Trial Outcomes & Findings for Treatment Patterns With Targeted Therapies In Mrcc In Sweden - A Retrospective Analysis Of Data From National Registries (NCT NCT04669366)
NCT ID: NCT04669366
Last Updated: 2024-07-19
Results Overview
Number of participants who had at least one filled prescription of sunitinib were analyzed and reported in this outcome measure.
COMPLETED
1205 participants
Data collected from index date up to 168 months (during retrospective observation period of 14 years, from 01-July-2005 to 31-Dec-2019). Index date was defined as the participant's first identified prescription date
2024-07-19
Participant Flow
Participants diagnosed with metastatic renal cell carcinoma (mRCC), aged above 18 years with at least one filled prescription of an oral targeted therapy relevant for treating mRCC, registered in the Swedish Prescribed Drug Register between 01-July-2005 and 31-Dec-2019, were included in this study and their data was observed retrospectively.
Participants were treated with sunitinib in the first line (1L) mRCC setting and with axitinib in the second line (2L) mRCC setting. The index date was the date of first identified prescription of the participant.
Participant milestones
| Measure |
Sunitinib 4:2 Schedule
Participants with mRCC who initiated first-line treatment with sunitinib on 4:2 (4 weeks on/2 weeks off) schedule in the daily clinical practice based on recommended dose in the Summary of Product Characteristics (SPC), between 01-July-2005 to 31-Dec-2019, were observed retrospectively.
|
Sunitinib 2:1 Schedule
Participants with mRCC who initiated first-line treatment with sunitinib on 2:1 (2 weeks on/1 week off) schedule in the daily clinical practice based on recommended dose in the SPC, between 01-July-2005 to 31-Dec-2019, were observed retrospectively.
|
Sunitinib: Switched From 4:2 to 2:1 Schedule
Participants with mRCC who initiated first-line treatment with sunitinib on 4:2 schedule then switched to 2:1 schedule in the daily clinical practice based on recommended dose in the SPC, between 01-July-2005 to 31-Dec-2019, were observed retrospectively.
|
Axitinib
Participants with mRCC who initiated axitinib as second-line treatment in continuous 4 week cycles, between 01- July-2005 to 31-Dec-2019 based on recommended dose in the SPC, were observed retrospectively.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
704
|
320
|
71
|
110
|
|
Overall Study
COMPLETED
|
704
|
320
|
71
|
110
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Sunitinib 4:2 Schedule
n=704 Participants
Participants with mRCC who initiated first-line treatment with sunitinib on 4:2 schedule in the daily clinical practice based on recommended dose in the SPC, between 01-July-2005 to 31-Dec-2019, were observed retrospectively.
|
Sunitinib 2:1 Schedule
n=320 Participants
Participants with mRCC who initiated first-line treatment with sunitinib on 2:1 schedule in the daily clinical practice based on recommended dose in the SPC, between 01-July-2005 to 31-Dec-2019, were observed retrospectively.
|
Sunitinib: Switched From 4:2 to 2:1 Schedule
n=71 Participants
Participants with mRCC who initiated first-line treatment with sunitinib on 4:2 schedule then switched to 2:1 schedule in the daily clinical practice based on recommended dose in the SPC, between 01-July-2005 to 31-Dec-2019, were observed retrospectively.
|
Axitinib
n=110 Participants
Participants with mRCC who initiated axitinib as second-line treatment in continuous 4 week cycles, between 01- July-2005 to 31-Dec-2019 based on recommended dose in the SPC, were observed retrospectively.
|
Total
n=1205 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
66.58 Years
STANDARD_DEVIATION 9.15 • n=704 Participants
|
67.85 Years
STANDARD_DEVIATION 9.70 • n=320 Participants
|
66.51 Years
STANDARD_DEVIATION 8.23 • n=71 Participants
|
65.53 Years
STANDARD_DEVIATION 9.89 • n=110 Participants
|
66.82 Years
STANDARD_DEVIATION 9.33 • n=1205 Participants
|
|
Sex: Female, Male
Female
|
209 Participants
n=704 Participants
|
103 Participants
n=320 Participants
|
25 Participants
n=71 Participants
|
26 Participants
n=110 Participants
|
363 Participants
n=1205 Participants
|
|
Sex: Female, Male
Male
|
495 Participants
n=704 Participants
|
217 Participants
n=320 Participants
|
46 Participants
n=71 Participants
|
84 Participants
n=110 Participants
|
842 Participants
n=1205 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
PRIMARY outcome
Timeframe: Data collected from index date up to 168 months (during retrospective observation period of 14 years, from 01-July-2005 to 31-Dec-2019). Index date was defined as the participant's first identified prescription datePopulation: Analysis population included all eligible participants whose data were retrieved from national registries and assessed.
