Resected NSCLC Patients Research Articles

P1.06C.05 The Impact of Lymphovascular Invasion as Prognostic Factor on Long-Term Survival in More Than 3500 Resected NSCLC Patients

P1.06C.05 The Impact of Lymphovascular Invasion as Prognostic Factor on Long-Term Survival in More Than 3500 Resected NSCLC Patients

Resectable Non-Small Cell Lung Cancer Heterogeneity and Recurrence Assessed by Tissue Next-Generation Sequencing Genotyping and Circulating Tumor Cell EZH2 Characterization

IntroductionNon-small cell lung cancer (NSCLC) is the most common type of lung neoplasm. Despite surgical resection, it has a high relapse rate, accounting for 30–55% of all cases. Next-generation sequencing (NGS) based on a customized gene panel and the analysis of circulating tumor cells (CTCs) can help identify heterogeneity, stratify high-risk patients, and guide treatment decisions. In this descriptive study involving a small prospective cohort, we focus on the phenotypic characterization of CTCs, particularly concerning EZH2 expression (a member of the Polycomb Repression Complex 2), as well as on the mutation profiles of the tissue using a customized gene panel and their association with poor outcomes in NSCLC. MethodsIsolation and characterization of EZH2 on CTCs were evaluated before surgical resection (CTC1) and one month after surgery (CTC2) in resectable NSCLC patients. Targeted NGS was performed using a customized 50-gene panel on tissue samples from a subset of patients. Results76 patients with resectable NSCLC were recruited. The top mutated genes in the cohort included TP53, FLT1, MUC5AC, EGFR, and NLRP3. Pair of genes that had mutually exclusive mutations was TP53-RIN3, and pairs of genes with co-occurring mutations were CD163-TLR4, FGF10-FOXP2, ADAMTSL3-FLT1, ADAMTSL3-MUC5AC and MUC5AC-NLRP3. CTCs decreased significantly between the two time points CTC1 and CTC2 (p<0.0001), and CTCs+ patients with high EZH2 expression had an 87% increased risk of death (p=0.018). ConclusionsIntegrating molecular profiling of tumors and CTC characterization can provide valuable insights into tumor heterogeneity and improve patient stratification for resectable NSCLC.

P3.03H.03 Feasibility of Metastatic Lymph Node-informed ctDNA Analysis in Surgically Resected NSCLC Patients

P3.03H.03 Feasibility of Metastatic Lymph Node-informed ctDNA Analysis in Surgically Resected NSCLC Patients

The utility of 18F-FDG PET/CT for predicting the pathological response and prognosis to neoadjuvant immunochemotherapy in resectable non-small-cell lung cancer

ObjectiveTo evaluate the potential utility of 18F-FDG PET/CT to assess response to neoadjuvant immunochemotherapy in patients with resectable NSCLC, and the ability to screen patients who may benefit from neoadjuvant immunochemotherapy.MethodsFifty one resectable NSCLC (stage IA–IIIB) patients were analyzed, who received two-three cycles neoadjuvant immunochemotherapy.18F-FDG PET/CT was carried out at baseline(scan-1) and prior to radical resection(scan-2). SULmax, SULpeak, MTV, TLG, T/N ratio, ΔSULmax%,ΔSULpeak%, ΔMTV%, ΔTLG%,ΔT/N ratio% were calculated. 18F-FDG PET/CT responses were classified using PERCIST. We then compared the RECIST 1.1 and PERCIST criteria for response assessment.With surgical pathology of primary lesions as the gold standard, the correlation between metabolic parameters of 18F-FDG PET/CT and major pathologic response (MPR) was analyzed. All metabolic parameters were compared to treatment response and correlated to PFS and OS.ResultsIn total of fifty one patients, MPR was achieved in 25(49%, 25/51) patients after neoadjuvant therapy. The metabolic parameters of Scan-1 were not correlated with MPR.The degree of pathological regression was negatively correlated with SULmax, SULpeak, MTV, TLG, T/N ratio of scan-2, and the percentage changes of the ΔSULmax%, ΔSULpeak%, ΔMTV%,ΔTLG%,ΔT/N ratio% after neoadjuvant therapy (p < 0.05). According to PERCIST, 36 patients (70.6%, 36/51) showed PMR, 12 patients(23.5%, 12/51) had stable metabolic disease(SMD), and 3 patients(5.9%, 3/51) had progressive metabolic disease (PMD). ROC indicated that all of scan-2 metabolic parameters and the percentage changes of metabolic parameters had ability to predict MPR and non-MPR, SULmax and T/N ratio of scan-2 had the best differentiation ability.The accuracy of RECIST 1.1 and PERCIST criteria were no statistical significance(p = 0.91). On univariate analysis, ΔMTV% has the highest correlation with PFS.ConclusionsMetabolic response by 18F-FDG PET/CT can predict MPR to neoadjuvant immunochemotherapy in resectable NSCLC. ΔMTV% was significantly correlated with PFS.

