Renal Cell Carcinoma
Conditions
Keywords
advanced renal cell carcinoma, disease progression, sunitinib, interferon alpha
Brief summary
This is a post-marketing Surveillance study to observe INLYTA® treatment dosing pattern, safety and effectiveness in Taiwan real world routine practice. The primary objective of this registry is to monitor the dose adjustment of INLYTA® in real world routine practice. The secondary objectives include safety profile, objective response rate, and progression-free rate in real world routine practice.
Detailed description
This is a multi-center chart review registry on mRCC patients treated with axitinib. Primary objective is the dose adjustment. Secondary objectives are safety profile, objective response rate and progression free survival. Efficacy assessment will be based on investigators' judgment. Patients treated with 1st dose of axitinib between May 7, 2013 and June 30, 2015 will be enrolled. The follow-up time is 12 months. Prior therapies should include sunitinib or interferon alpha.
Interventions
None listed
Sponsors
Pfizer
Study design
Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Patients diagnosed as advanced RCC by histology or cytology * Patients using axitinib as therapy after failure of sunitinib or cytokine * Patients received axitinib treatment and follow up in the health care center participating present registry * Patients agree to participate and signed inform consent or IRB waiving of signed informed consent document is available
Exclusion criteria
* Patients with first dose of axitinib earlier than 7th May 2013 * Patients with first dose of axitinib later than 30th June 2015. * Patients participating in clinical research involving axitinib * Patients with hypersensitivity to axitinib or to any other component of axitinib * Patients under 18-year of age * Pregnant women.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Duration of Axitinib Treatment | From initiation of axitinib treatment up to the end of the study (up to 40 months) |
| Mean Daily Dose of Axitinib | From initiation of axitinib treatment up to the end of the study (up to 40 months) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progression-Free Survival (PFS) | From initiation of axitinib treatment until PD or death from any cause (up to 40 months) | PFS was defined as the time duration in months from start of study treatment to the first documentation of PD or to death due to any cause, whichever occured first. PD was assessed by RECIST version 1.1. and defined as \>=20% increase in the sum of the diameters of the target lesions taking as a reference the smallest sum on study (this included the baseline sum if that was the smallest on study) or unequivocal progression in non-target lesions or the appearance of 1 or more new lesions. Progression free survival based on investigators' judgment on medical records was calculated. |
| Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | From initiation of axitinib treatment up to end of the study (up to 40 months) | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life- threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. A treatment-emergent AE was defined as an event that emerged during the treatment period that was absent before treatment, or worsened during the treatment period relative to the pretreatment state. AEs included both serious and non--serious events. |
| Objective Response Rate (ORR) | From initiation of axitinib treatment until PD or death from any cause (up to 40 months) | ORR was defined as percentage of participants with confirmed complete response (CR) or partial response (PR) according to response evaluation criteria in solid tumors (RECIST) version 1.1. CR was defined as disappearance of all target, non-target lesions and all lymph nodes decreased to non-pathological in size (less than \[\<\]10 millimeter \[mm\] short axis). PR was defined as at least 30 percent (%) decrease in sum of diameters of target lesions taking as reference the baseline sum, without progression of non-target lesions, no appearance of new lesions. Progression of disease (PD) was defined as greater than equal to (\>=) 20% increase in sum of diameters of the target lesions taking as reference the smallest sum on study (this included the baseline sum if that was the smallest on study) or unequivocal progression in non-target lesions or appearance of 1 or more new lesions. Response evaluation was based on investigators' judgment. |
| Number of Participants With Treatment-Related Adverse Events (AEs) | From initiation of axitinib treatment up to end of the study (up to 40 months) | A treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. |
| Number of Participants Discontinued Due to Adverse Events (AEs) | From initiation of axitinib treatment up to end of the study (up to 40 months) | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. |
| Number of Participants With Adverse Events (AEs) by Severity | From initiation of axitinib treatment up to end of the study (up to 40 months) | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Severity of the AEs was graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. Grade 1= mild; Grade 2= moderate; Grade 3= severe; Grade 4= life-threatening or disabling; Grade 5= death related to AE. |
| Duration of Response | From initiation of axitinib treatment until PD or death from any cause (up to 40 months) | Duration of response was defined as time from first documentation of objective tumor response (CR or PR), that was subsequently confirmed, to the first documentation of PD or to death due to any cause, whichever occurred first as per RECIST version 1.1. CR was defined as disappearance of all target, non-target lesions and all lymph nodes decreased to non-pathological in size (\<10 mm short axis). PR was defined as at least 30% decrease in sum of diameters of target lesions taking as reference the baseline sum, without progression of non-target lesions, no appearance of new lesions. PD was defined as \>=20% increase in sum of diameters of the target lesions taking as a reference smallest sum on study (this included the baseline sum if that was the smallest on study) or unequivocal progression in non-target lesions or appearance of 1 or more new lesions. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Axitinib (INLYTA) Participants diagnosed with advanced RCC and received axitinib therapy as per routine clinical practice according to the LPD under the physician's prescription were observed for 40 months. | 13 |
| Total | 13 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 1 |
| Overall Study | Death | 2 |
| Overall Study | Economic factor | 1 |
| Overall Study | Lack of Efficacy | 2 |
| Overall Study | Other | 1 |
| Overall Study | Progression of pleural effusion | 1 |
Baseline characteristics
| Characteristic | Axitinib (INLYTA) |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 4 Participants |
| Age, Categorical Between 18 and 65 years | 9 Participants |
| Sex: Female, Male Female | 3 Participants |
| Sex: Female, Male Male | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 10 / 13 |
| serious Total, serious adverse events | 2 / 13 |
Outcome results
Primary
Duration of Axitinib Treatment
Time frame: From initiation of axitinib treatment up to the end of the study (up to 40 months)
Population: Efficacy population included all the participants who were enrolled in the study.
