Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Research Questions:
To understand the clinical outcomes of patients treated with sunitinib in first line and axitinib in second line in a real world setting as therapies for metastatic and/or advanced renal cell carcinoma (mRCC).
Primary Objective:
Research Questions:
To understand the clinical outcomes of patients treated with sunitinib in first line and axitinib in second line in a real world setting as therapies for metastatic and/or advanced renal cell carcinoma (mRCC).
Primary Objective:
Secondary Objectives:
First Line:
What is the overall survival (OS) of all patients in first line with sunitinib, and stratified by MSKCC risk (favourable, intermediate, poor)?
What is the duration of therapy with sunitinib in first line (using time to treatment discontinuation [TTD]) for all patients and stratified by MSKCC risk (favourable, intermediate, poor)
Objective response rate (ORR)
Duration of objective response (complete response [CR] or partial response [PR])
Examine factors that predict TTD, e.g. risk stratification, or individual/grouped parameters that comprise the prognostic classification systems
Safety and tolerability data reporting for first line sunitinib
Second line:
What is the OS of all patients in second line with axitinib, and stratified by MSKCC risk (favourable, intermediate, poor)?
What is the duration of therapy with axitinib in second line (using TTD) for all patients and stratified by MSKCC risk (favourable, intermediate, poor)
ORR
Duration of objective response (CR or PR)
Examine factors that predict duration of TTD, e.g. risk stratification, or individual/grouped parameters that comprise the prognostic classification systems
Safety and tolerability reporting for second line axitinib
The objectives listed below will also be assessed as exploratory analyses for various patient subgroups of interest, and will be conducted if sufficient numbers of patients are available:
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with advanced RCC | Patients with a diagnosis of kidney cancer (renal cell carcinoma, advanced or metastatic) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sunitinib | Drug | Tyrosine kinase inhibitor, licensed for use in treatment of renal cell carcinoma. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival (PFS) | PFS was duration measured from the first date of each treatment line to the date of disease progression (PD), end of treatment date or date of death. Participants who were on treatment were censored on 30 June 2018. If a participant stopped due to toxicity, the earliest date from the date of progression or end of treatment date was assigned. PD per Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1 was defined as at least a 20 percent (%) increase in sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 millimeter (mm). The appearance of one or more new lesions was also considered progression. | From start of treatment to PD, death or end of treatment, whichever occurred first, from inception of database (2002) until 30 June 2018, anytime in these 16 years (from the data retrieved and observed retrospectively for approximately 1.2 years) |
| Progression Free Survival (PFS): Memorial Sloan-Kettering Cancer Center (MSKCC) Stratification | PFS: first date of each treatment line to the date of PD, end of treatment date or date of death. Participants who were on treatment were censored on 30 June 2018. If a participant stopped due to toxicity, the earliest date from date of PD or end of treatment date was assigned. MSKCC criteria had 5 risk factors: Karnofsky performance status (KPS) <80% (ability to perform ordinary tasks, 0 [dead] -100 [normal]); time from diagnosis to start of systemic therapy <12 months; hemoglobin <lower limit of normal (LLN); lactate dehydrogenase 1.5*upper limit of normal (ULN); corrected serum calcium >10 milligram per deciliter (mg/dL). Present risk factors were added, and participants were stratified as: favorable (0 factor), intermediate (1-2 factors), poor (>=3 factors). PD: >=20% increase in sum of diameters of target lesions, taking as reference smallest sum on study, the sum must also demonstrate an absolute increase of at least 5 mm. Appearance of 1 or more new lesions was considered PD. | From start of treatment to PD, death or end of treatment, whichever occurred first, from inception of database (2002) until 30 June 2018, anytime in these 16 years (from the data retrieved and observed retrospectively for approximately 1.2 years) |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) | OS was defined as the time between the index date and the date of death from any cause. Participants who were still alive at the study end date or the last visit date available were censored. Index date: date of initiation of first-line sunitinib therapy and second-line axitinib therapy. | From index date until death, from inception of database (2002) until 30 June 2018, anytime in these 16 years (from the data retrieved and observed retrospectively for approximately 1.2 years) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Started Systemic Therapy Within 1 Year of Diagnosis | Baseline (data retrieved and observed retrospectively for approximately 1.2 years) | |
| Number of Participants With Karnofsky Performance Status (KPS) Less Than 80 Percent (%) | KPS: used for rating participant activities of daily living on scale from 0-100, higher score = participant is better able to carry out daily activities. Score range: 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 on normal activity, 60 = requires occasional assistance, but able to care for most personal needs, 50 = requires considerable assistance and frequent medical care, 40 = disabled; requires special care, assistance, 30 = severely disabled; hospital admission is indicated although death not imminent, 20 = very sick; hospital admission necessary, 10 = moribund; fatal processes progressing rapidly and 0 = dead. The lower the score the worse is survival for most serious illnesses. Here, number of participants with KPS <80% were reported. |
