relative increase of 20%.
COMPLETED
102 participants
From the start of disease treatment until disease progression or death due to any cause (up to a maximum of 33 months)
2019-07-26
Participant Flow
Participant milestones
| Measure |
Metastatic Renal Cell Carcinoma (mRCC) Cohort
Participants who had metastatic renal cell carcinoma and registered in centers of 12 Nomenclature of Territorial Units for Statistics (NUTS) regions of Turkey and met the inclusion criteria were observed in this study for 12 months. After 12 months, participants were followed up only once for survival follow up within the maximum study duration of 33 months.
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|---|---|
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Overall Study
STARTED
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102
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Overall Study
COMPLETED
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102
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Overall Study
NOT COMPLETED
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Metastatic Renal Cell Carcinoma (mRCC) Cohort
n=102 Participants
Participants who had metastatic renal cell carcinoma and registered in centers of 12 Nomenclature of Territorial Units for Statistics (NUTS) regions of Turkey and met the inclusion criteria were observed in this study for 12 months. After 12 months, participants were followed up only once for survival follow up within the maximum study duration of 33 months.
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Age, Continuous
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60 years
STANDARD_DEVIATION 12 • n=102 Participants
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Sex: Female, Male
Female
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28 Participants
n=102 Participants
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Sex: Female, Male
Male
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74 Participants
n=102 Participants
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PRIMARY outcome
Timeframe: From the start of disease treatment until disease progression or death due to any cause (up to a maximum of 33 months)Population: Analysis was performed on all enrolled participants.
PFS was defined as the time duration (in months) during and after the treatment of disease that a participant lived with the disease but it did not get worse or progressed. Progressive disease as per response evaluation criteria in solid tumors (RECIST) version 1.1 defined as at least a 20 percent (%) increase in the sum of longest dimensions of target lesions, reference to the smallest sum of the longest dimensions recorded since the treatment started, or the appearance of one or more new lesions or increase of at least 5 millimeter (mm) in addition to the relative increase of 20%.
Outcome measures
| Measure |
Metastatic Renal Cell Carcinoma (mRCC) Cohort
n=102 Participants
Participants who had metastatic renal cell carcinoma and registered in centers of 12 Nomenclature of Territorial Units for Statistics (NUTS) regions of Turkey and met the inclusion criteria were observed in this study for 12 months. After 12 months, participants were followed up only once for survival follow up within the maximum study duration of 33 months.
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|---|---|
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Progression Free Survival (PFS)
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NA months
Data was not estimable due to less number of participants with events.
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PRIMARY outcome
Timeframe: Baseline until the maximum of 33 monthsPopulation: Analysis was performed on all enrolled participants.
Overall objective response was defined as the percentage of participants with best confirmed response (partial response \[PR\], stable disease \[SD\] or progressive disease \[PD\]) recorded from the start of the study treatment until the end of treatment as assessed by RECIST version 1.1. PR defined as a 30% or more decrease in the sum of longest dimensions of the target lesions, taking as reference the baseline sum of longest dimensions. PD defined as at least a 20% increase in the sum of longest dimensions of target lesions, reference to the smallest sum of the longest dimensions recorded since the treatment started, or the appearance of one or more new lesions or increase of at least 5 mm in addition to the relative increase of 20%. SD defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, reference to the smallest sum diameters while on study.
Outcome measures
| Measure |
Metastatic Renal Cell Carcinoma (mRCC) Cohort
n=102 Participants
Participants who had metastatic renal cell carcinoma and registered in centers of 12 Nomenclature of Territorial Units for Statistics (NUTS) regions of Turkey and met the inclusion criteria were observed in this study for 12 months. After 12 months, participants were followed up only once for survival follow up within the maximum study duration of 33 months.
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Percentage of Participants With Overall Objective Response
PR
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23.5 percentage of participants
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Percentage of Participants With Overall Objective Response
SD
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38.2 percentage of participants
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Percentage of Participants With Overall Objective Response
PD
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18.6 percentage of participants
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PRIMARY outcome
Timeframe: Baseline (Day 1 of Month 1)Population: Analysis was performed on all enrolled participants. Here, "overall number of participants analysed", indicates participants evaluable for this outcome measure.
FKSI was used to assess quality of life (QoL) of the participants and consisted of 15 items (lack of energy, side effects, pain, losing weight, bone pain, fatigue, enjoying life, short of breath, worsened condition, appetite, coughing, bothered by fevers, ability to work, hematuria and sleep). Each of the 15 items was answered on a 5-point Likert scale ranging from 0 to 4 (0= not at all, 1= a little bit, 2= somewhat, 3= quite a bit, 4= very much). Total FKSI score = sum of the 15 item scores; total range: 0 - 60; 0 (no symptoms) to 60 (very much); higher score indicated greater presence of symptoms/worse quality of life.
