title: Phase II trial of non-pegylated liposomal doxorubicin and low-dose prednisone in second-line chemotherapy for hormone-refractory prostate cancer.
abstract: OBJECTIVE
  Non-pegylated liposomal doxorubicin (NPLD) (Myocet) has shown marked in vitro activity in castration-resistant prostate cancer (CRPC) and also in docetaxel-resistant cells, higher than that shown by pegylated liposomal doxorubicin. Its activity would seem to be due to a high intracellular drug concentration and induction of Golgi-dependent apoptosis. On the basis of these results, a clinical study was designed to assess the activity of NPLD and low-dose prednisone in second-line therapy.
  
  
  METHODS
  Fifty-four patients were enrolled and evaluated. Eligibility criteria were histologically confirmed CRPC, PSA >20 ng/mL or measurable lesions according to the RECIST criteria, previous docetaxel-based chemotherapy, and adequate cardiac function. Patients were treated with weekly intravenous NPLD 25 mg/m2 and daily prednisone 10 mg until progression.
  
  
  RESULTS
  Median patient age was 69 years (range, 52-83) and median baseline PSA concentration was 120 ng/mL (range, 5.35-4350). Sixteen (29.6%) patients had measurable lesions. Objective or PSA responses (>50% reduction) were observed in 8 (14.8%) patients. The median time to progression was 2.8 months and the median overall survival was 11.3 months. Toxicity was generally mild (grade 1-2) and infrequent, with grade 3-4 neutropenia in 12.9% of cases. Grade 3 nonhematological toxicities included nausea in 2 patients (3.7%) and fatigue and stomatitis in 1 case (1.9%). No drug-related serious adverse events were reported.
  
  
  CONCLUSIONS
  Weekly administration of NPLD is a well tolerated treatment with proven albeit limited activity.
authors: Oncology Unit, Santa Maria delle Croci Hospital, Viale Randi 5, Ravenna, Italy. marcomontanarimail@libero.it
authors: Marco
authors: M
authors: Montanari
authors: Francesco
authors: F
authors: Fabbri
authors: Ermanno
authors: E
authors: Rondini
authors: Giovanni Luca
authors: GL
authors: Frassineti
authors: Rodolfo
authors: R
authors: Mattioli
authors: Silvia
authors: S
authors: Carloni
authors: Emanuela
authors: E
authors: Scarpi
authors: Wainer
authors: W
authors: Zoli
authors: Dino
authors: D
authors: Amadori
authors: Giorgio
authors: G
authors: Cruciani
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000903:Antibiotics, Antineoplastic / Q000008:administration & dosage / Q000009:adverse effects; D018931:Antineoplastic Agents, Hormonal / Q000008:administration & dosage / Q000009:adverse effects; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D014408:Biomarkers, Tumor / Q000097:blood*; D002277:Carcinoma / Q000097:blood / Q000188:drug therapy* / Q000556:secondary; D004317:Doxorubicin / Q000008:administration & dosage / Q000009:adverse effects; D004334:Drug Administration Schedule; D006801:Humans; D008081:Liposomes; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D009919:Orchiectomy; D011241:Prednisone / Q000008:administration & dosage / Q000009:adverse effects; D017430:Prostate-Specific Antigen / Q000097:blood*; D011471:Prostatic Neoplasms / Q000097:blood / Q000188:drug therapy* / Q000473:pathology; D013739:Testosterone / Q000097:blood*; D016896:Treatment Outcome
chemical_list: D000903:Antibiotics, Antineoplastic; D018931:Antineoplastic Agents, Hormonal; D014408:Biomarkers, Tumor; D008081:Liposomes; D013739:Testosterone; D004317:Doxorubicin; D017430:Prostate-Specific Antigen; D011241:Prednisone