Cancer of Kidney, Cancer of the Kidney, Kidney Cancer, Kidney Neoplasms, Renal Cancer, Renal Cell Cancer, Renal Cell Carcinoma
Conditions
Keywords
Advanced/ metastatic RCC (mRCC), Real World Evidence, Registry based study, Non-interventional study, Axitinib, Sunitinib, Pazopanib, Cabozantinib, Nivolumab, Sorafenib, Everolimus, Ipilimumab
Brief summary
The purpose of the study is to find out how patients with advanced kidney cancer have been treated in the hospital district of Southwest Finland over time.
Interventions
None listed
Sponsors
Pfizer
Study design
Observational model
OTHER
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
For the characteristic group: * Diagnosis of renal cell carcinoma (International Classification of Diseases 10th revision \[ICD\]-10:64) during 01 January 2010 and 31 December 2021 For the mRCC group: * ICD-10 diagnosis code for metastasis (C77\*-C79\*), or * American Joint Committee on Cancer (AJCC) stage 4, or AJCC stage data potentially not available for all patients * Visit to oncologist (specialty code 65) with RCC as main diagnosis, or In Finland, the ICD-10 codes for metastatic disease are rarely used. In contrast, RCC patients visit oncologist, when and only when disease metastasises and therefore, the visit can be used as a proxy to a metastatic disease * Initiation of treatment for mRCC
Exclusion criteria
For the characteristic group: * Prevalent mRCC patients (i.e. diagnosis of metastatic RCC before 01 January 2010) * Prevalent mRCC patients (i.e. diagnosis of RCC before 01 January 2010) if there is no records of metastatic disease during 2010-2021 For the mRCC group: * Prevalent patients with mRCC (i.e. diagnosis of metastatic RCC before 01 January 2010) * Patients without treatment for mRCC
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Classified According to Pathological Diagnosis (PAD) Histology | At index | Number of participants classified according to PAD were reported in this outcome measure. Histology included chromophobe renal cell carcinoma, clear cell renal cell carcinoma, oncocytoma renal cell carcinoma, papillary renal cell carcinoma, other (chromophobe, oncocytoma, and papillary renal cell carcinoma included if not reported separately) and missing. Index date was defined as the date of treatment initiation for mRCC. |
| Number of Participants According to Treatment Per Treatment Line Between 2018 to 2021 | Anytime between January 2018 to December 2021 (maximum up to 4 years) | Number of participants according to treatment per treatment line between 2018 to 2021 were reported in this outcome measure. |
| Mean Number of Laboratory Days Per Patient Year | Up to maximum of 12 years (retrospective data collection of 1 month) | Number of laboratory days per patient year were reported in this outcome measure. Per patient year was defined as total sum of events divided by the total sum of follow-up length of the participants. |
| Mean Number of Laboratory Days Per Patient Year Stratified by International Metastatic Database Consortium (IMDC) Risk Category | Up to maximum of 12 years (retrospective data collection of 1 month) | Number of laboratory days per patient year stratified by IMDC risk category were reported in this outcome measure. IMDC risk category included Score 0= favorable risk, no missing values allowed; Score 1-2= intermediate risk, total score=1: maximum 1 risk factor can have missing value, total score=2: no missing values allowed; Score 3-6= poor risk, maximum 3 risk factors allowed to have missing values; Unknown risk= when none of the above risk categories could be assigned. Per patient year was defined as total sum of events divided by the total sum of follow-up length of the participants. |
| Number of Participants Classified According to Karnofsky Performance Status (KPS) Stratified by IMDC Risk Category | At index | KPS:used for rating activities of daily living on 11-step scale from 0-100,higher score=participant better able to carry daily activities.Score:100=normal no complaints;no disease evidence,90=able to carry normal activity;minor signs/symptoms of disease,80=normal activity with effort;some signs/symptoms, 70=cares for self;unable to carry normal activity,60=required occasional assistance,able to care for personal needs,50=required considerable assistance & frequent medical care,40=disabled;required special care/assistance,30=severely disabled;hospital admission indicated;20=very sick;hospital admission necessary,10=moribund & 0=dead.IMDC risk category:0=favorable risk,no missing values allowed;1-2=intermediate risk,total score=1:max 1 risk factor could have missing value,total score=2:no missing values allowed;3-6=poor risk,max 3 risk factors allowed to have missing values; Unknown=none of the above risk categories could be assigned.Index date=date of treatment initiation for mRCC. |
| Number of Participants According to Co-Diagnoses Before Index | 3 years prior to index date | Number of participants according to co-diagnoses 3 years before participant's index were reported in this outcome measure. Index date was defined as the date of treatment initiation for mRCC. Co-diagnoses were based on International Classification of Diseases 10th revision (ICD-10) codes. One participant may have more than one co-diagnoses. |
| Number of Participants According to Co-Diagnoses After Index | Up to 3 years after index date | Number of participants according to co-diagnoses up to 3 years after participant's index were reported in this outcome measure. Index date was defined as the date of treatment initiation for mRCC. Co-diagnoses were based on ICD-10 codes. One participant may have more than one co-diagnoses. |
| Body Mass Index (BMI) | At index | BMI of participants at index was reported in this outcome measure. Index date was defined as the date of treatment initiation for mRCC. |
