Carcinoma, Renal Cell, Clear-cell Metastatic Renal Cell Carcinoma
Conditions
Keywords
mRCC, Metastatic Renal Cell Carcinoma, Clear-cell metastatic renal cell carcinoma
Brief summary
The purpose of this study is to understand how patients with mRCC respond to the study medicine (called sunitinib) when they receive it as the first line of treatment after finding out the cause for the disease. This study will look into how different and how well groups of people with high chances of developing the disease respond to the study medicine. All data for this study will be anonymously extracted from data already entered in RCC Registry which is owned by Turkish Oncology Group Association (TOGD). This study will pull out records from the Registry between 01-Mar-2019 and 30-Oct-2022 that belongs to people: * who are Turkish citizens * who are older than 18 years * who were found out to have mRCC * who received sunitinib as the first line treatment after finding out the cause for the disease This study will look at the responses, experiences and how long the patients use the study medicine sunitinib.
Detailed description
This study is designed as a local, non-interventional, retrospective, registry-based study to observe treatment response in patients with metastatic Renal Cell Carcinoma with Sunitinib First-Line Therapy based on data extracted and analyzed from the RCC Registry. The annual disease burden in contributing centers to RCC Registry is approximately 100 patient/center, the treatment of an average of 250 patients per year is continued in the centers. Therefore, it is estimated that information of approximately 400 eligible patients who were registered in RCC Registry from 2019 to 2022 will be included in the analysis. RCC Registry will be used as the sole data source for this study. For this purpose, no Case Report Forms (CRFs) or Data Collection Tools (DCTs) will be utilized, but the RCC Registry database will be used directly. Eligible patients' data will be anonymized and extracted for analysis by the registry owner, for this study.
Interventions
DRUGSunitinib
as provided in real world practice
Sponsors
Pfizer
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Being a Turkish citizen. * Being older than 18 years-old. * Being clinically diagnosed with mRCC and treated. * Being treated with Sunitinib in first line
Exclusion criteria
* Patients whose treatment was initiated but excluded from follow-up for any reason.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Response Rates According to Disease Risk Group in MSKCC | From initiation of sunitinib treatment (retrospective data) till PR/ CR/ SD/ death or progression (up to 30-Oct-2022, cut-off for data registry); approximate follow-up duration of 73 months [from data extracted from registry database] | RECIST1.1- CR: disappearance of all lesions and normalization of tumor marker level. Any pathological lymph nodes must have reduction in short axis to \<10 mm. 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; PD: at least 20% increase in sum of longest dimensions of target lesions, reference to the smallest sum of the longest dimensions recorded since treatment started, or the appearance of 1 or more new lesions or increase of at least 5 mm in addition to the relative increase of 20%; SD: neither shrinkage for CR/PR nor increase for PD taking as reference smallest sum of longest diameters since treatment start. MSKCC assessed as favourable (0), intermediate (1-2) or poor (\>=3) based on number of criteria present \[KPS \<80%, time from diagnosis to start of systemic therapy \<12 months, lactate dehydrogenase \>1.5\*ULN, hemoglobin \<LLN, serum calcium \>10 mg/dL\]. |
| Objective Response Rate (ORR) According to Disease Risk Group in IMDC | From initiation of sunitinib treatment (retrospective data) till PR and CR or death or progression (up to 30-Oct-2022, cut-off for data registry); approximate follow-up duration of 73 months [from data extracted from registry database] | ORR: percentage of participants with partial response (PR) and complete response (CR). As per response evaluation criteria in solid tumors (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 \<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. IMDC assessed as favorable (0), intermediate (1-2) or poor (\>=3) based on number of criteria present (KPS \<80%; time from diagnosis to start of systemic therapy \<1 year; corrected serum calcium \[Ca\]; neutrophils and platelets \>ULN; hemoglobin \[hg\] \<LLN). |
