Abstract
BackgroundTo evaluate the efficacy and safety of concurrent chemo-radiotherapy with weekly nedaplatin for the treatment of advanced squamous cell carcinoma of the uterine cervix.MethodsPatients 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).ResultsThirty 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.ConclusionsThis 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.
Highlights
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
In the 1990s, numerous attempts were made to improve the prognosis of advanced uterine cervical carcinoma with concurrent radiation therapy and chemotherapy
Patients Patients diagnosed with advanced squamous cell carcinoma of the uterine cervix were enrolled into this study according to the following criteria (Table 1)
Summary
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. Uterine cervical carcinomas have been treated via surgery, radiation therapy, or a combination of the two for a long time, the treatment outcomes were poor. In the 1990s, numerous attempts were made to improve the prognosis of advanced uterine cervical carcinoma with concurrent radiation therapy and chemotherapy. In February 1999, the US National Cancer Institute (NCI) stated that five randomized controlled trials of concurrent radiotherapy and chemotherapy (especially with the use of cisplatin) demonstrated that the treatment was the adverse events (especially gastrointestinal events) associated with cisplatinare usually severe. The radiation therapy leads to gastrointestinal adverse reactions as well. The concurrent application of these two therapies significantly aggravates gastrointestinal adverse reactions, making it more difficult for patients to tolerate. A drug with mild side effect is urgently needed for the concurrent chemo-radiotherapy
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