Inclusion criteria
Exclusion criteria
Patients meeting any of the following criteria will not be included in the study:
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer UK | London | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39382446 | Derived | Waddell T, Pillai M, Armitage K, Graham DM, Moran M, Dilleen M, Holmes S, Sleszynska-Dopiera E, Hawkins R. Real-world effectiveness of first- and second-line anti-angiogenesis therapy in RCC: analysis of a UK-based population. Future Oncol. 2024;20(33):2547-2558. doi: 10.1080/14796694.2024.2385882. Epub 2024 Oct 9. |
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
Not provided
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
Not provided
Not provided
Not provided
Not provided
Not provided
Data of participants treated with first-line sunitinib and/or second-line axitinib in real world settings for metastatic renal cell carcinoma (mRCC) and/or advanced renal cell carcinoma (aRCC), from 2002 until 30 June 2018, were retrieved from Christie National Health Service (NHS) database. Available data were extracted, curated and analyzed during approximately 1.2 years of this retrospective, observational study.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Participants With mRCC and/or aRCC | Participants who met the selection criteria, diagnosed with mRCC and/or aRCC, received sunitinib as first-line treatment and/or axitinib as second-line treatment from 2002 till 30 June 2018, according to normal routine healthcare practice in real-world setting, were included in this study. Data of these participants were derived from Christie NHS database. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Analysis population included all eligible participants with mRCC and/or aRCC, received sunitinib as first-line treatment and/or axitinib as second-line treatment from 2002 till 30 June 2018.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Participants With mRCC and/or aRCC | Participants who met the selection criteria, diagnosed with mRCC and/or aRCC, received sunitinib as first-line treatment and/or axitinib as second-line treatment from 2002 till 30 June 2018, according to normal routine healthcare practice in real-world setting, were included in this study. Data of these participants were derived from Christie NHS database. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Progression Free Survival (PFS) | PFS was duration measured from the first date of each treatment line to the date of disease progression (PD), end of treatment date or date of death. Participants who were on treatment were censored on 30 June 2018. If a participant stopped due to toxicity, the earliest date from the date of progression or end of treatment date was assigned. PD per Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1 was defined as at least a 20 percent (%) increase in sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 millimeter (mm). The appearance of one or more new lesions was also considered progression. | Analysis population included all eligible participants with mRCC and/or aRCC, received sunitinib as first-line treatment and/or axitinib as second-line treatment from 2002 till 30 June 2018. | Posted | Median | 95% Confidence Interval | Months | From start of treatment to PD, death or end of treatment, whichever occurred first, from inception of database (2002) until 30 June 2018, anytime in these 16 years (from the data retrieved and observed retrospectively for approximately 1.2 years) |
Not applicable as adverse events were not collected during the study
Minimum criteria for reporting an adverse event (i.e. identifiable participant, identifiable reporter, a suspect product, and event) could not met, hence, adverse events were not collected and reported.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Participants With mRCC and/or aRCC: First Line Sunitinib Treatment | Participants who met the selection criteria, diagnosed with mRCC and/or aRCC, received sunitinib as first-line treatment from 2002 till 30 June 2018, according to normal routine healthcare practice in real-world setting, were included in this reporting arm. Data of these participants were derived from Christie NHS database. |
Not provided
Not provided
Data was originally planned to be retrieved and analyzed from the database inception date (2002) until the end of June 2017. However, due to delay in data transfer, data retrieved and analysis was extended from end of June 2017 to end of June 2018. Required information for outcome measures- duration of response and durable response rate was not present in Christie NHS database. Hence, data could not be collected and analyzed for these outcome measures.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 14, 2019 | Dec 2, 2021 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D002277 | Carcinoma |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077210 | Sunitinib |
| D000077784 | Axitinib |
| ID | Term |
|---|---|
| D011758 | Pyrroles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
Not provided
Not provided
Not provided
| Axitinib | Drug | Tyrosine kinase inhibitor, licensed for use in treatment of renal cell carcinoma. |
|
|
| Progression Free Survival (PFS): International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) Stratification |
PFS: duration measured from first date of each treatment line to the date of PD, end of treatment date or date of death. Participants who were on treatment were censored on 30 June 2018. If a participant stopped due to toxicity, the earliest date from date of PD or end of treatment date was assigned. IMDC criteria had 6 risk factors: KPS <80% (ability to perform ordinary tasks, 0 [dead] -100 [normal]); time from diagnosis to start of systemic therapy <12 months; corrected serum calcium >10 mg/dL; neutrophils and platelets >LLN; hemoglobin <LLN. Present risk factors were added, and then participants were stratified as: favorable (0 factor), intermediate (1-2 factors), poor (>=3 factors). PD: >=20% increase in sum of diameters of target lesions, taking as reference smallest sum on study, the sum must also demonstrate an absolute increase of at least 5 mm. Appearance of 1 or more new lesions was also considered PD. |
