Evidence map›Paper›PMID 24628963›Full record

Trial reportBMC cancer2014

Bevacizumab plus octreotide and metronomic capecitabine in patients with metastatic well-to-moderately differentiated neuroendocrine tumors: the XELBEVOCT study.

Alfredo Berruti, Nicola Fazio, Anna Ferrero, Maria Pia Brizzi, Marco Volante, Elisabetta Nobili, Lucia Tozzi, Lisa Bodei, Mirella Torta, Antonio D'Avolio and 6 more

Registry-linked trialOpen access · goldAbstract readClinical Trial, Phase IIMulticenter Study
In one paragraph

Trial report in BMC cancer, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01203306 (Phase II Study of the Combination of Bevacizumab Plus Somatostatin Analogue and Metronomic Capecitabine in Patients With Advanced Inoperable Well-Differentiated Neuroendocrine Tumors), which is not on this map. Cited by 42 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
42citing papers in PubMed, 2 pooled it
8.4field-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.

NCT01203306 phase2unknown statusnot on this map

Phase II Study of the Combination of Bevacizumab Plus Somatostatin Analogue and Metronomic Capecitabine in Patients With Advanced Inoperable Well-Differentiated Neuroendocrine Tumors

TypeinterventionalSponsorUniversity of Turin, ItalyRan2006 to 2010Enrolled42ConditionsNeuroendocrine CarcinomasArmsbevacizumab + octreotide LAR + capecitabine
3 · Its place in the literature

Who cites it

42 citing papers in PubMed, 2 syntheses or guidelines pooled it, 86 citations in OpenAlex.

  1. Pooled it
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  14. Personalized functional profiling usingCancer biology & therapy · 2022
    Article
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  17. Chemotherapy in NEN: still has a role?Reviews in endocrine & metabolic disorders · 2021
    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

16 authors at 7 institutions in 1 country.

Alfredo BerrutiOncologia Medica, Dipartimento di Specialità Medico-Chirurgiche, Scienze Radiologiche e Sanità Pubblica, Università degli Studi di Brescia, Azienda Ospedaliera Spedali Civili Piazzale Spedali Civili 1, 25123 Brescia, Italy. alfredo.berruti@gmail.com.
Nicola Fazio
Anna Ferrero
Maria Pia Brizzi
Marco Volante
Elisabetta Nobili
Lucia Tozzi
Lisa Bodei
Mirella Torta
Antonio D'Avolio
Adriano Massimiliano Priola
Nadia Birocco
Vito Amoroso
Guido Biasco
Mauro Papotti
Luigi Dogliotti
University of Turin · ITUniversity of Brescia · ITCasa Sollievo della Sofferenza · ITOspedale Amedeo di Savoia · ITPoliclinico S.Orsola-Malpighi · ITRipamonti · ITUniversity of Bologna · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundWe assessed the activity and toxicity of the XELBEVOCT regimen in patients with metastatic well-to-moderately differentiated neuroendocrine neoplasms (WMD-NEN). Ancillary studies evaluated hypertension, proteinuria, and vascular endothelial growth factor (VEGF) polymorphisms in predicting progression-free survival (PFS) and the predictive role of serum vitamin D in progression-free survival and proteinuria onset.

methodsThis prospective phase 2 study included 45 patients with WMD-NEN arising from various primary sites. The treatment regimen was octreotide long-acting release (LAR), 20 mg monthly, metronomic capecitabine, 2000 mg/daily, and intravenous bevacizumab, 5 mg/kg every 2 weeks, without interruption for 9 months. Bevacizumab was continued until disease progression.

resultsPartial response was obtained in 8 patients (17.8%, 95% confidence interval [CI], 6.4%-28.2%); tumor response was more frequent in pancreatic than in non-pancreatic malignancies. The median PFS was 14.9 months; median overall survival was not attained. Biochemical and symptomatic responses were observed in 52.9% and 82.3% of cases, respectively. The treatment was well tolerated. Grade 3 toxicities included hand and foot syndrome (11.1%), proteinuria (4.4%), and renal toxicity (2.2%). Proteinuria (all grades) was correlated with longer PFS (p = 0.017). There was an inverse relationship between proteinuria and vitamin D levels. VEGF polymorphisms were not associated with patient outcome.

conclusionThe XELBEVOCT regimen is active and well tolerated in patients with metastatic WMD-NEN. Proteinuria correlated with hypovitaminosis D status and was the best predictive factor of treatment efficacy.

trial registrationTrial registration number NCT01203306.

Indexed as

Administration, MetronomicAdultAgedAntibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsBevacizumabCapecitabineDeoxycytidineDisease-Free SurvivalFemaleFluorouracilHumansMaleMiddle AgedNeoplasm MetastasisNeoplasm StagingAntibodies, Monoclonal, HumanizedBevacizumabCapecitabineDeoxycytidineFluorouracilOctreotide

Identifiers

PMID24628963
PMCPMC3996907
OpenAlexW2123731993

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.