Phase II Study of Concurrent Chemoradiotheapy Using Nedaplatin for Locally Advanced Uterine Cervical Carcinoma (KGROG0501): Final Results

  1. KAZUSHIGE HAYAKAWA2
  1. 1Department of Radiology, Toho University Omori Medical Center, Tokyo, Japan
  2. 2Department of Radiology and Radiation Oncology, Kitasato University School of Medicine, Sagamihara, Japan
  3. 3Department of Obstetrics and Gynecology, Kitasato University School of Medicine, Sagamihara, Japan
  4. 4Division of Molecular Medicine, Aichi Cancer Center Research Institute, Nagoya, Japan
  5. 5Department of Diagnostic Radiology, Kitasato University School of Medicine, Sagamihara, Japan
  1. Correspondence to: Associate Professor Yuzuru Niibe, MD, Ph.D., Department of Radiology, Toho University Omori Medical Center, 6-11-1, Omori-Nishi, Ota-ku, Tokyo 143-8541, Japan. Tel: +81 337624151, Fax: +81 337685386, e-mail: yniibe-toho{at}umin.org

Abstract

Aim: This phase II study using nedaplatin evaluated the effectiveness and safely of concurrent chemoradiotherapy for locally advanced uterine cervical carcinoma. Patients and Methods: Patients met the following eligibility criteria,: International Federation of Gynecology and Obstetrics (FIGO) stage Ib, IIa, IIb with bulky tumor (≥40 mm) or pelvic lymph node swelling (≥10 mm), in FIGO stage IIIa, IIIb or IVa. Treatment adopted external radiation therapy combined with intracavitary brachyhtherapy using weekly nedaplain at 30 mg/m2 totaling five cycles. The primary endpoint was 3-year overall survival. Results: From June 2005 to May 2010, 45 eligible patients with uterine cervical carcinoma were registered. Histopathology was squamous cell carcinoma in 36 and adenocarcinoma in nine. The median follow-up period was 39 months. The 3-year overall survival rate was 73.0% (95% confidence interval=56.2-84.2%). No severe acute or late toxicities occurred. Conclusion: This phase II study showed external radiation therapy combined with intracavitary brachyhtherapy using weekly nedaplain to be effective and safe.

Footnotes

  • Conflicts of Interest

    Dr. Niibe reports Grants from Shionogi &CO., Ltd. during part of the conduct of the study.

  • Received September 17, 2017.
  • Revision received October 15, 2017.
  • Accepted October 23, 2017.
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  1. Anticancer Research vol. 37 no. 12 6983-6988
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