科研之友
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摘要
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/m2 on day 1 of week 1 and a maintenance dose of 250 mg/m2 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 18F-FDG PET-CT scanning,may represent a prognostic indicator for long-term survival for these patients,which warrants further study.