| Mean Outpatient Visits and Emergent Room Visits Per Patient Year | Up to maximum of 12 years (retrospective data collection of 1 month) | The number of outpatient visits and emergency room (ER) visits per patient year for all contacts, disease-specific contacts and other contacts were reported in this outcome measure. All contacts included disease specific contacts and other contacts. Per patient year was defined as total sum of events divided by the total sum of follow-up length of the participants. |
| Mean Number of Hospitalizations Per Patient Year | Up to maximum of 12 years (retrospective data collection of 1 month) | The number of hospitalization visits per patient year for all contacts, disease-specific contacts and other contacts were reported in this outcome measure. All contacts included disease specific contacts and other contacts. Per patient year was defined as total sum of events divided by the total sum of follow-up length of the participants. |
| Mean Number of Procedures and Surgeries Per Patient Year | Up to maximum of 12 years (retrospective data collection of 1 month) | Number of procedures and surgeries per patient year were reported in this outcome measure. Per patient year was defined as total sum of events divided by the total sum of follow-up length of the participants. |
| Number of Participants According to Treatment | From initiation of treatment until death, moved outside of HDSF or end of study (maximum up to 12 years) | Number of participants receiving each treatment per treatment line were reported in this outcome measure. |
| Number of Participants According to Treatment Per Treatment Line Between 2010 to 2017 | Anytime between January 2010 to December 2017 (maximum up to 8 years) | Number of participants according to treatment per treatment line between 2010 to 2017 were reported in this outcome measure. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Time to Next Treatment (TTNT) | From start of current treatment to date of next line treatment or death or end of study (maximum up to 12 years) | Time to next treatment (TTNT) was defined as the interval between the start of current treatment and the start of the next-line treatment or death or end of study. Kaplan-Meier method was used for analysis. TTNT according to treatment lines were presented in this outcome measure. |
| Number of Participants Classified According to IMDC Risk Group Status at Initiation of Treatment | At index | Number of participants classified according to IMDC risk group status at initiation of treatment were reported in this outcome measure. IMDC risk category included score 0= favorable risk, no missing values allowed; score 1-2= Intermediate risk, total score=1: maximum 1 risk factor can have missing value, total score=2: no missing values allowed; Score 3-6= Poor risk, maximum 3 risk factors allowed to have missing values; Unknown risk= when none of the above risk categories could be assigned. Index date was defined as the date of treatment initiation for mRCC. |
| Mean Absolute Costs Associated With Healthcare Resource Utilization | Up to maximum of 12 years (retrospective data collection of 1 month) | Absolute costs associated with healthcare resource utilization for all contacts, disease-specific contacts and other contacts was reported in this outcome measure. All contacts included ER visits, hospitalizations, and outpatient contacts. |
| Overall Survival | From index until death due to any cause or end of study (maximum up to 12 years) | Overall Survival was defined as the time from index (start of each treatment line) until death due to any cause or end of study. Overall survival according to treatment lines (1, 2 or 3) was presented in this outcome measure. |
Countries
Finland
Participant flow
Recruitment details
This study included data from adult participants diagnosed with renal cell carcinoma (RCC) recorded in routine clinical practice and available in the medical records of the Hospital District of Southwest Finland (HDSF) data lake from January 2010 to December 2021.
Pre-assignment details
A total of 1112 participants with incident RCC were included in the study. Data was evaluated over 1 month in this retrospective study.
Participants by arm
| Arm | Count |
|---|---|
| All Participants With RCC This study included participants diagnosed with RCC (local or metastatic) whose medical records were available at HDSF data lake irrespective of whether they received treatment. Participants were followed up from first record of RCC (index) until death, moved outside of HDSF or up to 31-Dec-2021. | 1,112 |
| Total | 1,112 |
Baseline characteristics
| Characteristic | All Participants With RCC | — |
|---|---|---|
| Age, Continuous All RCC participants | 69.3 Years STANDARD_DEVIATION 12 | — |
| Age, Continuous Not-treated mRCC participants | 74.0 Years STANDARD_DEVIATION 11.7 | — |
| Age, Continuous Treated mRCC participants | 67.7 Years STANDARD_DEVIATION 8.5 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex: Female, Male All RCC participants Female | 418 Participants | — |
| Sex: Female, Male All RCC participants Male | 694 Participants | — |
| Sex: Female, Male Not-treated mRCC participants Female | 57 Participants | — |
| Sex: Female, Male Not-treated mRCC participants Male | 88 Participants | — |
| Sex: Female, Male Treated mRCC participants Female | 68 Participants | — |
| Sex: Female, Male Treated mRCC participants Male | 123 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 100 / 191 |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
Primary
Body Mass Index (BMI)
BMI of participants at index was reported in this outcome measure. Index date was defined as the date of treatment initiation for mRCC.
