Evidence map›Paper›PMID 29442179›Full record

ArticleMedical oncology (Northwood, London, England)2018

Efficacy and safety of nilotinib therapy in patients with newly diagnosed chronic myeloid leukemia in the chronic phase.

Michihide Tokuhira, Yuta Kimura, Keiji Sugimoto, Tomonori Nakazato, Maho Ishikawa, Isao Fujioka, Tomoiku Takaku, Noriyoshi Iriyama, Eriko Sato, Hiroyuki Fujita and 5 more

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Article in Medical oncology (Northwood, London, England), 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed
–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

10 citing papers in PubMed.

  1. Trial
  2. Article
  3. Dose Optimization of Tyrosine Kinase Inhibitors for Chronic Myeloid Leukemia.Clinical pharmacology : advances and applications · 2025
    Review
  4. Evaluation of real-world versus clinical trial outcomes of tyrosine kinase inhibitor therapy for chronic myeloid leukemia.Journal of oncology pharmacy practice : official publication of the International Society of Oncology Pharmacy Practitioners · 2024
    Review
  5. Article
  6. Article
  7. Article
  8. Article
  9. Observational
  10. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

15 authors.

Michihide TokuhiraDepartment of Hematology, Saitama Medical Center, Saitama Medical University, 1981 Kamoda, Kawagoe, Saitama, 350-8550, Japan. tokuhira@saitama-med.ac.jp.ORCID http://orcid.org/0000-0003-3780-5331
Yuta KimuraDepartment of Hematology, Saitama Medical Center, Saitama Medical University, 1981 Kamoda, Kawagoe, Saitama, 350-8550, Japan.
Keiji SugimotoDepartment of Hematology, Juntendo University Urayasu Hospital, Urayasu, Japan.
Tomonori NakazatoDepartment of Hematology, Yokohama Municipal Citizen's Hospital, Yokohama, Japan.
Maho IshikawaDepartment of Hemato-Oncology, Comprehensive Cancer Center, Saitama International Medical Center, Saitama Medical University, Saitama, Japan.
Isao FujiokaDepartment of Hematology, Juntendo University School of Medicine, Tokyo, Japan.
Tomoiku TakakuDepartment of Hematology, Juntendo University School of Medicine, Tokyo, Japan.
Noriyoshi IriyamaDivision of Hematology and Rheumatology, Department of Medicine, Nihon University School of Medicine, Tokyo, Japan.
Eriko SatoDivision of Hematology, Department of Medicine, Juntendo University Nerima Hospital, Tokyo, Japan.
Hiroyuki FujitaDepartment of Hematology, Saiseikai Yokohama Nanbu Hospital, Yokohama, Japan.
Yoshihiro HattaDivision of Hematology and Rheumatology, Department of Medicine, Nihon University School of Medicine, Tokyo, Japan.
Norio KomatsuDepartment of Hematology, Juntendo University School of Medicine, Tokyo, Japan.
Norio AsouDepartment of Hemato-Oncology, Comprehensive Cancer Center, Saitama International Medical Center, Saitama Medical University, Saitama, Japan.
Masahiro KizakiDepartment of Hematology, Saitama Medical Center, Saitama Medical University, 1981 Kamoda, Kawagoe, Saitama, 350-8550, Japan.
Tatsuya KawaguchiDepartment of Hematology and Infectious Diseases, Kumamoto University Hospital, Kumamoto, Japan.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

ABL1-tyrosine kinase inhibitors (TKIs) have led to dramatic changes in treatment strategies for chronic myeloid leukemia in the chronic phase (CML-CP). However, clinical studies have highlighted increasing numbers of adverse events (AE) with TKIs. Although TKI modification plays a key role in AE management, this process is poorly understood, particularly in terms of the TKI nilotinib. In the present study, we retrospectively analyzed the records of 70 patients with newly diagnosed (ND)-CML-CP who were treated with nilotinib to investigate the drug potency of nilotinib and treatment management. During a median observation period of 3.4 years, 76% of patients continued nilotinib as a first-line treatment. The 1-year and overall major molecular response (MMR) rates and the overall molecular response (MR) 4.5 rate for all patients receiving first-line nilotinib therapy were 70, 84.2, and 50%, respectively. No case progressed to the accelerated or blast phase during the study. To avoid AEs during the early phase, nilotinib doses were reduced to < 600 mg/day in a third of patients (Reduced group); these patients experienced better therapeutic efficacy and a lower rate of AEs relative to those in Standard group (300 mg twice daily). Ten patients who received < 600 mg/day of nilotinib throughout the study had a 1-year MMR rate and overall MR4.5 rate of 90 and 60%, respectively. In summary, our findings indicate that careful management, including dose reduction, can yield better outcomes in patients with ND-CML-CP.

Indexed as

Antineoplastic AgentsFemaleFollow-Up StudiesHumansLeukemia, Myelogenous, Chronic, BCR-ABL PositiveMaleMiddle AgedPrognosisPyrimidinesRetrospective StudiesSurvival RateAntineoplastic AgentsnilotinibPyrimidinesChronic myeloid leukemiaChronic phaseDose modificationNilotinibReal world

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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.