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.
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: G B Kristensen; I Vergote; G Stuart; J M Del Campo; J Kaern; A B Lopez; E Eisenhauer; E Aavall-Lundquist; M Ridderheim; H Havsteen; M R Mirza; M Scheistroen; E Vrdoljak Journal: Int J Gynecol Cancer Date: 2003 Nov-Dec Impact factor: 3.437
Authors: F M Muggia; P S Braly; M F Brady; G Sutton; T H Niemann; S L Lentz; R D Alvarez; P R Kucera; J M Small Journal: J Clin Oncol Date: 2000-01 Impact factor: 44.544
Authors: G Sarosy; E Kohn; D A Stone; M Rothenberg; J Jacob; D O Adamo; F P Ognibene; R E Cunnion; E Reed Journal: J Clin Oncol Date: 1992-07 Impact factor: 44.544
Authors: Michael A Bookman; Mark F Brady; William P McGuire; Peter G Harper; David S Alberts; Michael Friedlander; Nicoletta Colombo; Jeffrey M Fowler; Peter A Argenta; Koen De Geest; David G Mutch; Robert A Burger; Ann Marie Swart; Edward L Trimble; Chrisann Accario-Winslow; Lawrence M Roth Journal: J Clin Oncol Date: 2009-02-17 Impact factor: 44.544
Authors: W P McGuire; W J Hoskins; M F Brady; H D Homesley; W T Creasman; M L Berman; H Ball; J S Berek; J Woodward Journal: J Clin Oncol Date: 1995-07 Impact factor: 44.544
Authors: Kord M Kober; Melissa Mazor; Gary Abrams; Adam Olshen; Yvette P Conley; Marilyn Hammer; Mark Schumacher; Margaret Chesney; Betty Smoot; Judy Mastick; Steven M Paul; Jon D Levine; Christine Miaskowski Journal: J Pain Symptom Manage Date: 2018-08-30 Impact factor: 3.612