| Response Rates According to Disease Risk Group in IMDC | From initiation of sunitinib treatment (retrospective data) till PR/ CR/ SD/ death or progression (up to 30-Oct-2022, cut-off for data registry); approximate follow-up duration of 73 months [from data extracted from registry database] | RECIST1.1- CR: disappearance of all lesions & normalization of tumor marker level. Any pathological lymph nodes must have reduction in short axis to \<10 mm. 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; progressive disease (PD): at least 20% increase in sum of longest dimensions of target lesions, reference to the smallest sum of the longest dimensions recorded since treatment started, or appearance of 1 or more new lesions or increase of at least 5 mm in addition to the relative increase of 20%; stable disease (SD): neither shrinkage for CR/PR nor increase for PD taking as reference smallest sum of longest diameters since treatment start. IMDC: favorable (0), intermediate (1-2) or poor (\>=3) based on number of criteria present (KPS \<80%; time from diagnosis to start of systemic therapy \<1 year; corrected serum Ca\]; neutrophils & platelets \>ULN; hg \<LLN). |
| ORR According to Disease Risk Group in MSKCC | From initiation of sunitinib treatment (retrospective data) till PR and CR or death or progression (up to 30-Oct-2022, cut-off for data registry); approximate follow-up duration of 73 months [from data extracted from registry database] | ORR: percentage of participants with PR and CR. 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 \<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. MSKCC assessed as favorable (0), intermediate (1-2) or poor (\>=3) based on number of criteria present \[KPS \<80%, time from diagnosis to start of systemic therapy \<12 months, lactate dehydrogenase \>1.5\*ULN, hemoglobin \<LLN, serum calcium \>10 mg/dL\]. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival (OS) Rate According to Disease Risk Group in IMDC | From initiation of sunitinib treatment (retrospective data) till death or censored date (up to 30-Oct-2022, cut-off for data registry); approximate follow-up duration of 73 months [from data extracted from registry database] | OS was defined as the time from the start of the treatment until the date of death. If no death was recorded, data was censored at latest available date in data. IMDC assessed as favorable (0), intermediate (1-2) or poor (\>=3) based on number of criteria present (KPS \<80%; time from diagnosis to start of systemic therapy \<1 year; corrected serum Ca; neutrophils and platelets \>ULN; hg \<LLN). |
| Progression-Free Survival (PFS) According to Disease Risk Group in IMDC | From initiation of sunitinib treatment (retrospective data) till progression end of treatment date or date of death (up to 30-Oct-2022, cut-off for data registry); approximate follow-up duration of 73 months [from data extracted from registry database] | PFS: duration from start of treatment to disease progression (PD), end of treatment date or date of death. PD: at least 20% increase in sum of longest dimensions of target lesions, reference to the smallest sum of the longest dimensions recorded since treatment started, or the appearance of 1 or more new lesions or increase of at least 5 mm in addition to the relative increase of 20%. IMDC assessed as favorable (0), intermediate (1-2) or poor (\>=3) based on number of criteria present (KPS \<80%; time from diagnosis to start of systemic therapy \<1 year; corrected serum Ca; neutrophils and platelets \>ULN; hg \<LLN). |
| OS According to Disease Risk Group in MSKCC | From initiation of sunitinib treatment (retrospective data) till death or censored date (up to 30-Oct-2022, cut-off for data registry); approximate follow-up duration of 73 months [from data extracted from registry database] | OS was defined as the time from the start of the treatment until the date of death. If no death was recorded, data was censored at latest available date in data. MSKCC assessed as favourable (0), intermediate (1-2) or poor (\>=3) based on number of criteria present \[KPS \<80%, time from diagnosis to start of systemic therapy \<12 months, lactate dehydrogenase \>1.5\*ULN, hemoglobin \<LLN, serum calcium \>10 mg/dL\]. |
| PFS According to Disease Risk Group in MSKCC | From initiation of sunitinib treatment (retrospective data) till progression end of treatment date or date of death (up to 30-Oct-2022, cut-off for data registry); approximate follow-up duration of 73 months [from data extracted from registry database] | PFS: duration from start of treatment to PD, end of treatment date or date of death. PD: at least 20% increase in sum of longest dimensions of target lesions, reference to the smallest sum of the longest dimensions recorded since treatment started, or the appearance of 1 or more new lesions or increase of at least 5 mm in addition to the relative increase of 20%. MSKCC assessed as favourable (0), intermediate (1-2) or poor (\>=3) based on number of criteria present \[KPS \<80%, time from diagnosis to start of systemic therapy \<12 months, lactate dehydrogenase \>1.5\*ULN, hemoglobin \<LLN, serum calcium \>10 mg/dL\]. |
Countries
Turkey (Türkiye)
Participant flow
Recruitment details
Participants with metastatic renal cell carcinoma (mRCC), who were being treated with Sunitinib in first-line therapy and got registered in RCC database between 01-March-2019 and 30-October-2022 were included in this study and their data was observed retrospectively.
