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Clinical Outcomes for Patients With Renal Cell Carcinoma Who Received First-Line Sunitinib
trial testing Sunitinib in Metastatic Renal Cell Carcinoma in 1,769 participants. Completed in 2 September 2018.
| Lead sponsor | Pfizer |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 1,769 |
| Start date | 1 September 2018 |
| Primary completion | 2 September 2018 |
| Estimated completion | 2 September 2018 |
| Sites | 1 location across Canada |
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18 and older, any sex, with Metastatic Renal Cell Carcinoma. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
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.
| Group | Value | 95% CI |
|---|---|---|
| IMDC Prognostic Risk Group: Favorable | 52.1 | 43.4 – 61.2 |
| IMDC Prognostic Risk Group: Intermediate | 31.5 | 28.9 – 33.9 |
| IMDC Prognostic Risk Group: Poor | 9.8 | 8.3 – 11.4 |
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.
| Group | Value | 95% CI |
|---|---|---|
| IMDC Prognostic Risk Group: Favorable | 15.0 | 12.4 – 17.3 |
| IMDC Prognostic Risk Group: Intermediate | 8.5 | 8.0 – 9.5 |
| IMDC Prognostic Risk Group: Poor | 4.2 | 3.4 – 4.9 |
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.
| Group | Value | 95% CI |
|---|---|---|
| IMDC Prognostic Risk Group: Favorable | 91 | |
| IMDC Prognostic Risk Group: Intermediate | 316 | |
| IMDC Prognostic Risk Group: Poor | 122 |
| Group | Value | 95% CI |
|---|---|---|
| IMDC Prognostic Risk Group: Favorable | 52 | |
| IMDC Prognostic Risk Group: Intermediate | 141 | |
| IMDC Prognostic Risk Group: Poor | 42 |
| Group | Value | 95% CI |
|---|---|---|
| IMDC Prognostic Risk Group: Favorable | 11 | |
| IMDC Prognostic Risk Group: Intermediate | 54 | |
| IMDC Prognostic Risk Group: Poor | 22 |
| Group | Value | 95% CI |
|---|---|---|
| IMDC Prognostic Risk Group: Favorable | 2 | |
| IMDC Prognostic Risk Group: Intermediate | 17 | |
| IMDC Prognostic Risk Group: Poor | 13 |
| Group | Value | 95% CI |
|---|---|---|
| IMDC Prognostic Risk Group: Favorable | 1 | |
| IMDC Prognostic Risk Group: Intermediate | 8 | |
| IMDC Prognostic Risk Group: Poor | 7 |
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 t
| Group | Value | 95% CI |
|---|---|---|
| IMDC Prognostic Risk Group: Favorable | 38.5 | |
| IMDC Prognostic Risk Group: Intermediate | 34.6 | |
| IMDC Prognostic Risk Group: Poor | 21.7 |
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.
| Group | Value | 95% CI |
|---|---|---|
| IMDC Prognostic Risk Group: Favorable | 16.3 | |
| IMDC Prognostic Risk Group: Intermediate | 27.1 | |
| IMDC Prognostic Risk Group: Poor | 46.0 |
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.
| Group | Value | 95% CI |
|---|---|---|
| IMDC Prognostic Risk Group: Favorable | 45.1 | |
| IMDC Prognostic Risk Group: Intermediate | 38.4 | |
| IMDC Prognostic Risk Group: Poor | 32.3 |
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.
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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