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Cabozantinib and renal

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https://www.readbyqxmd.com/read/29784745/updates-to-the-management-of-kidney-cancer
#1
Eric Jonasch
Several updates were made to the 2018 NCCN Guidelines for Kidney Cancer. Adjuvant sunitinib is the first adjuvant therapy to be endorsed by the panel for patients with stage II and III clear cell histology renal cell carcinoma (RCC; category 2B). A promising new treatment-ipilimumab plus nivolumab for patients at intermediate and poor risk in the frontline setting-was added to the guidelines as well. Cabozantinib was added as a first-line option for poor- and intermediate-risk patients with advanced RCC.
May 2018: Journal of the National Comprehensive Cancer Network: JNCCN
https://www.readbyqxmd.com/read/29753637/safety-and-efficacy-of-cabozantinib-in-metastatic-renal-cell-carcinoma-real-world-data-from-an-italian-managed-access-program
#2
Giuseppe Procopio, Michele Prisciandaro, Roberto Iacovelli, Enrico Cortesi, Giuseppe Fornarini, Gaetano Facchini, Giacomo Cartenì, Roberto Sabbatini, Gabriella Del Bene, Luca Galli, Claudia Caserta, Andrea Giovanni Multari, Marco Bregni, Francesco Massari, Sebastiano Buti, Ugo De Giorgi, Fable Zustovich, Michele Milella, Fabio Calabrò, Maria Laura Mancini, Giampaolo Tortora, Claudio Vernieri, Daniele Santini, Mariella Sorarù, Riccardo Ricotta, Cristina Masini, Marcello Tucci, Stefano Luzi Fedeli, Cinzia Ortega, Antonella Mecozzi, Raffaele Ratta, Cora N Sternberg, Elena Verzoni
BACKGROUND: The randomized phase 3 METEOR study confirmed a survival benefit of cabozantinib over everolimus in patients with metastatic renal-cell carcinoma (mRCC) with disease that progressed after treatment with at least one previous antiangiogenic inhibitor. The aim of this analysis was to evaluate the safety and activity of cabozantinib in an unselected population. METHODS: Data were collected across 24 Italian centers. Cabozantinib therapy was initiated at physician request between September and December 2016...
April 19, 2018: Clinical Genitourinary Cancer
https://www.readbyqxmd.com/read/29741507/cabozantinib-approved-for-first-line-treatment-of-advanced-renal-cell-carcinoma
#3
(no author information available yet)
No abstract text is available yet for this article.
February 2018: Clinical Advances in Hematology & Oncology: H&O
https://www.readbyqxmd.com/read/29719414/cost-effectiveness-comparison-of-cabozantinib-with-everolimus-axitinib-and-nivolumab-in-the-treatment-of-advanced-renal-cell-carcinoma-following-the-failure-of-prior-therapy-in-england
#4
Jie Meng, Johanna Lister, Anne-Lise Vataire, Roman Casciano, Jerome Dinet
Purpose: The aim of this study was to compare the cost-effectiveness of cabozantinib with the standard of care in England in adult patients with advanced renal cell carcinoma (aRCC), following prior vascular endothelial growth factor receptor (VEGFR)-targeted therapy. Methods: We developed a partitioned-survival model with three health states to assess the cost-effectiveness of cabozantinib and its comparators. The model time horizon was 30 years. Efficacy and safety data were derived from pivotal clinical trials (METEOR: NCT01865747, CheckMate025: NCT01668784, and AXIS: NCT00678392)...
2018: ClinicoEconomics and Outcomes Research: CEOR
https://www.readbyqxmd.com/read/29708353/-treatment-of-metastatic-renal-cell-carcinoma
#5
Igor Richter, Josef Dvořák
INTRODUCTION: Renal cell cancer accounts for approximately 2-3% of all cases of malignancy. The incidence of kidney cancer in the Czech Republic is the highest in the world. Approximately 70% of renal cell carcinomas are clear-cell renal cancer. Various treatment options for metastatic renal cell cancer (mRCC) have been developed. Treatment regimens comprise antiangiogenic drugs in combination with vascular endothelial growth factor receptor inhibitors, mTOR inhibitors, and immunotherapy...
2018: Klinická Onkologie: Casopis Ceské a Slovenské Onkologické Spolecnosti
https://www.readbyqxmd.com/read/29687244/a-population-pharmacokinetic-model-of-cabozantinib-in-healthy-volunteers-and-patients-with-various-cancer-types
#6
Steven Lacy, Bei Yang, Jace Nielsen, Dale Miles, Linh Nguyen, Matt Hutmacher
PURPOSE: An integrated population pharmacokinetic (popPK) model was developed to describe the pharmacokinetics (PK) of tyrosine kinase inhibitor cabozantinib in healthy volunteers (HVs) and patients with various cancer types and to identify any differences in cabozantinib PK across these populations. METHODS: Plasma concentration data used to develop the popPK model were obtained from nine clinical trials (8072 concentrations from 1534 HVs or patients) of cabozantinib in HVs and patients with renal cell carcinoma (RCC), medullary thyroid carcinoma (MTC), glioblastoma multiforme, castration-resistant prostate cancer, or other advanced malignancies...