Time frame: At index
Population: All eligible participants were included. Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| All Participants With RCC | Body Mass Index (BMI) | All RCC participants | 27.3 Kilogram per meter square | Standard Deviation 5.3 |
| All Participants With RCC | Body Mass Index (BMI) | Treated mRCC participants | 25.1 Kilogram per meter square | Standard Deviation 4.3 |
| All Participants With RCC | Body Mass Index (BMI) | Not-treated mRCC participants | 26.5 Kilogram per meter square | Standard Deviation 5.9 |
Primary
Mean Number of Hospitalizations Per Patient Year
The number of hospitalization visits per patient year for all contacts, disease-specific contacts and other contacts were reported in this outcome measure. All contacts included disease specific contacts and other contacts. Per patient year was defined as total sum of events divided by the total sum of follow-up length of the participants.
Time frame: Up to maximum of 12 years (retrospective data collection of 1 month)
Population: All eligible advanced/metastatic RCC participants who initiated treatment for mRCC were included.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| All Participants With RCC | Mean Number of Hospitalizations Per Patient Year | All contacts | 1.25 Hospitalizations per patient year |
| All Participants With RCC | Mean Number of Hospitalizations Per Patient Year | Disease-specific | 0.55 Hospitalizations per patient year |
| All Participants With RCC | Mean Number of Hospitalizations Per Patient Year | Other contacts | 0.7 Hospitalizations per patient year |
Primary
Mean Number of Laboratory Days Per Patient Year
Number of laboratory days per patient year were reported in this outcome measure. Per patient year was defined as total sum of events divided by the total sum of follow-up length of the participants.
Time frame: Up to maximum of 12 years (retrospective data collection of 1 month)
Population: All eligible advanced/metastatic RCC participants who initiated treatment for mRCC were included.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| All Participants With RCC | Mean Number of Laboratory Days Per Patient Year | 21.85 Days per patient year |
Primary
Mean Number of Laboratory Days Per Patient Year Stratified by International Metastatic Database Consortium (IMDC) Risk Category
Number of laboratory days per patient year stratified by IMDC risk category were reported in this outcome measure. IMDC risk category included Score 0= favorable risk, no missing values allowed; Score 1-2= intermediate risk, total score=1: maximum 1 risk factor can have missing value, total score=2: no missing values allowed; Score 3-6= poor risk, maximum 3 risk factors allowed to have missing values; Unknown risk= when none of the above risk categories could be assigned. Per patient year was defined as total sum of events divided by the total sum of follow-up length of the participants.
Time frame: Up to maximum of 12 years (retrospective data collection of 1 month)
Population: All eligible advanced/metastatic RCC participants who initiated treatment for mRCC were included. Here, 'Number Analyzed' signifies participants evaluable for the specified rows.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| All Participants With RCC | Mean Number of Laboratory Days Per Patient Year Stratified by International Metastatic Database Consortium (IMDC) Risk Category | IMDC 0 | 21.46 Days per patient year |
| All Participants With RCC | Mean Number of Laboratory Days Per Patient Year Stratified by International Metastatic Database Consortium (IMDC) Risk Category | IMDC 1-2 | 20.26 Days per patient year |
| All Participants With RCC | Mean Number of Laboratory Days Per Patient Year Stratified by International Metastatic Database Consortium (IMDC) Risk Category | IMDC 3+ | 28.26 Days per patient year |
| All Participants With RCC | Mean Number of Laboratory Days Per Patient Year Stratified by International Metastatic Database Consortium (IMDC) Risk Category | IMDC Unknown | 19.71 Days per patient year |
Primary
Mean Number of Procedures and Surgeries Per Patient Year
Number of procedures and surgeries per patient year were reported in this outcome measure. Per patient year was defined as total sum of events divided by the total sum of follow-up length of the participants.
Time frame: Up to maximum of 12 years (retrospective data collection of 1 month)
Population: All eligible advanced/metastatic RCC participants who initiated treatment for mRCC were included.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| All Participants With RCC | Mean Number of Procedures and Surgeries Per Patient Year | Procedure: All contacts | 10.82 Events per patient year |
| All Participants With RCC | Mean Number of Procedures and Surgeries Per Patient Year | Surgeries: All contacts | 0.77 Events per patient year |
Primary
Mean Outpatient Visits and Emergent Room Visits Per Patient Year
The number of outpatient visits and emergency room (ER) visits per patient year for all contacts, disease-specific contacts and other contacts were reported in this outcome measure. All contacts included disease specific contacts and other contacts. Per patient year was defined as total sum of events divided by the total sum of follow-up length of the participants.
