Song Xinmao, Wang Shengzi, Li Ji, Yan Li, Chen Fu, Wang Jie
Department of Radiation Oncology, Eye, Ear, Nose and Throat Hospital of Fudan University, Shanghai, China.
Department of Otorhinolaryngology, Eye, Ear, Nose and Throat Hospital of Fudan University, Shanghai, China.
Arch Med Sci. 2019 Jul 17;17(5):1317-1324. doi: 10.5114/aoms.2019.86712. eCollection 2021.
This study investigated the best mode for the application of nimotuzumab (Nimo) in combination with chemoradiotherapy to treat nasopharyngeal carcinoma (NPC).
Data were prospectively collected from 168 patients with NPC from September 2009 to February 2014. One hundred twelve patients received 2-3 cycles of induction chemotherapy (IC) followed by concurrent chemoradiotherapy (CCRT), and 56 patients with well-matched propensity scores received IC + CCRT + Nimo. Patients were divided into 3 subgroups according to the application schedule of Nimo: group A, IC + CCRT; group B: IC (combined with Nimo) + CCRT; and group C: IC + CCRT (combined with Nimo). The 5-year overall survival (OS) and progression-free survival (PFS) and adverse events were investigated.
With a median follow-up of 61.4 months (range: 1.7-96.5 months), the 5-year OS and PFS for group A vs. groups B + C were 74.8 ±4.1% versus 87.0 ±4.6% ( = 0.043) and 72.7 ±4.3% vs. 83.1 ± 5.1% ( = 0.243), respectively. The 5-year OS of group B was significantly improved over that of group A (93.0 ±4.8% vs. 74.8 ±4.1%, = 0.038); however, there was no benefit to the 5-year PFS (89.3 ±5.9% vs. 72.7 ±4.3%, = 0.144). The 5-year OS and PFS for group C were 80.4 ±7.9% and 76.4 ±8.5%, respectively, and there was no statistically significant difference from group A ( = 0.257 and = 0.611, respectively). No significant increase in toxicities was observed with the addition of Nimo.
Nimo administered with chemoradiotherapy is effective for NPC. Nimo concurrent with IC followed by CCRT could be the optimal mode of sequential treatment.
本研究探讨了尼妥珠单抗（Nimo）联合放化疗治疗鼻咽癌（NPC）的最佳应用模式。
前瞻性收集2009年9月至2014年2月期间168例NPC患者的数据。112例患者接受2 - 3周期诱导化疗（IC），随后进行同步放化疗（CCRT），56例倾向评分匹配良好的患者接受IC + CCRT + Nimo。根据Nimo的应用方案将患者分为3个亚组：A组，IC + CCRT；B组：IC（联合Nimo）+ CCRT；C组：IC + CCRT（联合Nimo）。研究5年总生存期（OS）、无进展生存期（PFS）及不良事件。
中位随访61.4个月（范围：1.7 - 96.5个月），A组与B + C组的5年OS分别为74.8±4.1%和87.0±4.6%（P = 0.043），5年PFS分别为72.7±4.3%和83.1±5.1%（P = 0.243）。B组的5年OS显著优于A组（93.0±4.8%对74.8±4.1%，P = 0.038）；然而，5年PFS无获益（89.3±5.9%对72.7±4.3%，P = 0.144）。C组的5年OS和PFS分别为80.4±7.9%和76.4±8.5%，与A组无统计学显著差异（分别为P = 0.257和P = 0.611）。添加Nimo后未观察到毒性显著增加。
Nimo联合放化疗对NPC有效。Nimo与IC同步，随后进行CCRT可能是序贯治疗的最佳模式。
