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Real-world rcc

Nadja Sandmeier, Sacha I Rothschild, Christian Rothermundt, Richard Cathomas, Julian Schardt, Dominik Berthold, Philippe von Burg, Beat Müller, Jörg Beyer, Deborah R Vogt, Frank Stenner
INTRODUCTION: In metastatic renal-cell carcinoma (mRCC), physicians have a plethora of therapeutic choices, with the latest addition of checkpoint inhibitors. However, many questions regarding the best use of the respective drugs remain unanswered. Therefore, it is important to examine and summarize the outcome of real-world experiences to understand the practical value of the various drugs in daily use and foster optimal treatment algorithms for patients with renal-cell carcinoma. We sought to describe the pattern of care in mRCC under circumstances with access to all therapeutic options for patients...
February 2, 2018: Clinical Genitourinary Cancer
Raffaele Ratta, Elena Verzoni, Massimo Di Maio, Paolo Grassi, Maurizio Colecchia, Giovanni Fucà, Filippo de Braud, Giuseppe Procopio
BACKGROUND: The purpose of the present retrospective analysis was to describe the trends in exposure to multiple lines of treatment and overall survival (OS) in patients with metastatic renal cell carcinoma (mRCC) who started therapy in 2 different periods (period 1, 2004-2010; and period 2, 2011-2017). PATIENTS AND METHODS: The proportion of patients who received subsequent lines of treatment after disease progression was compared between the 2 groups. OS was measured from the start of first-line treatment for metastatic disease to death or the last follow-up examination...
February 5, 2018: Clinical Genitourinary Cancer
Rana Maroun, Laura Mitrofan, Laure Benjamin, Gaelle Nachbaur, Franck Maunoury, Philippe Le Jeunne, Isabelle Durand-Zaleski
BACKGROUND: Patient characteristics and survival outcomes in randomized trials may be different from those in real-life clinical practice. The objective of this study was to describe treatment pathways, safety, drug costs and survival in patients with metastatic Renal Cell Carcinoma (mRCC) in a real world setting. METHODS: A retrospective analysis was performed using IQVIA real world oncology cross-sectional survey data, a retrospective treatment database collecting anonymized patient-level data in Europe...
February 21, 2018: BMC Cancer
Jens Bedke, Marc-Oliver Grimm, Viktor Grünwald
Renal cell carcinoma (RCC) represents the seventh (men) respectively tenth (women) most frequent cancer in western countries. After one or more lines of VEGF-targeted therapy, immunotherapy with nivolumab is strongly recommended in patients with metastatic RCC. Nivolumab is the first, and so far, only approved programmed death 1 (PD-1) immune checkpoint inhibitor to demonstrate a gain in overall survival in RCC. We describe herein design and rationale of trial CA209653 ('NIS NORA'), a prospective, noninterventional cohort study investigating the effectiveness of nivolumab...
January 12, 2018: Future Oncology
Miguel A Climent, José Muñoz-Langa, Laura Basterretxea-Badiola, Carmen Santander-Lobera
A systematic review was conducted to identify real world studies reporting outcomes after first-line pazopanib in patients with metastatic renal cell carcinoma. Studies had to be observational and report survival data in terms of progression-free survival and overall survival in order to conduct meta-analysis techniques. These real-world data were compared to those obtained in the phase II and III randomized controlled trials of pazopanib. Real world evidence showed that the clinical and safety outcomes were consistent with those observed in the clinical trials despite the inclusion of unselected patients with a wide spectrum of prognostic features and comorbidities...
January 2018: Critical Reviews in Oncology/hematology
Jason Shafrin, Jeffrey Sullivan, Jacquelyn W Chou, Michael N Neely, Justin F Doan, J Ross Maclean
Objective: To examine how observed medication nonadherence to 2 second-line, oral anticancer medications (axitinib and everolimus) affects progression-free survival (PFS) among patients with renal cell carcinoma. Methods: We used an adherence-exposure-outcome model to simulate the impact of adherence on PFS. Using a pharmacokinetic/pharmacodynamic (PK/PD) population model, we simulated drug exposure measured by area under the plasma concentration-time curve (AUC) and minimum blood or trough concentration (Cmin) under 2 scenarios: 1) optimal adherence and 2) real-world adherence...
2017: Cancer Management and Research
Jeong Ho Kim, Wan Lee, Tae Nam Kim, Jong Kil Nam, Tae Hyo Kim, Ki Soo Lee
INTRODUCTION: The aim of this study was to investigate the real-world clinical outcomes of first-line pazopanib and second-line everolimus in Korean patients with metastatic renal cell carcinoma (mRCC). METHODS: Data of patients who had mRCC with clear-cell component between 2001 and 2015 at multiple institutions were collected retrospectively. To be included in the analysis, patients had to meet the following criteria: age ≥18 years; received first-line targeted therapy with pazopanib; and received second-line targeted therapy with everolimus...