1218P FALCONS, a non-interventional retrospective study in resected NSCLC patients using the EPITHOR database, first analysis

1218P FALCONS, a non-interventional retrospective study in resected NSCLC patients using the EPITHOR database, first analysis

Adjuvant modern radiotherapy in resected pN2 NSCLC patients: results from a multicentre retrospective analysis on acute and late toxicity on behalf of AIRO thoracic oncology study group: the RAC-TAC study.

Recently, the PORT-C and LUNG-ART trials, which evaluated the role of postoperative radiation therapy (PORT), have significantly altered the treatment landscape for NSCLC pN2 patients who previously underwent surgery. In response, the Italian Association of Radiotherapy and Oncology Thoracic Oncology study group has initiated an observational multicenter trial to assess both acute and late toxicities of PORT in pN2 NSCLC patients treated with modern techniques. Data on NSCLC patients submitted to PORT after radical surgery treated between 2015 and 2020 in six Italian Centers were collected. Heart, lung, and esophageal acute and late toxicities have been retrospectively analyzed and related to radiation therapy dosimetric parameters. Furthermore, loco-regional control, distant metastasis and overall survival have been analyzed. A total of 212 patients with a median age of 68years from six different centers were included in this analysis (142 males and 70 females). Prior to undergoing PORT, 96 patients (45.8%) had a history of heart disease, 110 patients (51.9%) had hypertension, and 51 patients (24%) had COPD. Acute toxicity was observed in 147 patients (69.3%), with lung toxicity occurring in 93 patients (G1 in 70 patients, G2 in 17 patients, and G3 in 4 patients), esophageal toxicity in 114 patients (G1 in 89 patients, G2 in 23 patients, and G3 in 1 patient), and cardiac toxicity in 4 patients (G1 in 2 patients and G3 in 2 patients). Late side effects were found in 60 patients (28.3%), predominantly involving the lungs (51 patients: 32 G1, 11 G2, and 1 G3) and the esophagus (11 patients: 8 G1 and 3 G2), with no reported late cardiac side effects. Various clinical and dosimetric parameters were found to correlate with both acute and chronic toxicities. Over a median follow-up period of 54months, 48 patients (22.6%) showed locoregional disease relapse, 106 patients (50%) developed distant metastases, and 66 patients (31.1%) died. RAC-TAC retrospective multicentric study showed the low toxicity of PORT when advanced technology is used. At the same time, it's noteworthy to underline that 50% of the patients develop distant recurrences in the follow up.

Neoadjuvant toripalimab plus chemotherapy for resectable stage II-IIIB non-squamous non-small cell lung cancer with EGFR mutations: A multi-center, multi-cohort, exploratory study.

