Efficacy of Sunitinib in Elderly Patients with Metastatic Renal Cell Carcinoma: Data from Real-World Clinical Practice

Poprach, Alexandr; Lakomý, Radek; Bortlíček, Zbyněk; Melichar, Bohuslav; Pavlík, Tomáš; Slabý, Ondřej; Vyzula, Rostislav; Svoboda, Marek; Kiss, Igor; Študentová, Hana; Zemanová, Milada; Fiala, Ondřej; Kubáčková, Kateřina; Dušek, Ladislav; Hornová, J; Büchler, Tomáš

doi:10.1007/s40266-016-0390-1

Cited by 17 publications

(20 citation statements)

References 13 publications

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“…The other possible explanation for the improved prognosis for older patients is optimal management of a therapeutic schedule personalized for each patient. Several previous studies have demonstrated the efficacy and safety of various agents [e.g., sunitinib (6,(15)(16)(17)(18) and sorafenib (19)] for older patients, and another study reported that an alternative schedule of sunitinib treatment provided a greater improvement in the OS rate compared with the standard schedule (20). Since sunitinib was prescribed on the basis of a personalized schedule in the later period, the data from our present study for patients treated with sunitinib is consistent with those reports (Fig.…”

Section: Discussionsupporting

confidence: 91%

Improved prognosis for elderly patients with metastatic renal cell carcinoma in the era of targeted therapy

et al. 2020

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The present study investigated the outcomes of targeted therapy for elderly patients with metastatic renal cell carcinoma (mRCC). A total of 277 patients with mRCC who were treated with tyrosine kinase inhibitor as a first-line therapy from January 2008 to May 2018 were retrospectively investigated by reviewing clinicopathological data. Patients 75 years or older were classified into the older-aged group (n=55) while all others were classified into the younger-aged group (n=222). The preoperative clinicopathological characteristics and the overall survival (OS) rate for these two groups were subsequently compared. The median age in the older-and younger-aged groups was 78 and 63 years (P<0.0001), respectively. A total of 7, 42 and 6 cases in the older-aged group and 46, 118 and 58 cases in the younger-aged group were classified into favorable, intermediate, and poor risk groups, respectively. The rate of patients with cardiovascular diseases (29.1%) and malignant diseases other than RCC (20.

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Section: Discussionsupporting

confidence: 91%

Improved prognosis for elderly patients with metastatic renal cell carcinoma in the era of targeted therapy

et al. 2020

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“…It would be reasonable to therefore question if the reported efficacy and safety of sunitinib was applicable to the elderly population. Our analysis included two RWD studies in elderly patients; each study population had a median age of 74 years and mPFS and mOS were consistent with the combined confidence estimate and phase III RCT [11,38,46]. Furthermore, several RWD studies have found no significant difference in PFS or OS between patients aged ≥ 70 years and those aged < 70 years [46,[59][60][61].…”

Section: Discussionmentioning

confidence: 85%

“…RWD studies used a variety of sources to extract data, including national and local cancer registries, insurance databases, pharmacy databases, and patient medical records [36][37][38][39][40][41][42][43][44][45][46][47][48][49][50]. Studies were from a wide range of countries, including USA, Canada, Australia, Spain, France, Greece, Italy, Netherlands, Czech Republic, China, Japan, Korea, and India.…”

Section: Systematic Reviewmentioning

confidence: 99%

Sunitinib for Metastatic Renal Cell Carcinoma: A Systematic Review and Meta-Analysis of Real-World and Clinical Trials Data

