Purpose: 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.
Methods: 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.
Results: 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).
Conclusions: 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.