J Gynecol Oncol.  2013 Oct;24(4):359-366. 10.3802/jgo.2013.24.4.359.

Feasibility, acceptability and preferences for intraperitoneal chemotherapy with paclitaxel and cisplatin after optimal debulking surgery for ovarian and related cancers: an ANZGOG study

• Blinman P
• Gainford C
• Donoghoe M
• Martyn J
• Blomfield
• Grant P
• Kichenadasse G
• Vaughan M
• Brand A
• Shannon C
• Gebski V
• Stockler M
• Friedlander M

• KMID: 2177878
• DOI: http://doi.org/10.3802/jgo.2013.24.4.359

Abstract

OBJECTIVE
Intraperitoneal (IP) chemotherapy in women with optimally debulked stage III ovarian cancer has been reported to prolong overall survival, but has not been widely adopted due to concerns about its toxicity, inconvenience and acceptability to patients. The purposes of this study were to determine the regimen's feasibility, adverse events, catheter-related complications, progression-free survival, health-related quality of life (HRQL), and patients' preferences for IP versus intravenous (IV) chemotherapy.
METHODS
We conducted a single arm, multi-center study of IP chemotherapy with IV paclitaxel 135 mg/m2 (D1) over 3 hours, IP cisplatin 75 mg/m2 (D2), and IP paclitaxel 60 mg/m2 (D8) for 6 cycles in women with optimally debulked stage III ovarian or related cancers.
RESULTS
Thirty-eight eligible patients were recruited from 12 sites between July 2007 and December 2009. Seventy-one percent (n=27) completed at least 4 cycles and 63% (n=24) completed all 6 cycles. Grade 3 or 4 adverse events included nausea (n=2), vomiting (n=2), abdominal pain (n=2), and diarrhea (n=1), but not febrile neutropenia, neurotoxicity, or nephropathy. There were no treatment-related deaths. Catheter-related complications were the most frequent cause of early discontinuation of treatment (16 patients, 21%). Apart from neurotoxicity HRQL which worsened over time, HRQL was stable or improved with time. Most patients (> or =50%) judged moderate benefits (e.g., an extra 6 months survival time or a 5% improvement in survival rates) necessary to make IP chemotherapy worthwhile.
CONCLUSION
IP chemotherapy was feasible, tolerable, and most participants considered moderate survival benefits sufficient to warrant the adverse effects and inconvenience.

Keyword

Chemotherapy; Decision-making; Ovarian neoplasms; Peritoneal infusions; Quality of life

MeSH Terms

Abdominal Pain
Arm
Cisplatin
Diarrhea
Disease-Free Survival
Female
Humans
Infusions, Parenteral
Nausea
Neutropenia
Ovarian Neoplasms
Paclitaxel
Quality of Life
Vomiting
Cisplatin
Paclitaxel

Figure

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  Fig. 1 Kaplan-Meier analysis of progression-free survival.

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  Fig. 2 Cumulative proportions of patients considering whether intraperitoneal (IP) chemotherapy would be worthwhile for various improvements in (A) survival times of 3 and 5 years and (B) survival rates of 50% at 3 years and 5 years (n=20).

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