Experience with Sunitinib in metastatic renal cell carcinoma (mRCC) patients: pooled analysis from 3 Spanish observational prospective studies. Issue 6 (3rd June 2018)

• Record Type: Journal Article
• Authors: Castellano, Daniel; Maroto, José Pablo; Espinosa, Enrique; Grande, Enrique; Bolós, M Victoria; Llinares, Julia; Esteban, Emilio; González del Alba, Aranzazu; Climent, Miguel Angel; Arranz, Jose Angel; Méndez, Mª José; Fernández Parra, Eva; Antón-Aparicio, Luis; Bayona, Cristina; Gallegos, Isabel; Gallardo, Enrique; Samaniego, Luz; García Donas, Jesús
• Is Part Of: Expert opinion on drug safety. Volume 17:Issue 6(2018)
• Page Start: 573
• Page End: 579
• Publication Date: 2018-06-03
• Subjects: Effectiveness -- routine clinical practice -- safety -- sunitinib; Drugs -- Side effects -- Periodicals; Drugs -- Toxicology -- Periodicals; Chemotherapy -- Periodicals; 615.704
• DOI: 10.1080/14740338.2017.1330410
• Languages: English
• ISSNs: 1474-0338

Abstract

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.