TPS8120 Background: Neoadjuvant immunotherapy has been widely applied in the treatment of resectable stage II-IIIB NSCLC patients without driver gene mutation. However, as for the EGFR-positive patients, the therapeutic effect of neoadjuvant treatment, either TKI or chemotherapy, is far from satisfied and the outcome of neoadjuvant immunotherapy plus chemotherapy in these patients remains an unanswered but crucial question. Herein, we conducted a phase 2 prospective trial (NCT05962021). Methods: This is a multicenter, multi-cohort prospective phase 2 study in the treatment-naïve patients with resectable stage II-IIIB (N2) (AJCC 8th edition) non-squamous NSCLC harboring EGFR mutations (19DEL or L858R). Enrolled patients will be divided into two cohorts according to EGFR status and receive neoadjuvant toripalimab (240mg, q3w) plus platinum-based doublet chemotherapy (pemetrexed 500mg/m2 plus carboplatin AUC 5, q3w) for 3 cycles. Surgery will be performed after completion of neoadjuvant therapy based on the multidisciplinary discussion, while local radiotherapy will be considered if the patient cannot undergo surgery due to disease progression. Key inclusion criteria: non-squamous NSCLC, resectable stage II-IIIB (N2), EGFR mutations (19DEL or L858R), age≥18 years, ECOG PS 0-1 and adequate cardiopulmonary function. Exclusion criteria: prior systemic anticancer treatment, contraindication to immunotherapy, active autoimmune disease. Adequate pre-treatment tissue samples are required for RT-PCR or next-generation sequencing to determine the EGFR mutation status and PD-L1 expression immunohistochemical detection. The primary study endpoint is complete pathological response (pCR) rate, per blinded independent pathologist review. Simon's optimal two-stage design will be used to test the null hypothesis of pCR rate ≤5% and alternative hypothesis of pCR rate ≥15%, and 5 or more pCRs among 56 patients per arm are needed for the primary endpoint to be met. Secondary endpoints include major pathological response (MPR) rate, pCR/MPR rate in different EGFR mutation subgroups (19DEL or L858R) and different PD-L1 expression subgroups (TPS &lt; 1% and ≥ 1%), event-free survival and safety and tolerability. Peripheral blood, stool and tissue samples will be obtained longitudinally at baseline, during perioperation and at follow-ups for exploratory analysis. Clinical trial information: NCT05962021 .

EP07.02-06 MIDRIXNEO-LUNG: Safety and Immunogenicity of a Neoantigen-Presenting Autologous Dendritic Cell Therapy in Resected NSCLC Patients

EP07.02-06 MIDRIXNEO-LUNG: Safety and Immunogenicity of a Neoantigen-Presenting Autologous Dendritic Cell Therapy in Resected NSCLC Patients

P1.11-01 Utility of ctDNA Monitoring during Surveillance in Surgically Resected NSCLC Patients

P1.11-01 Utility of ctDNA Monitoring during Surveillance in Surgically Resected NSCLC Patients

The predictive value of 18F-FDG PET/CT combined with inflammatory index for major pathological reactions in resectable NSCLC receiving neoadjuvant immunochemotherapy

ObjectivesTo investigate whether the combination of inflammatory biomarkers and metabolic parameters of 18F-FDG PET/CT could predict the major pathological reactions (MPR) in resectable NSCLC patients after neoadjuvant immunochemotherapy more accurately and screen out patients who may benefit from the neoadjuvant therapy. Materials and Methods114 resectable NSCLC patients who underwent neoadjuvant immunochemotherapy and radical surgery were retrospectively enrolled. Detailed clinical characteristics, B-R and 18F-FDG PET/CT images were collected for analyzing their correlation with MPR. A metabolic-inflammation comprehensive prognostic index (MICPI) combined 18F-FDG PET/CT metabolic parameters and inflammatory index was proposed to predict MPR. Results66.7 % patients achieved MPR. Smoking history, gender and ILO were influencing factors for MPR acquisition in NSCLC patients. High absolute neutrophils count (PreN ≥ 3.65), metabolic parameters (PreSUVmax ≥ 11.73) before treatment and ΔSUVmean (≥54.18) were significantly associated with MPR (P＜0.01, P＜0.05 and P＜0.001 respectively). MICPI-B based on PreN and PreSUVmax categorized NSCLC patients into three groups and among the groups of high, intermediate and low MICPI-B score, MPR accounted for 80.00 %, 51.72 % and 28.57 % respectively (P < 0.01). In high, intermediate and low MICPI-P groups which based on PreN and ΔSUVmean, MPR accounted for 92.31 %, 53.57 % and 11.11 %, respectively (P < 0.001). ConclusionPreN and metabolic parameter of 18F-FDG PET/CT may be an accurate alternative biomarker for predicting MPR in NSCLC patients after neoadjuvant immunochemotherapy. Moreover, MICPI can stratify patients into different groups based on their likelihood of obtaining MPR, allowing clinicians to identify patients who may most likely benefit from neoadjuvant immunochemotherapy.

