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2,803 results on '"Nishio, M"'

51. 1206MO ALINA: Exploratory biomarker analyses in patients (pts) with resected ALK+ non-small cell lung cancer (NSCLC) treated with adjuvant alectinib vs chemotherapy (chemo)

Author

Solomon, B.J., Wu, Y-L., Dziadziuszko, R., Barlesi, F., Nishio, M., Ahn, J.S., Horinouchi, H., Hochmair, M.J., de Marinis, F., Migliorino, M.R., Kurochkin, A., Harputluoglu, H., Planchard, D., Korphaisarn, K., Han, J-Y., Lohmann, T., Cardona Gavaldon, A., Archer, V.R., Nowicka, M., and Noe, J.

Published
2024
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54. First-line nivolumab + ipilimumab in advanced NSCLC : CheckMate 227 subpopulation analyses in Asian patients

Author

O'Byrne, K. J., Lee, K. H., Kim, S. W., Park, K., Nishio, M., Sakai, H., Ohe, Y., Fukuhara, T., Kang, J. H., Daga, H., Yu, C. J., Hotta, K., Tanaka, H., Takeda, M., Yokoyama, T., Nathan, F. E., Lee, J. S., O'Byrne, K. J., Lee, K. H., Kim, S. W., Park, K., Nishio, M., Sakai, H., Ohe, Y., Fukuhara, T., Kang, J. H., Daga, H., Yu, C. J., Hotta, K., Tanaka, H., Takeda, M., Yokoyama, T., Nathan, F. E., and Lee, J. S.

Abstract

Background: Nivolumab plus ipilimumab demonstrated clinically meaningful improvement in efficacy versus chemotherapy with a manageable safety profile in patients with advanced non-small cell lung cancer (NSCLC) and tumor programmed death-ligand 1 (PD-L1) expression ≥1% or <1% in Part 1 of CheckMate 227. Here we report efficacy and safety results for the Asian subpopulation. Methods: Patients with stage IV/recurrent NSCLC were randomized 1: 1: 1 to nivolumab plus ipilimumab, nivolumab monotherapy, or chemotherapy (PD-L1 ≥1%) or nivolumab plus ipilimumab, nivolumab plus chemotherapy, or chemotherapy (PD-L1 <1%). Overall survival (OS), progression-free survival, objective response rate, duration of response, and safety were evaluated among patients in Japan, South Korea, and Taiwan. Results: In the Asian subpopulation with PD-L1 ≥1%, 81 patients received nivolumab plus ipilimumab and 81 received chemotherapy. Median OS was not reached with nivolumab plus ipilimumab versus 24.8 months with chemotherapy; 3-year OS rate was 53% versus 37% [hazard ratio (HR), 0.72; 95% confidence interval (CI) 0.47-1.11]. The 3-year progression-free survival rate was 26% versus 7% (HR, 0.65; 95% CI 0.45-0.96), objective response rate was 56% versus 37%, and median duration of response was 29.0 months (95% CI 15.0 months-not reached) versus 6.9 months (95% CI 3.9-11.1 months). Similar results were observed regardless of tumor PD-L1 expression and in Japanese patients. Grade 3-4 treatment-related adverse events occurred in 40% of patients receiving nivolumab plus ipilimumab and 36% receiving chemotherapy, in the overall Asian subpopulation (tumor PD-L1 expression ≥1% and <1%); no new safety signals were identified. Conclusions: At 3-year follow-up, nivolumab plus ipilimumab provided durable long-term efficacy benefits versus chemotherapy regardless of tumor PD-L1 expression in the Asian subpopulation, including Japanese patients. Consistent with findings for all randomized patients, these

Published
2022

55. Rapid genomic profiling of circulating tumor DNA in non-small cell lung cancer using Oncomine Precision Assay with GenexusTM integrated sequencer

Author

Low, S-K, Ariyasu, R, Uchibori, K, Hayashi, R, Chan, HT, Chin, YM, Akita, T, Harutani, Y, Kiritani, A, Tsugitomi, R, Manabe, R, Ogusu, S, Amino, Y, Kitazono, S, Yanagitani, N, Nakamura, Y, Nishio, M, Low, S-K, Ariyasu, R, Uchibori, K, Hayashi, R, Chan, HT, Chin, YM, Akita, T, Harutani, Y, Kiritani, A, Tsugitomi, R, Manabe, R, Ogusu, S, Amino, Y, Kitazono, S, Yanagitani, N, Nakamura, Y, and Nishio, M

