Metastatic Renal Cell Carcinoma (mRCC)
Conditions
Brief summary
The study aims to assess clinical outcomes in mRCC patients treated with sunitinib in second-line following IO therapy in real world clinical practices.
Interventions
DRUGsunitinib
Patients to receive sunitinib as second line therapy for mRCC
Sponsors
International Metastatic Renal Cell Carcinoma Database Consortium (IMDC)
Analysis Group, Inc.
Pfizer
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients must meet all of the following inclusion criteria to be eligible for inclusion in the study: * Diagnosed with mRCC * Received IO therapy as 1L therapy * Received sunitinib as 2L therapy * Age 18 years or over at the time of mRCC diagnosis * Actively treated at an IMDC clinical center (to avoid incomplete data)
Exclusion criteria
None
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival (OS) After Initiation of Second Line Sunitinib Therapy | 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) | 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. |
| Time to Treatment Discontinuation (TTD) of Second Line Sunitinib Therapy | 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) | 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. |
| Time to Treatment Discontinuation (TTD) of First Line Immune-Oncologic Therapy | From the initiation of immune-oncologic therapy to discontinuation of immune-oncologic therapy (approximately up to 2 years) | 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. |
| Number of Participants Classified According to Reasons for Second-Line Sunitinib Treatment Discontinuation | 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) | 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. |
| Objective Response Rate (ORR) After Initiation of Second Line Sunitinib Therapy | 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) | 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. |
| Percentage of Participants With Progressive Disease (PD) After Initiation of Second Line Sunitinib Therapy | 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) | 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. |
| Percentage of Participants With Stable Disease (SD) After Initiation of Second Line Sunitinib Therapy | 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) | 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. |
| Time From First Line Immune-Oncologic Therapy Discontinuation to Initiation of Second Line Sunitinib Therapy | From the discontinuation of immune-oncologic therapy to the initiation of sunitinib therapy (approximately up to 2 years) | — |
| Number of Participants Classified According to Reasons for First-Line Immune-Oncologic Treatment Discontinuation | From the date of initiation of first line Immune-Oncologic to discontinuation or follow-up (approximately up to 2 years) | 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. |
Countries
Canada
Participant flow
Recruitment details
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.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 102 |
| Total | 102 |
Baseline characteristics
| Characteristic | Sunitinib Following Immune-oncologic Therapy |
|---|---|
| Age, Continuous | 61.3 Years STANDARD_DEVIATION 11 |
| Hemoglobin Level < LLN | 57 Participants |
| Hemoglobin Level >=LLN | 34 Participants |
| Histology Type Clear cell | 81 Participants |
| Histology Type Non-clear cell | 7 Participants |
| Karnofsky Performance Status (KPS) < 80% | 23 Participants |
| Karnofsky Performance Status (KPS) >= 80% | 68 Participants |
| Metastatic Sites 1 | 6 Participants |
| Metastatic Sites Greater than (>) 1 | 77 Participants |
| Neutrophil Count <= ULN | 68 Participants |
| Neutrophil Count > ULN | 22 Participants |
| Participants According to Time From RCC Diagnosis to First Line Therapy Greater than or equal to (>= 1) year | 35 Participants |
| Participants According to Time From RCC Diagnosis to First Line Therapy Less than (<) 1 year | 67 Participants |
| Platelets Count <= ULN | 74 Participants |
| Platelets Count > ULN | 17 Participants |
| Prior Nephrectomy Status No | 24 Participants |
| Prior Nephrectomy Status Yes | 78 Participants |
| Race/Ethnicity, Customized Race Non-White | 48 Participants |
| Race/Ethnicity, Customized Race White | 54 Participants |
| Serum Corrected Calcium Level Less than or equal to (<=) ULN | 78 Participants |
| Serum Corrected Calcium Level > ULN | 5 Participants |
| Sex: Female, Male Female | 24 Participants |
| Sex: Female, Male Male | 78 Participants |
| Site of Metastases Adrenal gland | 7 Participants |
| Site of Metastases Bone | 22 Participants |
| Site of Metastases Brain | 8 Participants |
| Site of Metastases Liver | 12 Participants |
| Site of Metastases Lung | 36 Participants |
| Site of Metastases Lymph nodes | 26 Participants |
| Site of Metastases Other (Soft tissues, kidney, pleura, pelvis, spleen, peritoneum, and perineal fat) | 21 Participants |
| Site of Metastases Pancreas | 5 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
Number of Participants Classified According to Reasons for First-Line Immune-Oncologic Treatment Discontinuation
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.
