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A phase II study of irinotecan combined with S-1 in patients with advanced or recurrent cervical cancer previously treated with platinum based chemotherapy
  1. Seiji Mabuchi1,
  2. Eriko Yokoi1,
  3. Kotaro Shimura1,
  4. Naoko Komura1,
  5. Yuri Matsumoto1,
  6. Kenjiro Sawada1,
  7. Aki Isobe2,
  8. Tateki Tsutsui3,
  9. Fuminori Kitada4 and
  10. Tadashi Kimura1
  1. 1 Department of Obstetrics and Gynecology, Osaka University Graduate School of Medicine, Osaka, Japan
  2. 2 Department of Obstetrics and Gynecology, Hyogo Prefectural Nishinomiya Hospital, Hyogo, Japan
  3. 3 Department of Obstetrics and Gynecology, Japan Community Health Care Organization Osaka Hospital, Osaka, Japan
  4. 4 Department of Obstetrics and Gynecology, Suita Tokusyukai Hospital, Osaka, Japan
  1. Correspondence to Seiji Mabuchi, Department of Obstetrics and Gynecology, Osaka University Graduate School of Medicine, Osaka 565-0871, Japan; smabuchi{at}gyne.med.osaka-u.ac.jp

Abstract

Objectives We conducted a phase II study to investigate the efficacy and toxicities of irinotecan plus oral S-1 in patients with advanced or recurrent uterine cervical cancer.

Methods Patients with advanced or recurrent cervical cancer previously treated with platinum based chemotherapy were enrolled. Irinotecan (150 mg/m2) was administered intravenously over the course of 90 min on day 1, and S-1 (80 mg/m2) was given orally in two divided doses from days 1 to 14 of a 21 day cycle. The primary endpoint of this phase II study was response rate. Secondary endpoints included safety, progression free survival, and overall survival.

Results A total of 19 patients were enrolled and treated. The response rate was 29.4%. Grade 3–4 hematologic toxicities were observed in three patients (15.7%). The only grade 3–4 non-hematologic toxicity observed was grade 3 diarrhea. The median progression free survival and overall survival were 3 months and 9 months, respectively.

Conclusion S-1 plus irinotecan in a 3 weekly setting is safe and active in women with advanced or recurrent cervical cancer previously treated with platinum based chemotherapy. Future corroborative clinical studies are warranted.

  • cervical cancer
  • chemotherapy
  • S-1
  • irinotecan
  • non-platinum doublet
  • phase II study

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Footnotes

  • Contributors SM: project design and writing of the manuscript; EY: performed statistical analyses; KS and NK: acquired the data; YM, KS and TK: edited the manuscript; AI, TT and FK: edited the manuscript and acquired the data.

  • Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.

  • Competing interests None declared.

  • Ethics approval This phase II study was approved by the institutional review board of Osaka University Hospital.

  • Provenance and peer review Not commissioned, externally peer reviewed.

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