International Journal of Clinical Oncology

, Volume 16, Issue 4, pp 335–344

The PCR-invader method (structure-specific 5′ nuclease-based method), a sensitive method for detecting EGFR gene mutations in lung cancer specimens; comparison with direct sequencing

  • Katsuhiko Naoki
  • Kenzo Soejima
  • Hiroaki Okamoto
  • Junko Hamamoto
  • Naoya Hida
  • Ichiro Nakachi
  • Hiroyuki Yasuda
  • Sohei Nakayama
  • Satoshi Yoda
  • Ryosuke Satomi
  • Shinnosuke Ikemura
  • Hideki Terai
  • Takashi Sato
  • Koshiro Watanabe
Original Article

DOI: 10.1007/s10147-011-0187-5

Cite this article as:
Naoki, K., Soejima, K., Okamoto, H. et al. Int J Clin Oncol (2011) 16: 335. doi:10.1007/s10147-011-0187-5

Abstract

Background

Several sensitive assays, including the PCR-invader method (structure-specific 5′ nuclease-based method), have been used to detect EGFR mutations in non-small-cell lung cancer (NSCLC). However, validation has not been reported. We assessed the detection rate of EGFR mutation by the PCR-invader method and direct sequencing using same clinical specimens.

Patients and methods

EGFR mutations were analyzed with the PCR-invader method and compared with direct sequencing using paraffin tissues and pleural and pericardial effusions from NSCLC patients. The relationships between the treatment responses and mutations were evaluated retrospectively.

Results

Fifty-four samples from 42 NSCLC patients were studied. EGFR mutations were identified in 52% of the patients and 52% of the samples with the PCR-invader method, but only in 43% of the patients and in 35% of the samples by direct sequencing. In the samples obtained from the same patients at different sites and different times, EGFR mutations were coincident in nine out of ten patients by the PCR-invader method but in six out of ten patients by direct sequencing. Seventeen patients with EGFR mutations were treated with gefitinib; the response rate (RR) and disease control rate (DCR) were 41 and 94%, and median treatment duration was more than 6 months. Seven EGFR mutation-negative patients were treated with gefitinib; the RR and DCR were 0 and 14%, and median treatment duration was 1 month.

Conclusion

The PCR-invader method was useful for detecting EGFR mutations in clinical lung cancer specimens and is more sensitive than direct sequencing.

Keywords

EGFR mutation Non-small-cell lung cancer PCR-invader method Direct sequencing Validation Gefitinib 

Copyright information

© Japan Society of Clinical Oncology 2011

Authors and Affiliations

  • Katsuhiko Naoki
    • 1
    • 2
  • Kenzo Soejima
    • 1
  • Hiroaki Okamoto
    • 3
  • Junko Hamamoto
    • 1
  • Naoya Hida
    • 3
  • Ichiro Nakachi
    • 1
  • Hiroyuki Yasuda
    • 1
  • Sohei Nakayama
    • 1
  • Satoshi Yoda
    • 1
  • Ryosuke Satomi
    • 1
  • Shinnosuke Ikemura
    • 1
  • Hideki Terai
    • 1
  • Takashi Sato
    • 1
  • Koshiro Watanabe
    • 3
  1. 1.Division of Pulmonary Medicine, Department of Internal MedicineKeio University School of MedicineTokyoJapan
  2. 2.Keio Cancer CenterKeio University School of MedicineTokyoJapan
  3. 3.Department of Pulmonary MedicineYokohama Municipal Citizen’s HospitalYokohamaJapan

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