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Pilot evaluation of a HER2 testing in non-small-cell lung cancer
  1. Katsuyuki Hotta1,2,
  2. Hiroyuki Yanai3,
  3. Kadoaki Ohashi1,
  4. Kiichiro Ninomiya1,
  5. Hiromi Nakashima1,
  6. Hiroe Kayatani1,
  7. Minoru Takata4,
  8. Katsuyuki Kiura1
  1. 1 Department of Respiratory Medicine, Okayama University Hospital, Okayama, Japan
  2. 2 Center of Innovative Clinical Medicine, Okayama University Hospital, Okayama, Japan
  3. 3 Department of Pathology, Okayama University Hospital, Okayama, Japan
  4. 4 Laboratory of DNA Damage Signaling, Department of Late Effects Studies, Radiation Biology Center, Graduate School Biostudies, Kyoto University, Kyoto, Japan
  1. Correspondence to Dr Katsuyuki Hotta, Okayama University Hospital, Okayama, Japan; khotta{at}


Aims HER2-positivity pattern in the specimens of immunohistochemistry (IHC) and fluorescence in situ hybridisation (FISH) has been hardly reported in non-small-cell lung cancer (NSCLC).

Methods We evaluated the characteristics of HER2-positivity pattern in formalin-fixed paraffin-embedded samples using IHC and FISH in 15 patients enrolled in a larger prospective cohort study to survey a HER2-positive NSCLC.

Results As for the immunostaining pattern, most specimens (79%) demonstrated incomplete or mixed-typed membranous immunoreactivity with heterogeneity, resembling that observed in gastric cancer rather than breast cancer. Concordance between IHC-positivity and FISH-positivity was 87.5% according to the criteria for breast cancer scoring system. On application of the gastric cancer scoring system to the examined tumours, the IHC score increased in the seven (43.8%) specimens, and the concordance between IHC positivity and FISH positivity rose to 93.8%.

Conclusions In our pilot series, the pattern of IHC reactivity closely resembled that observed in gastric cancer rather than breast cancer.

Trial registration number 000017003.

  • lung
  • cancer
  • staining

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  • Handling editor Runjan Chetty.

  • Contributors All of the authors contributed to the writing of the protocol. KH, HY, KO and KN also took part in the trial design and trial set-up.

  • Funding This research received a specific grant from the Japan Agency for Medical Research and Development, which is funded by the Japanese government.

  • Competing interests KH has received grants and personal fees from AstraZeneca, grants and personal fees from Eli Lilly, grants and personal fees from Bristol-Myers Squibb, personal fees from MSD, personal fees from Ono Pharmaceutical, personal fees from Nippon Kayaku, personal fees from Taiho pharmaceutical, personal fees from Novartis, personal fees from Daiichi-Sankyo, personal fees from Kyorin, personal fees from Kyowa-Kirin, personal fees from Boehringer Ingelheim, grants from Astellas, and grants and personal fees from Chugai pharmaceutical outside the submitted work. KO has received a research grant from Novartis Pharmaceuticals Japan. KK has received honoraria from Eli Lilly Japan, Nihon Kayaku, AstraZeneca, Daiichi-Sankyo Pharmaceutical, Chugai Pharmaceutical, Taiho Pharmaceutical and Sanofi-Aventis.

  • Patient consent for publication Not required.

  • Provenance and peer review Not commissioned; externally peer reviewed.