Department of Radiation Oncology, Affiliated Hospital of Guilin Medical University, Key Laboratory of Oncology (Guilin Medical University), Education Department of Guangxi Zhuang Autonomous Region, 15 Lequn Road, 541001, Guilin, China.
Department of Radiation Oncology, Wuzhou Red Cross Hospital, 543002, Wuzhou, China.
Strahlenther Onkol. 2024 Oct;200(10):867-875. doi: 10.1007/s00066-024-02201-1. Epub 2024 Feb 7.
This study aimed to investigate the clinical benefit of adding concurrent chemotherapy to intensity-modulated radiotherapy (IMRT) for nasopharyngeal carcinoma (NPC) patients with an intermediate risk (stage II and T3N0M0).
A multicenter phase II randomized trial was conducted in intermediate-risk NPC patients. Enrolled patients were previously untreated and aged ranged from 18 to 70 years without severe coexisting diseases. Patients were randomly assigned to receive IMRT alone or IMRT+concurrent chemotherapy (CC; three cycles of 80 mg/m cisplatin every 3 weeks). Primary endpoint was defined as 3‑year progression-free survival (PFS). The secondary endpoints were distant metastasis-free survival (DMFS), locoregional relapse-free survival (LRRFS), overall survival (OS), and treatment-associated toxicity. We registered this study with Chinese Clinical Trial Registry (CliCTR1800017132; registered July 13, 2018, study start July 13, 2018).
From November 2015 to July 2019, 42 patients with stage II and T3N0M0 NPC were enrolled; 20 patients received IMRT alone while 22 patients received IMRT+CC. After a median of 58 months of follow-up, we estimated the 3‑year PFS rates as 90% (IMRT group) and 86.4% (IMRT+CC group; hazard ratio 1.387, 95% confidence interval 0.240-8.014; P = 0.719). The 3‑year PFS, OS, and cumulative DMFS and LRRFS showed no significant differences between the two groups (P > 0.05). However, the IMRT group displayed a lower incidence of nausea/vomiting, leucopenia, and dry mouth than the IMRT+CC group.
Adding CC to IMRT provided no survival benefit but increased treatment-associated toxicities in patients with intermediate-risk NPC.
本研究旨在探讨中危（Ⅱ期和 T3N0M0）鼻咽癌患者在调强放疗（IMRT）基础上联合同期化疗的临床获益。
一项多中心Ⅱ期随机临床试验纳入了未经治疗的中危鼻咽癌患者，年龄 18-70 岁，无严重并存疾病。患者被随机分为单纯 IMRT 组或 IMRT+同期化疗（CC；每 3 周给予 80mg/m2顺铂 3 个周期）组。主要终点为 3 年无进展生存（PFS）。次要终点为无远处转移生存（DMFS）、无局部区域复发生存（LRRFS）、总生存（OS）和治疗相关毒性。本研究在中国临床试验注册中心（注册号：CliCTR1800017132；注册日期：2018 年 7 月 13 日，研究开始日期：2018 年 7 月 13 日）进行了注册。
2015 年 11 月至 2019 年 7 月，共纳入 42 例Ⅱ期和 T3N0M0 期鼻咽癌患者，20 例患者接受单纯 IMRT，22 例患者接受 IMRT+CC。中位随访 58 个月后，我们估计 3 年 PFS 率分别为 90%（IMRT 组）和 86.4%（IMRT+CC 组；危险比 1.387，95%置信区间 0.240-8.014；P=0.719）。两组间 3 年 PFS、OS 和累积 DMFS、LRRFS 无显著差异（P＞0.05）。然而，IMRT 组恶心/呕吐、白细胞减少和口干的发生率低于 IMRT+CC 组。
在中危鼻咽癌患者中，IMRT 基础上联合 CC 治疗并未带来生存获益，反而增加了治疗相关毒性。
