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Background: Thymic carcinoma is a rare cancer with an aggressive clinical presentation and no organotypic symptoms. Despite using platinum-based chemotherapy as first-line treatment, the prognosis remains poor, necessitating a novel therapeutic strategy., Methods: The artemis trial is a Phase II, single-arm, multicenter study designed to evaluate the efficacy and safety of carboplatin, paclitaxel, lenvatinib, and pembrolizumab as first-line chemotherapy for patients with advanced or recurrent thymic carcinoma. A total of 35 patients will be enrolled in this study and will receive induction therapy every 3 weeks for up to 4 cycles, followed by pembrolizumab every 3 weeks, and daily lenvatinib as maintenance therapy for up to 31 cycles (for 2 years). Lenvatinib will be continued until disease progression or unacceptable toxicity based on the discretion of the attending physician., Conclusion: The primary endpoint of the study is the objective response rate, with secondary endpoints including progression-free survival, overall survival, duration of response, disease control rate, and safety profile., Trial Registration: ClinicalTrials.gov NCT05832827 Registered on April 27, 2023, https://classic., Clinicaltrials: gov/ct2/show/NCT05832827. Japan Registry of Clinical Trials (jRCT), jRCT2031230114. Registered on May 22, 2023, https://jrct.niph.go.jp/latest-detail/jRCT2031230114., (Copyright © 2024 Elsevier Inc. All rights reserved.)

Background: Immune checkpoint inhibitor (ICI) monotherapy is more effective than cytotoxic chemotherapy in improving overall survival (OS) among patients with advanced-stage non-small cell lung cancer (NSCLC). Recently, chemotherapy combined with ICI has been found to yield good outcomes. However, ICI monotherapy is still considered an important treatment option. Data on long-term progression-free survival (PFS) and OS in real-world settings are limited., Patients and Methods: This was a multicenter retrospective observational study. A total of 435 consecutive patients histologically diagnosed with advanced, metastatic, or recurrent NSCLC treated with ICI monotherapy were enrolled in this study from December 2015 to December 2018. Clinical data were collected from electronic medical records and pharmacy databases., Results: The PFS and OS of the patients were 3.4 and 13.0 months, respectively. The objective response and disease control rates were 22.8% and 54.9%, respectively, and the 4-year survival rate was 17.9%. Multivariate analyses revealed that elder patients (>70 years), good Eastern Cooperative Oncology Group Performance Status (ECOG PS) score, programmed death-ligand 1 tumor proportion score (PD-L1 TPS) of ≥ 50%, absence of bone metastasis, and presence of immune-related skin toxicity, which is an immune-related adverse event, were correlated with good PFS. Moreover, good ECOG PS score, PD-L1 TPS of ≥ 50%, absence of bone metastasis, and presence of skin toxicity were correlated with good OS., Conclusions: The 4-year survival rate was 17.9%. Good ECOG PS score, PD-L1 TPS of ≥ 50%, absence of bone metastasis, and presence of skin toxicity were correlated with good PFS and OS., (Copyright © 2022 Elsevier Inc. All rights reserved.)

Background: In clinical trials, first-line treatment with pembrolizumab improved overall survival (OS) in patients with advanced non-small-cell lung cancer (NSCLC) with a programmed death ligand 1 (PD-L1) tumor proportion score of ≥ 50%. However, data on the efficacy of this treatment between clinical trials and actual clinical practice are inconsistent., Patients and Methods: Ninety-five patients with histologically diagnosed advanced or recurrent NSCLC and a PD-L1 tumor proportion score of ≥ 50% who received pembrolizumab as first-line treatment were consecutively enrolled onto this multicenter retrospective study from February 2017 to December 2018. Clinical data were collected from electronic medical records. We assessed the objective response rate, progression-free survival (PFS), OS, and immune-related adverse events (irAE), and determined their associations with clinical characteristics., Results: The objective response rate was 40.0%. The median PFS was 6.1 months, and OS did not reach the median. Multivariate analyses revealed that nonadenocarcinoma histology (hazard ratio, 1.78; 95% confidence interval, 1.05-3.03; P = .015) and ≥ 3 metastatic sites (hazard ratio, 3.97; 95% confidence interval, 1.97-8.01; P < .001) were independently correlated with poor PFS. Patients with irAE and patients without interstitial lung disease had significantly longer PFS (14.0 and 4.9 months, respectively; P = .011) than patients without irAE or patients with interstitial lung disease., Conclusion: The outcome of patients receiving first-line pembrolizumab treatment was worse in those with nonadenocarcinoma and with a large number of metastatic sites. Patients with irAE and without interstitial lung disease had a more favorable outcome., (Copyright © 2020 Elsevier Inc. All rights reserved.)

Background: Because most lung cancers are diagnosed at advanced stages, we are forced to conduct molecular testing using small biopsy samples. Endobronchial ultrasound-transbronchial needle aspiration (EBUS-TBNA) is emerging as a minimally invasive biopsy technique. Here, we examined the usefulness of EBUS-TBNA to evaluate programmed death-ligand 1 (PD-L1) expression in lung cancer., Methods: Using 97 consecutive cases of lung cancer diagnosed by EBUS-TBNA, from which 20 transbronchial biopsy (TBB) samples were available, we evaluated the number and morphological intactness of tumor cells in EBUS-TBNA and TBB samples. Additionally, given the intratumoral heterogeneity in primary lesions and the small sample size of biopsies, we also compared the tumor PD-L1 expression between the biopsy samples and the corresponding surgical materials., Results: EBUS-TBNA collected a significantly larger number of tumor cells than TBB (P < .001); the median number (interquartile range) of cells was 1149 (379-3334) in EBUS-TBNA and 435 (218-1085) in TBB. The crush rate in EBUS-TBNA was significantly lower than in TBB (P < .001). These showed the excellence of EBUS-TBNA. Additionally, PD-L1 positivity of EBUS-TBNA showed a good concordance with the corresponding primary tumor (r = 0.75; P = .086; n = 6) as well as with lymph node metastasis (r = 0.93; P = .02; n = 5). Moreover, PD-L1 positivity between EBUS-TBNA and TBB (n = 16), TBB and the corresponding primary tumor (n = 41), and lymph node metastasis and the corresponding primary tumor (n = 47) showed a moderate correlation (all r > 0.48; all P < .001), strengthening the potential concordance between EBUS-TBNA and primary tumor in PD-L1 positivity., Conclusion: Our study suggests EBUS-TBNA as a promising method to evaluate PD-L1 expression in lung cancer., (Copyright © 2017 Elsevier Inc. All rights reserved.)