International Journal of Clinical Oncology

, Volume 17, Issue 6, pp 584–589 | Cite as

Harmonization of molecular monitoring of chronic myeloid leukemia therapy in Japan

  • Chikashi YoshidaEmail author
  • Linda Fletcher
  • Kazuteru Ohashi
  • Hisashi Wakita
  • Takashi Kumagai
  • Masayuki Shiseki
  • Kousei Matsuei
  • Koiti Inokuchi
  • Yoshihiro Hatta
  • Yukari Shirasugi
  • Toshikazu Yamaguchi
  • Junichi Sakamoto
  • Susan Branford
  • Hisashi Sakamaki
Original Article



Real-time quantitative polymerase chain reaction (RQ-PCR) has been widely used for molecular monitoring for patients with chronic myeloid leukemia (CML). Currently, RQ-PCR is not based on the concept of international scale (IS) in Japan; mainly because none of the domestic laboratories have obtained their own conversion factor (CF) which makes it possible to convert locally scaled BCR-ABL (BCR-ABL L) value to the IS (BCR-ABL IS). To join the global trend of molecular assessment of BCR-ABL in CML patients, we have tried to obtain a CF in Japan.


Samples from 55 patients were exchanged between the Japanese laboratory and the reference laboratory in Adelaide, and BCR-ABL and internal control gene transcripts of the samples were measured using RQ-PCR. The patient bias conversion method was used to determine the CF for the IS using the Bland and Altman method.


The local CF in the Japanese laboratory was determined to be 0.87. Based on this CF, 0.1% BCR-ABL IS, defined as major molecular response, becomes equivalent to 731 copy/μg RNA BCR-ABL L.


This study is the first to introduce a laboratory-specific CF for harmonizing RQ-PCR methodology for detecting BCR-ABL transcripts to Japan, which may open new windows for molecular assessment of CML patients in Japan.


Chronic myeloid leukemia BCR-ABL Real-time quantitative PCR International scale Conversion factor 



This study was supported by the Epidemiological and Clinical Research Information Network (ECRIN). The following investigators in the Kanto CML study group participated in this study: Nobuyuki Aotsuka (Japanese Red Cross Soc., Narita Red Cross Hospital), Yokitaka Katsura (National Hospital Organization Mito Medical Center), Toshiko Motoji (Tokyo Women’s Medical University Hospital), Kentaro Yoshinaga (Tokyo Women’s Medical University Hospital), Masayuki Yamakura (Kameda General Hospital), Masami Takeuchi (Kameda General Hospital), Atsushi Wake (Toranomon Hospital), Hiroaki Tanaka (Oami Hospital), Naoshi Obara (University of Tsukuba), and Akihiro Nakajima (Tokyo Medical University Hachioji Medical Center).

Conflict of interest

Susan Branford received honoraria and research funding from Bristol Myers Squibb and Novartis. Chikashi Yoshida, Linda Fletcher, Kazuteru Ohashi, Hisashi Wakita, Takashi Kumagai, Masayuki Shiseki, Kousei Matsuei, Koiti Inokutchi, Yoshihiro Hatta, Yukari Shirasugi, Toshikazu Yamaguchi, Junichi Sakamoto, and Hisashi Sakamaki have no conflict of interest.


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Copyright information

© Japan Society of Clinical Oncology 2011

Authors and Affiliations

  • Chikashi Yoshida
    • 1
    Email author
  • Linda Fletcher
    • 2
  • Kazuteru Ohashi
    • 3
  • Hisashi Wakita
    • 4
  • Takashi Kumagai
    • 5
  • Masayuki Shiseki
    • 6
  • Kousei Matsuei
    • 7
  • Koiti Inokuchi
    • 8
  • Yoshihiro Hatta
    • 9
  • Yukari Shirasugi
    • 10
  • Toshikazu Yamaguchi
    • 11
  • Junichi Sakamoto
    • 12
  • Susan Branford
    • 2
  • Hisashi Sakamaki
    • 3
  1. 1.Department of HematologyNational Hospital Organization Mito Medical CenterHigashiibarakigunJapan
  2. 2.SA Pathology and School of MedicineUniversity of AdelaideAdelaideAustralia
  3. 3.Hematology DivisionTokyo Metropolitan Cancer and Infectious Diseases Center, Komagome HospitalTokyoJapan
  4. 4.Division of Hematology and OncologyJapanese Red Cross Society, Narita Red Cross HospitalNaritaJapan
  5. 5.Department of HematologyOhme Municipal General HospitalTokyoJapan
  6. 6.Department of HematologyTokyo Women’s Medical University HospitalTokyoJapan
  7. 7.Division of Haematology/Oncology, Department of MedicineKameda General HospitalKamogawaJapan
  8. 8.Division of Hematology, Department of Internal MedicineNippon Medical SchoolTokyoJapan
  9. 9.Department of Hematology and RheumatologyNihon University School of MedicineTokyoJapan
  10. 10.Division of Hematology, Department of Internal MedicineTokai University School of MedicineIseharaJapan
  11. 11.Department of Special AnalysisBiomedical Laboratories, Inc.TokyoJapan
  12. 12.Graduate School of Medicine, Health and Community MedicineNagoya University Graduate School of MedicineNagoyaJapan

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