Autoimmune adverse event following COVID-19 vaccination in Seoul, South Korea.

BACKGROUND: There is growing evidence that the coronavirus disease 2019 (COVID-19) vaccination can affect the regulation of the immune system, leading to the development of autoimmune diseases. However, the autoimmune adverse events (AEs) after COVID-19 vaccination remain largely unclear. OBJECTIVE: We sought to investigate the autoimmune AEs after COVID-19 vaccination from a population-based cohort in South Korea. METHODS: A total of 4,203,887 participants, representing 50% of the population residing in Seoul, were recruited from the National Health Insurance Service database and then divided into 2 groups on the basis of COVID-19 vaccination. The cumulative incidence, hazard ratios (HRs), and 95% CIs of autoimmune AEs were assessed following COVID-19 vaccination. RESULTS: The incidence of vitiligo has been observed to be significantly higher in the vaccination group compared with the no vaccination group. The cumulative incidence of vitiligo began to show a significant difference starting 2 weeks after vaccination, and it reached 2.2% in the vaccination group and 0.6% in the no vaccination group by 3 months after COVID-19 vaccination. Vitiligo (HR, 2.714; 95% CI, 1.777-4.146) was an increased risk among autoimmune AEs. Furthermore, the risk of vitiligo was the highest for heterologous vaccination (HR, 3.890; 95% CI, 2.303-6.573) compared with using cDNA vaccine (HR, 2.861; 95% CI, 1.838-4.453) or mRNA vaccine (HR, 2.475; 95% CI, 1.607-3.813). CONCLUSIONS: Vitiligo as an autoimmune AE was noted to be substantially higher in the COVID-19-vaccinated group compared with the controls. Therefore, the occurrence of vitiligo could be considered as one of the significant AEs post-COVID-19 vaccination.

Safety and efficacy of SNK01 (autologous natural killer cells) in combination with cytotoxic chemotherapy and/or cetuximab after failure of prior tyrosine kinase inhibitor in non-small cell lung cancer: non-clinical mouse model and phase I/IIa clinical study.

BACKGROUND: Choosing treatments for epidermal growth factor receptor (EGFR)-mutated non-small cell lung cancer (NSCLC) patients with osimertinib resistance is challenging. We evaluated the safety and efficacy of SNK01 (autologous natural killer (NK) cells) in combination with cytotoxic chemotherapy and/or cetuximab (an anti-EGFR monoclonal antibody) in treating EGFR-mutated NSCLC in this non-clinical and phase I/IIa clinical trial. METHODS: We developed a cell line-derived xenograft-humanized mouse model with an osimertinib-resistant lung cancer cell line. The mice were divided into four groups based on treatment (no treatment, cetuximab, SNK01, and combination groups) and treated weekly for 5 weeks. In the clinical study, 12 patients with EGFR-mutated NSCLC who failed prior tyrosine kinase inhibitor (TKI) received SNK01 weekly in combination with gemcitabine/carboplatin (n=6) or cetuximab/gemcitabine/carboplatin (n=6) and dose escalation of SNK01 following the "3+3" design. RESULTS: In the non-clinical study, an increase in NK cells in the blood and enhanced NK cell tumor infiltration were observed in the SNK01 group. The volume of tumor extracted after treatment was the smallest in the combination group. In the clinical study, 12 patients (median age, 60.9 years; all adenocarcinoma cases) received SNK01 weekly for 7-8 weeks (4×109 cells/dose (n=6); 6×109 cells/dose (n=6)). The maximum feasible dose of SNK01 was 6×109 cells/dose without dose-limiting toxicity. Efficacy outcomes showed an objective response rate of 25%, disease control rate of 100%, and median progression-free survival of 143 days. CONCLUSION: SNK01 in combination with cytotoxic chemotherapy, including cetuximab, for EGFR-mutated NSCLC with TKI resistance was safe and exerted a potential antitumor effect. TRIAL REGISTRATION NUMBER: NCT04872634.

Prognostic Factors for Predicting Post-COVID-19 Condition in Patients With COVID-19 in an Outpatient Setting.

BACKGROUND: Although data on post-coronavirus disease 2019 (COVID-19) conditions are extensive, the prognostic factors affecting symptom duration in non-hospitalized patients with COVID-19 are currently not well known. We aimed to investigate the various prognostic factors affecting symptom duration among outpatients with COVID-19. METHODS: Data were analyzed from 257 patients who were diagnosed with mild COVID-19 and visited the 'post-COVID-19 outpatient clinic' between April and December 2022 after a mandatory isolation period. The symptom duration was measured from diagnosis to symptom resolution. Laboratory and pulmonary function test results from their first visit were collected. RESULTS: The mean age of patients was 55.7 years, and the median symptom duration was 57 days. The development of post-COVID-19 conditions (> 12 weeks) were significantly correlated with not using antiviral drugs, leukocytosis (white blood cell > 10,000/µL), lower 25(OH)D3 levels, forced vital capacity (FVC) < 90% predicted, and presence of dyspnea and anxiety/depression. Additionally, in multivariable Cox regression analysis, not using antiviral drugs, lower 25(OH)D3 levels, and having dyspnea were poor prognostic factors for longer symptom duration. Particularly, vitamin D deficiency (< 20 ng/mL) and not using antivirals during the acute phase were independent poor prognostic factors for both post-COVID-19 condition and longer symptom duration. CONCLUSION: The non-use of antivirals, lower 25(OH)D3 levels, leukocytosis, FVC < 90% predicted, and the presence of dyspnea and anxiety/depression symptoms could be useful prognostic factors for predicting post-COVID-19 condition in outpatients with COVID-19. We suggest that the use of antiviral agents during the acute phase and vitamin D supplements might help reduce COVID-19 symptom duration.

The Real-World Outcome of First Line Atezolizumab in Extensive-Stage Small Cell Lung Cancer: A Multicenter Prospective Cohort Study.

PURPOSE: The addition of immune checkpoint inhibitors to chemotherapy has improved survival outcomes in patients with extensive-stage small cell lung cancer (ES-SCLC). However, their real-world effectiveness remains unknown. Therefore, we investigated the effectiveness of atezolizumab plus chemotherapy in ES-SCLC in actual clinical settings. MATERIALS AND METHODS: In this multicenter prospective cohort study, patients with ES-SCLC receiving or scheduled to receive atezolizumab in combination with etoposide and carboplatin were enrolled between June 2021 and August 2022. The primary outcomes were progression-free survival (PFS) and the 1-year overall survival (OS) rate. RESULTS: A total of 100 patients with ES-SCLC were enrolled from seven centers. Median age was 69 years, and 6% had an Eastern Cooperative Oncology Group performance status (ECOG PS) ≥ 2. The median PFS was 6.0 months, the 1-year OS rate was 62.2%, and the median OS was 13.5 months. An ECOG PS of 2-3 and progressive disease as the best response were poor prognostic factors for PFS, while an ECOG PS of 2-3 and brain metastasis were associated with poor prognosis for OS. In addition, consolidative thoracic radiotherapy was found to be an independent favorable prognostic factor for OS (hazard ratio, 0.336; p=0.021). Grade ≥ 3 treatment-related adverse events were observed in 7% of patients, with treatment-related deaths occurring in 2% of patients. CONCLUSION: We provided evidence of the favorable real-world effectiveness and safety of atezolizumab plus chemotherapy in ES-SCLC patients, including in the elderly and those with poor ECOG PS. Additional consolidative thoracic radiotherapy may also benefit ES-SCLC patients.

Blood Krebs von den Lungen-6 levels predict treatment response to antifibrotic therapy in patients with idiopathic pulmonary fibrosis.

BACKGROUND: Antifibrotic therapy can slow disease progression (DP) in patients with idiopathic pulmonary fibrosis (IPF). However, the prognostic biomarkers for DP in patients with IPF receiving antifibrotic therapy have not been identified. Therefore, we aimed to evaluate the prognostic efficacy of serum Krebs von den Lungen-6 (KL-6) for DP in patients with IPF receiving antifibrotic therapy. METHODS: The clinical data of 188 patients with IPF who initiated antifibrotic therapy at three tertiary hospitals was retrospectively analyzed. DP was defined as a relative decline in forced vital capacity (FVC) ≥ 10%, diffusing capacity for carbon monoxide ≥ 15%, acute exacerbation, or deaths during 6 months after antifibrotic therapy. RESULTS: The mean age of patients was 68.9 years, 77.7% were male, and DP occurred in 43 patients (22.9%) during follow-up (median, 7.6 months; interquartile range, 6.2-9.8 months). There was no difference in baseline KL-6 levels between the DP and no-DP groups; however, among patients with high baseline KL-6 levels (≥ 500 U/mL), changes in KL-6 levels over 1 month were higher in the DP group than those in the non-DP group, and higher relative changes in KL-6 over 1 month were independently associated with DP (odds ratio, 1.043; 95% confidence interval 1.005-1.084) in the multivariable logistic analysis adjusted for age and FVC. In the receiver operating characteristic curve analysis, the 1-month change in KL-6 was also useful for predicting DP (area under the curve = 0.707; P < 0.012). CONCLUSIONS: Our data suggest that the relative change in KL-6 over 1 month might be useful for predicting DP in patients with IPF receiving antifibrotic therapy when baseline KL6 is high.

Impact of gender on response to immune checkpoint inhibitors in patients with non-small cell lung cancer undergoing second- or later-line treatment.

Background: Several previous clinical trials have reported that male patients with non-small cell lung cancer (NSCLC) respond better to immunotherapy than females. However, the impact of gender on prognosis remains uncertain because no real-world study considering various factors that affect patients' response to immunotherapy with gender exists. Therefore, we evaluated the effect of gender on immunotherapy response adjusted by multiple factors in actual clinical practice. Methods: This study was a single-center real-world retrospective cohort study, comprising 387 patients with NSCLC who received pembrolizumab, nivolumab, or atezolizumab alone as second- or later-line treatments. Subsequently, we compared their progression free survival (PFS) and overall survival (OS) scores based on gender, then analyzed prognostic factors accounting for immunotherapy response. Results: The mean age of the understudied patients was 64.0 years old, comprising 68.7% males, with non-squamous cell carcinoma accounting for 70.3% of these patients. Male patients also showed higher smoking rates, programmed death-ligand 1 (PD-L1) expression, and expression of wild type epidermal growth factor receptor (EGFR), known as favorable prognostic factors. However, no difference in PFS and OS according to gender was observed [PFS 2.2 (male) vs. 2.1 (female) months, P=0.144; OS 7.6 (male) vs. 8.8 (female) months, P=0.383]. Furthermore, an Eastern Cooperative Oncology Group (ECOG) performance status ≥2, high expression of PD-L1, and EGFR mutations were proposed as prognostic factors in multivariate analysis for PFS. Besides, ECOG performance status ≥2 and squamous cell carcinoma were poor prognostic factors accounting for OS. Yet, gender was not an independent prognostic factor in PFS and OS. Conclusions: Gender was not an independent prognostic factor for immunotherapy in real-world data although various factors affected immunotherapy response, such as wild type EGFR and high expression of PD-L1, which frequently occur in males.

Automated extraction of information of lung cancer staging from unstructured reports of PET-CT interpretation: natural language processing with deep-learning.

BACKGROUND: Extracting metastatic information from previous radiologic-text reports is important, however, laborious annotations have limited the usability of these texts. We developed a deep-learning model for extracting primary lung cancer sites and metastatic lymph nodes and distant metastasis information from PET-CT reports for determining lung cancer stages. METHODS: PET-CT reports, fully written in English, were acquired from two cohorts of patients with lung cancer who were diagnosed at a tertiary hospital between January 2004 and March 2020. One cohort of 20,466 PET-CT reports was used for training and the validation set, and the other cohort of 4190 PET-CT reports was used for an additional-test set. A pre-processing model (Lung Cancer Spell Checker) was applied to correct the typographical errors, and pseudo-labelling was used for training the model. The deep-learning model was constructed using the Convolutional-Recurrent Neural Network. The performance metrics for the prediction model were accuracy, precision, sensitivity, micro-AUROC, and AUPRC. RESULTS: For the extraction of primary lung cancer location, the model showed a micro-AUROC of 0.913 and 0.946 in the validation set and the additional-test set, respectively. For metastatic lymph nodes, the model showed a sensitivity of 0.827 and a specificity of 0.960. In predicting distant metastasis, the model showed a micro-AUROC of 0.944 and 0.950 in the validation and the additional-test set, respectively. CONCLUSION: Our deep-learning method could be used for extracting lung cancer stage information from PET-CT reports and may facilitate lung cancer studies by alleviating laborious annotation by clinicians.

Comparison of mortality and clinical failure rates between vancomycin and teicoplanin in patients with methicillin-resistant Staphylococcus aureus pneumonia.

BACKGROUND: Very few studies have compared the effects and side effects of vancomycin and teicoplanin in patients with methicillin-resistant Staphylococcus aureus pneumonia. This study aimed to compare the efficacy and safety of vancomycin and teicoplanin in patients with methicillin-resistant Staphylococcus aureus pneumonia. METHODS: This study examined 116 patients with methicillin-resistant Staphylococcus aureus pneumonia who met the inclusion criteria and were treated with either vancomycin (n = 54) or teicoplanin (n = 62). The primary (i.e., clinical failure during treatment) and secondary outcomes (i.e., mortality rates, discontinuation of study drugs due to treatment failure, side effects, and clinical cure) were evaluated. RESULTS: The vancomycin group presented lower clinical failure rates (25.9% vs. 61.3%, p < 0.001), discontinuation due to treatment failure (22.2% vs. 41.9%, p = 0.024), and mortality rates (3.7% vs 19.4%, p = 0.010). The Cox proportional hazard model revealed that teicoplanin was a significant clinical failure predictor compared with vancomycin (adjusted odds ratio, 2.198; 95% confidence interval 1.163-4.154). The rates of drug change due to side effects were higher in the vancomycin group than in the teicoplanin group (24.1% vs. 1.6%, p < 0.001). CONCLUSIONS: Vancomycin presented favorable treatment outcomes and more side effects compared with teicoplanin, which suggests that clinicians would need to consider the efficacy and potential side effects of these drugs before prescription.

The Risk of Tuberculosis in Patients With Inflammatory Bowel Disease Treated With Vedolizumab or Ustekinumab in Korea.

The present study investigated the risk of active tuberculosis in patients with inflammatory bowel disease (IBD) treated with vedolizumab or ustekinumab, in actual clinical settings in a country with an intermediate tuberculosis burden. The medical records of 238 patients with IBD who received vedolizumab or ustekinumab were retrospectively reviewed at a tertiary referral center in South Korea. All patients had ≥ 3 months of follow-up duration and underwent a latent tuberculosis infection screening test before initiation of the administration of these drugs. Of the 238 patients enrolled, 181 had Crohn's disease, and 57 had ulcerative colitis. During the median 18.7 months of follow-up, active tuberculosis did not develop in any patient treated with vedolizumab or ustekinumab. Therefore, we concluded that the risk of tuberculosis appears to be low in patients with IBD treated with vedolizumab or ustekinumab in South Korea.

Changes in blood Krebs von den Lungen-6 predict the mortality of patients with acute exacerbation of interstitial lung disease.

Acute exacerbation (AE) significantly affects the prognosis of patients with interstitial lung disease (ILD). This study aimed to investigate the best prognostic biomarker for patients with AE-ILD. Clinical data obtained during hospitalization were retrospectively analyzed for 96 patients with AE-ILD at three tertiary hospitals. The mean age of all subjects was 70.1 years; the percentage of males was 66.7%. Idiopathic pulmonary fibrosis accounted for 60.4% of the cases. During follow-up (median: 88 days), in-hospital mortality was 24%. Non-survivors had higher lactate dehydrogenase and C-reactive protein (CRP) levels, lower ratio of partial pressure of oxygen to the fraction of inspiratory oxygen (P/F ratio), and higher relative change in Krebs von den Lungen-6 (KL-6) levels over 1 week after hospitalization than survivors. In multivariable analysis adjusted by age, the 1-week change in KL-6-along with baseline P/F ratio and CRP levels-was an independent prognostic factor for in-hospital mortality (odds ratio 1.094, P = 0.025). Patients with remarkable increase in KL-6 (≥ 10%) showed significantly worse survival (in-hospital mortality: 63.2 vs. 6.1%) than those without. In addition to baseline CRP and P/F ratio, the relative changes in KL-6 over 1 week after hospitalization might be useful for predicting in-hospital mortality in patients with AE-ILD.

A Phase I/IIa Randomized Trial Evaluating the Safety and Efficacy of SNK01 Plus Pembrolizumab in Patients with Stage IV Non-Small Cell Lung Cancer.

PURPOSE: The aim of this study is to evaluate the safety and efficacy of ex vivo activated and expanded natural killer (NK) cell therapy (SNK01) plus pembrolizumab in a randomized phase I/IIa clinical trial. MATERIALS AND METHODS: Overall, 18 patients with advanced non-small cell lung cancer (NSCLC) and a programmed death ligand 1 tumor proportion score of 1% or greater who had a history of failed frontline platinum-based therapy were randomized (2:1) to receive pembrolizumab every 3 weeks +/- 6 weekly infusions of SNK01 at either 2×109 or 4×109 cells per infusion (pembrolizumab monotherapy vs. SNK01 combination). The primary endpoint was safety, whereas the secondary endpoints were the objective response rate (ORR), progression-free survival (PFS), overall survival, and quality of life. RESULTS: Since no dose-limiting toxicity was observed, the maximum tolerated dose was determined as SNK01 4×109 cells/dose. The safety data did not show any new safety signals when SNK01 was combined with pembrolizumab. The ORR and the 1-year survival rate in the NK combination group were higher than those in patients who underwent pembrolizumab monotherapy (ORR, 41.7% vs. 0%; 1-year survival rate, 66.7% vs. 50.0%). Furthermore, the median PFS was higher in the SNK01 combination group (6.2 months vs. 1.6 months, p=0.001). CONCLUSION: Based on the findings of this study, the NK cell combination therapy may consider as a safe treatment method for stage IV NSCLC patients who had a history of failed platinum-based therapy without an increase in adverse events.

Different prognostic implications of hepatic metastasis according to front-line treatment in non-small cell lung cancer: a real-world retrospective study.

BACKGROUND: Although liver metastasis occurs in approximately 15% of metastatic non-small cell lung cancer (NSCLC) patients with poor prognosis, its prognostic effect in patients who receive immunotherapy is unclear. This study aimed to verify the effects of liver metastasis on the prognosis of metastatic NSCLC patients according to their first-line treatment. METHODS: Patients who were initially diagnosed with stage 4 NSCLC from January 2015 to December 2019 were analyzed in this retrospective real-world data-based study. The patients were divided into three groups according to the type of first-line chemotherapy they received: cytotoxic, targeted, and immunotherapy. Prognosis was then compared depending on the presence of liver metastasis in each treatment group. RESULTS: Among the 1,470 patients, 723 (49.2%) received cytotoxic chemotherapy, 678 (46.1%) received targeted therapy, and 69 (4.7%) received immunotherapy as their first-line chemotherapy. A total of 234 (15.9%) patients had liver metastasis at the initial diagnosis. The mean patient age was 63.7 years, and 59.1% were male. There was no difference in overall survival (OS) in the immunotherapy group in patients with or without liver metastasis (11.7 vs. 13.0 months, P=0.968); however, patients with liver metastasis had worse outcomes in the cytotoxic and targeted therapy groups compared to patients without liver metastasis. Furthermore, in patients with liver metastasis, the immunotherapy group had a longer OS than the cytotoxic chemotherapy group (11.7 vs. 4.4 months, P<0.001). Liver metastasis was associated with poor outcomes (hazard ratio of 1.438), as were age, male sex, bone, adrenal gland, or soft tissue metastasis, and three or more metastatic sites; however, lymph node, brain, collateral lung, and pleura metastasis did not affect prognosis. CONCLUSIONS: Although liver metastasis was associated with poor outcomes, it did not affect prognosis in patients who received immunotherapy.

The Effects of Simultaneous Pulmonary Rehabilitation during Thoracic Radiotherapy in the Treatment of Malignant Diseases.

BACKGROUND: Radiotherapy is a common treatment option for lung or esophageal cancer, particularly when surgery is not feasible for patients with poor lung function. However, radiotherapy can affect pulmonary function and thereby induce pneumonitis or pneumonia, which can be fatal in patients with respiratory impairment. The purpose of this study is to evaluate if reductions in pulmonary function after radiotherapy can be minimized through simultaneous pulmonary rehabilitation (PR). METHODS: In this matched case control study, we retrospectively analyzed patients who had undergone radiotherapy for thoracic malignant disease between January 2018 and June 2019. We analyzed results from pulmonary function tests and 6-minute walking tests (6MWT) conducted within the six months before and after radiotherapy treatment. RESULTS: In total, results from 144 patients were analyzed, with 11 of the patients receiving PR and radiotherapy simultaneously. Of the 133 patients in the control group, 33 were matched with 11 patients in the PR group. Changes in forced expiratory volume in one second (FEV1) and FEV1/forced vital capacity were significantly different between the PR group and the matched control group (240 mL vs. -10 mL, p=0.017 and 5.5% vs. 1.0%, p=0.038, respectively). The median distance of 6MWT in the PR group also increased significantly, from 407.5 m to 493.0 m after radiotherapy (p=0.017). CONCLUSION: Simultaneous PR improved pulmonary function, particularly in measures of FEV1, and exercise capacity for patients with lung or esophageal cancer even after radiotherapy treatment. These findings may provide an important base of knowledge for further large population studies with long-term follow-up analysis in the identification of the PR's effects during thoracic radiotherapy.

Efficacy of natural killer cell activity as a biomarker for predicting immunotherapy response in non-small cell lung cancer.

BACKGROUND: The establishment of biomarkers that can be used to predict the response to immunotherapy for malignancy is extremely important. In particular, noninvasive analysis of immune cells from peripheral blood before treatment has gained increased attention, and natural killer (NK) cell activity has been shown to be related to treatment response. Here, we aimed to confirm the relationship between the response to immunotherapy and NK cell activity. METHODS: In this prospective observational study, patients with advanced NSCLC who were scheduled for immunotherapy from October 2018 to December 2019 were enrolled. Baseline NK cell activity was compared according to the best clinical response to immunotherapy. RESULTS: A total of 54 patients with advanced NSCLC were enrolled, and 34 patients were analyzed. The baseline NK cell activity was significantly higher in the non-PD group than in the PD group (P = 0.002). At the cutoff level of ≥1200 pg/mL, baseline NK cell activity yielded a sensitivity of 80% and a specificity of 68.4% in predicting the response to immunotherapy (AUC = 0.8, P < 0.003). The median progression-free survival (PFS) was significantly better in the high NK group (P = 0.003), and correlation between baseline NK cell activity and PFS was also confirmed (r = 0.517, P = 0.002). CONCLUSIONS: Baseline NK cell activity was related to the response to immunotherapy and the PFS. We suggest that NK cell activity from peripheral blood before immunotherapy is a noninvasive, simple, and novel way to predicting the treatment response in patients with NSCLC. KEY POINTS: SIGNIFICANT FINDINGS OF THE STUDY: The response to immunotherapy was significantly better in patients with high baseline NK cell activity, and there was a significant correlation between baseline NK cell activity and PFS. What this study adds This study demonstrates the efficacy of baseline NK cell activity from peripheral blood as a biomarker for predicting immunotherapy response.

Natural Killer Cells as a Potential Biomarker for Predicting Immunotherapy Efficacy in Patients with Non-Small Cell Lung Cancer.

BACKGROUND: Immunotherapy with immune checkpoint inhibitors for non-small cell lung cancer (NSCLC) has emerged as an important treatment option. Although immunotherapy may significantly improve survival and quality of life, response rates are as low as 20% in NSCLC patients. OBJECTIVE: The identification of reliable biomarkers predicting response to immunotherapy is required urgently to determine patient selection guidelines. PATIENTS AND METHODS: Peripheral blood mononuclear cells (PBMCs) from nine NSCLC patients were collected pre- and post-treatment with immunotherapy. The immune cell composition of PBMCs was analyzed using CyTOF with an optimized 32-marker panel. The natural killer (NK) cell activity was assessed with the measurement of interferon (INF)-γ using an NK Vue™ kit. RESULTS: We found that the percentages of NK cell populations in the immune cells of PBMCs were prominently elevated in the immunotherapy responder group when compared with non-responders. While no meaningful differences were observed in other populations of immune cells, consistent with these results, the overall activity of NK cells in responders was highly elevated compared with that of non-responders. From the analysis of NK subsets, although differences in the population of early NK cells were not observed, the functionally differentiated late NK cells were prominently high in responders. CONCLUSIONS: The overall activity or number of NK cells may be a useful biomarker to predict immunotherapy response in patients with NSCLC.

Effect of medical thoracoscopy-guided intrapleural docetaxel therapy to manage malignant pleural effusion in patients with non-small cell lung cancer: A pilot study.

BACKGROUND: Although chemical pleurodesis is a useful treatment option for malignant pleural effusion, little is known about the effects of intrapleural docetaxel therapy. OBJECTIVES: This study aimed to evaluate the effects of medical thoracoscopy-guided intrapleural docetaxel therapy in patients with lung cancer. METHODS: Patients with lung cancer who diagnosed malignant pleural effusion were enrolled in this single-center prospective pilot study. The clinical response and toxicity were evaluated at two, six and 12 weeks post-treatment. RESULTS: Medical thoracoscopy-guided intrapleural docetaxel therapy was conducted in four patients between June 2016 and August 2017. The control rate of malignant pleural effusion was 100% (4/4), and the progression-free duration of effusion was 527 ± 109 days. No serious adverse events were observed, but only mild-to-moderate adverse events were observed and well controlled by conservative management. Although the overall quality of life assessed using questionnaires did not show significant improvement, symptom burden due to dyspnea was significantly improved. CONCLUSIONS: Intrapleural docetaxel therapy with medical thoracoscopy showed good clinical responses, relieving dyspnea symptoms and providing tolerable safety profiles in patients with non-small cell lung cancer (NSCLC) with malignant pleural effusion. A further prospective trial is warranted to evaluate the clinical effects of intrapleural docetaxel therapy in order to compare it with other treatment modalities.