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

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24 Citations (Scopus)

Abstract

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.

Original languageEnglish
Pages (from-to)777-785
Number of pages9
JournalJapanese journal of clinical oncology
Volume38
Issue number11
DOIs
Publication statusPublished - 2008 Nov 6

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Keywords

  • Chemo-gynaecology
  • Chemo-phase I-II-III
  • Hand-foot syndrome
  • Müllerian carcinoma
  • Ovarian carcinoma
  • Pegylated liposomal doxorubicin
  • Ynaecology

ASJC Scopus subject areas

  • Oncology
  • Radiology Nuclear Medicine and imaging
  • Cancer Research

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