A Retrospective Medical Record Review of First-Line Sunitinib Administration Schedules and Outcomes Among Patients With mRCC in Latin America (LA)

Pfizer

Status: Completed

Conditions: Metastatic Renal Cell Carcinoma ( mRCC)

Treatments: Drug: Sunitinib

Study type: Observational

Funder types: Industry

Identifiers

NCT04115189

A6181231

Details and patient eligibility

About

To describe real-world demographic and clinical characteristics, treatment characteristics, and clinical outcomes among patients in Latin America who were treated with first-line sunitinib for metastatic renal cell carcinoma and switched from the 4/2 to 2/1 administration schedule

Full description

Understanding characteristics of patients who switched from a 4/2 to a 2/1 sunitinib schedule or initiated the 2/1 schedule in Brazil, and the resulting clinical outcomes in the real-world setting

• Describing the occurrence of AEs on the 4/2 and 2/1 schedules

Enrollment: 57 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Diagnosed with metastatic RCC with clear cell histology

   a. The patient may have been initially diagnosed with Stage IV or initially diagnosed at an earlier stage and progressed to having disease at distant sites (i.e., metastatic disease)

2. Initiated first-line treatment for metastatic RCC with sunitinib on the 4/2 schedule (all countries) or initiated first-line treatment for metastatic RCC with sunitinib on the 2/1 schedule (Brazil only)

3. Switched to the 2/1 schedule (all countries) or initiated the 2/1 schedule (Brazil only) during the first treatment line between January 1, 2014, and June 30, 2018 a. The final dates defining this selection period will be dependent on country-specific ethics and reporting requirements

Exclusion criteria

1. Evidence of other malignant neoplasms (except nonmelanoma skin cancer or carcinoma in situ) within 5 years before switching to the sunitinib 2/1 schedule (all countries) or initiation of the 2/1 schedule (Brazil only)

Trial design

57 participants in 1 patient group

Patients with Metastatic RCC

Description:

Patients diagnosed with metastatic RCC with clear cell histology who switched from a 4/2 schedule to a 2/1 schedule of sunitinib in first-line metastatic treatment between January 1, 2014 and June 30, 2018

Treatment:

Drug: Sunitinib