Treatment Outcomes of 257 Patients with Locoregionally Advanced Nasopharyngeal Carcinoma Treated with Nimotuzumab Plus Intensity-Modulated Radiotherapy with or without Chemotherapy: A Single-Institution Experience

Abstract

OBJECTIVES: To report the long-term outcome and toxicity of locoregionally advanced nasopharyngeal carcinoma (LA NPC) treated with nimotuzumab (h-R3) plus intensity-modulated radiotherapy (IMRT) with or without chemotherapy. METHODS: From May 2008 to March 2014, 3022 newly histology-proven, nonmetastatic NPC patients were retrospectively reviewed; among them, 257 patients treated with h-R3 were enrolled in this study. The patients' age range was between 10 and 76 years. The distribution of patients by disease stage was 150 (58.4%) in stage III, 88 (34.2%) in stage IV A, and 19 (7.4%) in stage IV B. All the patients received the treatment of h-R3 plus IMRT, and from them, 239 cases were also treated with cisplatin-based chemotherapy. Acute and late radiation-related toxicities were graded according to the Acute and Late Radiation Morbidity Scoring Criteria of Radiation Therapy Oncology Group. The accumulated survival was calculated according to the Kaplan-Meier method. Log-rank test was used to compare the survival difference. Multivariate analysis was performed using Cox's proportional-hazard model. RESULTS: All 257 patients had completed combined treatment; 231 patients received h-R3 plus IMRT with induction chemotherapy (IC), while 26 patients received only h-R3 plus IMRT. With a median follow-up of 48 months (range, 13-75 months), the estimated 5-year local recurrence-free survival, regional recurrence-free survival, distant metastases-free survival, progression-free survival, and overall survival (OS) rates were 94.3%, 94.8%, 91.9%, 83.4%, and 86.2%, respectively. Univariate analysis showed that age, T stage, clinical stage, and IC were related with OS. Multivariate analysis indicated that T stage and IC were independent prognostic factors for OS. The incidence of grade 3 to 4 acute mucositis and leukocytopenia was 10.9% and 19.8%, respectively, with no cases of skin rash and infusion reaction. Xerostomia was the most common late complication, and the degree of dry mouth in most survivors was mild to moderate at the last follow-up time. CONCLUSION: h-R3 plus IMRT with or without chemotherapy showed promising outcomes in terms of locoregional control and survival without increasing the incidence of radiation-related toxicities for patients.

WITHDRAWN: Radiation-induced acute injury of intensity-modulated radiotherapy versus three-dimensional conformal radiotherapy in induction chemotherapy followed by concurrent chemoradiotherapy for nasopharyngeal carcinoma: a prospective cohort study

“…The investigation of IMRT dose distribution to the skin in head and neck squamous cell carcinoma was reported the incidence of grade 3 and 4 radiation dermatitis was 41.1% in patients included and 50% vs 36.6% in the cetuximab and cisplatin cohorts, respectively [26]. Grade 3-4 hematologic toxicities and radiotherapy-related oral mucositis during the period of locoregionally advanced nasopharyngeal carcinoma treated with nimotuzumab plus IMRT with chemotherapy were reported in 7.4% and 10.9% patients, and there were only 8.6% patients who complained of serious xerostomia [27]. The patients experienced severity toxic effects or cannot tolerate it during irradiation, which would either delay or suspend treatment.…”

Effectiveness and cost-effectiveness analysis of nimotuzumab for the radiotherapy of locoregionally advanced nasopharyngeal carcinoma

“…To further improve the therapeutic outcomes, many clinical trials have explored the effects of radiotherapy and chemotherapy administered in combination with novel therapies. With in-depth characterization of the molecular mechanisms of carcinogenesis and cancer progression, molecular targeted therapy for NPC patients has become a research hotspot [ 10 ]. The high expression of EGFR in NPC has been evaluated as a potential therapeutic target.…”

“…Epidermal growth factor receptor (EGFR) overexpression is observed in more than 80% of NPC [ 8 ], and is associated with tumor invasiveness, treatment resistance, and poor prognosis [ 9 ]. Nimotuzumab (NTZ) is a blocking monoclonal antibody against EGFR, which is highly humanized and has a higher effective dose concentration compared with other anti-EGFR drugs [ 10 ]. Nimotuzumab is designed to reduce immunoreactivity and to enhance radio sensitivity with few serious complications and acceptable safety.…”

WITHDRAWN: Radiation-Induced Acute Injury of Intensity-Modulated Radiotherapy vs. Three-Dimensional Conformal Radiotherapy in Induction Chemotherapy Followed by Concurrent Chemoradiotherapy for Locoregionally Advanced Nasopharyngeal Carcinoma: A Prospective Cohort Study

“…26 Grade 3-4 hematologic toxicities and radiotherapy-related oral mucositis during the period of locoregionally advanced nasopharyngeal carcinoma treated with nimotuzumab plus IMRT with chemotherapy were reported in 7.4% and 10.9% patients, and there were only 8.6% patients who complained of serious xerostomia. 27 The patients experienced severity toxic effects or cannot tolerate it during irradiation, which would either delay or suspend treatment. Nevertheless, it appears that wide rate of radiation-induced acute injuries may speculate on radiation technique, chemotherapy scheduling and the location of tumor.…”