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Cisplatin-based adjuvant chemotherapy is the standard of care for patients with resected stage II–IIIA non-small-cell lung cancer (NSCLC). RADIANT and SELECT trial data suggest patients with EGFR-mutant stage IB–IIIA resected NSCLC could benefit from adjuvant EGFR tyrosine kinase inhibitor treatment. We aimed to compare the efficacy of adjuvant gefitinib versus vinorelbine plus cisplatin in patients with completely resected EGFR-mutant stage II–IIIA (N1–N2) NSCLC. We did a randomised, open-label, phase 3 trial at 27 centres in China. We enrolled patients aged 18–75 years with completely resected (R0), stage II–IIIA (N1–N2), EGFR-mutant (exon 19 deletion or exon 21 Leu858Arg) NSCLC. Patients were stratified by N stage and EGFR mutation status and randomised (1:1) by Pocock and Simon minimisation with a random element to either gefitinib (250 mg once daily) for 24 months or intravenous vinorelbine (25 mg/m2 on days 1 and 8) plus intravenous cisplatin (75 mg/m2 on day 1) every 3 weeks for four cycles. The primary endpoint was disease-free survival in the intention-to-treat population, which comprised all randomised patients; the safety population included all randomised patients who received at least one dose of study medication. Enrolment to the study is closed but survival follow-up is ongoing. The study is registered with ClinicalTrials.gov, number NCT01405079. Between Sept 19, 2011, and April 24, 2014, 483 patients were screened and 222 patients were randomised, 111 to gefitinib and 111 to vinorelbine plus cisplatin. Median follow-up was 36·5 months (IQR 23·8–44·8). Median disease-free survival was significantly longer with gefitinib (28·7 months [95% CI 24·9–32·5]) than with vinorelbine plus cisplatin (18·0 months [13·6–22·3]; hazard ratio [HR] 0·60, 95% CI 0·42–0·87; p=0·0054). In the safety population, the most commonly reported grade 3 or worse adverse events in the gefitinib group (n=106) were raised alanine aminotransferase and asparate aminotransferase (two [2%] patients with each event vs none with vinorelbine plus cisplatin). In the vinorelbine plus cisplatin group (n=87), the most frequently reported grade 3 or worse adverse events were neutropenia (30 [34%] patients vs none with gefitinib), leucopenia (14 [16%] vs none), and vomiting (eight [9%] vs none). Serious adverse events were reported for seven (7%) patients who received gefitinib and 20 (23%) patients who received vinorelbine plus cisplatin. No interstitial lung disease was noted with gefitinib. No deaths were treatment related. Adjuvant gefitinib led to significantly longer disease-free survival compared with that for vinorelbine plus cisplatin in patients with completely resected stage II–IIIA (N1–N2) EGFR-mutant NSCLC. Based on the superior disease-free survival, reduced toxicity, and improved quality of life, adjuvant gefitinib could be a potential treatment option compared with adjuvant chemotherapy in these patients. However, the duration of benefit with gefitinib after 24 months might be limited and overall survival data are not yet mature. Guangdong Provincial Key Laboratory of Lung Cancer Translational Medicine; National Health and Family Planning Commission of People's Republic of China; Guangzhou Science and Technology Bureau; AstraZeneca China.

Background Controversy still exists in which subtype of non-small-cell lung cancer [squamous cell carcinoma (SCC) or adenocarcinoma] is more likely to have lymph node (LN) metastasis. The aim of this study is to compare the pattern of LN metastasis in two cohorts of matched patients surgically treated for SCC or adenocarcinoma. Methods A retrospective analysis of patients undergoing lobectomy or segmentectomy with systematic lymphadenectomy without preoperative treatment for lung SCC or adenocarcinoma was conducted in this study. Data for analysis consisted of age, gender, tumor size, lobe-specific tumor location, tumor location (peripheral or central), and pathologic findings. We conducted the propensity score-matched (PSM) analysis to eliminate potential bias effects of possible confounding factors. Results From January 2015 to December 2016 in our department, we finally included a total of 387 patients (including 63 patients with SCC and 324 patients with adenocarcinoma) for analysis. For the unmatched cohort, there was no sufficient evidence of significantly different number of positive LNs ( P  = 0.90) and rate of LN metastasis ( P  = 0.23) between SCC patients and adenocarcinoma patients. However, potential confounding factors, for example gender, tumor size, tumor location, tumor differentiation, and total number of dissected LNs, were significantly different between patients with SCC and those with adenocarcinoma. In the analysis of matched cohort after PSM analysis, those above confounding factors were comparable between the two groups. However, patients with adenocarcinoma had significantly more mean positive LNs (2.2 and 0.7; P  = 0.008) and a higher rate of LN metastasis (53% and 29%; P  = 0.016) than those with SCC. Conclusions Lung adenocarcinoma had a higher risk of LN metastasis than SCC, suggesting that different therapeutic modalities may be indicated for the two different subtypes of lung cancer.

