Publications by authors named "Makiko Yomota"

27 Publications

  • Page 1 of 1

How many coinfected patients with influenza and COVID-19 are there in a single Japanese hospital during the first wave?

Jpn J Infect Dis 2021 Apr 30. Epub 2021 Apr 30.

Department of Infectious diseases, Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital, Japan.

Coronavirus disease 2019 (COVID-19) and influenza may infect a person simultaneously; hence, adequate measures must be prepared for the next winter in Japan. In preparation for the future, this study aimed to clarify the rate of influenza coinfection in patients with COVID-19 in previous winter. We conducted a retrospective study of the medical records of 193 patients diagnosed as having COVID-19 between January 31, 2020, and April 23, 2020, in a single hospital. We measured the rate of coinfection with COVID-19 and influenza. We found no patient was coinfected with influenza using rapid diagnostic testing. The occurrence of coinfection with influenza and COVID-19 seems to be rare in the past winter in Japan.
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http://dx.doi.org/10.7883/yoken.JJID.2020.1009DOI Listing
April 2021

An analysis of the radiological factors associated with respiratory failure in COVID-19 pneumonia and the CT features among different age categories.

Jpn J Radiol 2021 Apr 12. Epub 2021 Apr 12.

Department of Infectious Diseases, Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital, Tokyo, Japan.

Purpose: To investigate CT patterns of COVID-19 pneumonia associated with respiratory failure (RF) focused on the distribution of lesions.

Materials And Methods: Eighty-five patients with COVID-19 pneumonia were reviewed. CT findings were classified as follows: Type A; patchy ground glass attenuation (GGA) with/without air-space consolidation, Type B; non-segmental GGA with/without air-space consolidation in both the central and peripheral lung portions especially with subpleural spare, and Type C; non-segmental GGA with/without air-space consolidation predominantly distributed in the peripheral lung portion without subpleural spare. We analyzed CT patterns and clinical factors associated with RF, including age categories.

Results: The number of patients with Type A, B and C was 31 (37%), 24 (28%) and 30 (35%), respectively. Type C and hypertension were independently associated with RF. On comparing between Types B and C, the frequency of traction bronchiectasis was higher in Type C than in Type B (P < 0.001). The ratio of Type C in patients ≥ 65 years old (66%) was higher than in patients < 40 years old (P < 0.001) and 40-49 years old (P = 0.001).

Conclusion: The Type C, increasing with age, was associated with RF. Traction bronchiectasis in the lesion was more frequent in Type C than in Type B. Secondary abstract A lesion adjacent to the pleura and hypertension is associated with respiratory failure in patients with COVID-19. The frequency of a lesion adjacent to the pleura increased with age. The distribution of lesions is a useful parameter to predict respiratory failure.
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http://dx.doi.org/10.1007/s11604-021-01118-4DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8040361PMC
April 2021

A Case of Cytokine Release Syndrome Induced by Immune-checkpoint Inhibitor Therapy for Non-small-cell Lung Cancer.

Intern Med 2021 Mar 29. Epub 2021 Mar 29.

Department of Respiratory Medicine, Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital, Japan.

Immune-related adverse events, including autoimmune toxicity, may develop as a consequence of immune-checkpoint inhibitor (ICI) cancer therapy. Cytokine release syndrome (CRS) is a severe and life-threatening cytokine-associated toxicity that can develop after adoptive T-cell therapy. We herein report a rare case of severe CRS after ICI therapy for advanced non-small-cell lung cancer. He presented with a prolonged high fever, cardiogenic shock, and disseminated intravascular coagulation after the first course of programed death ligand-1 inhibitor and platinum-based doublet chemotherapy. He recovered by steroid pulse therapy and tocilizumab. CRS is a rare but life-threatening adverse event of ICI therapy and therefore warrants awareness.
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http://dx.doi.org/10.2169/internalmedicine.5922-20DOI Listing
March 2021

A case series on the safety of immunotherapy with reduced blood testing frequency in lung cancer patients.

Int J Clin Oncol 2021 May 3;26(5):851-857. Epub 2021 Mar 3.

Department of Thoracic Oncology & Respiratory Medicine, Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital, 3-18-22 Honkomagome, Bunkyo-ku, Tokyo, Japan.

Background: The necessity of regular blood tests with the administration of immune checkpoint inhibitors has not been investigated. This study examined the safety of omitting a blood test every 2 weeks for patients with lung cancer who were injected an immune checkpoint inhibitor.

Methods: We conducted a retrospective review of the medical records of 201 patients diagnosed with lung cancer and administered with nivolumab or durvalumab between December 1, 2015, and February 30, 2020, in a single hospital. We extracted 16 patients who had treatments without blood testing every 2 weeks.

Results: Adverse events that resulted in discontinued treatment included two cases of interstitial pneumonia, one case of creatinine increase, and one infection. All four cases were detected by chest X-ray or their symptoms.

Conclusions: Our results indicate that immune checkpoint inhibitor administration without a blood test every 2 weeks did not subject patients to more adverse side effects.
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http://dx.doi.org/10.1007/s10147-021-01865-4DOI Listing
May 2021

Nivolumab treatment of elderly Japanese patients with non-small cell lung cancer: subanalysis of a real-world retrospective observational study (CA209-9CR).

ESMO Open 2020 07;5(4)

Department of Thoracic Oncology, National Cancer Center Hospital, Chuo-ku, Tokyo, Japan.

Objectives: We conducted a subanalysis of data from the multicentre, retrospective observational Nivolumab Japan Real World (CA209-9CR) study to evaluate nivolumab effectiveness and safety in elderly patients (aged ≥75 years) with advanced/metastatic non-small cell lung cancer.

Materials And Methods: Medical record data of patients initiating nivolumab treatment between April 2016 and December 2016 were collected using electronic data capture from 23 cancer hospitals in Japan between March 2017 and August 2018. Nivolumab treatment data were collected to investigate the treatment patterns by age group (<75 and ≥75 years), and the effectiveness and safety of nivolumab treatment.

