Resected Early-stage Non-small Cell Lung Research Articles

A retrospective analysis of treatment patterns, overall survival, and real-world disease-free survival in early-stage non-small cell lung cancer following complete resection

BackgroundReal-world data regarding patient characteristics, adjuvant treatment patterns, and long-term survival outcomes are needed to better understand unmet needs among patients with completely resected early-stage non-small cell lung cancer (NSCLC).MethodsElectronic medical records from the U.S.-based ConcertAI Patient360™ database were analyzed in patients with stage IB-IIIA NSCLC who underwent complete resection prior to March 1, 2016. Patients were followed until death or July 1, 2021. This study evaluated adjuvant chemotherapy use, and overall survival (OS) and real-world disease-free survival (rwDFS) outcomes using the Kaplan–Meier method. The correlation between OS and rwDFS was assessed using the Kendall rank test. Among patients who did not recur 5 years following surgery, landmark analyses of OS and rwDFS were conducted to understand the subsequent survival impact of remaining disease-free for at least 5 years.ResultsData from 441 patients with completely resected stage IB-IIIA NSCLC were included. About 35% of patients received adjuvant chemotherapy post-resection. Median OS and rwDFS from resection were 83.1 months and 42.4 months, respectively. The 5-year OS and rwDFS rates were 65.7% and 42.1%, respectively. OS and rwDFS were positively correlated (Kendall rank correlation coefficient = 0.67; p < 0.0001). Among patients without recurrence within 5 years after resection, the subsequent 5-year OS and rwDFS survival rates were 52.9% and 36.6%, respectively.ConclusionsUse of adjuvant chemotherapy was low, and the overall 5-year OS rate remained low despite all patients having undergone complete resection. Patients who remained non-recurrent over time had favorable subsequent long-term survival.

A retrospective analysis of treatment patterns, overall survival, and real-world disease-free survival in early-stage non-small cell lung cancer following complete resection

BackgroundReal-world data regarding patient characteristics, adjuvant treatment patterns, and long-term survival outcomes are needed to better understand unmet needs among patients with completely resected early-stage non-small cell lung cancer (NSCLC).MethodsElectronic medical records from the U.S.-based ConcertAI Patient360™ database were analyzed in patients with stage IB-IIIA NSCLC who underwent complete resection prior to March 1, 2016. Patients were followed until death or July 1, 2021. This study evaluated adjuvant chemotherapy use, and overall survival (OS) and real-world disease-free survival (rwDFS) outcomes using the Kaplan–Meier method. The correlation between OS and rwDFS was assessed using the Kendall rank test. Among patients who did not recur 5 years following surgery, landmark analyses of OS and rwDFS were conducted to understand the subsequent survival impact of remaining disease-free for at least 5 years.ResultsData from 441 patients with completely resected stage IB-IIIA NSCLC were included. About 35% of patients received adjuvant chemotherapy post-resection. Median OS and rwDFS from resection were 83.1 months and 42.4 months, respectively. The 5-year OS and rwDFS rates were 65.7% and 42.1%, respectively. OS and rwDFS were positively correlated (Kendall rank correlation coefficient = 0.67; p < 0.0001). Among patients without recurrence within 5 years after resection, the subsequent 5-year OS and rwDFS survival rates were 52.9% and 36.6%, respectively.ConclusionsUse of adjuvant chemotherapy was low, and the overall 5-year OS rate remained low despite all patients having undergone complete resection. Patients who remained non-recurrent over time had favorable subsequent long-term survival.

Comparison of SP263 and 22C3 immunohistochemistry PD-L1 assays for clinical efficacy of adjuvant atezolizumab in non-small cell lung cancer: results from the randomized phase III IMpower010 trial

BackgroundTumor samples from the phase III IMpower010 study were used to compare two programmed death-ligand 1 (PD-L1) immunohistochemistry assays (VENTANA SP263 and Dako 22C3) for identification of PD-L1 patient subgroups...

