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Adjuvant sunitinib

Thanaporn Bussabawalai, Kittiphong Thiboonboon, Yot Teerawattananon
Background: Many patients develop tumour recurrence within a few years after undergoing surgical resection of gastrointestinal stromal tumours (GIST). Adjuvant imatinib treatment is recommended for patients with high risk of GIST recurrence as it can improve recurrence-free survival and overall survival of patients. This study aims to assess the cost-utility of adjuvant imatinib in patients with high risk of GIST recurrence after surgery compared with no adjuvant therapy in Thailand. Methods: A Markov model was developed to estimate lifetime costs and outcomes of using adjuvant imatinib treatment and other treatment alternatives if recurrence occurred compared with the current situation of no adjuvant therapy in high-risk patients after surgery...
2019: Cost Effectiveness and Resource Allocation: C/E
Forouzan Amerizadeh, Majid Khazaei, Mona Maftouh, Ramin Mardani, Afsane Bahrami
Angiogenesis refers to the formation of recent blood vessels, which is one of the characteristics of cancer progression. and it has been deliberated a putative target to the treatment of many kinds of cancers. The VEGF signaling substrate is very important for angiogenesis and is commonly high-regulated in tumors. As a result, this molecule has attracted one of the most attention of researchers to develop antiangiogenic therapies. We have presented that VEGF blockage in neoadjuvant setting via bevacizumab, aflibercept and sunitinib not only have revealed some promising benefit but also it shows a large negative outcome in the adjuvant trials...
January 10, 2019: Current Pharmaceutical Design
Ronac Mamtani, Xin Victoria Wang, Bishal Gyawali, Robert S DiPaola, C Neill Epperson, Naomi B Haas, Janice P Dutcher
BACKGROUND: In phase 3 trials of patients with resected high-risk renal cell carcinoma, adjuvant sunitinib has demonstrated no overall survival (OS) benefit, an uncertain disease-free survival (DFS) benefit, and increased toxicity versus placebo. To identify patients who may derive benefit or harm from adjuvant therapy, the authors assessed the effects of age and sex on treatment outcomes in the phase 3 Adjuvant Sorafenib or Sunitinib for Unfavorable Renal Cancer (ASSURE) trial. METHODS: The authors conducted a post hoc subgroup analysis of age and sex among patients in the ASSURE trial...
January 8, 2019: Cancer
E Christina Tampaki, M Kontos, R Droeser, A Tampakis
No abstract text is available yet for this article.
December 3, 2018: Annals of Oncology: Official Journal of the European Society for Medical Oncology
Florence T H Wu, Ping Xu, Annabelle Chow, Shan Man, Janna Krüger, Kabir A Khan, Marta Paez-Ribes, Elizabeth Pham, Robert S Kerbel
BACKGROUND: There are phase 3 clinical trials underway evaluating anti-PD-L1 antibodies as adjuvant (postoperative) monotherapies for resectable renal cell carcinoma (RCC) and triple-negative breast cancer (TNBC); in combination with antiangiogenic VEGF/VEGFR2 inhibitors (e.g., bevacizumab and sunitinib) for metastatic RCC; and in combination with chemotherapeutics as neoadjuvant (preoperative) therapies for resectable TNBC. METHODS: This study investigated these and similar clinically relevant drug combinations in highly translational preclinical models of micro- and macro-metastatic disease that spontaneously develop after surgical resection of primary kidney or breast tumours derived from orthotopic implantation of murine cancer cell lines (RENCAluc or EMT-6/CDDP, respectively)...
November 30, 2018: British Journal of Cancer
Alain Ravaud
Adjuvant treatment with vascular endothelial growth factor receptor tyrosine kinase inhibitor in renal cell carcinoma after nephrectomy has been reported through three clinical trials: S-TRAC, ASSURE and PROTECT. Only S-TRAC has been significantly positive on primary end-point disease-free survival under sunitinib compared to placebo, whereas ASSURE and PROTECT did not show any gain under sunitinib, sorafenib or pazopanib. This short review presents the differences between the trials and provides hypotheses on why S-TRAC may have been positive...
November 2018: Asia-Pacific Journal of Clinical Oncology
T Sharma, C Tajzler, A Kapoor
Background: Although surgical resection remains the standard of care for localized kidney cancers, a significant proportion of patients experience systemic recurrence after surgery and hence might benefit from effective adjuvant therapy. So far, several treatment options have been evaluated in adjuvant clinical trials, but only a few have provided promising results. Nevertheless, with the recent development of targeted therapy and immunomodulatory therapy, a series of clinical trials are in progress to evaluate the potential of those novel agents in the adjuvant setting...