Time frame: Up to maximum of 12 years (retrospective data collection of 1 month)
Population: All eligible advanced/metastatic RCC participants who initiated treatment for mRCC were included.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| All Participants With RCC | Mean Outpatient Visits and Emergent Room Visits Per Patient Year | Outpatient visits: All contacts | 29.37 Visits per patient year |
| All Participants With RCC | Mean Outpatient Visits and Emergent Room Visits Per Patient Year | Outpatient visits: Disease-specific | 19.29 Visits per patient year |
| All Participants With RCC | Mean Outpatient Visits and Emergent Room Visits Per Patient Year | Outpatient visits: Other contacts | 10.07 Visits per patient year |
| All Participants With RCC | Mean Outpatient Visits and Emergent Room Visits Per Patient Year | ER visits: All contacts | 0.28 Visits per patient year |
| All Participants With RCC | Mean Outpatient Visits and Emergent Room Visits Per Patient Year | ER visits: Disease-specific | 0.15 Visits per patient year |
| All Participants With RCC | Mean Outpatient Visits and Emergent Room Visits Per Patient Year | ER visits: Other contacts | 0.14 Visits per patient year |
Primary
Number of Participants According to Co-Diagnoses After Index
Number of participants according to co-diagnoses up to 3 years after participant's index were reported in this outcome measure. Index date was defined as the date of treatment initiation for mRCC. Co-diagnoses were based on ICD-10 codes. One participant may have more than one co-diagnoses.
Time frame: Up to 3 years after index date
Population: All eligible advanced/metastatic RCC participants who initiated treatment for mRCC were included. This analysis was planned only in the treated mRCC participants.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| All Participants With RCC | Number of Participants According to Co-Diagnoses After Index | R10 Abdominal and pelvic pain | 15 Participants |
| All Participants With RCC | Number of Participants According to Co-Diagnoses After Index | Infection | 144 Participants |
| All Participants With RCC | Number of Participants According to Co-Diagnoses After Index | I10 Essential (primary) hypertension | 32 Participants |
| All Participants With RCC | Number of Participants According to Co-Diagnoses After Index | J18 Pneumonia, organism unspecified | 28 Participants |
| All Participants With RCC | Number of Participants According to Co-Diagnoses After Index | R50 Fever of other and unknown origin | 28 Participants |
| All Participants With RCC | Number of Participants According to Co-Diagnoses After Index | E11 Non-insulin-dependent diabetes mellitus | 15 Participants |
| All Participants With RCC | Number of Participants According to Co-Diagnoses After Index | D41 Neoplasm of uncertain or unknown behavior of urinary organs | 14 Participants |
| All Participants With RCC | Number of Participants According to Co-Diagnoses After Index | F43 Reaction to severe stress, and adjustment disorders | 14 Participants |
| All Participants With RCC | Number of Participants According to Co-Diagnoses After Index | E87 Other disorders of fluid, electrolyte and acid-base balance | 13 Participants |
| All Participants With RCC | Number of Participants According to Co-Diagnoses After Index | M54 Dorsalgia | 12 Participants |
| All Participants With RCC | Number of Participants According to Co-Diagnoses After Index | R06 Abnormalities of breathing | 12 Participants |
| All Participants With RCC | Number of Participants According to Co-Diagnoses After Index | R31 Unspecified hematuria | 12 Participants |
| All Participants With RCC | Number of Participants According to Co-Diagnoses After Index | R53 Malaise and fatigue | 12 Participants |
| All Participants With RCC | Number of Participants According to Co-Diagnoses After Index | G47 Sleep disorders | 11 Participants |
| All Participants With RCC | Number of Participants According to Co-Diagnoses After Index | R91 Abnormal findings on diagnostic imaging of lung | 10 Participants |
Primary
Number of Participants According to Co-Diagnoses Before Index
Number of participants according to co-diagnoses 3 years before participant's index were reported in this outcome measure. Index date was defined as the date of treatment initiation for mRCC. Co-diagnoses were based on International Classification of Diseases 10th revision (ICD-10) codes. One participant may have more than one co-diagnoses.
Time frame: 3 years prior to index date
Population: All eligible advanced/metastatic RCC participants who initiated treatment for mRCC were included. This analysis was planned only in the treated mRCC participants.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| All Participants With RCC | Number of Participants According to Co-Diagnoses Before Index | Infection | 139 Participants |
| All Participants With RCC | Number of Participants According to Co-Diagnoses Before Index | D41 Neoplasm of uncertain or unknown behavior of urinary organs | 45 Participants |
| All Participants With RCC | Number of Participants According to Co-Diagnoses Before Index | I10 Essential (primary) hypertension | 41 Participants |
| All Participants With RCC | Number of Participants According to Co-Diagnoses Before Index | R91 Abnormal findings on diagnostic imaging of lung | 26 Participants |
| All Participants With RCC | Number of Participants According to Co-Diagnoses Before Index | R31 Unspecified hematuria | 22 Participants |
| All Participants With RCC | Number of Participants According to Co-Diagnoses Before Index | E11 Non-insulin-dependent diabetes mellitus | 17 Participants |
| All Participants With RCC | Number of Participants According to Co-Diagnoses Before Index | E78 Disorders of lipoprotein metabolism and other lipidaemias | 16 Participants |
| All Participants With RCC | Number of Participants According to Co-Diagnoses Before Index | I48 Atrial fibrillation and flutter | 14 Participants |
| All Participants With RCC | Number of Participants According to Co-Diagnoses Before Index | G47 Sleep disorders | 13 Participants |
| All Participants With RCC | Number of Participants According to Co-Diagnoses Before Index | I26 Pulmonary embolism | 12 Participants |
| All Participants With RCC | Number of Participants According to Co-Diagnoses Before Index | H25 Senile cataract | 11 Participants |
| All Participants With RCC | Number of Participants According to Co-Diagnoses Before Index | J18 Pneumonia, organism unspecified | 11 Participants |
| All Participants With RCC | Number of Participants According to Co-Diagnoses Before Index | N40 Hyperplasia of prostate | 11 Participants |
| All Participants With RCC | Number of Participants According to Co-Diagnoses Before Index | R07 Pain in throat and chest | 11 Participants |
| All Participants With RCC | Number of Participants According to Co-Diagnoses Before Index | R10 Abdominal and pelvic pain | 11 Participants |
| All Participants With RCC | Number of Participants According to Co-Diagnoses Before Index | M17 Gonarthrosis [arthrosis of knee] | 10 Participants |
Primary
Number of Participants According to Treatment
Number of participants receiving each treatment per treatment line were reported in this outcome measure.
