title: Intraperitoneal catheter outcomes in a phase III trial of intravenous versus intraperitoneal chemotherapy in optimal stage III ovarian and primary peritoneal cancer: a Gynecologic Oncology Group Study.
abstract: OBJECTIVE
  To evaluate reasons for discontinuing intraperitoneal (IP) chemotherapy, and to compare characteristics of patients who did versus did not successfully complete six cycles of IP chemotherapy.
  
  
  METHODS
  In a phase III trial, women with optimal stage III ovarian or peritoneal carcinoma were randomly allocated to receive IP therapy (paclitaxel 135 mg/m(2) intravenously (IV) over 24 h, cisplatin 100 mg/m(2) IP day 2, paclitaxel 60 mg/m(2) IP day 8) every 21 days for six cycles. Patients unable to receive IP therapy were treated with the alternate (IV) regimen. Variables compared included surgical procedures prior to enrollment, timing of IP catheter insertion, and primary and contributing reasons for discontinuing IP therapy.
  
  
  RESULTS
  Among 205 eligible patients randomly allocated to the IP arm, 119 (58%) did not complete six cycles of IP therapy. Forty (34%) patients discontinued IP therapy primarily due to catheter complications and 34 (29%) discontinued for unrelated reasons. Hysterectomy, appendectomy, small bowel resection, and ileocecal resection were not associated with failure to complete six cycles. IP therapy was not initiated in 16% of patients who did versus 5% of those who did not have a left colon or rectosigmoid colon resection (P = 0.015). There was no association between timing of catheter insertion and failure to complete IP therapy.
  
  
  CONCLUSIONS
  In this multi-institutional setting, it was difficult to deliver six cycles of IP therapy without complications. There appears to be an association between rectosigmoid colon resection and the inability to initiate IP therapy. Catheter choice, timing of insertion, and how surgical treatment of ovarian cancer influences the successful completion of intraperitoneal chemotherapy require further study.
authors.affiliation: Department of Obstetrics and Gynecology, University of Oklahoma, PO Box 26901, Oklahoma City, OK 73190, USA. joan-walker@ouhsc.edu
authors.forename: Joan L
authors.initials: JL
authors.lastname: Walker
authors.forename: Deborah K
authors.initials: DK
authors.lastname: Armstrong
authors.forename: Helen Q
authors.initials: HQ
authors.lastname: Huang
authors.forename: Jeffrey
authors.initials: J
authors.lastname: Fowler
authors.forename: Kenneth
authors.initials: K
authors.lastname: Webster
authors.forename: Robert A
authors.initials: RA
authors.lastname: Burger
authors.forename: Daniel
authors.initials: D
authors.lastname: Clarke-Pearson
mesh_terms: D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage* / Q000009:adverse effects; D002408:Catheters, Indwelling / Q000009:adverse effects*; D002945:Cisplatin / Q000008:administration & dosage / Q000009:adverse effects; D005260:Female; D006801:Humans; D007262:Infusions, Intravenous; D007263:Infusions, Parenteral; D009367:Neoplasm Staging; D010051:Ovarian Neoplasms / Q000188:drug therapy* / Q000473:pathology / Q000601:surgery; D017239:Paclitaxel / Q000008:administration & dosage / Q000009:adverse effects; D016896:Treatment Outcome
chemical_list: D017239:Paclitaxel; D002945:Cisplatin