Journal ArticleDOI
Docetaxel and estramustine compared with mitoxantrone and prednisone for advanced refractory prostate cancer
Daniel P. Petrylak,Catherine M. Tangen,Maha Hussain,Primo N. Lara,Jeffrey A. Jones,Mary-Ellen Taplin,Patrick A. Burch,Donna L. Berry,Carol M. Moinpour,Manish Kohli,Mitchell C. Benson,Eric J. Small,Derek Raghavan,E. David Crawford +13 more
TLDR
The improvement in median survival of nearly two months with docetaxel and estramustine, as compared with mitoxantrone and prednisone, provides support for this approach in men with metastatic, androgen-independent prostate cancer.Abstract:
background Mitoxantrone-based chemotherapy palliates pain without extending survival in men with progressive androgen-independent prostate cancer. We compared docetaxel plus estramustine with mitoxantrone plus prednisone in men with metastatic, hormoneindependent prostate cancer. methods We randomly assigned 770 men to one of two treatments, each given in 21-day cycles: 280 mg of estramustine three times daily on days 1 through 5, 60 mg of docetaxel per square meter of body-surface area on day 2, and 60 mg of dexamethasone in three divided doses before docetaxel, or 12 mg of mitoxantrone per square meter on day 1 plus 5 mg of prednisone twice daily. The primary end point was overall survival; secondary end points were progression-free survival, objective response rates, and post-treatment declines of at least 50 percent in serum prostate-specific antigen (PSA) levels. results Of 674 eligible patients, 338 were assigned to receive docetaxel and estramustine and 336 to receive mitoxantrone and prednisone. In an intention-to-treat analysis, the median overall survival was longer in the group given docetaxel and estramustine than in the group given mitoxantrone and prednisone (17.5 months vs. 15.6 months, P=0.02 by the log-rank test), and the corresponding hazard ratio for death was 0.80 (95 percent confidence interval, 0.67 to 0.97). The median time to progression was 6.3 months in the group given docetaxel and estramustine and 3.2 months in the group given mitoxantrone and prednisone (P<0.001 by the log-rank test). PSA declines of at least 50 percent occurred in 50 percent and 27 percent of patients, respectively (P<0.001), and objective tumor responses were observed in 17 percent and 11 percent of patients with bidimensionally measurable disease, respectively (P=0.30). Grade 3 or 4 neutropenic fevers (P=0.01), nausea and vomiting (P<0.001), and cardiovascular events (P=0.001) were more common among patients receiving docetaxel and estramustine than among those receiving mitoxantrone and prednisone. Pain relief was similar in both groups. conclusions The improvement in median survival of nearly two months with docetaxel and estramustine, as compared with mitoxantrone and prednisone, provides support for this approach in men with metastatic, androgen-independent prostate cancer.read more
Citations
More filters
Journal ArticleDOI
Docetaxel plus Prednisone or Mitoxantrone plus Prednisone for Advanced Prostate Cancer
Ian F. Tannock,Ronald de Wit,William R. Berry,Jozsef Horti,Anna Pluzanska,Kim N. Chi,Stéphane Oudard,Christine Theodore,Nicholas D. James,Ingela Turesson,Mark Rosenthal,Mario A. Eisenberger +11 more
TL;DR: When given with prednisone, treatment with docetaxel every three weeks led to superior survival and improved rates of response in terms of pain, serum PSA level, and quality of life, as compared with mitoxantrone plusprednisone.
Journal ArticleDOI
Sipuleucel-T immunotherapy for castration-resistant prostate cancer.
Philip W. Kantoff,Celestia S. Higano,N. Shore,E. Roy Berger,Eric J. Small,David F. Penson,Charles H. Redfern,Anna C. Ferrari,Robert Dreicer,Robert B. Sims,Yi Xu,Mark W. Frohlich,Paul F. Schellhammer +12 more
TL;DR: The use of sipuleucel-T prolonged overall survival among men with metastatic castration-resistant prostate cancer and immune responses to the immunizing antigen were observed in patients who received sipuleUcel- T.
