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Japanese Journal of Clinical Oncology Advance Access originally published online on October 16, 2008
Japanese Journal of Clinical Oncology 2008 38(11):777-785; doi:10.1093/jjco/hyn101
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© 2008 The Author(s)
This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/2.0/uk/) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.

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 Katsumata1, Yasuhiro Fujiwara1, Toshiharu Kamura2, Toru Nakanishi3, Masayuki Hatae4, Daisuke Aoki5, Kenichi Tanaka6, Hiroshi Tsuda7, Shoji Kamiura8, Kazuhiro Takehara9, Toru Sugiyama10, Junzo Kigawa11, Keiichi Fujiwara12, Kazunori Ochiai13, Ryo Ishida14, Mitsuo Inagaki14 and Kiichiro Noda15

1 Department of Medical Oncology, National Cancer Center, Tokyo
2 Department of Obstetrics and Gynecology, Kurume University School of Medicine, Kurume, Fukuoka
3 Department of Gynecologic Oncology, Aichi Cancer Center Hospital, Nagoya
4 Department of Obstetrics and Gynecology, Kagoshima City Hospital, Kagoshima
5 Department of Obstetrics and Gynecology, School of Medicine, Keio University, Tokyo
6 Department of Obstetrics and Gynecology, Niigata University Graduate School of Medical and Dental Science, Niigata
7 Department of Obstetrics and Gynecology, Osaka City General Hospital, Osaka
8 Department of Gynecologic Oncology, Osaka Medical Center for Cancer and Cardiovascular Diseases, Osaka
9 Department of Gynecologic Oncology, National Hospital Organization Kure Medical Center and Chugoku Cancer Center, Kure, Hiroshima
10 Department of Obstetrics and Gynecology, Iwate Medical University School of Medicine, Morioka
11 Department of Obstetrics and Gynecology, Tottori University School of Medicine, Yonago, Tottori
12 Department of Obstetrics and Gynecology, Kawasaki Medical University, Kurashiki, Okayama
13 Department of Obstetrics and Gynecology, Jikei University School of Medicine, Tokyo
14 Clinical Research & Development Department, Janssen Pharmaceutical K.K., Tokyo
15 Kinki University School of Medicine, Osakasayama, Osaka, Japan

For reprints and all correspondence: Noriyuki Katsumata, Department of Medical Oncology, National Cancer Center, Tokyo, Japan. E-mail: nkatsuma{at}ncc.go.jp

Received June 27, 2008; accepted August 30, 2008

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.

Key Words: pegylated liposomal doxorubicin • Müllerian carcinoma • ovarian carcinoma • hand-foot syndrome • chemo-gynaecology • chemo-phase I-II-III • gynaecology


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