Overall Survival Following Salvage Thoracic Radiotherapy for Locoregional Recurrence in Patients with Completely Resected PIIIA-N2 NSCLC

Locoregional recurrence is a common failure pattern for patients with completely resected pIIIA-N2 NSCLC. The salvage thoracic radiotherapy is administered in some pIIIA-N2 NSCLC patients despite postoperative radiotherapy (PORT). Salvage thoracic radiotherapy could be well tolerated and might improve survival from several small sample retrospective studies, while the high-level clinical evidence is presently lacking. We conducted this retrospective case control study to demonstrate the efficacy of salvage thoracic radiotherapy for completely resected pIIIA-N2 NSCLC patients with locoregional recurrence. Between January 2003 and June 2019, patients who had undergone lobectomy or pneumonectomy plus mediastinal lymph node dissection or systematic sampling in our single institution were retrospectively reviewed. Those with pⅢA-N2 NSCLC that did not receive PORT and suffered locoregional recurrence being the first treatment failure were enrolled. The log-rank test was used to analyze differences between the groups, and the Kaplan-Meier method was used for survival analysis. Univariate and multivariate analyses using Cox proportional hazards regression models were performed to evaluate potential prognostic factors for survival. Statistically significant difference was set as p<0.05. Of all the patients with pⅢA-N2 NSCLC reviewed, 105 suffered locoregional recurrence as the first treatment failure and didn't receive PORT. Among these patients, 51 (48.6%) received salvage thoracic radiotherapy and 54 (51.4%) did not. The median OS was 47.7 months of all patients. Survival analysis showed that the median OS in salvage thoracic radiotherapy group (69.0 months) was significantly longer than that in non-salvage thoracic radiotherapy group (37.7 months) (p = 0.029). For patients of EGFR wild type, salvage thoracic radiotherapy group had significantly longer median OS of 69.0 months compared with non-salvage thoracic radiotherapy group of 31.3 months (p = 0.004). When assessed by histological types, salvage thoracic radiotherapy significantly improved the survival of patients with lung squamous cell carcinoma with median OS not reached compared with non-salvage thoracic radiotherapy group of 31.3 months (p<0.001), while in patients with non-squamous cell carcinoma, this survival benefit was not observed (p = 0.829). Salvage thoracic radiotherapy is an effective treatment for completely resected pIIIA-N2 NSCLC patients that have not received PORT and suffered post-operative locoregional recurrence.

The predictive role of hematologic markers in resectable NSCLC patients treated with neoadjuvant chemoimmunotherapy: a retrospective cohort study.

Neoadjuvant chemoimmunotherapy is an important therapeutic modality for resectable nonsmall cell lung cancer (NSCLC). The roles of the neutrophil-to-lymphocyte ratio (NLR), platelet-to-lymphocyte ratio, and lymphocyte-to-monocyte ratio in predicting the efficacy and prognosis of patients with resectable NSCLC receiving neoadjuvant chemoimmunotherapy remain uncertain. This study aimed to explore the association of baseline and preoperative NLR, platelet-to-lymphocyte ratio, and lymphocyte-to-monocyte ratio with the treatment response and survival of patients with resectable NSCLC treated with neoadjuvant chemoimmunotherapy. Data of patients with resectable NSCLC treated with neoadjuvant chemoimmunotherapy between May 2019 and July 2022 at our institute, were retrospectively analyzed. Peripheral blood cell counts were obtained at baseline and before surgery. Data that may affect treatment efficacy were also collected and analyzed, including age, sex, BMI, cumulative smoking exposure, pathological type, clinical stage, PD-L1 tumor proportion score, immune checkpoint inhibitors, dosage of neoadjuvant therapy, duration from final therapy to surgery, and baseline and preoperative oncological markers. The present work has been reported in compliance with REporting recommendations for tumor MARKer prognostic studies (REMARK) criteria and guidelines (Supplemental Digital Content 1, http://links.lww.com/JS9/A860 ). A total of 116 patients were included in the study. Univariate logistic regression analysis showed that a higher baseline NLR ( P =0.001) and preoperative NLR ( P =0.001) were associated with a lower incidence of pathological complete response (pCR) following neoadjuvant therapy. Multivariate analysis indicated that a lower incidence of pCR was achieved in the high baseline NLR group ( P =0.014). Higher baseline NLR ( P =0.021), preoperative NLR ( P =0.004) and higher preoperative CEA levels ( P =0.059) were associated with shorter disease-free survival (DFS). Multivariate Cox proportional hazard regression analyses showed that shorter DFS was achieved in the high preoperative NLR group ( P =0.033). In patients with resectable NSCLC treated with neoadjuvant chemoimmunotherapy, a higher baseline NLR was associated with a lower incidence of pCR, and a higher preoperative NLR was associated with a shorter DFS. However, a future prospective study with a large sample size and long-term follow-up is needed to verify the predictive value of NLR in these patients.

