Evidence map›Paper›PMID 33010107›Full record

Trial reportCancer science2020

Alectinib for relapsed or refractory anaplastic lymphoma kinase-positive anaplastic large cell lymphoma: An open-label phase II trial.

Reiji Fukano, Tetsuya Mori, Masahiro Sekimizu, Ilseung Choi, Akiko Kada, Akiko Moriya Saito, Ryuta Asada, Kengo Takeuchi, Takashi Terauchi, Ukihide Tateishi and 2 more

Open access · goldAbstract readClinical Trial, Phase II
In one paragraph

Trial report in Cancer science, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 62 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
62citing papers in PubMed, 2 pooled it
7.1field-weighted citation impact, top 2% 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.

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

62 citing papers in PubMed, 2 syntheses or guidelines pooled it, 94 citations in OpenAlex.

  1. Pooled it
  2. Treatment modalities of ALK-positive relapsed/refractory inflammatory myofibroblastic tumor of the brain and lungs in 7-year-old girl: case-based reviews.Child's nervous system : ChNS : official journal of the International Society for Pediatric Neurosurgery · 2023
    Pooled it
  3. Trial
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  5. Review
  6. Article
  7. Novel agents and therapeutic advances in T cell lymphoma.International journal of hematology · 2026
    Review
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  9. Article
  10. Article
  11. Review
  12. Article
  13. Review
  14. Article
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  20. Review

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

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

12 authors at 6 institutions in 1 country.

Reiji FukanoDepartment of Pediatrics, National Hospital Organization Kyushu Cancer Center, Fukuoka, Japan.ORCID https://orcid.org/0000-0002-4087-3426
Tetsuya MoriDepartment of Pediatrics, St. Marianna University School of Medicine Hospital, Kanagawa, Japan.
Masahiro SekimizuDepartment of Pediatrics, National Hospital Organization Nagoya Medical Center, Nagoya, Japan.
Ilseung ChoiDepartment of Hematology, National Hospital Organization Kyushu Cancer Center, Fukuoka, Japan.
Akiko KadaClinical Research Center, National Hospital Organization Nagoya Medical Center, Nagoya, Japan.
Akiko Moriya SaitoClinical Research Center, National Hospital Organization Nagoya Medical Center, Nagoya, Japan.
Ryuta AsadaInnovative and Clinical Research Promotion Center, Gifu University Hospital, Gifu, Japan.
Kengo TakeuchiDivision of Pathology, Cancer Institute, Japanese Foundation for Cancer Research, Tokyo, Japan.ORCID https://orcid.org/0000-0002-1599-5800
Takashi TerauchiDepartment of Nuclear Medicine, Cancer Institute Hospital, Japanese Foundation for Cancer Research, Tokyo, Japan.
Ukihide TateishiDepartment of Diagnostic Radiology and Nuclear Medicine, Tokyo Medical and Dental University, Tokyo, Japan.
Keizo HoribeDepartment of Pediatrics, National Hospital Organization Nagoya Medical Center, Nagoya, Japan.
Hirokazu NagaiClinical Research Center, National Hospital Organization Nagoya Medical Center, Nagoya, Japan.
National Hospital Organization · JPJapanese Foundation For Cancer Research · JPNational Hospital Organization Kyushu Cancer Center · JPGifu University Hospital · JPSt. Marianna University School of Medicine · JPTokyo Medical and Dental University · JP

Funding

Japan Agency for Medical Research and Development 15ck0106162h0001Japan Agency for Medical Research and Development 16ck0106162h0002Japan Agency for Medical Research and Development 17ck0106162h0003The Ministry of Health, Labour and Welfare 14533440
6 · The paper itself

Abstract

Anaplastic lymphoma kinase (ALK) inhibition is expected to be a promising therapeutic strategy for ALK-positive malignancies. We aimed to examine the efficacy and safety of alectinib, a second-generation ALK inhibitor, in patients with relapsed or refractory ALK-positive anaplastic large cell lymphoma (ALCL). This open-label, phase II trial included patients (aged 6 years or older) with relapsed or refractory ALK-positive ALCL. Alectinib 300 mg was given orally twice a day (600 mg/d) for 16 cycles, and the duration of each cycle was 21 days. Patients who weighed less than 35 kg were given a reduced dose of alectinib of 150 mg twice a day (300 mg/d). Ten patients were enrolled, and the median age was 19.5 years (range, 6-70 years). Objective responses were documented in eight of 10 patients (80%; 90% confidence interval, 56.2-95.9), with six complete responses. The 1-year progression-free survival, event-free survival, and overall survival rates were 58.3%, 70.0%, and 70.0%, respectively. The median duration of therapy was 340 days. No unexpected adverse events occurred. The most common grade 3 and higher adverse event was a decrease in neutrophil count in two patients. Alectinib showed favorable clinical activity and was well tolerated in patients with ALK-positive ALCL who had progressed on standard chemotherapy. Based on the results of the current study, the Ministry of Health, Labour and Welfare of Japan approved alectinib for the treatment of recurrent or refractory ALK-positive ALCL in February 2020.

Indexed as

Administration, OralAdultAgedAnaplastic Lymphoma KinaseCarbazolesChildConfidence IntervalsDrug Administration ScheduleDrug Resistance, NeoplasmFemaleHumansJapanLymphoma, Large-Cell, AnaplasticMalePiperidinesProgression-Free SurvivalalectinibAnaplastic Lymphoma KinaseCarbazolesPiperidinesProtein Kinase InhibitorsalectinibALK inhibitoranaplastic large cell lymphomarefractoryrelapse

Identifiers

PMID33010107
PMCPMC7734006
OpenAlexW3090473304

What OpenQuestion holds

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LicenceCC BY-NC
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Registered trials

None linked

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.