Time frame: From initiation of treatment until death, moved outside of HDSF or end of study (maximum up to 12 years)
Population: All eligible advanced/metastatic RCC participants who initiated treatment for mRCC were included.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| All Participants With RCC | Number of Participants According to Treatment | 1st line: Cabozantinib | 25 Participants |
| All Participants With RCC | Number of Participants According to Treatment | 1st line: Ipilimumab, Nivolumab | 8 Participants |
| All Participants With RCC | Number of Participants According to Treatment | 1st line: Other | 5 Participants |
| All Participants With RCC | Number of Participants According to Treatment | 1st line: Pazopanib | 24 Participants |
| All Participants With RCC | Number of Participants According to Treatment | 1st line: Sunitinib | 129 Participants |
| All Participants With RCC | Number of Participants According to Treatment | 2nd line: Axitinib | 21 Participants |
| All Participants With RCC | Number of Participants According to Treatment | 2nd line: Cabozantinib | 24 Participants |
| All Participants With RCC | Number of Participants According to Treatment | 2nd line: Everolimus | 15 Participants |
| All Participants With RCC | Number of Participants According to Treatment | 2nd line: Nivolumab | 12 Participants |
| All Participants With RCC | Number of Participants According to Treatment | 2nd line: Other | 0 Participants |
| All Participants With RCC | Number of Participants According to Treatment | 2nd line: Pazopanib | 22 Participants |
| All Participants With RCC | Number of Participants According to Treatment | 2nd line: Sorafenib | 9 Participants |
| All Participants With RCC | Number of Participants According to Treatment | 2nd line: Sunitinib | 6 Participants |
| All Participants With RCC | Number of Participants According to Treatment | 3rd line: Axitinib | 6 Participants |
| All Participants With RCC | Number of Participants According to Treatment | 3rd line: Cabozantinib | 8 Participants |
| All Participants With RCC | Number of Participants According to Treatment | 3rd line: Everolimus | 19 Participants |
| All Participants With RCC | Number of Participants According to Treatment | 3rd line: Nivolumab | 5 Participants |
| All Participants With RCC | Number of Participants According to Treatment | 3rd line: Pazopanib | 10 Participants |
| All Participants With RCC | Number of Participants According to Treatment | 3rd line: Sunitinib | 7 Participants |
Primary
Number of Participants According to Treatment Per Treatment Line Between 2010 to 2017
Number of participants according to treatment per treatment line between 2010 to 2017 were reported in this outcome measure.
Time frame: Anytime between January 2010 to December 2017 (maximum up to 8 years)
Population: All eligible advanced/metastatic RCC participants who initiated treatment for mRCC were included.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| All Participants With RCC | Number of Participants According to Treatment Per Treatment Line Between 2010 to 2017 | 1st line: Other | 0 Participants |
| All Participants With RCC | Number of Participants According to Treatment Per Treatment Line Between 2010 to 2017 | 1st line: Pazopanib | 19 Participants |
| All Participants With RCC | Number of Participants According to Treatment Per Treatment Line Between 2010 to 2017 | 1st line: Sunitinib | 86 Participants |
| All Participants With RCC | Number of Participants According to Treatment Per Treatment Line Between 2010 to 2017 | 2nd line: Axitinib | 18 Participants |
| All Participants With RCC | Number of Participants According to Treatment Per Treatment Line Between 2010 to 2017 | 2nd line: Cabozantinib | 5 Participants |
| All Participants With RCC | Number of Participants According to Treatment Per Treatment Line Between 2010 to 2017 | 2nd line: Everolimus | 12 Participants |
| All Participants With RCC | Number of Participants According to Treatment Per Treatment Line Between 2010 to 2017 | 2nd line: Other | 0 Participants |
| All Participants With RCC | Number of Participants According to Treatment Per Treatment Line Between 2010 to 2017 | 2nd line: Sorafenib | 9 Participants |
| All Participants With RCC | Number of Participants According to Treatment Per Treatment Line Between 2010 to 2017 | 3rd line: Axitinib | 6 Participants |
| All Participants With RCC | Number of Participants According to Treatment Per Treatment Line Between 2010 to 2017 | 3rd line: Everolimus | 12 Participants |
| All Participants With RCC | Number of Participants According to Treatment Per Treatment Line Between 2010 to 2017 | 3rd line: Other | 5 Participants |
| All Participants With RCC | Number of Participants According to Treatment Per Treatment Line Between 2010 to 2017 | 3rd line: Pazopanib | 9 Participants |
| All Participants With RCC | Number of Participants According to Treatment Per Treatment Line Between 2010 to 2017 | 3rd line: Sunitinib | 5 Participants |
| All Participants With RCC | Number of Participants According to Treatment Per Treatment Line Between 2010 to 2017 | 2nd line: Pazopanib | 18 Participants |
Primary
Number of Participants According to Treatment Per Treatment Line Between 2018 to 2021
Number of participants according to treatment per treatment line between 2018 to 2021 were reported in this outcome measure.
