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Paclitaxel and Carboplatin in Patients With Completely or Optimally Resected Carcinosarcoma of the Uterus: A Phase II Trial by the Japanese Uterine Sarcoma Group and the Tohoku Gynecologic Cancer Unit
  1. Ai Otsuki, MD*,
  2. Yoh Watanabe, MD, PhD*,,
  3. Hiroyuki Nomura, MD,
  4. Masayuki Futagami, MD§,
  5. Yoshihito Yokoyama, MD§,
  6. Kiyosumi Shibata, MD,
  7. Seiryu Kamoi, MD,
  8. Atsushi Arakawa, MD#,
  9. Hiroshi Nishiyama, MD**,
  10. Takahiro Katsuta, MD,,
  11. Wataru Kudaka, MD,,
  12. Muneaki Shimada, MD§§,
  13. Naoki Sato, MD∥∥,
  14. Kouhei Kotera, MD¶¶,
  15. Hidetaka Katabuchi, MD## and
  16. Nobuo Yaegashi, MD*
  1. *Department of Obstetrics and Gynecology, Tohoku University Graduate School of Medicine;
  2. Department of Clinical Research Network, Clinical Research, Innovation and Education Center, Tohoku University Hospital, Sendai;
  3. Department of Obstetrics and Gynecology, School of Medicine, Keio University, Tokyo;
  4. §Department of Obstetrics and Gynecology, Hirosaki University Graduate School of Medicine, Hirosaki;
  5. Department of Obstetrics and Gynecology, Nagoya University Graduate School of Medicine, Nagoya;
  6. Department of Obstetrics and Gynecology, Nippon Medical School Chiba Hokusoh Hospital, Chiba;
  7. #Department of Obstetrics and Gynecology, Nagoya City University Graduate School of Medicine, Nagoya;
  8. **Department of Obstetrics and Gynecology, Fukushima Medical University, Fukushima;
  9. ††Department of Obstetrics and Gynecology, Fukuoka University Hospital, Fukuoka;
  10. ‡‡Department of Obstetrics and Gynecology, Graduate School of Medical Science, University of Ryukyus, Okinawa;
  11. §§Department of Obstetrics and Gynecology, Tottori University School of Medicine, Yonago;
  12. ∥∥Department of Obstetrics and Gynecology, Akita University Graduate School of Medicine, Akita;
  13. ¶¶Department of Obstetrics and Gynecology, Nagasaki Harbour Medical Center City Hospital, Nagasaki;
  14. ##Department of Obstetrics and Gynecology, Faculty of Life Sciences Kumamoto University, Kumamoto, Japan.
  1. Address correspondence and reprint requests to Yoh Watanabe, MD, PhD, Department of Clinical Research Network, Clinical Research, Innovation and Education Center, Tohoku University Hospital, 1-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi 980-8574, Japan. E-mail: watanabe{at}med.tohoku.ac.jp.

Abstract

Objective This study aimed to evaluate the efficacy of paclitaxel and carboplatin in patients with completely or optimally resected uterine carcinosarcoma.

Materials and Methods We conducted a single-arm multicenter prospective phase II trial at 20 Japanese medical facilities. Eligible patients had histologically confirmed uterine carcinosarcoma without prior chemotherapy or radiotherapy. Patients received 6 courses of 175 mg/m2 paclitaxel over 3 hours, followed by a 30-minute intravenous administration of carboplatin at an area under the serum concentration-time curve of 6.

Results A total of 51 patients were enrolled in this study, 48 of whom underwent complete resection and 3 of whom underwent optimal resection. At 2 years, the progression-free survival and overall survival rates were 78.2% (95% confidence interval [CI], 64.1%–87.3%) and 87.9% (95% CI, 75.1%–94.4%), respectively. At 4 years, these rates were 67.9% (95% CI, 53.0%–79.0%) and 76.0% (95% CI, 60.5%–86.1%), respectively. Although 15 patients showed disease recurrence during the follow-up period (median, 47.8 months; range, 2.1–72.8 months), a total of 40 (78.4%) patients completed the 6 courses of treatment that had been planned.

Conclusions The combination of paclitaxel and carboplatin was a feasible and effective postoperative adjuvant therapy for patients with completely or optimally resected uterine carcinosarcoma.

  • Uterine carcinosarcoma
  • Adjuvant chemotherapy
  • Phase II trial

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Footnotes

  • Supported by Health Labour Sciences Grant, The National Cancer Center Research and Development Fund (26-A-4) and Grant-in-Aid for Scientific Research (B).

  • The authors declare no conflicts of interest.

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