Trial Outcomes & Findings for 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. (NCT NCT05745142)

Last Updated: 2024-08-05

Results Overview

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).

Recruitment status

COMPLETED

Target enrollment

376 participants

Primary outcome timeframe

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]

Results posted on

2024-08-05

Participant Flow

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.

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.

Participant milestones

Participant milestones
Measure	Sunitinib Participants diagnosed with mRCC, who were being treated with Sunitinib as first-line therapy in real world practice and who got registered in RCC registry in Turkey were included. The recommended dose of sunitinib in mRCC is 50 milligrams (mg) orally daily for 4 weeks, followed by 2 weeks off treatment (4/2 schedule).
Overall Study STARTED	376
Overall Study COMPLETED	376
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Sunitinib n=376 Participants 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).
Age, Continuous	58 Years n=376 Participants
Sex: Female, Male Female	95 Participants n=376 Participants
Sex: Female, Male Male	281 Participants n=376 Participants
Number of Participants With Comorbidities Hypertension	154 Participants n=376 Participants
Number of Participants With Comorbidities Diabetes Mellitus	81 Participants n=376 Participants
Number of Participants According to Previous Nephrectomy Status Yes	288 Participants n=376 Participants
Number of Participants According to Previous Nephrectomy Status No	83 Participants n=376 Participants
Number of Participants According to Previous Nephrectomy Status Missing	5 Participants n=376 Participants
Number of Participants According to Previous Interferon Use Yes	189 Participants n=376 Participants
Number of Participants According to Previous Interferon Use No	187 Participants n=376 Participants
Number of Participants According to International Metastatic RCC Database Consortium (IMDC) Groups Favorable	70 Participants n=376 Participants
Number of Participants According to International Metastatic RCC Database Consortium (IMDC) Groups Intermediate	168 Participants n=376 Participants
Number of Participants According to International Metastatic RCC Database Consortium (IMDC) Groups Poor	73 Participants n=376 Participants
Number of Participants According to International Metastatic RCC Database Consortium (IMDC) Groups Missing	65 Participants n=376 Participants
Number of Participants According to Memorial Sloan-Kettering Cancer Center (MSKCC) Groups Favorable	62 Participants n=376 Participants
Number of Participants According to Memorial Sloan-Kettering Cancer Center (MSKCC) Groups Intermediate	162 Participants n=376 Participants
Number of Participants According to Memorial Sloan-Kettering Cancer Center (MSKCC) Groups Poor	37 Participants n=376 Participants
Number of Participants According to Memorial Sloan-Kettering Cancer Center (MSKCC) Groups Missing	115 Participants n=376 Participants
Number of Participants According to Metastatic Sites Lung	295 Participants n=376 Participants
Number of Participants According to Metastatic Sites Bone	172 Participants n=376 Participants
Number of Participants According to Metastatic Sites Liver	80 Participants n=376 Participants
Number of Participants According to Metastatic Sites Central Nervous System	50 Participants n=376 Participants
Number of Participants According to Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1	271 Participants n=376 Participants
Number of Participants According to Eastern Cooperative Oncology Group (ECOG) Performance Status 2	69 Participants n=376 Participants
Number of Participants According to Eastern Cooperative Oncology Group (ECOG) Performance Status 3-4	12 Participants n=376 Participants
Number of Participants According to Eastern Cooperative Oncology Group (ECOG) Performance Status Missing	24 Participants n=376 Participants
Number of Participants According to Initial Tumor, Node, Metastasis (TNM) Stage 1	32 Participants n=376 Participants
Number of Participants According to Initial Tumor, Node, Metastasis (TNM) Stage 2	43 Participants n=376 Participants
Number of Participants According to Initial Tumor, Node, Metastasis (TNM) Stage 3	52 Participants n=376 Participants
Number of Participants According to Initial Tumor, Node, Metastasis (TNM) Stage 4	191 Participants n=376 Participants
Number of Participants According to Initial Tumor, Node, Metastasis (TNM) Stage Missing	58 Participants n=376 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Sunitinib n=132 Participants 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).
Objective Response Rate (ORR) According to Disease Risk Group in IMDC Intermediate	44.6 Percentage of participants
Objective Response Rate (ORR) According to Disease Risk Group in IMDC Poor	24.0 Percentage of participants
Objective Response Rate (ORR) According to Disease Risk Group in IMDC Favorable	57.5 Percentage of participants

PRIMARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	Sunitinib n=132 Participants 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).
Response Rates According to Disease Risk Group in IMDC CR: Favorable	3.0 Percentage of participants
Response Rates According to Disease Risk Group in IMDC CR: Intermediate	5.4 Percentage of participants
Response Rates According to Disease Risk Group in IMDC CR: Poor	4.0 Percentage of participants
Response Rates According to Disease Risk Group in IMDC PR: Favorable	54.5 Percentage of participants
Response Rates According to Disease Risk Group in IMDC PR: Intermediate	39.2 Percentage of participants
Response Rates According to Disease Risk Group in IMDC PR: Poor	20.0 Percentage of participants
Response Rates According to Disease Risk Group in IMDC SD: Favorable	18.2 Percentage of participants
Response Rates According to Disease Risk Group in IMDC SD: Intermediate	32.4 Percentage of participants
Response Rates According to Disease Risk Group in IMDC SD: Poor	36.0 Percentage of participants
Response Rates According to Disease Risk Group in IMDC PD: Favorable	24.2 Percentage of participants
Response Rates According to Disease Risk Group in IMDC PD: Intermediate	23.0 Percentage of participants
Response Rates According to Disease Risk Group in IMDC PD: Poor	40.0 Percentage of participants

PRIMARY outcome

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

Outcome measures

Outcome measures
Measure	Sunitinib n=108 Participants 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).
ORR According to Disease Risk Group in MSKCC Favorable	66.6 Percentage of participants
ORR According to Disease Risk Group in MSKCC Intermediate	44.1 Percentage of participants
ORR According to Disease Risk Group in MSKCC Poor	30 Percentage of participants

PRIMARY outcome

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

Outcome measures

Outcome measures
Measure	Sunitinib n=108 Participants 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).
Response Rates According to Disease Risk Group in MSKCC CR: Favorable	3.3 Percentage of participants
Response Rates According to Disease Risk Group in MSKCC CR: Intermediate	2.9 Percentage of participants
Response Rates According to Disease Risk Group in MSKCC CR: Poor	0.0 Percentage of participants
Response Rates According to Disease Risk Group in MSKCC PR: Favorable	63.3 Percentage of participants
Response Rates According to Disease Risk Group in MSKCC PR: Intermediate	41.2 Percentage of participants
Response Rates According to Disease Risk Group in MSKCC PR: Poor	30.0 Percentage of participants
Response Rates According to Disease Risk Group in MSKCC SD: Favorable	16.7 Percentage of participants
Response Rates According to Disease Risk Group in MSKCC SD: Intermediate	25.0 Percentage of participants
Response Rates According to Disease Risk Group in MSKCC PD: Intermediate	30.9 Percentage of participants
Response Rates According to Disease Risk Group in MSKCC PD: Poor	40.0 Percentage of participants
Response Rates According to Disease Risk Group in MSKCC SD: Poor	30.0 Percentage of participants
Response Rates According to Disease Risk Group in MSKCC PD: Favorable	16.7 Percentage of participants

SECONDARY outcome

Timeframe: 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.

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).

Outcome measures

Outcome measures
Measure	Sunitinib n=311 Participants 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).
Overall Survival (OS) Rate According to Disease Risk Group in IMDC Favorable	41.9 Months Interval 24.9 to 58.9
Overall Survival (OS) Rate According to Disease Risk Group in IMDC Intermediate	31.2 Months Interval 21.8 to 40.6
Overall Survival (OS) Rate According to Disease Risk Group in IMDC Poor	7.1 Months Interval 3.9 to 10.3

SECONDARY outcome

Timeframe: 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.

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).

Outcome measures

Outcome measures
Measure	Sunitinib n=311 Participants 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).
Progression-Free Survival (PFS) According to Disease Risk Group in IMDC Favorable	19.4 Months Interval 11.6 to 27.4
Progression-Free Survival (PFS) According to Disease Risk Group in IMDC Intermediate	13.14 Months Interval 10.0 to 16.2
Progression-Free Survival (PFS) According to Disease Risk Group in IMDC Poor	5.02 Months Interval 4.1 to 5.9

SECONDARY outcome

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.

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

Outcome measures

Outcome measures
Measure	Sunitinib n=261 Participants 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).
OS According to Disease Risk Group in MSKCC Favorable	52.2 Months Interval 31.8 to 72.7
OS According to Disease Risk Group in MSKCC Intermediate	24.0 Months Interval 13.9 to 34.1
OS According to Disease Risk Group in MSKCC Poor	4.9 Months Interval 3.6 to 6.8

SECONDARY outcome

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.

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

Outcome measures

Outcome measures
Measure	Sunitinib n=261 Participants 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).
PFS According to Disease Risk Group in MSKCC Favorable	NA Months In RCC registry, data was not available for PFS per MSKCC risk categories, hence could not be reported.
PFS According to Disease Risk Group in MSKCC Intermediate	NA Months In RCC registry, data was not available for PFS per MSKCC risk categories, hence could not be reported.
PFS According to Disease Risk Group in MSKCC Poor	NA Months In RCC registry, data was not available for PFS per MSKCC risk categories, hence could not be reported.

Adverse Events

Sunitinib

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Pfizer Inc.

Pfizer ClinicalTrials.gov Call Center

Phone: 1-800-718-1021

Email: [email protected]

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