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Objective:In recent years,the combination of cetuximab and chemoradiotherapy(CRT) has been used to treat stage III non-small cell lung cancer(NSCLC);however,limited data are available for Chinese patients.Herein,we report preliminary data from a phase Ⅰ/Ⅱ study testing the combination of cetuximab with inductive chemotherapy,followed by concurrent CRT(CCRT) in Chinese patients with stage HI NSCLC.Methods:Eligibility criteria were Zubrod performance status(PS) 0-1,forced expiratory volume in 1 second(FEVl) >1.2 L and adequate organ function.Enrolled patients received weekly cetuximab(initial dose of400 mg/m~2 on day 1 of week 1 and a maintenance dose of 250 mg/m~2 on week 2 to the end of CCRT) with cisplatin/vinorelbine(NP) chemotherapy(every 3 weeks for 2 cycles from week 2,followed by two cycles of concomitant NP chemotherapy and intensity-modulated thoracic radiotherapy(TRT)(60-66 Gy/2 Gy).The primary endpoints were toxicity and feasibility.All patients received positron emission tomographycomputerized tomography(PET-CT) scans within the 2 weeks prior to enrollment.Univariate analyses were used to assess the correlation between SUV-T,SUV-N,SUV-TOTAL,gender,age,histology,tumor-nodemetastasis(TNM) stage,PS and smoking status and survival.Survival curves were generated for different populations using the Kaplan-Meier method and compared using a log-rank test.Results:Seventeen patients were enrolled and 16 completed the full regime.The overall response rate(ORR)was 58.8%and 82.3%after the induction and CCRT phases,respectively.With a median follow-up duration of 27.6 months,the median survival was 27.6 months[95%confidence interval(CI):11.3-43.9 months]with 1-and 2-year survival rates of 88.2%(95%CI,60.6-96.9%) and 58.8%(95%CI,60.6-77.8%),respectively.Three patients remain progression-free to date,and the median progression-free survival(PFS) was 13.5 months(95%CI,6.8-20.2 months).No treatment-related death occurred;however,76%of the patients experienced grade3+ adverse events(AEs),including nausea/vomiting,intestinal obstruction,and esophagitis(<6%),while other AEs were mostly of hematological nature(71%).The cut-off values for SUV-T and SUV-TOTAL were 11 and20,respectively.Univariate analyses revealed SUV-TOTAL(P=0.027),SUV-T(P=0.025),and PS(P=0.006) as potential survival predictors,with a hazard ratio(HR) of 3.4,3.7,and 9.9,respectively.Conclusions:The combination of cetuximab with induction chemotherapy followed by CCRT appears feasible and promising.Local and locoregional maximal SUVs,defined by ~(18)F-FDG PET-CT scanning,may represent a prognostic indicator for long-term survival for these patients,which warrants further study.
Objective: In recent years, the combination of cetuximab and chemoradiotherapy (CRT) has been used to treat stage III non-small cell lung cancer (NSCLC); however, limited data are available for Chinese patients. Herein, we report preliminary data from a phase Ⅰ / Ⅱ study testing the combination of cetuximab with inductive chemotherapy, followed by concurrent CRT (CCRT) in Chinese patients with stage HI NSCLC. Methods: Eligibility criteria were Zubrod performance status (PS) 0-1, forced expiratory volume in 1 second (FEVl)> 1.2 L and adequate organ function. Enrolled patients received weekly cetuximab (initial dose of 400 mg / m ~ 2 on day 1 of week 1 and a maintenance dose of 250 mg / m ~ 2 on week 2 to the end of CCRT ) with primary or secondary cycles of concomitant NP chemotherapy and intensity-modulated thoracic radiotherapy (TRT) (60-66 Gy / 2 Gy) every 3 weeks for 2 cycles from week 2, followed by two cycles of were toxicity and feasibility. All patients received positron emission (PET-CT) scans within the 2 weeks prior to enrollment. Univariate analyzes were used to assess the correlation between SUV-T, SUV-N, SUV-TOTAL, gender, age, histology, tumor-node metaplasia , PS and smoking status and survival. Survival curves were generated for different populations using the Kaplan-Meier method and comparing using a log-rank test. Results: Seventeen patients were enrolled and 16 completed the full regime. The overall response rate (ORR) was 58.8% and 82.3% after the induction and CCRT phases, respectively. Time a median follow-up duration of 27.6 months, the median survival was 27.6 months [95% confidence interval (CI): 11.3-43.9 months] with 1-and 2-year survival rates of 88.2% (95% CI, 60.6-96.9%) and 58.8% (95% CI, 60.6-77.8%) respectively.Three patients remain progression-free to date, and the median progression-free survival (PFS) was 13.5 months (95% CI, 6.8-20.2 months) .No treatment-related death occurred; however, 76% of the patients experienced grade3 + a dverThe AEs, including nausea / vomiting, intestinal obstruction, and esophagitis (<6%), while other AEs were mostly mostly hematological nature (71%). The cut-off values for SUV-T and SUV-TOTAL were 11 and 20 respectively.Univariate analyzes revealed SUV-TOTAL (P = 0.027), SUV-T (P = 0.025), and PS (P = 0.006) as potential survival predictors, with a hazard ratio (HR) of 3.4, 3.7, and 9.9, respectively. Conclusions: The combination of cetuximab with induction chemotherapy followed by CCRT appeared feasible and promising. Local and locoregional maximal SUVs, defined by ~ (18) F-FDG PET-CT scanning, may represent a prognostic indicator for long- term survival for these patients, which warrants further study.