April 23, 2018: Cancer Chemotherapy and Pharmacology
https://www.readbyqxmd.com/read/29667066/population-exposure-response-analysis-of-cabozantinib-efficacy-and-safety-endpoints-in-patients-with-renal-cell-carcinoma
#7
Steven Lacy, Jace Nielsen, Bei Yang, Dale Miles, Linh Nguyen, Matt Hutmacher
BACKGROUND: In the phase III METEOR trial, tyrosine kinase inhibitor cabozantinib significantly improved progression-free survival (PFS), objective response rate (ORR), and overall survival compared to everolimus in patients with advanced renal cell carcinoma (RCC) who had received prior VEGFR inhibitor therapy. In METEOR, RCC patients started at a daily 60-mg cabozantinib tablet (Cabometyx™) dose but could reduce to 40- or 20-mg to achieve a tolerated exposure. OBJECTIVES AND METHODS: Exposure-response (ER) models were developed to characterize the relationship between cabozantinib at clinically relevant exposures in RCC patients enrolled in METEOR and efficacy (PFS and tumor response) and safety endpoints...
April 17, 2018: Cancer Chemotherapy and Pharmacology
https://www.readbyqxmd.com/read/29662541/cabozantinib-in-the-treatment-of-advanced-renal-cell-carcinoma-in-adults-following-prior-vascular-endothelial-growth-factor-targeted-therapy-clinical-trial-evidence-and-experience
#8
REVIEW
Susanne Osanto, Tom van der Hulle
Cabozantinib is an oral multitargeted tyrosine kinase inhibitor (TKI) that potently inhibits MET and AXL, both associated with poor prognosis in renal cell carcinoma (RCC), next to vascular endothelial growth factor receptor 2, KIT, FLT3 and RET. Chronic treatment with vascular endothelial growth factor receptor (VEGFR)-targeting sunitinib upregulates MET and AXL in RCC, indicating that cabozantinib may be particularly effective in patients with advanced RCC whose disease progressed on prior VEGFR-targeted treatment...
March 2018: Therapeutic Advances in Urology
https://www.readbyqxmd.com/read/29656851/first-line-systemic-therapy-for-metastatic-renal-cell-carcinoma-a-systematic-review-and-network-meta-analysis
#9
REVIEW
Christopher J D Wallis, Zachary Klaassen, Bimal Bhindi, Xiang Y Ye, Thenappan Chandrasekar, Ann M Farrell, Hanan Goldberg, Stephen A Boorjian, Bradley Leibovich, Girish S Kulkarni, Prakesh S Shah, Georg A Bjarnason, Daniel Heng, Raj Satkunasivam, Antonio Finelli
CONTEXT: In the last decade, there has been a proliferation of treatment options for metastatic renal cell carcinoma (mRCC). However, direct comparative data are lacking for most of these agents. OBJECTIVE: To indirectly compare the efficacy and safety of systemic therapies used in the first-line treatment of mRCC. EVIDENCE ACQUISITION: Medline, EMBASE, Web of Science, and Scopus databases were searched using the OvidSP platform for studies indexed from database inception to October 23, 2017...
April 13, 2018: European Urology
https://www.readbyqxmd.com/read/29587324/-immunotherapy-for-renal-cell-carcinoma-current-status
#10
Marc-Oliver Grimm, Susan Foller
Systemic treatment of metastatic renal cell carcinoma (mRCC) has substantially changed during the last 2 years due to approval of the immune-checkpoint inhibitor Nivolumab (Opdivo® ) and new multikinase inhibitors (Cabozantinib, Lenvatinib, Tivozanib). The german kidney tumor guideline strongly recommends Nivolumab and Cabozantinib as 2nd line treatments after prior VEGF targeted therapy. CheckMate 025, the prospective randomized trial which led to approval of Nivolumab demonstrated improved overall survival (26 month vs...
April 2018: Aktuelle Urologie
https://www.readbyqxmd.com/read/29578848/the-additional-costs-per-month-of-progression-free-survival-and-overall-survival-an-economic-model-comparing-everolimus-with-cabozantinib-nivolumab-and-axitinib-for-second-line-treatment-of-metastatic-renal-cell-carcinoma
#11
Elyse Swallow, Andrew Messali, Sameer Ghate, Evangeline McDonald, Emilie Duchesneau, Jose Ricardo Perez
BACKGROUND: When considering optimal second-line treatments for metastatic renal cell carcinoma (mRCC), clinicians and payers seek to understand the relative clinical benefits and costs of treatment. OBJECTIVE: To use an economic model to compare the additional cost per month of overall survival (OS) and of progression-free survival (PFS) for cabozantinib, nivolumab, and axitinib with everolimus for the second-line treatment of mRCC from a third-party U.S. payer perspective...
