Treatment Patterns With Targeted Therapies In Mrcc In Sweden - A Retrospective Analysis Of Data From National Registries

Conditions

Kidney Neoplasms

Brief summary

The objectives of this study is to investigate treatment patterns and outcomes for Sutent and Inlyta in mRCC patients in a nationwide population-based setting in Sweden.

Maria Jakobsson, Angela Strambi, Fredrik Nilsson, Johannes Arpegård, Johan Dalén

Future Oncology2024-06-231 citations

10.1080/14796694.2024.2351352

Interventions

DRUGsunitinib

As provided in real world

DRUGaxitinib

As provided in real world

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 99 Years

Healthy volunteers

No

Inclusion criteria

1. all patients aged ≥ 18 years with at least one filled prescription of an oral targeted therapy relevant for treating mRCC registered in the Swedish Prescribed Drug Register (PDR) between July 1st 2005 and June 30th 2020. The Anatomical Therapeutic Chemical (ATC) codes for the oral drugs relevant for treating mRCC are the following: L01XE04 (sunitinib), L01XE05 (sorafenib), L01XE11 (pazopanib), L01XE17 (axitinib), L01XE10 (everolimus), L01XE26 (cabozantinib), L01XE34 (tivozantib), L01XE29 (lenvatinib). 2. The patients identified in the PDR that also are identified in the SCR with the International Classification of Diseases and Related Health Problems (ICD)-7 diagnosis codes I800 or I809 and ICD-10 codes C64.0 and C64.9 from January 1st 2000 until December 31st 2019;excluding ICD-7 code I801 (cancer of the renal pelvis) will be included in the analysis set.

Exclusion criteria

Patients with ICD-7 code I801 will be excluded

Design outcomes

Primary

Measure	Time frame	Description
Number of Participants With at Least 1 Filled Sunitinib Prescription	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	Number of participants who had at least one filled prescription of sunitinib were analyzed and reported in this outcome measure.
Number of Participants With 4:2 Sunitinib Schedule Without Any Modification	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	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.
Number of Participants With 2:1 Sunitinib Schedule Without Any Modification	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	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.

Secondary

Measure	Time frame	Description
Number of Participants Switched From 4:2 Sunitinib Schedule to 2:1 Sunitinib Schedule	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	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.
Overall Survival (OS)	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	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.
Number of Participants on Second Line Treatment With at Least 1 Filled Axitinib Prescription	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	Number of participants that had at least one filled prescription of axitinib were reported in this outcome measure.
Time to Treatment Discontinuation (TTD)	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	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.

Countries

Sweden

Participant flow

Recruitment details

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.

Pre-assignment details

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.

Participants by arm

Arm	Count
Sunitinib 4:2 Schedule 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.	704
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.	320
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.	71
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.	110
Total	1,205

Baseline characteristics

Characteristic	Sunitinib 4:2 Schedule	Sunitinib 2:1 Schedule	Sunitinib: Switched From 4:2 to 2:1 Schedule	Axitinib	Total
Age, Continuous	66.58 Years STANDARD_DEVIATION 9.15	67.85 Years STANDARD_DEVIATION 9.7	66.51 Years STANDARD_DEVIATION 8.23	65.53 Years STANDARD_DEVIATION 9.89	66.82 Years STANDARD_DEVIATION 9.33
Race and Ethnicity Not Collected	—	—	—	—	0 Participants
Sex: Female, Male Female	209 Participants	103 Participants	25 Participants	26 Participants	363 Participants
Sex: Female, Male Male	495 Participants	217 Participants	46 Participants	84 Participants	842 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk	EG003 affected / at risk
deaths Total, all-cause mortality	627 / 704	168 / 320	53 / 71	82 / 110
other Total, other adverse events	0 / 0	0 / 0	0 / 0	0 / 0
serious Total, serious adverse events	0 / 0	0 / 0	0 / 0	0 / 0

Outcome results

Primary

Number of Participants With 2:1 Sunitinib Schedule Without Any Modification

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.