Results: Of the 901 patients evaluated, 178 (19.8%) were aged ≥75 years. Overall, patients received a median of five nivolumab treatments regardless of age group. Comparable progression-free survival was observed, with a median of 2.1 months in patients aged <75 years and 2.1 months in patients aged ≥75 years (p=0.5441). No significant differences were found in duration of response, overall response rate or disease control rate between the two age groups. Median overall survival in patients aged <75 and ≥75 years was 14.7 months and 12.3 months, respectively. Grade ≥3 adverse events (AEs) occurred in 29.2% and 28.1% of patients aged <75 and ≥75 years, respectively. Immune-related AEs decreased slightly with increasing age; time to onset and rates of improvement were similar for patients aged <75 and ≥75 years. The most common grade 3-4 AEs were interstitial lung disease in both age groups (4.0% in patients aged <75 years and 2.8% in those aged ≥75 years). Poor performance status was associated with worse outcomes in both age groups.

Conclusion: Based on Japanese real-world data, the effectiveness and safety of nivolumab were confirmed regardless of age.
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http://dx.doi.org/10.1136/esmoopen-2019-000656DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7373314PMC
July 2020

Bevacizumab plus chemotherapy in nonsquamous non-small cell lung cancer patients with malignant pleural effusion uncontrolled by tube drainage or pleurodesis: A phase II study North East Japan Study group trial NEJ013B.

Thorac Cancer 2020 07 18;11(7):1876-1884. Epub 2020 May 18.

Department of Pulmonary Medicine and Oncology, Graduate School of Medicine, Nippon Medical School, Tokyo, Japan.

Background: Pleurodesis is the standard of care for non-small cell lung cancer (NSCLC) patients with symptomatic malignant pleural effusion (MPE). However, there is no standard management for MPE uncontrolled by pleurodesis. Most patients with unsuccessful MPE control are unable to receive effective chemotherapy. Vascular endothelial growth factor (VEGF) plays an important role in the pathogenesis of MPE. This multicenter, phase II study investigated the effects of bevacizumab plus chemotherapy in nonsquamous NSCLC patients with unsuccessful management of MPE.

Methods: Nonsquamous NSCLC patients with MPE following unsuccessful tube drainage or pleurodesis received bevacizumab (15 mg/kg) plus chemotherapy every three weeks. The primary endpoint was pleural effusion control rate (PECR), defined as the percentage of patients without reaccumulation of MPE at eight weeks. Secondary endpoints included pleural progression-free survival (PPFS), safety, and quality of life (QoL).

Results: A total of 20 patients (median age: 69 years; 14 males; 20 adenocarcinomas; six epidermal growth factor receptor mutations) were enrolled in nine centers. The PECR was 80% and the primary end point was met. The PPFS and the overall survival (OS) were 16.6 months and 19.6 months, respectively. Patients with high levels of VEGF in the MPE had shorter PPFS (P = 0.010) and OS (P = 0.002). Toxicities of grade ≥ 3 included neutropenia (50%), thrombocytopenia (10%), proteinuria (10%), and hypertension (2%). The cognitive QoL score improved after treatment.

Conclusions: Bevacizumab plus chemotherapy is highly effective with acceptable toxicities in nonsquamous NSCLC patients with uncontrolled MPE, and should be considered as a standard therapy in this setting.

Key Points: SIGNIFICANT FINDINGS OF THE STUDY: Bevacizumab plus chemotherapy is highly effective with acceptable toxicities in nonsquamous NSCLC patients with uncontrolled MPE.

What This Study Adds: Bevacizumab plus chemotherapy should be considered as a standard treatment option for patients with uncontrolled MPE.

Clinical Trial Registration: UMIN000006868 was a phase II study of efficacy of bevacizumab plus chemotherapy for the management of malignant pleural effusion (MPE) in nonsquamous non-small cell lung cancer patients with MPE unsuccessfully controlled by tube drainage or pleurodesis (North East Japan Study Group Trial NEJ-013B) (http://umin.sc.jp/ctr/).
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http://dx.doi.org/10.1111/1759-7714.13472DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7327672PMC
July 2020

A phase I and extension study of S-1 and carboplatin for previously untreated patients aged 75 years or more with advanced non-small cell lung cancer -TCOG 1101.

Int J Clin Oncol 2020 May 14;25(5):867-875. Epub 2020 Feb 14.

Department of Pulmonary Medicine, Oncology and Infectious Disease, Graduate School of Medicine, Nippon Medical School, Tokyo, Japan.

Purpose: Combination carboplatin and S-1 is active in the treatment of non-small cell lung cancer (NSCLC). However, data on this combination for elderly patients with NSCLC are insufficient.

Methods: Eligibility criteria were no prior chemotherapy, Stage IIIB or IV NSCLC, performance status 0-1, age ≥ 75 years, and adequate hematological, hepatic, and renal functions. Carboplatin was administered on day 1 and S-1 was administered orally, twice a day, between days 1 and 14, repeated every 3 weeks. In phase I, the primary purpose was determination of the recommended dose. Starting doses of carboplatin and S-1 were area under the curve (AUC) of 4 and 80 mg/m/day, respectively. In the extension study, the effects and tolerability of this combination therapy of recommended dose were confirmed.

Results: A total of 10 patients were entered into phase I and 14 patients were entered into the extension study. The recommended doses for this drug combination are AUC 5 for carboplatin and 80 mg/m/day every 3 weeks for S-1. With carboplatin and S-1 combination therapy at the recommended dose, the response rate was 30.0% [95% confidence interval (CI) 12-54%] and the disease control rate was 90.0% (95% CI 68-99%). Thrombocytopenia and neutropenia were major adverse events.

Conclusions: The recommended doses for this combination therapy are carboplatin AUC 5 and S-1 80 mg/m/day every 3 weeks, and this combination is effective with tolerable toxicities for advanced NSCLC patients ≥ 75 years old.
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http://dx.doi.org/10.1007/s10147-020-01629-6DOI Listing
May 2020

Real-world effectiveness and safety of nivolumab in patients with non-small cell lung cancer: A multicenter retrospective observational study in Japan.

Lung Cancer 2020 02 20;140:8-18. Epub 2019 Nov 20.

