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

Moran, Michael; Nickens, Dana; Adcock, Katherine; Bennetts, Meg; Desscan, Arial; Charnley, Natalie; Fife, Kate

doi:10.1007/s11523-019-00653-5

Cited by 61 publications

(31 citation statements)

References 65 publications

Supporting

Mentioning

Contrasting

Unclassified

Order By: Relevance

“…The duration of exposure in 200 mg group and 100 mg group was 265 (range, 39−367) d and 114 (range, 56−367) d, respectively. The ORR of 22.2% and the median PFS of 9.9 months in patients treated with 200 mg of vorolanib were comparable with the results of a recent meta-analysis that reported a pooled ORR of 27.9% (95% CI: 24.2−32.0) and median PFS of 9.3 (8.6−10.2) months for sunitinib in patients with metastatic RCC ( 24 ). Notably, this study enrolled patients with advanced solid tumors who had not responded well to standard therapy; 91% of these patients had been previously treated with systemic therapy and 59% were previously treated with anti-angiogenic therapy.…”

Section: Discussionsupporting

confidence: 82%

Vorolanib, an oral VEGFR/PDGFR dual tyrosine kinase inhibitor for treatment of patients with advanced solid tumors: An open-label, phase I dose escalation and dose expansion trial

Song

Wang

Ren

et al. 2021

Chinese Journal of Cancer Research

View full text Add to dashboard Cite

Objective This study evaluated the safety and preliminary efficacy of vorolanib, a novel tyrosine kinase inhibitor, for treatment of patients with advanced solid tumors. Methods During dose escalation, patients received increasing doses of oral vorolanib (50−250 mg once daily) in cycles of four weeks for up to one year. During dose expansion, patients received recommended doses (100 and 200 mg) in 4-week cycles. The primary endpoint was to determine the safety and maximum tolerated dose and/or the recommended phase II dose (RP2D). The severity and type of adverse drug reactions (ADRs) were assessed using the Common Terminology Criteria for Adverse Events version 4.0. The second endpoint was preliminary efficacy in terms of objective response and progression-free survival (PFS). Results No dose-limiting toxicity occurred during dose escalation (50−250 mg). Five (26.3%) patients in the escalation cohort (n=19) and 12 (48.0%) in the expansion cohort (n=25) experienced grade 3 ADRs. The most common ADRs were hair color changes, fatigue, portal hypertension, hypertriglyceridemia, and proteinuria. During dose expansion, the patients treated with 200 mg and 100 mg (once daily) showed an objective response rate of 22.2% and 5.9%, respectively; the disease control rate was 88.9% and 73.3%, respectively; the median PFS was 9.9 [95% confidence interval (95% CI): 7.4−not reached] months and 3.8 (95% CI: 1.9−not reached) months, respectively. Conclusions Oral vorolanib at a dose of 200 mg (once daily) exhibited an acceptable safety profile and favorable clinical benefit for patients with advanced solid tumors. The RP2D for vorolanib was determined to be 200 mg as a daily regimen.

show abstract

Section: Discussionsupporting

confidence: 82%

Vorolanib, an oral VEGFR/PDGFR dual tyrosine kinase inhibitor for treatment of patients with advanced solid tumors: An open-label, phase I dose escalation and dose expansion trial

Song

Wang

Ren

et al. 2021

Chinese Journal of Cancer Research

View full text Add to dashboard Cite

show abstract

“…In fact, we know little about risks and benefits when these products are first on the market due, in part, to the increased complexities of treatment regimens and the lack of transparency and generalizability of clinical trial results [15,16]. Delivery of care is complex and a diversity of approaches to generating evidence should be embraced to maximize what can be learned and how it can inform healthcare and regulatory decisions [17]. Given the complexities of health systems, delivery of health care, and the high degree of variation in human responses to treatment, we should expect that results from RWE may differ from RCTs yet still be correct, as the Friends results illustrate.…”

Section: Discussionmentioning

confidence: 99%

Modernizing Regulatory Evidence with Trials and Real-World Studies

Dreyer

Hall

Christian

2020

Ther Innov Regul Sci

View full text Add to dashboard Cite

We are taught that randomized controlled trials (RCTs) are the gold standard for evaluating whether a treatment can achieve its intended benefit because they are designed to isolate treatment effects while essentially balancing all other factors, known and unknown. While an elegant tool, the results from RCTs are not always generalizable to less idealized settings and more diverse patients. Real-world evidence (RWE), conducted alongside or as an extension of clinical trials, can play an important role in completing the picture of how well a therapy works, for which patients, and under what conditions. Such evidence has long been used for treatment and reimbursement decisions; the question at hand is whether, when and how RWE should contribute to regulatory decision-making and be considered credible enough to be counted as 'substantial evidence of effectiveness.' Among numerous efforts to evaluate RWE suitability for regulatory use, a recent Friends of Cancer Research (Friends) study provides valuable lessons for RCT and RWE zealots alike. Here, we review the complementary nature of RCTs and RWE, discuss the key learnings from the Friends project, and reinforce the call for continued examination of methods and data sources to guide reliable regulatory use of RWE for evaluating therapies.Publisher's Note Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

show abstract

“…в РКИ соответственно). Авторы заключили, что эффективность сунитиниба, продемонстрированная в РКИ, подтверждается рутинной практикой [23].…”

Section: сунитиниб у неотобранных больных распространенным пкрunclassified

Does sunitinib still have a place in the current recommendations for the systemic treatment of advanced renal cell carcinoma?

Волкова

Kalinin

2021

Medicinskij sovet

View full text Add to dashboard Cite

Renal cancer is a common malignancy. The frequency of renal cell carcinoma (RCC) in the structure of oncological diseases is steadily increasing. Despite the migration of the stage towards an increase in the frequency of primary detection of localized forms of the disease, renal cancer belongs to the aggressive and unpredictable malignant neoplasms. One third of patients already have distant metastases at the time of diagnosis. Surgery is the only radical method of treatment of renal cancer. However, despite the successes of surgery in the treatment of RCC, according to various data, more than 30% of radically operated patients show dissemination of the tumor process during follow-up. Radiation therapy and chemotherapy are ineffective in treating metastatic RCC (mRCC). The results of nonspecific immunotherapy in the treatment of metastatic renal cancer were also unsatisfactory. Progress in the study of molecular biology has led to the discovery of a new group of anti-tumor drugs related to angiogenesis inhibitors. The use of targeted therapies has increased the efficacy of drug therapy in the treatment of mRCC several times over the use of cytokine immunotherapy. One of the first such drugs registered in 2007 for the treatment of mRCC was sunitinib, which in a number of clinical trials has demonstrated the greatest efficacy and acceptable toxicity. Along with new drug regimens, the multikinase inhibitor sunitinib remains the drug of choice for first-line therapy of inoperable locally advanced and disseminated clear cell and non-small cell RCC in patients with favorable prognosis. The literature review presents a critical analysis of the data related to sunitinib research in kidney cancer and changes in the position of monotherapy with this drug in advanced forms of the disease.

show abstract

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

Cited by 61 publications

References 65 publications

Vorolanib, an oral VEGFR/PDGFR dual tyrosine kinase inhibitor for treatment of patients with advanced solid tumors: An open-label, phase I dose escalation and dose expansion trial

Vorolanib, an oral VEGFR/PDGFR dual tyrosine kinase inhibitor for treatment of patients with advanced solid tumors: An open-label, phase I dose escalation and dose expansion trial

Modernizing Regulatory Evidence with Trials and Real-World Studies

Does sunitinib still have a place in the current recommendations for the systemic treatment of advanced renal cell carcinoma?

Contact Info

Product

Resources

About