Journal ArticleDOI
Androgen-deprivation therapy alone or with docetaxel in non-castrate metastatic prostate cancer (GETUG-AFU 15): a randomised, open-label, phase 3 trial
Gwenaelle Gravis,Karim Fizazi,Florence Joly,Stéphane Oudard,Franck Priou,Benjamin Esterni,Igor Latorzeff,Remy Delva,Ivan Krakowski,Brigitte Laguerre,Frederic Rolland,Christine Theodore,Gael Deplanque,Jean Marc Ferrero,Damien Pouessel,Loic Mourey,Philippe Beuzeboc,Sylvie Zanetta,Muriel Habibian,Jean-François Berdah,Jérôme Dauba,Marjorie Baciuchka,Christian Platini,Claude Linassier,Jean Luc Labourey,Jean-Pascal Machiels,Claude El Kouri,Alain Ravaud,Etienne Suc,Jean-Christophe Eymard,Ali Hasbini,Guilhem Bousquet,Michel Soulié +32 more
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TLDR
Docetaxel should not be used as part of first-line treatment for patients with non-castrate metastatic prostate cancer, and the data monitoring committee recommended treatment with granulocyte colony-stimulating factor.Abstract:
Summary Background Early chemotherapy might improve the overall outcomes of patients with metastatic non-castrate (ie, hormone-sensitive) prostate cancer. We investigated the effects of the addition of docetaxel to androgen-deprivation therapy (ADT) for patients with metastatic non-castrate prostate cancer. Methods In this randomised, open-label, phase 3 study, we enrolled patients in 29 centres in France and one in Belgium. Eligible patients were older than 18 years and had histologically confirmed adenocarcinoma of the prostate and radiologically proven metastatic disease; a Karnofsky score of at least 70%; a life expectancy of at least 3 months; and adequate hepatic, haematological, and renal function. They were randomly assigned to receive to ADT (orchiectomy or luteinising hormone-releasing hormone agonists, alone or combined with non-steroidal antiandrogens) alone or in combination with docetaxel (75 mg/m 2 intravenously on the first day of each 21-day cycle; up to nine cycles). Patients were randomised in a 1:1 ratio, with dynamic minimisation to minimise imbalances in previous systemic treatment with ADT, chemotherapy for local disease or isolated rising concentration of serum prostate-specific antigen, and Glass risk groups. Patients, physicians, and data analysts were not masked to treatment allocation. The primary endpoint was overall survival. Efficacy analyses were done by intention to treat. This trial is registered with ClinicalTrials.gov, number NCT00104715. Findings Between Oct 18, 2004, and Dec 31, 2008, 192 patients were randomly allocated to receive ADT plus docetaxel and 193 to receive ADT alone. Median follow-up was 50 months (IQR 39–63). Median overall survival was 58·9 months (95% CI 50·8–69·1) in the group given ADT plus docetaxel and 54·2 months (42·2–not reached) in that given ADT alone (hazard ratio 1·01, 95% CI 0·75–1·36). 72 serious adverse events were reported in the group given ADT plus docetaxel, of which the most frequent were neutropenia (40 [21%]), febrile neutropenia (six [3%]), abnormal liver function tests (three [2%]), and neutropenia with infection (two [1%]). Four treatment-related deaths occurred in the ADT plus docetaxel group (two of which were neutropenia-related), after which the data monitoring committee recommended treatment with granulocyte colony-stimulating factor. After this recommendation, no further treatment-related deaths occurred. No serious adverse events were reported in the ADT alone group. Interpretation Docetaxel should not be used as part of first-line treatment for patients with non-castrate metastatic prostate cancer. Funding French Health Ministry and Institut National du Cancer (PHRC), Sanofi-Aventis, AstraZeneca, and Amgen.read more
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Chemohormonal Therapy in Metastatic Hormone-Sensitive Prostate Cancer
Christopher Sweeney,Yu-Hui Chen,Michael A. Carducci,Glenn Liu,David F. Jarrard,Mario A. Eisenberger,Yu-Ning Wong,Noah M. Hahn,Manish Kohli,Matthew M. Cooney,Robert Dreicer,Nicholas J. Vogelzang,Joel Picus,Daniel H. Shevrin,Maha Hussain,Jorge A. Garcia,Robert S. DiPaola +16 more
TL;DR: Six cycles of docetaxel at the beginning of ADT for metastatic prostate cancer resulted in significantly longer overall survival than that with ADT alone.
