Related Experiment Video
Updated: Mar 2, 2026
A Syngeneic Mouse Model of Metastatic Renal Cell Carcinoma for Quantitative and Longitudinal Assessment of Preclinical Therapies
Published on: April 12, 2017
Experience with Sunitinib in metastatic renal cell carcinoma (mRCC) patients: pooled analysis from 3 Spanish
Daniel Castellano1, José Pablo Maroto2, Enrique Espinosa3
1a Hospital Universitario 12 de Octubre , Madrid , Spain.
Background:
A pivotal, randomized, phase III trial demonstrated a statistically significant superiority of sunitinib over interferon-α in metastatic renal cell carcinoma (mRCC) patients.
Objective:
To evaluate the effectiveness and safety of sunitinib in patients with advanced or mRCC in routine clinical practice.
Methods:
Retrospective pooled analysis of clinical data from three observational and prospective studies carried out between 2007 and 2011 in 33 Spanish hospitals. Tumor response, Progression-free survival (PFS) and overall survival (OS), and main sunitinib-related toxicities were registered.
Results:
224 patients were analyzed. Median PFS 10.6 months (95% CI: 9.02-12.25), median OS 21.9 months (95% CI: 17.2-26.6). Objective response rate (ORR) 43.8% (95% CI: 36.8-50.7). Median time to PR was 3.8 months (95% CI: 3.86-5.99) and to CR 8.2 months (95% CI: 4.75-9.77). The most common ≥ grade-3 AEs were asthenia/fatigue (18.7%), hand-foot syndrome (6.2%), hypertension (5.8%) and neutropenia (4.8%). Hand-foot syndrome, diarrhea and mucositis were confirmed as independent predictors for PFS and/or OS in a multivariate analysis (p < 0.05) Conclusions: Outcomes with sunitinib in daily clinical practice resemble those obtained in clinical trials. Long-term benefit with sunitinib is possible in advanced RCC patients but the appropriate management of toxicities is mandatory to enable patients to remain on treatment.
Insights
Sunitinib shows effectiveness and safety in metastatic renal cell carcinoma (mRCC) patients in real-world practice, similar to clinical trials. Managing toxicities is key for long-term benefits in advanced RCC.
Area of Science:
- Oncology
- Clinical Pharmacology
Background:
- Metastatic renal cell carcinoma (mRCC) is a significant clinical challenge.
- Sunitinib demonstrated superiority over interferon-α in a pivotal phase III trial for mRCC.
Purpose of the Study:
- To assess the real-world effectiveness and safety of sunitinib in advanced or mRCC patients.
- To evaluate treatment outcomes in routine clinical practice.
Main Methods:
- Retrospective pooled analysis of data from three observational and prospective studies (2007-2011).
- Involved 33 Spanish hospitals and 224 patients with advanced or mRCC.
- Evaluated tumor response, progression-free survival (PFS), overall survival (OS), and sunitinib-related toxicities.
Main Results:
- Median PFS was 10.6 months and median OS was 21.9 months.
- Objective response rate (ORR) was 43.8%.
- Common grade-3 adverse events included asthenia/fatigue, hand-foot syndrome, hypertension, and neutropenia. Hand-foot syndrome, diarrhea, and mucositis predicted PFS/OS.
Conclusions:
- Sunitinib outcomes in clinical practice mirror those from clinical trials.
- Long-term benefits are achievable in advanced RCC patients treated with sunitinib.
- Effective management of toxicities is crucial for sustained treatment and patient benefit.