Development and validation of a nomogram for predicting overall survival of resected N2 non-small cell lung cancer patients undergoing neoadjuvant radiotherapy.

Currently, the prognosis of resected N2 non-small cell lung cancer patients undergoing neoadjuvant radiotherapy is poor. The goal of this research was to develop and validate a novel nomogram for exactly predicting the overall survival (OS) of resected N2 NSCLC patients undergoing neoadjuvant radiotherapy. The data applied in our research were downloaded from the Surveillance, Epidemiology, and End Results (SEER) database. We divided selected data into a training cohort and a validation cohort using R software, with a ratio of 7:3. Univariate Cox regression and multivariate Cox regression were utilized to select significant variables to build the nomogram. To validate our nomogram, calibration curves, receiver operating characteristic curves (ROC), decision curve analysis (DCA), and Kaplan-Meier survival curves were employed. The nomogram model was also compared with the tumor-node-metastasis (TNM) staging system by utilizing net reclassification index (NRI) and integrated discrimination improvement (IDI). Eight variables-age, sex, operative type, LN removed number, chemotherapy, AJCC stage, M stage, histology-were statistically significant in the multivariate Cox regression analysis and were selected to develop our nomogram. Based on ROC curves, calibration curves, and DCA analysis, our novel nomogram demonstrated good predictive accuracy and clinical utility. Using Kaplan-Meier (KM) survival curves and log-rank tests, the risk stratification system was able to stratify patients based on their estimated mortality risk. The nomogram performed better than the TNM staging system based on the NRI and IDI indexes. We developed and validated a nomogram to predict prognosis of resected N2 NSCLC patients undergoing neoadjuvant radiotherapy. Using this nomogram, clinicians may find this nomogram useful in predicting OS of targeted patients and making more appropriate treatment decisions.

Differential expression analysis of circRUNX1 in patients with early resected EGFR-mutant NSCLC.

8529 Background: In the ADAURA study, patients with stage IB-IIIA of resected EGFR mutated lung adenocarcinoma receiving adjuvant osimertinib had a 2-year survival of 89% versus 52% in the placebo group (p&lt;0.001), however, predictive markers of response and recurrence are still needed. Circular RNA (circRNA) is a type of RNA which forms a covalently closed continuous loop. Some circRNAs have been reported as essential for tumor cell proliferation through functions distinct from the canonical linear RNA. In this project, we studied circRNA expression levels in formalin-fixed paraffin-embedded (FFPE) lung tumor samples in order to explore potential biomarkers that could predict the benefit of adjuvant EGFR TKIs in EGFR-mutant NSCLC patients. Methods: FFPE tumor samples from patients with EGFR-mutant, stage I-IIIB NSCLC (n=79) were collected. RNA was purified using the High Pure FFPET RNA Isolation Kit (Qiagen) and quantified by Nanodrop 2000 (Thermo Scientific). A total of 250 ng of RNA were subjected to overnight hybridization and downstream nCounter processing (NanoString) following manufacturer’s instructions for our circRNA custom panel. Differential expression analysis was performed using Excel (Microsoft) and Prism GraphPad (Dotmatics) software. Results: Analysis of the 79 samples included in the study shown a cluster of 3 circRNAs significantly upregulated (p&lt;0.05 and &gt;2 fold-change) in EGFR mutation-positive NSCLC relapsing withing the 36 months after resection, including circRUNX1, circFUT8 and circAASDH. Disease-free survival (DFS) was significantly shorter for the subgroup of patients with high versus low circRUNX1 expression. Additional multivariate analysis identified circRUNX1 expression and tumor stage as the only statically significant prognostic factors (circRUNX1 hazard ratio = 4.480, confidence interval = 2.172-9.239, P &lt; 0.001; pathological stage hazard ratio = 2.237, confidence interval = 1.183- 4.231, P = 0.008). Conclusions: CircRUNX1 could be a novel biomarker to predict the benefit of adjuvant EGFR TKIs with regards to DFS in EGFR-mutant resected NSCLC patients.