Outcome measures
| Measure |
Metastatic Renal Cell Carcinoma (mRCC) Cohort
n=99 Participants
Participants who had metastatic renal cell carcinoma and registered in centers of 12 Nomenclature of Territorial Units for Statistics (NUTS) regions of Turkey and met the inclusion criteria were observed in this study for 12 months. After 12 months, participants were followed up only once for survival follow up within the maximum study duration of 33 months.
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Functional Assessment of Cancer Therapy Kidney Symptom Index - 15 (FKSI-15) Score at Baseline
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26 units on a scale
Standard Deviation 6
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PRIMARY outcome
Timeframe: Baseline (Day 1 of Month 1), Month 3Population: Analysis was performed on all enrolled participants. Here, "overall number of participants analysed", indicates participants evaluable for this outcome measure.
FKSI was used to assess QoL of the participants and consisted of 15 items (lack of energy, side effects, pain, losing weight, bone pain, fatigue, enjoying life, short of breath, worsened condition, appetite, coughing, bothered by fevers, ability to work, hematuria and sleep). Each of the 15 items was answered on a 5-point Likert scale ranging from 0 to 4 (0= not at all, 1= a little bit, 2= somewhat, 3= quite a bit, 4= very much). Total FKSI score = sum of the 15 item scores; total range: 0 - 60; 0 (no symptoms) to 60 (very much); higher score indicated greater presence of symptoms/worse quality of life.
Outcome measures
| Measure |
Metastatic Renal Cell Carcinoma (mRCC) Cohort
n=82 Participants
Participants who had metastatic renal cell carcinoma and registered in centers of 12 Nomenclature of Territorial Units for Statistics (NUTS) regions of Turkey and met the inclusion criteria were observed in this study for 12 months. After 12 months, participants were followed up only once for survival follow up within the maximum study duration of 33 months.
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Change From Baseline in FKSI-15 Score at Month 3
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1.2 units on a scale
Standard Deviation 4.47
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PRIMARY outcome
Timeframe: Baseline (Day 1 of Month 1), Month 6Population: Analysis was performed on all enrolled participants. Here, "overall number of participants analysed", indicates participants evaluable for this outcome measure.
FKSI was used to assess quality of life (QoL) of the participants and consisted of 15 items (lack of energy, side effects, pain, losing weight, bone pain, fatigue, enjoying life, short of breath, worsened condition, appetite, coughing, bothered by fevers, ability to work, hematuria and sleep). Each of the 15 items was answered on a 5-point Likert scale ranging from 0 to 4 (0= not at all, 1= a little bit, 2= somewhat, 3= quite a bit, 4= very much). Total FKSI score = sum of the 15 item scores; total range: 0 - 60; 0 (no symptoms) to 60 (very much); higher score indicated greater presence of symptoms/worse quality of life.
Outcome measures
| Measure |
Metastatic Renal Cell Carcinoma (mRCC) Cohort
n=57 Participants
Participants who had metastatic renal cell carcinoma and registered in centers of 12 Nomenclature of Territorial Units for Statistics (NUTS) regions of Turkey and met the inclusion criteria were observed in this study for 12 months. After 12 months, participants were followed up only once for survival follow up within the maximum study duration of 33 months.
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Change From Baseline in FKSI-15 Score at Month 6
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1.21 units on a scale
Standard Deviation 4.22
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PRIMARY outcome
Timeframe: Baseline (Day 1 of Month 1), Month 9Population: Analysis was performed on all enrolled participants. Here, "overall number of participants analysed", indicates participants evaluable for this outcome measure.
FKSI was used to assess quality of life (QoL) of the participants and consisted of 15 items (lack of energy, side effects, pain, losing weight, bone pain, fatigue, enjoying life, short of breath, worsened condition, appetite, coughing, bothered by fevers, ability to work, hematuria and sleep). Each of the 15 items was answered on a 5-point Likert scale ranging from 0 to 4 (0= not at all, 1= a little bit, 2= somewhat, 3= quite a bit, 4= very much). Total FKSI score = sum of the 15 item scores; total range: 0 - 60; 0 (no symptoms) to 60 (very much); higher score indicated greater presence of symptoms/worse quality of life.
Outcome measures
| Measure |
Metastatic Renal Cell Carcinoma (mRCC) Cohort
n=37 Participants
Participants who had metastatic renal cell carcinoma and registered in centers of 12 Nomenclature of Territorial Units for Statistics (NUTS) regions of Turkey and met the inclusion criteria were observed in this study for 12 months. After 12 months, participants were followed up only once for survival follow up within the maximum study duration of 33 months.
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Change From Baseline in FKSI-15 Score at Month 9
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1.38 units on a scale
Standard Deviation 4.56
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PRIMARY outcome
Timeframe: Baseline (Day 1 of Month 1), last follow-up visit (up to 33 months)Population: Analysis was performed on all enrolled participants. Here, "overall number of participants analysed", indicates participants evaluable for this outcome measure.
