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Shreyas S Joshi, Elizabeth A Handorf, Matthew Zibelman, Elizabeth R Plimack, Robert G Uzzo, Alexander Kutikov, Marc C Smaldone, Daniel M Geynisman
BACKGROUND: Higher treatment facility (TF) volume has been linked with improved oncologic treatment outcomes. OBJECTIVE: To determine the association between TF volume and overall survival in patients with metastatic renal cell carcinoma (mRCC). DESIGN, SETTING, AND PARTICIPANTS: The National Cancer Database (NCDB) was queried for all patients with mRCC with survival data available (2004-2013, cohort A). Overall survival was assessed based on TF volumes, and increasingly narrow inclusion criteria were used to confirm the cohort A association: cohort B=mRCC patients with active treatment; cohort C=mRCC patients with systemic therapy; cohort D=mRCC patients with systemic therapy at the reporting institution; and cohort E=mRCC patients with systemic therapy at the reporting institution with known liver and lung metastatic status...
June 4, 2018: European Urology
P Penttilä, P Bono, K Peltola, F Donskov
BACKGROUND: The prognostication of metastatic renal cell carcinoma (mRCC) is based on Memorial Sloan Kettering Cancer Center (MSKCC) and International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) risk classifications. Research has shown that hyponatremia is associated with worse prognosis in cancer. We analyzed the association of hyponatremia and outcome in everolimus-treated mRCC patients. PATIENTS AND METHODS: Baseline and on-treatment (≤12 weeks) sodium in 233 mRCC patients was analyzed using Kaplan-Meier, Cox regression and logistic regression...
June 4, 2018: Acta Oncologica
Kazuyuki Numakura, Nobuhiro Fujiyama, Makoto Takahashi, Ryoma Igarashi, Hiroshi Tsuruta, Atsushi Maeno, Mingguo Huang, Mitsuru Saito, Shintaro Narita, Takamitsu Inoue, Shigeru Satoh, Norihiko Tsuchiya, Takenori Niioka, Masatomo Miura, Tomonori Habuchi
In this study, we examined the association between the pharmacokinetics (PK) level of sunitinib malate (SU) and its metabolite N-desethyl-sunitinib (DSU) in terms of adverse events (AEs) and clinical outcomes in patients with metastatic renal cell carcinoma (mRCC). The PK of sunitinib (SU and DSU) was examined in 26 patients (20 men and 6 women) with mRCC. The associations between SU/DSU C0 and AE occurrence, best response rate, time to treatment failure, progression-free survival (PFS), and overall survival (OS) were investigated...
May 18, 2018: Oncotarget
Peter Hale, Andrew W Hahn, Nityam Rathi, Sumanta K Pal, Benjamin Haaland, Neeraj Agarwal
INTRODUCTION: More than half of patients diagnosed with renal cell carcinoma (RCC) are age 65 or older. However, older patients are often unable to meet eligibility criteria for clinical trial enrollment due to multiple factors, such as comorbidities and polypharmacy, which leads to under-representation of this population in clinical trials. Given this, efficacy data from the registration trials may not apply to older patients. Our objective was to evaluate the efficacy of first-line and salvage-line treatment in older patients, and compare efficacy between older and younger patients with metastatic RCC (mRCC)...
May 31, 2018: Journal of Geriatric Oncology
W Cai, Y C Yuan, M Y Li, W Kong, B J Dong, Y H Chen, J Zhang, W Xue, Y R Huang, L X Zhou, J W Huang
Objective: To investigate the efficacy and drug related adverse reactions of sorafenib and sunitinib as first-line tyrosine-kinase inhibitors (TKIs) for patients with metastatic renal cell carcinoma (mRCC) and analyze the clinical prognostic factor for survival. Methods: The data of 271 patients with metastatic renal cell carcinoma who had complete clinicopathological data were retrospectively analyzed, including 174 cases in sorafenib group and 97 cases in sunitinib group, to access patients' overall survival (OS) and progression-free survival (PFS)...
