PURPOSE Patients with advanced or metastatic esophageal squamous cell carcinoma (ESCC) have poor prognosis. For these patients, treatment options are limited after first-line systemic therapy. PATIENTS AND METHODS In this open-label phase III clinical study, patients with advanced or metastatic ESCC, whose tumor progressed after first-line systemic treatment, were randomly assigned (1:1) to receive intravenous tislelizumab, an anti–programmed cell death protein 1 antibody, 200 mg every 3 weeks or chemotherapy (investigator's choice of paclitaxel, docetaxel, or irinotecan). The primary end point was overall survival (OS) in all patients. The key secondary end point was OS in patients with programmed death-ligand 1 tumor area positivity (TAP) score ≥ 10%. RESULTS In total, 512 patients across 11 countries/regions were randomly assigned. At final analysis, conducted after 410 death events occurred, OS was significantly longer with tislelizumab versus chemotherapy in all patients (median, 8.6 v 6.3 months; hazard ratio [HR], 0.70 [95% CI, 0.57 to 0.85]; one-sided P = .0001), and in patients with TAP ≥ 10% (median, 10.3 months v 6.8 months; HR, 0.54 [95% CI, 0.36 to 0.79]; one-sided P = .0006). Survival benefit was consistently observed across all predefined subgroups, including those defined by baseline TAP score, region, and race. Treatment with tislelizumab was associated with higher objective response rate (20.3% v 9.8%) and a more durable antitumor response (median, 7.1 months v 4.0 months) versus chemotherapy in all patients. Fewer patients experienced ≥ grade 3 treatment-related adverse events (18.8% v 55.8%) with tislelizumab versus chemotherapy. CONCLUSION Tislelizumab significantly improved OS compared with chemotherapy as second-line therapy in patients with advanced or metastatic ESCC, with a tolerable safety profile. Patients with programmed death-ligand 1 TAP ≥ 10% also demonstrated statistically significant survival benefit with tislelizumab versus chemotherapy.
Tumor size, solid components, poor differentiation, lymphovascular invasion, visceral pleural invasion and smoking history were significant factors predicting lymph node metastasis of clinical stage IA NSCLC. Patients with negative lobe-specific lymph node have very low risk of metastasis to the non-lobe specific lymph nodes. Lobe-specific lymph node dissection may become an alternative lymph node dissection mode for clinical stage IA NSCLC, especially for tumors ≤2 cm.
Background: The aim of this study was to evaluate the significance of spread through air spaces (STAS) in early lung adenocarcinomas after radical lobectomy and lymphadenectomy. Methods: A total of 242 patients with lung adenocarcinomas less than 4 cm (8th pStage I) were selected from the lung cancer patients surgically treated from January, 2009 to September, 2011. Pathological review focused on STAS as well as histological subtypes, blood vessel & neural invasion, pathological tumor size etc. Recurrence or disease-free survival (DFS) and overall survival (OS) were compared between patients as stratified by STAS and tumor size. Results: STAS was observed in 33.47% (81/242) patients, which was significantly correlated with histological predominant subtype (χ 2 =25.903, P=0.093×10 −3) and differentiation grade (χ 2 =23.986, P=0.025×10 −3). Patients with STAS (+) showed a comparable PFS (P=0.268) and OS rates (P=0.100) in all stage I cases, but a significant lower PFS (P=0.029) and OS (P=0.013) in tumors within 2< tumors ≤4 cm. Multivariate analysis revealed STAS to be an independent worse prognostic factor in lung adenocarcinomas within 2< tumors ≤4 cm, both for PFS (P=0.004) and OS (P=0.002) , while no significant difference was found in patients with tumors ≤2 cm (PFS, P=0.537; OS, P=0.448), after adjusting by other clinicopathological parameters as age, gender, smoking etc. Conclusions: Presence of STAS was a significant worse predictor for pStage I patients with lung adenocarcinoma >2 cm who underwent radical lobectomy, while it is not significant in patients with tumor ≤2 cm. These findings may be helpful in assessing postoperative therapy stratified by tumor size and STAS status.
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