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

摘要

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/m(2) 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.