A Study to go Back Into Records and Observe How People With Metastatic Renal Cell Carcinoma (mRCC) Who Received a Medicine Called Sunitinib Responded to This Medicine.

Completed

Conditions: Carcinoma, Renal Cell
Clear-cell Metastatic Renal Cell Carcinoma

Interventions: Drug: Sunitinib

Registration Number: NCT05745142

Lead Sponsor: Pfizer

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 376

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.

Study & Design

Study Type: OBSERVATIONAL

Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
metastatic Renal Cell Carcinoma patients	Sunitinib	metastatic Renal Cell Carcinoma patients with clear cell histology.

Primary Outcome Measures

Name	Time	Method
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 \[KPS \<80%, time from diagnosis to start of systemic therapy \<12 months, lactate dehydrogenase \>1.5\*ULN, hemoglobin \<LLN, serum calcium \>10 mg/dL\].
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 \[KPS \<80%, time from diagnosis to start of systemic therapy \<12 months, lactate dehydrogenase \>1.5\*ULN, hemoglobin \<LLN, serum calcium \>10 mg/dL\].

Secondary Outcome Measures

Name	Time	Method
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 \[KPS \<80%, time from diagnosis to start of systemic therapy \<12 months, lactate dehydrogenase \>1.5\*ULN, hemoglobin \<LLN, serum calcium \>10 mg/dL\].
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).
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 \[KPS \<80%, time from diagnosis to start of systemic therapy \<12 months, lactate dehydrogenase \>1.5\*ULN, hemoglobin \<LLN, serum calcium \>10 mg/dL\].
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).