Number of participants who had at least one filled prescription of sunitinib were analyzed and reported in this outcome measure.
Outcome measures
| Measure |
Sunitinib 4:2 Schedule
n=704 Participants
Participants with mRCC who initiated first-line treatment with sunitinib on 4:2 schedule in the daily clinical practice based on recommended dose in the SPC, between 01-July-2005 to 31-Dec-2019, were observed retrospectively.
|
Sunitinib 2:1 Schedule
n=320 Participants
Participants with mRCC who initiated first-line treatment with sunitinib on 2:1 schedule in the daily clinical practice based on recommended dose in the SPC, between 01-July-2005 to 31-Dec-2019, were observed retrospectively.
|
Sunitinib: Switched From 4:2 to 2:1 Schedule
n=71 Participants
Participants with mRCC who initiated first-line treatment with sunitinib on 4:2 schedule then switched to 2:1 schedule in the daily clinical practice based on recommended dose in the SPC, between 01-July-2005 to 31-Dec-2019, were observed retrospectively.
|
Axitinib
n=110 Participants
Participants with mRCC who initiated axitinib as second-line treatment in continuous 4 week cycles, between 01- July-2005 to 31-Dec-2019 based on recommended dose in the SPC, were observed retrospectively.
|
|---|---|---|---|---|
|
Number of Participants With at Least 1 Filled Sunitinib Prescription
|
704 Participants
|
320 Participants
|
71 Participants
|
53 Participants
|
PRIMARY outcome
Timeframe: Data collected from index date up to 168 months (during retrospective observation period of 14 years, from 01-July-2005 to 31-Dec-2019). Index date was defined as the participant's first identified prescription datePopulation: Analysis population included all eligible participants whose data were retrieved from national registries and assessed. This outcome measure was planned to be analyzed only for Sunitinib 4:2 Schedule reporting group.
Number of participants that initiated treatment with 4:2 (4 weeks on/2 weeks off) sunitinib schedule and did not have any modification in the schedule were reported in this outcome measure.
Outcome measures
| Measure |
Sunitinib 4:2 Schedule
n=704 Participants
Participants with mRCC who initiated first-line treatment with sunitinib on 4:2 schedule in the daily clinical practice based on recommended dose in the SPC, between 01-July-2005 to 31-Dec-2019, were observed retrospectively.
|
Sunitinib 2:1 Schedule
Participants with mRCC who initiated first-line treatment with sunitinib on 2:1 schedule in the daily clinical practice based on recommended dose in the SPC, between 01-July-2005 to 31-Dec-2019, were observed retrospectively.
|
Sunitinib: Switched From 4:2 to 2:1 Schedule
Participants with mRCC who initiated first-line treatment with sunitinib on 4:2 schedule then switched to 2:1 schedule in the daily clinical practice based on recommended dose in the SPC, between 01-July-2005 to 31-Dec-2019, were observed retrospectively.
|
Axitinib
Participants with mRCC who initiated axitinib as second-line treatment in continuous 4 week cycles, between 01- July-2005 to 31-Dec-2019 based on recommended dose in the SPC, were observed retrospectively.
|
|---|---|---|---|---|
|
Number of Participants With 4:2 Sunitinib Schedule Without Any Modification
|
704 Participants
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Data collected from index date up to 168 months (during retrospective observation period of 14 years, from 01-July-2005 to 31-Dec-2019). Index date was defined as the participant's first identified prescription datePopulation: Analysis population included all eligible participants whose data were retrieved from national registries and assessed. This outcome measure was planned to be analyzed only for Sunitinib 2:1 Schedule reporting group.
Number of participants that initiated treatment with 2:1 (2 weeks on/1 week off) sunitinib schedule and did not have any modification in the schedule were reported in this outcome measure.