October 2018: Current Oncology
M Staehler, R J Motzer, D J George, H S Pandha, F Donskov, B Escudier, A J Pantuck, A Patel, L DeAnnuntis, H Bhattacharyya, K Ramaswamy, G Zanotti, X Lin, M Lechuga, L Serfass, J Paty, A Ravaud
Background: Adjuvant sunitinib has significantly improved disease-free survival versus placebo in patients with renal cell carcinoma at high risk of recurrence post-nephrectomy (hazard ratio 0.76; 95% confidence interval, 0.59-0.98; two-sided P = 0.03). We report safety, therapy management, and patient-reported outcomes for patients receiving sunitinib and placebo in the S-TRAC trial. Patients and methods: Patients were stratified by the University of California, Los Angeles Integrated Staging System and Eastern Cooperative Oncology Group performance status score, and randomized (1 : 1) to receive sunitinib (50 mg/day) or placebo...
October 1, 2018: Annals of Oncology: Official Journal of the European Society for Medical Oncology
Daniel J George, Jean-Francois Martini, Michael Staehler, Robert J Motzer, Ahmed Magheli, Frede Donskov, Bernard Escudier, Sherry Li, Michelle Casey, Olga Valota, Brigitte Laguerre, Allan J Pantuck, Hardev Pandha, Anup Patel, Maria J Lechuga, Alain Ravaud
PURPOSE: In the S-TRAC trial, adjuvant sunitinib prolonged disease-free survival (DFS) versus placebo in patients with loco-regional renal cell carcinoma at high risk of recurrence after nephrectomy. An exploratory analysis evaluated associations between single nucleotide polymorphisms (SNPs) in several angiogenesis- or hypoxia-related genes and clinical outcomes in S-TRAC. EXPERIMENTAL DESIGN: Blood samples were genotyped for 10 SNPs and one insertion/deletion mutation using TaqMan assays...
November 6, 2018: Clinical Cancer Research: An Official Journal of the American Association for Cancer Research
Naomi B Haas, Robert G Uzzo
Recent adjuvant vascular endothelial growth factor tyrosine kinase inhibitor trials in resected high-risk renal cell carcinoma that compared sunitinib, sorafenib, pazopanib, and axitinib with placebo controls have demonstrated mixed impact on disease-free survival, no improvement in overall survival, and, thus, controversy. Here, we discuss the results and conduct of these trials to provide new insight into the goals and strategies of treating resected renal cell cancer that is at high risk for recurrence. The potential for leveraging what we have learned from these trials to conduct successful contemporary adjuvant and perioperative immune checkpoint inhibition trials and future adjuvant trial design is discussed...
October 29, 2018: Journal of Clinical Oncology: Official Journal of the American Society of Clinical Oncology
Mohamad B Sonbol, Belal Firwana, Talal Hilal, Zhen Wang, Diana Almader-Douglas, Richard W Joseph, Thai H Ho
Context: The role of antiangiogenic agents in advanced renal cell carcinoma (RCC) is well established. However, it is still not clear whether this benefit can be extrapolated to the adjuvant setting. Objective: To determine the efficacy and safety of antiangiogenic agents in patients with RCC and a high risk of relapse after nephrectomy. Evidence acquisition: We searched PubMed, Embase, and the Cochrane Central Register of Controlled Trials for randomized controlled trials (RCTs) evaluating the use of any oral antiangiogenic agent compared to placebo in post-nephrectomy RCC patients...
June 2018: European urology oncology
Ronan Flippot, Bernard Escudier, Laurence Albiges
Immune modulatory treatment regimens, led by immune checkpoint inhibitors, have transformed the treatment of clear-cell renal cell carcinoma. First-in-class, the PD-1 inhibitor nivolumab improved overall survival in advanced renal cell carcinoma following prior anti-angiogenic therapy, an important shift in the management of clear-cell renal cell carcinoma. Further improvements of long-term outcomes will be driven by combinations in the first-line setting, including PD-1/PD-L1 associated with antiangiogenic therapies, or PD1/PD-L1 inhibitors with other immune checkpoint inhibitors such as anti-CTLA-4, anti-LAG-3 or TIM-3 targeted therapies...
September 2018: Drugs
Nazli Dizman, Jacob J Adashek, JoAnn Hsu, Paulo G Bergerot, Cristiane D Bergerot, Sumanta K Pal
In parallel with advances in the treatment of metastatic renal cell carcinoma (RCC), multiple adjuvant treatments have been tested for RCC. Adjuvant approaches now extend beyond conventional immunotherapies, such as interferon alfa and interleukins, to targeted therapies and immune checkpoint inhibitors. Most treatment approaches before the targeted treatment era did not improve patient outcomes, or study results were mixed. For example, a recent study found that disease-free survival was longer with sunitinib than with placebo in high-risk clear cell RCC, which led to the regulatory approval of sunitinib...