| From start of treatment to PD, death or end of treatment, whichever occurred first, from inception of database (2002) until 30 June 2018, anytime in these 16 years (from the data retrieved and observed retrospectively for approximately 1.2 years) |
| Overall Survival (OS): Memorial Sloan-Kettering Cancer Center (MSKCC) Stratification | OS was defined as the time between the index date and the date of death from any cause. Participants who were still alive at the study end date or the last visit date available were censored. MSKCC criteria had 5 risk factors: KPS <80% (ability to perform ordinary tasks, 0 [dead] -100 [normal]); time from diagnosis to start of systemic therapy <12 months; hemoglobin <LLN; lactate dehydrogenase 1.5* ULN; corrected serum calcium >10.0 mg/dL. Present risk factors were added, and then participants were stratified in following prognosis group: favorable (0 factor), intermediate (1-2 factors), poor (>=3 factors), unknown/missing = no information available. Index date: date of initiation of first-line sunitinib therapy and second-line axitinib therapy. | From index date until death, from inception of database (2002) until 30 June 2018, anytime in these 16 years (from the data retrieved and observed retrospectively for approximately 1.2 years) |
| Overall Survival (OS): International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) Stratification | OS was defined as the time between the index date and the date of death from any cause. Participants who were still alive at the study end date or the last visit date available were censored. IMDC criteria had 6 risk factors: KPS <80% (ability to perform ordinary tasks, 0 [dead] -100 [normal]); time from diagnosis to start of systemic therapy <12 months; corrected serum calcium >10.0 mg/dL; neutrophils and platelets >LLN and hemoglobin <LLN. Present risk factors were added, and then participants were stratified in following prognosis group: favorable (0 factor), intermediate (1-2 factors), poor (>=3 factors), unknown/missing =no information available. Index date: date of initiation of first-line sunitinib therapy and second-line axitinib therapy. | From index date until death, from inception of database (2002) until 30 June 2018, anytime in these 16 years (from the data retrieved and observed retrospectively for approximately 1.2 years) |
| Number of Participants With Best Overall Response (BOR) for Complete Response (CR), Partial Response (PR), Stable Disease (SD), PD and Surgical CR as Per RECIST v 1.1 | BOR was recorded for CR, PR, SD, PD and surgical CR. RECIST v1.1, a) CR: disappearance of target, non-target lesions and normalization of tumor markers. Pathological lymph nodes had short axis measures <10mm; b) PR: >=30% decrease in sum of measures (longest diameter for tumor lesions, short axis measure for nodes) of target lesions, taking reference baseline sum of diameters. Non-target lesions must be non-PD; c) PD: >=20% increase in sum of diameters of target lesions, taking as reference smallest sum on study, sum must demonstrate absolute increase of at least 5mm. Appearance of 1 or more new lesions; d) SD: neither shrinkage for CR/PR nor increase for PD taking as reference smallest sum of longest diameters since treatment start; e) Surgical CR: disappearance of target, non-target lesions, normalization of tumor markers, pathological lymph nodes had short axis measuring <10mm as result of surgery. Alive participants with no events were censored at final study cutoff date. | Start of treatment till BOR of CR, PR, PD, SD, Surgical CR, or death/initiation of new therapy, whichever occurred first; from 2002 to 30 June 2018, anytime in these 16 years (data retrieved and observed retrospectively for approximately 1.2 years) |
| Objective Response Rate (ORR) | ORR was defined as the percentage of participants who achieved a BOR of CR or PR as per RECIST v1.1. CR was defined as disappearance of target and non-target lesions and normalization of tumor markers. Pathological lymph nodes must have short axis measures <10 mm. PR was defined as at least a 30% decrease in the sum of measures (longest diameter for tumor lesions and short axis measure for nodes) of target lesions, taking as reference baseline sum of diameters. Non-target lesions must be non-PD. PD was defined as at least a 20% increase in sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions was considered progression. Alive participants who did not have event were censored at final study cutoff date. | From start of treatment until CR,PR,PD,death/initiation of new therapy, whichever occurred first, from inception of database(2002) until 30 June 2018, anytime in these 16 years (from data retrieved and observed retrospectively for approximately 1.2 years) |
| Duration of Response (DOR) | DOR was defined as the time between the date of the first documented confirmed response (PR or CR) and the date of the first documented progression or death due to any cause. Alive participants who did not have event were censored at final study cutoff date. As per RECIST v1.1: CR was defined as disappearance of target and non-target lesions and normalization of tumor markers. Pathological lymph nodes short axis measures <10 mm. PR was defined as at least 30% decrease in sum of measures (tumor lesions- longest diameter and nodes- short axis) of target lesions, taking as reference baseline sum of diameters. PD was defined as at least 20% increase in sum of diameters of measured lesions taking as references smallest sum of diameters recorded on study (including baseline) and an absolute increase of >=5 mm or appearance of at least 1 new lesion. | From date of first documented CR/PR until PD/death/initiation of new therapy, whichever occurred first, from inception of database(2002) until 30 June 2018, anytime in these 16years (data retrieved and observed retrospectively for approximately 1.2 years) |