Department of Thoracic Oncology, National Cancer Center Hospital, Tokyo, Japan.

Objectives: To describe the treatment patterns and determine the effectiveness and safety of nivolumab treatment for non-small cell lung cancer (NSCLC) in real-world setting in Japan.

Materials And Methods: Japanese patients with NSCLC who received nivolumab were analyzed retrospectively. Patients who had started nivolumab treatment between April 2016 and December 2016 were enrolled. Information regarding patient demographics and clinical backgrounds, treatment patterns from diagnosis to post-nivolumab treatment, effectiveness and safety of nivolumab treatment and that of treatments just before and after nivolumab treatment, and programmed death-ligand 1 (PD-L1) expression status, if available, were collected. Factors associated with nivolumab effectiveness identified by univariate and multivariate analyses were further investigated for plotting Kaplan-Meier curves of epidermal growth factor receptor (EGFR) gene mutation status, PD-L1 expression status, and Eastern Cooperative Oncology Group performance status (ECOG PS).

Results: In this study, 901 NSCLC patients were enrolled. Nivolumab was used the most as a second line treatment with a median number of nivolumab doses of five. The median overall survival (OS) was 14.6 months, one-year survival rate was 54.3 %, and median progression-free survival (PFS) was 2.1 months. The objective response rate was 20.5 % and disease control rate was 57.4 %. According to multivariate analyses, better OS and PFS were associated with favorable ECOG PS and absence of liver metastasis. Better PFS was observed in patients without EGFR mutation and patients with smoking history. PFS and best overall response in PD-L1 expression subgroups were expression level-dependent. The overall incidence of irAEs was 45.8 %, and the incidence of adverse events of grade 3 or higher was 14.0 %.

Conclusion: The real-world effectiveness and safety of nivolumab is consistent with that reported by previous clinical trials and other real-world data. Subgroup analysis showed that ECOG PS, EGFR mutation status, smoking status, and PD-L1 were associated with the effectiveness of nivolumab.
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http://dx.doi.org/10.1016/j.lungcan.2019.11.014DOI Listing
February 2020

Impact of clinical features on the efficacy of osimertinib therapy in patients with T790M-positive non-small cell lung cancer and acquired resistance to epidermal growth factor receptor tyrosine kinase inhibitors.

J Thorac Dis 2019 Jun;11(6):2350-2360

Department of Thoracic Oncology and Respiratory Medicine, Tokyo Metropolitan Cancer and Infectious Diseases Centre, Komagome Hospital, Bunkyo, Tokyo, Japan.

Background: Osimertinib exhibits good efficacy in patients with T790M-positive non-small cell lung cancer (NSCLC) and acquired resistance to epidermal growth factor receptor (EGFR)-tyrosine kinase inhibitors (TKIs). Compared with the clinical trials, in real-world clinical practice, osimertinib must be administered to older patients and those with poor Eastern Cooperative Oncology Group performance status (ECOG-PS). Therefore, we investigated the association between osimertinib efficacy/safety and PS score, age, and other clinical features in patients with T790M-positive NSCLC.

Methods: We reviewed all patients with T790M-positive NSCLC and acquired resistance to initial EGFR-TKIs who were administered osimertinib between March 2016 and January 2018 at the Tokyo Metropolitan Cancer and Infectious Diseases Center in Komagome Hospital, Japan.

Results: In total, 31 patients, including 8 young (<65 years) and 23 elderly (≥65 years) patients, were included in the study. Of these, 10 (32.3%) patients had poor PS scores. The progression-free survival (PFS) was significantly shorter in young patients was than elderly patients [3.5 6.4 months, P=0.041; hazard ratio (HR), 2.41]. The overall survival (OS) of the young patients tended to be shorter than that of the elderly patients (5.3 19.4 months, P=0.067; HR, 2.58). The PFS (9.1 5.5 months; P=0.071; HR, 0.38) and the OS (not reached 6.6 months, P=0.061; HR, 0.39) were shorter in patients with poor ECOG-PS than those with good ECOG-PS. The toxic effects of osimertinib were manageable. By multivariate analysis, both age and ECOG-PS were independent predictors of osimertinib efficacy.

Conclusions: Poor ECOG-PS and younger age were associated with lower efficacy of osimertinib in T790M-positive NSCLC.
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http://dx.doi.org/10.21037/jtd.2019.06.03DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6626778PMC
June 2019

Nivolumab for advanced non-small cell lung cancer patients with mild idiopathic interstitial pneumonia: A multicenter, open-label single-arm phase II trial.

Lung Cancer 2019 08 3;134:274-278. Epub 2019 Jun 3.

Department of Respiratory Medicine, Kobe City Medical Center General Hospital, Kobe, Japan.

Objectives: The efficacy of nivolumab against metastatic non-small cell lung cancer (NSCLC) has been demonstrated; however, pneumonitis is relatively common and is a potentially life-threatening immune-related adverse event. Patients with idiopathic interstitial pneumonia (IIP) have a higher risk of pneumonitis and are generally excluded from clinical trials. Additionally, to date, a multicenter prospective trial for previously-treated NSCLC patients with IIP has not been performed. To fulfill this unmet medical need, we conducted a multicenter, open-label single-arm phase II trial to evaluate the efficacy and safety of nivolumab in NSCLC patients with mild IIP.

Materials And Methods: Eligible patients had previously-treated, inoperable NSCLC with mild IIPs. Mild IIP was defined as a predicted vital capacity of at least 80% and possible usual interstitial pneumonia (UIP) or inconsistent with UIP pattern by chest high-resolution computed tomography. Primary end point was the 6 months PFS rate and secondary end point was the safety of this therapy.

Results: Eighteen patients were enrolled in this trial. Six months PFS rate was 56%, response rate was 39%, and disease control rate was 72%. There were no treatment-related deaths. One drug-related grade 3/4 nonhematologic event (grade 3 neurotoxicity) was observed. Two patients had grade 2 pneumonitis which improved by corticosteroid therapy.

