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https://www.readbyqxmd.com/read/28430700/prescriber-compliance-with-liver-monitoring-guidelines-for-pazopanib-in-the-postapproval-setting-results-from-a-distributed-research-network
#1
Sumitra Shantakumar, Beth L Nordstrom, Susan A Hall, Luc Djousse, Myrthe P P van Herk-Sukel, Kathy H Fraeman, David R Gagnon, Karen Chagin, Jeanenne J Nelson
OBJECTIVES: Pazopanib received US Food and Drug Administration approval in 2009 for advanced renal cell carcinoma. During clinical development, liver chemistry abnormalities and adverse hepatic events were observed, leading to a boxed warning for hepatotoxicity and detailed label prescriber guidelines for liver monitoring. As part of postapproval regulatory commitments, a cohort study was conducted to assess prescriber compliance with liver monitoring guidelines. METHODS: Over a 4-year period, a distributed network approach was used across 3 databases: US Veterans Affairs Healthcare System, a US outpatient oncology community practice database, and the Dutch PHARMO Database Network...
April 20, 2017: Journal of Patient Safety
https://www.readbyqxmd.com/read/28429452/real-world-experience-of-the-feasibility-and-tolerability-of-the-2-1-dosing-schedule-with-sunitinib-in-the-treatment-of-patients-with-advanced-renal-cell-carcinoma-in-australia
#2
Megan Crumbaker, Alexander Guminski, Howard Gurney, Dhanusha Sabanathan, Shirley Wong, Nick Pavlakis
AIM: Sunitinib is a first-line treatment option for metastatic renal cell carcinoma (mRCC) funded by the Australian Pharmaceutical Benefits Scheme. Toxicities are common with the standard schedule leading to alternative dosing schedules to be suggested. We reviewed Australian treatment practices to evaluate the safety and outcomes of patients on a 2 weeks on, 1 week off treatment schedule (2/1). METHODS: We performed a retrospective review of 63 patients with mRCC treated with first-line sunitinib on a 2/1 schedule at four Australian centers...
April 21, 2017: Asia-Pacific Journal of Clinical Oncology
https://www.readbyqxmd.com/read/28424553/the-world-of-targeted-therapies-in-kidney-cancers-pitfalls-tips-and-tricks
#3
Alexis Vallard, Jane-Chloé Trone, Julien Langrand-Escure, Sophie Espenel, Jean-Baptiste Guy, Chloé Rancoule, Yaoxiong Xia, Anis El Meddeb Hamrouni, Majed Ben Mrad, Nicolas Magné
In the past few years, metastatic renal cell carcinoma prognosis was improved by the development of molecular targeted therapies (TTs). At the metastatic stage, the tolerance to treatment is a major concern, not only because of the challenge of the efficacy/toxicity ratio improvement but also because of the importance of an optimal adherence to oral treatments. The present case series relates the issues of dealing with uncommon and sometimes never described side effects of sunitinib and sorafenib. The first case report deals with grade 3 vomiting during hemodialysis with concurrent administration of sunitinib...
2017: OncoTargets and Therapy
https://www.readbyqxmd.com/read/28368708/design-and-rationale-of-the-metastatic-renal-cell-carcinoma-marcc-registry-a-prospective-academic-and-community-based-study-of-patients-with-metastatic-renal-cell-cancer
#4
Nrupen A Bhavsar, Michael R Harrison, Bradford R Hirsch, Patricia Creel, Steve P Wolf, Greg P Samsa, Amy P Abernethy, Ronit Simantov, Azah Borham, Daniel J George
The Metastatic Renal Cell Cancer Registry, a large, nationally representative, prospective registry of patients with metastatic renal cell carcinoma (mRCC), aims to understand real-world treatment patterns and outcomes of patients with mRCC in routine clinical practice across the United States. This observational study is designed to enroll 500 patients with previously untreated mRCC from approximately 60 academic and community treatment sites; as of December 7, 2016, 500 patients have enrolled at 54 sites...