Pre-assignment details
RCC registry was a data log where clinical information was recorded by inviting participants who met the selection criteria according to protocol (Turkish citizen, older than 18 years, being diagnosed with mRCC and being treated with sunitinib in first line). It was used as data source for this study and the participant data was retrospectively recorded in the study database. A total of 376 participants were included in this study which pulled out records from the RCC registry.
Participants by arm
| Arm | Count |
|---|---|
| Sunitinib Participants diagnosed with mRCC on treatment with Sunitinib as first-line therapy in real world practice and were registered in RCC registry in Turkey were included. The recommended dose of sunitinib in mRCC is 50 mg orally daily for 4 weeks, followed by 2 weeks off treatment (4/2 schedule). | 376 |
| Total | 376 |
Baseline characteristics
| Characteristic | Sunitinib | — |
|---|---|---|
| Age, Continuous | 58 Years | — |
| Number of Participants According to Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1 | 271 Participants | — |
| Number of Participants According to Eastern Cooperative Oncology Group (ECOG) Performance Status 2 | 69 Participants | — |
| Number of Participants According to Eastern Cooperative Oncology Group (ECOG) Performance Status 3-4 | 12 Participants | — |
| Number of Participants According to Eastern Cooperative Oncology Group (ECOG) Performance Status Missing | 24 Participants | — |
| Number of Participants According to Initial Tumor, Node, Metastasis (TNM) Stage 1 | 32 Participants | — |
| Number of Participants According to Initial Tumor, Node, Metastasis (TNM) Stage 2 | 43 Participants | — |
| Number of Participants According to Initial Tumor, Node, Metastasis (TNM) Stage 3 | 52 Participants | — |
| Number of Participants According to Initial Tumor, Node, Metastasis (TNM) Stage 4 | 191 Participants | — |
| Number of Participants According to Initial Tumor, Node, Metastasis (TNM) Stage Missing | 58 Participants | — |
| Number of Participants According to International Metastatic RCC Database Consortium (IMDC) Groups Favorable | 70 Participants | — |
| Number of Participants According to International Metastatic RCC Database Consortium (IMDC) Groups Intermediate | 168 Participants | — |
| Number of Participants According to International Metastatic RCC Database Consortium (IMDC) Groups Missing | 65 Participants | — |
| Number of Participants According to International Metastatic RCC Database Consortium (IMDC) Groups Poor | 73 Participants | — |
| Number of Participants According to Memorial Sloan-Kettering Cancer Center (MSKCC) Groups Favorable | 62 Participants | — |
| Number of Participants According to Memorial Sloan-Kettering Cancer Center (MSKCC) Groups Intermediate | 162 Participants | — |
| Number of Participants According to Memorial Sloan-Kettering Cancer Center (MSKCC) Groups Missing | 115 Participants | — |
| Number of Participants According to Memorial Sloan-Kettering Cancer Center (MSKCC) Groups Poor | 37 Participants | — |
| Number of Participants According to Metastatic Sites Bone | 172 Participants | — |
| Number of Participants According to Metastatic Sites Central Nervous System | 50 Participants | — |
| Number of Participants According to Metastatic Sites Liver | 80 Participants | — |
| Number of Participants According to Metastatic Sites Lung | 295 Participants | — |
| Number of Participants According to Previous Interferon Use No | 187 Participants | — |
| Number of Participants According to Previous Interferon Use Yes | 189 Participants | — |
| Number of Participants According to Previous Nephrectomy Status Missing | 5 Participants | — |
| Number of Participants According to Previous Nephrectomy Status No | 83 Participants | — |
| Number of Participants According to Previous Nephrectomy Status Yes | 288 Participants | — |
| Number of Participants With Comorbidities Diabetes Mellitus | 81 Participants | — |
| Number of Participants With Comorbidities Hypertension | 154 Participants | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex: Female, Male Female | 95 Participants | — |
| Sex: Female, Male Male | 281 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 0 |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
Primary
Objective Response Rate (ORR) According to Disease Risk Group in IMDC
ORR: percentage of participants with partial response (PR) and complete response (CR). As per response evaluation criteria in solid tumors (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 \<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. IMDC assessed as favorable (0), intermediate (1-2) or poor (\>=3) based on number of criteria present (KPS \<80%; time from diagnosis to start of systemic therapy \<1 year; corrected serum calcium \[Ca\]; neutrophils and platelets \>ULN; hemoglobin \[hg\] \<LLN).