PD-0961 Postoperative IMRT Radiotherapy in resected NSCLC patients: a multicentre retrospective analysis

PD-0961 Postoperative IMRT Radiotherapy in resected NSCLC patients: a multicentre retrospective analysis

Development and validation of machine learning models to predict survival of patients with resected stage-III NSCLC.

To compare the performance of three machine learning algorithms with the tumor, node, and metastasis (TNM) staging system in survival prediction and validate the individual adjuvant treatment recommendations plan based on the optimal model. In this study, we trained three machine learning madel and validated 3 machine learning survival models-deep learning neural network, random forest and cox proportional hazard model- using the data of patients with stage-al3 NSCLC patients who received resection surgery from the National Cancer Institute Surveillance, Epidemiology, and End Results (SEER) database from 2012 to 2017,the performance of survival predication from all machine learning models were assessed using a concordance index (c-index) and the averaged c-index is utilized for cross-validation. The optimal model was externally validated in an independent cohort from Shaanxi Provincial People's Hospital. Then we compare the performance of the optimal model and TNM staging system. Finally, we developed a Cloud-based recommendation system for adjuvant therapy to visualize survival curve of each treatment plan and deployed on the internet. A total of 4617 patients were included in this study. The deep learning network performed more stably and accurately in predicting stage-iii NSCLC resected patients survival than the random survival forest and Cox proportional hazard model on the internal test dataset (C-index=0.834 vs. 0.678 vs. 0.640) and better than TNM staging system (C-index=0.820 vs. 0.650) in the external validation. The individual patient who follow the reference from recommendation system had superior survival compared to those who did not. The predicted 5-year-survival curve for each adjuvant treatment plan could be accessed in the recommender system via the browser. Deep learning model has several advantages over linear model and random forest model in prognostic predication and treatment recommendations. This novel analytical approach may provide accurate predication on individual survival and treatment recommendations for resected Stage-iii NSCLC patients.

PSP.03 12-Gene Expression Signature: A Potential Key for Predicting Prognosis and Benefit to ACT for Resectable NSCLC Patients

PSP.03 12-Gene Expression Signature: A Potential Key for Predicting Prognosis and Benefit to ACT for Resectable NSCLC Patients

Real world practice of postoperative radiotherapy for patients with completely resected pIIIA-N2 non-small cell lung cancer: a national survey of radiation oncologists in China

BackgroundResults from Lung ART and PORT-C trials suggest that postoperative radiotherapy (PORT) cannot routinely be recommended as standard treatment in completely resected pIIIA-N2 NSCLC patients, but their effects on the real-world practice of PORT in China remain unclear.MethodsA national cross-section survey was conducted by using an online survey service. Participants were voluntarily recruited using a river sampling strategy. A link to the survey was posted on websites of radiation oncologist associations and tweets from public WeChat accounts. The survey collected the real names of participants to ensure that they were board-certified radiation oncologists.ResultsA total of 484 radiation oncologists were included with a median age of 40 years (IQR, 35–47). A total of 377 (77.9%) participants were male, and 282 (58.1%) had more than 10 years of clinical experience practicing thoracic radiotherapy. Before Lung ART and PORT-C trials were published, 313 (64.7%) respondents recommended PORT, 11 (2.3%) did not recommend it, and 160 (33.1%) reported that they made decisions based on risk factors. After the presentation of two trials, only 42 (8.7%) did not recommend PORT, while 108 (22.3%) recommended it, and 334 (69.0%) made decisions based on risk factors. The five most commonly considered risk factors among these 334 respondents were as follows: nodal extracapsular extension, the highest lymph node (LN) station involved, the number of dissected mediastinal LN stations, the number of positive mediastinal LN stations, and surgical approaches. In addition, the majority of all 484 respondents recommended a total dose of 50 Gy, lung stump + ipsilateral hilus + regions containing positive LNs as the targeted region, lung V20 < 25%, and heart V30 < 40% as dose constraints for PORT.ConclusionMost Chinese radiation oncologists recommended PORT for completely resected IIIA-N2 NSCLC patients based on risk factors, especially status of LN station.

