Abstract

Nedaplatin-based concurrent chemoradiotherapy (CCRT) regimen at 2 years was noninferior to cisplatin-based regimen in patients with locoregional, stage II to IVB nasopharyngeal carcinoma (NPC) and was associated with fewer late adverse events, but longer-term outcomes and toxicity are unclear. To evaluate the 5-year outcomes and late toxicity profile of nedaplatin-based CCRT in patients with locoregional, stage II to IVB NPC. This 5-year follow-up secondary analysis of an open-label, noninferiority, multicenter randomized clinical trial enrolled patients with nonkeratinizing stage II to IVB NPC between January 16, 2012, and July 16, 2014, with a median follow-up duration of 78 months (IQR, 3-99 months). Data analysis was conducted from November 10, 2020, to July 8, 2021. Patients were randomly assigned (1:1) to receive nedaplatin (100 mg/m2)- or cisplatin (100 mg/m2)-based chemotherapy every 3 weeks for 3 cycles concurrently with intensity-modulated radiotherapy. The primary end point was progression-free survival (PFS). Secondary end points were overall survival, distant metastasis-free survival, and locoregional relapse-free survival. A total of 402 eligible participants were enrolled (median [IQR] age, 45 [18-65] years; 302 [75.1%] male). Patients were randomly assigned to receive nedaplatin- or cisplatin-based CCRT (n = 201 for each): 196 patients (97.5%) started nedaplatin-based CCRT and 197 patients (98.0%) started cisplatin-based CCRT. Intention-to-treat analysis demonstrated a 5-year progression-free survival rate of 81.4% (95% CI, 75.9%-86.9%) for the cisplatin group and 79.8% (95% CI, 74.1%-85.5%) for nedaplatin group, with a difference of 1.6% (95% CI, -6.3% to 9.5%; P = .002 for noninferiority). No significant survival differences were observed between the cisplatin and nedaplatin groups for 5-year overall survival (89.4% vs 88.8%, P = .63), distant metastasis-free survival (85.9% vs 90.4%, P = .17), and locoregional relapse-free survival (92.6% vs 89.6%, P = .17) rates. The cisplatin group had a higher incidence of grade 3 and 4 auditory toxic effects than the nedaplatin group (35 [17.7%] vs 21 [10.5%], P = .04). In this secondary analysis of a randomized clinical trial, long-term analysis confirmed that nedaplatin-based CCRT could be regarded as an alternative doublet treatment strategy to cisplatin-based CCRT in stage II to IVB NPC. ClinicalTrials.gov Identifier: NCT01540136.

Highlights

  • No significant survival differences were observed between the cisplatin and nedaplatin groups for 5-year overall survival (89.4% vs 88.8%, P = .63), distant metastasis–free survival (85.9% vs 90.4%, P = .17), and locoregional relapse–free survival (92.6% vs 89.6%, P = .17) rates

  • Nedaplatin vs Cisplatin Among Patients With Stage II to IVB Nasopharyngeal Carcinoma. In this secondary analysis of a randomized clinical trial, long-term analysis confirmed that nedaplatin-based concurrent chemoradiotherapy (CCRT) could be regarded as an alternative doublet treatment strategy to cisplatin-based CCRT in stage II to IVB Nasopharyngeal carcinoma (NPC)

  • Publication of the early results of this trial included details of adverse events during treatment and the quality of life of patients.[9]. In this long-term analysis, we evaluated the late adverse events that occurred after the concurrent chemotherapy with nedaplatin or cisplatin (Table 2)

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Summary

Introduction

Nasopharyngeal carcinoma (NPC) is endemic in Southeast Asia and Southern China, and an age-standardized incidence rate of 3.0 to 10.2 per 100 000 population has been reported in China.[1,2,3] On the basis of its epidemiologic outcomes, aggressive behavior, and coexistence with Epstein-Barr virus (EBV) infection, NPC can be differentiated from other head and neck malignant tumors.[4,5] Cisplatin-based concurrent chemoradiotherapy (CCRT) has been established as the mainstay and standard of care for locoregionally advanced NPC based on several meta-analyses and prospective randomized clinical trials.[6,7,8] Radiotherapy administered concurrently with 100 mg/m2 of cisplatin every 3 weeks is recommended by the National Comprehensive Cancer Network for patients with stage II to IVB NPC. Another antitumor drug with similar therapeutic efficacy and fewer adverse effects is urgently needed

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