Conclusions: Nivolumab could be an effective therapy for NSCLC patients with mild IIPs.
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http://dx.doi.org/10.1016/j.lungcan.2019.06.001DOI Listing
August 2019

A single-arm phase II trial of weekly nanoparticle albumin-bound paclitaxel (nab-paclitaxel) monotherapy after standard of chemotherapy for previously treated advanced non-small cell lung cancer.

Cancer Chemother Pharmacol 2019 08 16;84(2):351-358. Epub 2019 Apr 16.

Department of Thoracic Oncology and Respiratory Medicine, Tokyo Metropolitan Cancer and Infectious Diseases Centre, Komagome Hospital, Honkomagome 3-18-22, Bunkyo, Tokyo, 113-0021, Japan.

Background: Few studies have investigated the clinical efficacy of third- and later-line of chemotherapy after standard chemotherapy for previously treated advanced non-small cell lung cancer (NSCLC). We prospectively evaluated the efficacy and safety of nanoparticle albumin-bound paclitaxel (nab-paclitaxel) following standard chemotherapies for previously treated advanced NSCLC.

Methods: The eligible patients having adequate organ functions with performance status 0-2 were enrolled after completing standard chemotherapy. They received weekly nab-paclitaxel 100 mg/m intravenously on days 1, 8, and 15 every 3 weeks. The primary end point was objective response rate (ORR). Median progression-free survival (PFS), overall survival (OS), and adverse events (AEs) were evaluated as secondary end points.

Results: This trial was discontinued because of late accrual. Twenty two patients were enrolled from April 2013 and February 2019. The total ORR was 22.7% [95% CI 7.8-45.4] and disease control rate (DCR) was 81.8% [95% CI 59.7-94.8]. Median PFS was 3.4 months [95% CI 2.3-4.1] and median OS was 7.4 months [95% CI 4.2-10.7]. Median follow-up interval was 6.7 months hematological AEs of Grade 3/4 included anemia (18%), leukopenia (18%), and neutropenia (32%), while the most frequent nonhematological AEs were fatigue (50%) and peripheral neuropathy (36.4%). Severe AEs related to treatment were observed in only one patient.

Conclusion: Nab-paclitaxel may be a safe and effective later-line chemotherapeutic option for previously treated advanced NSCLC after standard of chemotherapies based on other trials.
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http://dx.doi.org/10.1007/s00280-019-03843-0DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6647220PMC
August 2019

Acquisition of T790M resistance mutation in a patient with advanced adenocarcinoma harbouring uncommon mutations: a case report and literature review.

Onco Targets Ther 2019 22;12:745-748. Epub 2019 Jan 22.

Department of Thoracic Oncology and Respiratory Medicine, Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital, Tokyo, Japan,

Background: Osimertinib is the standard of care for patients with non-small-cell lung cancer (NSCLC) patients harboring acquired T790M resistance mutation. However, the frequency of T790M resistance mutation acquisition and the efficacy of osimertinib in patients harboring uncommon mutations, which accounts for approximately 10% of mutations, remain unclear.

Case Presentation: We present the case of a 72-year-old Japanese woman with recurrent NSCLC harboring uncommon mutations, who was subsequently found to have acquired the T790M resistance mutation and was treated with osimertinib. She died 9 days later because of worsening respiratory failure with disease progression.

Conclusion: The findings of the present case suggest that the T790M resistance mutation can occur even when the patient harbors an uncommon mutation after -tyrosine kinase inhibitor treatment, and the prognosis could be poor despite the presence of an acquired T790M resistance mutation.
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http://dx.doi.org/10.2147/OTT.S190034DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6348971PMC
January 2019

Management of cardiac tamponade during nivolumab of lung cancer with intrapericardial bleomycin: case report.

Immunotherapy 2019 04 7;11(6):467-472. Epub 2019 Feb 7.

Department of Thoracic Oncology & Respiratory Medicine, Tokyo Metropolitan Cancer & Infectious Diseases Center, Komagome Hospital, Bunkyo, Tokyo, Japan.

Immuno-checkpoint inhibitor response and immune-related adverse events remain controversial issues. Managing pericardial effusion during programmed cell death 1 inhibitor treatment is challenging. Here, we report a case of successfully managed cardiac tamponade caused by nivolumab-induced pseudoprogression. A 62-year-old male diagnosed with advanced lung adenocarcinoma started on nivolumab. Seven days later, he experienced cardiac tamponade and required pericardiocentesis, and other lesions were larger on computed tomography. The patient's condition stabilized after pericardiocentesis. However, although the lesions other than pericardial effusion were reduced on chest CT, cardiac tamponade recurred after 6 weeks. We considered that the case involved cardiac tamponade induced by pseudoprogression and administered intrapericardial bleomycin after pericardiocentesis. Thereafter, the patient was administered nivolumab for 7 months until disease progression.
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http://dx.doi.org/10.2217/imt-2019-0003DOI Listing
April 2019

Association between chronic bacterial airway infection and prognosis of bronchiolitis obliterans syndrome after hematopoietic cell transplantation.

Medicine (Baltimore) 2019 Jan;98(1):e13951

Department of Respiratory Medicine, Tokyo Metropolitan Komagome Hospital, 3-18-22 Honkomagome, Bunkyo-ku, Tokyo, Japan.

Bronchiolitis obliterans syndrome (BOS) is a rare pulmonary complication of hematopoietic stem cell transplantation (HSCT) with high mortality. Chronic bacterial airway infection (CAI) causes exacerbation and progression of several airway diseases, and bacterial airway colonization was shown to be associated with BOS after lung transplantation.We assessed the association between CAI and clinical course in patients with BOS after HSCT. This retrospective study included 910 patients undergoing allogeneic HSCT between 2005 and 2013 at our institution. BOS diagnosis was reevaluated according to the 2014 US National Institutes of Health criteria. Sputum and bronchial lavage culture results, pulmonary function, and survival were compared between patients with and without CAI.Median follow-up was 974.5 (261.5-2748.5) days. BOS was diagnosed in 27 (3.0%) patients, including 18 males. Median age at BOS diagnosis was 45 (40.5-58) years. Nine patients had ≥2 positive sputum cultures for bacteria or one positive bronchial lavage culture for nontuberculous mycobacteria (CAI+), whereas 9 patients had negative sputum/bronchial lavage culture or only one positive sputum culture (CAI-). Median change in forced expiratory volume in 1 s within 6 months after BOS diagnosis and overall survival were significantly worse in CAI+ patients than in CAI- patients (-250 vs +260 mL, P = .002, and 1340 days vs not reached, P = .04, respectively). No other factors including patient demographics or transplant protocol affected prognosis. There were no differences in clinical characteristics of patients with and without CAI, except for the time from transplantation to BOS diagnosis (214 vs 768 days for CAI+ and CAI-, respectively; P = .02).CAI was associated with worse outcomes in patients with BOS after HSCT. Further prospective studies should assess the association between the airway microbiome and changes in pulmonary function after HSCT to improve prognosis.
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http://dx.doi.org/10.1097/MD.0000000000013951DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6344207PMC
January 2019

