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

Joan L. Walker, Deborah Kay Armstrong, Helen Q. Huang, Jeffrey Fowler, Kenneth Webster, Robert A. Burger, Daniel Clarke-Pearson

Research output: Contribution to journalArticle

Abstract

Objectives. 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/m2 intravenously (IV) over 24 h, cisplatin 100 mg/m2 IP day 2, paclitaxel 60 mg/m2 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.

Original languageEnglish (US)
Pages (from-to)27-32
Number of pages6
JournalGynecologic Oncology
Volume100
Issue number1
DOIs
StatePublished - Jan 2006

Fingerprint

Catheters
Drug Therapy
Neoplasms
Therapeutics
Colon
Paclitaxel
Appendectomy
Hysterectomy
Ovarian Neoplasms
Cisplatin
Carcinoma

Keywords

  • Chemotherapy
  • Intraperitoneal
  • Ovarian neoplasm

ASJC Scopus subject areas

  • Obstetrics and Gynecology
  • Oncology

Cite this

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. / Walker, Joan L.; Armstrong, Deborah Kay; Huang, Helen Q.; Fowler, Jeffrey; Webster, Kenneth; Burger, Robert A.; Clarke-Pearson, Daniel.

In: Gynecologic Oncology, Vol. 100, No. 1, 01.2006, p. 27-32.

Research output: Contribution to journalArticle

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abstract = "Objectives. 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/m2 intravenously (IV) over 24 h, cisplatin 100 mg/m2 IP day 2, paclitaxel 60 mg/m2 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.",
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AB - Objectives. 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/m2 intravenously (IV) over 24 h, cisplatin 100 mg/m2 IP day 2, paclitaxel 60 mg/m2 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.

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