The ADJUVANT study reported the comparative superiority of adjuvant gefitinib over chemotherapy in disease-free survival of resected EGFR -mutant stage II–IIIA non-small cell lung cancer (NSCLC). However, not all patients experienced favorable clinical outcomes with tyrosine kinase inhibitors (TKI), raising the necessity for further biomarker assessment. In this work, by comprehensive genomic profiling of 171 tumor tissues from the ADJUVANT trial, five predictive biomarkers are identified ( TP53 exon4/5 mutations, RB1 alterations, and copy number gains of NKX2-1 , CDK4 , and MYC ). Then we integrate them into the Multiple-gene INdex to Evaluate the Relative benefit of Various Adjuvant therapies (MINERVA) score, which categorizes patients into three subgroups with relative disease-free survival and overall survival benefits from either adjuvant gefitinib or chemotherapy (Highly TKI-Preferable, TKI-Preferable, and Chemotherapy-Preferable groups). This study demonstrates that predictive genomic signatures could potentially stratify resected EGFR -mutant NSCLC patients and provide precise guidance towards future personalized adjuvant therapy. Adjuvant gefitinib improves outcomes in non-small cell lung cancer (NSCLC) patients compared to chemotherapy, but not in all cases. Here, the authors find genomic biomarkers of response to gefitinib in NSCLC patients from the ADJUVANT trial, and propose a score to stratify them by potential benefit from the treatment.

There is limited information about thymosin α1 (Tα1) as adjuvant immunomodulatory therapy, either used alone or combined with other treatments, in patients with non-small cell lung cancer (NSCLC). This study aimed to evaluate the effect of adjuvant Tα1 treatment on long-term survival in margin-free (R0)-resected stage IA-IIIA NSCLC patients. A total of 5746 patients with pathologic stage IA-IIIA NSCLC who underwent R0 resection were included. The patients were divided into the Tα1 group and the control group according to whether they received Tα1 or not. A propensity score matching (PSM) analysis was performed to reduce bias, resulting in 1027 pairs of patients. After PSM, the baseline clinicopathological characteristics were similar between the two groups. The 5-year disease-free survival (DFS) and overall survival (OS) rates were significantly higher in the Tα1 group compared with the control group. The multivariable analysis showed that Tα1 treatment was independently associated with an improved prognosis. A longer duration of Tα1 treatment was associated with improved OS and DFS. The subgroup analyses showed that Tα1 therapy could improve the DFS and/or OS in all subgroups of age, sex, Charlson Comorbidity Index (CCI), smoking status, and pathological tumor-node-metastasis (TNM) stage, especially for patients with non-squamous cell NSCLC and without targeted therapy. Tα1 as adjuvant immunomodulatory therapy can significantly improve DFS and OS in patients with NSCLC after R0 resection, except for patients with squamous cell carcinoma and those receiving targeted therapy. The duration of Tα1 treatment is recommended to be >24 months.

Background An evaluation of cardiopulmonary exercise testing (CPET) screening and pre‐operative pulmonary rehabilitation in reducing postoperative complications and improving fast‐track recovery in high‐risk patients who undergo resection for lung cancer. Methods Of 342 potential lung cancer cases, 142 high‐risk patients were finally divided into two groups: group R (n = 71) underwent an intensive pre‐operative pulmonary rehabilitation program (PRP), followed by lobectomy; group S (n = 71) underwent only lobectomy with conventional management. Postoperative complications, average days in hospital, postoperative days in hospital, and cost were analyzed. Results The 142 high‐risk patients were screened by smoking history and CPET. Sixty‐eight patients had bronchial hyperresponsiveness (BHR) and 47 patients had peak expiratory flow <250 L/minute by CPET. The rate of postoperative total complications in group R (16.90%) was significantly lower than in group S (83.31%) (P = 0.00), as was the rate of postoperative pulmonary complications PPC: group R (12.81%) versus S (13.55%) (P = 0.009); the PPC in the left lung (17.9%) was higher than in the right lung (2.3%) (P = 0.00). The average days in hospital in group S was significantly higher than in group R (P = 0.03). There was no difference between groups in average hospital cost (P = 0.304). Conclusion Pre‐operative screening using CPET is conducive to identifying high‐risk patients for lung resection. Pre‐operative pulmonary rehabilitation is helpful to reduce postoperative complications and improve fast‐track recovery.

Background Approximately 8.3–15.9% of patients with clinical stage I non‐small cell lung cancer are subsequently shown to have lymph node metastasis. However, the clinical characteristics of patients with lymph node metastasis in China are not fully understood. Methods This is a multicenter retrospective analysis of pathological T1 non‐small cell lung cancer patients who underwent surgical resection from 2 January 2014 to 27 December 2017. Clinical and pathological information was collected with the assistance of the Large‐scale Data Analysis Center of Cancer Precision Medicine‐LinkDoc database. The clinical and pathological factors associated with lymph node metastasis were analyzed by univariate and multivariate logistic regression. Results A total of 10 885 participants (51.6% women; 15.3% squamous cell carcinoma) were included in the analysis. The median age was 60.0 years (range 12.9–86.6 years). A total of 1159 patients (10.6%) had metastases in mediastinal nodes (N2), and 640 patients (5.9%) had metastasis in pulmonary lymph nodes (N1). Most patients had T1b lung cancer (4766, 43.8%). Of the patients, 3260 (29.9%) were current or former smokers. The univariate and multivariate analyses showed that younger age, squamous cell carcinoma, poor differentiation, larger tumor size, carcinoembryonic antigen level ≥5 ng/mL, and vascular invasion (+) were significantly associated with higher percentages of lymph node metastases (P < 0.001 for all). Conclusion This real‐world study showed the significant association of lymph node metastasis with age, tumor size, histology and differentiation, carcinoembryonic antigen levels, and status of vascular invasion. Female patients with T1a adenocarcinoma in the right upper lobe barely had lymph node metastasis.