Oral uracil-tegafur compared with intravenous chemotherapy as adjuvant therapy for resected early-stage non-small cell lung cancer patients.

Studies comparing the effectiveness of either adjuvant oral uracil-tegafur (UFT) or intravenous chemotherapy on early-stage (stage I and II) non-small cell lung cancer (NSCLC) patients treated with complete surgical treatment remain limited. From January 2011 to December 2017, patients with early-stage NSCLC (defined as tumor size >3 cm without mediastinal lymph node involvement or any distant metastasis) receiving either adjuvant oral UFT or intravenous chemotherapy after surgical resection were identified from the Taiwan Cancer Registry. Overall survival (OS) and relapse-free survival (RFS) were the primary and secondary outcomes, respectively. Propensity matching was used for controlling confounders. A total of 840 patients receiving adjuvant therapy after surgery (including 595 oral UFT and 245 intravenous chemotherapy) were enrolled. Before matching, patients using oral UFT had significantly longer OS (HR: 0.69, 95% CI: 0.49-0.98, p = 0.0387) and RFS (HR: 0.79, 95% CI: 0.61-0.97, p = 0.0392) than those with intravenous chemotherapy. A matched cohort of 352 patients was created using 1:1 propensity score-matching. In the Cox regression analysis, the UFT and the matched chemotherapy groups had similar OS (HR: 0.80, 95% CI: 0.48-1.32, p = 0.3753) and RFS (HR: 0.98, 95% CI: 0.72-1.34, p = 0.9149). Among subgroup analysis, oral UFT use was associated with longer RFS among the subgroups of non-drinker (HR: 0.66, 95% CI: 0.34-0.99, p = 0.0478) and patients with stage IB disease (HR: 0.67, 95% CI: 0.42-0.97, p = 0.0341). This population-based study in the real-world setting of Taiwan demonstrates comparable effectiveness between oral UFT and intravenous chemotherapy in terms of clinical outcomes for early-stage NSCLC patients after surgery.

The prognostic value of the preoperative albumin/globulin and monocyte ratio in resected early-stage non-small cell lung cancer

ObjectiveThis study investigated the prognostic value of the preoperative albumin/globulin to monocyte ratio (AGMR) in patients with resected non-small cell lung cancer (NSCLC). MethodsThe study retrospectively enrolled patients with resected NSCLC from the Department of Thoracic Surgery, China–Japan Union Hospital of Jilin University from January 2016 to December 2017. Baseline demographic and clinicopathological data were collected. The preoperative AGMR was calculated. Propensity score matching (PSM) analysis was applied. The receiver operating characteristic curve was used to determine the optimal AGMR cut-off value. The Kaplan–Meier method was used to calculate the overall survival (OS) and disease-free survival (DFS). The Cox proportional hazards regression model was used to evaluate the prognostic value of the AGMR. ResultsA total of 305 NSCLC patients were included. The optimal AGMR value was 2.80. Before PSM. The high AGMR (>2.80) group had a significantly longer OS (41.34 + 11.32 vs. 32.03 + 17.01 months; P < 0.01) and DFS (39.00 + 14.49 vs. 28.78 + 19.13 months; P < 0.01) compared with the low AGMR (≤2.80) group. Multivariate analyses showed that AGMR (P < 0.01) in addition to sex (P < 0.05), body mass index (P < 0.01), history of respiratory diseases (P < 0.01), lymph node metastasis (P < 0.01), and tumor size (P < 0.01) were associated with OS and DFS. After PSM, AGMR remained as an independent prognostic factor for OS (hazard ratio [HR] 2.572, 95% confidence interval [CI]: 1.470–4.502; P = 0.001) and DFS (HR 2.110, 95% CI: 1.228–3.626; P = 0.007). ConclusionThe preoperative AGMR is a potential prognostic indicator for OS and DFS in resected early-stage NSCLC.