Journal ArticleDOI
Addition of docetaxel, zoledronic acid, or both to first-line long-term hormone therapy in prostate cancer (STAMPEDE): survival results from an adaptive, multiarm, multistage, platform randomised controlled trial
Nicholas D. James,Nicholas D. James,Matthew R. Sydes,Noel W. Clarke,Malcolm David Mason,David P. Dearnaley,Melissa R. Spears,Alastair W. S. Ritchie,Chris Parker,J. Martin Russell,Gerhardt Attard,Johann S. de Bono,William Cross,Robert Jones,George N. Thalmann,Claire Amos,David Matheson,Robin Millman,Mymoona Alzouebi,Sharon Beesley,Alison Birtle,Susannah Brock,Richard Cathomas,Prabir Chakraborti,Simon Chowdhury,Audrey Cook,Tony Elliott,Joanna Gale,Stephanie Gibbs,John Graham,J. Hetherington,Robert Hughes,Robert W. Laing,Fiona McKinna,Duncan McLaren,Joe M. O'Sullivan,Omi Parikh,Clive Peedell,Andrew Protheroe,Angus Robinson,Narayanan Srihari,Rajaguru Srinivasan,John Staffurth,Santhanam Sundar,Shaun Tolan,David Tsang,John Wagstaff,Mahesh K.B. Parmar +47 more
TL;DR: Zoledronic acid showed no evidence of survival improvement and should not be part of standard of care for this population of men, and heterogeneity in treatment effect across prespecified subsets was not found.
Journal ArticleDOI
Abiraterone plus Prednisone in Metastatic, Castration-Sensitive Prostate Cancer.
Karim Fizazi,Nam Phuong Tran,Luis Fein,Nobuaki Matsubara,Alfredo Rodríguez-Antolín,Boris Alekseev,Mustafa Ozguroglu,Dingwei Ye,Susan Feyerabend,Andrew Protheroe,Peter De Porre,Thian Kheoh,Youn C. Park,Mary B. Todd,Kim N. Chi +14 more
TL;DR: The addition of abiraterone acetate and prednisone to androgen‐deprivation therapy significantly increased overall survival and radiographic progression‐free survival in men with newly diagnosed, metastatic, castration‐sensitive prostate cancer.
Journal ArticleDOI
EAU-ESTRO-SIOG Guidelines on Prostate Cancer. Part II: Treatment of Relapsing, Metastatic, and Castration-Resistant Prostate Cancer
Philip Cornford,Joaquim Bellmunt,Michel Bolla,Erik Briers,Maria De Santis,Tobias Gross,Ann Henry,Steven Joniau,Thomas B. Lam,Thomas B. Lam,Malcolm David Mason,Henk G. van der Poel,Theo H. van der Kwast,Olivier Rouvière,Thomas Wiegel,Nicolas Mottet +15 more
TL;DR: The 2016 EAU-ESTRO-SIOG Guidelines on PCa summarise the most recent findings and advice for use in clinical practice and reflect the multidisciplinary nature of PCa management.
Journal ArticleDOI
Abiraterone for Prostate Cancer Not Previously Treated with Hormone Therapy
Nicholas D. James,Johann S. de Bono,Melissa R. Spears,Noel W. Clarke,Malcolm David Mason,David P. Dearnaley,Alastair W. S. Ritchie,Claire Amos,Clare Gilson,Robert Jones,David Matheson,Robin Millman,Gerhardt Attard,Simon Chowdhury,William Cross,Silke Gillessen,Chris Parker,J. Martin Russell,Dominik Berthold,Chris Brawley,Fawzi Adab,San Aung,Alison Birtle,Jo Bowen,Susannah Brock,Prabir Chakraborti,C.L. Ferguson,Joanna Gale,Emma Gray,Mohan Hingorani,Peter Hoskin,Jason F. Lester,Zafar Malik,Fiona McKinna,Neil McPhail,Julian Money-Kyrle,Joe M. O'Sullivan,Omi Parikh,Andrew Protheroe,Angus Robinson,Narayanan Srihari,Carys Thomas,John Wagstaff,James D. Wylie,Anjali Zarkar,Mahesh K.B. Parmar,Matthew R. Sydes +46 more
TL;DR: Among men with locally advanced or metastatic prostate cancer, ADT plus abiraterone and prednisolone was associated with significantly higher rates of overall and failure‐free survival than ADT alone.
References
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New Guidelines to Evaluate the Response to Treatment in Solid Tumors
Patrick Therasse,Susan G. Arbuck,Elizabeth Eisenhauer,Jantien Wanders,Richard Kaplan,Larry Rubinstein,Jaap Verweij,Martine Van Glabbeke,Allan T. van Oosterom,Michaele C. Christian,S. Gwyther +10 more
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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.
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TL;DR: In this article, Chen et al. showed that a treatment effect that decreases with time can be directly visualized by smoothing an appropriate residual plot, which can be expressed as a weighted least-squares line fitted to the residual plot.
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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
TL;DR: 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.
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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.
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