Abstract

BACKGROUND: Genomic profiling of tumors from cancer patients facilitates molecular-guided therapy. The turnaround time is one of important issues to deliver results timely for clinical decisions. The Ion Torrent™ Genexus™ Integrated Sequencer automates all next generation sequencing (NGS) workflows and delivers results within a day. METHODS: In this study, we conducted a feasibility study to evaluate the detection rate of genomic alterations from cell-free total nucleic acid (cfTNA, containing cfDNA and cfRNA) of 119 non-small cell lung cancer using Oncomine Precision Assay on Genexus™ Integrated Sequencer. Oncomine Precision Assay (OPA) covers actionable mutations, copy number variations and fusion genes and that are applicable for the selection of targeted therapy. cfTNA isolated from plasma (derived from 14 ml of blood) were subjected to the Genexus system for library construction, templating, sequencing, and data analyses. RESULTS: The sequencing resulted in median overall depth of 35,773× and median molecular coverage of 2,192× with cfTNA input ranged from 11 to 36 ng. Among the 119 samples evaluated, we detected at least one genomic alteration in plasma cfTNA of 79 cases (66%). When comparing to standard-of-care testing, the sensitivity and specificity of mutation detection in non-small cell lung cancer related genes using liquid biopsy with Genexus-OPA ranged between 49-67% and 93-100%, respectively. 59% of actionable mutations, which were present in tumor tissues, were detected by the Genexus- Oncomine Precision Assay using plasma cfTNA. Among the 5 mutations detected from liquid biopsy only, three mutations are of level 1 evidence according to OncoKB database, highlighting the clinical utilities of liquid biopsy in addressing tumor heterogeneity. Extrathoracic metastasis and levels of lactate dehydrogenase (LDH), C-reactive protein (CRP) and Carcinoembryonic Antigen (CEA) are found to be associated with increased circulating tumor DNA detection. CONCLUSIONS

Published
2022

66. 13P Durvalumab + chemotherapy in patients (pts) with advanced EGFR mutation-positive (EGFRm) NSCLC whose disease progressed on first-line (1L) osimertinib: An ORCHARD study interim analysis

Author

Cho, B.C., primary, Ahn, M-J., additional, Baik, C., additional, García, R., additional, Goldman, J.W., additional, Kim, S-W., additional, Lee, J.S., additional, Nishio, M., additional, Ponce, S., additional, Salgia, R., additional, Teraoka, S., additional, Yoshida, T., additional, Yu, H.A., additional, Ambrose, H., additional, Cosaert, J., additional, Hartmaier, R., additional, Maidment, J., additional, Pluta, M., additional, and Okamoto, I., additional

Published
2022
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67. Efficacy of Brigatinib in Patients With Advanced Anaplastic Lymphoma Kinase-Positive Non-Small Cell Lung Cancer Who Progressed on Alectinib or Ceritinib: ALTA-2 Study

Author

Ignatius Ou SH, Nishio, M, Ahn, Mj, Mok, T, Barlesi, F, Zhou, C, Felip, E, de Marinis, F, Kim, Sw, Pérol, M, Liu, G, Migliorino, Mr, Kim, Dw, Novello, S, Bearz, A, Garrido, P, Mazieres, J, Morabito, A, Lin, Hm, Yang, H, Niu, H, Zhang, P, and Kim, Es.

