Feasibility of cetuximab and chemoradiotherapy combination in Chinese patients with unresectable stage III non-small cell lung cancer: a preliminary report.

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 from a phase I/II study testing with inductive chemotherapy, followed by concurrent CRT (CCRT) in patients NSCLC. Methods: Eligibility criteria were Zubrod performance status (PS) 0-1, forced expiratory volume 1 second (FEV1) ≥1.2 L adequate organ function. Enrolled received weekly (initial dose 400 mg/m 2 on day week maintenance 250 end CCRT) cisplatin/vinorelbine (NP) chemotherapy (every 3 weeks cycles 2, two concomitant NP intensity-modulated thoracic radiotherapy (TRT) (60-66 Gy/2 Gy). The primary endpoints toxicity feasibility. All positron emission tomographycomputerized tomography (PET-CT) scans within prior enrollment. Univariate analyses assess correlation between SUV-T, SUV-N, SUV-TOTAL, gender, age, histology, tumor-nodemetastasis (TNM) stage, PS smoking survival. Survival curves generated different populations using Kaplan-Meier method compared log-rank test. Results: Seventeen enrolled 16 completed full regime. overall response rate (ORR) was 58.8% 82.3% after induction CCRT phases, respectively. With median follow-up duration 27.6 months, survival months [95% confidence interval (CI): 11.3-43.9 months] 1- 2-year rates 88.2% (95% CI, 60.6-96.9%) 60.6-77.8%), Three remain progression-free date, (PFS) 13.5 6.8-20.2 months). No treatment-related death occurred; 76% experienced grade 3+ adverse events (AEs), including nausea/vomiting, intestinal obstruction, esophagitis (<6%), while other AEs mostly hematological nature (71%). cut-off values SUV-T SUV-TOTAL 11 20, revealed (P=0.027), (P=0.025), (P=0.006) as potential predictors, hazard ratio (HR) 3.4, 3.7, 9.9, Conclusions: appears feasible promising. Local locoregional maximal SUVs, defined 18F-FDG PET-CT scanning, may represent prognostic indicator long-term these patients, which warrants further study.