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1

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Evaluation of Programmed Death Ligand 1 ( PD-L1 ) Gene Amplification and Response to Nivolumab Monotherapy in Non–small Cell Lung Cancer

Inoue, Yusuke ; Yoshimura, Katsuhiro ; Nishimoto, Koji ; [et al.]

American Medical Association (AMA) ; 2020

In: JAMA Network Open Vol. 3, No. 9 ( 2020-09-21), p. e2011818-

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In: JAMA Network Open, American Medical Association (AMA), Vol. 3, No. 9 ( 2020-09-21), p. e2011818-

Type of Medium: Online Resource

ISSN: 2574-3805

URL: Article

DOI: 10.1001/jamanetworkopen.2020.11818

Language: English

Publisher: American Medical Association (AMA)

Publication Date: 2020

detail.hit.zdb_id: 2931249-8

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Prednisolone and tacrolimus versus prednisolone and cyclosporin A to treat polymyositis/dermatomyositis‐associated ILD : A randomized, open‐label trial

Fujisawa, Tomoyuki ; Hozumi, Hironao ; Kamiya, Yosuke ; [et al.]

Wiley ; 2021

In: Respirology Vol. 26, No. 4 ( 2021-04), p. 370-377

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In: Respirology, Wiley, Vol. 26, No. 4 ( 2021-04), p. 370-377

Abstract: The efficacy of combination therapy with corticosteroids and CNI, TAC and CsA, for PM/DM‐ILD has been described retrospectively. However, it remains unknown which CNI treatment regimens, TAC or CsA regimens, are more effective as initial treatments for patients with PM/DM‐ILD. Methods We conducted a prospective multicentre, open‐label, randomized, 52‐week phase 2 trial. Patients with PM/DM‐ILD were randomly allocated to receive PSL plus TAC (TAC group) or PSL plus CsA (CsA group). The primary endpoint was PFS rate in the intention‐to‐treat population at 52 weeks. The secondary endpoints were OS rate at 52 weeks, changes in pulmonary function tests from baseline to 52 weeks and AE. Results Fifty‐eight patients were randomly assigned to the TAC group ( n = 30) and the CsA group ( n = 28). The PFS rates at 52 weeks were 87% in the TAC group and 71% in the CsA group ( P = 0.16). The OS rates at 52 weeks were 97% in the TAC group and 93% in the CsA group ( P = 0.50). The %FVC at 52 weeks in the per‐protocol populations significantly increased in both groups. None of the patients discontinued the treatment due to AE. Conclusion PSL plus TAC treatment may achieve a better short‐term PFS rate compared with PSL plus CsA treatment. Further studies must be conducted to evaluate the long‐term efficacy and safety of such treatment.

Type of Medium: Online Resource

ISSN: 1323-7799 , 1440-1843

URL: Issue

URL: Article

DOI: 10.1111/resp.v26.4

DOI: 10.1111/resp.13978

Language: English

Publisher: Wiley

Publication Date: 2021

detail.hit.zdb_id: 2010720-1

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3

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Increased serum cholesterol and long-chain fatty acid levels are associated with the efficacy of nivolumab in patients with non-small cell lung cancer

Karayama, Masato ; Inui, Naoki ; Inoue, Yusuke ; [et al.]

Springer Science and Business Media LLC ; 2022

In: Cancer Immunology, Immunotherapy Vol. 71, No. 1 ( 2022-01), p. 203-217

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In: Cancer Immunology, Immunotherapy, Springer Science and Business Media LLC, Vol. 71, No. 1 ( 2022-01), p. 203-217

