A randomized double-blind placebo-controlled trial of an inhibitor of plasminogen activator inhibitor-1 (TM5614) in mild to moderate COVID-19.

An inhibitor of plasminogen activator inhibitor (PAI)-1, TM5614, inhibited thrombosis, inflammation, and fibrosis in several experimental mouse models. To evaluate the efficacy and safety of TM5614 in human COVID-19 pneumonia, phase IIa and IIb trials were conducted. In an open-label, single-arm trial, 26 Japanese COVID-19 patients with mild to moderate pneumonia were treated with 120-180 mg of TM5614 daily, and all were discharged without any notable side effects. Then, a randomized, double-blind, placebo-controlled trial was conducted in Japanese COVID-19 patients with mild to moderate pneumonia. The number of study participants was set to be 50 in each arm. Even after extension of the enrollment period, the number of study participants did not reach the initially intended sample size, and 75 patients were enrolled in the study. The total oxygenation scale from Day 1 to Day 14 as the primary endpoint was 1.5 in the TM5614 group vs 4.0 in the placebo group (p = 0.22), and the number of days of oxygen administration required as the secondary endpoint was 2.0 days in the TM5614 group vs 3.5 days in the placebo group (p = 0.34). Further studies will be necessary to verify the efficacy of PAI-1 inhibition for the treatment of COVID-19 pneumonia.Clinical trial registration: Two studies were conducted: a prospective, multicenter, open-label phase II study at https://jrct.niph.go.jp (jRCT2021200018) (First registration date 18/08/2020) and a prospective, multicenter, randomized, double-blind, placebo-controlled, phase II study at https://jrct.niph.go.jp (jRCT2021210006) (First registration date 28/05/2021).

Retracted: Chest digital dynamic radiography to detect changes in human pulmonary perfusion in response to alveolar hypoxia.

INTRODUCTION: Hypoxic pulmonary vasoconstriction optimises oxygenation in the lung by matching the local-blood perfusion to local-ventilation ratio upon exposure to alveolar hypoxia. It plays an important role in various pulmonary diseases, but few imaging evaluations of this phenomenon in humans. This study aimed to determine whether chest digital dynamic radiography could detect hypoxic pulmonary vasoconstriction as changes in pulmonary blood flow in healthy individuals. METHODS: Five Asian men underwent chest digital dynamic radiography before and after 60 sec breath-holding at the maximal inspiratory level in upright and supine positions. Alveolar partial pressure of oxygen and atmospheric pressure were calculated using the blood gas test and digital dynamic radiography imaging, respectively. To evaluate the blood flow, the correlation rate of temporal change in each pixel value between the lung fields and left cardiac ventricles was analysed. RESULTS: Sixty seconds of breath-holding caused a mean reduction of 26.7 ± 6.4 mmHg in alveolar partial pressure of oxygen. The mean correlation rate of blood flow in the whole lung was significantly lower after than before breath-holding (before, upright 51.5%, supine 52.2%; after, upright 45.5%, supine 46.1%; both P < 0.05). The correlation rate significantly differed before and after breath-holding in the lower lung fields (upright, 11.8% difference; supine, 10.7% difference; both P < 0.05). The mean radiation exposure of each scan was 0.98 ± 0.09 mGy. No complications occurred. CONCLUSIONS: Chest digital dynamic radiography could detect the rapid decrease in pulmonary perfusion in response to alveolar hypoxia. It may suggest hypoxic pulmonary vasoconstriction in healthy individuals.

Can MASCC and CISNE scores predict delays of lung cancer chemotherapy after febrile neutropenia?

BACKGROUND: Febrile neutropenia (FN) during cancer chemotherapy can lead to morbidity and mortality. The Multinational Association of Supportive Care in Cancer (MASCC) and clinical index of stable febrile neutropenia (CISNE) scores have been widely used to predict the risk of severe medical complications in patients with FN; however, there are few tools for predicting chemotherapy delays or discontinuation after FN. METHODS: Patients admitted to two university hospitals between 2014 and 2018 with a FN diagnosis during the first cycle of chemotherapy for lung cancer were reviewed retrospectively. RESULTS: Among 539 patients who received 813 courses of chemotherapy for lung cancer, 49 (9%) developed FN during the first treatment cycle. Although all the patients recovered from their primary infection, 19 patients (38.8%) developed serious medical complications, 11 (22.4%) were unable to resume chemotherapy and one (2.0%) declined to resume chemotherapy, and nine (18.4%) died within 90 days. Patients who failed to resume chemotherapy had a lower MASCC score (median 8.5 vs. 17, p < 0.01) and a higher CISNE score (median 3 vs. 1, p < 0.01) at the onset of FN. The specificity to predict the patient who failed to resume chemotherapy was 90% or more with MASCC score ≤9 or CISNE score ≥3, with the sensitivity of 61%. MASCC score ≤ 16 can also be a sensitive indicator with the sensitivity and specificity of 89 and 52%, respectively. CONCLUSION: The MASCC and CISNE scores are useful in identifying lung cancer patients who are unable to resume chemotherapy as scheduled after the onset of FN.

