title: Carboplatin and short-infusion paclitaxel in high-risk and advanced-stage ovarian carcinoma.
abstract: OBJECTIVE
  To present tolerance and toxicity information on previously untreated high-risk early-stage and advanced-stage primary epithelial ovarian cancer patients treated with adjuvant 3-hour paclitaxel and carboplatin.
  
  
  METHODS
  Consecutive patients with high-risk early-stage and advanced-stage epithelial ovarian cancer underwent maximal surgical debulking and/or staging. Paclitaxel (175 mg/m2) was infused over 3 hours followed by a 30-minute carboplatin infusion (area under the plasma concentration time curve = 7.0-7.5 mg/mL/min) for a planned six (q 21 day) courses.
  
  
  RESULTS
  Twenty-two patients underwent 132 cycles and were evaluable for toxicity. Myelosuppression was dose-limiting. Grade 4 granulocytopenia occurred in 31% of the cycles. Grade 3 and 4 thrombocytopenia was uncommon (5%, 1%) and predictable. Delay in administration was necessary in 10 of 132 (7.6%) cycles (5 of 22 patients). Eight of these 10 delays were 7 days. Seventeen of 22 (77%) patients completed therapy without a delay. Non-hematologic toxicity was mild. A significant individual weight gain of 2.5 kg was noted. Among 19 patients with advanced disease, 16 had a complete clinical remission after six cycles of therapy. Nine patients with stage IIB-IV disease have undergone reassessment procedures (four pathologic complete responses, three microscopic positive, two macroscopic positive). Sixteen of 22 (77%) have no evidence of disease, four have no evidence of disease following a secondary therapy, one is under therapy with salvage chemotherapy, and one is dead of disease. Median follow-up is 14 months (range: 6-30 months). Comparatively, the mean carboplatin dose administered was 440 mg/m2 (95% CI, 428-486 mg/m2).
  
  
  CONCLUSIONS
  Paclitaxel and carboplatin administered in this design are well tolerated, with predictable and acceptable hematologic and nonhematologic toxicity. Dose-limiting toxicity is granulocytopenia with relative platelet sparing. Outpatient administration is safe.
authors.affiliation: Department of Obstetrics and Gynecology, Creighton University School of Medicine, Omaha, Nebraska, USA.
authors.forename: R L
authors.initials: RL
authors.lastname: Coleman
authors.forename: K G
authors.initials: KG
authors.lastname: Bagnell
authors.forename: P M
authors.initials: PM
authors.lastname: Townley
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D001772:Blood Cell Count / Q000187:drug effects; D016190:Carboplatin / Q000008:administration & dosage; D004334:Drug Administration Schedule; D005260:Female; D006402:Hematologic Diseases / Q000139:chemically induced; D006801:Humans; D007262:Infusions, Intravenous; D008875:Middle Aged; D009367:Neoplasm Staging; D010051:Ovarian Neoplasms / Q000097:blood / Q000188:drug therapy* / Q000473:pathology; D017239:Paclitaxel / Q000008:administration & dosage; D012307:Risk Factors
chemical_list: D016190:Carboplatin; D017239:Paclitaxel