Experience with Sunitinib in metastatic renal cell carcinoma (mRCC) patients: pooled analysis from 3 Spanish observational prospective studies

ABSTRACT

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.

KEYWORDS:

• Effectiveness
• routine clinical practice
• safety
• sunitinib

Article highlights

• Observational studies in patients treated under common clinical conditions are needed in addition to clinical trials.

• Outcomes with sunitinib in daily clinical practice resemble those obtained in clinical trials, however new schemes of administration (2 wks on/1 wks off9 could be ameliorate the tolerance without change the clinical efficacy.

This box summarizes key points contained in the article.

Declaration of interest

P. Maroto has advisory roles at Pfizer, Novartis, Bayer, Astellas and Janssen-Cilag and funding for research grants from Pfizer. M. A. Climent has advisory roles at Pfizer, Bristol and Novartis. A. González del Alba has received honoraria from Bayer, Astellas and GlaxoSmithKline and has advisory roles at Bayer, Astellas, GlaxoSmithKline and Sanofi. J. García-Donas is a member of the speakers’ bureau for Pfizer. E. Grande has received honoraria for lectures and advisory board meetings and funding for research grants from Pfizer. E.Gallardo has received honoraria by lectures and/or advisory boards and travel expenses from Pfizer, Novartis and Bayer.M.V. Bolos and J. Linares are employees of Pfizer, S.L.U. The other authors declare that they have no conflicts of interest.

Additional information

Funding

This study was funded by Pfizer. Medical writing support was provided by Esther Tapia, PhD, freelance and was funded by Pfizer