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.
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.
Study Type
OBSERVATIONAL
Enrollment
376
as provided in real world practice
Pfizer
Istanbul, Turkey (Türkiye)
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]
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]
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]
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]
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]
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]
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]
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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]