Evidence map›Paper›PMID 23670576›Full record

Trial reportMolecular therapy : the journal of the American Society of Gene Therapy2013

A phase II, randomized, double-blind, placebo-controlled multicenter trial of Endostar in patients with metastatic melanoma.

Chuanliang Cui, Lili Mao, Zhihong Chi, Lu Si, Xinan Sheng, Yan Kong, Siming Li, Bin Lian, Kangsheng Gu, Min Tao and 5 more

2 registry-linked trialsOpen access · hybridAbstract readClinical Trial, Phase IIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Molecular therapy : the journal of the American Society of Gene Therapy, 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 54 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
54citing papers in PubMed, 5 pooled it
4.5field-weighted citation impact, top 5% 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.

NCT03095079 phase2unknown statusnot on this mapstarted 2016, after this paper: background citation

a Phase II Trial With Continuous Intravenous Infusion of Rh-endostatin in Combination With Dacarbazine and Cisplatin as the First Line Therapy for Metastatic Melanoma

TypeinterventionalSponsorPeking University Cancer Hospital & InstituteRan2016 to 2018Enrolled70ConditionsMelanomaArmsrecombinant human endostatin
NCT03989830 phase2unknown statusnot on this mapstarted 2019, after this paper: background citation

A Phase II Study of Second-line Chemotherapy Combined With Endostatin for Recurrent/Metastatic Head and Neck Epithelial Tumors That Cannot be Re-irradiated or Re-operated After Fist-line Platinum-based Chemotherapy

TypeinterventionalSponsorSun YanRan2019 to 2022Enrolled53ConditionsHead and Neck NeoplasmsArmssecond-line chemotherapy, Recombinant human endostatin
3 · Its place in the literature

Who cites it

54 citing papers in PubMed, 5 syntheses or guidelines pooled it, 103 citations in OpenAlex.

  1. Anti-angiogenesis agents plus chemoradiotherapy for locally advanced nasopharyngeal cancer: a systematic review and meta-analysis.European archives of oto-rhino-laryngology : official journal of the European Federation of Oto-Rhino-Laryngological Societies (EUFOS) : affiliated with the German Society for Oto-Rhino-Laryngology - Head and Neck Surgery · 2024
    Pooled it
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  3. Systemic treatments for metastatic cutaneous melanoma.The Cochrane database of systematic reviews · 2018
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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

15 authors at 7 institutions in 1 country.

Chuanliang CuiDepartment of Renal Cancer and Melanoma, The Key laboratory of Carcinogenesis and Translational Research, Ministry of Education, Peking University Cancer Hospital & Institute, Beijing, China.
Lili Mao
Zhihong Chi
Lu Si
Xinan Sheng
Yan Kong
Siming Li
Bin Lian
Kangsheng Gu
Min Tao
Xin Song
Tongyu Lin
Xiubao Ren
Shukui Qin
Jun Guo
Peking University · CNPeking University Cancer Hospital · CNAnhui Medical University · CNFirst Affiliated Hospital of Soochow University · CNKunming Third People's Hospital · CNSun Yat-sen University Cancer Center · CNTianjin Medical University Cancer Institute and Hospital · CN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Endostatin is a potent endogenous angiogenic inhibitor with implicated antitumor activity. However, efficacy of recombinant human endostatin (rhES) in clinical trials is controversial, and application of rhES in treatment of metastatic melanoma awaits further investigations. This phase II trial evaluated the efficacy and safety of a soluble and stable rhES (Endostar) plus dacarbazine in patients with metastatic melanomas that contains no mutations in c-kit and BRAF genes. A total of 110 patients received placebo plus dacarbazine (250 mg/m², n = 54) or Endostar (7.5 mg/m²) plus dacarbazine (250 mg/m², n = 56). The primary end points were progression-free survival (PFS) and overall survival (OS). Median PFS in the Endostar plus dacarbazine arm was 4.5 months versus 1.5 months in the placebo plus dacarbazine arm (hazard ratio (HR) = 0.578; P = 0.013). There were statistically significant improvements in OS (median, 12.0 months versus 8.0 months; HR, 0.522; P = 0.005) in favor of the Endostar plus dacarbazine arm. The regimen was generally well tolerated and had a manageable toxicity profile. Our trial suggests that Endostar plus dacarbazine is well tolerated in patients with metastatic melanoma harboring no genetic mutations popular for targeted therapy and yields a significant improvement in PFS and OS.

Indexed as

AdolescentAdultAgedAged, 80 and overAntineoplastic AgentsDacarbazineDisease-Free SurvivalDouble-Blind MethodEndostatinsFemaleHumansKaplan-Meier EstimateMaleMelanomaMiddle AgedNeoplasm MetastasisAntineoplastic AgentsDacarbazineEndostatins

Identifiers

PMID23670576
PMCPMC3702105
OpenAlexW2075868042

What OpenQuestion holds

Textmetadata
Read underepoch 390

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.