EE266 Societal Economic Impact of Treatment with Adjuvant Osimertinib in Patients with Early-Stage (IB-IIIA) EGFRm NSCLC

Adjuvant treatment with osimertinib significantly improves disease-free survival in patients with completely resected early-stage (IB-IIIA) EGFRm non-small cell lung cancer (NSCLC) compared with placebo, but the impact of osimertinib on societal economic costs is unknown. Here, we estimate the societal savings resulting from the use of adjuvant osimertinib vs. placebo in early-stage (IB-IIIA) EGFRm NSCLC in a United Kingdom (UK) setting.

91P Treatment (tx) patterns and outcomes in resectable early-stage non-small cell lung cancer (NSCLC): A global real-world (rw) study

91P Treatment (tx) patterns and outcomes in resectable early-stage non-small cell lung cancer (NSCLC): A global real-world (rw) study

95P Neoadjuvant treatment pattern and association between real-world event-free survival (rwEFS) and overall survival (OS) in patients (pts) with resected early-stage non-small cell lung cancer (eNSCLC)

95P Neoadjuvant treatment pattern and association between real-world event-free survival (rwEFS) and overall survival (OS) in patients (pts) with resected early-stage non-small cell lung cancer (eNSCLC)

Cost-effectiveness of adjuvant atezolizumab versus best supportive care in the treatment of patients with resectable early-stage non-small cell lung cancer and overexpression of PD-L1

AimsTo assess the cost-effectiveness of adjuvant atezolizumab in the treatment of early-stage NSCLC patients (stage II–IIIA) with expression PD-L1 ≥ 50% without mutations in EGFR or ALK rearrangements in Spain.Materials and methodsA 5-states Markov model (DFS, locoregional recurrence, 1 L-metastatic recurrence, 2 L-metastatic recurrence, and death states) was adapted to the Spanish setting. Demographic characteristics of the hypothetical cohort, transition probabilities from the DFS state, and safety parameters were obtained from IMpower010 study (GO29527). Transition probabilities from locoregional and metastatic health states were obtained from the literature. The usual clinical practice in Spain (use of health resources, management of the disease, etc.) was obtained from a previous analysis carried out by the authors of this study. A societal perspective was considered so both direct and indirect costs were included (expressed in € of 2021). A lifetime horizon was used, so costs and health outcomes were discounted at 3% per year. Sensitivity analyses were performed to evaluate uncertainty.ResultsOver a lifetime horizon, treatment with adjuvant atezolizumab provided greater effectiveness (+2.61 life years [LY] and +1.95 quality-adjusted life years [QALY]) and higher cost (€+22,538) than BSC. The incremental cost-effectiveness ratio (ICER) and incremental cost-utility ratios (ICUR) of the analysis were €8,625/LY gained and €11,583/QALY gained, respectively. Robustness of these base-case results was confirmed by the sensitivity analyses performed. In the probabilistic sensitivity analysis, 90% of the simulations performed showed that adjuvant atezolizumab is cost-effective versus BSC, considering a threshold of €30,000/QALY.ConclusionsOur results showed that adjuvant treatment with atezolizumab in patients with early-stage resected NSCLC with overexpression of PD-L1 and without EGFR and ALK mutations is cost-effective versus BSC as the ICERs and ICURs obtained are below the cost-effectiveness thresholds commonly considered in Spain, thus offering a new treatment alternative for these patients.