Time frame: From initiation of sunitinib treatment (retrospective data) till PR and CR or death or progression (up to 30-Oct-2022, cut-off for data registry); approximate follow-up duration of 73 months [from data extracted from registry database]
Population: Analysis population included all eligible participants whose data were retrieved and observed in this study. Here, Number of Participants Analyzed signified participants who were evaluable for this outcome measure and with non-missing data; Number Analyzed signified participants evaluable for specified rows.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Sunitinib | Objective Response Rate (ORR) According to Disease Risk Group in IMDC | Favorable | 57.5 Percentage of participants |
| Sunitinib | Objective Response Rate (ORR) According to Disease Risk Group in IMDC | Intermediate | 44.6 Percentage of participants |
| Sunitinib | Objective Response Rate (ORR) According to Disease Risk Group in IMDC | Poor | 24.0 Percentage of participants |
Primary
ORR According to Disease Risk Group in MSKCC
ORR: percentage of participants with PR and CR. 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 \<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. MSKCC assessed as favorable (0), intermediate (1-2) or poor (\>=3) based on number of criteria present \[KPS \<80%, time from diagnosis to start of systemic therapy \<12 months, lactate dehydrogenase \>1.5\*ULN, hemoglobin \<LLN, serum calcium \>10 mg/dL\].
Time frame: From initiation of sunitinib treatment (retrospective data) till PR and CR or death or progression (up to 30-Oct-2022, cut-off for data registry); approximate follow-up duration of 73 months [from data extracted from registry database]
Population: Analysis population included all eligible participants whose data were retrieved and observed in this study. Here, Number of Participants Analyzed signified participants who were evaluable for this outcome measure and with non-missing data; Number Analyzed signified participants evaluable for specified rows.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Sunitinib | ORR According to Disease Risk Group in MSKCC | Favorable | 66.6 Percentage of participants |
| Sunitinib | ORR According to Disease Risk Group in MSKCC | Intermediate | 44.1 Percentage of participants |
| Sunitinib | ORR According to Disease Risk Group in MSKCC | Poor | 30 Percentage of participants |
Primary
Response Rates According to Disease Risk Group in IMDC
RECIST1.1- CR: disappearance of all lesions & normalization of tumor marker level. Any pathological lymph nodes must have reduction in short axis to \<10 mm. 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; progressive disease (PD): at least 20% increase in sum of longest dimensions of target lesions, reference to the smallest sum of the longest dimensions recorded since treatment started, or appearance of 1 or more new lesions or increase of at least 5 mm in addition to the relative increase of 20%; stable disease (SD): neither shrinkage for CR/PR nor increase for PD taking as reference smallest sum of longest diameters since treatment start. IMDC: favorable (0), intermediate (1-2) or poor (\>=3) based on number of criteria present (KPS \<80%; time from diagnosis to start of systemic therapy \<1 year; corrected serum Ca\]; neutrophils & platelets \>ULN; hg \<LLN).
Time frame: From initiation of sunitinib treatment (retrospective data) till PR/ CR/ SD/ death or progression (up to 30-Oct-2022, cut-off for data registry); approximate follow-up duration of 73 months [from data extracted from registry database]
Population: Analysis population included all eligible participants whose data were retrieved and observed in this study. Here, Number of Participants Analyzed signified participants who were evaluable for this outcome measure and with non-missing data; Number Analyzed signified participants evaluable for specified rows.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Sunitinib | Response Rates According to Disease Risk Group in IMDC | CR: Favorable | 3.0 Percentage of participants |
| Sunitinib | Response Rates According to Disease Risk Group in IMDC | CR: Intermediate | 5.4 Percentage of participants |
| Sunitinib | Response Rates According to Disease Risk Group in IMDC | CR: Poor | 4.0 Percentage of participants |
| Sunitinib | Response Rates According to Disease Risk Group in IMDC | PR: Favorable | 54.5 Percentage of participants |
