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radium-223 post docetaxel

Benjamin Kearns, Abdullah Pandor, Matt Stevenson, Jean Hamilton, Duncan Chambers, Mark Clowes, John Graham, M Satish Kumar
As part of its single technology appraisal (STA) process, the National Institute for Health and Care Excellence (NICE) invited the company that manufactures cabazitaxel (Jevtana(®), Sanofi, UK) to submit evidence for the clinical and cost effectiveness of cabazitaxel for treatment of patients with metastatic hormone-relapsed prostate cancer (mHRPC) previously treated with a docetaxel-containing regimen. The School of Health and Related Research Technology Appraisal Group at the University of Sheffield was commissioned to act as the independent Evidence Review Group (ERG)...
October 22, 2016: PharmacoEconomics
Chad R Ritch, Michael S Cookson
Docetaxel based chemotherapy showed survival benefit and emerged as the mainstay of treatment for castration resistant prostate cancer (CRPC) in 2004. However, therapeutic options have expanded rapidly since 2011. The spectrum of new agents is broad and includes drugs that target the androgen axis (enzalutamide, abiraterone), immunotherapy (sipuleucel-T), bone seeking radionuclides (radium-223), and second line chemotherapy (cabazitaxel). In addition, new agents have been developed to reduce skeletal related events (denosumab)...
October 17, 2016: BMJ: British Medical Journal
Nicholas J Vogelzang, Robert E Coleman, Jeff M Michalski, Sten Nilsson, Joe M O'Sullivan, Christopher Parker, Anders Widmark, Marcus Thuresson, Lei Xu, Joseph Germino, Oliver Sartor
BACKGROUND: Myelosuppression is common in patients with progressive castration-resistant prostate cancer and bone metastases. Radium-223 prolongs overall survival in these patients but may cause myelosuppression; understanding risk factors will improve clinical decision making. We describe hematologic safety of radium-223 in ALSYMPCA and post hoc analyses identifying patients at increased risk for hematologic toxicity. PATIENTS AND METHODS: Hematologic parameters and adverse events were analyzed...
August 8, 2016: Clinical Genitourinary Cancer
S Nilsson, P Cislo, O Sartor, N J Vogelzang, R E Coleman, J M O'Sullivan, J Reuning-Scherer, M Shan, L Zhan, C Parker
BACKGROUND: Radium-223 dichloride (radium-223), a first-in-class α-emitting radiopharmaceutical, is recommended in both pre- and post-docetaxel settings in patients with castration-resistant prostate cancer (CRPC) and symptomatic bone metastases based on overall survival benefit demonstrated in the phase III ALSYMPCA study. ALSYMPCA included prospective measurements of health-related quality of life (QOL) using two validated instruments: the general EuroQoL 5D (EQ-5D) and the disease-specific Functional Assessment of Cancer Therapy-Prostate (FACT-P)...
May 2016: Annals of Oncology: Official Journal of the European Society for Medical Oncology
Benjamin A Gartrell, Fred Saad
The treatment armamentarium for metastatic castration-resistant prostate cancer (mCRPC) has increased significantly over the past several years. Approved drugs associated with improved survival include androgen pathway-targeted agents (abiraterone acetate and enzalutamide), chemotherapeutics (docetaxel and cabazitaxel), an autologous vaccine (sipuleucel-T) and a radiopharmaceutical (radium-223). Abiraterone acetate, a prodrug of abiraterone, inhibits the CYP17A enzyme, a critical enzyme in androgen biosynthesis...
August 2015: Therapeutic Advances in Urology
Sten Nilsson
INTRODUCTION: Approximately 10 - 20% of prostate cancer cases ultimately progress to castration-resistant prostate cancer (CRPC), for which there is a poor prognosis and a therapeutic need. Radium-223 dichloride (radium-223 [Xofigo]) is a first-in-class α-emitting radiopharmaceutical shown to significantly prolong overall survival in patients with CRPC with symptomatic bone metastases and no visceral metastases. Current treatment guidelines recommended it in both pre- and post-docetaxel settings...
