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.

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.
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.
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.
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.
AuthorsGisele A Sarosy, Mahrukh M Hussain, Michael V Seiden, Arlan F Fuller, Najmosama Nikrui, Annekathryn Goodman, Lori Minasian, Eddie Reed, Seth M Steinberg, Elise C Kohn
JournalCancer (Cancer) Vol. 116 Issue 6 Pg. 1476-84 (Mar 15 2010) ISSN: 0008-543X [Print] United States
PMID20091841 (Publication Type: Clinical Trial, Phase II, Journal Article, Research Support, N.I.H., Intramural)
Chemical References
  • Cyclophosphamide
  • Paclitaxel
  • Cisplatin
  • Adenocarcinoma (drug therapy, mortality, pathology)
  • Adult
  • Aged
  • Antineoplastic Combined Chemotherapy Protocols (adverse effects, therapeutic use)
  • Cisplatin (administration & dosage)
  • Cyclophosphamide (administration & dosage)
  • Drug Administration Schedule
  • Female
  • Humans
  • Middle Aged
  • Ovarian Neoplasms (drug therapy, pathology)
  • Paclitaxel (administration & dosage)
  • Prognosis
  • Treatment Outcome

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