Niibe Yuzuru, Onda Takashi, Matsuo Keitaro, Inoue Yusuke, Hayakawa Kazushige
Department of Radiology, Toho University Omori Medical Center, Tokyo, Japan
Department of Radiology and Radiation Oncology, Kitasato University School of Medicine, Sagamihara, Japan.
Anticancer Res. 2017 Dec;37(12):6983-6988. doi: 10.21873/anticanres.12166.
This phase II study using nedaplatin evaluated the effectiveness and safely of concurrent chemoradiotherapy for locally advanced uterine cervical carcinoma.
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/m totaling five cycles. The primary endpoint was 3-year overall survival.
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.
This phase II study showed external radiation therapy combined with intracavitary brachyhtherapy using weekly nedaplain to be effective and safe.
本项使用奈达铂的II期研究评估了同步放化疗对局部晚期子宫颈癌的有效性和安全性。
患者符合以下入选标准：国际妇产科联盟（FIGO）分期为Ib、IIa、IIb且肿瘤体积较大（≥40mm）或盆腔淋巴结肿大（≥10mm），或FIGO分期为IIIa、IIIb或IVa。治疗采用外照射放疗联合腔内近距离放疗，每周使用奈达铂30mg/m²，共五个周期。主要终点为3年总生存率。
2005年6月至2010年5月，登记了45例符合条件的子宫颈癌患者。组织病理学检查显示，36例为鳞状细胞癌，9例为腺癌。中位随访期为39个月。3年总生存率为73.0%（95%置信区间=56.2-84.2%）。未发生严重的急性或晚期毒性反应。
本II期研究表明，外照射放疗联合腔内近距离放疗并每周使用奈达铂是有效且安全的。