July 2015: Expert Opinion on Drug Safety
Tian Zhang, Jason Zhu, Daniel J George, Andrew J Armstrong
INTRODUCTION: Over the past decade, treatment options for men with metastatic castration-resistant prostate cancer (CRPC) have expanded with the addition of abiraterone acetate (AA), enzalutamide, sipuleucel-T, radium-223, docetaxel and cabazitaxel. The optimal sequencing of therapies in the context of efficacy and known cross-resistance remains uncertain. AREAS COVERED: We review the development of enzalutamide (MDV3100, Xtandi), a novel second-generation androgen receptor (AR), and AA (Zytiga), a selective, irreversible inhibitor of cytochrome P17...
March 2015: Expert Opinion on Pharmacotherapy
Hsin-Ho Liu, Yuh-Shyan Tsai, Chen-Li Lai, Chih-Hsin Tang, Chih-Ho Lai, Hsi-Chin Wu, Jer-Tsong Hsieh, Che-Rei Yang
With advances in molecular biologic and genomic technology, detailed molecular mechanisms for development of castration-resistant prostate cancer (CRPC) have surfaced. Metastatic prostate cancer (PCa) no longer represents an end stage, with many emerging therapeutic agents approved as effective in prolonging survival of patients from either pre- or post-docetaxel stage. Given tumor heterogeneity in patients, a one-size-fits-all theory for curative therapy remains questionable. With the support of evidence from continuing clinical trials, each treatment modality has gradually been found suitable for selective best-fit patients: e...
2014: BioMedicine
J Cassinello, M A Climent, A González del Alba, B Mellado, J A Virizuela
Androgen deprivation treatment is the current standard first-line treatment for metastatic prostate cancer. For several years, docetaxel was the only treatment with a proven survival benefit for castration-resistant prostate cancer (CRPC). Since docetaxel became standard of care for men with symptomatic metastatic castration-resistant prostate cancer (CRPC), three treatment virtual spaces, for treatment and drug development in CPRC, have emerged: pre-docetaxel, docetaxel combinations and post-docetaxel. Sipuleucel-T, cabazitaxel, abiraterone, enzalutamide and radium-223 have been approved in the pre- or post-docetaxel setting in metastatic CRPC during the last few years...
December 2014: Clinical & Translational Oncology
Oliver Sartor, Silke Gillessen
Six different treatments have demonstrated improved survival in phase III trials targeted to patients with metastatic castration-resistant prostate cancer (mCRPC). Front-line therapeutic options for mCRPC include docetaxel, sipuleucel-T, abiraterone and radium-223. Post-docetaxel options include cabazitaxel, abiraterone, enzalutamide and radium-223. Despite much progress in recent years, much is yet unknown and debates occur over optimal treatment choices and sequences. None of the new agents have been compared to one another, thus physicians in practice today must make choices based on non-randomized comparisons, toxicity considerations and various assumptions...
May 2014: Asian Journal of Andrology
Michael Hurwitz, Daniel P Petrylak
Ten years ago, the clinician treating metastatic castration-resistant prostate cancer (CRPC) had palliative options for treatment of symptomatic patients, such as the combination of mitoxantrone combined with prednisone, as well as isotope therapy. In 2004, docetaxel-based chemotherapy regimens were shown to provide an overall survival benefit for patients with CRPC. Today, the prostate cancer oncologist is in the enviable position of having six U.S. Food and Drug Administration-approved agents to choose from: immunotherapy (sipuleucel-T), hormonal therapies (abiraterone, enzalutamide), radiopharmaceuticals (radium-223), and chemotherapy (docetaxel, cabazitaxel), in addition to agents being administered in clinical trials...
November 2013: Oncology (Williston Park, NY)
Aurelius Omlin, Carmel Pezaro, Silke Gillessen Sommer
In the last three years, five novel treatments have been shown to improve survival in metastatic castration-resistant prostate cancer (CRPC). These novel treatments have distinct mechanisms of action: tubulin-binding chemotherapy (cabazitaxel); immunotherapy (sipuleucel-T); CYP-17 inhibition (abiraterone); androgen receptor (AR) blockade (enzalutamide); and radioisotope therapy (radium-223). For a number of years, docetaxel was the only treatment with a proven survival benefit for patients with CRPC. Therefore, somewhat artificially, three treatment spaces for drug development in CRPC have emerged: pre-docetaxel; docetaxel combinations; and post-docetaxel...
