title: Ten-year follow-up of a phase 2 study of dose-intense paclitaxel with cisplatin and cyclophosphamide as initial therapy for poor-prognosis, advanced-stage epithelial ovarian cancer.
abstract: BACKGROUND
  The objective of this study was to assess activity and toxicity in patients with newly diagnosed, advanced-stage epithelial ovarian cancer (EOC) who were receiving dose-intense paclitaxel, cyclophosphamide, cisplatin, and filgrastim delivered with a flexible dosing schedule.
  
  
  METHODS
  Patients with stage III/IV EOC received cyclophosphamide 750 mg/m(2), followed by a 24-hour infusion of paclitaxel 250 mg/m(2) and cisplatin 75 mg/m(2) on Day 2. Filgrastim began on Day 3 at 10 microg/kg daily for 9 days. Patients received 6 cycles of all drugs. Those who achieved a pathologic complete response or had microscopic residual disease at the conclusion of 6 cycles of therapy received an additional 2 to 4 cycles of paclitaxel with cyclophosphamide. Patients who had an objective response continued on cyclophosphamide and paclitaxel.
  
  
  RESULTS
  Sixty-two patients were enrolled. Thirty-two of 62 patients had stage IIIC disease, and 26 of 62 patients had stage IV disease. According to an intent-to-treat analysis, 55 patients (89%) experienced a clinical complete remission. At a median potential follow-up of 11.4 years, the median progression-free survival was 18.9 months, and the median survival was 5.4 years. The most serious toxicity was grade 3/4 neutropenic fever (35%). Although all participants developed peripheral neuropathy, improvement in neuropathic symptoms began with the decrease or cessation of paclitaxel.
  
  
  CONCLUSIONS
  The studied regimen yielded a high response rate and encouraging overall survival. The current data and those reported by the Japanese Gynecologic Oncology Group suggest that further study is warranted of dose-dense or dose-intense paclitaxel regimens in women with newly diagnosed, advanced-stage EOC.
authors.affiliation: Medical Oncology Branch, Center for Cancer Research, National Cancer Institute, 10 Center Drive, MSC 1906, Bethesda, MD 20892-1906, USA.
authors.forename: Gisele A
authors.initials: GA
authors.lastname: Sarosy
authors.forename: Mahrukh M
authors.initials: MM
authors.lastname: Hussain
authors.forename: Michael V
authors.initials: MV
authors.lastname: Seiden
authors.forename: Arlan F
authors.initials: AF
authors.lastname: Fuller
authors.forename: Najmosama
authors.initials: N
authors.lastname: Nikrui
authors.forename: Annekathryn
authors.initials: A
authors.lastname: Goodman
authors.forename: Lori
authors.initials: L
authors.lastname: Minasian
authors.forename: Eddie
authors.initials: E
authors.lastname: Reed
authors.forename: Seth M
authors.initials: SM
authors.lastname: Steinberg
authors.forename: Elise C
authors.initials: EC
authors.lastname: Kohn
mesh_terms: D000230:Adenocarcinoma / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D002945:Cisplatin / Q000008:administration & dosage; D003520:Cyclophosphamide / Q000008:administration & dosage; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D008875:Middle Aged; D010051:Ovarian Neoplasms / Q000188:drug therapy* / Q000473:pathology; D017239:Paclitaxel / Q000008:administration & dosage; D011379:Prognosis; D016896:Treatment Outcome
chemical_list: D003520:Cyclophosphamide; D017239:Paclitaxel; D002945:Cisplatin