title: Comparative effectiveness of mitoxantrone plus prednisone versus prednisone alone in metastatic castrate-resistant prostate cancer after docetaxel failure.
abstract: BACKGROUND
  Mitoxantrone was approved for use in metastatic castrate-resistant prostate cancer (mCRPC) based on pain palliation without observed survival benefit in a small phase III trial in 1996. To re-evaluate for possible survival benefits in a larger contemporary sample and to demonstrate analytic uses of the newly available Project Data Sphere online resource, we used data from control arms of completed clinical trials to compare survival and toxicity among patients with postdocetaxel mCRPC treated with mitoxantrone and prednisone.
  
  
  METHODS
  Control arm data from two phase III randomized control trials, SUN 1120 and TROPIC, were used to examine the efficacy of mitoxantrone plus prednisone (n = 305) versus prednisone alone (n = 257) among patients with postdocetaxel mCRPC. Propensity score matching was used to balance patient characteristics between the separate trials, conditioned on age and key prognostic variables of survival. The primary outcome was overall survival. Secondary endpoints evaluated safety.
  
  
  RESULTS
  Median survival was similar among patients receiving mitoxantrone plus prednisone versus prednisone alone (385 days vs. 336 days; deceleration factor = 0.04; 95% confidence interval: -0.12 to 0.22). Prevalence of several any-grade toxicity, including fatigue, back pain, and peripheral neuropathy, was increased among patients who received mitoxantrone.
  
  
  CONCLUSIONS
  There was no significant survival benefit for mitoxantrone plus prednisone over prednisone alone among men with mCRPC after docetaxel therapy. This finding is consistent with prior studies showing no survival advantage with mitoxantrone in the predocetaxel setting. Furthermore, our data suggest that mitoxantrone may be associated with increased toxicity compared with prednisone alone.
authors.affiliation: UNC Lineberger Comprehensive Cancer Center, Division of Hematology and Oncology, School of Medicine, Division of Pharmaceutical Outcomes and Policy, Eshelman School of Pharmacy, and Department of Health Policy and Management, Gillings School of Global Public Health, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA Angela.Green@unchealth.unc.edu.
authors.forename: Angela K
authors.initials: AK
authors.lastname: Green
authors.affiliation: UNC Lineberger Comprehensive Cancer Center, Division of Hematology and Oncology, School of Medicine, Division of Pharmaceutical Outcomes and Policy, Eshelman School of Pharmacy, and Department of Health Policy and Management, Gillings School of Global Public Health, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA.
authors.forename: Robert W
authors.initials: RW
authors.lastname: Corty
authors.affiliation: UNC Lineberger Comprehensive Cancer Center, Division of Hematology and Oncology, School of Medicine, Division of Pharmaceutical Outcomes and Policy, Eshelman School of Pharmacy, and Department of Health Policy and Management, Gillings School of Global Public Health, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA.
authors.forename: William A
authors.initials: WA
authors.lastname: Wood
authors.affiliation: UNC Lineberger Comprehensive Cancer Center, Division of Hematology and Oncology, School of Medicine, Division of Pharmaceutical Outcomes and Policy, Eshelman School of Pharmacy, and Department of Health Policy and Management, Gillings School of Global Public Health, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA.
authors.forename: Mathew
authors.initials: M
authors.lastname: Meeneghan
authors.affiliation: UNC Lineberger Comprehensive Cancer Center, Division of Hematology and Oncology, School of Medicine, Division of Pharmaceutical Outcomes and Policy, Eshelman School of Pharmacy, and Department of Health Policy and Management, Gillings School of Global Public Health, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA.
authors.forename: Katherine E
authors.initials: KE
authors.lastname: Reeder-Hayes
authors.affiliation: UNC Lineberger Comprehensive Cancer Center, Division of Hematology and Oncology, School of Medicine, Division of Pharmaceutical Outcomes and Policy, Eshelman School of Pharmacy, and Department of Health Policy and Management, Gillings School of Global Public Health, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA.
authors.forename: Ethan
authors.initials: E
authors.lastname: Basch
authors.affiliation: UNC Lineberger Comprehensive Cancer Center, Division of Hematology and Oncology, School of Medicine, Division of Pharmaceutical Outcomes and Policy, Eshelman School of Pharmacy, and Department of Health Policy and Management, Gillings School of Global Public Health, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA.
authors.forename: Matthew I
authors.initials: MI
authors.lastname: Milowsky
authors.affiliation: UNC Lineberger Comprehensive Cancer Center, Division of Hematology and Oncology, School of Medicine, Division of Pharmaceutical Outcomes and Policy, Eshelman School of Pharmacy, and Department of Health Policy and Management, Gillings School of Global Public Health, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA.
authors.forename: Stacie B
authors.initials: SB
authors.lastname: Dusetzina
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage* / Q000009:adverse effects; D000077143:Docetaxel; D019008:Drug Resistance, Neoplasm; D064420:Drug-Related Side Effects and Adverse Reactions / Q000473:pathology; D006801:Humans; D008297:Male; D008875:Middle Aged; D008942:Mitoxantrone / Q000008:administration & dosage* / Q000009:adverse effects; D011241:Prednisone / Q000008:administration & dosage* / Q000009:adverse effects; D064129:Prostatic Neoplasms, Castration-Resistant / Q000188:drug therapy* / Q000473:pathology; D016019:Survival Analysis; D043823:Taxoids / Q000008:administration & dosage
chemical_list: D043823:Taxoids; D000077143:Docetaxel; D008942:Mitoxantrone; D011241:Prednisone
keywords: Comparative effectiveness research; Mitoxantrone; Postdocetaxel; Project Data Sphere; Prostate cancer