title: A randomised dose-finding phase II study on ifosfamide in metastatic hormone-refractory prostate cancer (HRPC).
abstract: The palliative efficacy and toxicity of single-ifosfamide chemotherapy were investigated in patients with progressive metastatic hormone-refractory prostate cancer (HRPC). Thirty patients were randomised to receive ifosfamide by a 24-hour infusion on day 1 or a 3-hour infusion on days 1-4 at three week intervals until renewed disease progression or a total of six chemotherapy cycles. Response was analyzed according to the guidelines of the Prostate-Specific Antigen Working Group (1999). All 30 patients were included in the final analysis. 1 (3%) PSA normalization, 8 (27%) partial responses, 3 (10%) stabile diseases and 18 (60%) progressive diseases. The mean time to progression was 2.4 months, (range 0 -17) months and the median survival time was 13.6+ months, (range 2 -52). The treatment was well tolerated. No severe gr III-IV hematotoxicities were observed. In conclusion ifosfamide is effective and well tolerated as a single-agent in the treatment of HRPC. Further studies including ifosfamide in combination chemotherapy of HRPC are in progress.
authors.affiliation: Dept of Oncology, Tampere University Hospital and Medical School, University of Tampere, Finland. petteri.hervonen@pshp.fi
authors.forename: P
authors.initials: P
authors.lastname: Hervonen
authors.forename: T
authors.initials: T
authors.lastname: Lehtinen
authors.forename: T L
authors.initials: TL
authors.lastname: Tammela
authors.forename: P
authors.initials: P
authors.lastname: Kellokumpu-Lehtinen
mesh_terms: D000230:Adenocarcinoma / Q000188:drug therapy* / Q000556:secondary; D000368:Aged; D018906:Antineoplastic Agents, Alkylating / Q000008:administration & dosage* / Q000627:therapeutic use; D001859:Bone Neoplasms / Q000188:drug therapy* / Q000556:secondary; D018450:Disease Progression; D004305:Dose-Response Relationship, Drug; D006801:Humans; D007069:Ifosfamide / Q000008:administration & dosage* / Q000627:therapeutic use; D007262:Infusions, Intravenous; D008297:Male; D008875:Middle Aged; D017430:Prostate-Specific Antigen / Q000097:blood; D011471:Prostatic Neoplasms / Q000188:drug therapy* / Q000473:pathology; D012449:Safety; D015996:Survival Rate
chemical_list: D018906:Antineoplastic Agents, Alkylating; D017430:Prostate-Specific Antigen; D007069:Ifosfamide