title: A comparison of intravenous versus intraperitoneal chemotherapy for the initial treatment of ovarian cancer.
abstract: A phase III study was conducted comparing intraperitoneal (ip) versus intravenous (iv) cisplatin-based therapy for patients with newly diagnosed ovarian cancer to determine if the pharmacologic advantage of ip delivery could be translated into an improved response and survival rate. Twenty-nine patients were randomized to receive six cycles of ip cisplatin 200 mg/m2 plus ip etoposide 350 mg/m2 with iv thiosulfate protection given every 4 weeks; thirty-three patients were randomized to receive six cycles of iv cisplatin 100 mg/m2 plus iv cyclophosphamide 600 mg/m2 administered every 3 weeks. Patients were stratified by stage (IIC-IV) and size of residual disease (> or < or = 1 cm). The study was conducted in a community-wide setting. The complete response in evaluable patients was 48% in the ip group and 52% in the iv group. The surgical complete response rate for all patients on study, underestimated because not all patients in complete clinical remission had a second-look laparotomy, was 31% in the ip group and 33% in the iv group. There was no difference in the response rates between the treatment arms as a function of residual disease < or = or > 1 cm. With a median follow-up of 46 months (range 21-70 months) there is no difference in response duration or survival. Both regimens were well tolerated with comparable hematologic and nonhematologic toxicity.
authors.affiliation: Department of Medicine, University of California, San Diego, La Jolla 92093.
authors.forename: S
authors.initials: S
authors.lastname: Kirmani
authors.forename: P S
authors.initials: PS
authors.lastname: Braly
authors.forename: E F
authors.initials: EF
authors.lastname: McClay
authors.forename: S L
authors.initials: SL
authors.lastname: Saltzstein
authors.forename: S C
authors.initials: SC
authors.lastname: Plaxe
authors.forename: S
authors.initials: S
authors.lastname: Kim
authors.forename: C
authors.initials: C
authors.lastname: Cates
authors.forename: S B
authors.initials: SB
authors.lastname: Howell
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage* / Q000627:therapeutic use; D002277:Carcinoma / Q000188:drug therapy* / Q000473:pathology / Q000601:surgery; D002945:Cisplatin / Q000008:administration & dosage; D003131:Combined Modality Therapy; D003520:Cyclophosphamide / Q000008:administration & dosage; D004334:Drug Administration Schedule; D005047:Etoposide / Q000008:administration & dosage; D005260:Female; D006801:Humans; D007262:Infusions, Intravenous; D007263:Infusions, Parenteral; D008875:Middle Aged; D009367:Neoplasm Staging; D010051:Ovarian Neoplasms / Q000188:drug therapy* / Q000473:pathology / Q000601:surgery; D011446:Prospective Studies; D012074:Remission Induction; D016019:Survival Analysis
chemical_list: D005047:Etoposide; D003520:Cyclophosphamide; D002945:Cisplatin