January 2018: Canadian Urological Association Journal, Journal de L'Association des Urologues du Canada
Benjamin S Gerendash, Patricia A Creel
Cabozantinib is an oral tyrosine-kinase inhibitor whose targets include VEGFR, MET, and AXL. Cabozantinib is approved for the treatment of patients with advanced clear-cell renal-cell carcinoma (RCC) who have received prior antiangiogenic therapy. In the pivotal Phase III trial of second-line RCC, cabozantinib was associated with a significant improvement in overall survival, progression-free survival, and antitumor response compared with everolimus. Adverse events (AEs) were common for patients receiving cabozantinib, but were effectively managed with supportive care and dose modifications, as discontinuations of cabozantinib due to an AE were infrequent...
2017: OncoTargets and Therapy
Nicholas J Vogelzang, Sumanta K Pal, Sameer R Ghate, Elyse Swallow, Nanxin Li, Miranda Peeples, Miriam L Zichlin, Mark K Meiselbach, Jose Ricardo Perez, Neeraj Agarwal
INTRODUCTION: 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. METHODS: Advanced RCC patients aged 65 years or older who started first-line treatment with pazopanib or sunitinib (index drug; the initiation date was the index date) were identified from the 100% Medicare database plus Part D linkage (January 1, 2006 to December 31, 2014)...
November 2017: Advances in Therapy
Konstantinos Koutsoukos, Aristotelis Bamias, Kimon Tzannis, Marta Espinosa Montaño, Vasiliki Bozionelou, Christos Christodoulou, Dimitra Stefanou, Haralabos Kalofonos, Ignacio Duran, Konstantinos Papazisis
AIM: We aimed to provide real-life data on the outcomes of metastatic renal cell carcinoma (mRCC) patients treated with everolimus as second-line treatment after failure of first-line pazopanib. PATIENTS AND METHODS: Data from the medical charts of mRCC patients from 8 centers in Greece and Spain were reviewed. All patients had received or were continuing to receive second-line everolimus treatment after failure of first-line treatment with pazopanib. No other previous therapies were allowed...
2017: OncoTargets and Therapy
R B Verheijen, L E Swart, J H Beijnen, J H M Schellens, A D R Huitema, N Steeghs
BACKGROUND: Pazopanib is an angiogenesis inhibitor approved for the treatment of renal cell carcinoma and soft tissue sarcoma. Post hoc analysis of a clinical trial demonstrated a relationship between pazopanib trough concentrations (Cmin ) and treatment efficacy. The aim of this study was to explore the pharmacokinetics and exposure-survival relationships of pazopanib in a real-world patient cohort. PATIENTS AND METHODS: Renal cell cancer and soft tissue sarcoma patients who had at least one pazopanib plasma concentration available were included...
December 2017: Cancer Chemotherapy and Pharmacology
Anikó Maráz, András Csejtei, Judit Kocsis, Miklós Szűcs, Zsuzsanna Kahán, György Bodoky, Magdolna Dank, László Mangel, János Révész, Zoltán Varga, Lajos Géczi
Everolimus is indicated for adults with metastatic renal cell carcinoma (mRCC) after failure of vascular endothelial growth factor receptor-tyrosine kinase inhibitors (TKI). Currently, the therapeutic applicability of EVE has been changing. Multicenter evaluation of efficacy and safety of everolimus in daily routine and definition of patient characteristics with favorable outcome. Data of 165 patients from 9 oncology institutes in Hungary were analyzed retrospectively. Everolimus therapy was used after one TKI in 10 mg starting dose...
October 13, 2017: Pathology Oncology Research: POR
Ilya Tsimafeyeu, Tatiana Zolotareva, Sergei Varlamov, Ruslan Zukov, Vladislav Petkau, Mikhail Mazhbich, Galina Statsenko, Sufia Safina, Igor Zaitsev, Dina Sakaeva, Alexander Popov, Pavel Borisov, Liubov Vladimirova
BACKGROUND: The 5-year overall survival (OS) of patients with metastatic renal cell carcinoma (mRCC) has been rarely reported. The aim of the RENSUR5 registry study was to obtain real-world data on the use of therapy for mRCC and assess the 5-year OS in the Russian population. PATIENT AND METHODS: Patients were retrospectively identified at 11 cancer centers in different regions of Russia (Astrakhan, Barnaul, Ekaterinburg, Kazan, Krasnoyarsk, Obninsk, Omsk, Rostov-on-Don, Samara, St...
