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

The Effect of Vascular Endothelial Growth Factor Receptor (VEGFR) Tyrosine Kinase Inhibitors (TKI) on Clinical Outcomes Among Patients With Metastatic Renal Cell Carcinoma (mRCC) Who Received First-Line Sunitinib in the International mRCC Database Consortium (IMDC) Based on Prognostic Risk Score

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.

Study Overview

• Status: Completed
• Conditions: Metastatic Renal Cell Carcinoma
• Intervention / Treatment: Drug: Sunitinib

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 Type: Observational
• Enrollment (Actual): 1769

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Calgary, Alberta, Canada, P2N4N2
      • University of Calgary

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients diagnosed with clear cell mRCC at age 18 or older who initiated sunitinib as first-line treatment between 2010 and 2018

Description

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Favorable IMDC risk group; The cohort of mRCC patients receiving sunitinib as first-line treatment and classified as favorable IMDC risk group for having 0 individual risk factor	Drug: Sunitinib; patients who received sunitinib as first line therapy for mRCC
Intermediate IMDC risk group; 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	Drug: Sunitinib; patients who received sunitinib as first line therapy for mRCC
Poor IMDC risk group; 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	Drug: Sunitinib; patients who received sunitinib as first line therapy for mRCC

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Survival	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.	60 months
Time to First-Line Sunitinib Treatment Discontinuation	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.	60 months
Number of Participants Who Discontinued First-Line Sunitinib Treatment	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.	60 months
Percentage of Participants With Objective Response (OR)	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.	60 months
Percentage of Participants With Progressive Disease	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.	60 months
Percentage of Participants With Stable Disease	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.	60 months

Collaborators and Investigators

• Sponsor: Pfizer
• Collaborators: International Metastatic Renal Cell Carcinoma Database Consortium (IMDC); Analysis Group

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2018
• Primary Completion (Actual): September 2, 2018
• Study Completion (Actual): September 2, 2018

Study Registration Dates

• First Submitted: August 30, 2019
• First Submitted That Met QC Criteria: August 30, 2019
• First Posted (Actual): September 3, 2019

Study Record Updates

• Last Update Posted (Actual): April 6, 2023
• Last Update Submitted That Met QC Criteria: April 4, 2023
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: Sunitinib; Vascular endothelial growth factor (VEGF)
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Kidney Diseases; Urologic Diseases; Adenocarcinoma; Neoplasms, Glandular and Epithelial; Kidney Neoplasms; Carcinoma, Renal Cell; Carcinoma; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Protein Kinase Inhibitors; Sunitinib
• Other Study ID Numbers: A6181229

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Pfizer will provide access to related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests