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

Sponsor
Pfizer (Industry)
Overall Status
Completed
CT.gov ID
NCT04669366
Collaborator
(none)
1,095
Enrollment
1
Location
6.3
Actual Duration (Months)
173.6
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

Study Design

Study Type:
Observational
Actual Enrollment :
1095 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Treatment Patterns With Targeted Therapies in Metastatic Renal Cell Carcinoma (mRCC) in Sweden - A Retrospective Analysis of Data From National Registries
Actual Study Start Date :
Jan 20, 2021
Actual Primary Completion Date :
Jul 31, 2021
Actual Study Completion Date :
Jul 31, 2021

Arms and Interventions

Arm Intervention/Treatment
Patients in Sweden with metastatic renal cell carcinoma

The cohort of patients with metastatic renal cell carcinoma in Sweden

Drug: sunitinib
As provided in real world
Other Names:
  • Sutent

    • Drug: axitinib
    As provided in real world
    Other Names:
  • Inlyta

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Time to treatment discontinuation in first line sunitinib patients [July 1st 2005 to December 31th 2019]

      Time to treatment discontinuation in first line sunitinib patients. Time to event measure with timeframe 0 - 180 months from treatment initiation.

    Secondary Outcome Measures

    1. Overall survival (OS) for first line patients with sunitinib [July 1st 2005 to December 31th 2019]

      Overall survival in first line sunitinib patients. Time to event measure with time frame 0 - 180 months from treatment initiation.

    2. Time to treatment discontinuation in second line axitinib patients [July 1st 2005 to December 31th 2019]

      Time to treatment discontinuation in first line sunitinib patients. Time to event measure with timeframe 0 - 180 months from treatment initiation.

    3. Overall survival (OS) for second line patients with axitinib [July 1st 2005 to December 31th 2019]

      Overall survival in second line axitinib patients. Time to event measure with time frame 0 - 180 months from treatment initiation.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 99 Years
    Sexes Eligible for Study:
    All
    Accepts 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Pfizer Innovations AB Sollentuna Sweden 19190

    Sponsors and Collaborators

    • Pfizer

    Investigators

    • Study Director: Pfizer CT.gov Call Center, Pfizer

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Pfizer
    ClinicalTrials.gov Identifier:
    NCT04669366
    Other Study ID Numbers:
    • A6181234
    • RENCOMP3
    First Posted:
    Dec 16, 2020
    Last Update Posted:
    Sep 16, 2021
    Last Verified:
    Sep 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Additional relevant MeSH terms:
    Kidney Neoplasms
    Sunitinib
    Axitinib

    Study Results

    No Results Posted as of Sep 16, 2021