Journal ArticleDOI
Prednisone plus cabazitaxel or mitoxantrone for metastatic castration-resistant prostate cancer progressing after docetaxel treatment: a randomised open-label trial
Johann S. de Bono,Stéphane Oudard,Mustafa Ozguroglu,Steinbjørn Hansen,Jean-Pascal Machiels,Ivo Kocák,Gwenaelle Gravis,Istvan Bodrogi,Mary J. MacKenzie,Liji Shen,Martin Roessner,Sunil Gupta,A. Oliver Sartor +12 more
TL;DR: Treatment with cabazitaxel plus prednisone has important clinical antitumour activity, improving overall survival in patients with metastatic castration-resistant prostate cancer whose disease has progressed during or after docetaxel-based therapy.
Journal ArticleDOI
Abiraterone in Metastatic Prostate Cancer without Previous Chemotherapy
Charles J. Ryan,Matthew R. Smith,Johann S. de Bono,Arturo Molina,Christopher J. Logothetis,Paul de Souza,Karim Fizazi,Paul N. Mainwaring,Josep M. Piulats,Siobhan Ng,Joan Carles,Peter F.A. Mulders,Ethan Basch,Eric J. Small,Fred Saad,D. Schrijvers,Hendrik Van Poppel,Som D. Mukherjee,Henrik Suttmann,Winald R. Gerritsen,Thomas W. Flaig,Daniel J. George,Evan Y. Yu,Eleni Efstathiou,Allan J. Pantuck,Eric Winquist,Celestia S. Higano,Mary-Ellen Taplin,Youn C. Park,Thian Kheoh,Thomas W. Griffin,Howard I. Scher,Dana E. Rathkopf +32 more
TL;DR: Abiraterone improved radiographic progression-free survival, showed a trend toward improved overall survival, and significantly delayed clinical decline and initiation of chemotherapy in patients with metastatic castration-resistant prostate cancer.
Journal ArticleDOI
Design and end points of clinical trials for patients with progressive prostate cancer and castrate levels of testosterone: recommendations of the Prostate Cancer Clinical Trials Working Group.
Howard I. Scher,Susan Halabi,Ian F. Tannock,Michael J. Morris,Cora N. Sternberg,Michael A. Carducci,Mario A. Eisenberger,Celestia S. Higano,Glenn J. Bubley,Robert Dreicer,Daniel P. Petrylak,Philip W. Kantoff,Ethan Basch,William Kevin Kelly,William D. Figg,Eric J. Small,Tomasz M. Beer,George Wilding,Alison Martin,Maha Hussain +19 more
TL;DR: New consensus criteria for eligibility and outcome measures in trials that evaluate systemic treatment for patients with progressive prostate cancer and castrate levels of testosterone are defined, with increasing emphasis on time-to-event end points as decision aids in proceeding from phase II to phase III trials.
References
More filters
Journal ArticleDOI
Docetaxel plus Prednisone or Mitoxantrone plus Prednisone for Advanced Prostate Cancer
Ian F. Tannock,Ronald de Wit,William R. Berry,Jozsef Horti,Anna Pluzanska,Kim N. Chi,Stéphane Oudard,Christine Theodore,Nicholas D. James,Ingela Turesson,Mark Rosenthal,Mario A. Eisenberger +11 more
TL;DR: When given with prednisone, treatment with docetaxel every three weeks led to superior survival and improved rates of response in terms of pain, serum PSA level, and quality of life, as compared with mitoxantrone plusprednisone.
Journal ArticleDOI
Cancer Statistics, 2004
Ahmedin Jemal,Ram C. Tiwari,Taylor Murray,Asma Ghafoor,Alicia Samuels,Elizabeth Ward,Eric J. Feuer,Michael J. Thun +7 more
TL;DR: The American Cancer Society estimated the number of new cancer cases and deaths expected in the United States in the current year and compiles the most recent data on cancer incidence, mortality, and survival rates based on incidence data from National Cancer Institute and mortality data from the National Center for Health Statistics.
