Evidence map›Paper›PMID 37081722›Full record

ArticleCancer medicine2023

Pyrotinib alone or in combination with docetaxel in refractory HER2-positive gastric cancer: A dose-escalation phase I study.

Dan Liu, Furong Kou, Jifang Gong, Zhiqiang Wang, Xiaotian Zhang, Jian Li, Yan Li, Jie Li, Jun Zhou, Ming Lu and 7 more

Registry-linked trialOpen access · goldAbstract readMulticenter StudyClinical Trial, Phase I
In one paragraph

Article in Cancer medicine, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02378389 (A Phase I Study of Pyrotinib In Combination With Docetaxel In Patients With HER2 Positive Advanced Gastric Cancer), which is not on this map. Cited by 8 papers.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed
2.8field-weighted citation impact, top 9% 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.

NCT02378389 phase1unknown statusnot on this map

A Phase I Study of Pyrotinib In Combination With Docetaxel In Patients With HER2 Positive Advanced Gastric Cancer

TypeinterventionalSponsorJiangsu HengRui Medicine Co., Ltd.Ran2014 to 2017Enrolled28ConditionsHER2 Positive Gastric CancerArmsPyrotinib/Pyrotinib with Docetaxel
3 · Its place in the literature

Who cites it

8 citing papers in PubMed, 11 citations in OpenAlex.

  1. Advancements in targeted therapy for gastric cancer.Therapeutic advances in gastroenterology · 2026
    Review
  2. Article
  3. Article
  4. HER2-targeted therapies beyond breast cancer - an update.Nature reviews. Clinical oncology · 2024
    Review
  5. Review
  6. Review
  7. Article
  8. Article
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

17 authors at 3 institutions in 2 countries.

Dan LiuKey Laboratory of Carcinogenesis and Translational Research (Ministry of Education), Early Drug Development Center, Peking University Cancer Hospital & Institute, Beijing, China.
Furong KouKey Laboratory of Carcinogenesis and Translational Research (Ministry of Education), Department of Day Oncology Unit, Peking University Cancer Hospital & Institute, Beijing, China.ORCID 0000-0002-8969-6344
Jifang GongKey Laboratory of Carcinogenesis and Translational Research (Ministry of Education), Department of Gastrointestinal Oncology/Early Drug Development Center, Peking University Cancer Hospital & Institute, Beijing, China.
Zhiqiang WangDepartment of Medical Oncology, State Key Laboratory of Oncology in South China, Collaborative Innovation Center of Cancer Medicine, Sun Yat-sen University Cancer Center, Guangzhou, P. R. China.
Xiaotian ZhangKey Laboratory of Carcinogenesis and Translational Research (Ministry of Education), Department of Gastrointestinal Oncology, Peking University Cancer Hospital & Institute, Beijing, China.
Jian LiKey Laboratory of Carcinogenesis and Translational Research (Ministry of Education), Department of Gastrointestinal Oncology, Peking University Cancer Hospital & Institute, Beijing, China.ORCID 0000-0002-9333-3255
Yan LiKey Laboratory of Carcinogenesis and Translational Research (Ministry of Education), Department of Gastrointestinal Oncology, Peking University Cancer Hospital & Institute, Beijing, China.
Jie LiKey Laboratory of Carcinogenesis and Translational Research (Ministry of Education), Department of Gastrointestinal Oncology, Peking University Cancer Hospital & Institute, Beijing, China.
Jun ZhouKey Laboratory of Carcinogenesis and Translational Research (Ministry of Education), Department of Gastrointestinal Oncology, Peking University Cancer Hospital & Institute, Beijing, China.ORCID 0000-0003-0570-1730
Ming LuKey Laboratory of Carcinogenesis and Translational Research (Ministry of Education), Department of Gastrointestinal Oncology, Peking University Cancer Hospital & Institute, Beijing, China.
Xicheng WangKey Laboratory of Carcinogenesis and Translational Research (Ministry of Education), Department of Gastrointestinal Oncology, Peking University Cancer Hospital & Institute, Beijing, China.
Zhihao LuKey Laboratory of Carcinogenesis and Translational Research (Ministry of Education), Department of Gastrointestinal Oncology, Peking University Cancer Hospital & Institute, Beijing, China.ORCID 0000-0001-9091-4946
Yanshuo CaoKey Laboratory of Carcinogenesis and Translational Research (Ministry of Education), Department of Gastrointestinal Oncology, Peking University Cancer Hospital & Institute, Beijing, China.
Jianjun ZouJiangsu Hengrui Medicine Co., Ltd, Lianyungang, China.
Xiaoyu ZhuJiangsu Hengrui Medicine Co., Ltd, Lianyungang, China.
Ruihua XuDepartment of Medical Oncology, State Key Laboratory of Oncology in South China, Collaborative Innovation Center of Cancer Medicine, Sun Yat-sen University Cancer Center, Guangzhou, P. R. China.
Lin ShenKey Laboratory of Carcinogenesis and Translational Research (Ministry of Education), Department of Gastrointestinal Oncology/Early Drug Development Center, Peking University Cancer Hospital & Institute, Beijing, China.ORCID 0000-0003-1134-2922
Peking University · CNJiangsu Hengrui Medicine (China) · CNSun Yat-sen University · CN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimPyrotinib (an irreversible pan-ErbB small-molecular tyrosine kinase inhibitor) was approved in human epidermal growth factor receptor 2 (HER2)-positive breast cancer and showed great antitumor activity in preclinical studies of gastric cancer (GC). This study was first designed to prospectively assess pyrotinib in pretreated HER2-positive GC.

methodsThis multicenter, phase I study followed a standard "3 + 3" design and included two parts. In the pyrotinib part, pyrotinib was administered orally, once per day at dose levels of 240, 320, 400, and 480 mg. In the pyrotinib plus docetaxel part, patients received pyrotinib (qd, d1-21, q3W) combined with docetaxel (60 mg/m

resultsA total of 25 patients were enrolled and received pyrotinib (n = 15) or pyrotinib plus docetaxel (n = 10). One DLT was observed in pyrotinib monotherapy part (Grade 3 uncontrolled diarrhea after supportive care) and pyrotinib plus docetaxel part (Grade 4 neutropenia and leukopenia). In the pyrotinib monotherapy part, MTD was not reached. Diarrhea, anemia, neutropenia, and leukopenia were the most common treatment-related adverse events (TRAEs). The RP2D for pyrotinib monotherapy was recommended as 400 mg. After combining with docetaxel, the risk of leukopenia and neutropenia was increased. Grade ≥3 TRAEs were reported for four patients in the monotherapy part and for eight patients in the combination part. Mean t

conclusionsPyrotinib alone and combined with docetaxel showed acceptable toxicities in patients with pretreated HER2-positive GC.

trial registrationThis study was registered with ClinicalTrials.gov, NCT02378389.

Indexed as

Breast NeoplasmsNeutropeniaStomach NeoplasmsAcrylamidesAminoquinolinesAntineoplastic Combined Chemotherapy ProtocolsDocetaxelErb-b2 Receptor Tyrosine KinasesFemaleHumansAcrylamidesAminoquinolinesDocetaxelErb-b2 Receptor Tyrosine Kinasespyrotinibdocetaxelgastric cancerHER2phase I studypyrotinib

Identifiers

PMID37081722
PMCPMC10225203
OpenAlexW4366602181

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.