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Modeling Spontaneous Metastatic Renal Cell Carcinoma mRCC in Mice Following Nephrectomy
Published on: April 29, 2014
Real-world treatment patterns and adverse events in metastatic renal cell carcinoma from a large US claims database
Sumanta Pal1, Jun Gong2, Shivani K Mhatre3
1Department of Medical Oncology and Experimental Therapeutics, City of Hope National Medical Center, 1500 East Duarte Road, Duarte, CA, 91010, USA. spal@coh.org.
Background:
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). 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.
Methods:
US 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.
Results:
Ten-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.
Conclusions:
In 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.
Insights
First-line tyrosine kinase/VEGF inhibitor therapy is now standard for metastatic renal cell carcinoma (mRCC), with oral treatments preferred over IV. Common adverse events include nausea, hypertension, and renal issues.
Area of Science:
- Oncology
- Pharmacology
- Health Services Research
Background:
- Metastatic renal cell carcinoma (mRCC) has a poor prognosis, with a 5-year survival rate of approximately 10% despite available first-line (1L) treatments.
- Common 1L treatments for mRCC include vascular endothelial growth factor (VEGF), tyrosine kinase (TK), and mechanistic target of rapamycin kinase (mTOR) inhibitors.
- Real-world data are needed to understand contemporary treatment patterns and adverse events (AEs) in mRCC.
Purpose of the Study:
- To examine trends in 1L treatment initiation for mRCC in the US from 2006-2015.
- To characterize patterns of 1L treatments, patient demographics, comorbidities, and treatment-related AEs from 2011-2015.
- To provide insights into clinical, scientific, and payer considerations for mRCC management.
Main Methods:
- Retrospective, longitudinal, population-based, observational study using US administrative claims data (Truven Health MarketScan Commercial Databases).
- Analysis of 1L treatment initiation trends and patterns, including drug class, route of administration, patient characteristics, and comorbidities.
- Characterization of treatment-related AEs and their onset latency.
Main Results:
- TK/VEGF-directed therapies became more common than mTOR-directed therapies, with a preference for oral over intravenous (IV) administration.
- Sunitinib, pazopanib, temsirolimus, and bevacizumab were the most common 1L treatments.
- Nausea/vomiting, hypertension, and renal insufficiency were the most frequent AEs; several toxicities showed delayed onset.
Conclusions:
- First-line TK/VEGF inhibitor use in mRCC aligns with US approvals and guidelines, while second-line (2L) agent use is varied.
- Real-world treatment and AE patterns offer valuable insights for medical and payer decision-making.
- While claims data cannot establish causality, observed trends inform clinical practice and future research.
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