Evidence map›Paper›PMID 27716285›Full record

Trial reportJournal of hematology & oncology2016

Safety, pharmacokinetics, and antitumor properties of anlotinib, an oral multi-target tyrosine kinase inhibitor, in patients with advanced refractory solid tumors.

Yongkun Sun, Wei Niu, Feng Du, Chunxia Du, Shuting Li, Jinwan Wang, Li Li, Fengqing Wang, Yu Hao, Chuan Li and 1 more

2 registry-linked trialsAbstract readClinical Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Journal of hematology & oncology, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 293 papers, 7 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
293citing papers in PubMed, 7 pooled it
–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.

NCT03589950 phase2unknown statusnot on this mapstarted 2018, after this paper: background citation

A Parallel Control, Exploratory Trial to Compare Anlotinib Plus Chemotherapy Versus Chemotherapy as Second-line Treatment in Subjects With Advanced Non-small Cell Lung Cancer

TypeinterventionalSponsorThe First People's Hospital of LianyungangRan2018 to 2021Enrolled60ConditionsLung Neoplasms, Docetaxel, Pemetrexed, S-1Armsanlotinib plus chemotherapy, chemotherapy
NCT05659186 phase2unknown statusnot on this mapstarted 2022, after this paper: background citation

A Phase II Study of the Efficacy and Safety of PD-1 Inhibitor and Anlotinib Combined With Multimodal Radiotherapy in the Second-line Treatment of Recurrent or Metastatic Anaplastic Thyroid Cancer

TypeinterventionalSponsorWest China HospitalRan2022 to 2025Enrolled20ConditionsThyroid CancerArmsTislelizumab, Anlotinib, Radiotherapy
3 · Its place in the literature

Who cites it

293 citing papers in PubMed, 7 syntheses or guidelines pooled it.

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  14. First-Line Anlotinib Treatment for Soft-Tissue Sarcoma in Chemotherapy-Ineligible Patients: An Open-Label, Single-Arm, Phase 2 Clinical Trial.Clinical cancer research : an official journal of the American Association for Cancer Research · 2024
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233 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

11 authors.

Yongkun SunDepartment of Medical Oncology, Cancer Hospital, Chinese Academy of Medical Sciences and PUMC, Beijing, 100021, China.
Wei NiuThe State Key Laboratory of Drug Research, Shanghai Institute of Materia Medica, Chinese Academy of Sciences, Shanghai, 201203, China.
Feng DuThe VIPII Gastrointestinal Cancer Division of Medical Department, Peking University Cancer Hospital and Institute, Beijing, 100142, China.
Chunxia DuDepartment of Medical Oncology, Cancer Hospital, Chinese Academy of Medical Sciences and PUMC, Beijing, 100021, China.
Shuting LiDepartment of Medical Oncology, Cancer Hospital, Chinese Academy of Medical Sciences and PUMC, Beijing, 100021, China.
Jinwan WangDepartment of Medical Oncology, Cancer Hospital, Chinese Academy of Medical Sciences and PUMC, Beijing, 100021, China.
Li LiThe State Key Laboratory of Drug Research, Shanghai Institute of Materia Medica, Chinese Academy of Sciences, Shanghai, 201203, China.
Fengqing WangThe State Key Laboratory of Drug Research, Shanghai Institute of Materia Medica, Chinese Academy of Sciences, Shanghai, 201203, China.
Yu HaoSchool of Public Health, Nanjing Medical University, Nanjing, China.
Chuan LiThe State Key Laboratory of Drug Research, Shanghai Institute of Materia Medica, Chinese Academy of Sciences, Shanghai, 201203, China. chli@simm.ac.cn.
Yihebali ChiDepartment of Medical Oncology, Cancer Hospital, Chinese Academy of Medical Sciences and PUMC, Beijing, 100021, China. dryihebalichi@126.com.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundAnlotinib is a novel multi-target tyrosine kinase inhibitor that is designed to primarily inhibit VEGFR2/3, FGFR1-4, PDGFR α/β, c-Kit, and Ret. We aimed to evaluate the safety, pharmacokinetics, and antitumor activity of anlotinib in patients with advanced refractory solid tumors.

methodsAnlotinib (5-16 mg) was orally administered in patients with solid tumor once a day on two schedules: (1) four consecutive weeks (4/0) or (2) 2-week on/1-week off (2/1). Pharmacokinetic sampling was performed in all patients. Twenty-one patients were further enrolled in an expanded cohort study on the recommended dose and schedule. Preliminary tumor response was also assessed.

resultsOn the 4/0 schedule, dose-limiting toxicity (DLT) was grade 3 hypertension at 10 mg. On the 2/1 schedule, DLT was grade 3 hypertension and grade 3 fatigue at 16 mg. Pharmacokinetic assessment indicated that anlotinib had long elimination half-lives and significant accumulation during multiple oral doses. The 2/1 schedule was selected, with 12 mg once daily as the maximum tolerated dose for the expanding study. Twenty of the 21 patients (with colon adenocarcinoma, non-small cell lung cancer, renal clear cell cancer, medullary thyroid carcinoma, and soft tissue sarcoma) were assessable for antitumor activity of anlotinib: 3 patients had partial response, 14 patients had stable disease including 12 tumor burden shrinkage, and 3 had disease progression. The main serious adverse effects were hypertension, triglyceride elevation, hand-foot skin reaction, and lipase elevation.

conclusionsAt the dose of 12 mg once daily at the 2/1 schedule, anlotinib displayed manageable toxicity, long circulation, and broad-spectrum antitumor potential, justifying the conduct of further studies.

Indexed as

AdultAgedDrug Administration ScheduleDrug-Related Side Effects and Adverse ReactionsFemaleHumansIndolesMaleMaximum Tolerated DoseMetabolic Clearance RateMiddle AgedNeoplasmsProtein Kinase InhibitorsQuinolinesSalvage TherapyTreatment OutcomeanlotinibIndolesProtein Kinase InhibitorsQuinolinesAdvanced refractory solid tumorsAnlotinibAnti-angiogenesisPharmacokineticsPhase I studySafety

Identifiers

PMID27716285
PMCPMC5051080

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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.