Phase II Trial of Neoadjuvant Nab-Paclitaxel in High Risk Patients With Prostate Cancer Undergoing Radical Prostatectomy
2009; Lippincott Williams & Wilkins; Volume: 181; Issue: 4 Linguagem: Inglês
10.1016/j.juro.2008.11.121
ISSN1527-3792
AutoresDale R. Shepard, Robert Dreicer, J. Garcia, Paul Elson, Cristina Magi‐Galluzzi, Derek Raghavan, Andrew J. Stephenson, Eric A. Klein,
Tópico(s)Cancer, Lipids, and Metabolism
ResumoNo AccessJournal of UrologyAdult Urology1 Apr 2009Phase II Trial of Neoadjuvant Nab-Paclitaxel in High Risk Patients With Prostate Cancer Undergoing Radical Prostatectomy D.R. Shepard, R. Dreicer, J. Garcia, P. Elson, C. Magi-Galluzzi, D. Raghavan, A.J. Stephenson, and E.A. Klein D.R. ShepardD.R. Shepard Taussig Cancer Institute, Cleveland Clinic, Cleveland, Ohio , R. DreicerR. Dreicer Taussig Cancer Institute, Cleveland Clinic, Cleveland, Ohio Glickman Urologic and Kidney Institute, Cleveland Clinic, Cleveland, Ohio , J. GarciaJ. Garcia Taussig Cancer Institute, Cleveland Clinic, Cleveland, Ohio Glickman Urologic and Kidney Institute, Cleveland Clinic, Cleveland, Ohio , P. ElsonP. Elson Taussig Cancer Institute, Cleveland Clinic, Cleveland, Ohio , C. Magi-GalluzziC. Magi-Galluzzi Department of Anatomic Pathology, Cleveland Clinic, Cleveland, Ohio , D. RaghavanD. Raghavan Taussig Cancer Institute, Cleveland Clinic, Cleveland, Ohio Glickman Urologic and Kidney Institute, Cleveland Clinic, Cleveland, Ohio , A.J. StephensonA.J. Stephenson Glickman Urologic and Kidney Institute, Cleveland Clinic, Cleveland, Ohio , and E.A. KleinE.A. Klein Taussig Cancer Institute, Cleveland Clinic, Cleveland, Ohio Glickman Urologic and Kidney Institute, Cleveland Clinic, Cleveland, Ohio View All Author Informationhttps://doi.org/10.1016/j.juro.2008.11.121AboutFull TextPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract Purpose: 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. Materials and 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/m2 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. 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Google Scholar © 2009 by American Urological AssociationFiguresReferencesRelatedDetails Volume 181Issue 4April 2009Page: 1672-1677 Advertisement Copyright & Permissions© 2009 by American Urological AssociationKeywordsprostatic neoplasmsprostatectomyneoadjuvant therapy130-nm albumin-bound paclitaxelMetricsAuthor Information D.R. Shepard Taussig Cancer Institute, Cleveland Clinic, Cleveland, Ohio More articles by this author R. Dreicer Taussig Cancer Institute, Cleveland Clinic, Cleveland, Ohio Glickman Urologic and Kidney Institute, Cleveland Clinic, Cleveland, Ohio Financial interest and/or other relationship with Sanofi Aventis and Lilly. More articles by this author J. Garcia Taussig Cancer Institute, Cleveland Clinic, Cleveland, Ohio Glickman Urologic and Kidney Institute, Cleveland Clinic, Cleveland, Ohio More articles by this author P. Elson Taussig Cancer Institute, Cleveland Clinic, Cleveland, Ohio More articles by this author C. Magi-Galluzzi Department of Anatomic Pathology, Cleveland Clinic, Cleveland, Ohio More articles by this author D. Raghavan Taussig Cancer Institute, Cleveland Clinic, Cleveland, Ohio Glickman Urologic and Kidney Institute, Cleveland Clinic, Cleveland, Ohio More articles by this author A.J. Stephenson Glickman Urologic and Kidney Institute, Cleveland Clinic, Cleveland, Ohio More articles by this author E.A. Klein Taussig Cancer Institute, Cleveland Clinic, Cleveland, Ohio Glickman Urologic and Kidney Institute, Cleveland Clinic, Cleveland, Ohio More articles by this author Expand All Advertisement PDF downloadLoading ...
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