title: The efficacy and safety of docetaxel-based chemotherapy combined with dexamethasone 1 mg daily oral administration: JMTO Pca 10-01 phase II trial.
abstract: OBJECTIVE
  Previously, one randomized control trial (TAX327) revealed the efficacy of docetaxel-based chemotherapy combined with prednisone. On the other hand, several studies showed a high prostate specific antigen (PSA) response with low-dose dexamethasone in castration-resistant prostate cancer (CRPC) patients. The objective of this study was to evaluate the efficacy and safety of docetaxel-based chemotherapy combined with dexamethasone in CRPC patients.
  
  
  METHODS
  This study was a single-arm multi-institutional phase II trial. Patients received 75 mg/m2 of docetaxel, and 0.5 mg of dexamethasone orally twice a day continuing throughout the treatment period. Treatment was planned for 10 cycles, and continued for at least four cycles depending on the observation of PSA flare. The primary endpoint was PSA response defined as a reduction from baseline of at least 50% that continued for at least 3 weeks. Secondary endpoints were safety, PSA flare, time to PSA failure and adherence rate to protocol treatment (10 cycles).
  
  
  RESULTS
  Between January 2011 and February 2014, a total of 76 chemotherapy-naïve CRPC patients were enrolled. Seventy-five patients received docetaxel-based chemotherapy combined with dexamethasone. The median age and PSA level at enrollment were 71 years (53-85) and 23.2 ng/mL (2.9-852), respectively. PSA response rate was 76.8% (90% confidence interval (CI): 66.9-84.9). Of all patients, 30 patients completed 10 cycles of chemotherapy (40%). The incidence rate of PSA flare was 10.7% (eight patients). The median time to PSA failure was 369 days (95% CI: 245-369). The most frequently observed adverse event was hematotoxicity (neutropenia of G2 or greater: 100%).
  
  
  CONCLUSIONS
  The present study showed a significantly high PSA response compared with previous reports. Most patients tolerated the protocol treatment well, whereas hematotoxicity was often observed.
authors.affiliation: Nara Medical University, Department of Urology , Kashihara.
authors.forename: Nobumichi
authors.initials: N
authors.lastname: Tanaka
authors.affiliation: Osaka Medical Center for Cancer and Cardiovascular Diseases, Department of Urology, Osaka.
authors.forename: Kazuo
authors.initials: K
authors.lastname: Nishimura
authors.affiliation: Nara City Hospital, Department of Urology , Nara.
authors.forename: Eijiro
authors.initials: E
authors.lastname: Okajima
authors.affiliation: Nagoya Memorial Hospital, Department of Chemotherapy , Nagoya.
authors.forename: Kenji
authors.initials: K
authors.lastname: Ina
authors.affiliation: Kyoto University, Department of Urology , Kyoto.
authors.forename: Osamu
authors.initials: O
authors.lastname: Ogawa
authors.affiliation: Keio University, Department of Urology , Tokyo.
authors.forename: Hirohiko
authors.initials: H
authors.lastname: Nagata
authors.affiliation: JCHO Tokyo Shinjuku Medical Center, Department of Urology , Tokyo.
authors.forename: Koichiro
authors.initials: K
authors.lastname: Akakura
authors.affiliation: Nara Medical University, Department of Urology , Kashihara.
authors.forename: Kiyohide
authors.initials: K
authors.lastname: Fujimoto
authors.affiliation: Nagoya University, Department of Urology, Nagoya.
authors.forename: Momokazu
authors.initials: M
authors.lastname: Gotoh
authors.affiliation: Kyoto Prefectural University of Medicine, Department of Biostatistics, Kyoto.
authors.forename: Satoshi
authors.initials: S
authors.lastname: Teramukai
authors.affiliation: Nara Medical University, Department of Urology, Kashihara.|Osaka Gyoumeikan Hospital, Department of Urology, Osaka, Japan.
authors.forename: Yoshihiko
authors.initials: Y
authors.lastname: Hirao
mesh_terms: D000284:Administration, Oral; D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D003907:Dexamethasone / Q000494:pharmacology / Q000627:therapeutic use*; D000077143:Docetaxel; D006801:Humans; D008297:Male; D008875:Middle Aged; D017430:Prostate-Specific Antigen / Q000378:metabolism*; D064129:Prostatic Neoplasms, Castration-Resistant / Q000188:drug therapy* / Q000473:pathology; D043823:Taxoids / Q000008:administration & dosage / Q000494:pharmacology / Q000627:therapeutic use*; D016896:Treatment Outcome
chemical_list: D043823:Taxoids; D000077143:Docetaxel; D003907:Dexamethasone; D017430:Prostate-Specific Antigen
keywords: castration-resistant prostate cancer; chemotherapy; dexamethasone; docetaxel