Abstract
BackgroundVascular endothelial growth factor (VEGF), tyrosine kinase (TK) and mechanistic target of rapamycin kinase (mTOR) inhibitors are common first-line (1 L) treatments for metastatic renal cell carcinoma (mRCC). Despite treatment availability, the 5-year survival rate in patients diagnosed at the metastatic stage is only ≈ 10%. To gain contemporary insights into RCC treatment trends that may inform clinical, scientific and payer considerations, treatment patterns and adverse events (AEs) associated with 1 L therapy were examined in a retrospective, longitudinal, population-based, observational study of patients with mRCC.MethodsUS administrative claims data (Truven Health MarketScan Commercial Databases) were used to assess trends in 1 L treatment initiation in mRCC (2006–2015) and characterize patterns of individual 1 L treatments, baseline characteristics, comorbidities and treatment-related AEs from 2011 through 2015. Outcomes were evaluated by drug class and route of administration.ResultsTen-year trend analysis (n = 4270) showed that TK/VEGF-directed therapy rapidly became more common than mTOR-directed therapy, and oral treatments were favored over intravenous (IV) treatments. Overall, 1992 eligible patients initiated 1 L treatment for mRCC from 2011 through 2015: 1752 (88%) received TK/VEGF-directed agents and 233 (12%) received mTOR-directed agents; 1674 (84%) received oral treatments, and 318 (16%) received IV treatments. The most common 1 L treatment was sunitinib (n = 849), followed by pazopanib (n = 631), temsirolimus (n = 157) and bevacizumab (n = 154). Patient characteristics and comorbidities, including age, diabetes and congestive heart failure, were independent predictors of 1 L mRCC treatment choice. The three most common potentially 1 L treatment–related AEs were nausea/vomiting (128.2 per 100 patient-years [PY]), hypertension (69 per 100 PY) and renal insufficiency (44.6 per 100 PY). A wide variety of agents were used as second-line (2 L) therapy. Substantial latency of onset was observed for several potentially treatment-related toxicities in patients treated with TK/VEGF- or mTOR-directed agents.ConclusionsIn the US, 1 L TK/VEGF inhibitor uptake in recent years appears largely in line with national approvals and guidelines, with varied 2 L agent use. Although retrospective evaluation of claims data cannot assess underlying causality, insights from these real-world RCC treatment and AE patterns will be useful in informing medical and payer decisions.
Highlights
Vascular endothelial growth factor (VEGF), tyrosine kinase (TK) and mechanistic target of rapamycin kinase inhibitors are common first-line (1 L) treatments for metastatic renal cell carcinoma
In addition to nausea/vomiting and renal insufficiency, hypertension and anemia were among the four most common Adverse event (AE) when evaluated separately by treatment categories
There were AEs potentially associated with checkpoint inhibitors. The latency of these AEs was similar to that observed with checkpoint inhibitors [38, 39]. These results suggest that attributing toxicities to TK/ VEGF-directed therapies vs checkpoint inhibitors, when used in combination, may be challenging due to overlapping toxicities
Summary
Vascular endothelial growth factor (VEGF), tyrosine kinase (TK) and mechanistic target of rapamycin kinase (mTOR) inhibitors are common first-line (1 L) treatments for metastatic renal cell carcinoma (mRCC). Several tyrosine kinase (TK) inhibitors, vascular endothelial growth factor (VEGF) inhibitors (collectively, TK/VEGF inhibitors) and mechanistic target of rapamycin (mTOR) inhibitors have been approved in the United States for 1 L use in patients with mRCC. These agents have notably improved efficacy [4] compared with interferon (IFN)-α and interleukin 2 (IL-2), the previous standards of care [7, 8]. With the changing landscape in the 1 L treatment of mRCC, an understanding of real-world treatment use, sequencing and associated adverse events (AEs) of historic but widely used and recommended current standard of care treatments is required [15, 16] and can provide practitioner, researcher and payer insights into the care and benefit:risk profiles of mRCC treatment
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