Real-world clinical practice for advanced non-small-cell lung cancer in the very elderly: A retrospective multicenter analysis.

BACKGROUND: The optimal treatment for advanced non-small cell lung cancer (NSCLC) in very elderly patients is unclear. We aimed to evaluate their treatment in real-world clinical practice and identify suitable therapy that can improve their prognosis. MATERIALS AND METHODS: The medical records of 132 Japanese patients aged 80 years and older with advanced NSCLCs who were enrolled at a university hospital and its 9 affiliates were retrospectively analyzed. Clinical characteristics and overall survival (OS) were compared based on the Eastern Cooperative Oncology Group Performance Status (ECOG PS) and biomarker statuses. Patients were defined as biomarker-positive if programmed death-ligand 1 tumor proportion score (PD-L1 TPS) was ≥ 50% or activating mutations were present in epidermal growth factor receptor, anaplastic lymphoma kinase, or c-ros oncogene 1. Finally, the factors contributing to better prognosis were explored in both PS 0 - 2 and PS 3 - 4 patient groups. RESULTS: The PS 0 - 2 patients showed a longer median OS than the PS 3 - 4 patients (5.5 vs. 1.6 months). PS 0 - 2 patients with positive biomarkers who received chemotherapy showed a significantly longer median OS than those without (18.1 vs. 3.7 months). Among the biomarker-negative/unknown PS 0 - 2 patients, the median OS showed no significant difference between those who received chemotherapy and those who did not (4.5 vs. 3.1 months). The multivariate analysis showed that treatment with tyrosine kinase inhibitors or immune checkpoint inhibitors was related to better prognoses in the PS 0 - 2 group. CONCLUSION: Biomarker-matched therapy is effective even in very elderly patients. Meanwhile, the effectiveness of chemotherapy for biomarker-negative/unknown PS 0 - 2 patients is questionable.

Acute Limb Ischemia Caused by Embolus of Primary Lung Cancer Complicating Trousseau's Syndrome.

Limb ischemia caused by tumor embolus is rare. In this study, we report the case of a 77-year-old woman who suffered from acute ischemic limb. Computed tomography showed a tumor in the right bronchus invading the left atrium. The tumor fragments scattered resulting in the occlusion of the right iliac artery. The excluded embolus was revealed as a squamous cell carcinoma. Regarding the popliteal venous thrombus, Trousseau's syndrome was complicated. The patient was discharged without any complications. We believe that advanced lung cancer is a differential diagnosis of acute ischemic limbs and that successful limb rescue contributed to a patient's quality of life.

A new method for objectively evaluating nocturnal cough in adults.

BACKGROUND: For the management of cough diseases in adults, an objective method of evaluating nocturnal cough is required. METHODS: In Study 1, a cough monitoring system was evaluated using 25 adult volunteers. In Study 2, the cough monitoring system was validated using 20 samples from 10 adult patients with cough diseases obtained overnight. In hospitalized patients, our original cough monitoring system with a microphone and accelerometer was used. At the same time, coughs were recorded using a video camera with digital sound recording. The number of coughs in each 8-h video-audio recording was counted manually by three trained observers. All cough data were printed out, and the basal number of cough events, using both the printed-out data and video-audio recordings, were then calculated by three observers. RESULTS: In Study 1, the cough monitoring system demonstrated good agreement with the number of coughs counted by examiners (sensitivity 99.2%, specificity 98.9%). In Study 2, there was significant agreement in the counts of natural coughs between our system and the video-audio method (p < 0.0001) and between our system and the basal cough events (p < 0.0001). CONCLUSIONS: Our method demonstrated excellent agreement with the video-audio recording method in adults and is considered extremely useful for the objective monitoring of overnight cough in adult patients with cough diseases.