FKSI was used to assess quality of life (QoL) of the participants and consisted of 15 items (lack of energy, side effects, pain, losing weight, bone pain, fatigue, enjoying life, short of breath, worsened condition, appetite, coughing, bothered by fevers, ability to work, hematuria and sleep). Each of the 15 items was answered on a 5-point Likert scale ranging from 0 to 4 (0= not at all, 1= a little bit, 2= somewhat, 3= quite a bit, 4= very much). Total FKSI score = sum of the 15 item scores; total range: 0 - 60; 0 (no symptoms) to 60 (very much); higher score indicated greater presence of symptoms/worse quality of life.
Outcome measures
| Measure |
Metastatic Renal Cell Carcinoma (mRCC) Cohort
n=30 Participants
Participants who had metastatic renal cell carcinoma and registered in centers of 12 Nomenclature of Territorial Units for Statistics (NUTS) regions of Turkey and met the inclusion criteria were observed in this study for 12 months. After 12 months, participants were followed up only once for survival follow up within the maximum study duration of 33 months.
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Change From Baseline in FKSI-15 Score at Last Follow-up
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0.67 units on a scale
Standard Deviation 5.27
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PRIMARY outcome
Timeframe: Baseline (Day 1 of Month 1)Population: Analysis was performed on all enrolled participants. Here, "overall number of participants analysed", indicates participants evaluable for this outcome measure.
EQ-5D-3L, a health profile questionnaire was used to assess quality of life along 5 dimensions. Participants rated 5 aspects of health (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) by choosing from 3 answering options (1=no problems; 2=some problems; 3=extreme problems). The mean of the summed score ranged from 1 to 3 with "1" corresponding to no problems and "3" corresponding to severe problems in the 5 dimensions, where higher score indicates more severe problems. Total index EQ-5D-3L summary score is weighted with a range of -0.594 (worst) to 1.0 (best).
Outcome measures
| Measure |
Metastatic Renal Cell Carcinoma (mRCC) Cohort
n=100 Participants
Participants who had metastatic renal cell carcinoma and registered in centers of 12 Nomenclature of Territorial Units for Statistics (NUTS) regions of Turkey and met the inclusion criteria were observed in this study for 12 months. After 12 months, participants were followed up only once for survival follow up within the maximum study duration of 33 months.
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|---|---|
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EuroQol-5 Dimension-3 Level (EQ5D-3L) Scores at Baseline
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0.522 units on a scale
Standard Deviation 0.236
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PRIMARY outcome
Timeframe: Baseline (Day 1 of Month 1), Month 3Population: Analysis was performed on all enrolled participants. Here, "overall number of participants analysed", indicates participants evaluable for this outcome measure.
EQ-5D-3L, a health profile questionnaire was used to assess quality of life along 5 dimensions. Participants rated 5 aspects of health (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) by choosing from 3 answering options (1=no problems; 2=some problems; 3=extreme problems). The summed score ranged from 1-15 with "1" corresponding to no problems and "15" corresponding to severe problems in the 5 dimensions, where higher score indicates more severe problems.
Outcome measures
| Measure |
Metastatic Renal Cell Carcinoma (mRCC) Cohort
n=82 Participants
Participants who had metastatic renal cell carcinoma and registered in centers of 12 Nomenclature of Territorial Units for Statistics (NUTS) regions of Turkey and met the inclusion criteria were observed in this study for 12 months. After 12 months, participants were followed up only once for survival follow up within the maximum study duration of 33 months.
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|---|---|
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Change From Baseline in EQ5D-3L Scores at Month 3
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-0.07 units on a scale
Standard Deviation 0.17
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PRIMARY outcome
Timeframe: Baseline (Day 1 of Month 1), Month 6Population: Analysis was performed on all enrolled participants. Here, "overall number of participants analysed", indicates participants evaluable for this outcome measure.
EQ-5D-3L, a health profile questionnaire was used to assess quality of life along 5 dimensions. Participants rated 5 aspects of health (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) by choosing from 3 answering options (1=no problems; 2=some problems; 3=extreme problems). The summed score ranged from 1-15 with "1" corresponding to no problems and "15" corresponding to severe problems in the 5 dimensions, where higher score indicates more severe problems.
Outcome measures
| Measure |
Metastatic Renal Cell Carcinoma (mRCC) Cohort
n=57 Participants
Participants who had metastatic renal cell carcinoma and registered in centers of 12 Nomenclature of Territorial Units for Statistics (NUTS) regions of Turkey and met the inclusion criteria were observed in this study for 12 months. After 12 months, participants were followed up only once for survival follow up within the maximum study duration of 33 months.