Time frame: 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.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Sunitinib Following Immune-oncologic Therapy | Number of Participants Classified According to Reasons for First-Line Immune-Oncologic Treatment Discontinuation | Disease progression | 53 Participants |
| Sunitinib Following Immune-oncologic Therapy | Number of Participants Classified According to Reasons for First-Line Immune-Oncologic Treatment Discontinuation | Toxicity | 23 Participants |
| Sunitinib Following Immune-oncologic Therapy | Number of Participants Classified According to Reasons for First-Line Immune-Oncologic Treatment Discontinuation | Disease progression and Toxicity | 1 Participants |
| Sunitinib Following Immune-oncologic Therapy | Number of Participants Classified According to Reasons for First-Line Immune-Oncologic Treatment Discontinuation | Other (itchiness, mouth dryness, comorbidity, and other unspecified) | 25 Participants |
Primary
Number of Participants Classified According to Reasons for Second-Line Sunitinib Treatment Discontinuation
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.
Time frame: 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.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Sunitinib Following Immune-oncologic Therapy | Number of Participants Classified According to Reasons for Second-Line Sunitinib Treatment Discontinuation | Toxicity | 17 Participants |
| Sunitinib Following Immune-oncologic Therapy | Number of Participants Classified According to Reasons for Second-Line Sunitinib Treatment Discontinuation | Disease progression | 28 Participants |
| Sunitinib Following Immune-oncologic Therapy | Number of Participants Classified According to Reasons for Second-Line Sunitinib Treatment Discontinuation | Death | 3 Participants |
| Sunitinib Following Immune-oncologic Therapy | Number of Participants Classified According to Reasons for Second-Line Sunitinib Treatment Discontinuation | Disease progression and Toxicity | 1 Participants |
| Sunitinib Following Immune-oncologic Therapy | Number of Participants Classified According to Reasons for Second-Line Sunitinib Treatment Discontinuation | Disease progression and Death | 1 Participants |
| Sunitinib Following Immune-oncologic Therapy | 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
Objective Response Rate (ORR) After Initiation of Second Line Sunitinib Therapy
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.
Time frame: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Sunitinib Following Immune-oncologic Therapy | Objective Response Rate (ORR) After Initiation of Second Line Sunitinib Therapy | 22.5 Percentage of participants |
Primary
Overall Survival (OS) After Initiation of Second Line Sunitinib Therapy
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.
Time frame: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Sunitinib Following Immune-oncologic Therapy | Overall Survival (OS) After Initiation of Second Line Sunitinib Therapy | 15.6 Months |
Primary
Percentage of Participants With Progressive Disease (PD) After Initiation of Second Line Sunitinib Therapy
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.
Time frame: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Sunitinib Following Immune-oncologic Therapy | Percentage of Participants With Progressive Disease (PD) After Initiation of Second Line Sunitinib Therapy | 43.7 Percentage of participants |
Primary
Percentage of Participants With Stable Disease (SD) After Initiation of Second Line Sunitinib Therapy
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.
Time frame: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Sunitinib Following Immune-oncologic Therapy | Percentage of Participants With Stable Disease (SD) After Initiation of Second Line Sunitinib Therapy | 33.8 Percentage of participants |
Primary
Time From First Line Immune-Oncologic Therapy Discontinuation to Initiation of Second Line Sunitinib Therapy
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sunitinib Following Immune-oncologic Therapy | Time From First Line Immune-Oncologic Therapy Discontinuation to Initiation of Second Line Sunitinib Therapy | 3.1 Months | Standard Deviation 6.2 |
Primary
Time to Treatment Discontinuation (TTD) of First Line Immune-Oncologic Therapy
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sunitinib Following Immune-oncologic Therapy | Time to Treatment Discontinuation (TTD) of First Line Immune-Oncologic Therapy | 7.4 Months | Standard Deviation 8.8 |
Primary
Time to Treatment Discontinuation (TTD) of Second Line Sunitinib Therapy
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.
Time frame: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Sunitinib Following Immune-oncologic Therapy | Time to Treatment Discontinuation (TTD) of Second Line Sunitinib Therapy | 5.4 Months |