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      Real‐world data on NGS using the Oncomine DxTT for detecting genetic alterations in non‐small‐cell lung cancer: WJOG13019L

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          Abstract

          Considering the increasing number of identified driver oncogene alterations, additional genetic tests are required to determine the treatment for advanced non‐small‐cell lung cancer (NSCLC). Next‐generation sequencing can detect multiple driver oncogenes simultaneously, enabling the analysis of limited amounts of biopsied tissue samples. In this retrospective, multicenter study (UMIN ID000039523), we evaluated real‐world clinical data using the Oncomine Dx Target Test Multi‐CDx System (Oncomine DxTT) as a companion diagnostic system. Patients with NSCLC who were tested for a panel of 46 genes using the Oncomine DxTT between June 2019 and January 2020 were eligible for enrollment. Patients from 19 institutions affiliated to the West Japan Oncology Group were recruited. The primary endpoint of the study was the success rate of genetic alteration testing in four driver genes ( EGFR, ALK, ROS1, and BRAF) using the Oncomine DxTT. In total, 533 patients were enrolled in the study. The success rate of genetic alteration testing for all four genes was 80.1% (95% CI 76.5%‐83.4%). Surgical resection was associated with the highest success rate (88.0%), which was significantly higher than that for bronchoscopic biopsy (76.8%, P = .005). Multivariate analysis revealed a significant difference for surgical resection alone ( P = .006, 95% CI 1.36‐6.18, odds ratio 2.90). Although the success rate of genetic alteration testing immediately after Oncomine DxTT induction was not sufficient in this study, optimizing specimen quantity and quality may improve the use of driver gene testing in clinical settings.

          Abstract

          The mutation identification success rate for all four genes was 80.1%. Surgical resection was associated with the highest success rate. Multivariate analysis showed a significant difference for surgical resection alone.

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          Global cancer statistics.

          The global burden of cancer continues to increase largely because of the aging and growth of the world population alongside an increasing adoption of cancer-causing behaviors, particularly smoking, in economically developing countries. Based on the GLOBOCAN 2008 estimates, about 12.7 million cancer cases and 7.6 million cancer deaths are estimated to have occurred in 2008; of these, 56% of the cases and 64% of the deaths occurred in the economically developing world. Breast cancer is the most frequently diagnosed cancer and the leading cause of cancer death among females, accounting for 23% of the total cancer cases and 14% of the cancer deaths. Lung cancer is the leading cancer site in males, comprising 17% of the total new cancer cases and 23% of the total cancer deaths. Breast cancer is now also the leading cause of cancer death among females in economically developing countries, a shift from the previous decade during which the most common cause of cancer death was cervical cancer. Further, the mortality burden for lung cancer among females in developing countries is as high as the burden for cervical cancer, with each accounting for 11% of the total female cancer deaths. Although overall cancer incidence rates in the developing world are half those seen in the developed world in both sexes, the overall cancer mortality rates are generally similar. Cancer survival tends to be poorer in developing countries, most likely because of a combination of a late stage at diagnosis and limited access to timely and standard treatment. A substantial proportion of the worldwide burden of cancer could be prevented through the application of existing cancer control knowledge and by implementing programs for tobacco control, vaccination (for liver and cervical cancers), and early detection and treatment, as well as public health campaigns promoting physical activity and a healthier dietary intake. Clinicians, public health professionals, and policy makers can play an active role in accelerating the application of such interventions globally.
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            Osimertinib in Untreated EGFR-Mutated Advanced Non–Small-Cell Lung Cancer

            Osimertinib is an oral, third-generation, irreversible epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKI) that selectively inhibits both EGFR-TKI-sensitizing and EGFR T790M resistance mutations. We compared osimertinib with standard EGFR-TKIs in patients with previously untreated, EGFR mutation-positive advanced non-small-cell lung cancer (NSCLC).
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              Alectinib versus Crizotinib in Untreated ALK-Positive Non-Small-Cell Lung Cancer.

