title: Long-term follow-up of a phase II trial of chemotherapy plus hormone therapy for biochemical relapse after definitive local therapy for prostate cancer.
abstract: OBJECTIVE
  To evaluate long-term follow-up of a phase II trial of chemohormonal therapy in 62 men with prostate cancer biochemical relapse (BR).
  
  
  METHODS
  Treatment was 4 cycles of docetaxel (70 mg/m(2)) every 3 weeks and estramustine 280 mg three times a day (days 1-5) followed by 15 months of goserelin acetate/bicalutamide. The primary endpoint was the proportion with prostate-specific antigen (PSA) <0.1 with recovered testosterone 5 years after completion of therapy. Secondary endpoints included time to progression (TTP), time to reinitiate androgen deprivation therapy (ADT), the proportion with castration-resistant prostate cancer (CRPC), and overall survival (OS).
  
  
  RESULTS
  Median follow-up was 8.6 years (range 1.3-11.1 years). At 5 year follow-up, 7 patients (11%) had PSA <0.1 (5 undetectable); 8 (13%) had PSA >0.1 but without reinitiation of ADT (median PSA 0.37). Of the 15 (24%) men without reinitiation of ADT, and 14 have recovered testosterone to normal range. Median TTP for the complete cohort was 35.0 months (95% confidence interval [CI] 31.7-39.2). Baseline PSA <3.0 ng/dL, no prior ADT, and prostatectomy (vs radiation) were associated with longer TTP (P = .0001, P = .0055, and P = .0398, respectively). At the time of analysis, 42 men (68%) had restarted ADT, 23 men had CRPC (37%), and 11 (18%) had chemotherapy. Median time to reinitiation of ADT was 32.6 months (range 0-107.6 months). Median OS has not been reached; there were 15 deaths.
  
  
  CONCLUSIONS
  Chemotherapy plus ADT for BR resulted in durable (>5 years) complete responses (<0.1 ng/mL) in 7 men (11%). Twenty-four percent of men have not re-initiated ADT 5 years from completion of protocol therapy.
authors: Division of Medical Oncology, Department of Medicine, Lank Center for Genitourinary Oncology, Boston, MA 02215, USA.
authors: Mari
authors: M
authors: Nakabayashi
authors: Wanling
authors: W
authors: Xie
authors: Geoffrey
authors: G
authors: Buckle
authors: Glenn
authors: G
authors: Bubley
authors: Marc S
authors: MS
authors: Ernstoff
authors: William
authors: W
authors: Walsh
authors: Daniel E
authors: DE
authors: Morganstern
authors: Philip W
authors: PW
authors: Kantoff
authors: Mary-Ellen
authors: ME
authors: Taplin
mesh_terms: D000368:Aged; D000726:Androgen Antagonists / Q000627:therapeutic use*; D000813:Anilides / Q000627:therapeutic use*; D000970:Antineoplastic Agents / Q000008:administration & dosage*; D018931:Antineoplastic Agents, Hormonal / Q000008:administration & dosage; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D000077143:Docetaxel; D004359:Drug Therapy, Combination; D004961:Estramustine / Q000008:administration & dosage*; D005500:Follow-Up Studies; D017273:Goserelin / Q000008:administration & dosage*; D006801:Humans; D008297:Male; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000188:drug therapy*; D009570:Nitriles / Q000627:therapeutic use*; D011471:Prostatic Neoplasms / Q000188:drug therapy*; D012189:Retrospective Studies; D043823:Taxoids / Q000008:administration & dosage*; D013997:Time Factors; D014105:Tosyl Compounds / Q000627:therapeutic use*; D016896:Treatment Outcome
chemical_list: D000726:Androgen Antagonists; D000813:Anilides; D000970:Antineoplastic Agents; D018931:Antineoplastic Agents, Hormonal; D009570:Nitriles; D043823:Taxoids; D014105:Tosyl Compounds; D017273:Goserelin; D000077143:Docetaxel; D004961:Estramustine; C053541:bicalutamide