Evidence map›Paper›PMID 26686407›Full record

Trial reportThe Lancet. Haematology2015

Discontinuation of dasatinib in patients with chronic myeloid leukaemia who have maintained deep molecular response for longer than 1 year (DADI trial): a multicentre phase 2 trial.

Jun Imagawa, Hideo Tanaka, Masaya Okada, Hirohisa Nakamae, Masayuki Hino, Kazunori Murai, Yoji Ishida, Takashi Kumagai, Seiichi Sato, Kazuteru Ohashi and 17 more

Registry-linked trialAbstract readClinical Trial, Phase IIMulticenter Study
PubMed Publisher
In one paragraph

Trial report in The Lancet. Haematology, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04043676 (Multicenter, Open-Label, Single Arm, Phase II Exploratory Study to Evaluate the Effect of a One-Year Consolidation Treatment With Ponatinib 15 mg on Treatment Free-Remission Rate in Patients With Philadelphia-Positive Chronic Myeloid Leukemia, Who Had Previously Achieved a Deep Molecular Response With Imatinib), which is not on this map. Cited by 177 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
177citing papers in PubMed, 2 pooled it
22.7field-weighted citation impact, top 1% of its field
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.

NCT04043676 phase2unknown statusnot on this mapstarted 2019, after this paper: background citation

Multicenter, Open-Label, Single Arm, Phase II Exploratory Study to Evaluate the Effect of a One-Year Consolidation Treatment With Ponatinib 15 mg on Treatment Free-Remission Rate in Patients With Philadelphia-Positive Chronic Myeloid Leukemia, Who Had Previously Achieved a Deep Molecular Response With Imatinib

TypeinterventionalSponsorFundación Teófilo Hernando, SpainRan2019 to 2023Enrolled40ConditionsChronic Myeloid LeukemiaArmsPonatinib
3 · Its place in the literature

Who cites it

177 citing papers in PubMed, 2 syntheses or guidelines pooled it, 300 citations in OpenAlex.

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117 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

27 authors at 20 institutions in 1 country.

Jun ImagawaDepartment of Haematology and Oncology, Research Institute for Radiation Biology and Medicine, Hiroshima University, Hiroshima, Japan.
Hideo TanakaDepartment of Haematology, Hiroshima City Asa Hospital, Hiroshima, Japan.
Masaya OkadaDivision of Haematology, Department of Internal Medicine, Hyogo College of Medicine, Nishinomiya, Japan.
Hirohisa NakamaeDepartment of Haematology, Graduate School of Medicine, Osaka City University, Osaka, Japan.
Masayuki HinoDepartment of Haematology and Oncology, Iwate Medical University, Morioka, Japan.
Kazunori MuraiDepartment of Haematology and Oncology, Iwate Medical University, Morioka, Japan.
Yoji IshidaDepartment of Haematology and Oncology, Iwate Medical University, Morioka, Japan.
Takashi KumagaiDepartment of Haematology, Ohme Municipal General Hospital, Tokyo, Japan.
Seiichi SatoDepartment of Internal Medicine, Fujimoto Sogo Hospital, Miyakonojo, Japan.
Kazuteru OhashiHaematology Division, Tokyo Metropolitan Cancer and Infectious Diseases Centre Komagome Hospital, Tokyo, Japan.
Hisashi SakamakiHaematology Division, Tokyo Metropolitan Cancer and Infectious Diseases Centre Komagome Hospital, Tokyo, Japan.
Hisashi WakitaDivision of Haematology and Oncology, Japanese Red Cross Narita Hospital, Narita, Japan.
Nobuhiko UoshimaDepartment of Haematology, Matsushita Memorial Hospital, Moriguchi, Osaka, Japan.
Yasunori NakagawaDepartment of Haematology, Japanese Red Cross Medical Centre, Tokyo, Japan.
Yosuke MinamiDivision of Blood Transfusion and Division of Medical Oncology and Haematology, Kobe University Hospital, Kobe, Japan.
Masahiro OgasawaraDepartment of Haematology, Sapporo Hokuyu Hospital, Sapporo, Japan.
Tomoharu TakeokaDivision of Haematology and Immunology, Otsu Red Cross Hospital, Otsu, Japan.
Hiroshi AkasakaDepartment of Haematology, Shinko Hospital, Kobe, Japan.
Takahiko UtsumiDepartment of Haematology, Shiga Medical Centre for Adults, Moriyama, Japan.
Naokuni UikeDivision of Haematology, National Kyushu Cancer Centre, National Hospital Organisation, Fukuoka, Japan.
Tsutomu SatoFourth Department of Internal Medicine, Sapporo Medical, University School of Medicine, Sapporo, Japan.
Sachiko AndoDepartment of Haematology, Teine Keijinkai Hospital, Sapporo, Japan.
Kensuke UsukiDivision of Haematology, NTT Medical Centre Tokyo, Tokyo, Japan.
Satoshi MoritaDepartment of Biomedical Statistics and Bioinformatics, Kyoto University Graduate School of Medicine, Kyoto, Japan.
Junichi SakamotoNPO Epidemiological and Clinical Research Information Network (ECRIN), Okazaki, Japan.
Shinya KimuraDivision of Haematology, Respiratory Medicine and Oncology, Department of Internal Medicine, Faculty of Medicine, Saga University, Saga, Japan. Electronic address: shkimu@cc.saga-u.ac.jp.
DADI Trial Group
Iwate Medical University · JPTokyo Metropolitan Komagome Hospital · JPHiroshima City Asa Citizens Hospital · JPHiroshima University · JPHyogo Medical University · JPJapanese Red Cross Medical Center · JPJapanese Red Cross Narita Hospital · JPKobe University Hospital · JPKyoto University · JPMatsushita Memorial Hospital · JPNational Hospital Organization Kyushu Cancer Center · JPNTT Medical Center · JPOme Municipal General Hospital · JPOsaka City University · JPOtsu Red Cross Hospital · JPSaga University · JPSapporo Hokuyu Hospital · JPSapporo Medical University · JPShiga Medical Center for Adults · JPShinko Hospital · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundFirst-line imatinib treatment can be successfully discontinued in patients with chronic myeloid leukaemia after deep molecular response has been sustained for at least 2 years. We investigated the safety and efficacy of discontinuing second-line or subsequent dasatinib after at least 1 year of deep molecular response.

