Trial Outcomes & Findings for Clinical Outcomes For Patients With Metastatic Renal Cell Carcinoma (mRCC) Who Received Sunitinib After 1st Line Immune-oncology (IO) Treatments (NCT NCT04175262)
NCT ID: NCT04175262
Last Updated: 2023-05-03
Results Overview
Overall survival was defined as the time (in months) from second line sunitinib initiation to death. Participants were censored at their date of last follow-up. Kaplan-Meier method was used for analysis.
COMPLETED
102 participants
From the date of initiation of second line sunitinib to the date of death or censored date, up to a maximum of approximately 5.5 years (from the data collected and observed retrospectively for approximately 4 months)
2023-05-03
Participant Flow
Participants included in this study, were diagnosed with metastatic renal cell carcinoma (mRCC), who were treated with sunitinib from 2014 to 2019, after first-line immune-oncologic therapy.
In this study, data for participants was collected retrospectively through the international mRCC database consortium (IMDC) database. Data was collected and analyzed during study duration of approximately 4 months.
Participant milestones
| Measure |
Sunitinib Following Immune-oncologic Therapy
Participants with mRCC who received sunitinib as second line therapy from 2014 to 2019 after first line immune-oncologic therapy in real world clinical practices were included in this study.
|
|---|---|
|
Overall Study
STARTED
|
102
|
|
Overall Study
COMPLETED
|
102
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Here 'number analyzed" signifies participants evaluable for this baseline measure.
Baseline characteristics by cohort
| Measure |
Sunitinib Following Immune-oncologic Therapy
n=102 Participants
Participants with mRCC who received sunitinib as second line therapy from 2014 to 2019 after first line immune-oncologic therapy in real world clinical practices were included in this study.
|
|---|---|
|
Age, Continuous
|
61.3 Years
STANDARD_DEVIATION 11.0 • n=102 Participants
|
|
Sex: Female, Male
Female
|
24 Participants
n=102 Participants
|
|
Sex: Female, Male
Male
|
78 Participants
n=102 Participants
|
|
Race/Ethnicity, Customized
Race · White
|
54 Participants
n=102 Participants
|
|
Race/Ethnicity, Customized
Race · Non-White
|
48 Participants
n=102 Participants
|
|
Prior Nephrectomy Status
Yes
|
78 Participants
n=102 Participants
|
|
Prior Nephrectomy Status
No
|
24 Participants
n=102 Participants
|
|
Histology Type
Clear cell
|
81 Participants
n=88 Participants • Here 'number analyzed" signifies participants evaluable for this baseline measure.
|
|
Histology Type
Non-clear cell
|
7 Participants
n=88 Participants • Here 'number analyzed" signifies participants evaluable for this baseline measure.
|
|
Metastatic Sites
Greater than (>) 1
|
77 Participants
n=83 Participants • Here 'number analyzed" signifies participants evaluable for this baseline measure.
|
|
Metastatic Sites
1
|
6 Participants
n=83 Participants • Here 'number analyzed" signifies participants evaluable for this baseline measure.
|
|
Site of Metastases
Lung
|
36 Participants
n=83 Participants • Here 'Number analyzed" signifies participants evaluable for this baseline measure.
|
|
Site of Metastases
Lymph nodes
|
26 Participants
n=83 Participants • Here 'Number analyzed" signifies participants evaluable for this baseline measure.
|
|
Site of Metastases
Bone
|
22 Participants
n=83 Participants • Here 'Number analyzed" signifies participants evaluable for this baseline measure.
|
|
Site of Metastases
Liver
|
12 Participants
n=83 Participants • Here 'Number analyzed" signifies participants evaluable for this baseline measure.
|
|
Site of Metastases
Brain
|
8 Participants
n=83 Participants • Here 'Number analyzed" signifies participants evaluable for this baseline measure.
|
|
Site of Metastases
Adrenal gland
|
7 Participants
n=83 Participants • Here 'Number analyzed" signifies participants evaluable for this baseline measure.
|
|
Site of Metastases
Pancreas
|
5 Participants
n=83 Participants • Here 'Number analyzed" signifies participants evaluable for this baseline measure.
|
|
Site of Metastases
Other (Soft tissues, kidney, pleura, pelvis, spleen, peritoneum, and perineal fat)
|
21 Participants
n=83 Participants • Here 'Number analyzed" signifies participants evaluable for this baseline measure.