Outcome measures
| Measure |
Sunitinib 4:2 Schedule
n=320 Participants
Participants with mRCC who initiated first-line treatment with sunitinib on 4:2 schedule in the daily clinical practice based on recommended dose in the SPC, between 01-July-2005 to 31-Dec-2019, were observed retrospectively.
|
Sunitinib 2:1 Schedule
Participants with mRCC who initiated first-line treatment with sunitinib on 2:1 schedule in the daily clinical practice based on recommended dose in the SPC, between 01-July-2005 to 31-Dec-2019, were observed retrospectively.
|
Sunitinib: Switched From 4:2 to 2:1 Schedule
Participants with mRCC who initiated first-line treatment with sunitinib on 4:2 schedule then switched to 2:1 schedule in the daily clinical practice based on recommended dose in the SPC, between 01-July-2005 to 31-Dec-2019, were observed retrospectively.
|
Axitinib
Participants with mRCC who initiated axitinib as second-line treatment in continuous 4 week cycles, between 01- July-2005 to 31-Dec-2019 based on recommended dose in the SPC, were observed retrospectively.
|
|---|---|---|---|---|
|
Number of Participants With 2:1 Sunitinib Schedule Without Any Modification
|
320 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Data collected from index date up to 168 months (during retrospective observation period of 14 years, from 01-July-2005 to 31-Dec-2019). Index date was defined as the participant's first identified prescription datePopulation: Analysis population included all eligible participants whose data were retrieved from national registries and assessed. This outcome measure was planned to be analyzed only for Sunitinib: Switched From 4:2 to 2:1 Schedule reporting group.
Number of sunitinib users that started on a 4:2 (4 weeks on/2 weeks off) schedule and later was switched to a 2:1 (2 weeks on/1 week off) schedule were reported in this outcome measure.
Outcome measures
| Measure |
Sunitinib 4:2 Schedule
n=71 Participants
Participants with mRCC who initiated first-line treatment with sunitinib on 4:2 schedule in the daily clinical practice based on recommended dose in the SPC, between 01-July-2005 to 31-Dec-2019, were observed retrospectively.
|
Sunitinib 2:1 Schedule
Participants with mRCC who initiated first-line treatment with sunitinib on 2:1 schedule in the daily clinical practice based on recommended dose in the SPC, between 01-July-2005 to 31-Dec-2019, were observed retrospectively.
|
Sunitinib: Switched From 4:2 to 2:1 Schedule
Participants with mRCC who initiated first-line treatment with sunitinib on 4:2 schedule then switched to 2:1 schedule in the daily clinical practice based on recommended dose in the SPC, between 01-July-2005 to 31-Dec-2019, were observed retrospectively.
|
Axitinib
Participants with mRCC who initiated axitinib as second-line treatment in continuous 4 week cycles, between 01- July-2005 to 31-Dec-2019 based on recommended dose in the SPC, were observed retrospectively.
|
|---|---|---|---|---|
|
Number of Participants Switched From 4:2 Sunitinib Schedule to 2:1 Sunitinib Schedule
|
71 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Data collected from index date up to 168 months (during retrospective observation period of 14 years, from 01-July-2005 to 31-Dec-2019). Index date was defined as the participant's first identified prescription datePopulation: Analysis population included all eligible participants whose data were retrieved from national registries and assessed. This outcome measure was planned to be analyzed only for Axitinib reporting group.
Number of participants that had at least one filled prescription of axitinib were reported in this outcome measure.
Outcome measures
| Measure |
Sunitinib 4:2 Schedule
n=110 Participants
Participants with mRCC who initiated first-line treatment with sunitinib on 4:2 schedule in the daily clinical practice based on recommended dose in the SPC, between 01-July-2005 to 31-Dec-2019, were observed retrospectively.
|
Sunitinib 2:1 Schedule
Participants with mRCC who initiated first-line treatment with sunitinib on 2:1 schedule in the daily clinical practice based on recommended dose in the SPC, between 01-July-2005 to 31-Dec-2019, were observed retrospectively.
|
Sunitinib: Switched From 4:2 to 2:1 Schedule
Participants with mRCC who initiated first-line treatment with sunitinib on 4:2 schedule then switched to 2:1 schedule in the daily clinical practice based on recommended dose in the SPC, between 01-July-2005 to 31-Dec-2019, were observed retrospectively.
|
Axitinib
Participants with mRCC who initiated axitinib as second-line treatment in continuous 4 week cycles, between 01- July-2005 to 31-Dec-2019 based on recommended dose in the SPC, were observed retrospectively.
|
|---|---|---|---|---|
|
Number of Participants on Second Line Treatment With at Least 1 Filled Axitinib Prescription
|
110 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Data collected from index date up to 168 months (during retrospective observation period of 14 years, from 01-July-2005 to 31-Dec-2019). Index date was defined as the participant's first identified prescription datePopulation: Analysis population included all eligible participants whose data were retrieved from national registries and assessed.
