Sunitinib Articles

BERKELEY, CA (UroToday.com) -

Drug Tolerability in the Choice of Second-Line Therapy for Metastatic Renal Cell Carcinoma

Assess patient-level utility of suggested pretreatment biomarkers of sunitinib in advanced renal cell carcinoma.

Kaplan-Meier analysis of data from a randomized, Phase II study (n = 292) suggested baseline predictive value for circulating soluble Ang-2 and MMP-2 and HIF-1α percentage of tumor expression.

BERKELEY, CA (UroToday.com) - CXp 11.2 translocation renal cell carcinoma (RCC) is a rare RCC subtype and is defined by at least 6 different translocations involving the Xp 11.2 chromosome, resulting in gene fusion between the transcription factor that binds to IGHM enhancer 3 (TFE3) and papillary RCC (PRCC) or alveolar soft part sarcoma locus (ASPL; also known as ASPSCR1).

Sunitinib and pazopanib are both standard first-line therapies for clear-cell metastatic renal-cell carcinoma (mRCC). Everolimus is a well-established second-line treatment.

To estimate the efficacy and safety of second-line everolimus following pazopanib or sunitinib.

BERKELEY, CA (UroToday.com) - Angiogenesis is one of the hallmarks of renal cell carcinoma (RCC).

Non-clear cell renal cell cancers (nccRCC) are rare entities, and the optimal therapy in metastatic disease has still to be defined.

In this small prospectively randomized phase IIa multicenter trial, we investigated temsirolimus (TEM) versus sunitinib (SUN) as first-line therapy in patients with metastatic nccRCC.

Patients with International Metastatic RCC Database Consortium (IMDC) poor risk metastatic renal cell carcinoma (mRCC) rarely respond to first-line tyrosine kinase inhibitors (TKIs) including sunitinib, and carries a very poor prognosis.

While vascular endothelial growth factor-targeted therapy and mammalian target of rapamycin inhibition are effective strategies in treating clear cell renal cell carcinoma (ccRCC), the most effective therapeutic approach for patients with non-clear cell RCC (non-ccRCC) is unknown.

BERKELEY, CA (UroToday.com) - Our article establishes a proof-of-concept for a renal cell carcinoma (RCC) preclinical model.

Background and aim Vascular endothelial growth factor receptor tyrosine kinase inhibitors (VEGFR-TKIs) cause significant adverse events including thyroid dysfunction, mainly hypothyroidism, in a considerable proportion of patients.

Adaptive dosing strategy with oral targeted therapies in oncology is mostly based upon clinical signs. Using pharmacokinetics (PK) models to customize dosing could help saving time, i.e., by predicting clinical outcome through early monitoring of drug levels.

The role of antiangiogenic agents in advanced renal cell carcinoma (RCC) is well established. However, it is still not clear whether this benefit can be extrapolated to the adjuvant setting.

To determine the efficacy and safety of antiangiogenic agents in patients with RCC and a high risk of relapse after nephrectomy.

Treatment of the metastatic stage of renal cell carcinoma is specific because classical chemotherapy is not applicable here. The treatment is mainly based on molecularly targeted drugs, including inhibitors of tyrosine kinases.

Sunitinib malate, an oral multi-targeted tyrosine kinase inhibitor approved for the treatment of metastatic renal cell carcinoma, gastrointestinal stromal tumor, and well-differentiated pancreatic neuroendocrine tumors, has been identified as a potential candidate for therapeutic drug monitoring approach.

The objective of this prospective study was to identify baseline angiogenic and inflammatory markers in serum as well as the baseline levels of immune cells in whole blood to predict progression free survival in patients with metastatic renal cell carcinoma treated with sunitinib.

BERKELEY, CA (UroToday.com) - Almost a decade ago, systemic treatment options for metastatic renal cell carcinoma (mRCC) were limited to cytokine therapy (interleukin and interferon). Those treatments had modest benefit, albeit, significant toxicities.^{[1, 2]}

The approval of multiple biological therapies as a first line treatment for metastatic renal cell carcinoma (mRCC) in the last decade have led to the selection of the best treatment between these drugs, especially tyrosine kinase inhibitors (TKIs), a great challenge to oncologists and patients.

Elderly metastatic renal cell carcinoma (mRCC) patients are under-represented in clinical trials, whose results are therefore difficult to translate into routine management of older patients. We aimed at exploring treatment outcomes and prognostic factors in our real-life elderly mRCC cohort receiving first-line tyrosine kinase inhibitor (TKI) monotherapy.