Longitudinal Assessment of Prognostic Understanding in Patients with Advanced Lung Cancer and Its Association with Their Psychological Distress.

BACKGROUND: Accurate prognostic understanding in patients with advanced cancer is essential for shared decision making; however, patients may experience psychological burden through knowing the incurable nature of advanced cancer. It has been unclear how their prognostic understanding fluctuates and whether accurate prognostic understanding is associated with psychological distress from the time of diagnosis over time. MATERIALS AND METHODS: We longitudinally investigated prognostic understanding in 225 patients with newly diagnosed advanced lung cancer at 16 hospitals in Japan until 24 months after diagnosis. We examined associated factors with being consistently accurate in prognostic understanding, especially focusing on its association with psychological well-being. RESULTS: The proportion of patients with an inaccurate prognostic understanding remained approximately 20% over time with the presence of patients with inconsistent understanding. Patients with consistently accurate prognostic understanding showed a significantly lower Emotional Well-Being subscale score at both 3 and 6 months after diagnosis (p = .010 and p = .014, respectively). In multivariate analyses, being consistently accurate in prognostic understanding was significantly associated with female gender and higher lung cancer-specific symptom burden at 3 months (p = .008 and p = .005, respectively) and lower emotional well-being at 6 months (p = .006). CONCLUSION: Although substantial proportions of patients with advanced lung cancer had inaccurate prognostic understanding from the time of diagnosis over time, patients with consistently accurate prognostic understanding experienced greater psychological burden. Our findings highlight the importance of continuous psychological care and support for patients who understand their severe prognosis accurately. IMPLICATIONS FOR PRACTICE: This study demonstrated that approximately 20% of patients with advanced lung cancer had an inaccurate understanding about their prognosis, not only at the time of diagnosis but also at the later time points. Being consistently accurate in prognostic understanding was significantly associated with elevated levels of psychological distress. Although accurate prognostic understanding is essential for decision making for treatment and advance care planning, health care providers should be aware of psychological burdens in patients that accept their severe prognosis accurately. Appropriate care and support for such patients are warranted from diagnosis over time.

Trends of concerns from diagnosis in patients with advanced lung cancer and their family caregivers: A 2-year longitudinal study.

BACKGROUND: Both advanced cancer patients and their family caregivers experience distress and have a range of concerns after cancer diagnosis. However, longitudinal studies on this topic have been lacking. AIM: To investigate concerns in both patients with advanced lung cancer and their family caregivers longitudinally from diagnosis. DESIGN: A multi-center prospective questionnaire-based study. SETTING/PARTICIPANTS: We recruited patients with newly diagnosed advanced lung cancer and their family caregivers at 16 hospitals in Japan. We prospectively assessed the prevalence of their concerns using the Concerns Checklist and investigated the associations between their concerns and mental status as well as quality of life until 24 months after diagnosis. RESULTS: A total of 248 patients and their 232 family caregivers were enrolled. The prevalence of serious concerns was highest at diagnosis (patients: 68.3%, family caregivers: 65.3%). The most common serious concern was concern about the future in both groups at diagnosis (38.2% and 40.5%, respectively) and this remained high in prevalence over time, while the high prevalence of concern about lack of information improved 3 months after diagnosis in both groups. Approximately one-third of patient-family caregiver dyads had discrepant reports of serious concerns. The presence of serious concerns was significantly associated with anxiety and depression continuously in both groups. CONCLUSIONS: The majority of advanced lung cancer patients and their family caregivers have serious concerns from diagnosis, which is associated with their psychological distress. The spectrum of concerns alters over the disease trajectory, warranting efficient tailored care and support for both groups immediately after diagnosis.

Novel pulmonary perfusion imaging using chest digital dynamic radiography for pulmonary artery sarcoma.

Chest digital dynamic radiography (DDR) is a novel method for evaluating pulmonary perfusion and ventilation. It could depict ventilation-perfusion mismatch in a pulmonary artery sarcoma with severe stenosis in the right pulmonary artery. This report is the first demonstration of ventilation-perfusion mismatch in a malignant neoplasm using DDR.

Diagnosis of pleural empyema/parapneumonic effusion by next-generation sequencing.

BACKGROUND: Although a microbiological diagnosis of pleural infection is clinically important, it is often complicated by prior antibiotic treatment and/or difficulties with culturing some bacterial species. Therefore, we aimed to identify probable causative bacteria in pleural empyema/parapneumonic effusions by combining 16S ribosomal RNA (rRNA) gene amplification and next-generation sequencing (NGS). METHODS: Pleural fluids were collected from 19 patients with infectious effusions and nine patients with non-infectious malignant effusions. We analysed DNA extracted from the pleural fluid supernatant by NGS using the Genome Search Toolkit and GenomeSync database, either directly or after PCR amplification of the 16S rRNA gene. Infectious and non-infectious effusions were distinguished by semi-quantitative PCR of the 16S rRNA gene. RESULTS: Only 8 (42%) effusions were culture-positive, however, NGS of the 16S rRNA gene amplicon identified 14 anaerobes and 7 aerobes/facultative anaerobes in all patients, including Streptococcus sp. (n = 6), Fusobacterium sp. (n = 5), Porphyromonas sp. (n = 5), and Prevotella sp. (n = 4), accounting for >10% of the total genomes. The culture and NGS results were discordant for 3 out of 8 patients, all of whom had previously been treated with antibiotics. Total (2ΔCT value in semi-quantitative PCR of the 16S rRNA gene) and specific (total bacterial load multiplied by the proportion of primary bacteria in NGS) bacterial loads could efficiently distinguish empyema/parapneumonic effusion from non-infectious effusion. CONCLUSION: Combining NGS with semi-quantitative PCR can facilitate the diagnosis of pleural empyema/parapneumonic effusion and its causal bacteria.

A Case of Endovascular Treatment for In-Hospital Stroke with COVID-19 under Protected Code Stroke.

Objective: Coronavirus disease 2019 (COVID-19) is characterized by severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) and presents with respiratory symptoms. Overall, 5.7% of COVID-19 patients with severe respiratory status have been reported to develop acute cerebrovascular diseases (CVDs), and 41.3% of COVID-19 cases were considered nosocomial infections. Therefore, Protected Code Stroke, which is a guideline for acute stroke management that takes into account the safety of healthcare workers, has been developed. We created an operational manual for COVID-19 in the endovascular treatment center of our hospital and report our experience treating acute stroke in a COVID-19 patient. Case Presentation: A 67-year-old man presented with a 5-day history of fever. Chest CT showed ground glass opacity (GGO) on admission, and the polymerase chain reaction (PCR) test for COVID-19 was positive. Dysarthria, right-sided hemiparesis, and aphasia were discovered on the morning of the third day after hospitalization. MRI showed an acute ischemic stroke at the left corona radiata and occlusion of the left middle cerebral artery (MCA). Progression of right-sided hemiparesis and exacerbation of respiratory status developed after the MRI. Tracheal intubation was performed, and the patient was treated with intravenous alteplase and mechanical thrombectomy (MT). Recanalization of blood flow was not obtained, and the neurological deficits remained. Conclusion: MT was performed for large-vessel occlusion (LVO) in a COVID-19 patient during the COVID-19 pandemic. Safety for healthcare workers and appropriate rapid treatment for acute stroke patients are both vital in the current environment.

Pulmonary perfusion by chest digital dynamic radiography: Comparison between breath-holding and deep-breathing acquisition.

PURPOSE: Pulmonary perfusion is an important factor for gas exchange. Chest digital dynamic radiography (DDR) by the deep-breathing protocol can evaluate pulmonary perfusion in healthy subjects. However, respiratory artifacts may affect DDR in patients with respiratory diseases. We examined the feasibility of a breath-holding protocol and compared it with the deep-breathing protocol to reduce respiratory artifacts. MATERIALS AND METHODS: A total of 42 consecutive patients with respiratory diseases (32 males; age, 68.6 ± 12.3 yr), including 21 patients with chronic obstructive pulmonary disease, underwent chest DDR through the breath-holding protocol and the deep-breathing protocol. Imaging success rate and exposure to radiation were compared. The correlation rate of temporal changes in each pixel value between the lung fields and left cardiac ventricles was analyzed. RESULTS: Imaging success rate was higher with the breath-holding protocol vs the deep-breathing protocol (97% vs 69%, respectively; P < 0.0001). The entrance surface dose was lower with the breath-holding protocol (1.09 ± 0.20 vs 1.81 ± 0.08 mGy, respectively; P < 0.0001). The correlation rate was higher with the breath-holding protocol (right lung field, 41.7 ± 9.3%; left lung field, 44.2 ± 8.9% vs right lung field, 33.4 ± 6.6%; left lung field, 36.0 ± 7.1%, respectively; both lung fields, P < 0.0001). In the lower lung fields, the correlation rate was markedly different (right, 15.3% difference; left, 14.1% difference; both lung fields, P < 0.0001). CONCLUSION: The breath-holding protocol resulted in high imaging success rate among patients with respiratory diseases, yielding vivid images of pulmonary perfusion.

Bronchial artery embolization for haemothorax and haemoptysis caused by primary lung cancer.

Primary lung cancer (PLC) presents with various symptoms. However, there have been no reports of PLC causing haemothorax and haemoptysis simultaneously. We present an unusual case of massive haemothorax and haemoptysis caused by a PLC, in which haemostasis was secured with interventional radiology. A 58-year-old woman was hospitalized for a right secondary pneumothorax associated with emphysema. Chest computed tomography showed a mass shadow at the right lower lobe and on the right parietal pleura. Three days after air drainage, about 2000 mL of bloody pleural effusion accompanied by massive haemoptysis was observed. Haemoglobin concentration decreased to 4.9 g/dL and the patient was treated with selective embolization of the bronchial artery and the intercostal arteries. A diagnosis of PLC was made based on pleural fluid cytology. The patient was transferred to the palliative care hospital three months later without recurrence of haemothorax and haemoptysis.

Therapeutic effect of nintedanib on acute exacerbation of interstitial lung diseases.

Although the development of new antifibrotic agents (pirfenidone, nintedanib) has modified the disease progression of idiopathic pulmonary fibrosis (IPF), there is still no effective treatment for acute exacerbation of interstitial lung diseases (ILD) including IPF. We herein report a case of acute exacerbation of ILD (AE-ILD) treated only with nintedanib without any environmental changes and any other medications such as corticosteroid therapy, diuretic and anti-biotics, which resulted in the gradual improvement of the patient's clinical symptoms, high-resolution computed tomography findings, and forced vital capacity. This case might suggest the possibility that nintedanib not only modifies the disease progression of Idiopathic Pulmonary Fibrosis (IPF), but also facilitate the recovery from the acute exacerbation of ILD.

An Autopsy Case of Paradoxical Pulmonary Thromboembolism by Arteriovenous Fistula from Right Common Iliac Artery to Common Iliac Vein: A Rare Cause of Pulmonary Embolism.

BACKGROUND Pulmonary thromboembolism (PTE) sometimes leads to a shock state and sudden death due to acute massive pulmonary arterial thrombosis. The origins of pulmonary arterial thrombi are varied, but most arise from deep vein thrombosis. We herein presented a very rare cause of PTE due to paradoxical embolism caused by arteriovenous fistula from common iliac artery to common iliac vein. CASE REPORT A 74-year-old man was admitted because of increasing dyspnea on exertion. The diagnosis of idiopathic pulmonary fibrosis was made and corticosteroid therapy was started. On the 5th hospital day, the patient suddenly developed cardiopulmonary arrest and died despite cardiopulmonary resuscitation. An autopsy revealed that the left main pulmonary artery was occluded by a massive but organized thrombus that was similar to an arterial thrombus in the right common iliac artery. On histopathological examination, the emboli in the pulmonary artery demonstrated characteristics similar to thrombus in the common iliac artery. This suggested that the emboli had passed through the arteriovenous fistula from the right common iliac artery to the common iliac vein. CONCLUSIONS This is a very rare cause of fatal paradoxical pulmonary thromboembolism. Paradoxical emboli passing through arteriovenous fistula from the right common iliac artery to the common iliac vein are a rare cause of PTE.

Prognostic Understanding at Diagnosis and Associated Factors in Patients with Advanced Lung Cancer and Their Caregivers.

BACKGROUND: Prognostic understanding in advanced cancer patients and their caregivers may have an impact on the delivery of effective care. The aims of this study were to explore prognostic understanding at diagnosis in both patients with advanced lung cancer and their caregivers and to investigate correlates of their understanding. SUBJECTS, MATERIALS, AND METHODS: A total of 193 patients with newly diagnosed advanced lung cancer and their 167 caregivers were enrolled at 16 hospitals in Japan. We assessed their perceptions of prognosis and goals of therapy and examined their associations with their sociodemographic characteristics, clinical status, quality of life, mood symptoms, and the status of disclosure of information by their treating physicians. RESULTS: One fifth of patients and caregivers (21.7% and 17.6%, respectively) mistakenly believed that the patients' cancer was "completely curable." Substantial proportions of them (16.9% and 10.3%, respectively) mistakenly believed that the primary goal of therapy was to remove all the cancer. Levels of anxiety and depression in both patients and caregivers were significantly higher among those who had accurate understanding of prognosis. In multivariate analyses, inaccurate perceptions of prognosis in patients were associated with sex, better emotional well-being, and lower lung cancer-specific symptom burden. Caregivers' inaccurate perceptions of patients' prognoses were associated with better performance status and better emotional well-being of patients. CONCLUSION: Substantial proportions of advanced lung cancer patients and their caregivers misunderstood their prognosis. Interventions to improve their accurate prognostic understanding should be developed with careful attention paid to its associated factors. IMPLICATIONS FOR PRACTICE: This study demonstrated that substantial proportions of patients with newly diagnosed advanced lung cancer and their caregivers had misunderstandings about their prognosis. Accurate perceptions of prognosis, which are indispensable in the delivery of effective care, were associated with elevated levels of anxiety and depression in both patients and caregivers, warranting psychosocial care and support for them immediately after diagnosis. Inaccurate perceptions of prognosis in patients were associated with better emotional well-being and lower lung cancer-specific symptom burden. Illness understanding in caregivers was associated with patients' physical and mental status. Those findings provide insight into how they obtain accurate illness understanding.

A Stepwise Embolization Strategy for a Bronchial Arterial Aneurysm: Proximal Coil and Distal Glue with the Optional Use of a Microballoon Occlusion System.

PURPOSE: This study aimed to demonstrate a transcatheter embolization strategy for bronchial artery aneurysms (BAAs) using coils for the proximal lesion and glue (n-butyl-2-cyanoacrylate [NBCA]) embolization for the distal lesion with or without the use of a microballoon occlusion catheter. MATERIALS AND METHODS: Five patients with BAAs presenting with hemoptysis were enrolled in this study. A bronchial angiogram indicated a mediastinal BAA near the orifice, accompanied by dilated distal branches with or without intrapulmonary BAA. A stepwise procedure was performed. First, the intrapulmonary branches were embolized with glue, with or without the use of a microballoon catheter depending upon the anatomical and local flow hemodynamic conditions. Second, the mediastinal BAA was tightly packed with detachable coils. RESULTS: Glue embolization of intrapulmonary abnormal branches successfully controlled hemoptysis in all patients; microballoon catheters were used in five of the 10 arteries. The volume embolization ratio of coils within the mediastinal BAA ranged from 28 to 59%, and neither coil compaction nor signs of recanalization were observed during follow-up. CONCLUSION: The stepwise embolization procedure with the sequential use of glue (with or without a microballoon occlusion system) and detachable coils may represent a possible endovascular strategy for the treatment of complex BAAs. LEVEL OF EVIDENCE IV: Level 4: Case Series.

Real-world Efficacy and Safety of Nivolumab for Advanced Non-Small-cell Lung Cancer: A Retrospective Multicenter Analysis.

BACKGROUND: Nivolumab, an immune checkpoint inhibitor, is now a standard treatment for previously treated advanced non-small-cell lung cancer based on the results from phase III clinical trials. We evaluated the real-world efficacy and safety of nivolumab in a nonselected population and identified the clinical characteristics that influence efficacy. MATERIALS AND METHODS: A total of 142 patients with advanced non-small-cell lung cancer who were administered nivolumab at Keio University and affiliated hospitals in Japan from January to July 2016 were enrolled. The treatment efficacy and adverse events were retrospectively reviewed, and the clinical characteristics associated with the nivolumab response were evaluated using univariate and stratified analyses and the Cochran-Mantel-Haenszel test. RESULTS: The objective response rate was 17.0% (95% confidence interval [CI], 12.0%-24.0%), the median progression-free survival (PFS) was 58 days (95% CI, 50-67 days), and the proportion of patients with adverse events of any grade was 45.0%. EGFR/ALK mutation status was inversely associated with the treatment response (P < .05), and the difference in PFS for the mutation-positive versus mutation-negative patients was statistically significant (49 vs. 63 days; hazard ratio, 1.9; 95% CI, 1.1-5.2; P = .029). Previous radiotherapy also had a positive association with the treatment response (P = .012). CONCLUSION: The objective response rate, PFS, and adverse event profiles were comparable to those observed in previous clinical trials. EGFR/ALK mutation-negative status and previous radiotherapy might be key clinical characteristics associated with a positive treatment response. Our findings could aid in the efficient immunotherapeutic management of lung cancer.