Currently, there is no reliable biomarker to clinically predict the prognosis of lung adenocarcinoma (ADC). The receptor-tyrosine-kinase like orphan receptor 1 (ROR1) is reported to be overexpressed and associated with poor prognosis in several tumors. This study aimed to examine the expression of ROR1 and evaluate its prognostic significance in human lung ADC patients. In this present study, Western blot analysis and immunohistochemistry were performed to characterize expression of ROR1 protein in lung ADC patients. The results revealed that ROR1 protein expression was significantly higher in lung ADC tissues than that in their adjacent non-tumor tissues. Patients at advanced stages and those with positive lymph node metastasis expressed higher level of ROR1 ( P  < 0.001). Moreover, Chi-square test showed that ROR1 expression was correlated to gender ( P  = 0.028), the 7 th edition of the American Joint Committee on Cancer tumor-node-metastasis (AJCC TNM) staging system and lymph node metastasis ( P  < 0.001). Kaplan-Meier survival analysis indicated an association of high ROR1 expression with worse overall survival (OS) in lung ADC patients ( P  < 0.001). Multivariate COX regression analysis further confirmed that ROR1 is an independent prognostic predictor ( P  < 0.001, HR = 4.114, 95% CI: 2.513–6.375) for OS. Therefore, ROR1 expression significantly correlates with malignant attributes of lung ADC and it may serve as a novel prognostic marker in lung ADC patients.

The aim of this study was to compare the operative results in regard to reducing anastomotic leakage and stricture formation using a newly designed layered manual esophagogastric anastomosis versus a stapler esophagogastrostomy versus the conventional hand-sewn whole-layer anastomosis after resection for esophageal or gastric cardiac carcinoma. From January 2004 to September 2006, a total of 1024 patients with esophageal or gastric cardia carcinoma underwent a layered esophagogastric anastomosis with the assistance of a three-leaf clipper in a single university medical center. The mucosal layers of the esophagus and stomach were sutured continuously with 4/0 Vicryl plus antibacterial suture (polyglyconate). From May 2002 to December 2003, there were also 170 patients and 69 patients who underwent stapler and conventional whole-layer anastomosis, respectively; they served as control groups. The results were analyzed retrospectively. The operative mortality rate was 0.7% in the layered group compared to 5.9% and 7.2% for the stapler group and the whole-layer group ( p  < 0.01), The anastomotic leakage rates were 0%, 3.5%, and 5.8% for the layered group, stapler group, and whole-layer group, respectively ( p  < 0.01). All patients were followed postoperatively. Six patients in the layered group (0.6%) developed mild stricture formation compared to 16 patients in stapled group (9.9%) and 5 patients in the conventional whole-layer group (7.8%) ( p  < 0.01). The application of layered esophagogastric anastomosis could reduce the incidence of anastomotic leakage and stricture after esophagectomy compared with the stapler and whole-layer manual anastomoses. It is easy to apply and could be used as an alternative for esophagogastric anastomosis after resection for esophageal or cardiac carcinoma.

The concept of enhanced recovery after surgery (ERAS) has already been accepted by almost all the clinicians and nurses, the practice of which is based on interdisciplinary cooperation. The reason is still unclear why the effect of ERAS varies a lot though the same ERAS scheme is used. The main cause may be the same ERAS scheme can not be suitable for different patients. In other words, does ERAS also need to conform to Precision Medicine Theory? This study is focused on the necessity and clinical efficacy of \"Precision ERAS\" performed in lung cancer patients. The conclusions are the following: first of all, an accurate judgment of patients who need ERAS should be done properly before surgery, which means that the high risks assessment should be done accurately. Secondly, a specific ERAS scheme should be carried out in each independent patient who has obvious clinical symptoms in order to alleviate clinical symptoms and improve the ptients' quality of life (QOL). Thirdly, for the asymptomatic patitents who al

Enhanced recovery after surgery (ERAS) is a paradigm shift in perioperative care, resulting in substantial improvements in clinical outcomes, shorter length of hospital stay and cost savings. But the current ERAS either by application of breadth or depth is not enough, why? The main reason is the lack of \"operability, evaluation, repetition\" ERAS protocol and suitable for clinical extensive application protocol. How to form the clinical available protocol? Operational mainly refers to the clinical scheme is simple and feasible, and protocol compliance is good; Evaluate refers to the methods used before, during and after are the objective evaluation criteria and plan; Repeatable is clinical scheme repeatability in the process of single or multiple center.