| Sunitinib | Response Rates According to Disease Risk Group in IMDC | PR: Intermediate | 39.2 Percentage of participants |
| Sunitinib | Response Rates According to Disease Risk Group in IMDC | PR: Poor | 20.0 Percentage of participants |
| Sunitinib | Response Rates According to Disease Risk Group in IMDC | SD: Favorable | 18.2 Percentage of participants |
| Sunitinib | Response Rates According to Disease Risk Group in IMDC | SD: Intermediate | 32.4 Percentage of participants |
| Sunitinib | Response Rates According to Disease Risk Group in IMDC | SD: Poor | 36.0 Percentage of participants |
| Sunitinib | Response Rates According to Disease Risk Group in IMDC | PD: Favorable | 24.2 Percentage of participants |
| Sunitinib | Response Rates According to Disease Risk Group in IMDC | PD: Intermediate | 23.0 Percentage of participants |
| Sunitinib | Response Rates According to Disease Risk Group in IMDC | PD: Poor | 40.0 Percentage of participants |
Primary
Response Rates According to Disease Risk Group in MSKCC
RECIST1.1- CR: disappearance of all lesions and normalization of tumor marker level. Any pathological lymph nodes must have reduction in short axis to \<10 mm. 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; PD: at least 20% increase in sum of longest dimensions of target lesions, reference to the smallest sum of the longest dimensions recorded since treatment started, or the appearance of 1 or more new lesions or increase of at least 5 mm in addition to the relative increase of 20%; SD: neither shrinkage for CR/PR nor increase for PD taking as reference smallest sum of longest diameters since treatment start. MSKCC assessed as favourable (0), intermediate (1-2) or poor (\>=3) based on number of criteria present \[KPS \<80%, time from diagnosis to start of systemic therapy \<12 months, lactate dehydrogenase \>1.5\*ULN, hemoglobin \<LLN, serum calcium \>10 mg/dL\].
Time frame: From initiation of sunitinib treatment (retrospective data) till PR/ CR/ SD/ death or progression (up to 30-Oct-2022, cut-off for data registry); approximate follow-up duration of 73 months [from data extracted from registry database]
Population: Analysis population included all eligible participants whose data were retrieved and observed in this study. Here, Number of Participants Analyzed signified participants who were evaluable for this outcome measure and with non-missing data; Number Analyzed signified participants evaluable for specified rows.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Sunitinib | Response Rates According to Disease Risk Group in MSKCC | CR: Favorable | 3.3 Percentage of participants |
| Sunitinib | Response Rates According to Disease Risk Group in MSKCC | CR: Intermediate | 2.9 Percentage of participants |
| Sunitinib | Response Rates According to Disease Risk Group in MSKCC | CR: Poor | 0.0 Percentage of participants |
| Sunitinib | Response Rates According to Disease Risk Group in MSKCC | PR: Favorable | 63.3 Percentage of participants |
| Sunitinib | Response Rates According to Disease Risk Group in MSKCC | PR: Intermediate | 41.2 Percentage of participants |
| Sunitinib | Response Rates According to Disease Risk Group in MSKCC | PR: Poor | 30.0 Percentage of participants |
| Sunitinib | Response Rates According to Disease Risk Group in MSKCC | SD: Favorable | 16.7 Percentage of participants |
| Sunitinib | Response Rates According to Disease Risk Group in MSKCC | SD: Intermediate | 25.0 Percentage of participants |
| Sunitinib | Response Rates According to Disease Risk Group in MSKCC | SD: Poor | 30.0 Percentage of participants |
| Sunitinib | Response Rates According to Disease Risk Group in MSKCC | PD: Favorable | 16.7 Percentage of participants |
| Sunitinib | Response Rates According to Disease Risk Group in MSKCC | PD: Intermediate | 30.9 Percentage of participants |
| Sunitinib | Response Rates According to Disease Risk Group in MSKCC | PD: Poor | 40.0 Percentage of participants |
Secondary
OS According to Disease Risk Group in MSKCC
OS was defined as the time from the start of the treatment until the date of death. If no death was recorded, data was censored at latest available date in data. MSKCC assessed as favourable (0), intermediate (1-2) or poor (\>=3) based on number of criteria present \[KPS \<80%, time from diagnosis to start of systemic therapy \<12 months, lactate dehydrogenase \>1.5\*ULN, hemoglobin \<LLN, serum calcium \>10 mg/dL\].
