Real‐life patterns of use, safety and effectiveness of sunitinib in first‐line therapy of metastatic renal cell carcinoma: the SANTORIN cohort study

Noïze, Pernelle; Grelaud, Angela; Bay, Jacques‐Olivier; Chevreau, Christine; Gross‐Goupil, Marine; Culine, Stéphane; Ferrière, Jean-Marie; Moulin, Flore; Robinson, Philip; Balestra, A.; Lamarque, S.; Bernard, Marie-Agnès; Lassalle, R.; Rouyer, M.; Droz–Perroteau, C.; Moore, Nicholas; Fourrier‐Réglat, Annie; Ravaud, Alain

doi:10.1002/pds.4228

Cited by 18 publications

(12 citation statements)

References 34 publications

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“…Performance or risk status can have a dramatic effect on survival outcomes and may account for some of the variation in reported survival outcomes. Sunitinib efficacy outcomes reported by Schnadig et al and Noize et al were generally lower than those reported in RCTs and our combined confidence estimates; however, there were greater numbers of poor-risk patients and fewer favorable-risk patients in these studies compared with RCTs [44,47]. An RWD study by Rini [31].…”

Section: Discussionmentioning

confidence: 48%

“…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%

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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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Section: Discussionmentioning

confidence: 48%

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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“…Currently, the most commonly used agents are the tyrosine kinase inhibitors sunitinib and pazopanib, for the first-line treatment of mRCC patients with good or intermediate prognosis [7] stratified by MSKCC risk criteria based on phase III clinical trials [16,17]. The effectiveness and tolerability of both agents have been confirmed by real-world studies [18,19]. Everolimus and axitinib emerged as safe and effective second-line treatment options for mRCC patients after progression on VEGFtargeted therapy [14,20].…”

Section: Discussionmentioning

confidence: 99%

Survival Benefits of Second-line Axitinib Versus Everolimus After First Line Sunitinib Treatment in Metastatic Renal Cell Carcinoma

Gergely

Bodoky

Rokszin³

et al. 2020

Pathol. Oncol. Res.

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Background Targeted therapies significantly improve clinical outcomes among patients with metastatic renal cell carcinoma (mRCC). Several new agents have been approved for first-and second-line use. However, there is a lack of compelling evidence comparing sequencing strategies, and available comparative data regarding the real-world effectiveness of different therapeutic sequences are limited. Materials and Methods We identified mRCC patients who initiated targeted therapy between January 1, 2008 and May 31, 2017 from the National Health Insurance Fund (NHIF) database of Hungary. Overall survival (OS) and duration of first-line treatment (DFT) were obtained for patients receiving sunitinib-everolimus, sunitinib-axitinib, or pazopanib-everolimus treatment sequences. OS of sunitinib-everolimus and sunitinib-axitinib sequences was also determined for patients having better or worse response to sunitinib first-line therapy. Results Median OS was significantly longer among patients treated with sunitinib-axitinib compared to those receiving sunitinibeverolimus. Median DFT was also significantly longer in the sunitinib-axitinib vs. sunitinib-everolimus group. Sunitinib-axitinib was associated with significantly longer median OS compared to sunitinib-everolimus in patients with better response to first-line sunitinib in the pooled sunitinib population. In patients with worse response to sunitinib, sunitinib-axitinib was associated with a trend towards greater OS compared to sunitinib-everolimus, but the difference did not reach statistical significance. Conclusions In this nationwide database analysis, mRCC patients treated with the sunitinib-axitinib sequence had significantly longer OS compared to those receiving sunitinib-everolimus therapy. The OS benefits of second-line axitinib were consistent among patients with better response to sunitinib defined by DFT values.

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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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Real‐life patterns of use, safety and effectiveness of sunitinib in first‐line therapy of metastatic renal cell carcinoma: the SANTORIN cohort study

Cited by 18 publications

References 34 publications

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

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

Survival Benefits of Second-line Axitinib Versus Everolimus After First Line Sunitinib Treatment in Metastatic Renal Cell Carcinoma

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

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