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

Abstract

Doc number: 55

Abstract

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/m² , once weekly, 180 mg/m² 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.