Association Between Clinicopathological Features and Programmed Death Ligand 1 Expression in Non-small Cell Lung Cancer.

Anticancer Res 2018 02;38(2):1077-1083

Department of Thoracic Oncology and Respiratory Medicine, Tokyo Metropolitan Cancer and Infectious Diseases Centre, Komagome Hospital, Tokyo, Japan.

Background/aim: Programmed cell death ligand 1 (PD-L1) expression is a predictive marker for immunotherapy effects in advanced non-small cell lung cancer (NSCLC), but its association with patient characteristics or specimens is controversial. We aimed to retrospectively analyze the association of PD-L1 expression with clinicopathological features of NSCLC patients.

Materials And Methods: The PD-L1 expression and clinicopathological features of NSCLC patients were assessed from January 2017 to June 2017 in the Tokyo Metropolitan Cancer and Infectious Diseases Centre, Komagome Hospital were reviewed (n=108).

Results: For PD-L1 expressions of 0% and >1%, multivariate analysis showed that lymph node sample results were associated with positive PD-L1 expression. Archival samples and high serum carcinoembryonic antigen (CEA) levels were associated with negative PD-L1 expression. Sample preservation time and CEA levels correlated with PD-L1 expression.

Conclusion: Nodal metastasis, sample preservation time and CEA levels were associated with PD-L1 expression in NSCLC.
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http://dx.doi.org/10.21873/anticanres.12326DOI Listing
February 2018

Noninvasive monitoring of the genetic evolution of EGFR-mutant non-small-cell lung cancer by analyzing circulating tumor DNA during combination chemotherapy with gefitinib and pemetrexed or S-1.

Onco Targets Ther 2016 24;9:5287-95. Epub 2016 Aug 24.

Department of Thoracic Oncology and Respiratory Medicine, Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital, Tokyo.

Background: Repetitive genotyping is useful to assess the genetic evolution of non-small-cell lung cancer (NSCLC) during treatment, but the need for sampling by biopsy is a major obstacle. Digital polymerase chain reaction (PCR) is a promising procedure for the detection of mutant alleles in plasma of cancer patients.

Methods: This prospective study enrolled patients with NSCLC and known epidermal growth factor receptor (EGFR) mutations and who had experienced disease progression during ongoing EGFR-tyrosine kinase inhibitor (TKI) therapy. Eligible patients received daily gefitinib and either pemetrexed or S-1 every 3 weeks until disease progression or the development of unacceptable toxicity. Peripheral blood was collected before and after the combination therapy for digital PCR and hepatocyte growth factor measurement.

Results: From May 2012 to January 2014, nine patients with a median age of 67 (range 52-80) years were enrolled. Patterns of disease progression during adjacent EGFR-TKI therapy were acquired resistance, observed in seven patients, and primary resistance, observed in two patients. Known EGFR mutations were detected in plasma samples of six (67%) patients at study enrollment. Of these, T790M mutation was concurrently detected in three (50%) patients. Four patients underwent gefitinib plus pemetrexed therapy, and five patients underwent gefitinib and S-1 therapy. The median number of cycles delivered was five, and the median progression-free survival was 5.7 months. Efficacy outcomes did not differ between treatments. After the combination therapy, plasma T790M status changed to positive in two patients. Hepatocyte growth factor level did not significantly change through the combination therapy.

Conclusion: The usefulness of monitoring the genetic evolution of EGFR-driven tumors using noninvasive procedures was demonstrated. Since continuation of EGFR-TKI therapy with cytotoxic agents has an acceptable tolerability and a possibility of inducing T790M mutation, the combination therapy may be useful for EGFR-mutant NSCLC resistant to EGFR-TKI therapy without T790M mutation.
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http://dx.doi.org/10.2147/OTT.S105976DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5004997PMC
September 2016

Phase II study of oral vitamin B12 supplementation as an alternative to intramuscular injection for patients with non-small cell lung cancer undergoing pemetrexed therapy.

Cancer Chemother Pharmacol 2016 Mar 28;77(3):559-64. Epub 2016 Jan 28.

Department of Thoracic Oncology and Respiratory Medicine, Tokyo Metropolitan Cancer and Infectious Diseases Center, Komagome Hospital, 3-18-22 Honkomagome, Bunkyoku, Tokyo, 1138677, Japan.

Purpose: A vitamin B12 supplement is required in pemetrexed single agent therapy. Intramuscular administration is the method of choice; however, oral administration is simpler and easier and may be sufficiently effective. We conducted a Phase II study to evaluate the safety of oral administration of vitamin B12 in patients with advanced non-small cell lung cancer who received pemetrexed single agent therapy.

Methods: Folic acid and vitamin B12 were given orally for ˃ 1 week before pemetrexed administration. The primary end-point was onset of a grade ≥ 3 neutropenia ratio (50% of threshold expression ratios; an expectation expression ratio of 21%; α, 0.05; β, 0.1). Blood concentration of folic acid and homocysteine which are markers of vitamin B12 deficiency were also examined (UMIN000003180).