| Time to Treatment Discontinuation (TTD) | TTD was defined as the time between initiation of treatment to the end of treatment for any reason including PD, death, and lost-to follow up. Participants were censored on the study end date or at last office visit date without clinical or radiographic evidence of PD, whichever occurred first. | From start of the treatment until end of treatment, from inception of database (2002) until 30 June 2018, anytime in these 16 years (from the data retrieved and observed retrospectively for approximately 1.2 years) |
| Time to Treatment Discontinuation (TTD): Memorial Sloan-Kettering Cancer Center (MSKCC) Stratification | TTD was defined as the time between initiation of treatment to the end of treatment for any reason including PD, death, and lost-to follow up. Participants were censored on the study end date or at last office visit date without clinical or radiographic evidence of PD, whichever occurred first. MSKCC criteria had following 5 risk factors: KPS <80% (ability to perform ordinary tasks, 0 [dead] -100 [normal]); time from diagnosis to start of systemic therapy <12 months; hemoglobin <LLN; lactate dehydrogenase 1.5*ULN; corrected serum calcium >10.0 mg/dL. Present risk factors were added, and then participants were stratified in following prognosis group: favorable (0 factor), intermediate (1-2 factors), poor (>=3 factors), unknown/missing = no information available. | From start of the treatment until end of treatment, from inception of database (2002) until 30 June 2018, anytime in these 16 years (from the data retrieved and observed retrospectively for approximately 1.2 years) |
| Time to Treatment Discontinuation (TTD): International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) Stratification | TTD was defined as the time between initiation of treatment to the end of treatment for any reason including PD, death, and lost-to follow up. Participants were censored on the study end date or at last office visit date without clinical or radiographic evidence of PD, whichever occurred first. IMDC criteria had following 6 risk factors: KPS <80% (ability to perform ordinary tasks, 0 [dead] -100 [normal]); time from diagnosis to start of systemic therapy <12 months; corrected serum calcium >10.0 mg/dL; neutrophils and platelets >LLN and hemoglobin <LLN. Present risk factors were added, and then participants were stratified in following prognosis group: favorable (0 factor), intermediate (1-2 factors), poor (>=3 factors), unknown/missing =no information available. | From start of the treatment until end of treatment, from inception of database (2002) until 30 June 2018, anytime in these 16 years (from the data retrieved and observed retrospectively for approximately 1.2 years) |
| Durable Response Rate (DRR) | DRR was determined as the percentage of participants with objective response (CR or PR) with a duration of at least 6 months. As per RECIST v1.1: CR was defined as disappearance of target and non-target lesions and normalization of tumor markers. Pathological lymph nodes short axis measures <10 mm. PR was defined as at least 30% decrease in sum of measures (tumor lesions- longest diameter and nodes- short axis) of target lesions, taking as reference baseline sum of diameters. | 6 months from inception of database (2002) until 30 June 2018, anytime in these 16 years (from the data retrieved and observed retrospectively for approximately 1.2 years) |
| Baseline (data retrieved and observed retrospectively for approximately 1.2 years) |
| Number of Participants With Hemoglobin Less Than Lower Limit of Normal (LLN) | In this outcome measure number of participants with hemoglobin less than LLN were reported. For male participants LLN was 130 grams per liter and for female participants LLN was 115 grams per liter. | Baseline (data retrieved and observed retrospectively for approximately 1.2 years) |
| Number of Participants With Serum Calcium >Upper Limit of Normal (ULN), Neutrophil >ULN, Platelets >ULN and Lactate Dehydrogenase >1.5*ULN | Number of participants with serum calcium >ULN (3.00 millimole per liter [mmol/L]), neutrophils >ULN (7.5 *10^9/L), platelets >ULN (400 *10^9/L), lactate dehydrogenase >1.5*ULN were reported in this outcome measure. | Baseline (data retrieved and observed retrospectively for approximately 1.2 years) |
| Number of Participants Per Tumor Fuhrman Grades | The four-tiered Fuhrman grading evaluates nuclear size, nuclear shape and presence of nucleolar prominence. Grade 1: small (=10 micrometer [mcm]) nuclear diameter, round/uniform nuclear shape and absent/inconspicuous nucleoli; Grade 2: large (=15 mcm) nuclear diameter, irregular outline nuclear shape and visible at *400 magnification nucleoli; Grade 3: larger (=20 mcm) nuclear diameter, obvious irregular outline nuclear shape and visible and prominent at *100 magnification nucleoli; Grade 4: grade 3 plus bizarre multilobed nuclei +/- spindle cells. | Baseline (data retrieved and observed retrospectively for approximately 1.2 years) |
| Number of Participants With Tumor Subtype | In this outcome measure, number of participants were classified according to tumor subtype as clear cell, non-clear cell and unknown/missing. | Baseline (data retrieved and observed retrospectively for approximately 1.2 years) |
| Number of Participants With Adverse Events | An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship with the study treatment. | From start of treatment until death, from inception of database (2002) until 30 June 2018, anytime in these 16 years (from the data retrieved and observed retrospectively for approximately 1.2 years) |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| ID | Title | Description |
