Evidence map›Paper›PMID 22790797›Full record

ArticleBritish journal of cancer2012

Phase I dose-escalation study of aflibercept in combination with docetaxel and cisplatin in patients with advanced solid tumours.

G Freyer, N Isambert, B You, S Zanetta, C Falandry, L Favier, V Trillet-Lenoir, S Assadourian, K Soussan-Lazard, S Ziti-Ljajic and 1 more

Open access · hybridAbstract readClinical Trial, Phase IMulticenter Study
In one paragraph

Article in British journal of cancer, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed
3.2field-weighted citation impact, top 7% 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

7 citing papers in PubMed, 22 citations in OpenAlex.

  1. Trial
  2. Review
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  5. Angiogenesis-related pathways in the pathogenesis of ovarian cancer.International journal of molecular sciences · 2013
    Review
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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

11 authors at 4 institutions in 1 country.

G FreyerUniversité de Lyon, Service d'oncologie médicale, Centre d'Investigation des Thérapeutiques en Oncologie et Hématologie, Centre Hospitalier Lyon-Sud, Pierre Benite 69495, France. Gilles.Freyer@chu-lyon.fr
N Isambert
B You
S Zanetta
C Falandry
L Favier
V Trillet-Lenoir
S Assadourian
K Soussan-Lazard
S Ziti-Ljajic
P Fumoleau
Hôpital Lyon Sud · FRSanofi (France) · FRCentre Georges François Leclerc · FRInserm · FR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThis phase I cohort study investigated aflibercept (vascular endothelial growth factor (VEGF) trap) plus docetaxel and cisplatin in patients with advanced solid tumours.

methodsPatients received intravenous aflibercept 4, 5, or 6 mg kg(-1) with docetaxel and cisplatin (75 mg m(-2) each) on day 1 of a 3-week cycle until progressive disease or unacceptable toxicity. Primary objectives were determining cycle 1 dose-limiting toxicities (DLTs) and the aflibercept recommended phase II trial dose (RP2D) for this combination.

resultsDuring the dose-escalation phase (n=16), there were two DLTs of febrile neutropenia (at 4 and 5 mg kg(-1)). Granulocyte colony-stimulating factor prophylaxis was subsequently recommended. The RP2D of aflibercept was established at 6 mg kg(-1) and administered to 14 additional patients. The most frequent grade 3/4 adverse events (AEs) were neutropenia (43.3%), stomatitis (20.0%), asthenia/fatigue (20.0%), and hypertension (16.7%). All-grade AEs associated with VEGF blockade included epistaxis (83.3%), dysphonia (70.0%), proteinuria (53.3%), and hypertension (50.0%). There were five partial responses (16.7%) and 18 cases of stable disease (60.0%) (lasting >3 months in 10 patients). There were no pharmacokinetic (PK) interactions between the three drugs.

conclusionAflibercept 6 mg kg(-1) with docetaxel and cisplatin 75 mg m(-2) every 3 weeks is the RP2D based on tolerability, antitumour activity, and PKs.

Indexed as

AgedAntineoplastic Combined Chemotherapy ProtocolsCisplatinDocetaxelDrug Administration ScheduleFatigueFemaleHumansMaleMiddle AgedNeoplasmsNeutropeniaReceptors, Vascular Endothelial Growth FactorRecombinant Fusion ProteinsTaxoidsafliberceptCisplatinDocetaxelReceptors, Vascular Endothelial Growth FactorRecombinant Fusion ProteinsTaxoids

Identifiers

PMID22790797
PMCPMC3419955
OpenAlexW2076733823

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Registered trials

None linked

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.