Subjects
anaplastic lymphoma kinase, circulating tumor DNA, non–small cell lung cancer, tumor biomarker
Published
2022

71. P276 Prevalence, clinicopathological, and biological characteristics of serrated polyps in patients with ulcerative colitis

Author

Nishio, M, primary, Kunisaki, R, additional, Shibata, W, additional, Ajioka, Y, additional, Hirasawa, K, additional, Takase, A, additional, Chiba, S, additional, Inayama, Y, additional, Ueda, W, additional, Okawa, K, additional, Tsunoda, S, additional, Azuma, D, additional, Yaguchi, K, additional, Fujii, K, additional, Nakamori, Y, additional, Madarame, A, additional, Nishida, D, additional, Fuse, M, additional, Araki, K, additional, Saigusa, Y, additional, Kimura, H, additional, Kato, J, additional, and Maeda, S, additional

Published
2022
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72. P291 Effect of the preconception steroid-free remission period on disease activity during pregnancy and birth outcomes in women with Ulcerative Colitis: a retrospective cohort study

Author

Ikeda, A, primary, Kunisaki, R, additional, Aoki, S, additional, Yaguchi, K, additional, Asami, S, additional, Furusawa, K, additional, Atsusaka, R, additional, Azuma, D, additional, Tsunoda, S, additional, Fujii, K, additional, Nishida, D, additional, Madarame, A, additional, Nishio, M, additional, Ogashiwa, T, additional, Nakamori, Y, additional, Fuse, M, additional, Daibo, S, additional, Araki, K, additional, Kimura, H, additional, Suzuki, R, additional, Go, H, additional, Saigusa, Y, additional, and Maeda, S, additional

Published
2022
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74. 122MO Nivolumab (NIVO) + ipilimumab (IPI) as first-line (1L) treatment (tx) for patients (pts) with advanced NSCLC (aNSCLC) and baseline (BL) brain metastases (mets): Intracranial and systemic outcomes from CheckMate 227 Part 1

Author

Reck, M., primary, Ciuleanu, T.E., additional, Pluzanski, A., additional, Lee, J.S., additional, Bernabe Caro, R., additional, Linardou, H., additional, Burgers, J., additional, Gallardo, C., additional, Nishio, M., additional, Peters, S., additional, Paz-Ares, L.G., additional, Hellmann, M.D., additional, Borghaei, H., additional, Ramalingam, S.S., additional, O’Byrne, K., additional, Hu, N., additional, Bushong, J., additional, Eccles, L., additional, Grootendorst, D., additional, and Brahmer, J.R., additional

Published
2021
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85. FP04.01 Nivolumab 480 mg Every 4 Weeks as De Novo Second-line Treatment for Advanced Non-Small Cell Lung Cancer: CheckMate 907

Author

Leighl, N., primary, Alexandru, A., additional, Ohe, Y., additional, Ruff, P., additional, Hida, T., additional, Nishio, M., additional, Rothenstein, J., additional, Tomiak, A., additional, Lowry, P., additional, Kumagai, T., additional, Gore, I., additional, Ntambwe, I., additional, Marimuthu, S., additional, and Schenker, M., additional

Published
2021
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86. MA07.02 Evaluating Circulating Tumor DNA to Predict Overall Survival Risk in Non-Squamous Non-Small Cell Lung Cancer in IMpower150

Author

Assaf, Z.J., primary, Fine, A., additional, Zou, W., additional, Socinski, M., additional, Young, A., additional, Freidin, J., additional, Kennedy, M., additional, Polisecki, E., additional, Nishio, M., additional, Oxnard, G., additional, Cummings, C., additional, Rode, A., additional, Reck, M., additional, Patil, N., additional, Shames, D., additional, and Schulz, K., additional

Published
2021
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88. A randomized, double-blind, placebo-controlled, phase III trial of erlotinib with or without a c-Met inhibitor tivantinib (ARQ 197) in Asian patients with previously treated stage IIIB/IV nonsquamous nonsmall-cell lung cancer harboring wild-type epidermal growth factor receptor (ATTENTION study)

Author

Yoshioka, H., Azuma, K., Yamamoto, N., Takahashi, T., Nishio, M., Katakami, N., Ahn, M. J., Hirashima, T., Maemondo, M., Kim, S. W., Kurosaki, M., Akinaga, S., Park, K., Tsai, C. M., Tamura, T., Mitsudomi, T., and Nakagawa, K.