|---|---|---|
| OG000 | Participants With mRCC and/or aRCC: First Line Sunitinib Treatment | Participants who met the selection criteria, diagnosed with mRCC and/or aRCC, received sunitinib as first-line treatment from 2002 till 30 June 2018, according to normal routine healthcare practice in real-world setting, were included in this reporting arm. Data of these participants were derived from Christie NHS database. |
| OG001 | Participants With mRCC and/or aRCC: Second Line Axitinib Treatment | Participants who met the selection criteria, diagnosed with mRCC and/or aRCC, received axitinib as second-line treatment from 2002 till 30 June 2018, according to normal routine healthcare practice in real-world setting, were included in this reporting arm. Data of these participants were derived from Christie NHS database. |
|
|
| Primary | Progression Free Survival (PFS): Memorial Sloan-Kettering Cancer Center (MSKCC) Stratification | PFS: first date of each treatment line to the date of PD, end of treatment date or date of death. Participants who were on treatment were censored on 30 June 2018. If a participant stopped due to toxicity, the earliest date from date of PD or end of treatment date was assigned. MSKCC criteria had 5 risk factors: Karnofsky performance status (KPS) <80% (ability to perform ordinary tasks, 0 [dead] -100 [normal]); time from diagnosis to start of systemic therapy <12 months; hemoglobin <lower limit of normal (LLN); lactate dehydrogenase 1.5*upper limit of normal (ULN); corrected serum calcium >10 milligram per deciliter (mg/dL). Present risk factors were added, and participants were stratified as: favorable (0 factor), intermediate (1-2 factors), poor (>=3 factors). PD: >=20% increase in sum of diameters of target lesions, taking as reference smallest sum on study, the sum must also demonstrate an absolute increase of at least 5 mm. Appearance of 1 or more new lesions was considered PD. | Analysis population included all eligible participants with mRCC and/or aRCC, received sunitinib as first-line treatment and/or axitinib as second-line treatment from 2002 till 30 June 2018. Here "Number Analyzed" signifies number of participants evaluable for specified rows. | Posted | Median | 95% Confidence Interval | Months | From start of treatment to PD, death or end of treatment, whichever occurred first, from inception of database (2002) until 30 June 2018, anytime in these 16 years (from the data retrieved and observed retrospectively for approximately 1.2 years) |
|
|
|
|
| Primary | Progression Free Survival (PFS): International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) Stratification | PFS: duration measured from first date of each treatment line to the date of PD, end of treatment date or date of death. Participants who were on treatment were censored on 30 June 2018. If a participant stopped due to toxicity, the earliest date from date of PD or end of treatment date was assigned. IMDC criteria had 6 risk factors: KPS <80% (ability to perform ordinary tasks, 0 [dead] -100 [normal]); time from diagnosis to start of systemic therapy <12 months; corrected serum calcium >10 mg/dL; neutrophils and platelets >LLN; hemoglobin <LLN. Present risk factors were added, and then participants were stratified as: favorable (0 factor), intermediate (1-2 factors), poor (>=3 factors). PD: >=20% increase in sum of diameters of target lesions, taking as reference smallest sum on study, the sum must also demonstrate an absolute increase of at least 5 mm. Appearance of 1 or more new lesions was also considered PD. | Analysis population included all eligible participants with mRCC and/or aRCC, received sunitinib as first-line treatment and/or axitinib as second-line treatment from 2002 till 30 June 2018. Here "Number Analyzed" signifies number of participants evaluable for specified rows. | Posted | Median | 95% Confidence Interval | Months | From start of treatment to PD, death or end of treatment, whichever occurred first, from inception of database (2002) until 30 June 2018, anytime in these 16 years (from the data retrieved and observed retrospectively for approximately 1.2 years) |
|
|
|
|
| Secondary | Overall Survival (OS) | OS was defined as the time between the index date and the date of death from any cause. Participants who were still alive at the study end date or the last visit date available were censored. Index date: date of initiation of first-line sunitinib therapy and second-line axitinib therapy. | Analysis population included all eligible participants with mRCC and/or aRCC, received sunitinib as first-line treatment and/or axitinib as second-line treatment from 2002 till 30 June 2018. | Posted | Median | 95% Confidence Interval | Months | From index date until death, from inception of database (2002) until 30 June 2018, anytime in these 16 years (from the data retrieved and observed retrospectively for approximately 1.2 years) |
|
|
|
| Secondary | Overall Survival (OS): Memorial Sloan-Kettering Cancer Center (MSKCC) Stratification | OS was defined as the time between the index date and the date of death from any cause. Participants who were still alive at the study end date or the last visit date available were censored. MSKCC criteria had 5 risk factors: KPS <80% (ability to perform ordinary tasks, 0 [dead] -100 [normal]); time from diagnosis to start of systemic therapy <12 months; hemoglobin <LLN; lactate dehydrogenase 1.5* ULN; corrected serum calcium >10.0 mg/dL. Present risk factors were added, and then participants were stratified in following prognosis group: favorable (0 factor), intermediate (1-2 factors), poor (>=3 factors), unknown/missing = no information available. Index date: date of initiation of first-line sunitinib therapy and second-line axitinib therapy. | Analysis population included all eligible participants with mRCC and/or aRCC, received sunitinib as first-line treatment and/or axitinib as second-line treatment from 2002 till 30 June 2018. Here, "Number Analyzed" signifies number of participants evaluable for specified rows. | Posted | Median | 95% Confidence Interval | Months | From index date until death, from inception of database (2002) until 30 June 2018, anytime in these 16 years (from the data retrieved and observed retrospectively for approximately 1.2 years) |
