N/A
Completed N=57
A Retrospective Medical Record Review of First-Line Sunitinib Administration Schedules and Outcomes Among Patients With mRCC in Latin America (LA)
Source: ClinicalTrials.gov NCT04115189 ↗Enrolled (actual)
57
Serious AEs
12.1%
Results posted
May 2022
Primary outcomePrimary: Demographic Characteristic of Participants: Year of Birth — 1; 0; 1; 0 Participants
Summary
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
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Demographic Characteristic of Participants: Year of Birth |
1; 0; 1; 0; 1; 0 | — |
| PRIMARY Demographic Characteristic of Participants: Comorbidities |
1; 0; 1; 1; 3; 0 | — |
| PRIMARY Demographic Characteristic of Participants: Primary Health Insurance Type |
11; 7; 31; 6; 0; 2 | — |
| PRIMARY Demographic Characteristic of Participants: Height |
164.4; 168.9 | — |
| PRIMARY Demographic Characteristic of Participants: Weight |
73.5; 90.5 | — |
| PRIMARY Demographic Characteristic of Participants: Body Mass Index |
28.2; 31.8 | — |
| PRIMARY Clinical Characteristic of Participants: Year of Diagnosis of Metastatic Renal Cell Carcinoma |
1; 0; 2; 1; 3; 0 | — |
| PRIMARY Clinical Characteristic of Participants: Stages of Renal Cell Carcinoma (RCC) |
1; 0; 6; 1; 6; 1 | — |
| PRIMARY Clinical Characteristic of Participants: Risk Groups |
25; 6; 12; 7; 5; 2 | — |
| PRIMARY Clinical Characteristic of Participants: Sites of Distant Metastases |
13; 3; 10; 2; 3; 1 | — |
| PRIMARY Clinical Characteristic of Participants: Eastern Cooperative Oncology Group (ECOG) Performance Status |
13; 5; 23; 7; 3; 1 | — |
| PRIMARY Treatment Modalities Received Prior to Metastatic Renal Cell Carcinoma (mRCC) Diagnosis |
1; 0; 28; 8; 0; 0 | — |
| PRIMARY Duration Between Last Treatment Received and Metastatic Renal Cell Carcinoma (mRCC) Diagnosis |
46.0; 59.1 | — |
| PRIMARY Number of Systemic Lines of Treatment Received After the Diagnosis of Metastatic Renal Cell Carcinoma (mRCC) |
15; 14; 20; 0; 7; 1 | — |
| PRIMARY Duration of Each Systemic Lines of Treatment Received After the Diagnosis of Metastatic Renal Cell Carcinoma (mRCC) |
12.3; 37.5; 6.5; NA; 6.6; NA | — |
| PRIMARY Duration of Treatment With Sunitinib |
4.6; 7.5; 13.6 | — |
| PRIMARY Duration Between Discontinuation of 4/2 Schedule and Initiation of 2/1 Schedule |
0.6 | — |
| PRIMARY Participants With Reasons for Switching to 2/1 Treatment Schedule |
31; 2; 1; 10; 1; 1 | — |
| PRIMARY Duration of Sunitinib 2/1 Treatment Schedule After Switching From 4/2 Treatment Schedule |
6.7 | — |
| PRIMARY Number of Participants With Reasons for Sunitinib 2/1 Treatment Schedule Discontinuation |
4; 0; 2; 1; 26; 2 | — |
| PRIMARY Number of Participants With At-least 1 Dose Change |
4; 3; 2 | — |
| PRIMARY Number of Participants With Reason For Dose Change |
4; 3; 2; 2; 0; 0 | — |
| PRIMARY Number of Participants With Investigator Assessed Best Response to Treatment With Sunitinib |
4; 4; 14; 5; 17; 2 | — |
| PRIMARY Number of Participants With Different Supportive Care Elements During First Line Sunitinib Treatment |
3; 4; 4; 26; 14; 2 | — |
| PRIMARY Adverse Events Observed During First-line Treatment With Sunitinib |
42; 42; 14; 30; 24; 11 | — |
| PRIMARY Progression Free Survival (PFS) From Initial Metastatic Diagnosis |
19.1; NA | — |
| PRIMARY Progression Free Survival (PFS) From Initiation of Sunitinib 4/2 Treatment Schedule |
16.6 | — |
| PRIMARY Progression Free Survival (PFS) From Initiation of Sunitinib 2/1 Treatment Schedule |
12; NA | — |
| PRIMARY Overall Survival (OS) From Metastatic Diagnosis |
46.1; NA | — |
| PRIMARY Overall Survival (OS) From Initiation of Sunitinib 4/2 Treatment Schedule |
46.1 | — |
| PRIMARY Overall Survival (OS) From Initiation of Sunitinib 2/1 Treatment Schedule |
42.0; NA | — |
| PRIMARY Time to Initiate Second Line Treatment |
19.7; 37.5; 2.6; 28.0 | — |
Eligibility Criteria
Inclusion Criteria
- 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)
- 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)
- 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
- 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)
Data sourced from ClinicalTrials.gov (NCT04115189). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.