title: Paclitaxel (175 mg/m2 over 3 hours) with cisplatin or carboplatin in previously untreated ovarian cancer: an interim analysis.
abstract: The side effects of cisplatin (75 mg/m2) in combination with paclitaxel (Taxol; Bristol-Myers Squibb Company, Princeton, NJ) (175 mg/m2 over 3 hours) are expected to be more severe and frequent than those of carboplatin (area under the concentration-time curve of 5) in combination with the same dose of paclitaxel, but the combinations are expected to be equally effective. A disadvantage of the cisplatin-based regimen is that patients need to be admitted to the hospital. The carboplatin regimen can be administered to outpatients. We tested both combinations administered every 3 weeks in a randomized phase III study in patients with previously untreated epithelial ovarian cancer. An interim analysis for toxicity was performed in 145 patients shortly after study closure. We observed a difference in the incidence of nausea, vomiting, and neurotoxicity favoring the women treated with the carboplatin regimen, but this regimen caused more myelotoxicity. Maturation of the study is awaited before survival data can be analyzed and final conclusions can be drawn.
authors.affiliation: University Hospital Utrecht, The Netherlands.
authors.forename: J P
authors.initials: JP
authors.lastname: Neijt
authors.forename: S A
authors.initials: SA
authors.lastname: Engelholm
authors.forename: P O
authors.initials: PO
authors.lastname: Witteveen
authors.forename: M K
authors.initials: MK
authors.lastname: Tuxen
authors.forename: P G
authors.initials: PG
authors.lastname: Sørensen
authors.forename: M
authors.initials: M
authors.lastname: Hansen
authors.forename: F
authors.initials: F
authors.lastname: Hirsch
authors.forename: C
authors.initials: C
authors.lastname: Sessa
authors.forename: C
authors.initials: C
authors.lastname: de Swart
authors.forename: H C
authors.initials: HC
authors.lastname: van Houwelingen
authors.forename: B
authors.initials: B
authors.lastname: Lund
authors.forename: S W
authors.initials: SW
authors.lastname: Hansen
mesh_terms: D000328:Adult; D000368:Aged; D000553:Ambulatory Care; D000970:Antineoplastic Agents / Q000008:administration & dosage* / Q000009:adverse effects; D000972:Antineoplastic Agents, Phytogenic / Q000008:administration & dosage* / Q000009:adverse effects; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D019540:Area Under Curve; D001853:Bone Marrow / Q000187:drug effects; D016190:Carboplatin / Q000008:administration & dosage* / Q000009:adverse effects; D002277:Carcinoma / Q000188:drug therapy*; D002945:Cisplatin / Q000008:administration & dosage* / Q000009:adverse effects; D005260:Female; D005500:Follow-Up Studies; D006760:Hospitalization; D006801:Humans; D015994:Incidence; D007262:Infusions, Intravenous; D008875:Middle Aged; D009325:Nausea / Q000139:chemically induced; D009422:Nervous System Diseases / Q000139:chemically induced; D010051:Ovarian Neoplasms / Q000188:drug therapy*; D017239:Paclitaxel / Q000008:administration & dosage* / Q000009:adverse effects; D012074:Remission Induction; D015996:Survival Rate; D014839:Vomiting / Q000139:chemically induced
chemical_list: D000970:Antineoplastic Agents; D000972:Antineoplastic Agents, Phytogenic; D016190:Carboplatin; D017239:Paclitaxel; D002945:Cisplatin