title: Phase II trial of intraperitoneal cisplatin and mitoxantrone in patients with persistent ovarian cancer.
abstract: OBJECTIVE
  The aim of this study was to determine the feasibility and efficacy of intraperitoneal cisplatin and mitoxantrone in patients with very small-volume residual disease at second-look surgery after completion of primary platinum-based intravenous chemotherapy.
  
  
  METHODS
  Between February 1992 and February 1994, 42 patients were treated with up to five cycles of intraperitoneal cisplatin (100 mg/m2)/mitoxantrone (10 mg/m2). Patients were evaluated for surgically defined response rate and followed for progression-free (PFS) and overall survival (OS) using an intention-to-treat analysis, and grouped according to disease volume at initiation of treatment.
  
  
  RESULTS
  The mean age of all patients was 48.5 years. Thirty patients (71%) were Stage III at diagnosis; 18 patients (43%) had microscopic disease at the initiation of IP therapy, and 24 patients (57%) had macroscopic disease. Twenty-eight patients completed three or more cycles of protocol therapy, and 14 patients were changed to standard intravenous therapy after receiving fewer than three cycles of treatment secondary to catheter-related problems (12 patients), cisplatin ototoxicity (1 patient), or withdrawal from study (1 patient). Using an intention-to-treat analysis, the median PFS was 22.5 months, and the median OS of all patients (N = 42) was 47 months (6-72 months) with a median follow-up of 62.7 months. When grouped according to size of disease at initiation of treatment, the OS has not been reached at 62.7 months of follow-up in patients (N = 18) with microscopic disease.
  
  
  CONCLUSIONS
  (1) The combination of IP mitoxantrone and cisplatin has an unacceptable catheter failure rate due to mitoxantrone toxicity; (2) PFS and OS is longer in patients with microscopic rather than macroscopic residual disease; and (3) intraperitoneal platinum-based chemotherapy in patients with very small-volume residual disease may result in improved survival.
authors: Department of Surgery, Memorial Sloan-Kettering Cancer Center, New York, New York, 10021, USA.
authors: A
authors: A
authors: Husain
authors: P
authors: P
authors: Sabbatini
authors: D
authors: D
authors: Spriggs
authors: D
authors: D
authors: Fennelly
authors: C
authors: C
authors: Aghajanian
authors: R
authors: R
authors: Barakat
authors: J
authors: J
authors: Curtin
authors: E
authors: E
authors: Venkatraman
authors: W
authors: W
authors: Hoskins
authors: M
authors: M
authors: Markman
mesh_terms: D000328:Adult; D000368:Aged; D000970:Antineoplastic Agents / Q000008:administration & dosage; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D002945:Cisplatin / Q000008:administration & dosage; D018450:Disease Progression; D005240:Feasibility Studies; D005260:Female; D006801:Humans; D007263:Infusions, Parenteral; D008875:Middle Aged; D008942:Mitoxantrone / Q000008:administration & dosage; D009364:Neoplasm Recurrence, Local / Q000188:drug therapy; D010051:Ovarian Neoplasms / Q000188:drug therapy* / Q000401:mortality; D015996:Survival Rate
chemical_list: D000970:Antineoplastic Agents; D008942:Mitoxantrone; D002945:Cisplatin