Fujiwara K, Nagao S, Kigawa J, Noma J, Akamatsu N, Miyagi Y, Numa F, Okada M, Aotani E
Phase II Study of Intraperitoneal Carboplatin With Intravenous Paclitaxel in Patients With Suboptimal Residual Epithelial Ovarian or Primary Peritoneal Cancer: A Sankai Gynecology Cancer Study Group Study. [JOURNAL ARTICLE]
Int J Gynecol Cancer 2009 Jul; 19(5):834-837.
PURPOSE:: To assess the antitumor efficacy and safety of 2 treatment modalities: intraperitoneal carboplatin combined with intravenous (IV) paclitaxel.
PATIENTS AND METHODS:: Eligible patients were those with epithelial ovarian carcinoma or primary peritoneal carcinoma stages II to IV who underwent initial surgery and had a residual tumor size of 2 cm or larger. Patients received IV paclitaxel 175 mg/m followed by intraperitoneal carboplatin AUC6. The primary end point was a response. Secondary end points were toxicity, progression-free survival, and overall survival.
RESULTS:: Twenty-six patients were enrolled, and 24 patients were eligible for assessment. The response rate was 83.3% (95% CI, 62.6%-95.3%; ). The median progression-free survival was 25 months. The median overall survival had not been reached. Incidences of grade (G) 3/4 hematological toxicities were absolute neutrophil count, 96%; hemoglobin, 29%; and thrombocytopenia, 16%. Nonhematological toxicities included G2 liver function, 4%; G3 sensory neuropathy, 8%; and G3 myalgia and arthralgia, 4%.
CONCLUSIONS:: Intraperitoneal administration of carboplatin combined with IV paclitaxel was well tolerated and showed satisfactory response in the patients with bulky residual tumor. Large-scale phase III trial comparing with IV carboplatin is warranted in this patient population.
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