Time frame: From initiation of sunitinib treatment (retrospective data) till death or censored date (up to 30-Oct-2022, cut-off for data registry); approximate follow-up duration of 73 months [from data extracted from registry database]
Population: Analysis population included all eligible participants whose data were retrieved and observed in this study. Here, Number of Participants Analyzed signified participants with non-missing data and Number Analyzed signified participants evaluable for specified rows.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Sunitinib | OS According to Disease Risk Group in MSKCC | Favorable | 52.2 Months |
| Sunitinib | OS According to Disease Risk Group in MSKCC | Intermediate | 24.0 Months |
| Sunitinib | OS According to Disease Risk Group in MSKCC | Poor | 4.9 Months |
Secondary
Overall Survival (OS) Rate According to Disease Risk Group in IMDC
OS was defined as the time from the start of the treatment until the date of death. If no death was recorded, data was censored at latest available date in data. IMDC assessed as favorable (0), intermediate (1-2) or poor (\>=3) based on number of criteria present (KPS \<80%; time from diagnosis to start of systemic therapy \<1 year; corrected serum Ca; neutrophils and platelets \>ULN; hg \<LLN).
Time frame: From initiation of sunitinib treatment (retrospective data) till death or censored date (up to 30-Oct-2022, cut-off for data registry); approximate follow-up duration of 73 months [from data extracted from registry database]
Population: Analysis population included all eligible participants whose data were retrieved and observed in this study. Here, Number of Participants Analyzed signified participants with non-missing data and Number Analyzed signified participants evaluable for specified rows.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Sunitinib | Overall Survival (OS) Rate According to Disease Risk Group in IMDC | Favorable | 41.9 Months |
| Sunitinib | Overall Survival (OS) Rate According to Disease Risk Group in IMDC | Intermediate | 31.2 Months |
| Sunitinib | Overall Survival (OS) Rate According to Disease Risk Group in IMDC | Poor | 7.1 Months |
Secondary
PFS According to Disease Risk Group in MSKCC
PFS: duration from start of treatment to PD, end of treatment date or date of death. PD: at least 20% increase in sum of longest dimensions of target lesions, reference to the smallest sum of the longest dimensions recorded since treatment started, or the appearance of 1 or more new lesions or increase of at least 5 mm in addition to the relative increase of 20%. MSKCC assessed as favourable (0), intermediate (1-2) or poor (\>=3) based on number of criteria present \[KPS \<80%, time from diagnosis to start of systemic therapy \<12 months, lactate dehydrogenase \>1.5\*ULN, hemoglobin \<LLN, serum calcium \>10 mg/dL\].
Time frame: From initiation of sunitinib treatment (retrospective data) till progression end of treatment date or date of death (up to 30-Oct-2022, cut-off for data registry); approximate follow-up duration of 73 months [from data extracted from registry database]
Population: Analysis population included all eligible participants whose data were retrieved and observed in this study. Here, Number of Participants Analyzed signified participants with non-missing data and Number Analyzed signified participants evaluable for specified rows.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Sunitinib | PFS According to Disease Risk Group in MSKCC | Favorable | NA Months |
| Sunitinib | PFS According to Disease Risk Group in MSKCC | Intermediate | NA Months |
| Sunitinib | PFS According to Disease Risk Group in MSKCC | Poor | NA Months |
Secondary
Progression-Free Survival (PFS) According to Disease Risk Group in IMDC
PFS: duration from start of treatment to disease progression (PD), end of treatment date or date of death. PD: at least 20% increase in sum of longest dimensions of target lesions, reference to the smallest sum of the longest dimensions recorded since treatment started, or the appearance of 1 or more new lesions or increase of at least 5 mm in addition to the relative increase of 20%. IMDC assessed as favorable (0), intermediate (1-2) or poor (\>=3) based on number of criteria present (KPS \<80%; time from diagnosis to start of systemic therapy \<1 year; corrected serum Ca; neutrophils and platelets \>ULN; hg \<LLN).
Time frame: From initiation of sunitinib treatment (retrospective data) till progression end of treatment date or date of death (up to 30-Oct-2022, cut-off for data registry); approximate follow-up duration of 73 months [from data extracted from registry database]
Population: Analysis population included all eligible participants whose data were retrieved and observed in this study. Here, Number of Participants Analyzed signified participants with non-missing data and Number Analyzed signified participants evaluable for specified rows.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Sunitinib | Progression-Free Survival (PFS) According to Disease Risk Group in IMDC | Favorable | 19.4 Months |
| Sunitinib | Progression-Free Survival (PFS) According to Disease Risk Group in IMDC | Intermediate | 13.14 Months |
| Sunitinib | Progression-Free Survival (PFS) According to Disease Risk Group in IMDC | Poor | 5.02 Months |