Concurrent Chemoradiotherapy With Nedaplatin vs Cisplatin in Nasopharyngeal Carcinoma
As reported in The Lancet Oncology by Tang et al, a Chinese phase III noninferiority trial has shown similar progression-free survival with nedaplatin- vs cisplatin-based chemoradiotherapy in patients with stage II to IVB nasopharyngeal carcinoma, with nedaplatin being associated with fewer severe adverse events.
Nedaplatin is a cisplatin derivative developed to reduce toxicity associated with cisplatin.
Study Details
In the open-label trial, 402 patients aged 18–65 years with nonkeratinizing stage II to IVB (T1-4N1-3 or T3-4N0) disease from two Chinese centers were randomized between January 2012 and July 2014 to receive nedaplatin-based (n = 201) or cisplatin-based (n = 201) concurrent chemoradiotherapy. Treatment consisted of intravenous nedaplatin 100 mg/m² or cisplatin 100 mg/m² on days 1, 22, and 43 for three cycles with concurrent intensity-modulated radiotherapy. The primary endpoint was progression-free survival at 2 years, with noninferiority shown if the upper limit of the 95% confidence interval (CI) for the difference between groups did not exceed 10%. Analyses were by both intention to treat and per protocol (all patients who received at least one complete cycle of chemotherapy).
Progression-Free Survival
In the intention-to-treat population, 2-year progression-free survival was 88.0% in the nedaplatin group vs 89.9% in the cisplatin group, with a difference of 1.9% (95% CI = -4.2% to 8.0%, P for noninferiority = .0048). For 196 patients in the nedaplatin group and 197 in the cisplatin group in per-protocol analysis, 2-year progression-free survival was 88.7% vs 89.7%, with a difference of 1.0% (95% CI = -5.2% to 7.0%, P for noninferiority = .0020).
Adverse Events
Grade 3 or 4 vomiting (18% vs 6%), nausea (9% vs 2%), anorexia (27% vs 13%), weight loss (6% vs 2%), hypokalemia (5% vs < 1%), and hyponatremia (5% vs < 1%) were more common in the cisplatin group; grade 3 or 4 thrombocytopenia was more common in the nedaplatin group (6% vs 2%). No significant between-group differences were observed in rates of grade 3 or 4 leukopenia, neutropenia, anemia, constipation, hiccups, mucositis, dysphagia, dermatitis, allergic reaction, pain, fever, auditory or hearing toxicity, dry mouth, or hypocalcemia. A higher frequency of grade 3 or 4 late auditory/hearing toxicity occurred in the cisplatin group (6% vs 2%). No treatment-related deaths were reported.
The investigators concluded, “Our findings show that nedaplatin-based concurrent chemoradiotherapy represents an alternative…treatment strategy to cisplatin-based concurrent chemoradiotherapy for patients with locoregional, advanced nasopharyngeal carcinoma. Further investigations are needed to explore the potential use of this treatment as induction or adjuvant chemotherapy or in combination with other agents.”
The study was funded by the National Key R&D Program of China, National Natural Science Foundation of China, Sun Yat-sen University Clinical Research 5010 Program, and others.
Hai-Qiang Mai, MD, of the Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center, Guangzhou, is the corresponding author for The Lancet Oncology article.
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