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Poster display session

2350 - A large prospective cohort study of the clinical features of advanced lung cancer harboring HER2 aberrations (HER2-CS STUDY).


09 Sep 2017


Poster display session


Cancers in Adolescents and Young Adults (AYA);  Non-Small Cell Lung Cancer


Tae Tanaka


Annals of Oncology (2017) 28 (suppl_5): v460-v496. 10.1093/annonc/mdx380


T. Tanaka1, H. Yoshioka1, A. Bessho2, N. Ishikawa3, M. Yamasaki4, T. Shibayama5, K. Aoe6, T. Kozuki7, N. Fujimoto8, K. Genba9, Y. Ueda10, M. Inoue11, T. Murakami12, S. Kuyama13, H. Kawai14, K. Fujitaka15, K. Inoue16, M. Takata17, H. Yanai18, K. Kiura19

Author affiliations

  • 1 Respiratory Medicine, Kurashiki Central Hospital, 710-8602 - Kurashiki/JP
  • 2 Respiratory Medicine, Japanese Red Cross Okayama Hospital, 700-0491 - Okayama/JP
  • 3 Respiratory Medicine, Hiroshima Prefectural Hospital, Hiroshima/JP
  • 4 Respiratory Medicine, Hiroshima Red Cross Hospital and Atomic-bomb Survivors Hospital, Hiroshima/JP
  • 5 Respiratory Medicine, NHO Okayama Medical Center, Okayama/JP
  • 6 Respiratory Medicine, Yamaguchi-Ube Medical Center, Ube/JP
  • 7 Respiratory Medicine, NHO Shikoku Cancer Center, Matsuyama/JP
  • 8 Medical Oncology, Okayama Rosai Hospital, Okayama/JP
  • 9 Medical Oncology, Chugoku Central Hospital, Fukuyama/JP
  • 10 Respiratory Medicine, Kagawa Prefectural Central Hospital, Takamatsu/JP
  • 11 Thoracic Surgery, Shimonoseki City Hospital, Shimonoseki/JP
  • 12 Respiratory Medicine, Japanese Red Cross Society Himeji Hospital, Himeji/JP
  • 13 Respiratory Medicine, Iwakuni Medical Center, Iwakuni/JP
  • 14 Respiratory Medicine, Okayama Saiseikai General Hospital, Okayama/JP
  • 15 Respiratory Internal Medicine, Hiroshima University, 734-8551 - Hiroshima/JP
  • 16 Respiratory Medicine, Ehime Prefectural Central Hospital, Matsuyama/JP
  • 17 Department Of Late Effects Studies, Radiation Biology Center, Kyoto University, Kyoto/JP
  • 18 Diagnostic Pathology, Okayama University Hospital, Okayama/JP
  • 19 Respiratory Medicine, Okayama University Hospital, Okayama/JP


Abstract 2350


HER2 is a potential driver oncogene. HER2-targeted precision therapy has been tested in NSCLC. However, the demographics of HER2-positive NSCLC have not been defined systematically.


Pts with advanced NSCLC were registered. HER2-IHC and FISH assays were performed with commercial kits. HER2 mutations were identified by the direct sequencing. The aim of this study was to clarify the frequency, characteristics and outcome of HER2-positive NSCLC.


Of 1,126 tumors screened (Table A), 34 (3.0%) were IHC3+, and 34 (3.0%) were IHC2+/FISH+. Among the 724 EGFR wild-type tumors, 21 (2.9%) were HER2-mutant tumors, including A775_G776insYVMA (n = 15). Interestingly, the IHC3+ tumors and mutant tumors were entirely exclusive. Female pts had HER2 mutant tumors more frequently, while IHC/FISH+ tumors were detected more often in males (Table B). HER2-positive tumors had similar survival outcome to triple negative tumors, but significantly worse prognoses than EGFR-mutant and ALK-positive tumors (p 


This is the first prospective study showing a small fraction of NSCLC possessed HER2 aberrations. HER2-positive tumors had relatively poor prognosis. NSCLCs with HER2 IHC3+ and mutation seemed to be distinct subsets.

Clinical trial identification

UMIN registration number 000017003

Legal entity responsible for the study

HER2-CS Network


Japan Agency for Medical Research and Development


H. Yoshioka: Honoraria: Eli Lilly, Chugai Pharma., Boehringer Ingelheim, Taiho Pharmaceutical, Pfizer, AstraZeneca, Bristol-Myers Squibb, Ono Pharmaceutical, Takeda Pharma. T. Shibayama: Honoraria: Meiji Seika Pharma Co., Ltd. Astra Zeneca K.K. Boehringer Ingelheim Pharmaceuticals, Inc. Eli Lilly Japan K.K. K. Aoe: Eli Lilly, Astrazeneca, BMS, Ono Pharmaceutical Co., Ltd. T. Kozuki: Honoraria: Chugai Pharma., AstraZeneca, Eli lilly Japan, Pfizer, Ono Pharm., Bristol-Myers Squibb, Kyowa-Hakko Kirin, Boehringer Ingelheim. N. Fujimoto: Honoraria: Kissei Co. Ltd. S. Kuyama: Honoraria: Chugai Pharma., AstraZeneca, Pfizer, Ono Pharm., Boehringer Ingelheim, Meiji Seika Pharma. H. Yanai: Honoraria: Bayer Yakuhin, Ltd, Janssen Pharmaceutical K.K., Kyowa Hakko Kirin Co., Ltd., Becton, Dickinson and Company, Fujiyakuhin Co., Ltd. K. Kiura: Honoraria: Chugai Pharmaceutical Co., Ltd. Pfizer Japan Inc. Novartis Pharma K.K. Taiho Pharmceutical Co., Ltd. Eli Lilly Japan K.K. All other authors have declared no conflicts of interest.

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