Time frame: Anytime between January 2018 to December 2021 (maximum up to 4 years)
Population: All eligible advanced/metastatic RCC participants who initiated treatment for mRCC were included.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| All Participants With RCC | Number of Participants According to Treatment Per Treatment Line Between 2018 to 2021 | 1st line: Cabozantinib | 25 Participants |
| All Participants With RCC | Number of Participants According to Treatment Per Treatment Line Between 2018 to 2021 | 1st line: Ipilimumab, Nivolumab | 8 Participants |
| All Participants With RCC | Number of Participants According to Treatment Per Treatment Line Between 2018 to 2021 | 1st line: Other | 0 Participants |
| All Participants With RCC | Number of Participants According to Treatment Per Treatment Line Between 2018 to 2021 | 1st line: Pazopanib | 5 Participants |
| All Participants With RCC | Number of Participants According to Treatment Per Treatment Line Between 2018 to 2021 | 1st line: Sunitinib | 43 Participants |
| All Participants With RCC | Number of Participants According to Treatment Per Treatment Line Between 2018 to 2021 | 2nd line: Cabozantinib | 19 Participants |
| All Participants With RCC | Number of Participants According to Treatment Per Treatment Line Between 2018 to 2021 | 2nd line: Nivolumab | 10 Participants |
| All Participants With RCC | Number of Participants According to Treatment Per Treatment Line Between 2018 to 2021 | 2nd line: Other | 16 Participants |
| All Participants With RCC | Number of Participants According to Treatment Per Treatment Line Between 2018 to 2021 | 3rd line: Cabozantinib | 5 Participants |
| All Participants With RCC | Number of Participants According to Treatment Per Treatment Line Between 2018 to 2021 | 3rd line: Everolimus | 7 Participants |
| All Participants With RCC | Number of Participants According to Treatment Per Treatment Line Between 2018 to 2021 | 3rd line: Other | 6 Participants |
Primary
Number of Participants Classified According to Karnofsky Performance Status (KPS) Stratified by IMDC Risk Category
KPS:used for rating activities of daily living on 11-step scale from 0-100,higher score=participant better able to carry daily activities.Score:100=normal no complaints;no disease evidence,90=able to carry normal activity;minor signs/symptoms of disease,80=normal activity with effort;some signs/symptoms, 70=cares for self;unable to carry normal activity,60=required occasional assistance,able to care for personal needs,50=required considerable assistance & frequent medical care,40=disabled;required special care/assistance,30=severely disabled;hospital admission indicated;20=very sick;hospital admission necessary,10=moribund & 0=dead.IMDC risk category:0=favorable risk,no missing values allowed;1-2=intermediate risk,total score=1:max 1 risk factor could have missing value,total score=2:no missing values allowed;3-6=poor risk,max 3 risk factors allowed to have missing values; Unknown=none of the above risk categories could be assigned.Index date=date of treatment initiation for mRCC.