et al. 2019

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Background Randomized controlled trials (RCTs) have stringent inclusion criteria and may not fully represent patients seen in everyday clinical practice. Real-world data (RWD) can provide supportive evidence for the effectiveness of medical interventions in more heterogeneous populations than RCTs. Sunitinib is a widely used first-line treatment for patients with metastatic renal cell carcinoma (mRCC). Objective This is the first comprehensive meta-analysis to evaluate the efficacy of sunitinib using the novel approach of combining RCTs and RWD. Methods RCTs and RWD studies published between 2000 and 2017 were identified from PubMed, Ovid, MEDLINE, and EMBASE. Eligible studies contained a cohort of ≥ 50 adult patients with mRCC receiving first-line sunitinib treatment. The meta-analysis combined RWD and RCT treatment groups, adjusting for data type (RCT or RWD). Recorded outcomes were median progression-free survival (mPFS), median overall survival (mOS), and objective response rate (ORR). Publication bias was assessed via review of funnel plots for each outcome measure. A random effects model to account for study heterogeneity was applied to each endpoint. Sensitivity analyses evaluated the robustness of the overall estimates. Results Of the 3611 studies identified through medical database searches, 22 (15 RWD studies, 7 RCTs) met eligibility criteria and were analyzed. mPFS (18 studies), mOS (19 studies), and ORR (15 studies) were reported for aggregate measures based on 4815, 5321, and 4183 patients, respectively. Reported mPFS (RWD, 7.5-11.0 months; RCTs, 5.6-15.1 months) and ORR data (RWD, 14.0-34.6%; RCTs, 18.8-46.9%) were consistent with the overall confidence estimates (95% confidence interval [CI]) of 9.3 (8.6-10.2) months and 27.9% (24.2-32.0), respectively. Reported mOS showed greater variation in RWD (6.8-33.2 months) compared with RCTs (21.8-31.5 months), with an overall confidence estimate (95% CI) of 23.0 (19.2-27.6) months. Inspection of funnel plots and sensitivity analyses indicated that there was no publication bias for any efficacy endpoint. Sensitivity analyses showed no evidence of lack of robustness for mPFS, mOS, or ORR. Interpretation of these results is limited by differences in trial design, cohort characteristics, and missing data. Conclusions This novel, comprehensive meta-analysis validates sunitinib as an effective first-line treatment for patients with mRCC in both RCTs and everyday clinical practice. The methodology provides a framework for future analyses combining data from RCTs and RWD.

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“…The efficacy and safety of sunitinib in treatment‐naive patients with advanced clear cell RCC was demonstrated in the pivotal phase III trial, in which sunitinib significantly prolonged median progression‐free survival (mPFS) but not overall survival (OS) versus IFN‐α (Table ). Several real‐world studies confirm the effectiveness of first‐line sunitinib in patients with aRCC . Most large ( n > 150) real‐world studies are retrospective, multicenter analyses with a wide range in mPFS (7.0–20.0 months) and median OS (mOS; 18.7–45.1 months) reported across studies .…”

Section: Introductionmentioning

confidence: 94%

“…Several real‐world studies confirm the effectiveness of first‐line sunitinib in patients with aRCC . Most large ( n > 150) real‐world studies are retrospective, multicenter analyses with a wide range in mPFS (7.0–20.0 months) and median OS (mOS; 18.7–45.1 months) reported across studies . In one of the larger real‐world sunitinib studies that provided information about the effectiveness in patient subgroups often excluded from clinical trials, an expanded‐access trial in 4,543 patients with metastatic RCC demonstrated that the objective response rate (ORR) was 16% and mPFS and mOS were 9.4 and 18.7 months, respectively .…”

Section: Introductionmentioning

confidence: 99%

The Current and Evolving Landscape of First-Line Treatments for Advanced Renal Cell Carcinoma

Calvo¹,

Porta

Grünwald

et al. 2018

The Oncologist

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Vascular endothelial growth factor receptor tyrosine kinase inhibitors are approved by the U.S. Food and Drug Administration as first-line treatment options for advanced renal cell carcinoma; however, the treatment paradigm is rapidly evolving. The combination of nivolumab plus ipilimumab was recently approved for intermediate- and poor-risk patients, and other combination strategies and novel first-line agents will likely be introduced soon.

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Efficacy of Sunitinib in Elderly Patients with Metastatic Renal Cell Carcinoma: Data from Real-World Clinical Practice

Abstract: The differences in patient profile and dose-reduction rates point to a different approach in the management of older and younger patients in daily clinical practice. The lower dose intensity of sunitinib in the elderly population may have translated into inferior survival.

Cited by 17 publications

References 13 publications

Improved prognosis for elderly patients with metastatic renal cell carcinoma in the era of targeted therapy

Improved prognosis for elderly patients with metastatic renal cell carcinoma in the era of targeted therapy

Sunitinib for Metastatic Renal Cell Carcinoma: A Systematic Review and Meta-Analysis of Real-World and Clinical Trials Data

The Current and Evolving Landscape of First-Line Treatments for Advanced Renal Cell Carcinoma

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