A phase II study of concurrent chemo-radiotherapy with weekly nedaplatin in advanced squamous cell carcinoma of the uterine cervix

BACKGROUND: To evaluate the efficacy and safety of concurrent chemo-radiotherapy with weekly nedaplatin for the treatment of advanced squamous cell carcinoma of the uterine cervix. METHODS: Patients with stage Ib2 to IIIb squamous cell carcinoma of the uterine cervix were treated with concurrent radiotherapy and chemotherapy. The radiotherapy regimen included external beam radiation therapy (45–50.4Gy/25-28 fractions with central shielding after 30.6Gy) and high-dose-rate brachytherapy irradiation (35-49Gy/5-7 fractions to point A). The chemotherapy regimen was weekly intravenous infusion of nedaplatin (30 mg/m(2), once weekly, 180 mg/m(2) for 6 weeks). RESULTS: Thirty patients were enrolled in this study from April 2010 to October 2010. The median age was 50.5 years (34–62). Three patients were at the clinical stage IIa2, twenty at stage IIb and seven at stage IIIb. Acute hematological toxicities included grade 3 leukopenia (8), neutropenia (5), anemia (2), grade 4 anemia (1), and grade 2 thrombocytopenia (6). Acute non-hematological toxicities included grade 2 liver disorders (1), diarrhea (2), nausea (2), and renal toxicity (1). There were not grade 3 or worse toxicities. 24 patients completed the treatment regimen and were evaluated for efficacy. 23 patients (95.8%) had CR (complete response) and 1 (4.2%) had PR (partial response) (100% response rate). The median follow-up duration was 36 months (23–39), during which three patients relapsed after the treatment. The 3-year PFS and OS rates were 87.5% and 91.7%, respectively. CONCLUSIONS: This phase II study suggested that concurrent chemo-radiotherapy with weekly nedaplatin was effective and safe for the treatment of advanced squamous cell carcinoma of the uterine cervix.