Phase II clinical trial of pegylated liposomal doxorubicin (JNS002) in Japanese patients with müllerian carcinoma (Epithelial ovarian carcinoma, primary carcinoma of fallopian tube, peritoneal carcinoma) having a therapeutic history of platinum-based chemotherapy: A phase II study of the Japanese gynecologic oncology group

Noriyuki Katsumata, Yasuhiro Fujiwara, Toshiharu Kamura, Toru Nakanishi, Masayuki Hatae, Daisuke Aoki, Kenichi Tanaka, Hiroshi Tsuda, Shoji Kamiura, Kazuhiro Takehara, Toru Sugiyama, Junzo Kigawa, Keiichi Fujiwara, Kazunori Ochiai, Ryo Ishida, Mitsuo Inagaki, Kiichiro Noda

研究成果: Article査読

32 被引用数 (Scopus)

抄録

Objective: This study was conducted to evaluate the efficacy and safety of pegylated liposomal doxorubicin (PLD) in Japanese patients with Müllerian carcinoma having a therapeutic history of platinum-based chemotherapy. Methods: Patients who were diagnosed with Müllerian carcinoma (epithelial ovarian carcinoma, primary carcinoma of fallopian tube and peritoneal carcinoma) by histological examination and had received the initial platinum-based chemotherapy were included in the study. The study drug was administered to the patients at 50 mg/m2 every 4 weeks. Results: Seventy-four patients were enrolled in the study. All patients had received platinum-based chemotherapy as first-line regimen and more than 90% of patients had also received taxanes. The overall response rate was 21.9% (95% confidence interval, 13.1-33.1%) and 38.4% of patients had stable disease. The median time to progression was 166 days. The major non-haematological toxicities were hand-foot syndrome (Grade 3; 16.2%) and stomatitis (Grade 3; 8.1%). Myelosuppression such as leukopenia (Grade 3; 52.7%, Grade 4; 6.8%), neutropenia (Grade 3; 31.1%, Grade 4; 36.5%) and decreased haemoglobin (Grade 3; 14.9%, Grade 4; 2.7%) were the most common haematological toxicities. Conclusion: We confirmed that a 50 mg/m2 every 4 weeks regimen of PLD was active in Japanese patients with Müllerian carcinoma having a therapeutic history of platinum-based chemotherapy and toxicity was manageable by dose modification of PLD or supportive care.

本文言語English
ページ(範囲)777-785
ページ数9
ジャーナルJapanese journal of clinical oncology
38
11
DOI
出版ステータスPublished - 2008

ASJC Scopus subject areas

  • 腫瘍学
  • 放射線学、核医学およびイメージング
  • 癌研究

フィンガープリント

「Phase II clinical trial of pegylated liposomal doxorubicin (JNS002) in Japanese patients with müllerian carcinoma (Epithelial ovarian carcinoma, primary carcinoma of fallopian tube, peritoneal carcinoma) having a therapeutic history of platinum-based chemotherapy: A phase II study of the Japanese gynecologic oncology group」の研究トピックを掘り下げます。これらがまとまってユニークなフィンガープリントを構成します。

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