Evidence map›Paper›PMID 28926529›Full record

Trial reportBritish journal of cancer2017

First-line FOLFIRI and bevacizumab in patients with advanced colorectal cancer prospectively stratified according to serum LDH: final results of the GISCAD (Italian Group for the Study of Digestive Tract Cancers) CENTRAL (ColorEctalavastiNTRiAlLdh) trial.

Riccardo Giampieri, Marco Puzzoni, Bruno Daniele, Daris Ferrari, Sara Lonardi, Alberto Zaniboni, Luigi Cavanna, Gerardo Rosati, Nicoletta Pella, Maria Giulia Zampino and 9 more

Abstract readClinical Trial, Phase II
In one paragraph

Trial report in British journal of cancer, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed
–field-weighted citation impact
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

9 citing papers in PubMed.

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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

19 authors.

Riccardo GiampieriDepartment of Medical Oncology Unit, University Hospital and Università Politecnica delle Marche, Ancona, Italy.
Marco PuzzoniDepartment of Medical Oncology Unit, University Hospital and University of Cagliari, Cagliari, Italy.
Bruno DanieleDepartment of Medical Oncology Unit, Ospedale G. Rummo, Benevento, Italy.
Daris FerrariDepartment of Medical Oncology Unit, Azienda Ospedaliera San Paolo, Milano, Italy.
Sara LonardiDepartment of Medical Oncology Unit 1, Istituto Oncologico Veneto-IRCCS, Padova, Italy.
Alberto ZaniboniDepartment of Medical Oncology Unit, Fondazione Poliambulanza, Brescia, Italy.
Luigi CavannaDepartment of Medical Oncology Unit, Ospedale di Piacenza, Piacenza, Italy.
Gerardo RosatiDepartment of Medical Oncology Unit, Ospedale San Carlo, Potenza, Italy.
Nicoletta PellaDepartment of Medical Oncology Unit, Azienda Ospedaliero Universitaria Santa Maria della Misericordia, Udine, Italy.
Maria Giulia ZampinoDepartment of Gastrointestinal Medical Oncology Unit and Neuroendocrine Tumors, Istituto Europeo di Oncologia-IRCCS, Milano, Italy.
Pietro SozziDepartment of Medical Oncology Unit, Nuovo Ospedale degli Infermi, Biella, Italy.
Domenico GermanoDepartment of Medical Oncology Unit, Ospedale G. Rummo, Benevento, Italy.
Vittorina ZagonelDepartment of Medical Oncology Unit 1, Istituto Oncologico Veneto-IRCCS, Padova, Italy.
Carla CodecàDepartment of Medical Oncology Unit, Azienda Ospedaliera San Paolo, Milano, Italy.
Michela LibertiniDepartment of Medical Oncology Unit, Fondazione Poliambulanza, Brescia, Italy.
Roberto LabiancaDepartment of Medical Oncology Unit, ASST Papa Giovanni XXIII, Bergamo, Italy.
Stefano CascinuDepartment of Modena Cancer Center, Università di Modena e Reggio Emilia, Modena, Italy.
Italian Group for the Study of Gastrointestinal Cancer (GISCAD)
Mario ScartozziDepartment of Medical Oncology Unit, University Hospital and University of Cagliari, Cagliari, Italy.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundPrevious findings suggested that bevacizumab might be able to improve response rate (RR) in colorectal cancer patients with high lactic dehydrogenase (LDH) basal levels.

methodsWe conducted a phase II trial to prospectively ascertain whether bevacizumab in combination with FOLFIRI could have an improved clinical activity in patients with high LDH serum levels. Primary end point of the study was RR; secondary end points were median overall survival and median progression-free survival (mPFS).

resultsA total of 81 patients were enrolled. No difference in terms of ORR (39% vs 31% for low vs high LDH level stratum, P=0.78) and mPFS (14.16 vs 10.29 months, HR: 1.07, 95% CI: 0.51-2.24, P=0.83) between the strata was observed, whereas overall survival (OS) was significantly longer for patients with low LDH (24.85 vs 15.14 months, HR: 4.08, 95% CI: 1.14-14.61, P=0.0004). In a not-pre-planned exploratory analysis using different cut-off ranges for LDH, we observed RR up to 70%, with no improvement in progression-free survival or OS.

conclusionsThe CENTRAL trial failed to demonstrate that high LDH levels were related to a significantly improved RR in patients receiving first-line FOLFIRI and bevacizumab. The LDH serum levels should then no further be investigated as a predictive factor in this setting.

Indexed as

AdultAgedAged, 80 and overAngiogenesis InhibitorsAntineoplastic Combined Chemotherapy ProtocolsBevacizumabCamptothecinColorectal NeoplasmsDisease-Free SurvivalFemaleFluorouracilHumansLeucovorinL-Lactate DehydrogenaseMaleMiddle AgedAngiogenesis InhibitorsBevacizumabCamptothecinFluorouracilLeucovorinL-Lactate Dehydrogenase

Identifiers

PMID28926529
PMCPMC5674092

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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.