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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
  1. Keiichi Fujiwara, MD, PhD*,
  2. Shoji Nagao, MD, PhD*,
  3. Junzo Kigawa, MD, PhD,
  4. Jun Noma, MD, PhD,
  5. Nobuo Akamatsu, MD, PhD§,
  6. Yasunari Miyagi, MD, PhD,
  7. Fumitaka Numa, MD, PhD,
  8. Makoto Okada, MD, PhD** and
  9. Eriko Aotani, RN, MSN††
  1. *Department of Gynecologic Oncology, Saitama Medical University, International Medical Center, Hidaka, Saitama, Japan;
  2. Tottori University, Koyama-Minami, Tottori, Japan;
  3. Hiroshima City Hospital;
  4. §Himeji Red Cross Hospital, Tatsunomachi, Himejishi, Japan;
  5. Okayama Ofuku Clinic,
  6. Tokuyama Central Hospital, Tokuyama, Japan;
  7. **Yamaguchi Red Cross Hospital, Yahatababa, Yamaguchi-shi, Yamaguchi, Japan;
  8. ††Kitasato University, Minato, Tokyo, Japan.
  1. Address correspondence and reprint requests to Keiichi Fujiwara, MD, PhD, Department of Gynecologic Oncology, Saitama Medical University, International Medical Center, 1397-1 Yamane, Hidaka, Saitama 350-1298 Japan. E-mail: fujiwara{at}saitama-med.ac.jp.

Abstract

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/m2 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.

  • Intraperitoneal chemotherapy
  • Carboplatin
  • Ovarian cancer
  • Suboptimal residual disease
  • Phase II study

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Footnotes

  • Conflict of Interest Statement: The authors declare that there are no conflicts of interest.

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