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|---|---|
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Change From Baseline in EQ5D-3L Score at Month 6
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-0.11 units on a scale
Standard Deviation 0.34
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PRIMARY outcome
Timeframe: Baseline (Day 1 of Month 1), Month 9Population: Analysis was performed on all enrolled participants. Here, "overall number of participants analysed", indicates participants evaluable for this outcome measure.
EQ-5D-3L, a health profile questionnaire was used to assess quality of life along 5 dimensions. Participants rated 5 aspects of health (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) by choosing from 3 answering options (1=no problems; 2=some problems; 3=extreme problems). The summed score ranged from 1-15 with "1" corresponding to no problems and "15" corresponding to severe problems in the 5 dimensions, where higher score indicates more severe problems.
Outcome measures
| Measure |
Metastatic Renal Cell Carcinoma (mRCC) Cohort
n=37 Participants
Participants who had metastatic renal cell carcinoma and registered in centers of 12 Nomenclature of Territorial Units for Statistics (NUTS) regions of Turkey and met the inclusion criteria were observed in this study for 12 months. After 12 months, participants were followed up only once for survival follow up within the maximum study duration of 33 months.
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Change From Baseline in EQ5D-3L Score at Month 9
|
-0.06 units on a scale
Standard Deviation 0.2
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PRIMARY outcome
Timeframe: Baseline (Day 1 of Month 1), last follow up visit (up to 33 months)Population: Analysis was performed on all enrolled participants. Here, "overall number of participants analysed", indicates participants evaluable for this outcome measure.
EQ-5D-3L, a health profile questionnaire was used to assess quality of life along 5 dimensions. Participants rated 5 aspects of health (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) by choosing from 3 answering options (1=no problems; 2=some problems; 3=extreme problems). The summed score ranged from 1-15 with "1" corresponding to no problems and "15" corresponding to severe problems in the 5 dimensions, where higher score indicates more severe problems.
Outcome measures
| Measure |
Metastatic Renal Cell Carcinoma (mRCC) Cohort
n=30 Participants
Participants who had metastatic renal cell carcinoma and registered in centers of 12 Nomenclature of Territorial Units for Statistics (NUTS) regions of Turkey and met the inclusion criteria were observed in this study for 12 months. After 12 months, participants were followed up only once for survival follow up within the maximum study duration of 33 months.
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|---|---|
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Change From Baseline in EQ5D-3L Score at Last Follow-up
|
-0.05 units on a scale
Standard Deviation 0.39
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PRIMARY outcome
Timeframe: Baseline (Day 1 of Month 1)Population: Analysis was performed on all enrolled participants. Here, "overall number of participants analysed", indicates participants evaluable for this outcome measure.
FKSI-DRS was used to assess quality of life in participants and consisted of 9 items (lack of energy, pain, losing weight, bone pain, fatigue, short of breath, coughing, bothered by fevers, and hematuria). Each of the 9 items was answered on a 5-point Likert scale ranging from 0 to 4 (0= not at all, 1= a little bit, 2= somewhat, 3= quite a bit, 4= very much). Total FKSI-DRS score = sum of the 9 item scores; total range: 0 - 36; 0 (no symptom) to 36 (very much); higher score indicated greater presence of symptom.
Outcome measures
| Measure |
Metastatic Renal Cell Carcinoma (mRCC) Cohort
n=100 Participants
Participants who had metastatic renal cell carcinoma and registered in centers of 12 Nomenclature of Territorial Units for Statistics (NUTS) regions of Turkey and met the inclusion criteria were observed in this study for 12 months. After 12 months, participants were followed up only once for survival follow up within the maximum study duration of 33 months.
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|---|---|
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Functional Assessment of Cancer Therapy Kidney Symptom Index-Disease-Related Symptoms (FKSI-DRS) Score at Baseline
|
14.56 units on a scale
Standard Deviation 5.73
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PRIMARY outcome
Timeframe: Baseline (Day 1 of Month 1), Month 3Population: Analysis was performed on all enrolled participants. Here, "overall number of participants analysed", indicates participants evaluable for this outcome measure.
FKSI-DRS was used to assess quality of life in participants and consisted of 9 items (lack of energy, pain, losing weight, bone pain, fatigue, short of breath, coughing, bothered by fevers, and hematuria). Each of the 9 items was answered on a 5-point Likert scale ranging from 0 to 4 (0= not at all, 1= a little bit, 2= somewhat, 3= quite a bit, 4= very much). Total FKSI-DRS score = sum of the 9 item scores; total range: 0 - 36; 0 (no symptom) to 36 (very much); higher score indicated greater presence of symptom.
Outcome measures
| Measure |
Metastatic Renal Cell Carcinoma (mRCC) Cohort
n=82 Participants
Participants who had metastatic renal cell carcinoma and registered in centers of 12 Nomenclature of Territorial Units for Statistics (NUTS) regions of Turkey and met the inclusion criteria were observed in this study for 12 months. After 12 months, participants were followed up only once for survival follow up within the maximum study duration of 33 months.