|
|
Participants According to Time From RCC Diagnosis to First Line Therapy
Less than (<) 1 year
|
67 Participants
n=102 Participants
|
|
Participants According to Time From RCC Diagnosis to First Line Therapy
Greater than or equal to (>= 1) year
|
35 Participants
n=102 Participants
|
|
Karnofsky Performance Status (KPS)
< 80%
|
23 Participants
n=91 Participants • Here 'number analyzed" signifies participants evaluable for this baseline measure.
|
|
Karnofsky Performance Status (KPS)
>= 80%
|
68 Participants
n=91 Participants • Here 'number analyzed" signifies participants evaluable for this baseline measure.
|
|
Hemoglobin Level
< LLN
|
57 Participants
n=91 Participants • Here 'number analyzed" signifies participants evaluable for this baseline measure.
|
|
Hemoglobin Level
>=LLN
|
34 Participants
n=91 Participants • Here 'number analyzed" signifies participants evaluable for this baseline measure.
|
|
Serum Corrected Calcium Level
> ULN
|
5 Participants
n=83 Participants • Here 'number analyzed" signifies participants evaluable for this baseline measure.
|
|
Serum Corrected Calcium Level
Less than or equal to (<=) ULN
|
78 Participants
n=83 Participants • Here 'number analyzed" signifies participants evaluable for this baseline measure.
|
|
Neutrophil Count
> ULN
|
22 Participants
n=90 Participants • Here 'number analyzed" signifies participants evaluable for this baseline measure.
|
|
Neutrophil Count
<= ULN
|
68 Participants
n=90 Participants • Here 'number analyzed" signifies participants evaluable for this baseline measure.
|
|
Platelets Count
> ULN
|
17 Participants
n=91 Participants • Here 'number analyzed" signifies participants evaluable for this baseline measure.
|
|
Platelets Count
<= ULN
|
74 Participants
n=91 Participants • Here 'number analyzed" signifies participants evaluable for this baseline measure.
|
PRIMARY outcome
Timeframe: From the date of initiation of second line sunitinib to the date of death or censored date, up to a maximum of approximately 5.5 years (from the data collected and observed retrospectively for approximately 4 months)Population: Analysis population included all eligible participants whose data was collected and analyzed in this study.
Overall survival was defined as the time (in months) from second line sunitinib initiation to death. Participants were censored at their date of last follow-up. Kaplan-Meier method was used for analysis.
Outcome measures
| Measure |
Sunitinib Following Immune-oncologic Therapy
n=102 Participants
Participants with mRCC who received sunitinib as second line therapy from 2014 to 2019 after first line immune-oncologic therapy in real world clinical practices were included in this study.
|
|---|---|
|
Overall Survival (OS) After Initiation of Second Line Sunitinib Therapy
|
15.6 Months
Interval 9.8 to 21.7
|
PRIMARY outcome
Timeframe: From the date of initiation of second line sunitinib to discontinuation or censored date, up to a maximum of approximately 5.5 years (from the data collected and observed retrospectively for approximately 4 months)Population: Analysis population included all eligible participants whose data was collected and analyzed in this study.
TTD was defined as the time (in months) between initiation of second line sunitinib therapy and discontinuation of therapy for any reason including progression, death, and toxicity. Participants were censored at their date of last follow-up. As per response evaluation criteria in solid tumors (RECIST) 1.1 criteria: disease progression was at least a 20% increase in sum of diameters of target lesions, taking as a reference smallest sum on treatment, the sum must also demonstrate an absolute increase of at least 5 millimeter (mm), or the appearance of at least 1 new lesion. Unequivocal progression of existing non-target lesions. Kaplan-Meier method was used for analysis.
Outcome measures
| Measure |
Sunitinib Following Immune-oncologic Therapy
n=102 Participants
Participants with mRCC who received sunitinib as second line therapy from 2014 to 2019 after first line immune-oncologic therapy in real world clinical practices were included in this study.
|
|---|---|
|
Time to Treatment Discontinuation (TTD) of Second Line Sunitinib Therapy
|
5.4 Months
Interval 4.2 to 7.2
|
PRIMARY outcome
Timeframe: From the initiation of immune-oncologic therapy to discontinuation of immune-oncologic therapy (approximately up to 2 years)Population: Analysis population included all eligible participants whose data was collected and analyzed in this study.