Economic burden of locoregional and metastatic relapses in resectable early-stage non-small cell lung cancer in Spain

BackgroundThere are scarce data of the costs of non-small cell lung cancer (NSCLC) recurrence in Spain. The objective of this study is to assess the economic burden of disease recurrence, for both locoregional and/or metastatic relapses, after appropriate early-stage NSCLC treatment in Spain.Materials and methodsA two-round consensus panel of Spanish oncologists and hospital pharmacists was conducted to collect information on patient’s flow, treatments, use of healthcare resources and sick leaves in patients with relapsed NSCLC. A decision-tree model was developed to calculate the economic burden of disease recurrence after appropriate early-stage NSCLC. Both direct and indirect costs were considered. Direct costs included drug acquisition and healthcare resources costs. Indirect costs were estimated using the human-capital approach. Unit costs were obtained from national databases (euros of 2022). A multi-way sensitivity analysis was performed to provide a range to the mean values.ResultsAmong a cohort of 100 patients with relapsed NSCLC, 45 patients would have locoregional relapse (36.3 would eventually progress to metastasis and 8.7 would be considered in remission) and 55 patients would have metastatic relapse. Over time, 91.3 patients would experience a metastatic relapse (55 as first relapse and 36.6 after previous locoregional relapse). The overall cost incurred by the 100-patients cohort is €10,095,846 (€9,336,782 direct costs, €795,064 indirect costs). The average cost of a locoregional relapse is €25,194 (€19,658 direct costs, €5536 indirect costs), while the average cost a patient with metastasis who receives up to 4 lines of treatment is €127,167 (€117,328 direct, €9839 indirect).ConclusionsTo our knowledge, this is the first study that specifically quantifies the cost of relapse in NSCLC in Spain. Our findings shown that the overall cost of a relapse after appropriate treatment of early-stage NSCLC patients is substantial, and it increases considerably in the metastatic relapse setting, mainly due to the high cost and long duration of first-line treatments.

EE495 Cost-Effectiveness Analysis of Adjuvant Atezolizumab Versus Best Supportive Care in the Treatment of Patients With Resectable Early-Stage Non-Small Cell Lung Cancer and PD-L1≥50% Expression

Adjuvant atezolizumab vs. best-supportive care (BSC) after complete resection and adjuvant platinum-based chemotherapy in patients with early-stage resected non-small cell lung cancer (NSCLC) was evaluated in IMpower010 trial, showing an improvement in disease-free survival (DFS) in favor of atezolizumab. We aimed to assess the cost-effectiveness of adjuvant atezolizumab in the treatment of early-stage NSCLC patients (stage II-IIIA) with expression of programmed death-ligand 1 PD-L1≥50% without mutations in EGFR or ALK rearrangements in Spain.

Clinical impact of number of lymph nodes dissected on postoperative survival in node-negative small cell lung cancer.

Small cell lung cancer (SCLC) is a lethal histologic subtype of lung cancer. Although the Commission on Cancer recommends pathological examination of at least 10 lymph nodes dissected (LNDs) for resected early-stage non-small cell lung cancer, its survival benefit of LNDs in patients with early-stage SCLC is unknown. The National Cancer Database was queried for SCLC patients with clinical stage I-II and clinical N0, NX disease per AJCC 7th edition who had undergone lobectomy between 2004 and 2017. Overall survival of SCLC patients by the number of LNDs was compared using Log-rank tests. Univariate and multivariable Cox proportional hazards analyses were performed. In total, 688 (42%), 311 (20%), 247 (16%), 196 (12%), 126 (8%), and 36 (2%) of 1,584 patients with early-stage SCLC had ≥10, 7-9, 5-6, 3-4, 1-2, and 0 LNDs, respectively. The sequential improvement in the HRs was no longer evident if the number of LNDs exceeds 4. Patients with ≥3 LNDs (n = 1,422) had a significantly longer overall survival than those with <3 LNDs (n = 162) (hazard ratio for death: 0.76, 95% confidence interval: 0.62-0.94, P = 0.0087). Multivariate analysis revealed that ≥3 LNDs was an independent factor for predicting overall survival (hazard ratio for death: 0.76, 95% confidence interval: 0.61-0.93, P = 0.0083). Although we are reluctant to recommend a definitive "optimal number" of LNDs, our findings suggest the prognostic and therapeutic roles for performing ≥3 LNDs in patients with early-stage SCLC who undergo lobectomy.

