Clinical Outcomes for Patients With Renal Cell Carcinoma Who Received First-Line Sunitinib

Completed

• Conditions: Metastatic Renal Cell Carcinoma
• Interventions: Drug: Sunitinib

• Registration Number: NCT04076787
• Lead Sponsor: Pfizer

Brief Summary

This is a retrospective, longitudinal cohort study that assessed clinical outcomes of patients with metastatic renal cell carcinoma (mRCC) who received sunitinib as first-line treatment.

Detailed Description

Clear cell mRCC patients who initiated sunitinib as first-line treatment between 2010 and 2018 were identified from the IMDC database. Patients were classified as favorable, intermediate, or poor prognostic risk group according to IMDC criteria. Overall survival, time to treatment discontinuation, and physician-assessed tumor response were evaluated.

Study Timeline

• Study Start: 2018-09-01
• Primary Completion: 2018-09-02
• Study Completion: 2018-09-02
• Study First Submitted: 2019-08-30
• Study First Submitted QC: 2019-08-30
• Study First Posted: 2019-09-03
• Results First Submitted: 2019-09-16
• Results First Submitted QC: 2019-09-16
• Results First Posted: 2019-10-10
• Status Verified: 2021-02
• Last Update Submitted: 2023-04-04
• Last Update Posted: 2023-04-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1769

Inclusion Criteria

• Diagnosed with mRCC
• Initiated treatment post mRCC diagnosis and received sunitinib as first-line therapy
• Age 18 years or over at the time of mRCC diagnosis
• Actively treated at an IMDC clinical center

Read More

Exclusion Criteria

• Initiated first line sunitinib treatment before 2010
• Had non-clear cell mRCC

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Poor IMDC risk group	Sunitinib	The cohort of mRCC patients receiving sunitinib as first-line treatment and classified as poor IMDC risk group for having 3 or more individual risk factors
Favorable IMDC risk group	Sunitinib	The cohort of mRCC patients receiving sunitinib as first-line treatment and classified as favorable IMDC risk group for having 0 individual risk factor
Intermediate IMDC risk group	Sunitinib	The cohort of mRCC patients receiving sunitinib as first-line treatment and classified as intermediate IMDC risk group for having 1 or 2 individual risk factors

Primary Outcome Measures

Name	Time	Method
Overall Survival	60 months	Overall survival was defined as the time between index date and death due to any cause or end of data availability. The index date was defined as the date of initiation of first-line sunitinib therapy.
Time to First-Line Sunitinib Treatment Discontinuation	60 months	Time to treatment discontinuation was defined as the time between index date and either discontinuation of first-line sunitinib therapy due to any reason including disease progression, death, toxicity, both disease progression and toxicity, other or end of data availability. The index date was defined as the date of initiation of first-line sunitinib therapy.
Number of Participants Who Discontinued First-Line Sunitinib Treatment	60 months	In this outcome measure, participants who discontinued treatment due to any reason like disease progression, death, toxicity, both disease progression and toxicity, other or end of data availability are reported.
Percentage of Participants With Objective Response (OR)	60 months	Percentage of participants with OR based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Confirmed responses are those that persist on repeat imaging study at least 4 weeks after initial documentation of response. CR are defined as the disappearance of all lesions (target and/or non target). Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 millimeter. PR are those with at least 30 percent (%) decrease in the sum of diameters of the target lesions taking as a reference the baseline sum diameters.
Percentage of Participants With Progressive Disease	60 months	Progressive disease (PD) was defined as an increase in visible disease. According to Response Evaluation Criteria in Solid Tumors (RECIST 1.1) progressive disease: - at least a 20% increase in the sum of diameters of target lesions taking as reference the smallest sum on the study. This includes the baseline sum if that is the smallest on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered progression.
Percentage of Participants With Stable Disease	60 months	Stable disease was defined as no change in size of visible disease. According to Response Evaluation Criteria in Solid Tumors (RECIST 1.1), stable disease neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. Progressive disease: - at least a 20% increase in the sum of diameters of target lesions taking as reference the smallest sum on the study. PR are those with at least 30 percent (%) decrease in the sum of diameters of the target lesions taking as a reference the baseline sum diameters.

Trial Locations

Locations (1)

University of Calgary; 🇨🇦 Calgary, Alberta, Canada