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| Axitinib (INLYTA) | Duration of Axitinib Treatment | 15.2 months | 95% Confidence Interval 13.32 |
Primary
Mean Daily Dose of Axitinib
Time frame: From initiation of axitinib treatment up to the end of the study (up to 40 months)
Population: Efficacy population included all the participants who were enrolled in the study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Axitinib (INLYTA) | Mean Daily Dose of Axitinib | 9.24 milligram | Standard Deviation 3.31 |
Secondary
Duration of Response
Duration of response was defined as time from first documentation of objective tumor response (CR or PR), that was subsequently confirmed, to the first documentation of PD or to death due to any cause, whichever occurred first as per RECIST version 1.1. CR was defined as disappearance of all target, non-target lesions and all lymph nodes decreased to non-pathological in size (\<10 mm short axis). PR was defined as at least 30% decrease in sum of diameters of target lesions taking as reference the baseline sum, without progression of non-target lesions, no appearance of new lesions. PD was defined as \>=20% increase in sum of diameters of the target lesions taking as a reference smallest sum on study (this included the baseline sum if that was the smallest on study) or unequivocal progression in non-target lesions or appearance of 1 or more new lesions.
Time frame: From initiation of axitinib treatment until PD or death from any cause (up to 40 months)
Population: Efficacy population included all the participants who were enrolled in the study. Here 'number of participants analyzed' signifies participants who achieved a confirmed CR or PR.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Axitinib (INLYTA) | Duration of Response | 1 months |
Secondary
Number of Participants Discontinued Due to Adverse Events (AEs)
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.
Time frame: From initiation of axitinib treatment up to end of the study (up to 40 months)
Population: Safety population included all the enrolled participants who received at least one dose of the axitinib. Here 'number of participants analyzed' signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Axitinib (INLYTA) | Number of Participants Discontinued Due to Adverse Events (AEs) | 1 partcicipants |
Secondary
Number of Participants With Adverse Events (AEs) by Severity
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Severity of the AEs was graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. Grade 1= mild; Grade 2= moderate; Grade 3= severe; Grade 4= life-threatening or disabling; Grade 5= death related to AE.
Time frame: From initiation of axitinib treatment up to end of the study (up to 40 months)
Population: Safety population included all the enrolled participants who received at least one dose of the axitinib. Here 'number of participants analyzed' signifies participants evaluable for this outcome measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Axitinib (INLYTA) | Number of Participants With Adverse Events (AEs) by Severity | Grade 1 | 5 participants |
| Axitinib (INLYTA) | Number of Participants With Adverse Events (AEs) by Severity | Grade 2 | 3 participants |
| Axitinib (INLYTA) | Number of Participants With Adverse Events (AEs) by Severity | Grade 3 | 3 participants |
| Axitinib (INLYTA) | Number of Participants With Adverse Events (AEs) by Severity | Grade 4 | 0 participants |
| Axitinib (INLYTA) | Number of Participants With Adverse Events (AEs) by Severity | Grade 5 | 0 participants |
Secondary
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life- threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. A treatment-emergent AE was defined as an event that emerged during the treatment period that was absent before treatment, or worsened during the treatment period relative to the pretreatment state. AEs included both serious and non--serious events.
Time frame: From initiation of axitinib treatment up to end of the study (up to 40 months)
Population: Safety population included all the enrolled participants who received at least one dose of the axitinib.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Axitinib (INLYTA) | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | AEs | 11 participants |
| Axitinib (INLYTA) | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | SAEs | 2 participants |
Secondary
Number of Participants With Treatment-Related Adverse Events (AEs)
A treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug.
Time frame: From initiation of axitinib treatment up to end of the study (up to 40 months)
Population: Safety population included all the enrolled participants who received at least one dose of the axitinib. Here 'number of participants analyzed' signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Axitinib (INLYTA) | Number of Participants With Treatment-Related Adverse Events (AEs) | 8 participants |
Secondary
Objective Response Rate (ORR)
ORR was defined as percentage of participants with confirmed complete response (CR) or partial response (PR) according to response evaluation criteria in solid tumors (RECIST) version 1.1. CR was defined as disappearance of all target, non-target lesions and all lymph nodes decreased to non-pathological in size (less than \[\<\]10 millimeter \[mm\] short axis). PR was defined as at least 30 percent (%) decrease in sum of diameters of target lesions taking as reference the baseline sum, without progression of non-target lesions, no appearance of new lesions. Progression of disease (PD) was defined as greater than equal to (\>=) 20% increase in sum of diameters of the target lesions taking as reference the smallest sum on study (this included the baseline sum if that was the smallest on study) or unequivocal progression in non-target lesions or appearance of 1 or more new lesions. Response evaluation was based on investigators' judgment.
Time frame: From initiation of axitinib treatment until PD or death from any cause (up to 40 months)
Population: Efficacy population included all the participants who were enrolled in the study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Axitinib (INLYTA) | Objective Response Rate (ORR) | 7.69 percentage of participants |
Secondary
Progression-Free Survival (PFS)
PFS was defined as the time duration in months from start of study treatment to the first documentation of PD or to death due to any cause, whichever occured first. PD was assessed by RECIST version 1.1. and defined as \>=20% increase in the sum of the diameters of the target lesions taking as a reference the smallest sum on study (this included the baseline sum if that was the smallest on study) or unequivocal progression in non-target lesions or the appearance of 1 or more new lesions. Progression free survival based on investigators' judgment on medical records was calculated.
Time frame: From initiation of axitinib treatment until PD or death from any cause (up to 40 months)
Population: Efficacy population included all the participants who were enrolled in the study.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Axitinib (INLYTA) | Progression-Free Survival (PFS) | 32.73 months |