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OpenTrials
Completed

NCT Number: NCT04669366

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

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.

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Key information

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Pfizer Innovations AB

Sollentuna, 19190, Sweden

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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).
  • 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

Treatment and study plan

Sunitinib

Drug

As provided in real world

Other names: Sutent

Axitinib

Drug

As provided in real world

Other names: Inlyta

Primary outcomes

  1. Number of Participants With at Least 1 Filled Sunitinib Prescription

    Time frame: 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.

  2. Number of Participants With 4:2 Sunitinib Schedule Without Any Modification

    Time frame: 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.

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

    Time frame: 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 outcomes

  1. Number of Participants Switched From 4:2 Sunitinib Schedule to 2:1 Sunitinib Schedule

    Time frame: 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.

  2. Number of Participants on Second Line Treatment With at Least 1 Filled Axitinib Prescription

    Time frame: 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.

  3. Time to Treatment Discontinuation (TTD)

    Time frame: 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.

  4. Overall Survival (OS)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

Treatment Patterns With Targeted Therapies in Metastatic Renal Cell Carcinoma (mRCC) in Sweden - A Retrospective Analysis of Data From National Registries

Important dates

Study start
2021
Primary completion
2021
Study completion
2022
First posted
Dec 16, 2020
Registry last updated
Jul 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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