Department of Otorhinolaryngology, Weifang People's Hospital, Weifang, China.
J BUON. 2021 Jan-Feb;26(1):116-123.
To investigate the efficacy and safety of nimotuzumab + cisplatin and 5-fluorouracil (PF) induction chemotherapy combined with concurrent chemoradiotherapy in treating locally advanced nasopharyngeal carcinoma.
The clinical data of 126 patients with stage III-IVa nasopharyngeal carcinoma who were admitted to and treated in our department from September 2013 to May 2016 were collected, and the patients were randomly divided into two groups and treated with nimotuzumab combined with PF induction therapy (NPF group, n=65) and induction therapy of docetaxel, cisplatin and fluorouracil (TPF) regimen (TPF group, n=65). After 2 cycles of induction therapy, all the patients received cisplatin combined with concurrent intensity-modulated radiation therapy (IMRT). Moreover, the clinical efficacy, changes in patients' quality of life and incidence of adverse reactions were observed and compared between the two groups, and the survival of the patients was followed up and recorded.
The objective response rate (ORR) and disease control rate (DCR) were remarkably higher in NPF group than those in TPF group [78.5% (51/65) vs. 58.5% (38/65), 93.8% (61/65) vs. 80.0% (52/65)] (p=0.014, p=0.019). During induction therapy, the patients in NPF group had notably ameliorated leukopenia compared with those in TPF group (p=0.018). Only 8 cases of skin rash (grade I) occurred in NPF group (p=0.004), which subsided spontaneously after treatment with nimotuzumab. In the stage of concurrent chemoradiotherapy, NPF group exhibited better tolerance to treatment, but there were no statistically significant differences in adverse reactions between the two groups (p>0.05). Besides, according to the scores of functional assessment of cancer therapy-head and neck (FACT-H&N) scale for measuring the quality of life of patients with head and neck neoplasms in the two groups after treatment, the quality-of-life scores were improved to different extents in both groups. Besides, the functional status score [(19.85±4.74) points vs. (18.14±4.49) points, p=0.037], head and neck additional items score [(23.95±5.20) points vs. (22.21±4.84) points, p=0.040] and total scale score [(108.55±14.65) points vs. (104.65±13.23) points, p=0.023] in NPF group were markedly superior to those in TPF group. It was shown in the results of follow-up that the median overall survival (OS) was (18.9±3.6) months and (16.3±3.8) months in NPF group and TPF group, respectively. Through log-rank test, it was found that the OS was distinctly longer in NPF group than that in TPF group (p=0.017).
Compared with TPF induction chemotherapy, nimotuzumab and PF induction chemotherapy combined with concurrent chemoradiotherapy results in better short-term clinical efficacy in treating locally advanced nasopharyngeal carcinoma, higher quality of life and long-term survival rate as well as tolerable adverse reactions.
研究尼妥珠单抗联合顺铂和氟尿嘧啶（PF）诱导化疗联合同期放化疗治疗局部晚期鼻咽癌的疗效和安全性。
收集 2013 年 9 月至 2016 年 5 月在我科收治的 126 例局部晚期鼻咽癌患者的临床资料，将患者随机分为两组，分别接受尼妥珠单抗联合 PF 诱导化疗（NPF 组，n=65）和多西紫杉醇、顺铂和氟尿嘧啶诱导化疗（TPF 组，n=65）。2 个周期诱导化疗后，所有患者均接受顺铂联合同步调强放疗（IMRT）。观察并比较两组患者的临床疗效、生活质量变化及不良反应发生率，随访并记录患者的生存情况。
NPF 组客观缓解率（ORR）和疾病控制率（DCR）显著高于 TPF 组[78.5%（51/65）比 58.5%（38/65），93.8%（61/65）比 80.0%（52/65）]（p=0.014，p=0.019）。在诱导化疗期间，NPF 组白细胞减少的发生率明显低于 TPF 组（p=0.018）。NPF 组仅 8 例出现皮疹（I 级）（p=0.004），经尼妥珠单抗治疗后皮疹自行消退。在同期放化疗阶段，NPF 组对治疗的耐受性更好，但两组不良反应发生率无统计学差异（p>0.05）。此外，根据两组患者治疗后头颈部肿瘤功能评估癌症治疗-头颈部（FACT-H&N）量表测量的生活质量评分，两组患者的生活质量评分均有不同程度的提高。此外，NPF 组的功能状态评分[（19.85±4.74）分比（18.14±4.49）分，p=0.037]、头颈部附加项目评分[（23.95±5.20）分比（22.21±4.84）分，p=0.040]和总评分[（108.55±14.65）分比（104.65±13.23）分，p=0.023]明显优于 TPF 组。随访结果显示，NPF 组和 TPF 组的中位总生存期（OS）分别为（18.9±3.6）个月和（16.3±3.8）个月。通过对数秩检验发现，NPF 组的 OS 明显长于 TPF 组（p=0.017）。
与 TPF 诱导化疗相比，尼妥珠单抗联合 PF 诱导化疗联合同期放化疗治疗局部晚期鼻咽癌具有更好的短期临床疗效、更高的生活质量和长期生存率，且不良反应可耐受。