TTD was defined as the time (in months) between initiation of first line Immune-Oncologic therapy and discontinuation of therapy for any reason including progression, death, and toxicity. Participants were censored at their date of last follow-up. As per RECIST 1.1 criteria: disease progression was at least a 20% increase in sum of diameters of target lesions, taking as a reference smallest sum on treatment, the sum must also demonstrate an absolute increase of at least 5 mm, or the appearance of at least 1 new lesion. Unequivocal progression of existing non-target lesions. Kaplan-Meier method was used for analysis.
Outcome measures
| Measure |
Sunitinib Following Immune-oncologic Therapy
n=102 Participants
Participants with mRCC who received sunitinib as second line therapy from 2014 to 2019 after first line immune-oncologic therapy in real world clinical practices were included in this study.
|
|---|---|
|
Time to Treatment Discontinuation (TTD) of First Line Immune-Oncologic Therapy
|
7.4 Months
Standard Deviation 8.8
|
PRIMARY outcome
Timeframe: From the date of initiation of second line sunitinib to discontinuation or censored date, up to a maximum of approximately 5.5 years (from the data collected and observed retrospectively for approximately 4 months)Population: Analysis population included all eligible participants whose data was collected and analyzed in this study. Here, "Overall Number of Participants Analyzed" signifies participants who discontinued second line sunitinib treatment.
Reasons for treatment discontinuation included disease progression, death, toxicity and other reasons including urosepsis, nausea, vomiting, diarrhea, comorbidity, and other unspecified. As per RECIST v1.1. criteria, disease progression was at least a 20% increase in sum of diameters of target lesions, taking as a reference smallest sum on treatment, the sum must also demonstrate an absolute increase of at least 5 mm, or the appearance of at least 1 new lesion. Unequivocal progression of existing non-target lesions.
Outcome measures
| Measure |
Sunitinib Following Immune-oncologic Therapy
n=58 Participants
Participants with mRCC who received sunitinib as second line therapy from 2014 to 2019 after first line immune-oncologic therapy in real world clinical practices were included in this study.
|
|---|---|
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Number of Participants Classified According to Reasons for Second-Line Sunitinib Treatment Discontinuation
Disease progression
|
28 Participants
|
|
Number of Participants Classified According to Reasons for Second-Line Sunitinib Treatment Discontinuation
Toxicity
|
17 Participants
|
|
Number of Participants Classified According to Reasons for Second-Line Sunitinib Treatment Discontinuation
Death
|
3 Participants
|
|
Number of Participants Classified According to Reasons for Second-Line Sunitinib Treatment Discontinuation
Disease progression and Toxicity
|
1 Participants
|
|
Number of Participants Classified According to Reasons for Second-Line Sunitinib Treatment Discontinuation
Disease progression and Death
|
1 Participants
|
|
Number of Participants Classified According to Reasons for Second-Line Sunitinib Treatment Discontinuation
Other (urosepsis, nausea, vomiting, diarrhea, comorbidity, and other unspecified)
|
8 Participants
|
PRIMARY outcome
Timeframe: From the date of initiation of second line sunitinib to the date of PR and CR or censored date, up to a maximum of approximately 5.5 years (from the data collected and observed retrospectively for approximately 4 months)Population: Analysis population included all eligible participants whose data was collected and analyzed in this study.
The objective response rate was defined as the percentage of participants with partial response (PR) and complete response (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 normalisation of tumour 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.
Outcome measures
| Measure |
Sunitinib Following Immune-oncologic Therapy
n=102 Participants
Participants with mRCC who received sunitinib as second line therapy from 2014 to 2019 after first line immune-oncologic therapy in real world clinical practices were included in this study.
|
|---|---|
|
Objective Response Rate (ORR) After Initiation of Second Line Sunitinib Therapy
|
22.5 Percentage of participants
Interval 12.6 to 32.5
|
PRIMARY outcome
Timeframe: From the date of initiation of second line sunitinib to occurrence of disease progression, up to a maximum of approximately 5.5 years (from the data collected and observed retrospectively for approximately 4 months)Population: Analysis population included all eligible participants whose data was collected and analyzed in this study.