Journal ArticleDOI
Chemotherapy with mitoxantrone plus prednisone or prednisone alone for symptomatic hormone-resistant prostate cancer: a Canadian randomized trial with palliative end points.
Ian F. Tannock,David Osoba,Martin R. Stockler,D. S. Ernst,Alan J. Neville,Malcolm J. Moore,G. R. Armitage,J. J. Wilson,Peter Venner,C. M. L. Coppin,K. C. Murphy +10 more
TL;DR: Chemotherapy with mitoxantrone and prednisone provides palliation for some patients with symptomatic hormone-resistant prostate cancer and most responding patients had an improvement in quality-of-life scales and a decrease in serum prostate-specific antigen (PSA) level.
Journal ArticleDOI
A controlled trial of leuprolide with and without flutamide in prostatic carcinoma.
E. D. Crawford,Mario A. Eisenberger,David G. McLeod,J T Spaulding,Ralph C. Benson,F A Dorr,Brent A. Blumenstein,M A Davis,P J Goodman +8 more
TL;DR: Treatment with le uprolide and flutamide is superior to treatment with leuprolide alone in patients with advanced prostate cancer, and Symptomatic improvement was greatest during the first 12 weeks of the combined androgen blockade.
Journal ArticleDOI
Eligibility and Response Guidelines for Phase II Clinical Trials in Androgen-Independent Prostate Cancer: Recommendations From the Prostate-Specific Antigen Working Group
Glenn J. Bubley,Michael A. Carducci,William L. Dahut,Nancy A. Dawson,Danai Daliani,Mario A. Eisenberger,William D. Figg,Boris Freidlin,Susan Halabi,Gary R. Hudes,Maha Hussain,Richard Kaplan,Charles E. Myers,William Oh,Daniel P. Petrylak,Eddie Reed,Bruce J. Roth,Oliver Sartor,Howard I. Scher,Jonathan W. Simons,V. J. Sinibaldi,Eric J. Small,Matthew R. Smith,Donald L. Trump,Robin T. Vollmer,George Wilding +25 more
TL;DR: The purpose of determining the number of patients whose PSA level drops in a phase II trial of AIPC is to guide the selection of agents for further testing and phase III trials and developed practical guidelines for using PSA as a measurement of outcome.
Related Papers (5)
Abiraterone and Increased Survival in Metastatic Prostate Cancer
Johann S. de Bono,Christopher J. Logothetis,Arturo Molina,Karim Fizazi,Scott North,Luis Chu,Kim N. Chi,Robert Jones,Oscar B. Goodman,Fred Saad,John Staffurth,Paul N. Mainwaring,S. J. Harland,Thomas W. Flaig,Thomas E. Hutson,Tina Cheng,Helen Patterson,John D. Hainsworth,Charles J. Ryan,Cora N. Sternberg,Susan Ellard,Aude Flechon,Mansoor N. Saleh,Mark C. Scholz,Eleni Efstathiou,Andrea Zivi,Diletta Bianchini,Yohann Loriot,Nicole Chieffo,Thian Kheoh,Christopher M. Haqq,Howard I. Scher +31 more
Increased Survival with Enzalutamide in Prostate Cancer after Chemotherapy
Howard I. Scher,Karim Fizazi,Fred Saad,Mary-Ellen Taplin,Cora N. Sternberg,Kurt Miller,Ronald de Wit,Peter F.A. Mulders,Kim N. Chi,Neal D. Shore,Andrew J. Armstrong,Thomas W. Flaig,Aude Flechon,Paul N. Mainwaring,Mark D. Fleming,John D. Hainsworth,Mohammad Hirmand,Bryan Selby,Lynn Seely,Johann S. de Bono,B Ch +20 more