Abstract: Lipids have immunomodulatory functions and the potential to affect cancer immunity. Methods The associations of pretreatment serum cholesterol and long-chain fatty acids with the objective response rate (ORR), progression-free survival (PFS), and overall survival (OS) were evaluated in 148 patients with non-small cell lung cancer who received nivolumab. Results When each lipid was separately evaluated, increased low-density lipoprotein (LDL)-cholesterol ( P 〈 0.001), high-density lipoprotein (HDL)-cholesterol ( P = 0.014), total cholesterol ( P = 0.007), lauric acid ( P = 0.015), myristic acid ( P = 0.022), myristoleic acid ( P = 0.035), stearic acid ( P = 0.028), linoleic acid ( P = 0.005), arachidic acid ( P = 0.027), eicosadienoic acid ( P = 0.017), dihomo-γ-linolenic acid ( P = 0.036), and behenic acid levels ( P = 0.032) were associated with longer PFS independent of programmed death ligand 1 (PD-L1) expression. Meanwhile, increased LDL-cholesterol ( P 〈 0.001), HDL-cholesterol ( P = 0.009), total cholesterol ( P = 0.036), linoleic acid ( P = 0.014), and lignoceric acid levels ( P = 0.028) were associated with longer OS independent of PD-L1 expression. When multiple lipids were evaluated simultaneously, LDL-cholesterol ( P = 0.003), HDL-cholesterol ( P = 0.036), and lauric acid ( P = 0.036) were independently predictive of PFS, and LDL-cholesterol ( P = 0.008) and HDL-cholesterol ( P = 0.031) were predictive of OS. ORR was not associated with any serum lipid. Conclusions Based on the association of prolonged survival in patients with increased serum cholesterol and long-chain fatty acid levels, serum lipid levels may be useful for predicting the efficacy of immune checkpoint inhibitor therapy.

Type of Medium: Online Resource

ISSN: 0340-7004 , 1432-0851

URL: Article

DOI: 10.1007/s00262-021-02979-4

Language: English

Publisher: Springer Science and Business Media LLC

Publication Date: 2022

detail.hit.zdb_id: 1458489-X

detail.hit.zdb_id: 195342-4

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4

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Switch maintenance therapy with docetaxel and bevacizumab after induction therapy with cisplatin, pemetrexed, and bevacizumab in advanced non-squamous non-small cell lung cancer: a phase II study

Nishimoto, Koji ; Karayama, Masato ; Inui, Naoki ; [et al.]

Springer Science and Business Media LLC ; 2018

In: Medical Oncology Vol. 35, No. 7 ( 2018-7)

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In: Medical Oncology, Springer Science and Business Media LLC, Vol. 35, No. 7 ( 2018-7)

Type of Medium: Online Resource

ISSN: 1357-0560 , 1559-131X

URL: Article

DOI: 10.1007/s12032-018-1172-x

Language: English

Publisher: Springer Science and Business Media LLC

Publication Date: 2018

detail.hit.zdb_id: 1201189-7

detail.hit.zdb_id: 605563-1

detail.hit.zdb_id: 2008172-8

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5

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Serum immune modulators associated with immune-related toxicities and efficacy of atezolizumab in patients with non-small cell lung cancer

Inoue, Yusuke ; Inui, Naoki ; Karayama, Masato ; [et al.]

Springer Science and Business Media LLC ; 2023

In: Journal of Cancer Research and Clinical Oncology Vol. 149, No. 7 ( 2023-07), p. 2963-2974

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In: Journal of Cancer Research and Clinical Oncology, Springer Science and Business Media LLC, Vol. 149, No. 7 ( 2023-07), p. 2963-2974

Type of Medium: Online Resource

ISSN: 0171-5216 , 1432-1335

URL: Article

DOI: 10.1007/s00432-022-04193-w

RVK:

XA 52301

Language: English

Publisher: Springer Science and Business Media LLC

Publication Date: 2023

detail.hit.zdb_id: 1459285-X

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6

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〈p〉Effect of PD-1 inhibitor on exhaled nitric oxide and pulmonary function in non-small cell lung cancer patients with and without COPD〈/p〉

Suzuki, Yuzo ; Inui, Naoki ; Karayama, Masato ; [et al.]

Informa UK Limited ; 2019

In: International Journal of Chronic Obstructive Pulmonary Disease Vol. Volume 14 ( 2019-08), p. 1867-1877

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In: International Journal of Chronic Obstructive Pulmonary Disease, Informa UK Limited, Vol. Volume 14 ( 2019-08), p. 1867-1877

Type of Medium: Online Resource

ISSN: 1178-2005

URL: Journal

URL: Article

DOI: 10.2147/COPD

DOI: 10.2147/COPD.S214610

Language: English

Publisher: Informa UK Limited

Publication Date: 2019

detail.hit.zdb_id: 2212419-6

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7

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Prognostic Role of Interferon‐λ3 in Anti–Melanoma Differentiation–Associated Gene 5–Positive Dermatomyositis‐Associated Interstitial Lung Disease

Fukada, Atsuki ; Fujisawa, Tomoyuki ; Hozumi, Hironao ; [et al.]

