Department of Radiaotherapy, Jiangsu Cancer Hospital & Jiangsu Institute of Cancer Research, The Affiliated Cancer Hospital of Nanjing Medical University, Nanjing, China.
Department of Radiotherapy, Xuzhou Center Hospital, Xuzhou, China.
Cancer Med. 2020 Sep;9(17):6166-6172. doi: 10.1002/cam4.3260. Epub 2020 Jul 12.
This study aimed to compare the efficacy and toxicity of raltitrexed (Saiweijian ) plus cisplatin (SP regimen) and 5-fluorouracil plus cisplatin (FP regimen) as concurrent chemoradiotherapy (CCRT) in patients with locally advanced nasopharyngeal carcinoma (LA-NPC).
Eligible patients (N = 135) were allocated randomly in a ratio of 1:1 to receive CCRT with either SP or FP. At least 2 cycles of chemotherapy was administrated during radiotherapy. Progression free survival (PFS) was primary endpoint. Secondary endpoints included overall survival (OS), loco-regional relapse free survival (LRRFS), distant metastasis free survival (DMFS) and toxicity.
In this study, 68 patients received SP as CCRT, and 67 received FP. Objective responses were noted in 97.1% of the patients in the SP group and in 97.0% of the patients in the FP group (P = 1.00). At the end of a median 36 months follow-up period, the estimated 3-year PFS rates were 70.1% for SP and 66.6% for FP, respectively. The 3-year LRRFS, DMFS and OS rates were 88.9%, 74.7% and 84.0%, respectively, for the SP group, and 92.3%, 71.0% and 73.7%, respectively, for the FP group. Overall, there was no difference between treatment groups with regard to response or survival. The most frequent acute toxicities monitored in both groups were bone marrow suppression, gastrointestinal side effects and oral mucositis (OM). The overall incidence of grade 3-4 OM in the FP group (47.8%) was higher than in the SP group (11.8%). However, the incidence of other adverse effects observed in both groups was similar (P > .05).
These data indicate that SP and FP therapies have similar efficacy in treating LA-NPC. The SP regimen showed a tolerable safety profile along with a lower frequency of severe OM and therefore, an improved life quality. In conclusion, SP was a well tolerated, effective, regimen for LA-NPC treatment.
本研究旨在比较雷替曲塞（赛维健）联合顺铂（SP 方案）与 5-氟尿嘧啶联合顺铂（FP 方案）作为局部晚期鼻咽癌（LA-NPC）患者同步放化疗（CCRT）的疗效和毒性。
符合条件的患者（N=135）按 1:1 的比例随机分配接受 SP 或 FP 的 CCRT。在放疗期间至少给予 2 个周期的化疗。无进展生存期（PFS）是主要终点。次要终点包括总生存期（OS）、局部区域无复发生存期（LRRFS）、远处转移无复发生存期（DMFS）和毒性。
在这项研究中，68 例患者接受 SP 作为 CCRT，67 例患者接受 FP。SP 组患者的客观缓解率为 97.1%，FP 组为 97.0%（P=1.00）。在中位 36 个月的随访期结束时，SP 组的 3 年 PFS 率为 70.1%，FP 组为 66.6%。SP 组的 3 年 LRRFS、DMFS 和 OS 率分别为 88.9%、74.7%和 84.0%，FP 组分别为 92.3%、71.0%和 73.7%。总的来说，两组在反应或生存方面没有差异。两组监测到的最常见的急性毒性是骨髓抑制、胃肠道副作用和口腔黏膜炎（OM）。FP 组（47.8%）的 3-4 级 OM 总发生率高于 SP 组（11.8%）。然而，两组观察到的其他不良反应发生率相似（P>.05）。
这些数据表明 SP 和 FP 疗法在治疗 LA-NPC 方面具有相似的疗效。SP 方案具有可耐受的安全性特征，严重 OM 的发生率较低，因此生活质量得到改善。总之，SP 是一种耐受良好、有效的 LA-NPC 治疗方案。
