Evidence map›Paper›PMID 38747937›Full record

ArticleJapanese journal of clinical oncology2024

Real-world outcomes of ponatinib treatment in 724 patients with CML and Ph+ ALL: a post-marketing surveillance study with a special interest in arterial occlusive events in Japan.

Naoto Takahashi, Takeshi Kondo, Yuji Ikari, Yoshihiro Fukumoto, Kiyohiko Hatake, Akira Masunari, Seiji Nishibayashi, Akiko Kageyama, Yasuhiko Fukuta, Arinobu Tojo

Abstract read
In one paragraph

Article in Japanese journal of clinical oncology, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing 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

7 citing papers in PubMed.

  1. Article
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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

10 authors.

Naoto TakahashiDepartment of Hematology, Nephrology and Rheumatology, Akita University Graduate School of Medicine, Akita, Japan.
Takeshi KondoDepartment of Hematology, Blood Disorders Center, Aiiku Hospital, Sapporo, Japan.
Yuji IkariDepartment of Cardiology, Tokai University Hospital, Isehara, Japan.
Yoshihiro FukumotoDivision of Cardiovascular Medicine, Department of Internal Medicine, Kurume University School of Medicine, Kurume, Japan.
Kiyohiko HatakeDepartment of Lymphoma/Hematology Center, Mita Hospital, International University of Health and Welfare, Tokyo, Japan.
Akira MasunariOtsuka Pharmaceutical Co., Ltd, Tokyo.
Seiji NishibayashiOtsuka Pharmaceutical Co., Ltd, Tokyo.
Akiko KageyamaOtsuka Pharmaceutical Co., Ltd, Tokyo.
Yasuhiko FukutaOtsuka Pharmaceutical Co., Ltd, Tokyo.
Arinobu TojoTokyo Medical and Dental University, Tokyo, Japan.

Funding

Otsuka Pharmaceutical Co., Ltd.
6 · The paper itself

Abstract

backgroundIn September 2016, ponatinib was approved in Japan for the treatment of patients with chronic myeloid leukemia with resistance/intolerance to prior tyrosine kinase inhibitors and patients with relapsed or refractory Philadelphia chromosome-positive acute lymphoblastic leukemia.

methodsWe conducted a post-marketing all-case surveillance to study the safety and efficacy of ponatinib in clinical practice, focusing on arterial occlusive events.

resultsData from 724 patients were collected for 2 years from the initiation of ponatinib. The arterial occlusive events were reported in 6.49% (47/724) with an exposure-adjusted incidence rate of 6.8/100 person-years. The risks associated with arterial occlusive events were age and comorbidities including hypertension and diabetes. At 104 weeks, the cumulative major molecular response rate in patients with chronic-phase chronic myeloid leukemia was 67.2% and the complete cytogenetic response in patients with Philadelphia chromosome-positive acute lymphoblastic leukemia was 80.0%. Furthermore, the estimated 1-year overall survival rate was 98.5% for chronic-phase chronic myeloid leukemia and 68.6% for Philadelphia chromosome-positive acute lymphoblastic leukemia.

conclusionsThis surveillance demonstrated that ponatinib has a favorable safety and efficacy profile in Japanese patients and also showed the necessity of closely monitoring arterial occlusive events in older adults and patients with predisposing factors for atherosclerosis.

Indexed as

Arterial Occlusive DiseasesImidazolesLeukemia, Myelogenous, Chronic, BCR-ABL PositivePrecursor Cell Lymphoblastic Leukemia-LymphomaProduct Surveillance, PostmarketingPyridazinesAdolescentAdultAgedAged, 80 and overAntineoplastic AgentsFemaleHumansJapanMaleMiddle AgedAntineoplastic AgentsImidazolesponatinibPyridazinesacute lymphoblastic leukemiaarterial occlusive eventschronic myeloid leukemiaponatinibpost-marketing surveillance

Identifiers

PMID38747937
PMCPMC11322879

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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.