Benefit of adjuvant chemotherapy for resected pathologic N1 non-small cell lung cancer is unrecognized: A subgroup analysis of the JBR10 trial

Adjuvant chemotherapy is underutilized in clinical practice, in part, because its anticipated survival benefit is limited. We evaluated the impact of AC on overall and recurrence-free survival among completely resected pN1 NSCLC patients enrolled in the North American Intergroup phase III (JBR10) trial. A post-hoc subgroup analysis of pN1 NSCLC patients was performed. Participants were randomized to cisplatin+vinorelbine (AC) (n = 118) or observation (n = 116) following complete resection. The primary endpoint was overall survival (OS). The secondary endpoint was recurrence free survival (RFS). Kaplan-Meier methods were used to compare OS and RFS between the two treatment groups. Cox regression was used to identify factors associated with OS and RFS endpoints. Both groups had similar baseline characteristics. AC patients had improved 5-year OS (AC 61.4% vs observation 41.0%, log-rank p = .008) and 5-year RFS (AC 56.2% vs observation 39.9%, log-rank p = .011) rates compared to observation. Cox regression analyses confirmed the OS (HR 0.583, 95% CI 0.402-0.846, p = .005) and RFS (HR 0.573, 95% CI 0.395-0.830, p = .003) benefit associated with AC. AC was associated with a lower risk (HR 0.648, 95% CI 0.435-0.965, p = .0326) and a lower cumulative incidence (Subdistribution Hazard Ratio [SHR], 0.67, 95% CI 0.449-0.999, p = .0498) of lung cancer deaths. In the JBR10 trial, treatment with AC conferred a significant OS and RFS advantage over observation for pN1 NSCLC patients. These data suggest that pN1 NSCLC patients may experience a disproportionately greater clinical benefit from AC than the 6% survival advantage estimated by the LACE meta-analysis.

The Value of Radiotherapy in Patients With Resectable Stage IIIA Non–Small-Cell Lung Cancer in the Era of Individualized Treatment: A Population-Based Analysis

IntroductionNo consensus has been achieved on the benefit of radiotherapy for resected stage IIIA NSCLC patients. The division of stage IIIA has changed significantly in 2017. This study aims to explore the effects of radiotherapy on the survival of patients with resectable stage IIIA NSCLC in the new era. Patients and MethodsPatients diagnosed with NSCLC between 2010 and 2018 were identified in the 8th edition TNM classification from the Surveillance, Epidemiology, and End Results database. A nomogram was developed by integrating all independent predictors for lung cancer-specific survival (LCSS). The Propensity Score Matching (PSM) and subgroup analysis were applied to mitigate potential bias. Survival analyses were conducted using the Kaplan Meier curves and Cox proportional hazards regression. ResultsA total of 2632 stage IIIA NSCLC patients were enrolled. The C-index of the nomogram for the prediction of LCSS was 0.636 (95% CI, 0.616-0.656). In the group of patients with N2 stage who featured more than 5 positive regional lymph nodes, compared with non-PORT, PORT did prolong postoperative survival time (50 vs. 31 months; P= .005). N2 patients with visceral pleural invasion (VPI), older (age >65), or had a larger tumor (size >3 cm) could also benefit from adjuvant radiotherapy. ConclusionTreatment protocol for stage IIIA NSCLC patients should be individualized. Based on our findings, N2 patients with more than 5 positive regional lymph nodes, VPI, larger tumor size (greater than 3 cm), and older (age above 65) could benefit from adjuvant radiotherapy. Further well-designed randomized trials are warranted.