              Background Alectinib, a highly selective inhibitor of anaplastic lymphoma kinase (ALK), has shown systemic and central nervous system (CNS) efficacy in the treatment of ALK-positive non-small-cell lung cancer (NSCLC). We investigated alectinib as compared with crizotinib in patients with previously untreated, advanced ALK-positive NSCLC, including those with asymptomatic CNS disease. Methods In a randomized, open-label, phase 3 trial, we randomly assigned 303 patients with previously untreated, advanced ALK-positive NSCLC to receive either alectinib (600 mg twice daily) or crizotinib (250 mg twice daily). The primary end point was investigator-assessed progression-free survival. Secondary end points were independent review committee-assessed progression-free survival, time to CNS progression, objective response rate, and overall survival. Results During a median follow-up of 17.6 months (crizotinib) and 18.6 months (alectinib), an event of disease progression or death occurred in 62 of 152 patients (41%) in the alectinib group and 102 of 151 patients (68%) in the crizotinib group. The rate of investigator-assessed progression-free survival was significantly higher with alectinib than with crizotinib (12-month event-free survival rate, 68.4% [95% confidence interval (CI), 61.0 to 75.9] with alectinib vs. 48.7% [95% CI, 40.4 to 56.9] with crizotinib; hazard ratio for disease progression or death, 0.47 [95% CI, 0.34 to 0.65]; P<0.001); the median progression-free survival with alectinib was not reached. The results for independent review committee-assessed progression-free survival were consistent with those for the primary end point. A total of 18 patients (12%) in the alectinib group had an event of CNS progression, as compared with 68 patients (45%) in the crizotinib group (cause-specific hazard ratio, 0.16; 95% CI, 0.10 to 0.28; P<0.001). A response occurred in 126 patients in the alectinib group (response rate, 82.9%; 95% CI, 76.0 to 88.5) and in 114 patients in the crizotinib group (response rate, 75.5%; 95% CI, 67.8 to 82.1) (P=0.09). Grade 3 to 5 adverse events were less frequent with alectinib (41% vs. 50% with crizotinib). Conclusions As compared with crizotinib, alectinib showed superior efficacy and lower toxicity in primary treatment of ALK-positive NSCLC. (Funded by F. Hoffmann-La Roche; ALEX ClinicalTrials.gov number, NCT02075840 .).
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                Author and article information

                Contributors
                kohei.otsubo@gmail.com
                Journal
                Cancer Sci
                Cancer Sci
                10.1111/(ISSN)1349-7006
                CAS
                Cancer Science
                John Wiley and Sons Inc. (Hoboken )
                1347-9032
                1349-7006
                07 November 2021
                January 2022
                : 113
                : 1 ( doiID: 10.1111/cas.v113.1 )
                : 221-228
                Affiliations
                [ 1 ] Department of Respiratory Medicine Kumamoto University Hospital Kumamoto Japan
                [ 2 ] Department of Respiratory Medicine Kitakyushu Municipal Medical Center Kitakyushu, Fukuoka Japan
                [ 3 ] Department of Medical Statistics Osaka City University Graduate School of Medicine Osaka Japan
                [ 4 ] Respiratory Center Matsusaka Municipal Hospital Matsusaka, Mie Japan
                [ 5 ] Department of Pulmonary Medicine Sendai Kousei Hospital Sendai, Miyagi Japan
                [ 6 ] Internal Medicine III Wakayama Medical University Wakayama Japan
                [ 7 ] Department of Respiratory Medicine Juntendo University Tokyo Japan
                [ 8 ] Research Institute for Diseases of the Chest Graduate School of Medical Sciences Kyushu University Fukuoka Japan
                [ 9 ] Department of Medical Oncology Faculty of Medicine Kindai University Osaka‐Sayama, Osaka Japan
                [ 10 ] Thoracic Oncology Osaka International Cancer Institute Osaka Japan
                [ 11 ] Department of Respiratory Medicine Kanagawa Cardiovascular and Respiratory Center Yokohama, Kanagawa Japan
                [ 12 ] Department of Internal Medicine Niigata Cancer Center Hospital Niigata Japan
                [ 13 ] Division of Thoracic Oncology Shizuoka Cancer Center Shizuoka Japan
                [ 14 ] Department of Thoracic Oncology Kansai Medical University Hospital Hirakata, Osaka Japan
                [ 15 ] Department of Medical Oncology Kobe Minimally Invasive Cancer Center Kobe, Hyogo Japan
                Author notes
                [*] [* ] Correspondence

                Kohei Otsubo, MD, PhD, Department of Respiratory Medicine, Kitakyushu Municipal Medical Center, 2‐1‐1, Bashaku, Kokurakita‐ku, Kitakyushu, Fukuoka, 802‐0077, Japan.

                Email: kohei.otsubo@ 123456gmail.com

                Author information
                https://orcid.org/0000-0002-9476-8840
                https://orcid.org/0000-0001-5461-9894
                https://orcid.org/0000-0002-1767-6854
                https://orcid.org/0000-0001-7868-6661
                https://orcid.org/0000-0001-7724-0481
                Article
                CAS15176
                10.1111/cas.15176
                8748216
                34704312
                776988be-781c-47dc-b8a2-3a2b70b26f70
                © 2021 The Authors. Cancer Science published by John Wiley & Sons Australia, Ltd on behalf of Japanese Cancer Association.

                This is an open access article under the terms of the http://creativecommons.org/licenses/by-nc/4.0/ License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited and is not used for commercial purposes.

                History
                : 12 October 2021
                : 20 August 2021
                : 15 October 2021
                Page count
                Figures: 3, Tables: 4, Pages: 8, Words: 5320
                Funding
                Funded by: Thermo Fisher Scientific, Life Technologies Japan
                Categories
                Original Article
                Original Articles
                Clinical Research
                Custom metadata
                2.0
                January 2022
                Converter:WILEY_ML3GV2_TO_JATSPMC version:6.7.0 mode:remove_FC converted:10.01.2022

                Oncology & Radiotherapy
                next‐generation sequencing gene panel,non‐small‐cell lung cancer,oncomine dx,turnaround time

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