21P Circulating free and extracellular vesicles-derived microRNA as prognostic biomarkers in resected early-stage non-small cell lung cancer

Non-small cell lung cancer (NSCLC) is the primary cause of cancer-related death. About 20% of cases are diagnosed at an early stage, allowing an effective pulmonary resection but many patients experience disease recurrence. Biomarkers able to identify patients with a higher risk of relapse could be very useful. Circulating microRNAs (miRNAs), in both extracellular vesicles (EV)-free and EV-encapsulated forms, represent promising markers in this setting.

Abstract 5114: Ultra-sensitive detection of minimal residual disease (MRD) through whole genome sequencing (WGS) using an AI-based error suppression model in resected early-stage non-small cell lung cancer (NSCLC)

Abstract Background: Early detection of recurrence and monitoring of MRD post-surgery is critical for clinical decision-making to tailor adjuvant therapy. In early-stage NSCLC, circulating tumor DNA (ctDNA) detection is especially challenging, requiring highly sensitive and specific assays. Therefore, we used a WGS approach (MRDetect) for ultra-sensitive ctDNA detection in NSCLC patients (pts) undergoing curative surgery. Methods: We conducted a pilot study to evaluate the MRDetect approach in serial plasma samples (including pre-surgery, post-surgery and follow-up [f/u] timepoints) from resected stage IB-IIIA NSCLC pts. Pts underwent routine surveillance by computed tomography scans. ctDNA was extracted from ~1mL plasma. MRDetect uses WGS by a tumor-informed approach (sequencing coverage 40x for tumor, 20x for plasma DNA) combined with AI-based error suppression models (trained and calibrated with a non-cancer cohort, n=17) to increase the signal to noise ratio for precise ctDNA detection, and improve the accuracy of readouts especially for low tumor burden scenarios. The assay reports the detection and quantification of ctDNA burden in blood with a prognostic value for risk of recurrence. The ability of the assay to predict recurrence from a single sample, taken at the clinical landmark point (median 1.6 mths post-surgery, range 0.1-6.5) was evaluated. Results: Overall, 52 NSCLC pts were enrolled (n=88 plasma samples) with median clinical f/u of 32.6 mths (range 3.1-98.6). There were 43 pts with post-surgery landmark samples, with median age 62 years, 70% were male, 79% were adenocarcinoma and 49% were EGFR mutated. 26% were stage IB and 37% each were stage II and III. There were 15/18 (sensitivity 83%) pts with confirmed radiological recurrence in which MRDetect was positive, including 6/7 (86%) EGFR mutated pts. The median RFS in MRDetect positive pts was 15.2 mths (range 3.7-33.4). Among 25 pts with no recurrence (median f/u 25.6 mths), MRDetect reported 4 pts to be MRD positive (specificity 84%). These results were consistent between EGFR mutated (sensitivity 86%, specificity 86%) and wildtype pts (sensitivity 82%, specificity 82%). For longitudinal samples (n=17 pts), negative ctDNA was associated with absence of recurrence in 14/15 pts (specificity 93%). At the AACR meeting, results from a planned larger validation study will be presented. Conclusion: Using a robust WGS implemented AI-based computational platform (MRDetect), we demonstrate high sensitivity and specificity detection of MRD in both EGFR mutated and wildtype NSCLC. With an increasing number of therapeutic options in the adjuvant setting for NSCLC, an ultra-sensitive MRD assay has the potential to facilitate personalized clinical decision-making for tailoring both the need and choice of adjuvant therapies. Citation Format: Aaron C. Tan, Stephanie P. Saw, Gillianne G. Lai, Kevin L. Chua, Angela Takano, Boon-Hean Ong, Tina P. Koh, Amit Jain, Wan Ling Tan, Quan Sing Ng, Ravindran Kanesvaran, Tanujaa Rajasekaran, Sunil Deochand, Dillon Maloney, Danielle Afterman, Tomer Lauterman, Noah Friedman, Imane Bourzgui, Nidhi Ramaraj, Zohar Donenhirsh, Ronel Veksler, Jonathan Rosenfeld, Ravi Kandasamy, Iman Tavassoly, Boris Oklander, Asaf Zviran, Wan-Teck Lim, Eng-Huat Tan, Anders J. Skanderup, Mei-Kim Ang, Daniel S. Tan. Ultra-sensitive detection of minimal residual disease (MRD) through whole genome sequencing (WGS) using an AI-based error suppression model in resected early-stage non-small cell lung cancer (NSCLC) [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2022; 2022 Apr 8-13. Philadelphia (PA): AACR; Cancer Res 2022;82(12_Suppl):Abstract nr 5114.

