Abstract
Three large randomized clinical trials have shown a survival benefit in women with stage iii epithelial ovarian cancer (eoc) who receive intraperitoneal (IP) chemotherapy after optimal primary debulking surgery. The most recent Gynecologic Oncology Group study, gog 172, showed an improvement in median overall survival of approximately 17 months. That result led to a U.S. National Cancer Institute (nci) clinical announcement recommending that IP chemotherapy be considered for this group of women with eoc. However, IP chemotherapy is associated with increased toxicity, and rates for completion of treatment are low (42% in gog 172). The optimal IP regimen and duration of treatment has yet to be defined. Women undergoing chemotherapy before optimal debulking surgery were not included in the studies or in the nci clinical announcement. The National Cancer Institute of Canada Clinical Trials Group has developed a protocol for a randomized phase ii/iii study which will examine whether IP platinum-taxane-based chemotherapy benefits women who have received neoadjuvant chemotherapy before optimal surgical debulking. To address whether the less systemically toxic carboplatin can be substituted for cisplatin IP, the first phase of the study will have 3 arms: 1 intravenous-only, and 2 IP-containing regimens. At the end of the first stage, and provided that IP therapy is feasible to administer in this patient population, one of the IP regimens, either IP carboplatin or IP cisplatin, will proceed into a phase iii comparison with the intravenous arm. This exciting new study has gathered international support.
Highlights
Epithelial ovarian cancer is the leading cause of gynecologic malignancy death in North America 1.Despite the efficacy of intravenous (IV) platinum and paclitaxel chemotherapy, more than 75% of patients with stage iii and iv eoc relapse and die of their disease 2.1.1 Intraperitoneal ChemotherapyThe peritoneal cavity is the principle site of spread and recurrence in women with eoc
2.4.4 Evaluation of Outcomes Related to Nursing Management An exciting part of the ov.[21] study is that, for the first time, it provides an opportunity to prospectively answer some basic questions relating to best nursing practice and the delivery of IP chemotherapy
IP chemotherapy was associated with a 21.6% decrease in risk of death, translating into a 12-month increase in median overall survival for women with optimally debulked (≤1 cm) stage iii eoc
Summary
Epithelial ovarian cancer (eoc) is the leading cause of gynecologic malignancy death in North America 1.Despite the efficacy of intravenous (IV) platinum and paclitaxel chemotherapy, more than 75% of patients with stage iii and iv eoc relapse and die of their disease 2.1.1 Intraperitoneal ChemotherapyThe peritoneal cavity is the principle site of spread and recurrence in women with eoc. Intraperitoneal (IP) administration of chemotherapy, as a means of increasing the dose intensity delivered to the tumour while minimizing systemic toxicity, is an attractive therapeutic approach 3. Advantages of this administration route include high IP concentration and longer half-life of the drug in the peritoneal cavity than are observed with IV administration. IP–IV chemotherapy was associated with a 21.6% decrease in risk of death (hazard ratio: 0.78; 95% confidence interval: 0.69 to 0.89) 5–12 They concluded that IP–IV chemotherapy should be considered a standard of care for a select group of women with eoc
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