April 3, 2017: Cancer Investigation
https://www.readbyqxmd.com/read/28253548/patterns-of-care-among-patients-receiving-sequential-targeted-therapies-for-advanced-renal-cell-carcinoma-a-retrospective-chart-review-in-the-usa
#5
Sumanta K Pal, James E Signorovitch, Nanxin Li, Miriam L Zichlin, Zhimei Liu, Sameer R Ghate, Jose Ricardo Perez, Nicholas J Vogelzang
OBJECTIVES: To assess real-world treatment patterns of targeted therapies after failure of first-line tyrosine kinase inhibitors in patients with advanced renal cell carcinoma. METHODS: A large, retrospective review of medical charts of patients with advanced renal cell carcinoma in the USA was carried out. Descriptive statistics were used to summarize physicians' and patients' characteristics, treatment sequences, and reasons for treatment choices. P-values were calculated using χ(2) -tests for categorical variables and Wilcoxon rank-sum tests for continuous variables...
April 2017: International Journal of Urology: Official Journal of the Japanese Urological Association
https://www.readbyqxmd.com/read/28188447/a-prospective-observational-study-on-the-evaluation-of-everolimus-related-adverse-events-in-metastatic-renal-cell-carcinoma-after-first-line-anti-vascular-endothelial-growth-factor-therapy-the-afinite-study-in-france
#6
Florence Joly, Jean-Christophe Eymard, Laurence Albiges, Thierry Nguyen, Aline Guillot, Frederic Rolland, Dominique Spaeth, Brigitte Laguerre, Thierry Lebret, Nadia Kelkouli, Khemaies Slimane, Alain Ravaud
PURPOSE: The objective of the study was to describe the occurrence of stomatitis and noninfectious lung disease in patients with metastatic renal cell carcinoma (mRCC) treated with second-line everolimus in a real-world setting. METHODS: This multicenter, prospective, observational study was conducted in France by physicians with experience of treatment of patients with mRCC. Patients aged ≥18 years who received everolimus after first-line antivascular endothelial growth factor (VEGF) therapy were included in the study...
February 10, 2017: Supportive Care in Cancer: Official Journal of the Multinational Association of Supportive Care in Cancer
https://www.readbyqxmd.com/read/28152737/financial-risk-sharing-agreements-using-options-to-make-marginal-benefits-cost-effective
#7
(no author information available yet)
41 Background: New cancer treatments have become increasingly costly. Although new drugs may be sufficiently cost-efficiency for a primary indication (i1) to receive funding, subsequent indications (ia) may not prove cost-effective. A financial risk-sharing agreement to increase access is proposed. A potential 2012 real-world implementation in Canada for pazopanib use in metastatic renal cell carcinoma (mRCC) as i1, and soft-tissue sarcoma (STS) as ia is presented. METHODS: The market value of an indication can be approximated by its net-present-value (NPV) of expected cash flows...
March 2016: Journal of Clinical Oncology: Official Journal of the American Society of Clinical Oncology
https://www.readbyqxmd.com/read/28144093/managing-metastatic-renal-cell-carcinoma-challenges-pitfalls-and-outcomes-in-the-real-world
#8
Karnam Ashok Kumar, Gundeti Sadashivudu, K V Krishnamani, Vijay Gandhi Linga, Lakshmi Srinivas Maddali, Raghunadha Rao Digumarti
INTRODUCTION: Renal cell carcinoma (RCC) is the most common cancer of the kidney accounting for 85% of renal tumors. Metastatic RCC (mRCC) had a poor prognosis and with the introduction of tyrosine-kinase inhibitors, such as sunitinib, pazopanib the outcomes improved. There is only one study reported from India on the use of sunitinib in mRCC. We present our analysis of mRCC and use of sunitinib at our institute over 5 years. MATERIALS AND METHODS: All patients with mRCC receiving sunitinib were analyzed with respect to patient characteristics, response, toxicity, and outcomes...
October 2016: Indian Journal of Medical and Paediatric Oncology
https://www.readbyqxmd.com/read/28139444/real-world-survival-outcomes-and-prognostic-factors-among-patients-receiving-first-targeted-therapy-for-advanced-renal-cell-carcinoma-a-seer-medicare-database-analysis
#9
Sumanta K Pal, Sameer R Ghate, Nanxin Li, Elyse Swallow, Miranda Peeples, Miriam L Zichlin, Jose Ricardo Perez, Neeraj Agarwal, Nicholas J Vogelzang
BACKGROUND: The real-world survival outcomes and prognostic factors among patients receiving first-line targeted therapy for advanced renal cell carcinoma (aRCC) are not well known. PATIENTS AND METHODS: Adult patients diagnosed with RCC and treated with first-line targeted therapy were identified from the Surveillance, Epidemiology, and End Results-Medicare database (January 1, 1993 to December 31, 2012). The patients were grouped into early (2006-2009) or late (2010-2012) targeted therapy era cohorts by the year of the first-line targeted therapy initiation...
January 5, 2017: Clinical Genitourinary Cancer
https://www.readbyqxmd.com/read/28077238/patterns-of-care-and-clinical-outcomes-in-patients-with-metastatic-renal-cell-carcinoma-results-from-a-tertiary-cancer-center-in-india
#10
Anant Ramaswamy, Amit Joshi, Vanita Noronha, Vijay M Patil, Rushabh Kothari, Arvind Sahu, Ram Abhinav Kannan, Nilesh Sable, Palak Popat, Santosh Menon, Kumar Prabhash
INTRODUCTION: The current treatment of metastatic renal cell carcinoma (mRCC) revolves around targeted agents, which have resulted in a median overall survival of 22 to 26 months in registration trials. However, the outcomes in a non-trial, real-world Indian population have not yet been evaluated. MATERIALS AND METHODS: The present study was a part of a prospective Clinical Trials Registry-India-registered study, the Kidney Cancer Registry, a prospectively maintained kidney cancer registry...
October 19, 2016: Clinical Genitourinary Cancer
https://www.readbyqxmd.com/read/27973139/real-world-experience-of-sunitinib-in-patients-with-metastatic-renal-cell-carcinoma-results-from-compassionate-use-program-in-malaysia
#11
Y Y Lee, T O Lim, L W Hong
No abstract text is available yet for this article.
November 2016: Value in Health: the Journal of the International Society for Pharmacoeconomics and Outcomes Research
https://www.readbyqxmd.com/read/27924664/assessment-of-ethnic-differences-in-sunitinib-outcome-between-caucasian-and-asian-patients-with-metastatic-renal-cell-carcinoma-a-meta-analysis
#12
Xiaoyan Liu, Marta Fiocco, Jesse J Swen, Henk-Jan Guchelaar
BACKGROUND: An increasing number of studies have reported ethnic differences in sunitinib outcome in metastatic renal cell carcinoma (mRCC) patients. However, a comprehensive analysis is still lacking. Therefore, we systematically collected available published data and performed a meta-analysis to compare sunitinib efficacy and toxicity in Asian and Caucasian mRCC patients. METHODS: Data were extracted from published results from clinical trials, expanded access program and real-world clinical practice...
April 2017: Acta Oncologica
https://www.readbyqxmd.com/read/27733829/axitinib-after-sunitinib-in-metastatic-renal-cancer-preliminary-results-from-italian-real-world-sax-study
#13
Carmine D'Aniello, Maria G Vitale, Azzurra Farnesi, Lorenzo Calvetti, Maria M Laterza, Carla Cavaliere, Chiara Della Pepa, Vincenza Conteduca, Anna Crispo, Ferdinando De Vita, Francesco Grillone, Enrico Ricevuto, Michele De Tursi, Rocco De Vivo, Marilena Di Napoli, Sabrina C Cecere, Gelsomina Iovane, Alfonso Amore, Raffaele Piscitelli, Giuseppe Quarto, Salvatore Pisconti, Gennaro Ciliberto, Piera Maiolino, Paolo Muto, Sisto Perdonà, Massimiliano Berretta, Emanuele Naglieri, Luca Galli, Giacomo Cartenì, Ugo De Giorgi, Sandro Pignata, Gaetano Facchini, Sabrina Rossetti
Axitinib is an oral angiogenesis inhibitor, currently approved for treatment of metastatic renal cell carcinoma (mRCC) after failure of prior treatment with Sunitinib or cytokine. The present study is an Italian Multi-Institutional Retrospective Analysis that evaluated the outcomes of Axitinib, in second-line treatment of mRCC. The medical records of 62 patients treated with Axitinib, were retrospectively reviewed. The Progression Free Survival (PFS), the Overall Survival (OS), the Objective Response Rate (ORR), the Disease Control Rate (DCR), and the safety profile of axitinib and sunitinib-axitinib sequence, were the primary endpoint...
2016: Frontiers in Pharmacology
https://www.readbyqxmd.com/read/27630568/pazopanib-in-metastatic-renal-cancer-a-real-world-experience-at-national-cancer-institute-fondazione-g-pascale
#14
Sabrina C Cecere, Sabrina Rossetti, Carla Cavaliere, Chiara Della Pepa, Marilena Di Napoli, Anna Crispo, Gelsomina Iovane, Raffaele Piscitelli, Domenico Sorrentino, Gennaro Ciliberto, Piera Maiolino, Paolo Muto, Sisto Perdonà, Massimiliano Berretta, Sandro Pignata, Gaetano Facchini, Carmine D'Aniello
Pazopanib is an oral angiogenesis inhibitor, currently approved for treatment of metastatic renal cell carcinoma (mRCC) and soft tissue sarcoma. The present study analyzed the outcomes of pazopanib in first-line treatment of mRCC, in a single Italian cancer center. In the light of the retrospective, observational nature and the unselected population, our experience can be defined a "real-world" study. The medical records of 38 mRCC patients treated with front-line pazopanib were retrospectively reviewed and analyzed...
2016: Frontiers in Pharmacology
https://www.readbyqxmd.com/read/27541802/efficacy-of-sunitinib-in-elderly-patients-with-metastatic-renal-cell-carcinoma-data-from-real-world-clinical-practice
#15
Alexandr Poprach, Radek Lakomy, Zbynek Bortlicek, Bohuslav Melichar, Tomas Pavlik, Ondrej Slaby, Rostislav Vyzula, Marek Svoboda, Igor Kiss, Hana Studentova, Milada Zemanova, Ondrej Fiala, Katerina Kubackova, Ladislav Dusek, Jana Hornova, Tomas Buchler
BACKGROUND: Although a significant proportion of patients with metastatic renal cell carcinoma (mRCC) are elderly, the data on the outcomes of targeted therapies in this population are limited. The aim of the present retrospective registry-based study was to analyse efficacy and toxicity of sunitinib as the first-line targeted therapy of elderly mRCC patients. PATIENTS AND METHODS: The national RENal information system registry of mRCC patients treated with targeted agents in the Czech Republic was used as the data source...
September 2016: Drugs & Aging
https://www.readbyqxmd.com/read/27484998/a-korean-multi-center-real-world-retrospective-study-of-first-line-pazopanib-in-unselected-patients-with-metastatic-renal-clear-cell-carcinoma
#16
MULTICENTER STUDY
Moon Jin Kim, Se Hoon Park, Jae-Lyun Lee, Se-Hoon Lee, Su Jin Lee, Ho Yeong Lim
BACKGROUND: The efficacy and/or tolerability of pazopanib in patients with metastatic renal cell carcinoma (mRCC) have been found to differ in Western and Asian populations. This retrospective multicenter study analyzed the results of first-line pazopanib treatment in 93 consecutive patients with mRCC who were treated at the medical oncology departments of three tertiary cancer centers in Seoul, Korea. METHODS: The decision to administer pazopanib as first-line therapy was at the discretion of the treating physician in all patients with mRCC...
August 2, 2016: BMC Urology
https://www.readbyqxmd.com/read/27473522/assessment-of-efficacy-safety-and-quality-of-life-of-124-patients-treated-with-axitinib-as-second-line-therapy-for-metastatic-renal-cell-carcinoma-experience-in-real-world-clinical-practice-in-japan
#17
Hideaki Miyake, Ken-Ichi Harada, Seiichiro Ozono, Masato Fujisawa
PURPOSE: To comprehensively analyze the efficacy of axitinib for metastatic renal-cell carcinoma (mRCC) patients. PATIENTS AND METHODS: This study included 124 consecutive Japanese patients treated with axitinib as second-line systemic therapy for mRCC in a routine clinical setting. RESULTS: In addition to 4 indeterminate patients (3.2%), 0 (0%), 21 (16.9%), 87 (70.2%), and 12 (9.7%) were judged to show complete response, partial response, stable disease, and progressive disease, respectively, as the best responses to axitinib...
July 5, 2016: Clinical Genitourinary Cancer
https://www.readbyqxmd.com/read/27459661/real-world-treatment-patterns-and-costs-for-patients-with-renal-cell-carcinoma-initiating-treatment-with-sunitinib-and-pazopanib
#18
Elizabeth MacLean, Jack Mardekian, Laura A Cisar, Caroline J Hoang, James Harnett
BACKGROUND: Sunitinib and pazopanib are among the most prescribed targeted therapies for the systemic management of advanced renal cell carcinoma (RCC), but published cost comparisons between the 2 agents are few and limited by methodological and population differences. Also, sunitinib is administered on a 4-week on/2-week off cycle, and pazopanib is taken continuously. Thus, appropriate use and cost comparisons between the 2 drugs require methodological approaches to account for these differences...
August 2016: Journal of Managed Care & Specialty Pharmacy
https://www.readbyqxmd.com/read/27283478/clinical-benefit-of-everolimus-as-second-line-therapy-in-metastatic-renal-cell-carcinoma-the-french-retrospective-sector-study
#19
Stéphane Oudard, Florence Joly, Lionnel Geoffrois, Brigitte Laguerre, Nadine Houede, Philippe Barthelemy, Marine Gross-Goupil, Yann Vano, Oliver Lucidarme, Francois Bidault, Nadia Kelkouli, Khemaies Slimane, Bernard Escudier
BACKGROUND: Real-world data of everolimus after vascular endothelial growth factor receptor (VEGFR)-tyrosine kinase inhibitor (TKI) therapy in metastatic renal cell carcinoma (mRCC) are limited. PATIENTS AND METHODS: The retrospective, noninterventional SECTOR (SECond line with afiniTOR) study (N = 165) assessed outcomes of second-line everolimus after initial VEGFR-TKI (TKI-everolimus, n = 144) and of third-line VEGFR-TKI after everolimus (TKI-everolimus-TKI, n = 59) in patients with mRCC...
May 2, 2016: Clinical Genitourinary Cancer
https://www.readbyqxmd.com/read/27231799/real-world-axitinib-use-in-the-united-states-a-retrospective-study-using-linked-datasets
#20
Elizabeth MacLean, Laura Cisar, Kimberly Mehle, Daria Eremina, Jane M Quigley
BACKGROUND: Axitinib is approved by the FDA for the treatment of advanced renal cell carcinoma (RCC) after failure of 1 previous systemic therapy and is distributed primarily through specialty pharmacies. Although the efficacy and safety of axitinib have been established in clinical trials, information from real-world populations will help to elucidate patients' clinical profiles and utilization patterns. Prescription records alone provide limited information on patient characteristics and other treatment experiences...
June 2016: Journal of Managed Care & Specialty Pharmacy
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