Results: A total of 25 cases were registered from February 2010 to July 2014. The ratio of grade ≥ 3 neutropenia was 36% (95% CI 22-52 %). Grade ≥ 3 non-hematologic toxicity and hematologic toxicity were seen in 20% (5 cases) and 44% (11 cases) of patients, respectively. In addition, the homocysteine blood concentration just before the first cycle dosage of pemetrexed was significantly elevated relative to the 2-3 cycle.

Conclusion: This study failed to meet its primary endpoint. We could not demonstrate the safety and efficacy of the 1-week vitamin B12 oral administration protocol as compared with intramuscular administration.
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http://dx.doi.org/10.1007/s00280-015-2954-xDOI Listing
March 2016

Retrospective analysis of unknown primary cancers with malignant pleural effusion at initial diagnosis.

Thorac Cancer 2016 01 7;7(1):39-43. Epub 2015 May 7.

Department of Medical Oncology, Graduate School of Medicine Chiba University Chiba Japan.

Background: Malignant pleural effusion (MPE) can occur during the progression of various cancers. However, factors, such as the incidence of MPE associated with different types of cancers and its potential for diagnosing previously undetected cancers, are unknown. Moreover, MPE may accompany potentially curable cancers or those with a favorable survival prognosis with adequate treatment. The present study determined the types of cancers accompanied by MPE at initial diagnosis and investigated appropriate related methods for diagnosing previously unknown cancers.

Methods: We retrospectively reviewed the medical records of 35 patients with MPE at initial cancer diagnosis between 2004 and 2012. We evaluated the patient characteristics, final diagnosis, and diagnostic processes.

Results: Of the 35 patients, 10 had lung cancer, seven ovarian or peritoneal cancer, four malignant pleural mesothelioma, one breast cancer, one lymphoma, one pancreatic cancer, and 11 had cancers of unknown origin. Diagnoses of the primary lesions were confirmed using the MPE cellblock method for seven of 11 patients (63.6%), by excisional biopsy or aspiration from other sites in four of nine patients, by exploratory laparotomy in two of three patients, and by peritoneal washing cytology in five patients.

Conclusion: Lung cancer and cancer of unknown origin are major causes of MPE at initial presentation. However, these groups also contain cancers that are curable and those with good long-term prognosis. The MPE cellblock method represents an accurate method for identifying cancer origin.
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http://dx.doi.org/10.1111/1759-7714.12271DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4718124PMC
January 2016

Feasibility study of docetaxel plus bevacizumab as first line therapy for elderly patients with advanced non-small-cell lung cancer: Thoracic Oncology Research Group (TORG) 1014.

BMC Cancer 2015 Oct 19;15:740. Epub 2015 Oct 19.

Yokohama Municipal Citizen's Hospital, 56 Kazawa-cho, Hodogaya-ku, Yokohama, 240-8555, Japan.

Background: Docetaxel monotherapy is one of the standard treatments for non-small-cell lung cancer in elderly patients. The addition of bevacizumab to docetaxel seems promising; however, the feasibility of this combination has not been investigated in such patients.

Methods: Patients with advanced non-squamous non-small-cell lung cancer aged 70 years or older who had not previously received cytotoxic chemotherapy were enrolled. Patients in the Level 0 cohort received docetaxel 60 mg/m(2) and bevacizumab 15 mg/kg, whereas those in the Level-1 cohort received docetaxel 50 mg/m(2) and bevacizumab 15 mg/kg. Chemotherapy was repeated 3 weekly for six cycles. The primary endpoint was toxicity and the secondary endpoints were response rate, progression-free survival, overall survival, and proportion of patients who underwent three or more cycles of chemotherapy.

Results: Twenty-one patients were enrolled from December 2010 to September 2012 at six institutes. Of the nine patients enrolled in Level 0, two experienced dose-limiting toxicity (febrile neutropenia and prolonged Grade 4 neutropenia in one patient, and Grade 3 infection in another patient) during the first cycle. Enrollment to the Level 0 cohort was terminated because two patients developed Grade 4 sepsis during later cycles. The remaining 12 patients were enrolled in the Level-1 cohort, in which two dose-limiting toxicities (prolonged Grade 4 neutropenia and Grade 3 increased aminotransferase level) were observed. No patient in the Level-1 cohort experienced Grade 4 nonhematologic toxicity. Grade 4 neutropenia occurred in 89 % of Level 0 patients and 50 % of Level-1 patients. The proportion of patients who experienced Grade 3/4 infection, febrile neutropenia or sepsis was 44 % in the Level 0 cohort, and 8 % in the Level-1 cohort. The overall response rate to chemotherapy and progression-free survival were 29 % (95 % CI, 11-52 %) and 5.9 months (95 % CI, 3.6-9.1 months), respectively. Efficacy outcomes did not differ significantly between the cohorts.

Conclusions: Toxicities were tolerable in level-1 cohort. The recommended dose of combination chemotherapy with docetaxel and bevacizumab for elderly patients was determined as 50 mg/m(2) of docetaxel and 15 mg/kg of bevacizumab and toxicities were tolerable. Further studies are warranted.

Trial Registration: UMIN Clinical Trial Registry; UMIN000004240 .
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http://dx.doi.org/10.1186/s12885-015-1756-1DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4612532PMC
October 2015

A prospective study of shortened vitamin supplementation prior to cisplatin-pemetrexed therapy for non-small cell lung cancer.

Oncologist 2014 Nov 26;19(11):1194-9. Epub 2014 Sep 26.

Department of Thoracic Oncology and Respiratory Medicine, Tokyo Metropolitan Cancer and Infectious Diseases Center, Komagome Hospital, Tokyo, Japan; Department of Thoracic Oncology, National Cancer Center Hospital, Tokyo, Japan; Department of Respiratory Medicine and Medical Oncology, Yokohama Municipal Citizen's Hospital, Yokohama, Japan; Department of Internal Medicine, Tokyo Metropolitan Matsuzawa Hospital, Tokyo, Japan.

Background: Prior supplementation with folic acid and vitamin B12 is required to reduce pemetrexed therapy toxicity; the recommended lead-in time is at least 7 days. On the basis of previous pharmacokinetic and clinical studies, we hypothesized that the lead-in time could be shortened to 24 hours, enabling earlier commencement of standard chemotherapy; thus, we planned the first prospective trial of this regimen.

