Patterns of Care in Patients with Metastatic Renal Cell Carcinoma Among a U.S. Payer Population with Commercial or Medicare Advantage Membership

Miller, Lesley-Ann; Stemkowski, Stephen; Saverno, Kim; Lane, Daniel C.; Tao, Zhuliang; Hackshaw, Michelle D.; Loy, Bryan A.

doi:10.18553/jmcp.2016.22.3.219

Cited by 14 publications

(20 citation statements)

References 17 publications

(21 reference statements)

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“…Reported results of real-world studies are mixed. For example, the observed sunitinib and sorafenib treatment durations were similar to those reported by Feinberg et al (5.9 and 5.5 months, respectively) [32] and only slightly longer than those reported by Miller et al (5.6 and 5.3 months, respectively), who also reported durations of 5.3 months for pazopanib and 4.5 months for everolimus [14]. However, these durations are slightly longer than those reported by Hess et al (3.2 and 4.0 months, respectively; 2.6 months for temsirolimus) [33] and Vogelzang et al (sunitinib, 4.1 months; pazopanib 4.8 months) [15].…”

Section: Discussionsupporting

confidence: 84%

“…For 1 L treatment of clear cell RCC, current National Comprehensive Cancer Network (NCCN) guidelines recommend several treatment options with distinct mechanisms of action, including sunitinib or pazopanib as category 1 options [8]. Since the introduction of these agents, however, data on their use in routine clinical practice have been limited [12–14] and have tended to focus on specific patient subgroups or selective treatments. 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.…”

Section: Introductionmentioning

confidence: 99%

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Real-world treatment patterns and adverse events in metastatic renal cell carcinoma from a large US claims database

et al. 2019

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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. Electronic supplementary material The online version of this article (10.1186/s12885-019-5716-z) contains supplementary material, which is available to authorized users.

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Section: Discussionsupporting

confidence: 84%

Section: Introductionmentioning

confidence: 99%

Real-world treatment patterns and adverse events in metastatic renal cell carcinoma from a large US claims database

et al. 2019

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“…Pathologic staging of RCC is essential for guiding clinical treatment decision-making process and selecting patients for potential adjuvant therapy (32). High-risk stage II and stage III RCC patients with clear cell histology are considered candidates for adjuvant therapy according to the National Comprehensive Cancer Network (NCCN) guidelines (33).…”

Section: Discussionmentioning

confidence: 99%

Reassessment of American Joint Committee on Cancer Staging for Stage III Renal Cell Carcinoma With Nodal Involvement: Propensity Score Matched Analyses of a Large Population-Based Study

Han

et al. 2020

Front. Oncol.

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Background: To assess the role of nodal involvement in stage III renal cell carcinoma (RCC) according to the American Joint Committee on Cancer (AJCC) 8th staging system. We compared the survival outcomes of RCC patients with pT 1−3 N 1 M 0 disease and those with pT 3 N 0 M 0 or stage IV (stratified as pT 4 N any M 0 and pT any N any M 1) disease in a large population-based cohort. Methods: A cohort of 3,112 eligible patients with RCC was identified from the Surveillance, Epidemiology, and End Results (SEER) database, registered between January 2004 and December 2015. Kaplan-Meier and Cox proportional hazards models were used to evaluate the overall survival (OS), and cancer-specific survival (CSS). The prognostic value of the modified stage for pT 1−3 N 1 M 0 disease was assessed by nomogram-based analyses. Propensity score matching (PSM) was used to adjust for potential baseline confounding. Results: Patients with pT 1−3 N 1 M 0 disease showed similar survival outcomes (median OS 41.0 vs. 38.0 months, P = 0.77; CSS 45.0 vs. 39.0 months, P = 0.59) to pT 4 N any M 0 patients, whereas the significantly better survival outcome was found for pT 3 N 0 M 0 patients. After PSM, comparable survival rates were observed between pT 1−3 N 1 M 0 group and pT 4 N any M 0 group, which were still significantly worse than the survival of pT 3 N 0 M 0 patients. The modified stage IIIA (pT 3 N 0 M 0), IIIB (pT 1−3 N 1 M 0 , pT 4 N any M 0), and IV (pT any N any M 1) showed higher predictive accuracy than AJCC stage system in the nomogram-based analyses (concordance index: 0.70 vs. 0.68, P < 0.001 for OS; 0.71 vs. 0.69, P < 0.001 for CSS). Conclusions: The pT 1−3 N 1 M 0 RCC might be reclassified as stage IIIB together with pT 4 N any M 0 disease for better prediction of prognosis, further examination and validation are warranted.

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“…VEGFR-targeted therapies such as sunitinib and pazopanib have been the most commonly used first-line therapies in the United States over the past decade. [32] Sunitinib was shown in phase III study to confer improved overall survival (OS), progression-free survival (PFS), and objective response rate (ORR) as compared to interferon alfa in treatment-naïve patients with clear cell mRCC. [16] Later, the randomized phase III COMPARZ trial demonstrated pazopanib to be non-inferior to sunitinib in OS and PFS,[18,19] and both COMPARZ and a separate randomized phase IIIb study (PISCES trial) suggested pazopanib to be better tolerated than sunitinib.…”

Section: Overview Of the Marketmentioning

confidence: 99%

Ipilimumab in combination with nivolumab for the treatment of renal cell carcinoma

Gào

McDermott

2018

Expert Opinion on Biological Therapy

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Renal cell carcinoma (RCC) is a highly immunogenic neoplasm, and cytokine-based immunotherapies have been used for decades with limited success. In recent years, antibody-based immunotherapies targeting immune checkpoint receptors PD-1 and CTLA-4 have demonstrated clinical efficacy in metastatic RCC (mRCC) patients, leading to FDA approval of the combination of nivolumab and ipilimumab in treatment-naïve patients with intermediate- or poor-risk disease in April 2018. Areas covered: The pharmacodynamics and pharmacokinetics of nivolumab and ipilimumab are reviewed. Clinical safety and efficacy results from pivotal phase I and III trials of the combination of nivolumab plus ipilimumab in mRCC are summarized, and the combination is reviewed in the context of other available systemic therapies for RCC. Ongoing clinical studies involving the combination of nivolumab plus ipilimumab in RCC are discussed. Expert opinion: The combination of nivolumab and ipilimumab has demonstrated superior efficacy for treatment-naïve patients with intermediate- and poor-risk mRCC with clear cell histology and is likely to replace anti-angiogenic therapies as the treatment-of-choice in this patient population in the United States. Development of additional combination strategies, novel trial designs, and predictive biomarkers of response will be important to further optimize therapeutic selection and clinical outcomes.

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Patterns of Care in Patients with Metastatic Renal Cell Carcinoma Among a U.S. Payer Population with Commercial or Medicare Advantage Membership

Abstract: Patterns of use were similar for each of the prescribed systemic treatments for mRCC, and the majority of patients were highly persistent and compliant with first-line therapies. Time to treatment discontinuation was slightly longer with oral agents compared with injectable drugs.

Cited by 14 publications

References 17 publications

Real-world treatment patterns and adverse events in metastatic renal cell carcinoma from a large US claims database

Real-world treatment patterns and adverse events in metastatic renal cell carcinoma from a large US claims database

Reassessment of American Joint Committee on Cancer Staging for Stage III Renal Cell Carcinoma With Nodal Involvement: Propensity Score Matched Analyses of a Large Population-Based Study

Ipilimumab in combination with nivolumab for the treatment of renal cell carcinoma

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