Wiley ; 2024

In: Arthritis & Rheumatology Vol. 76, No. 5 ( 2024-05), p. 796-805

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In: Arthritis & Rheumatology, Wiley, Vol. 76, No. 5 ( 2024-05), p. 796-805

Abstract: Interferon‐λ3 (IFNλ3) is a cytokine with antiviral functions on barrier surfaces, and it is associated with disease activity in autoimmune diseases. This study assessed the clinical significance of serum IFNλ3 levels in polymyositis/dermatomyositis (PM/DM)–associated interstitial lung disease (ILD). Methods We measured serum IFNλ3 levels in 221 patients with PM/DM‐ILD (155 in the derivation cohort, 66 in the validation cohort) and 38 controls. We evaluated factors associated with mortality risk among 79 patients with anti‐melanoma differentiation–associated gene 5 (MDA5) antibody–positive DM‐ILD. Results Serum IFNλ3 levels at diagnosis were significantly higher in patients with PM/DM‐ILD than in healthy controls. Remarkably, serum IFNλ3 levels were specifically increased in patients with anti‐MDA5 antibody–positive DM‐ILD in both the derivation and validation cohorts. In anti‐MDA5 antibody–positive DM‐ILD, patients with high IFNλ3 levels ( 〉 120 pg/mL) had significantly lower survival rates than those with low IFNλ3 levels (≤120 pg/mL). A multivariate analysis revealed that high IFNλ3 levels, as well as old age and low Pa o 2 , were significantly associated with poor prognoses in patients with anti‐MDA5 antibody–positive DM‐ILD. In a classification analysis of patients with anti‐MDA5 antibody–positive DM‐ILD based on age, IFNλ3 level, and Pa o 2 , patients with old age ( 〉 53 years), high IFNλ3 levels ( 〉 120 pg/mL), and low Pa o 2 ( 〈 75 mm Hg) had the worst survival. In lung pathologic analyses, IFNλ3‐positive staining was observed in macrophages, airway epithelial cells, the pleural region, and intrapulmonary veins in patients with anti‐MDA5 antibody–positive DM‐ILD. Conclusion Serum IFNλ3 is a promising biomarker for identifying patients at high risk of poor outcomes in anti‐MDA5 antibody–positive DM‐ILD.

Type of Medium: Online Resource

ISSN: 2326-5191 , 2326-5205

URL: Issue

URL: Article

DOI: 10.1002/art.v76.5

DOI: 10.1002/art.42785

RVK:

XA 10000

RVK:

XA 30325

Language: English

Publisher: Wiley

Publication Date: 2024

detail.hit.zdb_id: 2754614-7

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8

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Six-week oral prednisolone therapy for immune-related pneumonitis: a single-arm phase II study

Karayama, Masato ; Inui, Naoki ; Inoue, Yusuke ; [et al.]

BMJ ; 2023

In: Journal for ImmunoTherapy of Cancer Vol. 11, No. 7 ( 2023-07), p. e007056-

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In: Journal for ImmunoTherapy of Cancer, BMJ, Vol. 11, No. 7 ( 2023-07), p. e007056-

Abstract: There has been no prospective trial for treatment of immune-related pneumonitis (irP) occurred after immune checkpoint inhibitors (ICIs). Methods In this single-arm phase II study, patients with cancer with grade ≥2 irP received oral prednisolone (1 mg/kg/day), tapered over 6 weeks. The primary endpoint was a pneumonitis control rate at 6 weeks from the start of the study treatment, defined as complete disappearance or partial improvement of irP in high-resolution CT of the chest. Results Among 57 patients enrolled, 56 were included in the final analysis. The most frequent cause of irP was single ICI therapy (51.8%), followed by combination with chemotherapy plus ICI (39.3%). Thirty-five (62.5%) patients had grade 2 irP and 21 (37.5%) had grade ≥3. Fifty-one (91.1%) patients completed the study treatment while 5 discontinued the study treatment because of relapse of irP (n=1), death from cancer (n=1), occurrence of immune-related hepatitis (n=1), extension of the treatment duration more than 6 weeks (n=1), and attending physician’s decision (n=1). Six weeks after the start of the study treatment, 16 (28.5%) patients demonstrated complete recovery from irP, 35 (62.5%) had a partial improvement in irP, 1 (1.8%) had a relapse of irP, and 4 (7.1%) were not evaluable. The pneumonitis control rate at 6 weeks was 91.1% (95% CI, 80.7% to 96.1%). Twelve weeks after the start of the study treatment, 5 (8.9%), 27 (48.2%), and 15 (26.8%) patients demonstrated complete recovery, partial improvement, and relapse, respectively, and 9 (16.1%) were not evaluable. The pneumonitis control rate at 12 weeks was 57.1% (95% CI, 44.1% to 69.2%). During the observation period, 18 (32.1%) patients experienced a relapse of irP, and of those, 17 received re-treatment with corticosteroids. Grade ≥3 adverse events occurred in 10 (17.9%) patients, in which hyperglycemia was most frequent (n=6). There was no treatment-related death. Conclusions In this first prospective study for irP, prednisolone at 1 mg/kg/day, tapered over 6 weeks, demonstrated a promising clinical benefit and manageable toxicity, suggesting a potential treatment option for irP. Trial registration number jRCT: 1041190029.