Time frame: At index
Population: All eligible advanced/metastatic RCC participants who initiated treatment for mRCC were included.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| All Participants With RCC | Number of Participants Classified According to Karnofsky Performance Status (KPS) Stratified by IMDC Risk Category | KPS: 10-40; IMDC 0 | 0 Participants |
| All Participants With RCC | Number of Participants Classified According to Karnofsky Performance Status (KPS) Stratified by IMDC Risk Category | KPS: 10-40; IMDC 1-2 | 0 Participants |
| All Participants With RCC | Number of Participants Classified According to Karnofsky Performance Status (KPS) Stratified by IMDC Risk Category | KPS: 10-40; IMDC 3+ | 8 Participants |
| All Participants With RCC | Number of Participants Classified According to Karnofsky Performance Status (KPS) Stratified by IMDC Risk Category | KPS: 10-40; IMDC unknown | 0 Participants |
| All Participants With RCC | Number of Participants Classified According to Karnofsky Performance Status (KPS) Stratified by IMDC Risk Category | KPS: 50-60; IMDC 0 | 0 Participants |
| All Participants With RCC | Number of Participants Classified According to Karnofsky Performance Status (KPS) Stratified by IMDC Risk Category | KPS: 50-60; IMDC 1-2 | 17 Participants |
| All Participants With RCC | Number of Participants Classified According to Karnofsky Performance Status (KPS) Stratified by IMDC Risk Category | KPS: 50-60; IMDC 3+ | 29 Participants |
| All Participants With RCC | Number of Participants Classified According to Karnofsky Performance Status (KPS) Stratified by IMDC Risk Category | KPS: 50-60; IMDC unknown | 5 Participants |
| All Participants With RCC | Number of Participants Classified According to Karnofsky Performance Status (KPS) Stratified by IMDC Risk Category | KPS: 70-80; IMDC 0 | 10 Participants |
| All Participants With RCC | Number of Participants Classified According to Karnofsky Performance Status (KPS) Stratified by IMDC Risk Category | KPS: 70-80; IMDC 1-2 | 48 Participants |
| All Participants With RCC | Number of Participants Classified According to Karnofsky Performance Status (KPS) Stratified by IMDC Risk Category | KPS: 70-80; IMDC 3+ | 34 Participants |
| All Participants With RCC | Number of Participants Classified According to Karnofsky Performance Status (KPS) Stratified by IMDC Risk Category | KPS: 70-80; IMDC unknown | 10 Participants |
| All Participants With RCC | Number of Participants Classified According to Karnofsky Performance Status (KPS) Stratified by IMDC Risk Category | KPS: 90-100; IMDC 0 | 0 Participants |
| All Participants With RCC | Number of Participants Classified According to Karnofsky Performance Status (KPS) Stratified by IMDC Risk Category | KPS: 90-100; IMDC 1-2 | 10 Participants |
| All Participants With RCC | Number of Participants Classified According to Karnofsky Performance Status (KPS) Stratified by IMDC Risk Category | KPS: 90-100; IMDC 3+ | 0 Participants |
| All Participants With RCC | Number of Participants Classified According to Karnofsky Performance Status (KPS) Stratified by IMDC Risk Category | KPS: 90-100; IMDC unknown | 0 Participants |
| All Participants With RCC | Number of Participants Classified According to Karnofsky Performance Status (KPS) Stratified by IMDC Risk Category | Missing; IMDC 0 | 0 Participants |
| All Participants With RCC | Number of Participants Classified According to Karnofsky Performance Status (KPS) Stratified by IMDC Risk Category | Missing; IMDC 1-2 | 0 Participants |
| All Participants With RCC | Number of Participants Classified According to Karnofsky Performance Status (KPS) Stratified by IMDC Risk Category | Missing; IMDC 3+ | 0 Participants |
| All Participants With RCC | Number of Participants Classified According to Karnofsky Performance Status (KPS) Stratified by IMDC Risk Category | Missing; IMDC unknown | 0 Participants |
Primary
Number of Participants Classified According to Pathological Diagnosis (PAD) Histology
Number of participants classified according to PAD were reported in this outcome measure. Histology included chromophobe renal cell carcinoma, clear cell renal cell carcinoma, oncocytoma renal cell carcinoma, papillary renal cell carcinoma, other (chromophobe, oncocytoma, and papillary renal cell carcinoma included if not reported separately) and missing. Index date was defined as the date of treatment initiation for mRCC.
Time frame: At index
Population: All eligible participants were included. Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| All Participants With RCC | Number of Participants Classified According to Pathological Diagnosis (PAD) Histology | RCC participants: Chromophobe renal cell carcinoma | 41 Participants |
| All Participants With RCC | Number of Participants Classified According to Pathological Diagnosis (PAD) Histology | RCC participants: Clear cell renal cell carcinoma | 597 Participants |
| All Participants With RCC | Number of Participants Classified According to Pathological Diagnosis (PAD) Histology | RCC participants: Oncocytoma renal cell carcinoma | 27 Participants |
| All Participants With RCC | Number of Participants Classified According to Pathological Diagnosis (PAD) Histology | RCC participants: Papillary renal cell carcinoma | 105 Participants |
| All Participants With RCC | Number of Participants Classified According to Pathological Diagnosis (PAD) Histology | RCC participants: Other | 0 Participants |
| All Participants With RCC | Number of Participants Classified According to Pathological Diagnosis (PAD) Histology | RCC participants: Missing | 342 Participants |
| All Participants With RCC | Number of Participants Classified According to Pathological Diagnosis (PAD) Histology | Treated mRCC participants: Chromophobe renal cell carcinoma | 0 Participants |
| All Participants With RCC | Number of Participants Classified According to Pathological Diagnosis (PAD) Histology | Treated mRCC participants: Clear cell renal cell carcinoma | 115 Participants |
| All Participants With RCC | Number of Participants Classified According to Pathological Diagnosis (PAD) Histology | Treated mRCC participants: Oncocytoma renal cell carcinoma | 0 Participants |