Methods: Patients with advanced nonsquamous non-small cell lung cancer who had not previously received cytotoxic chemotherapy were enrolled. After measurement of homocysteine concentrations, the patients received 1,000 μg of vitamin B12 by intramuscular injection and began taking 350-500 μg of oral folic acid daily. Starting 24-48 hours after the vitamin B12 injection, the patients received intravenous 500 mg/m(2) pemetrexed and 75 mg/m(2) cisplatin for 4 cycles at 3 weekly intervals. The primary endpoint was the proportion of patients who developed neutropenia grade ≥3.

Results: Thirty patients received chemotherapy starting within 48 hours of the vitamin B12 injection. No treatment-related deaths or grade 4 toxicity occurred. Neutropenia grade ≥3, other laboratory toxicities grade ≥3, and nonlaboratory toxicities grade ≥3 occurred in 6.7%, 13%, and 13% of patients, respectively. The baseline homocysteine concentrations were not higher in patients with grade ≥3 toxicities than in the remainder of the cohort (mean values, 8.6 and 10.7 μmol/L, respectively). The response rate to chemotherapy was 43%.

Conclusion: The shortened vitamin supplementation was well tolerated and retained antitumor efficacy. Analysis of baseline homocysteine concentrations confirmed the efficacy of short-term vitamin supplementation.
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http://dx.doi.org/10.1634/theoncologist.2014-0221DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4221372PMC
November 2014

Evaluation of the chronic obstructive pulmonary disease assessment test in Japanese outpatients.

Clin Respir J 2014 Apr 15;8(2):213-9. Epub 2014 Jan 15.

Department of Internal Medicine and Clinical Immunology, Yokohama City University Graduate School of Medicine, Yokohama, Japan.

Objective: The Chronic Obstructive Pulmonary Disease (COPD) Assessment Test (CAT) is a quality-of-life (QOL) questionnaire that proved to correlate with St. George's Respiratory Questionnaire. Correlations between CAT scores and other COPD parameters have not been thoroughly evaluated in Japanese outpatients.

Methods: Cross-sectional study of 85 outpatients with COPD at a Japanese community-based hospital.

Patients: We observed 70 men and 15 women, whose average age was 72.0 ± 9.0 years. Mean forced expiratory volume in 1 s (FEV1) (% predicted) was 45.8 ± 14.7%. Mean CAT score was 10.1 ± 7.9 (range: 0-31). We calculated Spearman's rank correlation coefficient for CAT score and the following variables: r=0.81 for 'the Body Mass Index, Airflow Obstruction, Dyspnea and Exercise Capacity Index'; r=-0.05 for body mass index; r=-0.56 for FEV1 (% predicted); r=0.88 for Modified Medical Research Council Dyspnea Scale; r=-0.71 for 6-min walk distance; r=0.68 for 'the Age, Dyspnoea,and Airflow Obstruction Index'; and r=-0.40 for oxygen saturation in artery. Each COPD parameter, except for body mass index, had a significant (P<0.001) correlation with the CAT score.

Conclusions: The CAT score, which is obtainable by a simple questionnaire originally designed for QOL assessment, had strong correlations with airflow obstruction, dyspnea, exercise tolerance, prognostic index and oxygenation in Japanese outpatients.
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http://dx.doi.org/10.1111/crj.12062DOI Listing
April 2014

Eligibility for bevacizumab as an independent prognostic factor for patients with advanced non-squamous non-small cell lung cancer: a retrospective cohort study.

PLoS One 2013 26;8(3):e59700. Epub 2013 Mar 26.

Department of Thoracic Oncology and Respiratory Medicine, Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital, Tokyo, Japan.

Background: Bevacizumab requires some unique eligibility criteria, such as absence of hemoptysis and major blood vessel invasion by the tumor. The prognostic impact of these bevacizumab-specific criteria has not been evaluated.

Methods: Patients with stage IIIB/IV, non-squamous non-small cell lung cancer who started chemotherapy before the approval of bevacizumab were reviewed. Patients with impaired organ function, poor performance status or untreated/symptomatic brain metastasis were excluded before the evaluation of bevacizumab eligibility. We compared overall survival and time to treatment failure among patients who were eligible (Group A) or ineligible (Group B) to receive bevacizumab.

Results: Among 283 patients with stage IIIB/IV non-squamous non-small cell lung cancer, eligibility for bevacizumab was evaluated in 154 patients. Fifty-seven patients were considered ineligible (Group B) based on one or more of a history of hemoptysis (n = 20), major blood vessel invasion (n = 43) and cardiovascular disease (n = 8). The remaining 97 patients were classified into Group A. Overall survival was significantly better in Group A (median, 14.6 months) than in Group B (median, 7.1 months; p<0.0001). Time to treatment failure was also significantly longer in Group A (median, 6.9 months) than in Group B (median, 3.0 months; p<0.0001). Adjusted hazard ratios of bevacizumab eligibility for overall survival and time to treatment failure were 0.48 and 0.38 (95% confidence intervals, 0.33-0.70 and 0.25-0.58), respectively.

Conclusion: Eligibility for bevacizumab itself represents a powerful prognostic factor for patients with non-squamous non-small cell lung cancer. The proportion of patients who underwent first-line chemotherapy without disease progression or unacceptable toxicity can also be biased by bevacizumab eligibility. Selection bias can be large in clinical trials of bevacizumab, so findings from such trials should be interpreted with extreme caution.
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http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0059700PLOS
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3608561PMC
September 2013

Depression in Japanese patients with chronic obstructive pulmonary disease: a cross-sectional study.

Respir Care 2013 Jul 4;58(7):1196-203. Epub 2012 Dec 4.

Department of Internal Medicine and Clinical Immunology, Yokohama City University Graduate School of Medicine, Yokohama, Japan.

Background: Some investigations have revealed an association between depression and physical measurements of COPD patients in North America and Europe, but few related studies have been performed in Asia.