December 2017: Clinical Genitourinary Cancer
Keith A Lawson, Olli Saarela, Zhihui Liu, Luke T Lavallée, Rodney H Breau, Lori Wood, Michael A S Jewett, Anil Kapoor, Simon Tanguay, Ronald B Moore, Ricardo Rendon, Frederic Pouliot, Peter C Black, Jun Kawakami, Darrel Drachenberg, Antonio Finelli
INTRODUCTION: There is a lack of validated quality metrics to evaluate the care of patients receiving surgery for renal cell carcinoma (RCC). To address this, the Kidney Cancer Research Network of Canada defined a list of quality indicators (QI) to assess hospital-level performance. We have case-mix adjusted these QIs to benchmark RCC surgical care at Canadian academic centres. METHODS: The Canadian Kidney Cancer information system (CKCis) was used to measure six QIs: laparoscopic approach proportion (LA), partial nephrectomy proportion (PN), partial nephrectomy in patients with chronic kidney disease (CKDPN), positive margin rate (PMR), partial nephrectomy complication rate (PNCx), and warm ischemia time (WIT)...
August 2017: Canadian Urological Association Journal, Journal de L'Association des Urologues du Canada
Rana Maroun, Laetitia Fleury, Gaelle Nachbaur, Franck Maunoury, Jean-Louis Vanhille, Isabelle Durand-Zaleski
OBJECTIVES: The objective of this study was to describe treatment patterns, survival, healthcare use and costs in patients with metastatic renal cell carcinoma (mRCC) in a real-world setting. RESEARCH DESIGN AND METHODS: We used the National Health Insurance (NHI) claims database for the Ile-de-France region to perform a retrospective cohort analysis of patients with mRCC treated by a first-line targeted therapy. Treatment naïve patients were identified combining the 10th revision of the International Classification of Diseases (ICD-10) codes (C64 & C77-C79) and a first prescription of targeted therapies...
August 7, 2017: Current Medical Research and Opinion
Sandy Srinivas, Dara Stein, Dana Y Teltsch, Sunning Tao, Laura Cisar, Krishnan Ramaswamy
Purpose The purpose is to describe management of adverse events of special interest across tyrosine kinase inhibitors approved for metastatic renal cell carcinoma. Methods We conducted a retrospective chart review in metastatic renal cell carcinoma patients initiating tyrosine kinase inhibitor monotherapy between 15 November 2010 and 15 November 2013, and experiencing ≥ 1 adverse events of special interest (diarrhea, fatigue, hand-foot syndrome, hypertension, or stomatitis/mucositis) within 3 months of initiation...
January 1, 2017: Journal of Oncology Pharmacy Practice
James E Frampton
Pazopanib (Votrient®), an orally administered multi-targeted tyrosine kinase inhibitor that predominantly inhibits vascular endothelial growth factor receptor-1, -2 and -3, platelet-derived growth factor receptor-α and -β, and the stem cell factor receptor c-Kit, is approved in the EU, the USA and other countries for the treatment of advanced renal cell carcinoma (RCC). In randomized controlled trials in patients with advanced, predominantly clear-cell RCC, pazopanib significantly improved progression-free survival (PFS) compared with placebo in both treatment-naïve and cytokine-pretreated patients and, as a first-line therapy, was noninferior to intermittent sunitinib with respect to PFS...
August 2017: Targeted Oncology
Magnus Lindskog, Thomas Wahlgren, Rickard Sandin, Jan Kowalski, Maria Jakobsson, Sven Lundstam, Börje Ljungberg, Ulrika Harmenberg
BACKGROUND: This retrospective study investigated overall survival (OS) and factors influencing OS in Swedish patients with metastatic renal cell carcinoma (mRCC) during the pre- (2002-2005), early (2006-2008), and late (2009-2012) targeted therapy (TT) era. METHODS: Three national Swedish registries identified patients with mRCC. Median OS was estimated using the Kaplan-Meier method. Multivariate analysis was performed using Cox proportional hazards regression...
June 13, 2017: Urologic Oncology
Mascha Thurm, Britt-Inger Kröger Dahlin, Ola Winsö, Börje Ljungberg
OBJECTIVE: This study evaluated whether more effective perioperative analgesia can be part of a multimodal approach to minimizing morbidity and improving postoperative management after the open surgical approaches frequently used in the treatment of renal cell carcinoma (RCC). The aim of the study was to determine whether spinal anesthesia with clonidine can enhance postoperative analgesia, speed up mobilization and reduce the length of hospital stay (LOS). MATERIALS AND METHODS: Between 2012 and 2015, 135 patients with RCC were randomized, in addition to general anesthesia, to receive either spinal analgesia with clonidine or epidural analgesia, stratified to surgical technique...
May 22, 2017: Scandinavian Journal of Urology
S De Groot, H M Blommestein, W K Redekop, S Sleijfer, L A L M Kiemeney, E Oosterwijk, C A Uyl-de Groot
INTRODUCTION: Randomised controlled trials have shown that targeted therapies like sunitinib are effective in metastatic renal cell carcinoma (mRCC). Little is known about the current use of these therapies, and their associated costs and effects in daily clinical practice. We estimated the real-world cost-effectiveness of different treatment strategies comprising one or more sequentially administered drugs. METHODS: Analyses were performed using patient-level data from a Dutch population-based registry including patients diagnosed with primary mRCC from January 2008 to December 2010 (i...
2017: PloS One
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