Concurrent Chemoradiotherapy with Triweekly Nedaplatin versus Weekly Nedaplatin in Stage II–IVa Nasopharyngeal Carcinoma

Abstract

Nedaplatin is currently considered to be similar effectiveness but less gastrointestinal toxicity than cisplatin in term of concurrent chemoradiotherapy in treating patients with advanced nasopharyngeal carcinoma. Our trial is in order to compare the effectiveness of triweekly nedaplatin versus weekly nedaplatin with intensity-modulated radiation therapy (IMRT) chemoradiotherapy in treating patients with locoregional, stage II–IVa nasopharyngeal carcinoma. Patients aged 18–65 years with non-keratinizing stage II–IVa (T1–4N1–3 or T3–4N0) nasopharyngeal carcinoma, a Karnofsky score of at least 70, and adequate hematological, renal, and hepatic function were randomly assigned (1:1) to receive intravenously either nedaplatin 100 mg/m2 triweekly for three cycles or nedaplatin 40 mg/m2 weekly for seven cycles concurrently with intensity-modulated radiotherapy. The primary endpoint was progression-free survival at 2 years and the prespecified secondary endpoints was toxicity profile. This trial is currently in follow-up. We randomly assigned 60 patients to triweekly nedaplatin-based (n = 30) or weekly nedaplatin-based (n = 30) concurrent chemoradiotherapy. The 2-year progression-free survival was 82.4% (95% CI 73.2–91.6) in the triweekly nedaplatin group and 80.0% (95% CI 71.1–88.9) in the weekly nedaplatin group, with no statistically significant difference (P = 0.91). Patients in the triweekly nedaplatin group had a higher frequency of grade 3 or 4 leukopenia than did patients in the weekly nedaplatin group (grade 3 or 4: 9 [15.0%] in the triweekly nedaplatin group vs 4 [6.7%] in the weekly nedaplatin group, P<0.05). 4 (6.7%) patients in the triweekly nedaplatin group had grade 3 or 4 thrombocytopenia compared with 3 (5%) in the weekly nedaplatin group (P>0.05). The frequencies of any grade or grade 3 or 4 adverse events of mucositis, dermatitis, dysphagia, pain, dry mouth, vomiting, nausea, fatigue and anorexia did not differ between the treatment groups. No patients died from treatment-related causes. Our study reveals that the use of weekly nedaplatin-based concurrent chemoradiotherapy is an effective regimen as well as lowering the incidence of severe leukopenia, therefore improving patient tolerability and compliance.