May 23, 2018: Zhonghua Zhong Liu za Zhi [Chinese Journal of Oncology]
Shinya Takasaki, Yoshihide Kawasaki, Masafumi Kikuchi, Masaki Tanaka, Masato Suzuka, Aoi Noda, Yuji Sato, Shinichi Yamashita, Koji Mitsuzuka, Hideo Saito, Akihiro Ito, Hiroaki Yamaguchi, Yoichi Arai, Nariyasu Mano
BACKGROUND: The aim was to investigate the relationships between total sunitinib plasma concentrations (sunitinib plus its active metabolite; N-desethyl sunitinib) and clinical outcomes in Japanese patients with metastatic renal cell carcinoma (mRCC). METHODS: Twenty patients with mRCC were enrolled following treatment with sunitinib. To assess safety, the total sunitinib concentration range up to discontinuation of treatment and dosage reduction associated with adverse events within 6 weeks from initiating administration were analyzed...
June 2, 2018: International Journal of Clinical Oncology
Matteo Santoni, Francesco Massari, Francesco Piva, Francesco Carrozza, Vincenzo Di Nunno, Alessia Cimadamore, Angelo Martignetti, Rodolfo Montironi, Nicola Battelli
Renal cell carcinoma (RCC) represents a heterogeneous group of cancers with distinct histological features, molecular alterations, prognosis, and response to therapy. Target agents directed against vascular endothelial growth factor and its receptor and mammalian target of rapamycin (mTOR) inhibitors have completely changed the landscape of RCC. However, the rate of complete response is still low, thus supporting the research of novel therapeutic agents. Area covered: The authors describe the chemical features of tivozanib, its pharmacodynamic and pharmacokinetic properties, and the results obtained in human phase I-III clinical trials...
May 31, 2018: Expert Opinion on Pharmacotherapy
Hideaki Miyake, Ryota Aki, Yuto Matsushita, Keita Tamura, Daisuke Motoyama, Toshiki Ito, Takayuki Sugiyama, Atsushi Otsuka
BACKGROUND/AIM: To date, it has not been well characterized whether sunitinib is effective in elderly patients with metastatic renal cell carcinoma (mRCC). The objective of this study was to investigate the impact of age on clinical outcomes of mRCC patients receiving sunitinib. PATIENTS AND METHODS: The efficacy and safety of first-line sunitinib in 154 consecutive mRCC patients were retrospectively compared between patients aged <75 (n=125) and ≥75 (n=29) years...
June 2018: Anticancer Research
John A Thompson, Robert J Motzer, Ana M Molina, Toni K Choueiri, Elisabeth I Heath, Bruce G Redman, Randeep S Sangha, D Scott Ernst, Roberto Pili, Stella K Kim, Leonard Reyno, Aya Wiseman, Fabio Trave, Banmeet Anand, Karen Morrison, Fernando Doñate, Christian Kollmannsberger
PURPOSE: To determine the safety, pharmacokinetics, and recommendedphase2 dose of an antibody drug conjugate (ADC) targeting ectonucleotide phosphodiesterases-pyrophosphatase 3 (ENPP3) conjugated to monomethyl auristatin F (MMAF) in subjects with advanced metastatic renal cell carcinoma (mRCC). EXPERIMENTAL DESIGN: Two phase 1 studies were conducted sequentially with 2 ADCs considered equivalent, hybridoma derived AGS-16M8F and Chinese Hamster Ovary derived AGS-16C3F...
May 30, 2018: Clinical Cancer Research: An Official Journal of the American Association for Cancer Research
Dehua Liao, Dangang Shangguan, Dunwu Yao, Qing Zhu, Lizhi Cao, Minghui Long, Yi Wu, Daxiong Xiang, Nong Yang
Targeted therapy has been widely used in the treatment of patients with metastatic renal cell carcinoma (mRCC). The current available therapies focus on the inhibition of angiogenesis through targeting the vascular endothelial growth factor receptor (VEGFR), and protein kinase such as the mammalian target of rapamycin (mTOR). Compared with other traditional chemotherapies and radiotherapies, targeted therapies dramatically improved progression-free survival (PFS). However, the microenvironment of patients' body, drug-drug interactions, as well as polymorphisms of metabolic enzymes and drug transporters ABC could influence pharmacokinetic characteristics...