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Change From Baseline in FKSI-DRS Score at Month 3
|
1.13 units on a scale
Standard Deviation 3.81
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PRIMARY outcome
Timeframe: Baseline (Day 1 of Month 1), Month 6Population: Analysis was performed on all enrolled participants. Here, "overall number of participants analysed", indicates participants evaluable for this outcome measure.
FKSI-DRS was used to assess quality of life in participants and consisted of 9 items (lack of energy, pain, losing weight, bone pain, fatigue, short of breath, coughing, bothered by fevers, and hematuria). Each of the 9 items was answered on a 5-point Likert scale ranging from 0 to 4 (0= not at all, 1= a little bit, 2= somewhat, 3= quite a bit, 4= very much). Total FKSI-DRS score = sum of the 9 item scores; total range: 0 - 36; 0 (no symptom) to 36 (very much); higher score indicated greater presence of symptom.
Outcome measures
| Measure |
Metastatic Renal Cell Carcinoma (mRCC) Cohort
n=57 Participants
Participants who had metastatic renal cell carcinoma and registered in centers of 12 Nomenclature of Territorial Units for Statistics (NUTS) regions of Turkey and met the inclusion criteria were observed in this study for 12 months. After 12 months, participants were followed up only once for survival follow up within the maximum study duration of 33 months.
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|---|---|
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Change From Baseline in FKSI-DRS Score at Month 6
|
1.04 units on a scale
Standard Deviation 4.98
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PRIMARY outcome
Timeframe: Baseline (Day 1 of Month 1), Month 9Population: Analysis was performed on all enrolled participants. Here, "overall number of participants analysed", indicates participants evaluable for this outcome measure.
FKSI-DRS was used to assess quality of life in participants and consisted of 9 items (lack of energy, pain, losing weight, bone pain, fatigue, short of breath, coughing, bothered by fevers, and hematuria). Each of the 9 items was answered on a 5-point Likert scale ranging from 0 to 4 (0= not at all, 1= a little bit, 2= somewhat, 3= quite a bit, 4= very much). Total FKSI-DRS score = sum of the 9 item scores; total range: 0 - 36; 0 (no symptom) to 36 (very much); higher score indicated greater presence of symptom.
Outcome measures
| Measure |
Metastatic Renal Cell Carcinoma (mRCC) Cohort
n=37 Participants
Participants who had metastatic renal cell carcinoma and registered in centers of 12 Nomenclature of Territorial Units for Statistics (NUTS) regions of Turkey and met the inclusion criteria were observed in this study for 12 months. After 12 months, participants were followed up only once for survival follow up within the maximum study duration of 33 months.
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|---|---|
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Change From Baseline in FKSI-DRS Score at Month 9
|
0.68 units on a scale
Standard Deviation 4.94
|
PRIMARY outcome
Timeframe: Baseline (Day 1 of Month 1), last follow up visit (up to 33 months)Population: Analysis was performed on all enrolled participants. Here, "overall number of participants analysed", indicates participants evaluable for this outcome measure.
FKSI-DRS was used to assess quality of life in participants and consisted of 9 items (lack of energy, pain, losing weight, bone pain, fatigue, short of breath, coughing, bothered by fevers, and hematuria). Each of the 9 items was answered on a 5-point Likert scale ranging from 0 to 4 (0= not at all, 1= a little bit, 2= somewhat, 3= quite a bit, 4= very much). Total FKSI-DRS score = sum of the 9 item scores; total range: 0 - 36; 0 (no symptom) to 36 (very much); higher score indicated greater presence of symptom.
Outcome measures
| Measure |
Metastatic Renal Cell Carcinoma (mRCC) Cohort
n=30 Participants
Participants who had metastatic renal cell carcinoma and registered in centers of 12 Nomenclature of Territorial Units for Statistics (NUTS) regions of Turkey and met the inclusion criteria were observed in this study for 12 months. After 12 months, participants were followed up only once for survival follow up within the maximum study duration of 33 months.
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|---|---|
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Change From Baseline in FKSI-DRS Score at Last Follow-up
|
1.6 units on a scale
Standard Deviation 6.66
|
SECONDARY outcome
Timeframe: From the start of 3rd line treatment until death due to any cause (up to a maximum of 33 months)Population: Analysis was performed on all enrolled participants.
Overall survival was defined as the time from the start of 3rd line treatment until date of death due to any cause.
Outcome measures
| Measure |
Metastatic Renal Cell Carcinoma (mRCC) Cohort
n=102 Participants
Participants who had metastatic renal cell carcinoma and registered in centers of 12 Nomenclature of Territorial Units for Statistics (NUTS) regions of Turkey and met the inclusion criteria were observed in this study for 12 months. After 12 months, participants were followed up only once for survival follow up within the maximum study duration of 33 months.
