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

NCT ID: NCT04669366

Last Updated: 2024-07-19

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1205 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-01-20

Study Completion Date

2022-03-18

Brief Summary

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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.

Detailed Description

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Conditions

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Kidney Neoplasms

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Patients in Sweden with metastatic renal cell carcinoma

The cohort of patients with metastatic renal cell carcinoma in Sweden

sunitinib

Intervention Type DRUG

As provided in real world

axitinib

Intervention Type DRUG

As provided in real world

Interventions

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sunitinib

As provided in real world

Intervention Type DRUG

axitinib

As provided in real world

Intervention Type DRUG

Other Intervention Names

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Sutent Inlyta

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Innovations AB

Sollentuna, , Sweden

Site Status

Countries

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Sweden

References

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Jakobsson M, Strambi A, Nilsson F, Arpegard J, Dalen J. Real-world experience of second-line axitinib in metastatic renal cell carcinoma: analysis of the Swedish population. Future Oncol. 2024;20(20):1385-1392. doi: 10.1080/14796694.2024.2351352. Epub 2024 Jul 26.

Reference Type DERIVED
PMID: 39057291 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Related Links

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https://pmiform.com/clinical-trial-info-request?StudyID=A6181234

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Other Identifiers

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RENCOMP3

Identifier Type: OTHER

Identifier Source: secondary_id

A6181234

Identifier Type: -

Identifier Source: org_study_id

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