title: Feasibility study on combination chemotherapy using nogitecan hydrochloride (topotecan) and cisplatin for patients with metastatic, persistent, or recurrent uterine cervical cancer.
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/m2on day 1 by intravenous infusion, and then NGT at a dose of 0.75 mg/m2on 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.
authors.affiliation: Department of Obstetrics and Gynecology, Tottori University School of Medicine, 36-1 Nishi-cho, Yonago, Tottori, 683-8504, Japan. mshima12@med.tottori-u.ac.jp.
authors.forename: Muneaki
authors.initials: M
authors.lastname: Shimada
authors.affiliation: Department of Obstetrics and Gynecology, Tottori University School of Medicine, 36-1 Nishi-cho, Yonago, Tottori, 683-8504, Japan.
authors.forename: Shinya
authors.initials: S
authors.lastname: Sato
authors.affiliation: Department of Obstetrics and Gynecology, Tottori University School of Medicine, 36-1 Nishi-cho, Yonago, Tottori, 683-8504, Japan.
authors.forename: Tetsuro
authors.initials: T
authors.lastname: Oishi
authors.affiliation: Department of Obstetrics and Gynecology, Iwate Medical University, 19-1 Uchimaru, Morioka, Iwate, 020-8505, Japan.
authors.forename: Hiroaki
authors.initials: H
authors.lastname: Itamochi
authors.affiliation: Matsue City Hospital, 32-1 Noshira-cho, Matsue, Shimane, 690-8508, Japan.
authors.forename: Junzo
authors.initials: J
authors.lastname: Kigawa
authors.affiliation: Department of Gynecology, Cancer Institute Hospital, 3-8-31 Ariake, Koto-ku, Tokyo, 135-8550, Japan.
authors.forename: Nobuhiro
authors.initials: N
authors.lastname: Takeshima
authors.affiliation: Department of Obstetrics and Gynecology, Keio University School of Medicine, 35 Shinanomachi, Shinjuku, Tokyo, 160-8582, Japan.
authors.forename: Daisuke
authors.initials: D
authors.lastname: Aoki
authors.affiliation: Department of Obstetrics and Gynecology, Graduate School of Medical Science, University of the Ryukyus, 207 Aza Uehara, Nishihara-cho, Okinawa, 903-0215, Japan.
authors.forename: Yoichi
authors.initials: Y
authors.lastname: Aoki
authors.affiliation: Pharmaceuticals Group, Nippon Kayaku Co., Ltd., 2-1-1 Marunouchi, Chiyoda, Tokyo, 100-0005, Japan.
authors.forename: Yoshihiro
authors.initials: Y
authors.lastname: Nambu
authors.affiliation: Department of Obstetrics and Gynecology, Jikei University School of Medicine, 3-25-8 Nishi-shimbashi, Minato, Tokyo, 105-8461, Japan.
authors.forename: Kazunori
authors.initials: K
authors.lastname: Ochiai
mesh_terms: D000328:Adult; D000368:Aged; D000740:Anemia / Q000139:chemically induced; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D002945:Cisplatin / Q000008:administration & dosage; D005240:Feasibility Studies; D005260:Female; D006801:Humans; D007564:Japan; D007970:Leukopenia / Q000139:chemically induced; D008875:Middle Aged; D009362:Neoplasm Metastasis; D009364:Neoplasm Recurrence, Local / Q000188:drug therapy*; D009367:Neoplasm Staging; D009503:Neutropenia / Q000139:chemically induced; D066066:Response Evaluation Criteria in Solid Tumors; D013921:Thrombocytopenia / Q000139:chemically induced; D019772:Topotecan / Q000008:administration & dosage; D002583:Uterine Cervical Neoplasms / Q000188:drug therapy* / Q000473:pathology*
chemical_list: D019772:Topotecan; D002945:Cisplatin
keywords: Chemotherapy; Cisplatin; Nogitecan hydrochloride (topotecan); Uterine cervical cancer