Evidence map›Paper›PMID 23860537›Full record

ArticleBritish journal of cancer2013

Phase 1 study of lenvatinib combined with carboplatin and paclitaxel in patients with non-small-cell lung cancer.

M Nishio, T Horai, A Horiike, H Nokihara, N Yamamoto, T Takahashi, H Murakami, N Yamamoto, F Koizumi, K Nishio and 3 more

2 registry-linked trialsAbstract readClinical Trial, Phase IMulticenter Study
In one paragraph

Article in British journal of cancer, 2013. 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 22 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
22citing papers in PubMed, 1 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.

NCT04274270 naunknown statusnot on this mapstarted 2020, after this paper: background citation

Safety and Efficacy of Sequential Stereotactic Radiotherapy With S1 Combined With Endostar in the Treatment of Stage IV Lung Squamous Cell Carcinoma: Prospective, Multicenter, Exploratory Study

TypeinterventionalSponsorPeking University Third HospitalRan2020 to 2023Enrolled60ConditionsRadiotherapy Side EffectArmsEndostar
NCT05832827 phase2recruitingnot on this mapstarted 2023, after this paper: background citation

First-line Carboplatin/Paclitaxel/Lenvatinib/Pembrolizumab Combination for Previously Untreated Advanced or Recurrent Thymic Carcinomas

TypeinterventionalSponsorNational Cancer Center, JapanRan2023 to 2028Enrolled35ConditionsUntreated Advanced or Recurrent Thymic CarcinomasArmsMK-3475, Lenvatinib, Carboplatin, Paclitaxel
3 · Its place in the literature

Who cites it

22 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
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  9. Role of GdOncology letters · 2020
    Article
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  20. Lenvatinib and Palbociclib.Hospital pharmacy · 2015
    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

13 authors.

M NishioDepartment of Thoracic Medical Oncology, Cancer Institute Hospital of Japanese Foundation for Cancer Research, Koto-ku, Japan. mnishio@jfcr.or.jp
T Horai
A Horiike
H Nokihara
N Yamamoto
T Takahashi
H Murakami
N Yamamoto
F Koizumi
K Nishio
W Yusa
N Koyama
T Tamura

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThis dose-finding study evaluated lenvatinib, an oral multitargeted receptor tyrosine kinase inhibitor, in combination with carboplatin/paclitaxel in chemotherapy-naïve non-small-cell lung cancer (NSCLC) patients. PATIENTS AND

methodsPatients received lenvatinib twice daily (BID) with carboplatin (area under the curve 6 mg ml(-1) min(-1), day 1)/paclitaxel (200 mg m(-2), day 1) every 3 weeks. The initial dose of lenvatinib was 6 mg BID. The primary end point was maximum tolerated dose (MTD) of lenvatinib. At the MTD, the cohort was expanded by 16 patients. Safety, pharmacokinetics, pharmacodynamics, and antitumor effects were evaluated.

resultsTwenty-eight patients were treated. At 6 mg BID, dose-limiting toxicities (DLTs) included febrile neutropenia/gingival infection (n=2). No DLTs occurred with 4 mg BID, the recommended MTD for the expansion. Common grade 3/4 toxicities included neutropenia, leukopenia, hypertension, and thrombocytopenia. The combination had no significant impact on individual drug pharmacokinetics. Response rate and median progression-free survival were 68% and 9.0 months, respectively, with 4 mg BID. In the plasma biomarker analysis, stromal cell-derived factor 1α, stem cell factor, and granulocyte colony-stimulating factor correlated with antitumor activity.

conclusionThe MTD for lenvatinib with carboplatin/paclitaxel is 4 mg BID in advanced NSCLC patients. This regimen demonstrated manageable tolerability and encouraging antitumor activity.

Indexed as

AdultAgedAntineoplastic Combined Chemotherapy ProtocolsCarboplatinCarcinoma, Non-Small-Cell LungDose-Response Relationship, DrugDrug Administration ScheduleFemaleHumansLung NeoplasmsMaleMiddle AgedPaclitaxelPhenylurea CompoundsQuinolinesCarboplatinlenvatinibPaclitaxelPhenylurea CompoundsQuinolines

Identifiers

PMID23860537
PMCPMC3738144

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.