|
|
|
|
| Secondary | Overall Survival (OS): International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) Stratification | OS was defined as the time between the index date and the date of death from any cause. Participants who were still alive at the study end date or the last visit date available were censored. IMDC criteria had 6 risk factors: KPS <80% (ability to perform ordinary tasks, 0 [dead] -100 [normal]); time from diagnosis to start of systemic therapy <12 months; corrected serum calcium >10.0 mg/dL; neutrophils and platelets >LLN and hemoglobin <LLN. Present risk factors were added, and then participants were stratified in following prognosis group: favorable (0 factor), intermediate (1-2 factors), poor (>=3 factors), unknown/missing =no information available. Index date: date of initiation of first-line sunitinib therapy and second-line axitinib therapy. | Analysis population included all eligible participants with mRCC and/or aRCC, received sunitinib as first-line treatment and/or axitinib as second-line treatment from 2002 till 30 June 2018. Here, "Number Analyzed" signifies number of participants evaluable for specified rows. | Posted | Median | 95% Confidence Interval | Months | From index date until death, from inception of database (2002) until 30 June 2018, anytime in these 16 years (from the data retrieved and observed retrospectively for approximately 1.2 years) |
|
|
|
|
| Secondary | Number of Participants With Best Overall Response (BOR) for Complete Response (CR), Partial Response (PR), Stable Disease (SD), PD and Surgical CR as Per RECIST v 1.1 | BOR was recorded for CR, PR, SD, PD and surgical CR. RECIST v1.1, a) CR: disappearance of target, non-target lesions and normalization of tumor markers. Pathological lymph nodes had short axis measures <10mm; b) PR: >=30% decrease in sum of measures (longest diameter for tumor lesions, short axis measure for nodes) of target lesions, taking reference baseline sum of diameters. Non-target lesions must be non-PD; c) PD: >=20% increase in sum of diameters of target lesions, taking as reference smallest sum on study, sum must demonstrate absolute increase of at least 5mm. Appearance of 1 or more new lesions; d) SD: neither shrinkage for CR/PR nor increase for PD taking as reference smallest sum of longest diameters since treatment start; e) Surgical CR: disappearance of target, non-target lesions, normalization of tumor markers, pathological lymph nodes had short axis measuring <10mm as result of surgery. Alive participants with no events were censored at final study cutoff date. | Analysis population included all eligible participants with mRCC and/or aRCC, received sunitinib as first-line treatment and/or axitinib as second-line treatment from 2002 till 30 June 2018. | Posted | Count of Participants | Participants | Start of treatment till BOR of CR, PR, PD, SD, Surgical CR, or death/initiation of new therapy, whichever occurred first; from 2002 to 30 June 2018, anytime in these 16 years (data retrieved and observed retrospectively for approximately 1.2 years) |
|
|
|
| Secondary | Objective Response Rate (ORR) | ORR was defined as the percentage of participants who achieved a BOR of CR or PR as per RECIST v1.1. CR was defined as disappearance of target and non-target lesions and normalization of tumor markers. Pathological lymph nodes must have short axis measures <10 mm. PR was defined as at least a 30% decrease in the sum of measures (longest diameter for tumor lesions and short axis measure for nodes) of target lesions, taking as reference baseline sum of diameters. Non-target lesions must be non-PD. PD was defined as at least a 20% increase in sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions was considered progression. Alive participants who did not have event were censored at final study cutoff date. | Analysis population included all eligible participants with mRCC and/or aRCC, received sunitinib as first-line treatment and/or axitinib as second-line treatment from 2002 till 30 June 2018. | Posted | Number | 95% Confidence Interval | Percentage of participants | From start of treatment until CR,PR,PD,death/initiation of new therapy, whichever occurred first, from inception of database(2002) until 30 June 2018, anytime in these 16 years (from data retrieved and observed retrospectively for approximately 1.2 years) |
|
|
|
| Secondary | Duration of Response (DOR) | DOR was defined as the time between the date of the first documented confirmed response (PR or CR) and the date of the first documented progression or death due to any cause. Alive participants who did not have event were censored at final study cutoff date. As per RECIST v1.1: CR was defined as disappearance of target and non-target lesions and normalization of tumor markers. Pathological lymph nodes short axis measures <10 mm. PR was defined as at least 30% decrease in sum of measures (tumor lesions- longest diameter and nodes- short axis) of target lesions, taking as reference baseline sum of diameters. PD was defined as at least 20% increase in sum of diameters of measured lesions taking as references smallest sum of diameters recorded on study (including baseline) and an absolute increase of >=5 mm or appearance of at least 1 new lesion. | Analysis population included all eligible participants with mRCC and/or aRCC, received sunitinib as first-line treatment and/or axitinib as second-line treatment from 2002 till 30 June 2018. Required information for this outcome measure was not present in Christie NHS database. Hence, data could not be collected and analyzed for this outcome measure. | Posted | From date of first documented CR/PR until PD/death/initiation of new therapy, whichever occurred first, from inception of database(2002) until 30 June 2018, anytime in these 16years (data retrieved and observed retrospectively for approximately 1.2 years) |
