Evidence map›Paper›PMID 30421023›Full record

Trial reportInternational journal of clinical oncology2019

Feasibility of the imatinib stop study in the Japanese clinical setting: delightedly overcome CML expert stop TKI trial (DOMEST Trial).

Shin Fujisawa, Yasunori Ueda, Kensuke Usuki, Hajime Kobayashi, Eisei Kondo, Noriko Doki, Takafumi Nakao, Yoshinobu Kanda, Nobuharu Kosugi, Hiroshi Kosugi and 22 more

Abstract readClinical Trial, Phase IIMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in International journal of clinical oncology, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 21 papers.

0numbers the graph read from it
0cells of the map it votes in
21citing 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

21 citing papers in PubMed.

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  8. Treatment-Free Remission in Chronic Myeloid Leukemia.Journal of clinical medicine · 2024
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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

32 authors.

Shin FujisawaDepartment of Hematology, Yokohama City University Medical Center, Yokohama, Japan.
Yasunori UedaDepartment of Hematology/Oncology, Kurashiki Central Hospital, Kurashiki, Japan.
Kensuke UsukiDepartment of Hematology, NTT Medical Center, Tokyo, Japan.
Hajime KobayashiDepartment of Hematology, Obihiro Kosei Hospital, Obihiro, Japan.
Eisei KondoDepartment of General Medicine, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences, Okayama, Japan.
Noriko DokiHematology Division, Tokyo Metropolitan Cancer and Infectious Diseases Center, Komagome Hospital, Tokyo, Japan.
Takafumi NakaoDepartment of Hematology, Osaka City General Hospital, Osaka, Japan.
Yoshinobu KandaDepartment of Hematology, Saitama Medical Center, Jichi Medical University, Saitama, Japan.
Nobuharu KosugiDepartment of Hematology, Numazu City Hospital, Numazu, Japan.
Hiroshi KosugiDepartment of Hematology, Ogaki Municipal Hospital, Ogaki, Japan.
Takashi KumagaiDepartment of Hematology, Ome Municipal General Hospital, Ome, Japan.
Hiroshi HaradaDivision of Hematology, Department of Medicine, Showa University Fujigaoka Hospital, Yokohama, Japan.
Masato ShikamiDepartment of Hematology, Daiyukai General Hospital, Ichinomiya, Japan.
Yasuhiro MaedaDepartment of Hematology, National Hospital Organization Osaka Minami Medical Center, Osaka, Japan.
Toru SakuraDepartment of Hematology, Saiseikai Maebashi Hospital, Maebashi, Japan.
Koiti InokuchiDepartment of Hematology, Nippon Medical School, Tokyo, Japan.
Akio SaitoDepartment of Hematology, Fujioka General Hospital, Fujioka, Japan.
Yuichiro NawaDepartment of Hematology, Ehime Prefectural Central Hospital, Matsuyama, Japan.
Masahiro OgasawaraDepartment of Hematology, Sapporo Hokuyu Hospital, Sapporo, Japan.
Junji NishidaDivision of Hematology, Saitama Medical Center, Jichi Medical University, Saitama, Japan.
Takeshi KondoDepartment of Hematology, Hokkaido University Hospital, Sapporo, Japan.
Chikashi YoshidaDepartment of Hematology, National Hospital Organization Mito Medical Center, Mito, Japan.
Hiroyuki KurodaDepartment of Gastroenterology and Hematology/Clinical Oncology, Steel Muroran Memorial Hospital, Muroran, Japan.
Yoko TabeDepartment of Next Generation Hematology Laboratory Medicine, Juntendo University Faculty of Medicine, Tokyo, Japan.
Yoshinobu MaedaDepartment of Hematology and Oncology, Okayama University Hospital, Okayama, Japan.
Kenji ImajoDepartment of Internal Medicine, Okayama Municipal Hospital, Okayama, Japan.
Kensuke KojimaDivision of Hematology, Respiratory Medicine and Oncology, Department of Internal Medicine, Faculty of Medicine, Saga University, Saga, Japan.
Satoshi MoritaDepartment of Biomedical Statistics and Bioinformatics, Kyoto University Graduate School of Medicine, Kyoto, Japan.
Sho KomukaiDivision of Biomedical Statistics, Department of Integrated Medicine, Graduate School of Medicine, Osaka University, Osaka, Japan.
Atsushi KawaguchiDivision of Biomedical Statistics, Department of Integrated Medicine, Graduate School of Medicine, Osaka University, Osaka, Japan.
Junichi SakamotoTokai Central Hospital, Kakamigahara, Japan.
Shinya KimuraDivision of Hematology, Respiratory Medicine and Oncology, Department of Internal Medicine, Faculty of Medicine, Saga University, Saga, Japan. shkimu@cc.saga-u.ac.jp.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundTreatment-free remission (TFR), the ability to maintain a molecular response (MR), occurs in approximately 50% of patients with chronic myelogenous leukemia (CML) treated with tyrosine kinase inhibitors (TKIs).

methodsA multicenter phase 2 trial (Delightedly Overcome CML Expert Stop TKI Trial: DOMEST Trial) was conducted to test the safety and efficacy of discontinuing imatinib. Patients with CML with a sustained MR of 4.0 or MR4.0-equivalent for at least 2 years and confirmed MR4.0 at the beginning of the study were enrolled. In the TFR phase, the international scale (IS) was regularly monitored by IS-PCR testing. Molecular recurrence was defined as the loss of MR4.0. Recurrent patients were immediately treated with dasatinib or other TKIs including imatinib.

resultsOf 110 enrolled patients, 99 were evaluable. The median time from diagnosis to discontinuation of imatinib was 103 months, and the median duration of imatinib therapy was 100 months. Molecular recurrence-free survival rates were 69.6%, 68.6% and 64.3% at 6, 12, and 24 months, respectively. After discontinuation of imatinib therapy, 26 patients showed molecular recurrence, and 25 re-achieved deep MR after dasatinib treatment. Molecular response MR4.0 was achieved in 23 patients within 6 months and 25 patients within 12 months. Multivariate analysis revealed that a longer time from diagnosis to discontinuation of imatinib therapy (p = 0.0002) and long duration of imatinib therapy (p = 0.0029) predicted a favorable prognosis.

conclusionsThis DOMEST Trial showed the feasibility of TKI discontinuation in a Japanese clinical setting.

Indexed as

AdultAgedAged, 80 and overAntineoplastic AgentsDasatinibFemaleHumansImatinib MesylateJapanLeukemia, Myelogenous, Chronic, BCR-ABL PositiveMaleMiddle AgedNeoplasm Recurrence, LocalProtein Kinase InhibitorsTime FactorsTreatment OutcomeAntineoplastic AgentsDasatinibImatinib MesylateProtein Kinase InhibitorsChronic myelogenous leukemiaDeep molecular responseImatinibMolecular recurrence-free survivalTreatment-free remission

Identifiers

PMID30421023
PMCPMC6438937

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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.