In phase 3 trials of patients with resected high-risk renal cell carcinoma, adjuvant sunitinib has demonstrated no overall survival (OS) benefit, an uncertain disease-free survival (DFS) benefit, and increased toxicity versus placebo.

In the phase 3 JAVELIN Renal 101 trial (NCT02684006), first-line treatment with avelumab + axitinib resulted in significantly longer progression-free survival (PFS) and a higher objective response rate (ORR) vs sunitinib in patients with advanced renal cell carcinoma (aRCC).

BERKELEY, CA (UroToday.com) - Although results with antiangiogenics did not show positive overall survival, a rationale still exists for the study of the angiogenic pathway.

BERKELEY, CA (UroToday.com) - The assessment of tumor hypoxia with ¹⁸F-FMISO PET/CT in metastases of renal cell carcinoma provides some comprehension of the mechanism of action of sunitinib,

BERKELEY, CA (UroToday.com) - Sunitinib is an oral, multitargeted tyrosine kinase inhibitor of vascular endothelial growth factor receptors (VEGFR-1, -2 and -3) and platelet-derived growth factor receptors (PDGFR-α and –β), approved multinationally for the treatment of first- and second-line advanced renal cell carcinoma (RCC).¹

BERKELEY, CA (UroToday.com) - Until recently, immunotherapy was considered the only therapeutic option for patients with advanced and metastatic renal cell carcinoma (RCC).

The randomised phase 2 CABOSUN trial comparing cabozantinib with sunitinib as initial therapy for advanced renal cell carcinoma (RCC) of intermediate or poor risk met the primary end-point of improving progression-free survival (PFS) as assessed by investigator.

To evaluate the potential role of levocarnitine supplementation for cancer-related fatigue in patients treated with sunitinib.

Patients treated with sunitinib for unresectable or metastatic renal cell carcinoma were enrolled prospectively.

This study aimed to explore the effect of CD276 expression on the sunitinib sensitivity of clear cell renal cell carcinoma (ccRCC) cell and animal models and the potential mechanisms involved.

CD276 expression levels of ccRCC and normal samples were analyzed via online databases and real-time quantitative PCR (RT-qPCR).

Sunitinib continues to be administered as a first-line therapeutic agent in metastatic renal cell carcinoma (mRCC). This study aimed to examine the role of CD44 in sunitinib resistance and as a predictive marker in mRCC.

Renal cell carcinoma (RCC) is the most predominant type of kidney cancer in adults and is responsible for approximately 85% of clinical cases. The tumor-specific microenvironment includes both cellular and physical factors, and it regulates the homeostasis and function of cancer cells.

To evaluate whether sunitinib and pazopanib treatments are associated with change in skeletal muscle area (SMA) and total lean body mass (LBM) as well as to compare their efficacies and safety profiles in patients with metastatic renal cell cancer (mRCC).

Recent trials have suggested predictive biomarkers in advanced clear-cell renal cell carcinoma (accRCC): International Metastatic RCC Database Consortium (IMDC) good risk or angiogenic gene signature for sunitinib and IMDC intermediate/poor risk for ipilimumab-nivolumab and T-effector cell signature or sarcomatoid dedifferentiation for atezolizumab-bevacizumab.

To assess the efficacy and tolerability of sunitinib rechallenge in the third-line or later setting in patients with metastatic renal cell carcinoma (mRCC).

This observational study comprised 61 mRCC patients at 19 centres in France who received sunitinib rechallenge between January 2006 and May 2013.

Studies indicate similar survival and toxicity between pazopanib and sunitinib, but few have examined real-world outcomes among elderly patients with advanced renal cell carcinoma (RCC). The purpose of this retrospective claims analysis was to assess real-world overall survival (OS), healthcare resource utilization (HRU), and healthcare costs (both all-cause and associated with RCC diagnosis) among elderly advanced RCC patients starting pazopanib or sunitinib treatment.

The treatment of renal cell carcinoma has achieved certain curative effects with the innovation of clinical drugs, such as sunitinib. However, the clinical efficacy and complication rate of the sunitinib 2/1 and 4/2 schedule in metastatic renal cell cancer remain unclear.

Sunitinib is approved multinationally for the first-line treatment of metastatic renal cell carcinoma (mRCC). After mRCC progressed in patients, we escalated the sunitinib dose in selected patients and then retrospectively evaluated the efficacy and safety of dose-escalated sunitinib in these selected patients.