April 2018: Journal of Managed Care & Specialty Pharmacy
https://www.readbyqxmd.com/read/29576624/long-term-follow-up-of-overall-survival-for-cabozantinib-versus-everolimus-in-advanced-renal-cell-carcinoma
#12
Robert J Motzer, Bernard Escudier, Thomas Powles, Christian Scheffold, Toni K Choueiri
BACKGROUND: In the phase 3 METEOR trial (NCT01865747), cabozantinib significantly improved progression-free survival, overall survival, and objective response rate compared with everolimus in patients with advanced renal cell carcinoma (RCC) after prior antiangiogenic therapy. A statistically significant improvement in overall survival was observed at a second interim analysis with 320 recorded deaths. METHODS: 658 patients with advanced RCC who had received at least one prior VEGFR tyrosine kinase inhibitor were randomised 1:1 to cabozantinib (60 mg daily) or everolimus (10 mg daily)...
March 26, 2018: British Journal of Cancer
https://www.readbyqxmd.com/read/29550566/cabozantinib-versus-sunitinib-as-initial-therapy-for-metastatic-renal-cell-carcinoma-of-intermediate-or-poor-risk-alliance-a031203-cabosun-randomised-trial-progression-free-survival-by-independent-review-and-overall-survival-update
#13
Toni K Choueiri, Colin Hessel, Susan Halabi, Ben Sanford, M Dror Michaelson, Olwen Hahn, Meghara Walsh, Thomas Olencki, Joel Picus, Eric J Small, Shaker Dakhil, Darren R Feldman, Milan Mangeshkar, Christian Scheffold, Daniel George, Michael J Morris
BACKGROUND: 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. We report PFS by independent radiology review committee (IRC) assessment, ORR per IRC and updated overall survival (OS). PATIENTS AND METHODS: Previously untreated patients with advanced RCC of intermediate or poor risk by IMDC criteria were randomised 1:1 to cabozantinib 60 mg daily or sunitinib 50 mg daily (4 weeks on/2 weeks off)...
May 2018: European Journal of Cancer
https://www.readbyqxmd.com/read/29492762/cabozantinib-versus-standard-of-care-comparators-in-the-treatment-of-advanced-metastatic-renal-cell-carcinoma-in-treatment-na%C3%A3-ve-patients-a-systematic-review-and-network-meta-analysis
#14
Elvira Schmidt, Johanna Lister, Monika Neumann, Witold Wiecek, Shuai Fu, Anne-Lise Vataire, Jelena Sostar, Shengnan Huang, Florence Marteau
BACKGROUND: Cabozantinib has recently been evaluated as a first-line treatment in advanced renal cell carcinoma (aRCC). OBJECTIVE: To indirectly assess efficacy of cabozantinib versus standard-of-care (SoC) comparators in the first-line treatment of aRCC. METHODS: We conducted a systematic literature review (SLR) to identify randomized controlled studies in the first-line setting for aRCC. The outcomes analyzed were overall survival (OS) and progression-free survival (PFS)...
April 2018: Targeted Oncology
https://www.readbyqxmd.com/read/29487224/second-line-treatment-landscape-for-renal-cell-carcinoma-a-comprehensive-review
#15
REVIEW
Nizar M Tannir, Sumanta K Pal, Michael B Atkins
The management of advanced clear-cell renal cell carcinoma has steadily improved over the past decade with the introduction of antiangiogenic and targeted therapies. Recently, three new therapies have been approved for use as second-line options that further advance the treatment armamentarium: nivolumab, a monoclonal antibody targeting the programmed cell death receptor; cabozantinib, a small-molecule tyrosine kinase inhibitor (TKI) of vascular endothelial growth factor receptor (VEGFR), MET, and AXL; and lenvatinib, a small-molecule TKI of VEGF and fibroblast growth factor receptors that is used in combination with everolimus, an inhibitor of the mechanistic target of rapamycin...
May 2018: Oncologist
https://www.readbyqxmd.com/read/29393024/axitinib-cabozantinib-everolimus-nivolumab-sunitinib-and-best-supportive-care-in-previously-treated-renal-cell-carcinoma-a-systematic-review-and-economic-evaluation
#16
Steve J Edwards, Victoria Wakefield, Peter Cain, Charlotta Karner, Kayleigh Kew, Mariana Bacelar, Natalie Masento, Fatima Salih
BACKGROUND: Several therapies have recently been approved for use in the NHS for pretreated advanced or metastatic renal cell carcinoma (amRCC), but there is a lack of comparative evidence to guide decisions between them. OBJECTIVE: To evaluate the clinical effectiveness and cost-effectiveness of axitinib (Inlyta® , Pfizer Inc., NY, USA), cabozantinib (Cabometyx® , Ipsen, Slough, UK), everolimus (Afinitor® , Novartis, Basel, Switzerland), nivolumab (Opdivo® , Bristol-Myers Squibb, NY, USA), sunitinib (Sutent® , Pfizer, Inc...
