Clinical Outcomes Of Patients With Stage T4 Nasopharyngeal Carcinoma Treated With Rituximab Plus RadiotheraPy

Objective:To explore the clinical efficacy and toxicity of cetuximab combined with chemotherapy and factors influencing the prognosis of T4 stage of comprehensive treatment of T4 nasopharyngeal carcinoma (NPC).Methods and Materials:RetrosPectively collected in our hospital in 2006 January to 2012 to December of T4 stage (UICC2002 staging) all cetuximab therapy and radical intensity-modulated radiotherapy (IMRT) in Patients with nasoPharyngeal carcinoma (NPC) received a total of 30 cases, as treatment group. Matching treatment groups of patients with age, sex, pathology, N staging, dose of radiotherapy and chemotheraPy screened in 2006 January to December 2012 to accept radical IMRT treatment and without any target to drug treatment of T4 nasoPharyngeal carcinoma Patients in 30 cases, as the control group. The median age was 42 years (17-69 years old). The initial dose of rituximab was 400mg/m2 Per week, followed by 250mg/m2, a total of 4-13 times a week.Nasopharyngeal gross tumor volume (GTVnx) in a dose D95 74Gy 69.4～80.6Gy/30～37F, high-risk clinical target volume (CTV1) in a dose D95 66gy 60～70Gy/29～34F, low-risk clinical target volume (CTV2) in a dose D95 58Gy 45～62Gy/25～33F.The treating Physician is shown according to the CT/MRI target area, midcourse correction of target 1-6, and by the Physician with a suPerior audit. All Patients were treated with cisplatin based concurrent chemotherapy.78% Patients with cisplatin based neoadjuvant or adjuvant chemotherapy. The local regional control rate, survival and subgroups and toxicity of the two groups were statistically analyzed. Survival analysis using the KaPlan Meier method and group survival were compared using the log-rank test, multivariate analysis by Cox Proportional hazard regression model, the toxicity of statistics the Crosstabs of chi square test.Results:All the 60 Patients were followed up for more than 36 months, and the median follow-up time was 51 months. The results of statistical analysis showed that cetuximab treatment group and control group in 5-year OS were 69.7% and 56.6%(P=0.384). The treatment group and the control group in 5-year PFS were 58.3%、55.3% (P=0.72); 5-year DMFS were 68.1%、61.4%(P=0.689).5-year LCR were 100%,87.3%(P=0.071).On T stage subgroups of infringement parts detailed classification,masticatory muscle violations subgroups of OS, PFS, improved significantly, P=0.041,0.066, respectively.The rest of the group of survival is no statistical significance.Cetuximab treatment groups of multi factor analysis, the results show that treatment of anemia is influential factors of OS (P=0.007) and PFS (P=0.046),Pathological types were independent factors affecting OS (P = 0.019), N staging may affect the result of OS (P= 0.068).Whether to use cetuximab treatment may affect the result of OS,but P= 0.068.In line with the OS the survival curves separate the trend, because of small sample size and no statistical significance.According to the T4 nasal Pharyngeal substructure violations, dural invasion is influential factors of OS、PFS and DMFS (P= 0.019、0.003、<0.001).Patient age, sex, whether neoadjuvant, cetuximab use cycle and other substructure invasion is not affect survival factors. Toxicity was evaluated according to CTCAE 3.0, EORTC/RTOG standard. Most of the acute toxicity of the two groups were in 1-2 degrees, above level 3 main blood learn toxicity and oral mucosa reaction, in the early response statistics celecoxib treatment group oral mucosa reaction serious than control group significantly (P= 0.006), acne like rash of occurrence rate than that of the control group increased significantly (P= 0.000). The main level is above 3 late reaction for hearing impairment, the incidence rate of no significant difference between two groups in the late reaction.Conclusion:Cetuximab combined with chemoradiotherapy may improve local Regiona lcontrol rate of T4 Patients with nasopharyngeal carcinoma, also has a tendency to promote OS, especially for patients T4 invaded the masticatory muscle clearance OS obtain obvious improve, for many of the survival of other subgroups have ascending trend, to expand the sample continue to follow-up.Tumor anemia is OS T4 patients before treatment and the influence factors of PFS;The influence factors of the WHO III pathological type is OS;N staging, the higher the OS the worse, cetuximab treatment can raise the OS. Nasopharyngeal Primary dural invasion will significantly reduce the survival outcome of Patients with T4, especially DMFS.Cetuximab combined with radiotherapy and chemotherapy can increase T4 Patients with oral mucosa reaction and acne like rash, but were within the acceptable range, does not increase the late toxicities.