EORTC-1416-LCG/ETOP 8-15 – PEARLS/KEYNOTE-091 study of pembrolizumab versus placebo for completely resected early-stage non-small cell lung cancer (NSCLC): Outcomes in subgroups related to surgery, disease burden, and adjuvant chemotherapy use.

8512 Background: At the second interim analysis (IA2) of the triple-blind, phase 3 PEARLS/KEYNOTE-091 study (NCT02504372), pembrolizumab significantly improved DFS compared with placebo in patients (pts) with completely resected stage IB (T ≥4 cm) to IIIA NSCLC per AJCC v7, regardless of PD-L1 expression (N = 1177, HR 0.76, 95% CI 0.63-0.91, P = 0.0014). We present DFS in subgroups related to surgery, disease burden, and adjuvant chemotherapy use. Methods: Pts had pathologically confirmed, completely resected stage IB (T ≥4 cm) to IIIA NSCLC of any PD-L1 expression and ECOG PS 0-1. Systematic complete or lobe-specific mediastinal lymph node dissection was recommended; minimally, the subcarinal and 1 lobe-specific lymph node must have been examined. Adjuvant chemotherapy of ≤4 cycles was given as indicated by local guidelines. Eligible pts were randomized 1:1 to pembrolizumab 200 mg or placebo Q3W for 18 doses (̃1 y). Treatment effects on DFS were assessed in prespecified subgroups of with and without adjuvant chemotherapy and in exploratory subgroups defined by surgery type, pN stage, tumor size, no. of adjuvant chemotherapy cycles, and adjuvant regimen; only subgroups of &gt; 50 pts were analyzed. Data cutoff for IA2 was September 20, 2021 (median time from randomization to cutoff, 35.6 mo). Results: By surgery type, the HR (95% CI) for DFS was 0.78 (0.64-0.96) for lobectomy (n = 925), 0.85 (0.43-1.69) for bilobectomy (n = 92), and 0.71 (0.40-1.24) for pneumonectomy (n = 127). For subgroups based on nodal status, HR (95% CI) for DFS was 0.63 (0.46-0.86) for pN0 (n = 490), 0.77 (0.57-1.03) for pN1 (n = 456), and 1.00 (0.71-1.41) for pN2 (n = 231). By tumor size, and irrespective of nodal status, the HR (95% CI) for DFS was 0.91 (0.69-1.20) for size ≤4 cm (n = 491) and 0.70 (0.55-0.89) for size &gt; 4 cm (n = 685). The HR (95% CI) for DFS was 0.73 (0.60-0.89) in pts who received adjuvant chemotherapy (n = 1010) and 1.25 (0.76-2.05) in those who did not (n = 167). Among pts who received adjuvant chemotherapy, HR (95% CI) for DFS by number of cycles was 0.59 (0.28-1.26) for 1-2 (n = 67) and 0.74 (0.61-0.91) for 3-4 (n = 943); by regimen, it was 0.74 (0.55-0.98) for cisplatin + vinorelbine (n = 491), 0.51 (0.31-0.83) for carboplatin + vinorelbine (n = 151), 1.21 (0.73-1.98) for carboplatin + paclitaxel (n = 135), 0.65 (0.30-1.40) for cisplatin + gemcitabine (n = 57), and 0.68 (0.41-1.14) for other regimen (n = 176). Conclusions: Pembrolizumab generally improved DFS versus placebo regardless of type of surgery, lymph node involvement, tumor size, and type and extent of adjuvant chemotherapy in pts with completely resected stage IB (T ≥4 cm) to IIIA NSCLC. These data support the benefit of pembrolizumab as adjuvant therapy for early-stage NSCLC following complete resection and, if indicated, adjuvant chemotherapy. Clinical trial information: NCT02504372.

