Evidence map›Paper›PMID 28859471›Full record

ArticleCancer research and treatment2018

Phase 1 Studies of Poziotinib, an Irreversible Pan-HER Tyrosine Kinase Inhibitor in Patients with Advanced Solid Tumors.

Tae Min Kim, Keun-Wook Lee, Do-Youn Oh, Jong-Seok Lee, Seock-Ah Im, Dong-Wan Kim, Sae-Won Han, Yu Jung Kim, Tae-You Kim, Jee Hyun Kim and 3 more

Abstract readClinical Trial, Phase I
In one paragraph

Article in Cancer research and treatment, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 39 papers.

0numbers the graph read from it
0cells of the map it votes in
39citing 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

39 citing papers in PubMed.

  1. Trial
  2. Trial
  3. Poziotinib in Non-Small-Cell Lung Cancer HarboringJournal of clinical oncology : official journal of the American Society of Clinical Oncology · 2022
    Trial
  4. Trial
  5. A phase I/II study of poziotinib combined with paclitaxel and trastuzumab in patients with HER2-positive advanced gastric cancer.Gastric cancer : official journal of the International Gastric Cancer Association and the Japanese Gastric Cancer Association · 2019
    Trial
  6. Article
  7. Article
  8. Review
  9. Review
  10. HER2-targeted therapies beyond breast cancer - an update.Nature reviews. Clinical oncology · 2024
    Review
  11. Article
  12. Review
  13. Review
  14. Article
  15. Review
  16. Article
  17. Article
  18. Article
  19. Review
  20. Deciphering the Impact ofJournal of personalized medicine · 2022
    Review
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

13 authors.

Tae Min KimDepartment of Internal Medicine, Seoul National University College of Medicine, Seoul, Korea.
Keun-Wook LeeDepartment of Internal Medicine, Seoul National University College of Medicine, Seoul, Korea.
Do-Youn OhDepartment of Internal Medicine, Seoul National University College of Medicine, Seoul, Korea.
Jong-Seok LeeDepartment of Internal Medicine, Seoul National University College of Medicine, Seoul, Korea.
Seock-Ah ImDepartment of Internal Medicine, Seoul National University College of Medicine, Seoul, Korea.
Dong-Wan KimDepartment of Internal Medicine, Seoul National University College of Medicine, Seoul, Korea.
Sae-Won HanDepartment of Internal Medicine, Seoul National University College of Medicine, Seoul, Korea.
Yu Jung KimDepartment of Internal Medicine, Seoul National University College of Medicine, Seoul, Korea.
Tae-You KimDepartment of Internal Medicine, Seoul National University College of Medicine, Seoul, Korea.
Jee Hyun KimDepartment of Internal Medicine, Seoul National University College of Medicine, Seoul, Korea.
Hyesun HanHanmi Pharm. Co., Ltd., Seoul, Korea.
Woo Ho KimSeoul National University Cancer Research Institute, Seoul, Korea.
Yung-Jue BangDepartment of Internal Medicine, Seoul National University College of Medicine, Seoul, Korea.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposePoziotinib, a pan-human epidermal growth factor receptor 2 (HER) tyrosine kinase inhibitor, has shown potent activity againstwild type of epidermal growth factorreceptor(EGFR) family kinases including EGFR, HER2, and HER4 and EGFR-mutant cells in vitro. Two phase I studies were conducted to determine the maximum tolerated dose (MTD), pharmacokinetics, safety, and antitumor activity against advanced solid tumors. MATERIALS AND

methodsStandard 3+3 dose escalation scheme using two different dosing schedules were studied: once daily, 14-day on, and 7-day off (intermittent schedule); and once daily continuous dosing with food effect. Additional patients were enrolled in an expansion cohort.

resultsA total of 75 patients were enrolled in the two studies. The most common drug-related treatment-emergent adverse eventswere diarrhea,rash, stomatitis, pruritus, and anorexia. Doselimiting toxicities were grade 3 diarrhea in the intermittent schedule and grade 3 anorexia and diarrhea in the continuous dosing schedule. The MTDs were determined as 24 mg/day in the intermittent dosing schedule and 18 mg/day in the continuous dosing schedule. Eight (16%) and 24 (47%) of 51 evaluable patients in the intermittent schedule achieved partial response (PR) and stable disease (SD), respectively. Four (21%) and six (32%) of 19 evaluable patients in continuous dosing schedule achieved PR and SD, respectively. Patients with PR (n=7) or SD ≥ 12 weeks (n=7) had HER2 amplification (n=7; breast cancer, 5; and stomach cancer, 2) and EGFR amplification (n=1, squamous cell lung cancer).

conclusionPoziotinib was safe and well tolerated in patients with advanced solid tumors. It showed an encouraging activity against EGFR-mutant and HER2-amplified cancers.

Indexed as

AdultAgedAged, 80 and overDrug Administration ScheduleErb-b2 Receptor Tyrosine KinasesErbB ReceptorsFemaleGene AmplificationHumansMaleMaximum Tolerated DoseMiddle AgedNeoplasmsProtein Kinase InhibitorsQuinazolinesTreatment OutcomeEGFR protein, humanERBB2 protein, humanErb-b2 Receptor Tyrosine KinasesErbB ReceptorsHM781-36BProtein Kinase InhibitorsQuinazolinesEGFR mutationHER2 amplificationNon-small-cell lung carcinomaPoziotinib

Identifiers

PMID28859471
PMCPMC6056959

What OpenQuestion holds

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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.