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|---|---|
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Overall Survival
|
NA months
Data was not estimable due to less number of participants with events.
|
SECONDARY outcome
Timeframe: Baseline until death due to any cause (up to 1 year)Population: Analysis was performed on all enrolled participants.
Overall survival at Year 1 (Month 12) was defined as the time from the start of 3rd line treatment until death or 1 year due to any cause (measured at the end of 12 month follow-up/observation period). Percentage of participants who survived at the completion of 1 year (12 months) period were reported in this outcome measure.
Outcome measures
| Measure |
Metastatic Renal Cell Carcinoma (mRCC) Cohort
n=102 Participants
Participants who had metastatic renal cell carcinoma and registered in centers of 12 Nomenclature of Territorial Units for Statistics (NUTS) regions of Turkey and met the inclusion criteria were observed in this study for 12 months. After 12 months, participants were followed up only once for survival follow up within the maximum study duration of 33 months.
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|---|---|
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Overall Survival at Year 1: Percentage of Participants Who Survived at Year 1
|
79.9 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline until disease progression or discontinuation, due to any cause (up to 33 months)Population: Analysis was performed on all enrolled participants. Here, "overall number of participants analysed", indicates participants evaluable for this outcome measure.
Time to treatment failure was defined as the time from the start of treatment to the date of disease progression or date of permanent discontinuation. PD as per RECIST version 1.1 was defined as at least a 20% increase in the sum of longest dimensions of target lesions, reference to the smallest sum of the longest dimensions recorded since the treatment started, or the appearance of one or more new lesions or increase of at least 5 mm in addition to the relative increase of 20%.
Outcome measures
| Measure |
Metastatic Renal Cell Carcinoma (mRCC) Cohort
n=83 Participants
Participants who had metastatic renal cell carcinoma and registered in centers of 12 Nomenclature of Territorial Units for Statistics (NUTS) regions of Turkey and met the inclusion criteria were observed in this study for 12 months. After 12 months, participants were followed up only once for survival follow up within the maximum study duration of 33 months.
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|---|---|
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Time to Treatment Failure
|
4 months
Interval 1.0 to 16.0
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SECONDARY outcome
Timeframe: Baseline up to 12 monthsPopulation: Analysis was performed on all enrolled participants.
An AE was any untoward medical occurrence in a participant who received disease treatment without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant and jeopardized the participants or required treatment to prevent other AE outcomes for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment emergent AEs were events which occurred between start of disease treatment and up to Month 12 follow-up visit, that were absent before treatment or that worsened relative to pre-treatment state. AEs included both non-SAE and SAEs.
Outcome measures
| Measure |
Metastatic Renal Cell Carcinoma (mRCC) Cohort
n=102 Participants
Participants who had metastatic renal cell carcinoma and registered in centers of 12 Nomenclature of Territorial Units for Statistics (NUTS) regions of Turkey and met the inclusion criteria were observed in this study for 12 months. After 12 months, participants were followed up only once for survival follow up within the maximum study duration of 33 months.
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|---|---|
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Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
AEs
|
33 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
SAEs
|
5 Participants
|
SECONDARY outcome
Timeframe: Baseline up to 12 monthsPopulation: Analysis was performed on all enrolled participants.
An AE was any untoward medical occurrence in a participant who received disease treatment without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant and jeopardized the participants or required treatment to prevent other AE outcomes for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs were graded according to the National Cancer Institute- Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03 and coded using the Medical Dictionary for Regulatory Activities (MedDRA) as Grade 1: Mild, Grade 2: Moderate, Grade 3: Severe, Grade 4: Life threatening, Grade 5: Death related to AE. AEs included both SAEs and non-SAEs.
Outcome measures
| Measure |
Metastatic Renal Cell Carcinoma (mRCC) Cohort
n=102 Participants
Participants who had metastatic renal cell carcinoma and registered in centers of 12 Nomenclature of Territorial Units for Statistics (NUTS) regions of Turkey and met the inclusion criteria were observed in this study for 12 months. After 12 months, participants were followed up only once for survival follow up within the maximum study duration of 33 months.
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|---|---|
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Number of Participants With Grade 3 or Higher Severe Adverse Events (AEs) Based on NCI CTCAE Version 4.03
|
13 Participants
|
SECONDARY outcome
Timeframe: Baseline up to 12 monthsPopulation: Analysis was performed on all enrolled participants.
An AE was any untoward medical occurrence in a participant who received disease treatment without regard to possibility of causal relationship. Treatment emergent AEs during third line targeted treatment were events which occurred between first dose of third line targeted treatment and up to Month 12 follow-up visit, that were absent before treatment or that worsened relative to pre-treatment state.
