title: Pilot study of outpatient paclitaxel, carboplatin and gemcitabine for advanced stage epithelial ovarian, peritoneal, and fallopian tube cancer.
abstract: OBJECTIVE
  The purpose of this study was to determine the feasibility, response rate, and toxicity of paclitaxel, carboplatin, and gemcitabine as an outpatient regimen in the treatment of ovarian/non-ovarian and tubal adenocarcinoma. This is the largest completed study using this regimen as first-line treatment of these patients.
  
  
  METHODS
  Following cytoreductive surgery, eligible patients were initially treated with paclitaxel (175 mg/m(2) via 1 h infusion), carboplatin (AUC = 5), and gemcitabine (800 mg/m(2)) as an outpatient every 21 days. Gemcitabine (800 mg/m(2)) was repeated on day 8. After six cycles of treatment, responders were eligible for an additional three cycles of paclitaxel and gemcitabine. Colony-stimulating factors were used at the discretion of the treating physician.
  
  
  RESULTS
  Fifty-seven patients (median age = 58; range 41-81) with stage III/IV epithelial carcinoma of the ovary, fallopian tube, and peritoneum received a total of 476 cycles of chemotherapy. Grades 3 and 4 neutropenia developed in 19.7% and 9% of cycles while grades 3 and 4 thrombocytopenia developed in 4.2% and 1.3% of the cycles. One hundred thirty-seven (28.8%) cycles of a possible 476 cycles of gemcitabine were delayed primarily due to grades 3 and 4 neutropenia. Forty-five (84.9%) patients exhibited a complete response and three (5.7%) patients demonstrated a partial response, for a total response rate of 90.4%. Twenty-two patients developed some degree of neuropathy, although there was no reported interference with activities of daily living. The patients' median progression-free interval and median overall survival was 15.5 and 40.8 months, respectively. Forty-one of the original 57 patients were alive at the conclusion of data collection.
  
  
  CONCLUSIONS
  This report represents the largest completed study in the world employing this triplet regimen in the first-line treatment of advanced stage epithelial ovarian, fallopian tube, or peritoneal cancer patients. Although the study exhibited a high response rate, the neuropathy encountered in the study, and the need to eliminate gemcitabine in 54% of the patients due to bone marrow suppression merits further investigation of the dosing schedule. More recent gemcitabine data suggest that lower doses and a 2-week regimen may be as effective with less toxicity. A comparison of our results with the GOG-0182 study, that utilizes the same regimen, should be informative.
authors.affiliation: Gynecologic Oncology Associates, Hoag Cancer Center, Newport Beach, CA 92663, USA. research@gynoncology.com
authors.forename: John P
authors.initials: JP
authors.lastname: Micha
authors.forename: Bram H
authors.initials: BH
authors.lastname: Goldstein
authors.forename: Mark A
authors.initials: MA
authors.lastname: Rettenmaier
authors.forename: Julie
authors.initials: J
authors.lastname: Mattison
authors.forename: Cheri
authors.initials: C
authors.lastname: Graham
authors.forename: Connie L
authors.initials: CL
authors.lastname: Birk
authors.forename: John V
authors.initials: JV
authors.lastname: Brown
mesh_terms: D000230:Adenocarcinoma / Q000188:drug therapy* / Q000473:pathology / Q000601:surgery; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D016190:Carboplatin / Q000008:administration & dosage / Q000009:adverse effects; D003131:Combined Modality Therapy; D003841:Deoxycytidine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D018572:Disease-Free Survival; D005185:Fallopian Tube Neoplasms / Q000188:drug therapy* / Q000473:pathology / Q000601:surgery; D005260:Female; D006801:Humans; D008875:Middle Aged; D009367:Neoplasm Staging; D010051:Ovarian Neoplasms / Q000188:drug therapy* / Q000473:pathology / Q000601:surgery; D017239:Paclitaxel / Q000008:administration & dosage / Q000009:adverse effects; D010534:Peritoneal Neoplasms / Q000188:drug therapy* / Q000473:pathology / Q000601:surgery; D010865:Pilot Projects; D000093542:Gemcitabine
chemical_list: D003841:Deoxycytidine; D016190:Carboplatin; D017239:Paclitaxel; D000093542:Gemcitabine