May 30, 2018: Protein and Peptide Letters
Min Liu, Huizi Wu, Dangang Shangguan, Yueping Jiang, Xiangping Li, Shao Liu, Boting Zhou, Tao Yin, Zhicheng Gong
Renal cell carcinoma (RCC) is the most common tumor originating from the kidneys. In comparison to other solid tumors, RCC is poorly sensitive to conventional therapeutic modalities. As such, metastatic RCC (mRCC) continues to be associated with high rates of morbidity and mortality. Targeted agents have shown remarkable progress in RCC management with improved patients' outcomes, but rarely induce complete response and patients develop resistance to therapy eventually. However, it is well known that RCC represents one of the most immunogenic cancers and is able to evoke immune response naturally, thus prompted the emergence of several immunotherapeutic strategies in the management of RCC with variable degrees of success...
May 30, 2018: Protein and Peptide Letters
Yasuomi Shimizu, Taro Iguchi, Satoshi Tamada, Sayaka Yasuda, Minoru Kato, Noriko Ninomiya, Takeshi Yamasaki, Tatsuya Nakatani
Since the introduction of molecular targeted agents for the treatment of metastatic renal cell cancer (mRCC), several treatment outcomes, including those from our facilities, have been reported. However, the outcome of these drugs, classified by the metastatic organs, is not well known. The present study reported the treatment results of molecular-targeted agents as classified by the metastatic organ at Osaka City University Graduate School of Medicine. A total of 180 consecutively treated patients who had received molecular targeted agents for metastatic renal cancer for 3 or more months were retrospectively analyzed...
June 2018: Molecular and Clinical Oncology
J Kováčová, J Juráček, A Poprach, T Büchler, J Kopecký, O Fiala, M Svoboda, M Lojová, O Slabý
BACKGROUND: Renal cell carcinoma (RCC) accounts for 2-3% of all malignant tumours. Metastatic RCC (mRCC) is commonly treated with tyrosine kinase inhibitors (TKI). Effective TKIs administration can be achieved only by accurate prediction of therapeutical response. Therefore, the aim of this study was to analyse papers concerning predictive potential of microRNA (miRNA). MATERIAL AND METHODS: We chose seven candidate miRNAs and analysed their expression on 44 patients divided into cohort with poor and good response to sunitinib treatment...
2018: Klinická Onkologie: Casopis Ceské a Slovenské Onkologické Spolecnosti
Roberto Iacovelli, Ugo De Giorgi, Luca Galli, Paolo Zucali, Franco Nolè, Roberto Sabbatini, Anna Paola Fraccon, Umberto Basso, Alessandra Mosca, Francesco Atzori, Daniele Santini, Gaetano Facchini, Giuseppe Fornarini, Felice Pasini, Cristina Masini, Francesco Massari, Sebastiano Buti, Teodoro Sava, Cosimo Sacco, Riccardo Ricotta, Isabella Sperduti, Giampaolo Tortora, Camillo Porta
BACKGROUND: The International mRCC (metastatic renal cell carcinoma) Database Consortium (IMDC) is the standard classification for mRCC. We aimed to evaluate the outcomes of a large cohort of patients with an intermediate or a poor prognosis treated with sunitinib using a different cutoff point for IMDC to improve the classification. PATIENTS AND METHODS: Patients with an intermediate or a poor prognosis according to the IMDC criteria and treated with sunitinib were included in the present study...
May 7, 2018: Clinical Genitourinary Cancer
Pedro Coelho Barata, Alfonso Gomez De Liano, Prateek Mendiratta, Valerie Crolley, Bernadett Szabados, Laura Morrison, Laura Wood, Kimberly Allman, Allison Tyler, Allison Martin, Timothy Gilligan, Petros Grivas, Moshe Ornstein, Jorge A Garcia, Thomas Powles, Brian I Rini
BACKGROUND: The outcome of patients who progress on front-line immune-based combination regimens (IC) including immune checkpoint inhibitors (CPI) and receive subsequent systemic therapy is unknown. METHODS: Retrospective analysis of consecutive patients with clear-cell mRCC who progressed on one of seven clinical trials investigating an IC and received ≥1 line of subsequent VEGFR TKI therapy. RESULTS: Thirty-three patients [median age 57 (37-77), 85% male, 73% ECOG 0] were included...