August 2018: Clinical Advances in Hematology & Oncology: H&O
Vivek Narayan, Maneka Puligandla, Naomi B Haas, Pearl Subramanian, Robert S DiPaola, Robert Uzzo
PURPOSE: The natural history of non-clear cell renal cell carcinomas (non-ccRCC) following surgery with curative intent remains poorly defined, with post-operative surveillance informed by guidelines largely intended for clear cell RCC (ccRCC). We evaluated the patterns of relapse and potential implications for post-nephrectomy surveillance for patients with non-ccRCC enrolled in the largest randomized trial of adjuvant anti-angiogenic therapy for high-risk RCC (E2805). MATERIALS AND METHODS: This was a retrospective analysis of patients with completely resected non-ccRCC...
August 18, 2018: Journal of Urology
Christie Hancock, Linda Green, Timothy Lestingi, Jacob Bitran Md
Objective We wanted to examine the incremental cost-effective ratio (ICER) for a variety of Food and Drug Administration (FDA) approved oncology drugs in the adjuvant or curative setting to determine the value provided. Design We examined the annualized incremental drug costs of a variety of FDA approved chemotherapeutic drugs used in an adjuvant or curative setting based on National Comprehensive Cancer Network (NCCN) category 1 practice guidelines for melanoma, Her2/neu over-expressive breast cancer, renal cell carcinoma, stage IIIA non-small cell lung cancer, myeloma, B cell lymphoma, and Hodgkin lymphoma...
June 14, 2018: Curēus
F Gómez-Veiga, A Alcaraz-Asensio, J Burgos-Revilla, J Cózar-Olmo
OBJECTIVE: To put forth new findings of urologic oncology with impact on clinical practice presented during 2017 in the main annual meetings. METHODS: This document reviews abstracts on prostate, kidney and bladder cancer presented at the congresses of 2016 (EAU, AUA, ASCO, ESMO and ASTRO) and publications with the highest impact in this period valued with the highest scores by the OncoForum committee. RESULTS: Among patients at high risk of recurrent renal cell carcinoma after nephrectomy, adjuvant sunitinib compared to placebo showed a benefit in patients at higher risk of recurrence...
October 2018: Actas Urologicas Españolas
Pierre I Karakiewicz, Emanuele Zaffuto, Anil Kapoor, Naveen S Basappa, Georg A Bjarnason, Normand Blais, Rodney H Breau, Christina Canil, Darrel Drachenberg, Sebastien J Hotte, Claudio Jeldres, Michael A S Jewett, Wassim Kassouf, Christian Kollmannsberger, Luke T Lavallée, Ranjena Maloni, Francois Patenaude, Frédéric Pouliot, M Neil Reaume, Robert Sabbagh, Bobby Shayegan, Alan So, Denis Soulières, Simon Tanguay, Lori Wood, Marco Bandini
INTRODUCTION: The Kidney Cancer Research Network of Canada (KCRNC) collaborated to prepare this consensus statement about the use of target agents as adjuvant therapy in patients with non-metastatic renal cell carcinoma (nmRCC) after nephrectomy. We reviewed the published data and performed a meta-analysis of studies that focused on vascular endothelial growth factor receptor (VEGFR) tyrosine kinase inhibitors (TKIs). METHODS: A systematic literature search identified seven trials on adjuvant target therapy in nmRCC...
June 2018: Canadian Urological Association Journal, Journal de L'Association des Urologues du Canada
Lin Mei, Wei Du, Michael Idowu, Margaret von Mehren, Sosipatros A Boikos
Gastrointestinal stromal tumors (GISTs) originate from interstitial cells of Cajal and account for over 5,000 newly diagnosed cases in the United States. The discovery of activated KIT and PDGFRA mutations and introduction of imatinib revolutionized the treatment strategy and opened up the new era of target therapy for solid tumors. Although surgery remains the primary modality of treatment for curative purpose, almost half of the patients experienced disease recurrence. Tailoring (neo)-adjuvant treatment with imatinib is ongoing to meet the need for an effective therapy...
2018: Frontiers in Oncology
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
Maxine Sun, Lorenzo Marconi, Tim Eisen, Bernard Escudier, Rachel H Giles, Naomi B Haas, Lauren C Harshman, David I Quinn, James Larkin, Sumanta K Pal, Thomas Powles, Christopher W Ryan, Cora N Sternberg, Robert Uzzo, Toni K Choueiri, Axel Bex
CONTEXT: Contradictory data exist with regard to adjuvant vascular endothelial growth factor receptor (VEGFR)-targeted therapy in surgically managed patients for localized renal cell carcinoma (RCC). OBJECTIVE: To systematically evaluate the current evidence regarding the therapeutic benefit (disease-free survival [DFS] and overall survival [OS]) and grade 3-4 adverse events (AEs) for adjuvant VEGFR-targeted therapy for resected localized RCC. EVIDENCE ACQUISITION: A critical review of PubMed/Medline, Embase, and the Cochrane Library in January 2018 according to the Preferred Reporting Items for Systematic Review and Meta-Analysis (PRISMA) statement was performed...
November 2018: European Urology
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