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  • 1
    In: Journal for ImmunoTherapy of Cancer, BMJ, Vol. 8, No. 2 ( 2020-07), p. e000779-
    Abstract: Several immune-related adverse events (irAEs) are reported to be associated with therapeutic efficacy of immune checkpoint inhibitors, yet whether pituitary dysfunction, a life-threatening irAE, affects overall survival (OS) in patients with malignancies is unclear. This prospective study examined the association of pituitary dysfunction (pituitary-irAE) with OS of patients with non-small cell lung carcinoma (NSCLC) or malignant melanoma (MM). Methods A total of 174 patients (NSCLC, 108; MM, 66) treated with ipilimumab, nivolumab, pembrolizumab, or atezolizumab at Nagoya University Hospital were evaluated for OS and the development of pituitary-irAE. Kaplan-Meier curves of OS as a function of the development of pituitary-irAE were produced with the log-rank test as a primary endpoint. Results Pituitary-irAE was observed in 16 patients (4 (3.7%) with NSCLC, 12 (18.2%) with MM) having two different disease types: hypophysitis with deficiency of multiple anterior pituitary hormones accompanied by pituitary enlargement, and isolated adrenocorticotropic hormone (ACTH) deficiency without pituitary enlargement. Among these patients, 6 developed pituitary-irAE while being treated with ipilimumab (6/25 patients (24.0%) treated with ipilimumab) and 10 developed pituitary-irAE during treatment with nivolumab or pembrolizumab (10/167 (6.0%)). All 16 patients had ACTH deficiency and were treated with physiological doses of hydrocortisone. The development of pituitary-irAE was associated with better OS in patients with NSCLC (not reached vs 441 (95% CI not calculated) days, p 〈 0.05) and MM (885 (95% CI 434 to 1336) vs 298 (95% CI 84 to 512) days, p 〈 0.05). Conclusions In our study cohort, the incidence of pituitary-irAE was higher than previously reported and the development of pituitary-irAE predicted better prognosis for both NSCLC and MM when patients were treated with physiological doses of hydrocortisone. Clinical trials registration UMIN000019024.
    Type of Medium: Online Resource
    ISSN: 2051-1426
    Language: English
    Publisher: BMJ
    Publication Date: 2020
    detail.hit.zdb_id: 2719863-7
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  • 2
    In: BMJ Open Gastroenterology, BMJ, Vol. 8, No. 1 ( 2021-06), p. e000662-
    Abstract: Serum albumin is used as a marker of acute inflammation. Several studies have addressed the association between serum albumin and clinical outcome in patients with ulcerative colitis (UC). While mucosal healing (MH) has been indicated as the therapeutic goal for UC, the association between serum albumin and MH remains unclear. We evaluated this issue in patients with UC overall and explored whether duration of UC affected this association. Design This cross-sectional study recruited consecutive patients with UC. Study subjects consisted of 273 Japanese patients with UC. Serum albumin was divided into tertiles based on its distribution in all study subjects. One endoscopy specialist was responsible for measuring partial MH and MH, which were defined as a Mayo endoscopic subscore of 0–1 and 0, respectively. The association between serum albumin and clinical outcomes was assessed by multivariate logistic regression. Results Rates of clinical remission, partial MH and MH were 57.9%, 63% and 26%, respectively. Only high serum albumin ( 〉 4.4 mg/dL) was significantly positively associated with MH (OR 2.29 (95% CI: 1.03 to 5.29), p for trend=0.043). In patients with short UC duration ( 〈 7 years) only, high serum albumin was significantly positively associated with MH and clinical remission. In patients with long UC duration (≥7 years), in contrast, no association between serum albumin and clinical outcomes was found. Conclusion In Japanese patients with UC, serum albumin was significantly positively associated with MH. In patients with short UC duration, serum albumin might be a useful complementary marker for MH.
    Type of Medium: Online Resource
    ISSN: 2054-4774
    Language: English
    Publisher: BMJ
    Publication Date: 2021
    detail.hit.zdb_id: 2884818-4
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  • 3
    In: BMJ Open Gastroenterology, BMJ, Vol. 9, No. 1 ( 2022-10), p. e001000-
    Abstract: Socioeconomic status is a risk factor for worse outcomes in many diseases. However, evidence on the association between socioeconomic status and clinical outcome in patients with ulcerative colitis (UC) is limited. In the clinical setting, the therapeutic goal for UC is to achieve mucosal healing (MH). Thus, the aim of this study is to examine the association between socioeconomic status and MH in patients with UC. Methods The study population consisted of 298 patients with UC. Education status and household income were divided into three groups based on a self-administered questionnaire. MH and complete MH were defined as a Mayo endoscopic subscore of 0–1 and 0, respectively. The association of socioeconomic status with MH and complete MH was assessed by multivariate logistic regression analysis. Patients with UC were divided into a younger group ( 〈 51 years old) and an older group (≥51 years old) based on median age. Results The percentage of MH and complete MH was 62.4% and 25.2%, respectively. In all patients, socioeconomic status was not associated with MH and complete MH, respectively. In the older group, education but not household income was independently positively associated with MH and complete MH. In contrast, in the younger group, no association between socioeconomic status and MH and complete MH was found. Conclusion In older Japanese patients with UC, education status but not household income was independently positively associated with MH and complete MH.
    Type of Medium: Online Resource
    ISSN: 2054-4774
    Language: English
    Publisher: BMJ
    Publication Date: 2022
    detail.hit.zdb_id: 2884818-4
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