May 24, 2018: British Journal of Cancer
Emilie Werbrouck, Julie Bastin, Diether Lambrechts, Annelies Verbiest, Thomas Van Brussel, Evelyne Lerut, Jean-Pascal Machiels, Vincent Verschaeve, Vincent Richard, Philip R Debruyne, Brigitte Decallonne, Patrick Schöffski, Oliver Bechter, Pascal Wolter, Benoit Beuselinck
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. In a series of metastatic renal cell carcinoma (mRCC) patients treated with sunitinib, we aimed to study the correlation between hypothyroidism and single nucleotide polymorphisms (SNPs) in genes involved in sunitinib pharmacokinetics and pharmacodynamics. Patients and methods We included 79 mRCC patients who started sunitinib between November 2005 and March 2016...
May 23, 2018: Acta Clinica Belgica
Hugo Simard, Robert Sabbagh, Simon Ouellet, Patrick Richard, Claudio Jeldres
INTRODUCTION: We assessed the impact of targeted therapies on healthcare resource use and compared treatment regimens used in patients diagnosed with metastatic renal cell carcinoma (mRCC). METHODS: Clinicopathological and administrative data of patients with mRCC from our institution were retrospectively collected from January 2000 to August 2014. Patients were divided into two groups based on the use of targeted therapies. Healthcare resource use (HCRU) data included non-scheduled total number of hospitalizations, total days hospitalized, emergency department visits, and healthcare professional consultations...
May 14, 2018: Canadian Urological Association Journal, Journal de L'Association des Urologues du Canada
Takashi Ikeda, Hiroki Ishihara, Toshio Takagi, Tsunenori Kondo, Kazuhiko Yoshida, Junpei Iizuka, Kazunari Tanabe
BACKGROUND: According to the Response Evaluation Criteria in Solid Tumors (RECIST) classification, progressive disease (PD) is defined as target lesion growth (TLG), unequivocal non-target lesion growth (NTLG), or new lesion appearance (NLA). The prognostic impact of the components of PD in tyrosine kinase inhibitor (TKI) therapy for metastatic renal cell carcinoma (mRCC) remains unknown. OBJECTIVE: We retrospectively evaluated the prognostic impact of these PD components on survival in patients with mRCC after first-line TKI therapy...
May 21, 2018: Targeted Oncology
Kevin Zarrabi, Shenhong Wu
The treatment paradigm for metastatic renal cell carcinoma (mRCC) has undergone a revolution with the rapid market approval of multiple agents over a three-year period. The immunogenicity of RCC provided the biological rationale to assess the clinical efficacy of nivolumab, an immune checkpoint inhibitor. Nivolumab is approved for second-line treatment after failure of angiogenesis targeted therapy and in combination therapy with ipilimumab for previously untreated intermediate or poor-risk advanced renal cell carcinoma...
May 21, 2018: Expert Opinion on Biological Therapy
Julie Bastin, Emilie Werbrouck, Annelies Verbiest, Kevin Punie, Oliver Bechter, Sherida Feng Woei-A-Jin, Pascal Wolter, Hans Wildiers, Evelyne Lerut, Herlinde Dumez, Brigitte Decallonne, Paul Clement, Dirk Vanderschueren, Maarten Albersen, Raymond Oyen, Patrick Schöffski, Benoit Beuselinck
Objectives To study the prevalence of hypogonadism in male patients with metastatic renal cell carcinoma (mRCC) starting with targeted therapies and the impact of the vascular endothelial growth factor receptor tyrosine kinase inhibitors (VEGFR-TKIs) sunitinib and pazopanib on the luteinizing hormone (LH)/testosterone (TT)-axis. Methods Male mRCC patients starting with targeted therapies were prospectively included in this study. TT- and LH-levels were sampled at start as well as during systemic therapy. Endpoints of the study were gonadal status (TT- and LH-levels) at start of targeted therapy and TT- and LH-evolution during targeted therapy...
May 18, 2018: Acta Clinica Belgica
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