title: Monthly paclitaxel and carboplatin with oral estramustine phosphate in patients with hormone-refractory prostate cancer.
abstract: BACKGROUND
  We aimed to determine the safety and efficacy of monthly paclitaxel and carboplatin with oral estramustine phosphate in patients with hormone-refractory prostate cancer (HRPC).
  
  
  METHODS
  Patients with prostate cancer that was progressing despite androgen ablation therapy were treated with i.v. paclitaxel, 175 mg/m2, over 3 h, followed by carboplatin (area under the curve, 5) on day 1, with oral estramustine phosphate, 280 mg twice daily, for a 28-day treatment cycle. Estramustine phosphate was precluded in those patients who had experienced adverse effects during prior chemotherapies. Patients were evaluated for response every cycle, and the treatment was continued until the cancer progressed.
  
  
  RESULTS
  Twenty-one patients with progressive hormone-refractory disease were treated for a median of 4 cycles (range, 1 to 11 cycles). Estramustine phosphate was precluded in seven patients. Post-therapy decreases in serum prostate-specific antigen levels of 50% and 75%, respectively, were seen in 43% and 19% of the patients (95% confidence intervals, 22% to 64% and 2% to 36%). Of the nine patients with measurable disease, 1 (11%) had a complete response and 2 (22%) had a partial response. The overall median time to progression was 4 months, and the median survival time for all patients was 11 months. Major grade 3 or 4 adverse effects were anemia (29%), neutropenia (48%), and thrombocytopenia (24%). Mild peripheral neuropathy and myalgia/arthralgia were observed in 11 (52%) and 9 (43%) patients, respectively.
  
  
  CONCLUSIONS
  Monthly paclitaxel and carboplatin with oral estramustine phosphate has significant antitumor activity and is well tolerated in patients with progressive HRPC.
authors.affiliation: Department of Urology, Graduate School of Medicine, Kyoto University, 54 Shogoin-Kawaharacho, Kyoto 606-8507, Japan.
authors.forename: Takehiko
authors.initials: T
authors.lastname: Segawa
authors.forename: Toshiyuki
authors.initials: T
authors.lastname: Kamoto
authors.forename: Hidefumi
authors.initials: H
authors.lastname: Kinoshita
authors.forename: Yasuharu
authors.initials: Y
authors.lastname: Kunishima
authors.forename: Koji
authors.initials: K
authors.lastname: Yoshimura
authors.forename: Akihiro
authors.initials: A
authors.lastname: Ito
authors.forename: Takeshi
authors.initials: T
authors.lastname: Takahashi
authors.forename: Shin
authors.initials: S
authors.lastname: Higashi
authors.forename: Eijiro
authors.initials: E
authors.lastname: Nakamura
authors.forename: Hirofumi
authors.initials: H
authors.lastname: Nishiyama
authors.forename: Noriyuki
authors.initials: N
authors.lastname: Ito
authors.forename: Shingo
authors.initials: S
authors.lastname: Yamamoto
authors.forename: Tomonori
authors.initials: T
authors.lastname: Habuchi
authors.forename: Osamu
authors.initials: O
authors.lastname: Ogawa
mesh_terms: D000284:Administration, Oral; D000368:Aged; D018931:Antineoplastic Agents, Hormonal / Q000008:administration & dosage / Q000009:adverse effects; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D016190:Carboplatin / Q000008:administration & dosage / Q000009:adverse effects; D004334:Drug Administration Schedule; D004961:Estramustine / Q000008:administration & dosage / Q000009:adverse effects; D006801:Humans; D007262:Infusions, Intravenous; D008297:Male; D008875:Middle Aged; D017239:Paclitaxel / Q000008:administration & dosage / Q000009:adverse effects; D011471:Prostatic Neoplasms / Q000188:drug therapy* / Q000401:mortality; D015996:Survival Rate
chemical_list: D018931:Antineoplastic Agents, Hormonal; D004961:Estramustine; D016190:Carboplatin; D017239:Paclitaxel