Increases in the mean corpuscular volume (MCV) have been observed in patients with metastatic renal cell carcinoma (mRCC) on tyrosine kinase inhibitor (TKI) treatment; however, its association with progression-free-survival (PFS) is unknown.

We aimed to compare oncological outcomes and safety of axitinib and sunitinib in patients with treatment-naïve metastatic renal cell carcinoma (mRCC). We retrospectively evaluated 169 patients with mRCC who were treated with axitinib or sunitinib as the first-line therapy in five hospitals between October 2008 and August 2018.

Sorafenib and sunitinib are widely used as first-line targeted therapy for metastatic renal cell carcinoma (mRCC) in China. This study aimed to compare the efficacy, safety, and quality of life (QoL) in Chinese mRCC patients treated with sorafenib and sunitinib as first-line therapy.

Advanced clear cell renal cell carcinoma (ccRCC) seriously affects the life and health of patients, but effective treatment for this disease is still lacking in clinic. This study investigated the efficacy of nivolumab plus cabozantinib versus sunitinib in the treatment of elderly patients with advanced ccRCC.

The phase III COMPARZ study showed noninferior efficacy of pazopanib versus sunitinib in advanced renal cell carcinoma. In this COMPARZ post hoc analysis we characterized pazopanib responders, patient subgroups with better outcomes, and the effect of dose modification on efficacy and safety.

There is poor data on the prognostic role of Comprehensive Geriatric Assessment (CGA) in older patients with metastatic renal cell carcinoma (mRCC) treated with first line Tyrosine Kinase Inhibitors (TKIs).

Disease-free survival (DFS) did not reflect accurate individual prognosis after initial diagnosis. As conditional DFS (CDFS) could provide dynamic prognostic information, we evaluated CDFS in these patients treated with or without sunitinib.

Targeted therapies including sunitinib, sorafenib, axitinib, and everolimus have recently become the mainstay for the treatment of metastatic renal cell carcinoma (mRCC). The objective of this study was to estimate the costs of sequential treatment regimens for mRCC and associated adverse events (AEs) from the Chinese payers' perspective.

Pembrolizumab was recently approved as an adjuvant treatment of renal cell carcinoma (RCC), based on prolonged disease-free survival compared to placebo in the phase III KEYNOTE-564 trial. The objective of this study was to evaluate the cost-effectiveness of pembrolizumab as monotherapy in the adjuvant treatment of RCC post-nephrectomy, from a US health sector perspective.

Nivolumab plus ipilimumab improves overall survival and is associated with less toxicity compared with sunitinib in the first-line setting of advanced renal-cell carcinoma (RCC). The current study aimed to assess the cost-effectiveness of nivolumab plus ipilimumab for first-line treatment of advanced RCC from the payer perspectives high- and middle-income regions.

To analyze if exposure to sunitinib in the SURTIME trial which investigated opposite sequences of cytoreductive nephrectomy (CN) and systemic therapy is associated with the overall survival (OS) benefit observed in the deferred CN arm.

The two recent prospective randomized trials CARMENA and SURTIME have changed the therapy paradigm of metastatic renal cell carcinoma. The CARMENA trial was conducted to investigate whether cytoreductive nephrectomy (CN) is required in the targeted therapy area, whereas SURTIME studied whether deferred CN in combination with sunitinib can be used to identify patients with inherent targeted therapy resistance.

Sunitinib is an increasingly used, orally administered targeted therapy, approved by the European Medicines Agency for the treatment of various types of cancer, including gastrointestinal stromal tumor unresectable or metastatic disease, following disease progression or intolerance to imatinib, and advanced or metastatic renal cell carcinoma, progressive well-differentiated pancreatic neuroendocrine tumors in patients with unresectable, locally advanced or metastatic disease.

In patients with metastatic renal cell cancer, based on limited evidence, increased sunitinib exposure is associated with better outcome. The survival and toxicity data of patients receiving individualized dose escalated sunitinib therapy as compared to standard management were analyzed in this study.

Dose individualization of sunitinib has been proposed using therapeutic drug monitoring (TDM) or toxicity-adjusted dose (TAD). We prospectively studied aspects of TDM and TAD to inform future trials, namely (1) intrapatient variability (CV) of sunitinib and (2) feasibility of a TAD protocol.