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Feasibility study on combination chemotherapy using nogitecan hydrochloride (topotecan) and cisplatin for patients with metastatic, persistent, or recurrent uterine cervical cancer

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Abstract

Background

The standard chemotherapeutic regimen for stage IVB, persistent, or recurrent uterine cervical cancer is platinum-based combination chemotherapy such as cisplatin (CDDP)/paclitaxel and CDDP/nogitecan hydrochloride (NGT, topotecan). Because it is unclear whether the CDDP/NGT combination chemotherapy is tolerable for Japanese patients, we conducted the present study to assess the feasibility of CDDP/NGT combination chemotherapy.

Methods

Between June 2012 and April 2014, 15 patients with stage IVB, persistent, or recurrent uterine cervical cancer were enrolled in this study. Patients underwent six cycles of NGT at a dose of 0.75 mg/m2, followed immediately by CDDP at a dose of 50 mg/m2 on day 1 by intravenous infusion, and then NGT at a dose of 0.75 mg/m2 on days 2 and 3.

Results

Of 15 patients, 9 patients underwent at least 6 cycles of NGT/CDDP combination chemotherapy. Of a total of 83 cycles, 70 cycles (84.3 %) of NGT/CDDP combination chemotherapy could be continued at the starting dose of NGT (0.75 mg/m2). Grade 3/4 hematological toxicities included leukopenia in 10 patients (66.7 %), neutropenia in 15 (100 %), anemia in 6 (40.0 %), thrombocytopenia in 4 (26.7 %), and febrile neutropenia in 4 (26.7 %). The response rate according to RECIST was 27 % (3/11), with partial response in 3 patients.

Conclusions

NGT/CDDP combination chemotherapy may be a tolerable and effective regimen for Japanese patients with stage IVB, persistent, or recurrent uterine cervical cancer. Based on the results of this study, NGT/CDDP combination chemotherapy was approved in Japan in November 2015.

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Authors and Affiliations

  1. Department of Obstetrics and Gynecology, Tottori University School of Medicine, 36-1 Nishi-cho, Yonago, Tottori, 683-8504, Japan

    Muneaki Shimada, Shinya Sato & Tetsuro Oishi

  2. Department of Obstetrics and Gynecology, Iwate Medical University, 19-1 Uchimaru, Morioka, Iwate, 020-8505, Japan

    Hiroaki Itamochi

  3. Matsue City Hospital, 32-1 Noshira-cho, Matsue, Shimane, 690-8508, Japan

    Junzo Kigawa

  4. Department of Gynecology, Cancer Institute Hospital, 3-8-31 Ariake, Koto-ku, Tokyo, 135-8550, Japan

    Nobuhiro Takeshima

  5. Department of Obstetrics and Gynecology, Keio University School of Medicine, 35 Shinanomachi, Shinjuku, Tokyo, 160-8582, Japan

    Daisuke Aoki

  6. Department of Obstetrics and Gynecology, Graduate School of Medical Science, University of the Ryukyus, 207 Aza Uehara, Nishihara-cho, Okinawa, 903-0215, Japan

    Yoichi Aoki

  7. Pharmaceuticals Group, Nippon Kayaku Co., Ltd., 2-1-1 Marunouchi, Chiyoda, Tokyo, 100-0005, Japan

    Yoshihiro Nambu

  8. Department of Obstetrics and Gynecology, Jikei University School of Medicine, 3-25-8 Nishi-shimbashi, Minato, Tokyo, 105-8461, Japan

    Kazunori Ochiai

Authors
  1. Muneaki Shimada
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  2. Shinya Sato
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  3. Tetsuro Oishi
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  4. Hiroaki Itamochi
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  5. Junzo Kigawa
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  6. Nobuhiro Takeshima
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  7. Daisuke Aoki
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  8. Yoichi Aoki
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  9. Yoshihiro Nambu
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  10. Kazunori Ochiai
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Corresponding author

Correspondence to Muneaki Shimada.

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Conflict of interest

Yoshihiro Nambu serves as an employee of Pharmaceuticals Group, Nippon Kayaku Co. Ltd. Yasuhiro Nambu has stock ownership in Nippon Kayaku. The other authors have no conflict of interest.

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Cite this article

Shimada, M., Sato, S., Oishi, T. et al. Feasibility study on combination chemotherapy using nogitecan hydrochloride (topotecan) and cisplatin for patients with metastatic, persistent, or recurrent uterine cervical cancer . Int J Clin Oncol 21, 969–974 (2016). https://doi.org/10.1007/s10147-016-0984-y

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  • DOI: https://doi.org/10.1007/s10147-016-0984-y

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