| All Participants With RCC | Number of Participants Classified According to Pathological Diagnosis (PAD) Histology | Treated mRCC participants: Papillary renal cell carcinoma | 0 Participants |
| All Participants With RCC | Number of Participants Classified According to Pathological Diagnosis (PAD) Histology | Treated mRCC participants: Other | 11 Participants |
| All Participants With RCC | Number of Participants Classified According to Pathological Diagnosis (PAD) Histology | Treated mRCC participants: Missing | 65 Participants |
| All Participants With RCC | Number of Participants Classified According to Pathological Diagnosis (PAD) Histology | Non-treated mRCC participants: Chromophobe renal cell carcinoma | 0 Participants |
| All Participants With RCC | Number of Participants Classified According to Pathological Diagnosis (PAD) Histology | Non-treated mRCC participants: Clear cell renal cell carcinoma | 65 Participants |
| All Participants With RCC | Number of Participants Classified According to Pathological Diagnosis (PAD) Histology | Non-treated mRCC participants: Oncocytoma renal cell carcinoma | 0 Participants |
| All Participants With RCC | Number of Participants Classified According to Pathological Diagnosis (PAD) Histology | Non-treated mRCC participants: Papillary renal cell carcinoma | 0 Participants |
| All Participants With RCC | Number of Participants Classified According to Pathological Diagnosis (PAD) Histology | Non-treated mRCC participants: Other | 8 Participants |
| All Participants With RCC | Number of Participants Classified According to Pathological Diagnosis (PAD) Histology | Non-treated mRCC participants: Missing | 72 Participants |
Other Pre-specified
Mean Absolute Costs Associated With Healthcare Resource Utilization
Absolute costs associated with healthcare resource utilization for all contacts, disease-specific contacts and other contacts was reported in this outcome measure. All contacts included ER visits, hospitalizations, and outpatient contacts.
Time frame: Up to maximum of 12 years (retrospective data collection of 1 month)
Population: All eligible advanced/metastatic RCC participants who initiated treatment for mRCC were included.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| All Participants With RCC | Mean Absolute Costs Associated With Healthcare Resource Utilization | All contacts | 15,473.75 Euros per patient year |
| All Participants With RCC | Mean Absolute Costs Associated With Healthcare Resource Utilization | Disease-specific contacts | 9,114.95 Euros per patient year |
| All Participants With RCC | Mean Absolute Costs Associated With Healthcare Resource Utilization | Other contacts | 6,358.79 Euros per patient year |
Other Pre-specified
Number of Participants Classified According to IMDC Risk Group Status at Initiation of Treatment
Number of participants classified according to IMDC risk group status at initiation of treatment were reported in this outcome measure. IMDC risk category included score 0= favorable risk, no missing values allowed; score 1-2= Intermediate risk, total score=1: maximum 1 risk factor can have missing value, total score=2: no missing values allowed; Score 3-6= Poor risk, maximum 3 risk factors allowed to have missing values; Unknown risk= when none of the above risk categories could be assigned. Index date was defined as the date of treatment initiation for mRCC.
Time frame: At index
Population: All eligible advanced/metastatic RCC participants who initiated treatment for mRCC were included.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| All Participants With RCC | Number of Participants Classified According to IMDC Risk Group Status at Initiation of Treatment | IMDC 0 | 15 Participants |
| All Participants With RCC | Number of Participants Classified According to IMDC Risk Group Status at Initiation of Treatment | IMDC 1-2 | 81 Participants |
| All Participants With RCC | Number of Participants Classified According to IMDC Risk Group Status at Initiation of Treatment | IMDC 3+ | 74 Participants |
| All Participants With RCC | Number of Participants Classified According to IMDC Risk Group Status at Initiation of Treatment | IMDC Unknown | 21 Participants |
Other Pre-specified
Overall Survival
Overall Survival was defined as the time from index (start of each treatment line) until death due to any cause or end of study. Overall survival according to treatment lines (1, 2 or 3) was presented in this outcome measure.
Time frame: From index until death due to any cause or end of study (maximum up to 12 years)
Population: All eligible advanced/metastatic RCC participants who initiated treatment for mRCC were included. Here, 'Number Analyzed' signifies participants evaluable for the specified rows.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| All Participants With RCC | Overall Survival | Treatment line 1 | 21.4 Months |
| All Participants With RCC | Overall Survival | Treatment line 2 | 14.9 Months |
| All Participants With RCC | Overall Survival | Treatment line 3 | 13.8 Months |
Other Pre-specified
Time to Next Treatment (TTNT)
Time to next treatment (TTNT) was defined as the interval between the start of current treatment and the start of the next-line treatment or death or end of study. Kaplan-Meier method was used for analysis. TTNT according to treatment lines were presented in this outcome measure.
Time frame: From start of current treatment to date of next line treatment or death or end of study (maximum up to 12 years)
Population: All eligible advanced/metastatic RCC participants who initiated treatment for mRCC were included. Here, 'Number Analyzed' signifies participants evaluable for the specified rows.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| All Participants With RCC | Time to Next Treatment (TTNT) | Treatment line 1 | 9.3 Months |
| All Participants With RCC | Time to Next Treatment (TTNT) | Treatment line 2 | 7.7 Months |
| All Participants With RCC | Time to Next Treatment (TTNT) | Treatment line 3 | 7.3 Months |