Evidence map›Paper›PMID 38968156›Full record

Trial reportBlood advances2024

Nilotinib vs dasatinib in achieving MR4.5 for de novo chronic myeloid leukemia: the randomized JALSG CML212 study.

Itaru Matsumura, Shigeki Ohtake, Yoshiko Atsuta, Mio Kurata, Yosuke Minami, Naoto Takahashi, Chiaki Nakaseko, Noriyoshi Iriyama, Katsumichi Fujimaki, Kazuhiko Kakihana and 13 more

Abstract readRandomized Controlled TrialClinical Trial, Phase III
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Blood advances, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
13citing papers in PubMed, 2 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

13 citing papers in PubMed, 2 syntheses or guidelines pooled it.

  1. Pooled it
  2. Guideline
  3. Trial
  4. Article
  5. Article
  6. Road to treatment-free remission in chronic myeloid leukemia.International journal of hematology · 2026
    Review
  7. Review
  8. Review
  9. Review
  10. Article
  11. Article
  12. Review
  13. Review
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

23 authors.

Itaru MatsumuraDepartment of Hematology and Rheumatology, Kindai University Faculty of Medicine, Osaka, Japan.ORCID 0000-0003-2818-4270
Shigeki OhtakeKanazawa University, Kanazawa, Japan.ORCID 0000-0003-0112-6564
Yoshiko AtsutaJapanese Data Center for Hematopoietic Cell Transplantation, Nagakute, Japan.ORCID 0000-0003-4404-2870
Mio KurataJapanese Data Center for Hematopoietic Cell Transplantation, Nagakute, Japan.
Yosuke MinamiDepartment of Hematology, National Cancer Center Hospital East, Kashiwa, Japan.ORCID 0000-0003-0863-0739
Naoto TakahashiDepartment of Hematology, Nephrology, and Rheumatology, Akita University Graduate School of Medicine, Akita, Japan.ORCID 0000-0002-6758-3787
Chiaki NakasekoDepartment of Hematology, International University of Health and Welfare, Narita, Japan.ORCID 0000-0003-1175-226X
Noriyoshi IriyamaDivision of Hematology and Rheumatology, Department of Medicine, Nihon University School of Medicine, Tokyo, Japan.ORCID 0000-0001-9176-1988
Katsumichi FujimakiDepartment of Hematology, Fujisawa City Hospital, Fujisawa, Japan.
Kazuhiko KakihanaHematology Division, Tokyo Metropolitan Cancer and Infectious Diseases Center, Komagome Hospital, Tokyo, Japan.
Yoji OgasawaraDivision of Clinical Oncology and Hematology, Department of Internal Medicine, The Jikei University School of Medicine, Tokyo, Japan.
Takaaki OnoDepartment of Transfusion and Cell Therapy, Hamamatsu University School of Medicine, Hamamatsu, Japan.ORCID 0000-0003-3922-7432
Masaya OkadaDivision of Hematology, Department of Internal Medicine, Hyogo College of Medicine, Nishinomiya, Japan.
Tetsuzo TauchiShin-Yurigaoka General Hospital, Kawasaki City, Japan.
Toshihiro MiyamotoDepartment of Medicine and Biosystemic Science, Kyushu University Graduate School of Medical Science, Fukuoka, Japan.
Kazunori OhnishiShubun University, Ichinomiya, Japan.
Emiko SakaidaDepartment of Hematology, Chiba University Hospital, Chiba, Japan.ORCID 0000-0002-7254-1928
Shin FujisawaDepartment of Hematology, Yokohama City University Medical Center, Yokohama, Japan.ORCID 0000-0003-2028-0209
Yukio KobayashiInternational University of Health and Welfare, Mita Hospital, Tokyo, Japan.
Norio AsouDepartment of Hemato-Oncology, Saitama Medical University, International Medical Center, Saitama, Japan.
Tomoki NaoeNational Hospital Organization Nagoya Medical Center, Nagoya, Japan.
Hitoshi KiyoiDepartment of Hematology and Oncology, Nagoya University Graduate School of Medicine, Nagoya, Japan.ORCID 0000-0001-6382-9498
Yasushi MiyazakiDepartment of Hematology, Atomic Bomb Disease Institute, Nagasaki University, Nagasaki, Japan.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

abstractDeep molecular response (DMR) is a prerequite for treatment-free remission (TFR) in chronic myeloid leukemia in chronic phase (CML-CP). The JALSG (Japan Adult Leukemia Study Group) conducted a prospective randomized phase 3 CML212 study for de novo CML-CP to compare the cumulative achievement of molecular response 4.5 (MR4.5; international scale BCR::ABL1 ≤0.0032%) by 18 months between nilotinib and dasatinib treatment as a primary end point. A total of 454 patients were randomly assigned to the 300 mg nilotinib twice daily arm or to the 100 mg dasatinib daily arm (both n = 227). BCR::ABL1 messenger RNA levels were monitored every 3 months. Study treatment was stopped if the patients were judged as failure according to the European LekemiaNet 2009 criteria or showed intolerance. The cumulative achievement rates of MR4.5 by 18 months were 32.6% (95% confidence interval [CI], 26.5-39.1) in the nilotinib arm and 30.8% (95% CI, 24.9-37.3) in the dasatinib arm with no significant difference (P = .66). The cumulative achievement rates of early molecular response, complete cytogenetic response, and major molecular response by 12, 18, 24, and 36 months were almost the same between the 2 arms. There was no significant difference in progression-free survival (PFS) or overall survival (OS) between the 2 arms by log-rank tests (PFS, P = .58; OS, P = .64). These results suggest that nilotinib and dasatinib would be equally effective for patients with de novo CML-CP. This trial was registered in the University Hospital Medical Information Network Clinical Trials Registry as #UMIN000007909.

Indexed as

DasatinibLeukemia, Myelogenous, Chronic, BCR-ABL PositivePyrimidinesAdultAgedAged, 80 and overAntineoplastic AgentsFemaleFusion Proteins, bcr-ablHumansMaleMiddle AgedProtein Kinase InhibitorsTreatment OutcomeYoung AdultAntineoplastic AgentsDasatinibFusion Proteins, bcr-ablnilotinibProtein Kinase InhibitorsPyrimidines

Identifiers

PMID38968156
PMCPMC11493191

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.