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

Research output: Contribution to journalArticle

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

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Phase II Clinical Trials
Fallopian Tubes
Platinum
Carcinoma
Drug Therapy
Therapeutics
Hand-Foot Syndrome
Taxoids
Stomatitis
liposomal doxorubicin
Leukopenia
Neutropenia
Hemoglobins
Confidence Intervals
Safety

Keywords

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

ASJC Scopus subject areas

  • Oncology
  • Cancer Research
  • Radiology Nuclear Medicine and imaging

Cite this

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

In: Japanese Journal of Clinical Oncology, Vol. 38, No. 11, 2008, p. 777-785.

Research output: Contribution to journalArticle

Katsumata, Noriyuki ; Fujiwara, Yasuhiro ; Kamura, Toshiharu ; Nakanishi, Toru ; Hatae, Masayuki ; Aoki, Daisuke ; Tanaka, Kenichi ; Tsuda, Hiroshi ; Kamiura, Shoji ; Takehara, Kazuhiro ; Sugiyama, Toru ; Kigawa, Junzo ; Fujiwara, Keiichi ; Ochiai, Kazunori ; Ishida, Ryo ; Inagaki, Mitsuo ; Noda, Kiichiro. / 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. In: Japanese Journal of Clinical Oncology. 2008 ; Vol. 38, No. 11. pp. 777-785.
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abstract = "Objective: This study was conducted to evaluate the efficacy and safety of pegylated liposomal doxorubicin (PLD) in Japanese patients with M{\"u}llerian carcinoma having a therapeutic history of platinum-based chemotherapy. Methods: Patients who were diagnosed with M{\"u}llerian 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 M{\"u}llerian carcinoma having a therapeutic history of platinum-based chemotherapy and toxicity was manageable by dose modification of PLD or supportive care.",
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author = "Noriyuki Katsumata and Yasuhiro Fujiwara and Toshiharu Kamura and Toru Nakanishi and Masayuki Hatae and Daisuke Aoki and Kenichi Tanaka and Hiroshi Tsuda and Shoji Kamiura and Kazuhiro Takehara and Toru Sugiyama and Junzo Kigawa and Keiichi Fujiwara and Kazunori Ochiai and Ryo Ishida and Mitsuo Inagaki and Kiichiro Noda",
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T1 - 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

T2 - A phase II study of the Japanese gynecologic oncology group

AU - Katsumata, Noriyuki

AU - Fujiwara, Yasuhiro

AU - Kamura, Toshiharu

AU - Nakanishi, Toru

AU - Hatae, Masayuki

AU - Aoki, Daisuke

AU - Tanaka, Kenichi

AU - Tsuda, Hiroshi

AU - Kamiura, Shoji

AU - Takehara, Kazuhiro

AU - Sugiyama, Toru

AU - Kigawa, Junzo

AU - Fujiwara, Keiichi

AU - Ochiai, Kazunori

AU - Ishida, Ryo

AU - Inagaki, Mitsuo

AU - Noda, Kiichiro

PY - 2008

Y1 - 2008

N2 - 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.

AB - 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.

KW - Chemo-gynaecology

KW - Chemo-phase I-II-III

KW - Hand-foot syndrome

KW - Müllerian carcinoma

KW - Ovarian carcinoma

KW - Pegylated liposomal doxorubicin

KW - Ynaecology

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