Multidisciplinary Management of Resectable Early-Stage Non-Small Cell Lung Cancer.

During JADPRO Live Virtual 2021, three advanced practitioners—in surgery, radiation oncology, and medical oncology—discussed their collaboration in the management of resectable early-stage non–small cell lung cancer. The presenters discussed the role of screening and early surgical resection, cancer surveillance after resection, adjuvant and neoadjuvant therapies, as well as novel therapies and their associated toxicities.

Prognostic value of postoperative decrease in serum albumin on surgically resected early-stage non-small cell lung carcinoma: A multicenter retrospective study.

Preoperative nutritional status is an important host-related prognostic factor for non-small cell lung carcinoma (NSCLC); however, the significance of postoperative changes in nutritional status remains unclear. This study aimed to elucidate the significance of postoperative decreases in serum albumin (ΔAlb) on the outcomes of early-stage NSCLC. We analyzed 443 training cohort (TC) and 642 validation cohort (VC) patients with pStage IA NSCLC who underwent surgery and did not recur within 1 year. We measured preoperative serum albumin levels (preAlb) and postoperative levels 1 year after surgery (postAlb), and calculated ΔAlb as (preAlb - postAlb)/preAlb × 100%. A cutoff value of 11% for ΔAlb was defined on the basis of the receiver operating characteristic curve for the TC. Patients were divided into ΔAlb-Decreased and ΔAlb-Stable groups, including 100 (22.6%) and 343 (77.4%) in the TC, and 58 (9.0%) and 584 (90.1%) in the VC. ΔAlb-Decreased was associated with male sex (p = 0.0490), smoking (p = 0.0156), and non-adenocarcinoma (p<0.0001) in the TC, and pT1b (p = 0.0169) and non-adenocarcinoma (p = 0.0251) in the VC. Multivariable analysis identified ΔAlb as an independent prognostic factor for disease-free survival (DFS) and overall survival (OS) in both cohorts (VC: DFS, HR = 1.9, 95%CI: 1.10-3.15, p = 0.0197; OS, HR = 2.0, 95%CI: 1.13-3.45, p = 0.0173). Moreover, subgroup analysis demonstrated that the prognostic value of ΔAlb was consistent for age, sex, smoking history, surgical procedure, and histological type. We demonstrated a negative impact of postoperative decrease of the serum albumin on the prognosis of patients with early-stage NSCLC. Postoperative changes in nutritional status might be important in NSCLC outcomes.

The role of galectin-3 and its genetic variants in tumor risk and survival of patients with surgically resected early-stage non-small cell lung cancer.

