Evidence map›Paper›PMID 27582078›Full record

Trial reportBMC cancer2016

Sunitinib added to FOLFIRI versus FOLFIRI in patients with chemorefractory advanced adenocarcinoma of the stomach or lower esophagus: a randomized, placebo-controlled phase II AIO trial with serum biomarker program.

Markus Moehler, Irina Gepfner-Tuma, Annett Maderer, Peter C Thuss-Patience, Joern Ruessel, Susanna Hegewisch-Becker, Hansjochen Wilke, Salah-Eddin Al-Batran, Mohammad-Reza Rafiyan, Florian Weißinger and 11 more

Registry-linked trialOpen access · goldAbstract readClinical Trial, Phase IIMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in BMC cancer, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01020630 (A Randomized, Placebo-controlled Phase II Trial Investigating SUNITINIB Versus Placebo in Patients With Chemorefractory Advanced Adenocarcinoma of the Stomach or Lower Esophagus Treated With Chemotherapy FOLFIRI), which is not on this map. Cited by 39 papers, 9 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
39citing papers in PubMed, 9 pooled it
6.9field-weighted citation impact, top 3% 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.

NCT01020630 phase2completednot on this map

A Randomized, Placebo-controlled Phase II Trial Investigating SUNITINIB Versus Placebo in Patients With Chemorefractory Advanced Adenocarcinoma of the Stomach or Lower Esophagus Treated With Chemotherapy FOLFIRI

TypeinterventionalSponsorPD Dr Markus MöhlerRan2009 to 2013Enrolled91ConditionsAdenocarcinomaArmsSunitinib, Placebo
3 · Its place in the literature

Who cites it

39 citing papers in PubMed, 9 syntheses or guidelines pooled it, 66 citations in OpenAlex.

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  19. EarlyCancers · 2021
    Article
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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

21 authors at 12 institutions in 1 country.

Markus MoehlerUniversity Medical Center, Johannes Gutenberg-University Mainz, I. Medizinische Klinik und Poliklinik, Langenbeckstraße 1, 55131, Mainz, Germany. markus.moehler@unimedizin-mainz.de.
Irina Gepfner-TumaUniversity Medical Center, Johannes Gutenberg-University Mainz, I. Medizinische Klinik und Poliklinik, Langenbeckstraße 1, 55131, Mainz, Germany.
Annett MadererUniversity Medical Center, Johannes Gutenberg-University Mainz, I. Medizinische Klinik und Poliklinik, Langenbeckstraße 1, 55131, Mainz, Germany.
Peter C Thuss-PatienceCharité Campus Virchow-Klinikum, Berlin, Germany.
Joern RuesselUniversity Hospital Halle (Saale), Halle (Saale), Germany.
Susanna Hegewisch-BeckerHämatologisch-Onkologische Praxis Eppendorf, Hamburg, Germany.
Hansjochen WilkeKliniken Essen-Mitte - Evang. Huyssens-Stiftung, Essen, Germany.
Salah-Eddin Al-BatranKrankenhaus Nordwest, Frankfurt, Germany.
Mohammad-Reza RafiyanKrankenhaus Nordwest, Frankfurt, Germany.
Florian WeißingerEvangelisches Krankenhaus Bielefeld, Bielefeld, Germany.
Hans-Joachim SchmollUniversity Hospital Halle (Saale), Halle (Saale), Germany.
Frank KullmannKliniken Nordoberpfalz - Klinikum Weiden, Weiden, Germany.
Ludwig Fischer von WeikersthalGesundheitszentrum St. Marien GmbH, Amberg, Germany.
Jens T SivekeKlinikum rechts der Isar, Technical University Munich, Munich, Germany.
Jens WeusmannUniversity Medical Center, Johannes Gutenberg-University Mainz, I. Medizinische Klinik und Poliklinik, Langenbeckstraße 1, 55131, Mainz, Germany.
Stephan KanzlerLeopoldina Krankenhaus, Schweinfurt, Germany.
Carl Christoph SchimanskiMarienkrankenhaus Darmstadt, Darmstadt, Germany.
Melanie OttePraxisgemeinschaft für Onkologie und Urologie, Wilhelmshaven, Germany.
Lukas SchollenbergerInterdisciplinary Center for Clinical Trials (IZKS), Mainz, Germany.
Jochem KoenigInstitute of Medical Biostatistics, Epidemiology and Informatics (IMBEI) of the University Medical Center Mainz, Mainz, Germany.
Peter R GalleUniversity Medical Center, Johannes Gutenberg-University Mainz, I. Medizinische Klinik und Poliklinik, Langenbeckstraße 1, 55131, Mainz, Germany.
Johannes Gutenberg University Mainz · DEKrankenhaus Nordwest · DEPraxis für Hämatologie und Onkologie · DEUniversity Hospital in Halle · DECharité - Universitätsmedizin Berlin · DEEvangelisches Krankenhaus Bielefeld · DEKliniken Essen-Mitte · DEKlinikum Darmstadt · DEKlinikum rechts der Isar · DEKlinikum St. Marien Amberg · DEKlinikum Weiden · DELeopoldina Krankenhaus Schweinfurt · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundAs a multi-targeted anti-angiogenic receptor tyrosine kinase (RTK) inhibitor sunitinib (SUN) has been established for renal cancer and gastrointestinal stromal tumors. In advanced refractory esophagogastric cancer patients, monotherapy with SUN was associated with good tolerability but limited tumor response.

methodsThis double-blind, placebo-controlled, multicenter, phase II clinical trial was conducted to evaluate the efficacy, safety and tolerability of SUN as an adjunct to second and third-line FOLFIRI (NCT01020630). Patients were randomized to receive 6-week cycles including FOLFIRI plus sodium folinate (Na-FOLFIRI) once every two weeks and SUN or placebo (PL) continuously for four weeks followed by a 2-week rest period. The primary study endpoint was progression-free survival (PFS). Preplanned serum analyses of VEGF-A, VEGF-D, VEGFR2 and SDF-1α were performed retrospectively.

resultsOverall, 91 patients were randomized, 45 in each group (one patient withdrew). The main grade ≥3 AEs were neutropenia and leucopenia, observed in 56 %/20 % and 27 %/16 % for FOLFIRI + SUN/FOLFIRI + PL, respectively. Median PFS was similar, 3.5 vs. 3.3 months (hazard ratio (HR) 1.11, 95 % CI 0.70-1.74, P = 0.66) for FOLFIRI + SUN vs. FOLFIRI + PL, respectively. For FOLFIRI + SUN, a trend towards longer median overall survival (OS) compared with placebo was observed (10.4 vs. 8.9 months, HR 0.82, 95 % CI 0.50-1.34, one-sided P = 0.21). In subgroup serum analyses, significant changes in VEGF-A (P = 0.017), VEGFR2 (P = 0.012) and VEGF-D (P < 0.001) serum levels were observed.

conclusionsAlthough sunitinib combined with FOLFIRI did not improve PFS and response in chemotherapy-resistant gastric cancer, a trend towards better OS was observed. Further biomarker-driven studies with other anti-angiogenic RTK inhibitors are warranted.

trial registrationThis study was registered prospectively in the NCT Clinical Trials Registry (ClinicalTrials.gov) under NCT01020630 on November 23, 2009 after approval by the leading ethics committee of the Medical Association of Rhineland-Palatinate, Mainz, in coordination with the participating ethics committees (see Additional file 2) on September 16, 2009.

Indexed as

AdenocarcinomaAdultAgedAged, 80 and overAntineoplastic Combined Chemotherapy ProtocolsBiomarkers, TumorCamptothecinDisease-Free SurvivalDouble-Blind MethodEnzyme-Linked Immunosorbent AssayEsophageal NeoplasmsFemaleFluorouracilHumansIndolesKaplan-Meier EstimateBiomarkers, TumorCamptothecinFluorouracilIndolesLeucovorinPyrrolesSunitinibChemorefractory advanced gastric cancerFOLFIRISunitinibTyrosine kinase inhibitorVEGF

Identifiers

PMID27582078
PMCPMC5006426
OpenAlexW2516702596

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.