TTD was defined as the difference between the start and end-dates for a treatment episode regardless of reason for discontinuation. The start date for a treatment episode was defined as the date of first dispensed package and the end date was defined as the date of the last dispensed package with the same Anatomical Therapeutic Chemical (ATC) code, plus the number of days that package, as well as accumulated medicine was intended to cover. End date was overruled if there was a new filled prescription of another relevant ATC code or death happens before this, then either of these dates represents the end date. If no end of prescribed supply was recorded, data was censored at latest available date in data.
Outcome measures
| Measure |
Sunitinib 4:2 Schedule
n=704 Participants
Participants with mRCC who initiated first-line treatment with sunitinib on 4:2 schedule in the daily clinical practice based on recommended dose in the SPC, between 01-July-2005 to 31-Dec-2019, were observed retrospectively.
|
Sunitinib 2:1 Schedule
n=320 Participants
Participants with mRCC who initiated first-line treatment with sunitinib on 2:1 schedule in the daily clinical practice based on recommended dose in the SPC, between 01-July-2005 to 31-Dec-2019, were observed retrospectively.
|
Sunitinib: Switched From 4:2 to 2:1 Schedule
n=71 Participants
Participants with mRCC who initiated first-line treatment with sunitinib on 4:2 schedule then switched to 2:1 schedule in the daily clinical practice based on recommended dose in the SPC, between 01-July-2005 to 31-Dec-2019, were observed retrospectively.
|
Axitinib
n=110 Participants
Participants with mRCC who initiated axitinib as second-line treatment in continuous 4 week cycles, between 01- July-2005 to 31-Dec-2019 based on recommended dose in the SPC, were observed retrospectively.
|
|---|---|---|---|---|
|
Time to Treatment Discontinuation (TTD)
|
4.55 Months
Interval 4.3 to 5.6
|
6.20 Months
Interval 5.6 to 7.2
|
13.91 Months
Interval 8.1 to 20.6
|
5.19 Months
Interval 3.7 to 6.1
|
SECONDARY outcome
Timeframe: Data collected from index date up to 168 months (during retrospective observation period of 14 years, from 01-July-2005 to 31-Dec-2019). Index date was defined as the participant's first identified prescription datePopulation: Analysis population included all eligible participants whose data were retrieved from national registries and assessed.
OS was defined as the time (number of days) from the start of the treatment (the date of the first dispensed package of Sunitinib or axitinib) until the date of death as documented in the Cause of Death Register. If no death was recorded, data was censored at latest available date in data.
Outcome measures
| Measure |
Sunitinib 4:2 Schedule
n=704 Participants
Participants with mRCC who initiated first-line treatment with sunitinib on 4:2 schedule in the daily clinical practice based on recommended dose in the SPC, between 01-July-2005 to 31-Dec-2019, were observed retrospectively.
|
Sunitinib 2:1 Schedule
n=320 Participants
Participants with mRCC who initiated first-line treatment with sunitinib on 2:1 schedule in the daily clinical practice based on recommended dose in the SPC, between 01-July-2005 to 31-Dec-2019, were observed retrospectively.
|
Sunitinib: Switched From 4:2 to 2:1 Schedule
n=71 Participants
Participants with mRCC who initiated first-line treatment with sunitinib on 4:2 schedule then switched to 2:1 schedule in the daily clinical practice based on recommended dose in the SPC, between 01-July-2005 to 31-Dec-2019, were observed retrospectively.
|
Axitinib
n=110 Participants
Participants with mRCC who initiated axitinib as second-line treatment in continuous 4 week cycles, between 01- July-2005 to 31-Dec-2019 based on recommended dose in the SPC, were observed retrospectively.
|
|---|---|---|---|---|
|
Overall Survival (OS)
|
13.48 Months
Interval 12.3 to 15.8
|
21.79 Months
Interval 18.1 to 26.1
|
32.20 Months
Interval 25.1 to 48.3
|
12.23 Months
Interval 7.7 to 14.2
|
Adverse Events
Sunitinib 4:2 Schedule
Sunitinib 2:1 Schedule
Sunitinib: Switched From 4:2 to 2:1 Schedule
Axitinib
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER