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Background and Objectives: The incidence of coronavirus disease 2019 (COVID-19) has increased in Wakayama, Japan, due to the spread of the highly infectious B.1.1.7 variant. Before this event, the medical systems were almost unaffected. We aimed to assess the clinical characteristics of patients hospitalized with COVID-19 and the risk factors for therapeutic intervention of remdesivir during the fourth pandemic period in Wakayama, Japan. Materials and Methods: This single-center retrospective study enrolled 185 patients with mild to moderate COVID-19 hospitalized in our hospital without intensive care between 14 March and 31 May 2021. Results: In this period, 125 (67.6%) of the 185 patients had the B.1.1.7 variant. Sixty-three patients (34.1%) required remdesivir treatment. Age upon admission and length of hospitalization were significantly different between remdesivir treatment and careful observation groups (mean (standard deviation); 59.6 (14.7) versus 45.3 (20.6) years; p < 0.001 and median (interquartile range); 10 (9-12) versus 9 (8-10) years; p < 0.001). One patient was transferred to another hospital because of disease progression. At hospital admission, age ≥60 years (odds ratio (OR) 6.90, p < 0.001), a previous history of diabetes mellitus (OR 20.9, p = 0.002), B.1.1.7 variant (OR 5.30; p = 0.005), lower respiratory symptoms (OR 3.13, p = 0.011), headache (OR 3.82, p = 0.011), and fever ≥37.5 °C (OR 4.55, p = 0.001) were independent risk factors to require remdesivir treatment during the admission. Conclusions: Many patients with mild to moderate COVID-19 required the therapeutic intervention of remdesivir during the fourth pandemic period in Wakayama, Japan. From the clinical data obtained at admission, these risk factors could contribute to a prediction regarding the requirement of remdesivir treatment in cases of mild to moderate COVID-19.
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Tratamiento Farmacológico de COVID-19 , SARS-CoV-2 , Adenosina Monofosfato/análogos & derivados , Alanina/análogos & derivados , Humanos , Japón/epidemiología , Persona de Mediana Edad , Pandemias , Estudios Retrospectivos , Factores de RiesgoRESUMEN
We report a case series of 6 patients with confirmed coronavirus disease 2019 (COVID-19) in Wakayama prefecture, Japan. All 6 of the patients tested positive via pharyngeal swab polymerase chain reaction (PCR) tests, and 2 of the 6 were still positive at 3 weeks after onset. All of the patients exhibited bilateral ground glass opacities on computed tomography (CT). This article also reports narrative information on the spectrum of symptoms collected directly from the patients. It would be difficult to triage patients with COVID-19 based on the typical symptoms of fever and/or cough, although PCR and CT are definitive in diagnosis.
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Betacoronavirus , Infecciones por Coronavirus , Pandemias , Neumonía Viral , Adulto , Anciano , Anciano de 80 o más Años , COVID-19 , Prueba de COVID-19 , Técnicas de Laboratorio Clínico , Infecciones por Coronavirus/diagnóstico , Infecciones por Coronavirus/diagnóstico por imagen , Infecciones por Coronavirus/fisiopatología , Tos , Femenino , Fiebre , Humanos , Japón , Pulmón/diagnóstico por imagen , Masculino , Persona de Mediana Edad , Faringe/virología , Neumonía Viral/diagnóstico , Neumonía Viral/diagnóstico por imagen , Neumonía Viral/fisiopatología , Reacción en Cadena de la Polimerasa , SARS-CoV-2 , Tomografía Computarizada por Rayos XRESUMEN
BACKGROUND: Although predictive value of immune-related adverse events (irAEs) induced by immune checkpoint inhibitors (ICIs) have been suggested by several studies, their assessments were insufficient because patients were categorized only by the occurrence of irAEs. It has not been elucidated whether irAEs also play a significant role even in responders. MATERIALS AND METHODS: Between December 2015 and September 2018, 106 patients with advanced non-small cell lung cancer treated with ICIs were enrolled in our prospective biomarker study. Twenty-three of these were responders, defined as those with complete or partial response. We investigated the proportion of irAEs among overall and responders. For responders, progression-free survival (PFS) and overall survival of ICIs were compared between those with and without irAEs. As an exploratory analysis, we measured 41 proteins from peripheral blood before and after ICI treatment. RESULTS: The proportion of irAEs was significantly higher in responders than nonresponders (65.2% vs. 19.3%, p < .01). Among responders, clinical characteristics did not differ regardless of the occurrence of irAEs. However, there was a significant difference in PFS among responders (irAE group 19.1 months vs. non-irAE group 5.6 months; hazard ratio: 0.30 [95% confidence interval: 0.10-0.85]; p = .02). Of 41 protein analyses, fibroblast growth factor-2 at baseline and monocyte chemoattractant protein fold change showed significant differences between them (p < .04). CONCLUSION: Although this is a small sample-sized study, irAE might be a predictive factor of durable efficacy, even in patients who responded to ICIs. Investigation into the significance of irAEs in responders will contribute to the establishment of optimal administration of ICI. IMPLICATIONS FOR PRACTICE: Although the predictive value of immune-related adverse events (irAEs) induced by immune checkpoint inhibitors (ICIs) has been suggested by several studies, it has not been elucidated whether irAEs also play a significant role even in responders. This study showed that more than 60% of responders had irAEs. It demonstrated the strong correlation between irAEs and efficacy even in responders. Investigation into the significance of irAEs in responders will contribute to the establishment of optimal administration of ICI.
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Carcinoma de Pulmón de Células no Pequeñas , Efectos Colaterales y Reacciones Adversas Relacionados con Medicamentos , Neoplasias Pulmonares , Neoplasias , Carcinoma de Pulmón de Células no Pequeñas/tratamiento farmacológico , Humanos , Inhibidores de Puntos de Control Inmunológico , Neoplasias Pulmonares/tratamiento farmacológico , Neoplasias/tratamiento farmacológico , Estudios Prospectivos , Estudios RetrospectivosRESUMEN
Mycobacterium malmoense is a rare species of non-tuberculosis mycobacteria detected in Japan that causes pulmonary infection and cervical lymphadenitis. Here, we report a case of pulmonary infection caused by M. malmoense, which was difficult to distinguish from Mycobacterium tuberculosis (Mtb) infection. A 64-year-old Japanese woman with a history of pulmonary tuberculosis had bloody phlegm, a cough, and discomfort in her chest. Chest computed tomography revealed a cavity, infiltration, and a nodule. A smear test for acid-fast bacilli was positive, a Mycobacterium avium complex transcription reverse-transcription concerted (TRC) test was negative, and an Mtb TRC test was withheld because the internal control was negative. After diluting the specimens, the internal control tested positive, and the sample tested negative. We diagnosed pulmonary M. malmoense infection based on a culture test. In conclusion, attention should be paid to the concentration of bacteria in Mtb TRC test samples, ensuring that the internal control provides expected results.
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Rosai-Dorfman disease presenting solely with intrathoracic lesions is exceptionally rare. Herein, we report the case of a 53-year-old man presenting with a posterior mediastinal tumour. Computed tomography revealed a 7-cm soft tissue shadow in the posterior mediastinum. Positron emission tomography-computed tomography demonstrated a high maximum standardized uptake value of 10.35 in the tumour, with no evidence of lymph node or other organ involvement. Serum marker levels were within the normal range. Thoracoscopic surgery was performed to obtain a biopsy for a definitive diagnosis and treatment planning. Postoperative histological findings revealed a diffuse infiltration of eosinophilic histiocytes, lymphocytes, and plasma cells. Immunohistochemical analysis indicated positivity for S-100 protein, oct-2, and cyclin D1 in these histiocytes. Consequently, the patient was diagnosed with Rosai-Dorfman disease and is currently asymptomatic, undergoing regular monitoring without treatment as an outpatient. The absence of characteristic findings, such as bilateral cervical lymphadenopathy, posed challenges in preoperative diagnosis.
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BACKGROUND: Mannitol is exclusively recommended in the National Comprehensive Cancer Network guidelines for diuresis in cisplatin (CDDP)-based chemotherapy. The utility of furosemide, a widely used and convenient diuretic, thus requires clarification. METHODS: This is a prospective, single-centered, open-label, noninferiority phase II study. Patients with thoracic malignancies who planned to receive CDDP-based chemotherapy were randomly assigned to receive either mannitol (arm A) or furosemide (arm B). The primary end point was set as the proportion of patients who experienced any grade of "creatinine (Cr) increased" based on the upper limit of the normal range (ULN) during the first cycle as assessed by Common Terminology Criteria for Adverse Events Version 4.0. Secondary end points were Cr increased based on the baseline value during the first cycle, Cr increased after the completion of CDDP, and the proportion of patients with phlebitis. RESULTS: Between April 2018 and March 2022, 115 patients were enrolled and 106 were analyzed. Any grade of Cr increased based on the ULN during the first cycle was 17.3% (arm A) and 24.1% (arm B), respectively (p = 0.34). Therefore, the primary end point was not met. After completion of chemotherapy, any grade of Cr increased was observed in 23.1% (arm A) and 31.5% (arm B), respectively. However, the actual serum Cr level and Cr clearance during the courses were not different between the arms. Phlebitis occurred more frequently in arm A (28.8%) than arm B (16.7%). CONCLUSIONS: Mannitol should remain the standard diuresis in CDDP-based chemotherapy assessed by conventional CTCAE grading, but furosemide can be room for consideration when assessed by actual serum Cr level and Cr clearance.
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Flebitis , Neoplasias Torácicas , Humanos , Cisplatino/efectos adversos , Furosemida/efectos adversos , Manitol/efectos adversos , Flebitis/inducido químicamente , Flebitis/tratamiento farmacológico , Estudios ProspectivosRESUMEN
CONTEXT: The efficacy and tolerability of high-flow nasal cannula (HFNC) for relieving dyspnea in advanced cancer patients with limited prognosis requires elucidation. OBJECTIVES: The primary aim of this trial was to assess the efficacy and tolerability of HFNC regarding dyspnea including severe as well as moderate for longer durations in patients under palliative care. METHODS: In this prospective study, hospitalized patients with advanced cancer who had dyspnea at rest (numeric rating scale, NRS≥3) and hypoxemia were enrolled. They were treated with HFNC for five days in the respiratory unit. Primary endpoint was mean change of modified Borg scale at 24 hours. Key secondary endpoints consisted of mean changes in modified Borg scale during the study period and feasibility (Trial Identifier, UMIN000035738). RESULTS: Between February 2019 and February 2022, 25 patients were enrolled and 21 were analyzed. Twenty patients used inspired oxygen and the mean fraction of inspired oxygen (FiO2) was 0.34 (range, 0.21-1.0). At baseline, mean NRS (dyspnea) was 5.9 (range, 3-10). Median survival time was 19 days (range, 3-657). The mean change of modified Borg scale was 1.4 (80% confidence interval [CI]: 0.8-1.9) at 24 hours, 12 patients (57%) showed 1.0 points improvement of modified Borg scale. Within two hours, 15 patients showed 1.0 points improvement of modified Borg scale and such early responders were likely to maintain dyspnea improvement for 24 hours. Nineteen patients could continue HFNC for 24 hours and 11 patients completed five days of HFNC. CONCLUSION: To our knowledge, this trial is the first prospective study to assess the five-day efficacy and tolerability of HFNC for dyspnea in patients under palliative care. Although this did not reach the prespecified endpoint, about half of the patients showed 1.0 point improvement, a minimally clinically important difference (MCID) in the chronic lung disease. HFNC can be a palliative treatment option in advanced cancer patients with dyspnea.
