Evidence map›Paper›PMID 26673352›Full record

Trial reportAnnals of oncology : official journal of the European Society for Medical Oncology2016

Vinflunine-gemcitabine versus vinflunine-carboplatin as first-line chemotherapy in cisplatin-unfit patients with advanced urothelial carcinoma: results of an international randomized phase II trial (JASINT1).

M De Santis, P J Wiechno, J Bellmunt, C Lucas, W-C Su, L Albiges, C-C Lin, E Senkus-Konefka, A Flechon, L Mourey and 5 more

Open access · greenAbstract readClinical Trial, Phase IIMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Annals of oncology : official journal of the European Society for Medical Oncology, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 20 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
20citing papers in PubMed, 1 pooled it
7.7field-weighted citation impact, top 2% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

20 citing papers in PubMed, 1 synthesis or guideline pooled it, 55 citations in OpenAlex.

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  20. Urothelial carcinoma management in elderly or unfit patients.EJC supplements : EJC : official journal of EORTC, European Organization for Research and Treatment of Cancer ... [et al.] · 2016
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

15 authors at 13 institutions in 8 countries.

M De SantisLudwig Boltzmann Institute for ACR VIEnna/LB-CTO ACR-ITR VIEnna, KFJ-Spital, Vienna, Austria Cancer Research Centre, University of Warwick, Coventry, UK maria@desantis.cc.
P J WiechnoOncology Institute, Instytut im Sklodowskiej-Curie, Warsaw, Poland.
J BellmuntDana-Farber Cancer Institute-Harvard Medical School, Boston, USA.
C LucasInstitut de Recherche Pierre Fabre, Boulogne-Billancourt, France.
W-C SuDepartment of Internal Medicine, National Cheng Kung University Hospital, Taipei, Taiwan.
L AlbigesDepartment of Medical Oncology, Institut Gustave Roussy, Villejuif, France.
C-C LinDepartment of Oncology, National Taiwan University Hospital, Taipei, Taiwan.
E Senkus-KonefkaDepartment of Oncology and Radiotherapy, Medical University of Gdansk, Gdansk, Poland.
A FlechonDepartment of Medicine, Centre Léon Bérard, Lyon.
L MoureyDepartment of Oncology, Institut Claudius Regaud, Toulouse, France.
A NecchiDepartment of Medical Oncology, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy.
W C LoidlDepartment of Urology, KH Barmherzige Schwestern Linz, Linz, Austria.
M M RetzDepartment of Urology, University Hospital Rechts Der Isar, Munich, Germany.
N VaissièreInstitut de Recherche Pierre Fabre, Boulogne-Billancourt, France.
S CulineDepartment of Medical Oncology, Hopital Saint-Louis-APHP, Paris-Diderot University, Paris, France.
Pierre Fabre (France) · FRCentre Léon Bérard · FRDana-Farber Cancer Institute · USFondazione IRCCS Istituto Nazionale dei Tumori · ITGdańsk Medical University · PLInstitut Claudius Regaud · FRInstitut Gustave Roussy · FRKlinikum rechts der Isar · DENational Cheng Kung University Hospital · TWNational Taiwan University Hospital · TWThe Maria Sklodowska-Curie National Research Institute of Oncology · PLUniversité Paris Cité · FRUniversity of Warwick · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThere is no standard first-line chemotherapy for advanced urothelial carcinoma (aUC) in cisplatin-ineligible (cisplatin-unfit) patients. The study assessed the efficacy and tolerability profile of two vinflunine-based cytotoxic regimens in this setting. PATIENTS AND

methodsPatients with aUC a creatinine clearance (CrCl) of <60 but ≥30 ml/min, performance status 0 or 1 and no prior chemotherapy for advanced disease were randomized (1 : 1). They received vinflunine 250 or 280 mg/m(2) (based on baseline CrCl) on day 1, plus either gemcitabine [750 mg/m(2) escalated to 1000 mg/m(2) in cycle 2 if no toxicity grade (G) ≥2 on days 1 and 8 (VG) or plus carboplatin area under the curve 4.5 day 1 (VC) every 21 days]. To detect a 22% improvement in each arm compared with H0 (41%) in the primary end point, disease control rate (DCR = complete response + partial response + stable disease), 31 assessable patients per arm were required (α = 5%, β = 20%).

resultsSixty-nine patients were enrolled (34 VG, 35 VC). Less G3/4 haematological adverse events (AEs) were reported with VG: neutropaenia was seen in 38% (versus 68% with VC) and febrile neutropaenia in 3% (versus 14% with VC) of patients. No major differences were observed for non-haematological AEs. DCR was 77% in both groups; overall response rate (ORR) was 44.1% versus 28.6%, with a median progression-free survival of 5.9 versus 6.1 months and median OS of 14.0 versus 12.8 months with VG and VC, respectively.

conclusionBoth vinflunine-based doublets offer a similar DCR, ORR and OS. The better haematological tolerance favours the VG combination, which warrants further study. CLINICALTRIALS.GOV PROTOCOL IDENTIFIER: NCT 01599013.

Indexed as

AdultAgedAntineoplastic Combined Chemotherapy ProtocolsCarboplatinCarcinoma, Transitional CellCisplatinDeoxycytidineDisease-Free SurvivalFemaleGemcitabineHumansMaleMiddle AgedTreatment OutcomeUrinary Bladder NeoplasmsVinblastineCarboplatinCisplatinDeoxycytidineGemcitabineVinblastinevinfluninebladder cancercisplatin-ineligiblerenal impairmenturothelial carcinomavinflunine

Identifiers

PMID26673352
PMCPMC4769994
OpenAlexW2259411705

What OpenQuestion holds

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Registered trials

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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.