Background The aim of this study was to investigate the possible relationship between galectin-3 gene variants, serum level, gene expression level, and the risks and survivals of resectable non-small cell lung cancer patients. Methods The rs4644 and rs4652 variants of galectin-3 were genotyped by TaqMan single nucleotide polymorphism assay using genomic deoxyribonucleic acid isolated from the peripheral blood of 65 (54 males, 11 females; mean age: 60.1±11.9 years; range, 34 to 83 years) with Stage IA-IIIA non-small cell lung cancer who underwent primary surgical treatment and 95 healthy individuals (48 males, 47 females; mean age: 53.9±13.5 years; range, 32 to 87 years) between March 2017 and September 2018. Circulating galectin-3 levels in serum samples of the patient and control groups were assessed by enzyme-linked immunosorbent assay. Messenger ribonucleic acid expression of galectin-3 in tumor and surrounding tissues of the patient group was examined by real-time quantitative polymerase chain reaction. Both predictive and prognostic significance of the results were analyzed. Results The presence of angiolymphatic invasion was significant in the patients with rs4652 AA genotype (p=0.04). Serum galectin-3 levels were significantly higher in the patients than the controls (p<0.0001). The patients with rs4644 CA/CC (p<0.0001 and p<0.0001) and rs4652 AA/AC (p=0.001 and p<0.0001) genotypes had higher serum galectin-3 levels than their corresponding controls. Serum galectin-3 levels increased in the presence of vascular invasion in patients with both rs4644 AC (p=0.03) and rs4652 AC (p=0.019) genotypes. The receiver operating characteristic curve suggested serum galectin-3 level as a strong predictive marker for the patient group with a cut-off value of 17.089 ng/mL (area under the curve: 0.910±0.04; 95% confidence interval: 0.832-0.988; p<0.001). Univariate analysis revealed the association of lower serum galectin-3 levels with better survival (p=0.048). Multivariate survival analysis showed that only high serum galectin-3 levels tended to be related to survival of the patients (hazard ratio: 5.106; 95% confidence interval: 0.956-27.267; p=0.056). Conclusion The presence of galectin-3 gene variants may lead to histopathological differences among patients with non-small cell lung cancer. Serum galectin-3 level may be a valuable diagnostic biomarker and be associated with survival of these patients.

CheckMate 77 T: A phase 3 trial of neoadjuvant nivolumab (NIVO) + chemotherapy (chemo) followed by adjuvant NIVO in resectable early-stage non-small cell lung cancer (NSCLC)

CheckMate 77 T: A phase 3 trial of neoadjuvant nivolumab (NIVO) + chemotherapy (chemo) followed by adjuvant NIVO in resectable early-stage non-small cell lung cancer (NSCLC)

Sarcopenia is poor risk for unfavorable short- and long-term outcomes in stage I non-small cell lung cancer.

BackgroundSarcopenia characterized by skeletal muscle loss may influence postoperative outcomes through physical decline and weakened immunity. We aimed to investigate clinical significance of sarcopenia in resected early-stage non-small cell lung cancer (NSCLC).MethodsWe retrospectively reviewed 315 consecutive patients with pathologic stage I NSCLC who had undergone lobectomy with systematic nodal dissection. Sarcopenia was defined as the lowest quartile of psoas muscle area on the 3rd vertebra on the high-resolution computed tomography (HRCT) image. Clinicopathological variables were used to investigate the correlation to postoperative complications as well as overall and recurrence-free survival.ResultsUpon multivariable analysis, male sex [odds ratio (OR) =5.780, 95% confidence interval (CI): 2.681–12.500, P<0.001], and sarcopenia (OR =21.00, 95% CI: 10.30–42.80, P<0.001) were independently associated with postoperative complications. The sarcopenia group showed significantly lower 5-over all survival (84.4% vs. 69.1%, P<0.001) and recurrence-free survival (77.2% vs. 62.0%, P<0.001) comparing with the non-sarcopenia group. In a multivariable analysis, sarcopenia was an independent prognostic factor [hazard ratio (HR) =1.978, 95% CI: 1.177–3.326, P=0.010] together with age ≥70 years (HR =1.956, 95% CI: 1.141–3.351, P=0.015) and non-adenocarcinoma histology (HR =1.958, 95% CI: 1.159–3.301, P=0.016).ConclusionsThis is the first study which demonstrates that preoperative sarcopenia is significantly associated with unfavorable postoperative complications as well as long-term survival in pathologic stage I NSCLC. This readily available factor on HRCT may provide valuable information to consider possible choice of surgical procedure and perioperative management.