Outcome measures
| Measure |
Metastatic Renal Cell Carcinoma (mRCC) Cohort
n=102 Participants
Participants who had metastatic renal cell carcinoma and registered in centers of 12 Nomenclature of Territorial Units for Statistics (NUTS) regions of Turkey and met the inclusion criteria were observed in this study for 12 months. After 12 months, participants were followed up only once for survival follow up within the maximum study duration of 33 months.
|
|---|---|
|
Number of Participants With Treatment-Emergent Adverse Events (AEs) During Third Line Targeted Treatment
|
6 Participants
|
SECONDARY outcome
Timeframe: Baseline up to Month 3, 6, 9 and 12Population: Analysis was performed on all enrolled participants. Here, "Number analyzed, indicates participants evaluable for specified category".
Number of participants that required dose modifications of third line treatment due to AEs were reported in this outcome measure. Dose modification was categorized as escalation (increase in dose), delay or interruptions (change in dose time or skipping any dose), reduction (decrease in dose).
Outcome measures
| Measure |
Metastatic Renal Cell Carcinoma (mRCC) Cohort
n=102 Participants
Participants who had metastatic renal cell carcinoma and registered in centers of 12 Nomenclature of Territorial Units for Statistics (NUTS) regions of Turkey and met the inclusion criteria were observed in this study for 12 months. After 12 months, participants were followed up only once for survival follow up within the maximum study duration of 33 months.
|
|---|---|
|
Number of Participants With Dose Modifications of Third-Line Treatment Due to Adverse Events
Escalation: Month 3
|
7 Participants
|
|
Number of Participants With Dose Modifications of Third-Line Treatment Due to Adverse Events
Interruption/delay: Month 3
|
13 Participants
|
|
Number of Participants With Dose Modifications of Third-Line Treatment Due to Adverse Events
Reduction: Month 3
|
4 Participants
|
|
Number of Participants With Dose Modifications of Third-Line Treatment Due to Adverse Events
None: Month 3
|
58 Participants
|
|
Number of Participants With Dose Modifications of Third-Line Treatment Due to Adverse Events
Escalation: Month 6
|
5 Participants
|
|
Number of Participants With Dose Modifications of Third-Line Treatment Due to Adverse Events
Interruption/delay: Month 6
|
7 Participants
|
|
Number of Participants With Dose Modifications of Third-Line Treatment Due to Adverse Events
Reduction: Month 6
|
2 Participants
|
|
Number of Participants With Dose Modifications of Third-Line Treatment Due to Adverse Events
None: Month 6
|
43 Participants
|
|
Number of Participants With Dose Modifications of Third-Line Treatment Due to Adverse Events
Escalation: Month 9
|
0 Participants
|
|
Number of Participants With Dose Modifications of Third-Line Treatment Due to Adverse Events
Interruption/delay: Month 9
|
5 Participants
|
|
Number of Participants With Dose Modifications of Third-Line Treatment Due to Adverse Events
Reduction: Month 9
|
0 Participants
|
|
Number of Participants With Dose Modifications of Third-Line Treatment Due to Adverse Events
None: Month 9
|
33 Participants
|
|
Number of Participants With Dose Modifications of Third-Line Treatment Due to Adverse Events
Escalation: Month 12
|
0 Participants
|
|
Number of Participants With Dose Modifications of Third-Line Treatment Due to Adverse Events
Interruption/delay: Month 12
|
4 Participants
|
|
Number of Participants With Dose Modifications of Third-Line Treatment Due to Adverse Events
Reduction: Month 12
|
0 Participants
|
|
Number of Participants With Dose Modifications of Third-Line Treatment Due to Adverse Events
None: Month 12
|
25 Participants
|
SECONDARY outcome
Timeframe: Baseline up to Month 12 follow-up visitPopulation: Analysis was performed on all enrolled participants.
Outcome measures
| Measure |
Metastatic Renal Cell Carcinoma (mRCC) Cohort
n=102 Participants
Participants who had metastatic renal cell carcinoma and registered in centers of 12 Nomenclature of Territorial Units for Statistics (NUTS) regions of Turkey and met the inclusion criteria were observed in this study for 12 months. After 12 months, participants were followed up only once for survival follow up within the maximum study duration of 33 months.
|
|---|---|
|
Correlation Coefficient Between Efficacy and Dose Modifications Due to AEs
|
NA Correlation coefficient
Data was not estimable due to less number of participants with dose modifications due to AEs.
|
SECONDARY outcome
Timeframe: Baseline up to Month 12 follow-up visitPopulation: Analysis was performed on all enrolled participants.