January 2018: Health Technology Assessment: HTA
https://www.readbyqxmd.com/read/29377755/quality-of-life-outcomes-for-cabozantinib-versus-everolimus-in-patients-with-metastatic-renal-cell-carcinoma-meteor-phase-iii-randomized-trial
#17
David Cella, Bernard Escudier, Nizar M Tannir, Thomas Powles, Frede Donskov, Katriina Peltola, Manuela Schmidinger, Daniel Y C Heng, Paul N Mainwaring, Hans J Hammers, Jae Lyun Lee, Bruce J Roth, Florence Marteau, Paul Williams, John Baer, Milan Mangeshkar, Christian Scheffold, Thomas E Hutson, Sumanta Pal, Robert J Motzer, Toni K Choueiri
Purpose In the phase III METEOR trial ( ClinicalTrials.gov identifier: NCT01865747), 658 previously treated patients with advanced renal cell carcinoma were randomly assigned 1:1 to receive cabozantinib or everolimus. The cabozantinib arm had improved progression-free survival, overall survival, and objective response rate compared with everolimus. Changes in quality of life (QoL), an exploratory end point, are reported here. Patients and Methods Patients completed the 19-item Functional Assessment of Cancer Therapy-Kidney Symptom Index (FKSI-19) and the five-level EuroQol (EQ-5D-5L) questionnaires at baseline and throughout the study...
March 10, 2018: Journal of Clinical Oncology: Official Journal of the American Society of Clinical Oncology
https://www.readbyqxmd.com/read/29368125/overview-of-current-and-future-first-line-systemic-therapy-for-metastatic-clear-cell-renal-cell-carcinoma
#18
REVIEW
David M Gill, Andrew W Hahn, Peter Hale, Benjamin L Maughan
Treatment of metastatic clear cell renal cancer (mccRCC) has seen substantial progress over the last 20 years, with many regulatory approvals since 2006 culminating in a substantial increase to overall survival (OS). Six therapies are currently available for first-line use, with additional treatments currently being tested in this setting, some of which are expected to be approved soon based on new data from the CABOSUN and CheckMate-214 trials. Based on the available evidence, we strongly believe that vascular endothelial growth factor tyrosine kinase inhibitor (VEGF-TKI) therapy over mechanistic target or rapamycin (mTOR; formerly known as mammalian target of rapamycin) inhibitor therapy is the most effective first-line option regardless of risk category assignment...
January 24, 2018: Current Treatment Options in Oncology
https://www.readbyqxmd.com/read/29283440/cabozantinib-a-multitargeted-oral-tyrosine-kinase-inhibitor
#19
REVIEW
Jordan N Markowitz, Karen M Fancher
Cabozantinib is an oral small-molecule multitargeted tyrosine kinase inhibitor (TKI) that may confer an advantage over other TKIs that target a single receptor. It was approved by the U.S. Food and Drug Administration for the treatment of both advanced renal cell carcinoma and progressive metastatic medullary thyroid cancer, and it is being investigated for a wide array of other malignancies. Rationale for use, clinical trial data, and current recommendations for cabozantinib in renal cell cancer, thyroid cancer, prostate cancer, hepatocellular cancer, and lung cancer are detailed in this article...
March 2018: Pharmacotherapy
https://www.readbyqxmd.com/read/29223605/updated-european-association-of-urology-guidelines-recommendations-for-the-treatment-of-first-line-metastatic-clear-cell-renal-cancer
#20
Thomas Powles, Laurence Albiges, Michael Staehler, Karim Bensalah, Saeed Dabestani, Rachel H Giles, Fabian Hofmann, Milan Hora, Markus A Kuczyk, Thomas B Lam, Lorenzo Marconi, Axel S Merseburger, Sergio Fernández-Pello, Rana Tahbaz, Alessandro Volpe, Börje Ljungberg, Axel Bex
The randomised phase III clinical trial Checkmate-214 showed a survival superiority for the combination of ipilimumab and nivolumab when compared with the previous standard of care in first-line metastatic/advanced clear cell renal cell carcinoma (RCC) (Escudier B, Tannir NM, McDermott DF, et al. CheckMate 214: efficacy and safety of nivolumab plus ipilimumab vs sunitinib for treatment-naïve advanced or metastatic renal cell carcinoma, including IMDC risk and PD-L1 expression subgroups. LBA5, ESMO 2017, 2017)...
December 7, 2017: European Urology
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