Type of Medium: Online Resource

ISSN: 2051-1426

URL: Article

DOI: 10.1136/jitc-2023-007056

Language: English

Publisher: BMJ

Publication Date: 2023

detail.hit.zdb_id: 2719863-7

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9

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Switch maintenance therapy with S-1 after induction therapy with carboplatin and nanoparticle albumin-bound paclitaxel in advanced lung squamous cell carcinoma

Akiyama, Norimichi ; Karayama, Masato ; Inui, Naoki ; [et al.]

Springer Science and Business Media LLC ; 2019

In: Investigational New Drugs Vol. 37, No. 3 ( 2019-06-15), p. 531-537

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In: Investigational New Drugs, Springer Science and Business Media LLC, Vol. 37, No. 3 ( 2019-06-15), p. 531-537

Type of Medium: Online Resource

ISSN: 0167-6997 , 1573-0646

URL: Article

DOI: 10.1007/s10637-019-00747-x

Language: English

Publisher: Springer Science and Business Media LLC

Publication Date: 2019

detail.hit.zdb_id: 2009846-7

SSG: 15,3

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10

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Efficacy of immune checkpoint inhibitors in non-small cell lung cancer with uncommon histology: a propensity-score-matched analysis

Miyashita, Koichi ; Karayama, Masato ; Inoue, Yusuke ; [et al.]

Springer Science and Business Media LLC ; 2021

In: BMC Pulmonary Medicine Vol. 21, No. 1 ( 2021-12)

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In: BMC Pulmonary Medicine, Springer Science and Business Media LLC, Vol. 21, No. 1 ( 2021-12)

Abstract: Clinical efficacy of immune checkpoint inhibitors (ICIs) for non-small cell lung cancer (NSCLC) with uncommon histology ( u NSCLC) is unknown. Methods Patients with NSCLC treated with ICI monotherapy between January 2014 and December 2018 in 10 Japanese hospitals were retrospectively evaluated. The patients were divided into: (1) NSCLC with common histology ( c NSCLC), defined as adenocarcinoma and squamous cell carcinoma; and (2) u NSCLC, defined as incompatibility with morphological and immunohistochemical criteria for adenocarcinoma or squamous cell carcinoma. Propensity score matching was performed to balance the two groups. Results Among a total of 175 patients included, 44 with u NSCLC (10 pleomorphic carcinomas, 9 large cell neuroendocrine carcinomas, 2 large cell carcinomas, and 23 not otherwise specified) and 44 with matched c NSCLC (32 adenocarcinomas and 12 squamous cell carcinomas) were selected for analyses. Median progression-free survival (PFS) (4.4 months, 95% confidence interval [CI] 1.8–7.7 months) and overall survival (OS) (11.4 months, 95% CI 7.4–27.4 months) in the u NSCLC patients were not significantly different from those in matched c NSCLC patients (5.4 months, 95% CI 3.1–7.6 months, p = 0.761; and 14.1 months, 95% CI 10.6–29.6 months, p = 0.381). In multivariate analysis, Eastern Cooperative Oncology Group performance status (ECOG-PS) of 0–1 and programmed death ligand-1 (PD-L1) expression were predictive for PFS and OS in u NSCLC. Conclusions ICIs had similar clinical efficacy for treatment of u NSCLC and c NSCLC. Good ECOG-PS and PD-L1 expression were predictive for efficacy of ICIs in u NSCLC.

Type of Medium: Online Resource

ISSN: 1471-2466

URL: Article

DOI: 10.1186/s12890-021-01681-6

Language: English

Publisher: Springer Science and Business Media LLC

Publication Date: 2021

detail.hit.zdb_id: 2059871-3

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