|
|
| Secondary | Time to Treatment Discontinuation (TTD) | TTD was defined as the time between initiation of treatment to the end of treatment for any reason including PD, death, and lost-to follow up. Participants were censored on the study end date or at last office visit date without clinical or radiographic evidence of PD, whichever occurred first. | Analysis population included all eligible participants with mRCC and/or aRCC, received sunitinib as first-line treatment and/or axitinib as second-line treatment from 2002 till 30 June 2018. | Posted | Median | 95% Confidence Interval | Months | From start of the treatment until end of treatment, from inception of database (2002) until 30 June 2018, anytime in these 16 years (from the data retrieved and observed retrospectively for approximately 1.2 years) |
|
|
|
| Secondary | Time to Treatment Discontinuation (TTD): Memorial Sloan-Kettering Cancer Center (MSKCC) Stratification | TTD was defined as the time between initiation of treatment to the end of treatment for any reason including PD, death, and lost-to follow up. Participants were censored on the study end date or at last office visit date without clinical or radiographic evidence of PD, whichever occurred first. MSKCC criteria had following 5 risk factors: KPS <80% (ability to perform ordinary tasks, 0 [dead] -100 [normal]); time from diagnosis to start of systemic therapy <12 months; hemoglobin <LLN; lactate dehydrogenase 1.5*ULN; corrected serum calcium >10.0 mg/dL. Present risk factors were added, and then participants were stratified in following prognosis group: favorable (0 factor), intermediate (1-2 factors), poor (>=3 factors), unknown/missing = no information available. | Analysis population included all eligible participants with mRCC and/or aRCC, received sunitinib as first-line treatment and/or axitinib as second-line treatment from 2002 till 30 June 2018. Here, "Number Analyzed" signifies number of participants evaluable for specified rows. | Posted | Median | 95% Confidence Interval | Months | From start of the treatment until end of treatment, from inception of database (2002) until 30 June 2018, anytime in these 16 years (from the data retrieved and observed retrospectively for approximately 1.2 years) |
|
|
|
|
| Secondary | Time to Treatment Discontinuation (TTD): International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) Stratification | TTD was defined as the time between initiation of treatment to the end of treatment for any reason including PD, death, and lost-to follow up. Participants were censored on the study end date or at last office visit date without clinical or radiographic evidence of PD, whichever occurred first. IMDC criteria had following 6 risk factors: KPS <80% (ability to perform ordinary tasks, 0 [dead] -100 [normal]); time from diagnosis to start of systemic therapy <12 months; corrected serum calcium >10.0 mg/dL; neutrophils and platelets >LLN and hemoglobin <LLN. Present risk factors were added, and then participants were stratified in following prognosis group: favorable (0 factor), intermediate (1-2 factors), poor (>=3 factors), unknown/missing =no information available. | Analysis population included all eligible participants with mRCC and/or aRCC, received sunitinib as first-line treatment and/or axitinib as second-line treatment from 2002 till 30 June 2018. Here, "Number Analyzed" signifies number of participants evaluable for specified rows. | Posted | Median | 95% Confidence Interval | Months | From start of the treatment until end of treatment, from inception of database (2002) until 30 June 2018, anytime in these 16 years (from the data retrieved and observed retrospectively for approximately 1.2 years) |
|
|
|
|
| Secondary | Durable Response Rate (DRR) | DRR was determined as the percentage of participants with objective response (CR or PR) with a duration of at least 6 months. As per RECIST v1.1: CR was defined as disappearance of target and non-target lesions and normalization of tumor markers. Pathological lymph nodes short axis measures <10 mm. PR was defined as at least 30% decrease in sum of measures (tumor lesions- longest diameter and nodes- short axis) of target lesions, taking as reference baseline sum of diameters. | Analysis population included all eligible participants with mRCC and/or aRCC, received sunitinib as first-line treatment and/or axitinib as second-line treatment from 2002 till 30 June 2018. Required information for this outcome measure was not present in Christie NHS database. Hence, data could not be collected and analyzed for this outcome measure. | Posted | 6 months from inception of database (2002) until 30 June 2018, anytime in these 16 years (from the data retrieved and observed retrospectively for approximately 1.2 years) |
|
|
| Other Pre-specified | Number of Participants Who Started Systemic Therapy Within 1 Year of Diagnosis | Analysis population included all eligible participants with mRCC and/or aRCC, received sunitinib as first-line treatment and/or axitinib as second-line treatment from 2002 till 30 June 2018. | Posted | Count of Participants | Participants | Baseline (data retrieved and observed retrospectively for approximately 1.2 years) |
|
|
|