methodsThe Dasatinib Discontinuation trial was a prospective multicentre trial done in Japan. Eligible patients taking dasatinib and with confirmed stable deep molecular response were enrolled between April 1, 2011, and March 31, 2012. All patients received dasatinib consolidation therapy for at least 1 year. In those with sustained deep molecular response, dasatinib was discontinued. Patients were followed up every month in year 1 (clinical cutoff), every 3 months in year 2, and every 6 months in year 3 for deep molecular response and immunological profiles. The primary endpoint was the proportion of patients with treatment-free remission at 6 months after discontinuation. Molecular relapse was defined as loss of deep molecular response at any assessment. This study is registered, number UMIN000005130.

findings88 patients were enrolled in the consolidation phase, 24 were excluded from the discontinuation phase due to fluctuations in BCR-ABL1 transcript levels. One patient was excluded because of positive expression of major and minor BCR-ABL1 transcripts in chronic myeloid leukaemia cells and the detection of minor BCR-ABL1 transcripts during consolidation. Thus, 63 patients discontinued dasatinib treatment. The 25 patients who were excluded from discontinuation continued to receive dasatinib and none showed disease progression. Median follow-up was 20.0 months (IQR 16.5-24.0). Of the 63 patients who discontinued and were not excluded, 30 patients maintained deep molecular response while 33 patients had molecular relapses, all within the first 7 months after discontinuation. The estimated overall treatment-free remission was 49% (95% CI 36-61) at 6 months. No severe treatment-related toxic effects were seen. Treatment was restarted in the 33 patients with relapse; rapid molecular responses were seen in all 33 patients, of whom 29 (88%) regained deep molecular response within 3 months, as did the remaining four by 6 months.

interpretationDasatinib discontinuation after sustained deep molecular response for more than 1 year is feasible.

fundingEpidemiological and Clinical Research Information Network (ECRIN).

Indexed as

AdultAgedAged, 80 and overAntineoplastic AgentsDasatinibFemaleHumansJapanLeukemia, Myelogenous, Chronic, BCR-ABL PositiveMaleMiddle AgedNeoplasm Recurrence, LocalProspective StudiesRemission InductionTreatment OutcomeYoung AdultAntineoplastic AgentsDasatinib

Identifiers

PMID26686407
OpenAlexW2189113171

What OpenQuestion holds

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Registered trials

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.