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`ORIGINAL REPORTS Urologic Oncology
`Cabazitaxel Versus Docetaxel As First-
`Line Therapy for Patients With
`Metastatic Castration-Resistant
`Prostate Cancer: A Randomized
`Phase III Trial—FIRSTANA
`
`, Karim Fizazi, Lisa Sengeløv, Gedske
`Stéphane Oudard
`Daugaard, Fred Saad, Steinbjørn Hansen, Marie Hjälm-Eriksson,
`Jacek Jassem, Antoine Thiery-Vuillemin, Orazio Caffo, Daniel
`Castellano, Paul N. Mainwaring, John Bernard, Liji Shen,
`Mustapha Chadjaa, and Oliver Sartor
`
`Stéphane Oudard, Georges Pompidou European Hospital, Rene
`Descartes University; Mustapha Chadjaa; Sanofi, Paris; Karim
`Fizazi, Institut Gustave Roussy, University of Paris Sud, Villejuif;
`Antoine Thiery-Vuillemin, Centre Hospitalier Universitaire Minjoz
`Besançon, Besançon, France; Lisa Sengeløv, Herlev Hospital,
`Herlev; Gedske Daugaard, Copenhagen University Hospital,
`Rigshospitalet, Copenhagen; Steinbjørn Hansen, Odense
`University Hospital, Odense, Denmark; Fred Saad, Centre
`Hospitalier de l’Université de Montréal, Montréal, Quebec,
`Canada; Marie Hjälm-Eriksson, Karolinska University Hospital,
`Stockholm, Sweden; Jacek Jassem, Medical University of Gdansk,
`Gdansk, Poland; Orazio Caffo, Santa Chiara Hospital, Trento,
`Italy; Daniel Castellano, University Hospital 12 de Octubre,
`Madrid, Spain; Paul N. Mainwaring, Icon Cancer Care, Brisbane,
`Queensland, Australia; John Bernard, Sanofi, Cambridge, MA; Liji
`Shen, Sanofi, Bridgewater, NJ; and Oliver Sartor, Tulane Cancer
`Center, New Orleans, LA.
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`COMPANION
`ARTICLES
`
`No companion articles
`ARTICLE CITATION
`
`DOI:
`10.1200/JCO.2016.72.1068
`Journal of Clinical Oncology
`35, no. 28 (October 1 2017)
`3189-3197.
`
`PMID: 28753384
`
`WE RECOMMEND
`
`The Who, What, and How of
`Cabazitaxel Treatment in
`Metastatic Castration-
`Resistant Prostate Cancer
`Tian Zhang et al., J Clin Oncol
`
`Phase III Study Comparing a
`Reduced Dose of Cabazitaxel
`(20 mg/m2) and the Currently
`
`NEPTUNE GENERICS EX. 1047 00001
`
`

`

`Purpose
`In patients with metastatic castration-resistant
`prostate cancer (mCRPC), overall survival (OS) is
`significantly improved with cabazitaxel versus
`mitoxantrone after prior docetaxel treatment.
`FIRSTANA (ClinicalTrials.gov identifier: NCT01308567)
`assessed whether cabazitaxel 20 mg/m (C20) or 25
`2
`mg/m (C25) is superior to docetaxel 75 mg/m (D75)
`2
`2
`in terms of OS in patients with chemotherapy-naïve
`mCRPC.
`
`Patients and Methods
`Patients with mCRPC and Eastern Cooperative
`Oncology Group performance status of 0 to 2 were
`randomly assigned 1:1:1 to receive C20, C25, or D75
`intravenously every 3 weeks plus daily prednisone. The
`primary end point was OS. Secondary end points
`included safety; progression-free survival (PFS); tumor,
`prostate-specific antigen, and pain response;
`pharmacokinetics; and health-related quality of life.
`
`Results
`Between May 2011 and April 2013, 1,168 patients were
`randomly assigned. Baseline characteristics were
`similar across cohorts. Median OS was 24.5 months
`with C20, 25.2 months with C25, and 24.3 months with
`D75. Hazard ratio for C20 versus D75 was 1.01 (95% CI,
`0.85 to 1.20; P = .997), and hazard ratio for C25 versus
`D75 was 0.97 (95% CI, 0.82 to 1.16; P = .757). Median
`PFS was 4.4 months with C20, 5.1 months with C25,
`and 5.3 months with D75, with no significant
`differences between treatment arms. Radiographic
`tumor responses were numerically higher for C25
`(41.6%) versus D75 (30.9%; nominal P = .037, without
`multiplicity test adjustment). Rates of grade 3 or 4
`treatment-emergent adverse events were 41.2%,
`60.1%, and 46.0% for C20, C25, and D75, respectively.
`Febrile neutropenia, diarrhea, and hematuria were
`more frequent with C25; peripheral neuropathy,
`peripheral edema, alopecia, and nail disorders were
`more frequent with D75.
`
`Conclusion
`C20 and C25 did not demonstrate superiority for OS
`versus D75 in patients with chemotherapy-naïve
`mCRPC. Tumor response was numerically higher with
`C25 versus D75; pain PFS was numerically improved
`with D75 versus C25. Cabazitaxel and docetaxel
`demonstrated different toxicity profiles, with overall
`less toxicity with C20.
`
`Approved Dose (25 mg/m2) in
`Postdocetaxel Patients With
`Metastatic Castration-
`Resistant Prostate Cancer—
`PROSELICA
`Mario Eisenberger et al., J Clin
`Oncol
`
`Randomized, Double-Blind,
`Placebo-Controlled Phase III
`Trial Comparing Docetaxel and
`Prednisone With or Without
`Bevacizumab in Men With
`Metastatic Castration-
`Resistant Prostate Cancer:
`CALGB 90401
`William Kevin Kelly et al., J Clin
`Oncol
`
`First-Line Cabazitaxel vs
`Docetaxel in Metastatic
`Castration-Resistant Prostate
`Cancer
`By Matthew Stenger, The
`ASCO Post
`
`Prediction of favorable
`outcome in a docetaxel
`rechallenge setting in
`metastatic castration-resistant
`prostate cancer.
`Matthias Michael Heck et al., J
`Clin Oncol
`
`Pain Management for
`Advanced Breast Cancer
`WebMD
`
`Are Your Medications Causing
`Uncontrolled Movements?
`WebMD
`
`Targeting androgen receptor
`and DNA repair in metastatic
`castration-resistant prostate
`cancer: Results from NCI 9012
`
`Journal of Clinical Oncology
`
`Copanlisib, low-dose
`cabazitaxel receive FDA go
`ahead
`Medicine Matters oncology
`
`Ramucirumab plus docetaxel
`prolongs PFS in advanced
`urothelial cancers
`Medicine Matters oncology
`
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