Effectiveness and safety of combined nimotuzumab and S-1 chemotherapy with concurrent radiotherapy for locally advanced esophageal cancer in malnourished and elderly patients: A prospective phase II study.

Objective: Definitive chemoradiotherapy (dCRT) is the standard treatment for unresectable locally advanced esophageal cancer. However, this treatment is associated with substantial toxicity, and most malnourished or elderly patients are unable to complete this therapy. Therefore, there is a need for a more suitable radiotherapy combination regimen for this population. This study was aimed to evaluate the efficacy and safety of a combination regimen comprising chemotherapy with nimotuzumab and S-1 and concurrent radiotherapy for patients with fragile locally advanced esophageal cancer with a high Nutritional Risk Screening 2002 (NRS-2002) score. Methods: Eligible patients with unresectable esophageal carcinoma who had an NRS-2002 score of 2 or higher were enrolled. They were treated with S-1 and nimotuzumab with concurrent radiotherapy, followed by surgery or definitive radiotherapy. The primary endpoint was the locoregional control (LRC) rate. Results: A total of 55 patients who met the study criteria were enrolled. After completion of treatment, surgery was performed in 15 patients and radiotherapy was continued in 40 patients. The median follow-up period was 33.3 [95% confidence interval (95% CI), 31.4-35.1)] months. The LRC rate was 77.2% (95% CI, 66.6%-89.4%) at 1 year in the entire population. The overall survival (OS) rate and event-free survival (EFS) rate were 57.5% and 51.5% at 3 years, respectively. Surgery was associated with better LRC [hazard ratio (HR)=0.16; 95% CI, 0.04-0.70; P=0.015], OS (HR=0.19; 95% CI, 0.04-0.80; P=0.024), and EFS (HR=0.25; 95% CI, 0.08-0.75; P=0.013). Most adverse events were of grade 1 or 2, and no severe adverse events occurred. Conclusions: For malnourished or elderly patients with locally advanced esophageal cancer, radiotherapy combined with nimotuzumab and S-1 is effective and has a good safety profile.

[Outcome of concurrent chemoradiotherapy in locally advanced non-small-cell lung cancer patients].

OBJECTIVE: To analyze the efficacy and toxicity of concurrent chemoradiotherapy (CCRT) for patients with locally advanced non-small-cell lung cancer (LA-NSCLC). METHODS: Clinical data of 251 patients with stage III (76 IIIA and 175 IIIB) NSCLC who received CCRT as initial treatment between Jan 2001 and Dec 2010 in our hospital were reviewed. A median total radiotherapy dose of 60 Gy (range, 50-74 Gy) were delivered. 174 patients were treated with IMRT, 51 with 3D-CRT and 26 with 2D-radiotherapy. EP chemotherapy regimen was administered in 112 patients, PC regimen in 99 patients, topotecan regimen in 18 patients and other regimens in the remaining 22 patients. The efficacy and toxicity of CCRT were retrospectively analyzed. RESULTS: 244 patients were assessable for response, including 6 (2.5%) patients with CR, 183 (75.0%) with PR, 42 (17.2%) with SD and 13 (5.3%) with PD. At a median follow-up period of 20 months, the 1-, 3-, 5- year OS were 69.2%, 31.2%, 23.2%, respectively, and the median OS was 21 months. The 1-, 3-, 5- year PFS were 40.9%, 22.1%, 17.7%, respectively, and the median PFS was 10 months. Patients with stage IIIA NSCLC achieved better 5-year OS than that with IIIB NSCLC (29.2% vs. 20.7%, χ2=2.254, P=0.133). Failure pattern was assessable in 244 patients, including 61 (25.0%) locoregional progression alone, 55 (22.5%) distant metastasis alone and 77 (31.6%) with both. The rates of grade≥3 radiation pneumonitis, esophagitis and hematologic toxicity were 4.4%, 11.2% and 26.4%, respectively. CONCLUSIONS: CCRT provide stage III NSCLC patients favorable outcome with acceptable toxicity. CCRT is standard therapeutic approach for patients with unresectable locally advanced NSCLC.

Prognosis of R1-resection at the bronchial stump in patients with non-small cell lung cancer.

BACKGROUND: The prognosis of R1-resection at the bronchial stump in patients with non-small cell lung cancer (NSCLC) remains unclear. This study intends to identify the prognostic factors and to optimize treatments for these patients under update conditions. METHODS: The data of 124 NSCLC patients who underwent R1-resection at the bronchial stump was reviewed. There were 41 patients in the surgery group (S), 21 in the postoperative radiotherapy (PORT) group (S+R), 30 in the postoperative chemotherapy (POCT) group (S+C), and 32 in the PORT plus POCT group (S+R+C). The constitute proportion in different groups was tested using the χ(2) method, univariate analysis was performed using the Kaplan-Meier and log-rank method, and multivariate analysis was done using the Cox hazard regression with entry factors including age, sex, pathological type and stage, classification of the residual disease, and treatment procedure. The process was performed stepwise backward with a maximum iteration of 20 and an entry possibility of 0.05 as well as an excluded possibility of 0.10 at each step. RESULTS: In univariate analysis, survival was more favorable for patients with squamous cell carcinoma, early pathological T or N stage, and chemotherapy or radiotherapy. There was no significant difference in the survival for patients with different types of the residual disease, except for the difference between patients with carcinoma in situ and lymphangiosis carcinomatosa (P = 0.030). The survival for patients receiving chemoradiotherapy was superior to that for those undergoing surgery alone (P = 0.016). In multivariate analysis, the pathological type (HR 2.51, 95% CI 1.59 to 3.96, P = 0.000), pathological T (HR 1.29, 95% CI 1.04 to 1.60, P = 0.021) or N stage (HR 2.04, 95% CI 1.40 to 2.98, P = 0.000), and chemotherapy (HR 0.24, 95% CI 0.13 to 0.43, P = 0.000) were independent prognostic factors. CONCLUSION: Patients with squamous cell carcinoma, early pathological T or N stage, or receiving chemotherapy had a more favorable prognosis.