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Neoplasias , Insuficiencia Respiratoria , Humanos , Cánula , Estudios Prospectivos , Disnea/etiología , Disnea/terapia , Oxígeno , Neoplasias/complicaciones , Neoplasias/terapia , Terapia por Inhalación de Oxígeno , Insuficiencia Respiratoria/terapiaRESUMEN
Background: An association exists among the diagnostic yield of transbronchial biopsy using endobronchial ultrasonography with a guide sheath (EBUS-GS-TBB) and several factors, such as simple within or adjacent endobronchial ultrasonography (EBUS) findings. Here, we aimed to investigate whether more detailed EBUS findings affect the diagnostic yield of lung cancer in EBUS-GS-TBB. Methods: We conducted this retrospective single-center cohort study, enrolling consecutive patients with lung cancer who underwent EBUS-GS-TBB. The primary outcome was examination of predictive factors affecting the diagnostic yield of lung cancer using EBUS-GS-TBB. The secondary outcome was a subgroup analysis of within and adjacent lesions. The adjacent angle was defined as the angle formed by the midpoint of the probe and the two points where the edge of the probe and shadow of the tumor intersected. Results: Of the 179 lesions investigated, 140 (78.2%) were diagnosed using EBUS-GS-TBB. The diagnostic yields of within and adjacent lesions were 91.6% and 51.7%, respectively. In the multivariable analysis, within lesions had significantly higher diagnostic yields than did the adjacent lesions (P<0.001). The adjacent angle was larger in lesions diagnosed using EBUS-GS-TBB than in undiagnosed lesions (P=0.003). In adjacent lesions, the diagnostic yields were 75.0% and 36.1% for lesions ≥180° and <180°, respectively. Conclusions: In adjacent lesions, the diagnostic yields differed significantly depending on the adjacent angle. Even if EBUS findings are adjacent, the operator should identify the branch of the bronchus with a greater adjacent angle. Future studies should investigate improvements in diagnostic yields via additional procedures for lesions with small adjacent angles.
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INTRODUCTION: Improving physical activity in patients with chronic obstructive pulmonary disease (COPD) is a very important issue; however, effective recommended targets for individual patients remain to be determined. MATERIAL AND METHODS: We developed a method for setting a target value for the step count for each patient using a measured value and the predicted step count. We then evaluated the effect of providing a pedometer or a pedometer with this target value for eight weeks on the step count in patients with COPD. RESULTS: Sixteen stable COPD patients were included in the analysis. Overall, no significant increase in the step count was obtained by providing the target value; however, when the patients were divided into two groups based on the median step count at baseline, a significant increase in the step count was observed in the low step-count group. In both the overall population and the low step-count group, there was a significant increase in the target achievement rate in patients who received a pedometer with a target value in comparison to patients who were given a pedometer without a target value. CONCLUSIONS: Physical activity may be improved by providing a newly developed individual target step count to COPD patients with a low step count at baseline.
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PURPOSE: The effects of immune checkpoint inhibitors have been reported to be linked with immune-related adverse events (irAEs). In patients with advanced non-small-cell lung cancer, who tested positive for programmed death-ligand 1 (PD-L1), pembrolizumab, an immune checkpoint inhibitor can be used as a treatment, and it was found to improve overall survival. However, there are only a few reports on the relationship between the therapeutic effects of pembrolizumab in patients with lung cancer and the irAEs of pembrolizumab. The purpose of this study was to determine the correlation between immune-related adverse events and the effects of pembrolizumab monotherapy in patients with non-small-cell lung cancer. PATIENTS AND METHODS: From February 2017 to August 2019, we conducted a retrospective analysis of the effects of pembrolizumab treatment and immune-related adverse events in 94 patients with non-small-cell lung cancer treated with pembrolizumab only. RESULTS: In 63 cases, irAEs were observed. The most common irAE was rash. PD-L1 positivity ≥ 50% tended to cause irAEs. The median progression-free survival (PFS) rates with and without irAEs were 371 days (95% CI, 184-NR) and 67 days (95% CI, 51-87 days), respectively. In a multivariate analysis, irAEs and Eastern Cooperative Oncology Group performance status (PS) were the factors related to PFS. CONCLUSION: In patients with lung cancer, who were treated with pembrolizumab monotherapy, the development of irAEs was likely indicative of the positive effects of pembrolizumab. This novel finding appears to be useful for clinicians who work with pembrolizumab for lung cancer treatment.