title: Phase II trial of neoadjuvant nab-paclitaxel in high risk patients with prostate cancer undergoing radical prostatectomy.
abstract: OBJECTIVE
  Taxane based chemotherapy has activity in advanced prostate cancer but previous studies of neoadjuvant docetaxel demonstrated a prostate specific antigen response with no obvious antitumor activity. The efficacy and safety of neoadjuvant albumin-bound paclitaxel (nab-paclitaxel, Abraxane), a novel nanoparticle based formulation, were assessed in patients with high risk, locally advanced prostate cancer.
  
  
  METHODS
  Eligible patients had locally advanced prostatic adenocarcinoma, clinical stage cT2b or greater, Gleason score 8 or greater, or serum prostate specific antigen 15 ng/ml or greater without metastatic disease. Patients received 2 cycles of 150 mg/m(2) nab-paclitaxel weekly for 3 weeks during each 4-week cycle, followed by radical prostatectomy with bilateral lymphadenectomy. Efficacy assessments included pathological and prostate specific antigen response.
  
  
  RESULTS
  A total of 19 patients completed neoadjuvant therapy and 18 underwent radical prostatectomy. Median pretreatment prostate specific antigen was 8.5 ng/ml and median Gleason score was 8. Despite the lack of complete pathological responses 5 of 18 patients (28%) had organ confined disease and 9 of 18 (50%) had specimen confined disease. Post-chemotherapy prostate specific antigen was decreased in 18 of 19 (95%) patients and median decrease was 2.9 ng/ml (35%, p <0.001). An initial prostate specific antigen after radical prostatectomy of 0.02 ng/ml or less was achieved in 17 of 18 (94%) patients. There were no significant perioperative complications. Cytoplasmic vacuolization (focal in 10 and extensive in 7) was evident in all but 1 patient (94%). Ten patients (56%) had grade 3 and 1 had grade 4 neutropenia with no febrile neutropenia.
  
  
  CONCLUSIONS
  Neoadjuvant nab-paclitaxel was well tolerated. Similar to our experience with neoadjuvant docetaxel there were no pathological complete responses, although a possible histological antitumor effect was observed.
authors.affiliation: Taussig Cancer Institute, Cleveland Clinic, Cleveland, Ohio, USA.
authors.forename: D R
authors.initials: DR
authors.lastname: Shepard
authors.forename: R
authors.initials: R
authors.lastname: Dreicer
authors.forename: J
authors.initials: J
authors.lastname: Garcia
authors.forename: P
authors.initials: P
authors.lastname: Elson
authors.forename: C
authors.initials: C
authors.lastname: Magi-Galluzzi
authors.forename: D
authors.initials: D
authors.lastname: Raghavan
authors.forename: A J
authors.initials: AJ
authors.lastname: Stephenson
authors.forename: E A
authors.initials: EA
authors.lastname: Klein
mesh_terms: D000230:Adenocarcinoma / Q000188:drug therapy* / Q000601:surgery*; D000368:Aged; D000418:Albumins / Q000627:therapeutic use*; D006801:Humans; D008297:Male; D008875:Middle Aged; D020360:Neoadjuvant Therapy; D017239:Paclitaxel / Q000627:therapeutic use*; D011468:Prostatectomy; D011471:Prostatic Neoplasms / Q000188:drug therapy* / Q000601:surgery*; D012307:Risk Factors
chemical_list: C520255:130-nm albumin-bound paclitaxel; D000418:Albumins; D017239:Paclitaxel