Methods: In this cross-sectional study, 84 consecutive, stable out-patients with COPD (mean ± SD age 72.0 ± 9.0 y, percent-of-predicted FEV1 46 ± 15%, 15 [17.9%] female) in a Japanese community hospital were recruited. "Probable depression" was defined as a score of ≥ 6 on the short-form Geriatric Depression Scale (SF-GDS). Relationships among commonly used physical measurements, SF-GDS raw score, and probable depression were evaluated with the Spearman rank correlation test, multiple linear regression analysis, logistic regression analysis, and receiver operating characteristic curves.

Results: Thirty-two subjects (38.1%) had probable depression. Body mass index, obstruction, dyspnea, exercise capacity index, percent-of-predicted FEV1, Modified Medical Research Council dyspnea score, 6-min walk distance, and SpO2 had: simple correlations (r 0.42-0.60, P < .001 for all) with the SF-GDS raw score; partial correlations (r 0.25-0.51, P < .05 for all) with the SF-GDS raw score after adjusting for demographic and social factors; association with probable depression in the logistic regression analysis after adjusting for demographic and social factors (P < .05 for all); and areas under the receiver operating characteristic curve of 0.72-0.84 (P < .001 for any) for probable depression.

Conclusions: Physical parameters were associated with depression in our Japanese COPD out-patients.
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http://dx.doi.org/10.4187/respcare.02065DOI Listing
July 2013

Serum immunoglobulin G is a marker for the risk of opportunistic infection in steroid-dependent severe asthmatic patients.

Intern Med 2012 1;51(19):2715-9. Epub 2012 Oct 1.

Department of Allergy and Respiratory Medicine, The Fraternity Memorial Hospital, Japan.

Background: Approximately 10% of asthmatic patients are refractory to inhaled corticosteroids and therefore need long-term oral corticosteroid therapy, which is associated with a risk of opportunistic infections due to immunosuppression.

Objective: To ascertain the applicability of serum Immunoglobulin G (IgG) as a marker for predicting the risk of opportunistic infections in patients undergoing oral corticosteroid therapy.

Methods: Three thousand asthmatics were screened, and 14 patients who had been administered daily oral corticosteroids for more than two years were enrolled. The patients enrolled were maintained under observation with ordinary check-ups and treatments for one year. After the observation period, the patients were divided into two groups according to the presence (OPI) or absence (non-OPI) of opportunistic infections during the period. The differences in the clinical parameters between the groups were investigated.

Results: There were no statistically significant differences in age, forced expiratory volume in 1 second (FEV(1)), smoking status or serum albumin between the groups. The serum IgG level of the OPI group was significantly lower than that of the non-OPI group (567.2±151.1 mg/dL vs. 931.6±198.8 mg/dL, p<0.01). The average total dose of corticosteroids administered during the one year period was higher in the OPI group (2,633±554.2 mg) than that in the Non-OPI group (1,793±466.2 mg) (p<0.05). There was a significant correlation between the serum IgG and total dose of corticosteroids administered during the one-year period (r = -0.75, p<0.01). The area under the receiver operating characteristic curve regarding the serum IgG and incidence of opportunistic infections was 0.97, which suggests that the serum IgG level has a high accuracy for predicting the risk of opportunistic infections.

Conclusion: The serum IgG was therefore found to be a useful marker for predicting the risk of opportunistic infections in steroid-dependent asthmatics.
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http://dx.doi.org/10.2169/internalmedicine.51.7775DOI Listing
March 2013

[A case of bird related hypersensitivity pneumonitis had a progressive course].

Nihon Kokyuki Gakkai Zasshi 2008 Jul;46(7):558-63

Department of Respiratory Medicine, Tokyo Metropolitan Hiroo Hospital.

A 50-year-old woman was admitted due to productive cough continuing for 3 years. A chest computed tomography showed appearance of nonspecific interstitial pneumonia (NSIP). Thoracoscopic lung biopsy specimens showed mainly a pattern of NSIP with multinucleated cells and cholesterol clefts. She was not a bird fancier, but had indirect exposure to birds in her living environment, and had been using feather-filled duvets for a long time. We established a diagnosis of bird-related hypersensitivity pneumonitis based on antibodies in serum positive to pigeon dropping extracts. She was treated by coadministration of corticosteroids and immunosuppressants, and avoidance of bird-related antigens, but had a progressive course and died of respiratory failure.
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July 2008

[Clinical statistics of outpatients investigated for asbestos-related lung diseases at a general hospital in Tokyo].

Nihon Kokyuki Gakkai Zasshi 2008 Jul;46(7):522-5

Department of Respiratory Medicine, Tokyo Metropolitan Hiroo Hospital.

We evaluated 122 outpatients who visited our hospital for examination of asbestos-related diseases between November, 2005 and October, 2006. Patients were divided into three groups; occupational exposure, non-occupational exposure and non-exposure groups. The occupational exposure group showed a significantly higher rate of asbestos-related abnormal findings than the non-occupational exposure plus the non-exposure group (33% vs. 5%, respectively; P = 0.001). Pleural plaque was the most common abnormal finding related to asbestos. Only four of 24 patients with pleural plaques could obtain personal health records for workers enjoyed in dangerous work, whereas the rest of them were not able to mainly because they were self-employed. A health support system is necessary to also cover non-employees.
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July 2008

Left ventricular involvement in arrhythmogenic right ventricular cardiomyopathy demonstrated by multidetector-row computed tomography.

Int J Cardiol 2007 Feb 12;115(3):e129-31. Epub 2006 Dec 12.

Arrhythmogenic right ventricular cardiomyopathy (ARVC) is a condition in which the right ventricle is partially or totally replaced by the adipose tissue. Pathological abnormalities affect the left ventricle as well as the right ventricle, particularly the epimyocardium. Multidetector-row computed tomography, which allowed excellent visualization of not only the coronary arteries but also the myocardium with submillimeter spatial resolution and high signal-to-noise ratio, would be more suitable for the assessment of the extent of adipose tissue involvement in the right and left ventricular myocardium. We present a patient who was diagnosed as having ARVC with left ventricular involvement and underwent cardioverter defibrillator implantation.
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http://dx.doi.org/10.1016/j.ijcard.2006.09.012DOI Listing
February 2007