| Other Pre-specified | Number of Participants With Karnofsky Performance Status (KPS) Less Than 80 Percent (%) | KPS: used for rating participant activities of daily living on scale from 0-100, higher score = participant is better able to carry out daily activities. Score range: 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 on normal activity, 60 = requires occasional assistance, but able to care for most personal needs, 50 = requires considerable assistance and frequent medical care, 40 = disabled; requires special care, assistance, 30 = severely disabled; hospital admission is indicated although death not imminent, 20 = very sick; hospital admission necessary, 10 = moribund; fatal processes progressing rapidly and 0 = dead. The lower the score the worse is survival for most serious illnesses. Here, number of participants with KPS <80% were reported. | Analysis population included all eligible participants with mRCC and/or aRCC, received sunitinib as first-line treatment and/or axitinib as second-line treatment from 2002 till 30 June 2018. | Posted | Count of Participants | Participants | Baseline (data retrieved and observed retrospectively for approximately 1.2 years) |
|
|
|
| Other Pre-specified | Number of Participants With Hemoglobin Less Than Lower Limit of Normal (LLN) | In this outcome measure number of participants with hemoglobin less than LLN were reported. For male participants LLN was 130 grams per liter and for female participants LLN was 115 grams per liter. | Analysis population included all eligible participants with mRCC and/or aRCC, received sunitinib as first-line treatment and/or axitinib as second-line treatment from 2002 till 30 June 2018. | Posted | Count of Participants | Participants | Baseline (data retrieved and observed retrospectively for approximately 1.2 years) |
|
|
|
| Other Pre-specified | Number of Participants With Serum Calcium >Upper Limit of Normal (ULN), Neutrophil >ULN, Platelets >ULN and Lactate Dehydrogenase >1.5*ULN | Number of participants with serum calcium >ULN (3.00 millimole per liter [mmol/L]), neutrophils >ULN (7.5 *10^9/L), platelets >ULN (400 *10^9/L), lactate dehydrogenase >1.5*ULN were reported in this outcome measure. | Analysis population included all eligible participants with mRCC and/or aRCC, received sunitinib as first-line treatment and/or axitinib as second-line treatment from 2002 till 30 June 2018. | Posted | Count of Participants | Participants | Baseline (data retrieved and observed retrospectively for approximately 1.2 years) |
|
|
|
| Other Pre-specified | Number of Participants Per Tumor Fuhrman Grades | The four-tiered Fuhrman grading evaluates nuclear size, nuclear shape and presence of nucleolar prominence. Grade 1: small (=10 micrometer [mcm]) nuclear diameter, round/uniform nuclear shape and absent/inconspicuous nucleoli; Grade 2: large (=15 mcm) nuclear diameter, irregular outline nuclear shape and visible at *400 magnification nucleoli; Grade 3: larger (=20 mcm) nuclear diameter, obvious irregular outline nuclear shape and visible and prominent at *100 magnification nucleoli; Grade 4: grade 3 plus bizarre multilobed nuclei +/- spindle cells. | Analysis population included all eligible participants with mRCC and/or aRCC, received sunitinib as first-line treatment and/or axitinib as second-line treatment from 2002 till 30 June 2018. | Posted | Count of Participants | Participants | Baseline (data retrieved and observed retrospectively for approximately 1.2 years) |
|
|
|
| Other Pre-specified | Number of Participants With Tumor Subtype | In this outcome measure, number of participants were classified according to tumor subtype as clear cell, non-clear cell and unknown/missing. | Analysis population included all eligible participants with mRCC and/or aRCC, received sunitinib as first-line treatment and/or axitinib as second-line treatment from 2002 till 30 June 2018. | Posted | Count of Participants | Participants | Baseline (data retrieved and observed retrospectively for approximately 1.2 years) |
|
|
|
| Other Pre-specified | Number of Participants With Adverse Events | An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship with the study treatment. | Minimum criteria for reporting an AE (i.e. identifiable participant, identifiable reporter, a suspect product, and event) could not met, hence, adverse events were not collected and reported. | Posted | From start of treatment until death, from inception of database (2002) until 30 June 2018, anytime in these 16 years (from the data retrieved and observed retrospectively for approximately 1.2 years) |
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Participants With mRCC and/or aRCC: Second Line Axitinib Treatment | Participants who met the selection criteria, diagnosed with mRCC and/or aRCC, received axitinib as second-line treatment from 2002 till 30 June 2018, according to normal routine healthcare practice in real-world setting, were included in this reporting arm. Data of these participants were derived from Christie NHS database. | 0 | 0 | 0 | 0 | 0 | 0 |
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.
| D007211 |
| Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D001549 | Benzamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D001565 | Benzoates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D007191 | Indazoles |
| D011720 | Pyrazoles |
| Intermediate |
|
|
| Poor |
|
|
| Unknown/missing (no information available) |
|
|
| <0.0001 |
| Other |
| Intermediate |
|
|
| Poor |
|
|
| Unknown/missing (no information available) |
|
|
| 0.0068 |
| Other |
| Intermediate |
|
|
| Poor |
|
|
| Unknown/missing (no information available) |
|
|
| 0.0004 |
| Other |
| Intermediate |
|
|
| Poor |
|
|
| Unknown/missing (no information available) |
|
|
| 0.0014 |
| Other |
| SD |
|
| PD |
|
| Surgical CR |
|
| NA/Missing (no clinical response recorded in data base) |
|
| Intermediate |
|
|
| Poor |
|
|
| Unknown/missing (no information available) |
|
|
| <0.0001 |
| Other |
| Intermediate |
|
|
| Poor |
|
|
| Unknown/missing (no information available) |
|
|
| 0.0094 |
| Other |
| Platelets >ULN |
|
| Lactate Dehydrogenase >1.5*ULN |
|
| 3 |
|
| 4 |
|
| Missing (no information available) |
|
| Unknown/missing (no information available) |
|