February 2014: Therapeutic Advances in Urology
Deborah Mukherji, Aurelius Omlin, Carmel Pezaro, Ali Shamseddine, Johann de Bono
With five novel therapies shown to improve survival in metastatic castration-resistant prostate cancer (CRPC) in the last 3 years, patients are now living longer and experiencing better quality of life. Since docetaxel became standard of care for men with symptomatic metastatic CRPC, three artificial treatment "spaces" have emerged for prostate cancer drug development: pre-docetaxel, docetaxel combinations, and following docetaxel. Multiple therapies are currently under development in both early and late stage CRPC...
September 2014: Cancer Metastasis Reviews
D Lorente, J S De Bono
Prostate cancer is the most common malignancy in Western Europe, of which approximately 10-20% presents with advanced or metastatic disease. Initial response with androgen deprivation therapy is almost universal, but progression to castration resistant prostate cancer (CRPC), an incurable disease, occurs in approximately 2-3 years. In recent years, the novel taxane cabazitaxel, the hormonal agents abiraterone and enzalutamide, the immunotherapeutic agent sipuleucel-T and the radiopharmaceutical radium-223 have been shown to prolong survival in large randomised trials, thus widely increasing the therapeutic armamentarium against the disease...
March 2014: European Journal of Cancer
C G Drake, P Sharma, W Gerritsen
For the past decade, docetaxel has remained the global standard of care for frontline treatment of metastatic castration-resistant prostate cancer (mCRPC). Until recently, there were limited options for patients with mCRPC following docetaxel failure or resistance, but now the approved treatment choices for these patients have expanded to include abiraterone acetate, cabazitaxel and enzalutamide. Additionally, the radioactive therapeutic agent radium-223 dichloride has been recently approved in patients with CRPC with bone metastases...
October 23, 2014: Oncogene
Song Zhao, Evan Y Yu
PURPOSE OF REVIEW: Prior to 2010, docetaxel was the only treatment shown to prolong survival in metastatic castrate-resistant prostate cancer (CRPC). In the past 3 years, several therapeutic agents have demonstrated survival improvements for CRPC after the receipt of prior docetaxel, leading to multiple approvals by the US Food and Drug Administration. RECENT FINDINGS: The development of these novel agents, each with a distinct mechanism of action, is the fruition of sedulous preclinical research and well designed clinical trials...
May 2013: Current Opinion in Urology
Alvaro Pinto, Patricia Cruz
In the last few years, the treatment of castration-resistant prostate carcinoma (CRPC) has changed completely. The approval of docetaxel and subsequent investigation in this field have led to development of new agents that have demonstrated an improvement in overall survival in the post-docetaxel setting, such as cabazitaxel and abiraterone. Radium-223 chloride is a radioisotope that has recently shown efficacy after docetaxel and in patients unfit for docetaxel, with improvements in overall survival and the time to the first skeletal-related event, compared with placebo, without increasing toxicity...
December 1, 2012: Drugs in R&D
Stéphane Oudard
The landscape of prostate cancer treatment is rapidly changing as extensive research into potential therapies yields new options. In this article, the literature is reviewed to identify emerging therapies for advanced prostate cancer. Emphasis is placed on agents that have been approved in the United States of America (USA) and the European Union, or that have reached phase III clinical studies. Several new therapies have been approved in recent years across different stages of the natural history of the disease...
May 2013: Cancer Treatment Reviews
Sumanta K Pal, Brian Lewis, Oliver Sartor
The treatment of metastatic castration-resistant prostate cancer has evolved since the approval of docetaxel-based therapy. Since docetaxel approval, three new agents have gained approval for this indication: sipuleucel-T, cabazitaxel, and abiraterone. Recent Phase III trials have also demonstrated survival benefits for MDV-3100 and radium-223 though regulatory approval ispending. Practicing physicians face the challenge of determining the optimal sequencing of these new agents. This dilemma is particularly relevant to the post-docetaxel setting, in which the indication for several of these agents overlaps...
November 2012: Urologic Clinics of North America
Celestia S Higano
Chemotherapy for men with metastatic castration-resistant prostate cancer (CRPC) conferred no survival advantage until 2004 when docetaxel was shown to improve survival when compared with mitoxantrone, which was approved for palliation of symptomatic disease in 1996. Since then, clinical trials have concentrated on three main populations of patients with metastatic CRPC: those who are chemotherapy naïve and are asymptomatic or minimally symptomatic, those who need docetaxel therapy, and those who have received docetaxel previously and/or those with symptomatic disease...
August 2012: Cancer Treatment Reviews
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