Outcome measures
| Measure |
Metastatic Renal Cell Carcinoma (mRCC) Cohort
n=102 Participants
Participants who had metastatic renal cell carcinoma and registered in centers of 12 Nomenclature of Territorial Units for Statistics (NUTS) regions of Turkey and met the inclusion criteria were observed in this study for 12 months. After 12 months, participants were followed up only once for survival follow up within the maximum study duration of 33 months.
|
|---|---|
|
Correlation Coefficient Between Efficacy and High Blood Pressure (>150 / 90 Millimeter of Mercury )
|
NA Correlation coefficient
Data was not estimable due to less number of participants with High blood pressure.
|
Adverse Events
Metastatic Renal Cell Carcinoma (mRCC) Cohort
Serious adverse events
| Measure |
Metastatic Renal Cell Carcinoma (mRCC) Cohort
n=102 participants at risk
Participants who had metastatic renal cell carcinoma and registered in centers of 12 Nomenclature of Territorial Units for Statistics (NUTS) regions of Turkey and met the inclusion criteria were observed in this study for 12 months. After 12 months, participants were followed up only once for survival follow up within the maximum study duration of 33 months.
|
|---|---|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.98%
1/102 • Baseline up to 12 months
|
|
Infections and infestations
Pneumonia
|
0.98%
1/102 • Baseline up to 12 months
|
|
Investigations
Blood creatinine increased
|
0.98%
1/102 • Baseline up to 12 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastasis
|
0.98%
1/102 • Baseline up to 12 months
|
|
General disorders
Mass in right on brochis
|
0.98%
1/102 • Baseline up to 12 months
|
Other adverse events
| Measure |
Metastatic Renal Cell Carcinoma (mRCC) Cohort
n=102 participants at risk
Participants who had metastatic renal cell carcinoma and registered in centers of 12 Nomenclature of Territorial Units for Statistics (NUTS) regions of Turkey and met the inclusion criteria were observed in this study for 12 months. After 12 months, participants were followed up only once for survival follow up within the maximum study duration of 33 months.
|
|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
7.8%
8/102 • Baseline up to 12 months
|
|
General disorders
Asthenia
|
7.8%
8/102 • Baseline up to 12 months
|
|
Vascular disorders
Hypertension
|
4.9%
5/102 • Baseline up to 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.9%
3/102 • Baseline up to 12 months
|
|
Cardiac disorders
Angina pectoris
|
0.98%
1/102 • Baseline up to 12 months
|
|
Cardiac disorders
Palpitations
|
0.98%
1/102 • Baseline up to 12 months
|
|
Endocrine disorders
Hypogonadism
|
0.98%
1/102 • Baseline up to 12 months
|
|
Endocrine disorders
Hypothyroidism
|
2.0%
2/102 • Baseline up to 12 months
|
|
Gastrointestinal disorders
Nausea
|
2.9%
3/102 • Baseline up to 12 months
|
|
Gastrointestinal disorders
Oral pain
|
2.9%
3/102 • Baseline up to 12 months
|
|
Gastrointestinal disorders
Vomiting
|
2.0%
2/102 • Baseline up to 12 months
|
|
Gastrointestinal disorders
Stomatitis
|
2.0%
2/102 • Baseline up to 12 months
|
|
Gastrointestinal disorders
Abdominal pain
|
0.98%
1/102 • Baseline up to 12 months
|
|
General disorders
Chills
|
0.98%
1/102 • Baseline up to 12 months
|
|
General disorders
Fatigue
|
0.98%
1/102 • Baseline up to 12 months
|
|
General disorders
Mucosal inflammation
|
0.98%
1/102 • Baseline up to 12 months
|
|
General disorders
Pyrexia
|
0.98%
1/102 • Baseline up to 12 months
|
|
General disorders
Swelling
|
0.98%
1/102 • Baseline up to 12 months
|
|
Infections and infestations
Acute sinusitis
|
0.98%
1/102 • Baseline up to 12 months
|
|
Infections and infestations
Bronchitis
|
0.98%
1/102 • Baseline up to 12 months
|
|
Infections and infestations
Conjunctivitis
|
0.98%
1/102 • Baseline up to 12 months
|
|
Infections and infestations
Upper respiratory tract infection
|
0.98%
1/102 • Baseline up to 12 months
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.98%
1/102 • Baseline up to 12 months
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.98%
1/102 • Baseline up to 12 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastasis
|
0.98%
1/102 • Baseline up to 12 months
|
|
Psychiatric disorders
Insomnia
|
0.98%
1/102 • Baseline up to 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.98%
1/102 • Baseline up to 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.98%
1/102 • Baseline up to 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.98%
1/102 • Baseline up to 12 months
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.98%
1/102 • Baseline up to 12 months
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
0.98%
1/102 • Baseline up to 12 months
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.98%
1/102 • Baseline up to 12 months
|
|
Vascular disorders
Deep vein thrombosis
|
2.0%
2/102 • Baseline up to 12 months
|
|
General disorders
Cotton in mouth
|
0.98%
1/102 • Baseline up to 12 months
|
|
General disorders
Inappetency
|
2.0%
2/102 • Baseline up to 12 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER