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Real-world rcc

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
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
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
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...
2016: BMC Urology
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
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
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
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
Lesley-Ann Miller, Stephen Stemkowski, Kim Saverno, Daniel C Lane, Zhuliang Tao, Michelle D Hackshaw, Bryan Loy
BACKGROUND: Several systemic therapies are now approved for first- and second-line treatment of metastatic renal cell carcinoma (mRCC). Although the National Comprehensive Cancer Network (NCCN) guidelines offer physicians evidence-based recommendations for therapy, there are few real-world studies to help inform the utilization of these agents in clinical practice. OBJECTIVES: To (a) describe the patterns of use associated with systemic therapies for mRCC among Humana members in the United States diagnosed with mRCC, (b) assess consistency with the NCCN guidelines for treatment, and (c) to describe the initial first-line therapy regimen by prescriber specialty and site of care...
March 2016: Journal of Managed Care & Specialty Pharmacy
Marco Maruzzo, Umberto Basso, Alberto Diminutto, Anna Roma, Fable Zustovich, Antonella Brunello, Pasquale Fiduccia, Alberto Banzato, Filiberto Zattoni, Vittorina Zagonel
UNLABELLED: AIM, PATIENTS & METHODS: To evaluate the real-world setting use of sunitinib, we reviewed data of our patients from January 2007 to December 2014. RESULTS: In 114 patients, sunitinib was used as first-line TKI. Out of 110 evaluable patients, 5 complete responses, 37 partial responses, 42 stabilizations were reported. Median progression-free survival and overall survival (OS) were 14.3 and 28.4 months. Patients who received ≥ 4 full-dose cycles had a better OS (p = 0...
April 2016: Future Oncology
David Cella, Jennifer L Beaumont
Pazopanib is an orally available multitargeted tyrosine kinase inhibitor (a class of targeted therapies) that inhibits tumor angiogenesis and cell proliferation. The safety and efficacy of pazopanib (noninferior to sunitinib for progression-free survival) in patients with advanced or metastatic renal cell carcinoma (mRCC) have been demonstrated in several clinical trials. However, in addition to therapeutic efficacy, treatment choices should also take into account health-related quality of life (HRQoL) aspects of cancer therapy...
February 2016: Therapeutic Advances in Urology
Sumanta K Pal, James E Signorovitch, William M Reichmann, Nanxin Li, Valerie Koo, Zhimei Liu, Jose Ricardo Perez, Nicholas J Vogelzang
BACKGROUND: The effect of first targeted therapy on outcomes with second targeted therapy for metastatic renal cell carcinoma is not well known. The purpose of this study was to compare outcomes for patients receiving a second targeted therapy with everolimus by type of first targeted therapy. PATIENTS AND METHODS: Data were drawn from 3 separate retrospective chart reviews conducted in 2011, 2012, and 2014. Inclusion criteria and study design were similar across the 3 studies...
April 2016: Clinical Genitourinary Cancer
Kazuhiro Yoshimura, Hirotsugu Uemura
The standard treatment for advanced renal cell carcinoma has changed dramatically in the past decade, from cytokine therapy to targeted therapy. Since sorafenib was approved in April 2008, four tyrosine kinase inhibitors and two mammalian target of rapamycin inhibitors have become available in Japan. Most Japanese renal cell carcinoma patients are treated by urologists who are involved in not only kidney surgeries, but also targeted therapy using tyrosine kinase inhibitors, as well as mammalian target of rapamycin inhibitors...
March 2016: International Journal of Urology: Official Journal of the Japanese Urological Association
Sumanta K Pal, Eric Jonasch, James E Signorovitch, William M Reichmann, Nanxin Li, Zhimei Liu, Jose Ricardo Perez, Nicholas J Vogelzang
OBJECTIVE: To describe dosing patterns and to compare the drug costs per month spent in progression-free survival (PFS) among patients with advanced renal cell carcinoma (aRCC) treated with everolimus or axitinib following a first tyrosine kinase inhibitor (TKI). METHODS: A medical record retrospective review was conducted among medical oncologists and hematologists/oncologists in the US. Patient eligibility criteria included: (1) age ≥18 years; (2) discontinuation of first TKI (sunitinib, sorafenib, or pazopanib) for medical reasons; (3) initiation of axitinib or everolimus as a second targeted therapy during February 2012-January 2013...
2016: Journal of Medical Economics
Pengxiang Li, Yu-Ning Wong, Katrina Armstrong, Naomi Haas, Prasun Subedi, Margaret Davis-Cerone, Jalpa A Doshi
Between December 2005 and October 2009, FDA approved six targeted therapies shown to significantly extend survival for advanced renal cell carcinoma (RCC) patients in clinical trials. This study aimed to examine changes in survival between the pretargeted and targeted therapy periods in advanced RCC patients in a real-world setting. Utilizing the 2000-2010 SEER Research files, a pre-post study design with a contemporaneous comparison group was employed to examine differences in survival outcomes for patients diagnosed with advanced RCC (study group) or advanced prostate cancer (comparison group, for whom no significant treatment innovations happened during this period) across the pretargeted therapy era (2000-2005) and the targeted therapy era (2006-2010)...
February 2016: Cancer Medicine
Christopher W Ryan
Within the past decade, treatment options for metastatic renal cell carcinoma have expanded dramatically. Currently, seven targeted agents are approved for use in metastatic renal cell carcinoma and have superseded the use of parenteral cytokine therapy with interleukin-2 or interferon, the former standards of care for metastatic renal cell carcinoma. Targeted agents include inhibitors of the vascular endothelial growth factor pathway (i.e. sorafenib, sunitinib, pazopanib, axitinib, and bevacizumab) and inhibitors of the mammalian target of rapamycin pathway (i...
November 30, 2015: Journal of Oncology Pharmacy Practice
J Wagstaff, R Jones, R Hawkins, E Porfiri, L Pickering, A Bahl, J Brown, S Buchan
BACKGROUND: The aim of the RECCORD registry was to gather real-world UK data on the use of targeted therapies in renal cell carcinoma (RCC) and assess clinical outcomes. Here, demographic and outcome data are presented with the treatment patterns and demographic profile of patients on the registry. PATIENTS AND METHODS: Patients were retrospectively identified at seven UK hospitals with large cancer centres in England (5), Scotland (1) and Wales (1). Anonymised data were collected through an online registry covering demographics, treatments and outcomes...
January 2016: Annals of Oncology: Official Journal of the European Society for Medical Oncology
Daniele Alesini, Claudia Mosillo, Giuseppe Naso, Enrico Cortesi, Roberto Iacovelli
Everolimus is an oral inhibitor of mammalian target of rapamycin (mTOR-I) and is currently approved for the treatment of metastatic renal cell carcinoma (mRCC) after failure of first-line vascular endothelial growth factor receptor tyrosine kinase inhibitor (TKI). In this narrative review, we aim to report the available evidence about the use of everolimus as second-line therapy for mRCC. A literature search was performed using PubMed/MEDLINE and abstracts from major conferences on clinical oncology as sources...
October 2015: Therapeutic Advances in Urology
Miriam Argyropulo-Palmer, Aaron Jenkins, Davinder Singh Theti, James Larkin, David Montgomery
BACKGROUND: Real world data (RWD) are increasingly used to inform drug reimbursement decisions, but it is unclear how well outcomes from real world studies compare to those of clinical trials. This systematic review seeks to compare outcomes for sunitinib in routine UK clinical practice with the sunitinib registrational and expanded-access program clinical trials. METHOD: Systematic review of the real world published literature was undertaken. UK observational studies recording first- or second-line sunitinib efficacy were included...
2015: Frontiers in Oncology
Sergio Bracarda, Sylvie Rottey, Amit Bahl, Christian Eichelberg, Begoña Mellado, László Mangel, Agnese Cattaneo, Ashok Panneerselvam, Viktor Grünwald
AIM: RAD001 Expanded Access Clinical Trial (REACT) provided everolimus to patients with metastatic RCC before its commercial availability. This retrospective subgroup analysis evaluated eventual differences, mainly in safety, between the large European population (n = 906; 66.3%) and the overall population (n = 1367). PATIENTS & METHODS: REACT enrolled patients from 34 countries who received everolimus 10 mg/day until progression/discontinuation or commercial availability...
2015: Future Oncology
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