2009年7月
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
INTERNATIONAL JOURNAL OF GYNECOLOGICAL CANCER
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- 巻
- 19
- 号
- 5
- 開始ページ
- 834
- 終了ページ
- 837
- 記述言語
- 英語
- 掲載種別
- DOI
- 10.1111/IGC.0b013e3181a29dfe
- 出版者・発行元
- LIPPINCOTT WILLIAMS & WILKINS
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 11 to IV who underwent initial surgery and had a residual tumor size of 2 cm or larger. Patients received IV paclitaxel 175 mg/m(2) 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%; Table 4). 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.
Patients and Methods: Eligible patients were those with epithelial ovarian carcinoma or primary peritoneal carcinoma stages 11 to IV who underwent initial surgery and had a residual tumor size of 2 cm or larger. Patients received IV paclitaxel 175 mg/m(2) 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%; Table 4). 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.
- リンク情報
- ID情報
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- DOI : 10.1111/IGC.0b013e3181a29dfe
- ISSN : 1048-891X
- PubMed ID : 19574769
- Web of Science ID : WOS:000267980800006