Published
2015
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92. Capmatinib in Patients with METex14-Mutated Non-Small Cell Lung Cancer: GEOMETRY Mono-1 Asian Subgroup Analysis

Author

Han, J., Wolf, J., Garon, E., Groen, H., Heist, R., Ang, M., Ohashi, K., Toyozawa, R., Kim, T. M., Hida, T., Takeda, M., Sugawara, S., Chang, W., Yu, C., Moizumi, S., Robeva, A., Le Mouhaer, S., Waldron-Lynch, M., Agostinho, A. Chassot, Myers, A., Nishio, M., Guided Treatment in Optimal Selected Cancer Patients (GUTS), and Damage and Repair in Cancer Development and Cancer Treatment (DARE)

Subjects
Capmatinib, MET, NSCLC
Published
2021

93. P415 Paradoxical onset of Takayasu’s arteritis in patients with inflammatory bowel disease treated with anti-tumour necrosis factor-α agents

Author

Matsune, Y, primary, Kouyama, J, additional, Tsuru, Y, additional, Shimizu, K, additional, Asami, S, additional, Matsuyama, S, additional, Katsuki, S, additional, Ishihara, H, additional, Onizawa, R, additional, Shonai, S, additional, Tatsuno, M, additional, Nishikawa, Y, additional, Takeuchi, K, additional, Watanabe, M, additional, Nakamori, Y, additional, Hirayama, A, additional, Toyoda, J, additional, Ikeda, A, additional, Madarame, A, additional, Nishio, M, additional, Ogashiwa, T, additional, Matsubayashi, M, additional, Fujii, A, additional, Kimura, H, additional, and Kunisaki, R, additional

Published
2021
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94. First-Line Nivolumab Plus Ipilimumab Versus Chemotherapy in Advanced NSCLC With 1% or Greater Tumor PD-L1 Expression: Patient-Reported Outcomes From CheckMate 227 Part 1

Author

Reck, M. Ciuleanu, T.-E. Lee, J.-S. Schenker, M. Audigier-Valette, C. Zurawski, B. Linardou, H. Otterson, G.A. Salman, P. Nishio, M. de la Mora Jimenez, E. Lesniewski-Kmak, K. Albert, I. Ahmed, S. Syrigos, K. Penrod, J.R. Yuan, Y. Blum, S.I. Nathan, F.E. Sun, X. Moreno-Koehler, A. Taylor, F. O'Byrne, K.J.

Abstract

Introduction: In CheckMate 227 (NCT02477826), patients with treatment-naive stage IV or recurrent NSCLC and 1% or greater tumor programmed death ligand 1 expression had significantly improved overall survival with nivolumab plus ipilimumab versus chemotherapy. We present the patient-reported outcomes (PROs). Methods: Patients (N = 1189) were randomized to nivolumab plus ipilimumab, nivolumab, or chemotherapy. PROs were exploratory. Changes in Lung Cancer Symptom Scale (LCSS) average symptom burden index, LCSS 3-item global index, EQ-5D visual analog scale (VAS), and EQ-5D utility index were analyzed descriptively. Mixed-effect model repeated measures and time-to-first deterioration and improvement analyses were conducted. Results: PRO completion rates were generally greater than 80%. On-treatment improvements from baseline in LCSS measures of symptom burden and global health status with nivolumab plus ipilimumab generally met or exceeded the minimal important difference (smallest clinically meaningful change) from weeks 24 and 30, respectively; improvements with chemotherapy generally remained below the minimal important difference. Mean on-treatment EQ-5D VAS scores for both treatments approached the U.K. population norm at week 24, remaining so throughout the treatment period. Mixed-effect model repeated measures analyses revealed numerically greater improvements from baseline with nivolumab plus ipilimumab versus chemotherapy across LCSS average symptom burden index and 3-item global index, and EQ-5D VAS and utility index. Nivolumab plus ipilimumab had delayed time-to-first deterioration (hazard ratio [95% confidence interval] 0.74 [0.56 to 0.98]) and a trend for more rapid time-to-first improvement (1.24 [0.98 to 1.59]) versus chemotherapy. Conclusions: Nivolumab plus ipilimumab revealed delayed deterioration and numerical improvement in symptoms and health-related quality of life versus chemotherapy in patients with advanced NSCLC and 1% or greater programmed death ligand 1 expression. © 2021 International Association for the Study of Lung Cancer

Published
2021

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