Progressive disease (PD) was defined as an increase in visible disease. According to RECIST 1.1; PD = at least a 20% increase in the sum of diameters of target lesions taking as reference the smallest sum on the study. This includes the baseline sum if that is the smallest on study. In addition to the relative increase of 20%, the sum also demonstrated an absolute increase of at least 5 mm or the appearance of at least 1 new lesion. Unequivocal progression of existing non-target lesions.
Outcome measures
| Measure |
Sunitinib Following Immune-oncologic Therapy
n=102 Participants
Participants with mRCC who received sunitinib as second line therapy from 2014 to 2019 after first line immune-oncologic therapy in real world clinical practices were included in this study.
|
|---|---|
|
Percentage of Participants With Progressive Disease (PD) After Initiation of Second Line Sunitinib Therapy
|
43.7 Percentage of participants
Interval 31.8 to 55.5
|
PRIMARY outcome
Timeframe: From the date of initiation of second line sunitinib to the date stable disease or censored date, up to a maximum of approximately 5.5 years (from the data collected and observed retrospectively for approximately 4 months)Population: Analysis population included all eligible participants whose data was collected and analyzed in this study.
Stable disease was defined as no change in size of visible disease. According to RECIST 1.1, stable disease: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease , taking as reference the smallest sum diameters while on study; PD = at least a 20% increase in the sum of diameters of target lesions taking as reference the smallest sum on the study. This includes the baseline sum if that is the smallest on study. In addition to the relative increase of 20%, the sum also demonstrated an absolute increase of at least 5 mm or the appearance of at least 1 new lesion. Unequivocal progression of existing non-target lesions. PR = at least 30% decrease in sum of diameters of target lesions taking as reference baseline sum diameters.
Outcome measures
| Measure |
Sunitinib Following Immune-oncologic Therapy
n=102 Participants
Participants with mRCC who received sunitinib as second line therapy from 2014 to 2019 after first line immune-oncologic therapy in real world clinical practices were included in this study.
|
|---|---|
|
Percentage of Participants With Stable Disease (SD) After Initiation of Second Line Sunitinib Therapy
|
33.8 Percentage of participants
Interval 22.5 to 45.1
|
PRIMARY outcome
Timeframe: From the discontinuation of immune-oncologic therapy to the initiation of sunitinib therapy (approximately up to 2 years)Population: Analysis population included all eligible participants whose data was collected and analyzed in this study.
Outcome measures
| Measure |
Sunitinib Following Immune-oncologic Therapy
n=102 Participants
Participants with mRCC who received sunitinib as second line therapy from 2014 to 2019 after first line immune-oncologic therapy in real world clinical practices were included in this study.
|
|---|---|
|
Time From First Line Immune-Oncologic Therapy Discontinuation to Initiation of Second Line Sunitinib Therapy
|
3.1 Months
Standard Deviation 6.2
|
PRIMARY outcome
Timeframe: From the date of initiation of first line Immune-Oncologic to discontinuation or follow-up (approximately up to 2 years)Population: Analysis population included all eligible participants whose data was collected and analyzed in this study.
Reasons for treatment discontinuation included disease progression, toxicity and other reasons including itchiness, mouth dryness, comorbidity, and other unspecified. As per RECIST 1.1 criteria: disease progression was at least a 20% increase in sum of diameters of target lesions, taking as a reference smallest sum on treatment, the sum must also demonstrate an absolute increase of at least 5 mm, or the appearance of at least 1 new lesion. Unequivocal progression of existing non-target lesions.
Outcome measures
| Measure |
Sunitinib Following Immune-oncologic Therapy
n=102 Participants
Participants with mRCC who received sunitinib as second line therapy from 2014 to 2019 after first line immune-oncologic therapy in real world clinical practices were included in this study.
|
|---|---|
|
Number of Participants Classified According to Reasons for First-Line Immune-Oncologic Treatment Discontinuation
Disease progression
|
53 Participants
|
|
Number of Participants Classified According to Reasons for First-Line Immune-Oncologic Treatment Discontinuation
Toxicity
|
23 Participants
|
|
Number of Participants Classified According to Reasons for First-Line Immune-Oncologic Treatment Discontinuation
Disease progression and Toxicity
|
1 Participants
|
|
Number of Participants Classified According to Reasons for First-Line Immune-Oncologic Treatment Discontinuation
Other (itchiness, mouth dryness, comorbidity, and other unspecified)
|
25 Participants
|
Adverse Events
Sunitinib Following Immune-oncologic Therapy
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
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