Evidence map›Paper›PMID 31077164›Full record

Trial reportBMC cancer2019

AVAiLABLE NIS - AVASTIN® in lung cancer treatment in routine oncology practice in Germany.

Mark-Oliver Zahn, Dominik Linck, Christoph Losem, Christian Gessner, Holger Metze, Vincent E Gaillard, Hans Werner Tessen

Registry-linked trialAbstract readClinical Trial
In one paragraph

Trial report in BMC cancer, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02596958 (Available - Avastin in Addition to Platinum-based Chemotherapy is Indicated for First-lime Treatment of Patients With Locally Advanced, Metastatic or Recurrent Non-small Lung Cancer Other Than Predominantly Squamous Cell Histology), which is not on this map. Cited by 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing 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.

NCT02596958 completednot on this map

Available - Avastin in Addition to Platinum-based Chemotherapy is Indicated for First-lime Treatment of Patients With Locally Advanced, Metastatic or Recurrent Non-small Lung Cancer Other Than Predominantly Squamous Cell Histology

TypeobservationalSponsorHoffmann-La RocheRan2007 to 2013Enrolled996ConditionsNon-Squamous Non-Small Cell Lung CancerArmsBevacizumab
3 · Its place in the literature

Who cites it

7 citing papers in PubMed.

  1. Trial
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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

7 authors.

Mark-Oliver ZahnOnkologische Schwerpunktpraxis Goslar, Kösliner Str. 14, 38642, Goslar, Germany. studien@onkologie-goslar.de.ORCID http://orcid.org/0000-0002-0528-5311
Dominik LinckOnkologische Schwerpunktpraxis Euskirchen, Gottfried-Disse-Str. 42, 53879, Euskirchen, Germany.
Christoph LosemMVZ für Onkologie und Hämatologie im Rhein-Kreis Neuss, Am Hasenberg 44, 41462, Neuss, Germany.
Christian GessnerPneumologische Schwerpunktpraxis mit pneumologischer Onkologie Leipzig, Tauchaer Str. 12, 04357, Leipzig, Germany.
Holger MetzePneumologie des Rhön-Klinikums Frankfurt/Oder, Müllroser Chaussee 7, 15236, Frankfurt/Oder, Germany.
Vincent E GaillardF. Hoffmann-La Roche Ltd, Product Development Medical Affairs, Grenzacherstrasse, 4070, Basel, Switzerland.
Hans Werner TessenOnkologische Schwerpunktpraxis Goslar, Kösliner Str. 14, 38642, Goslar, Germany.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundBevacizumab (Avastin®), a recombinant humanized monoclonal antibody, in combination with platinum-doublet chemotherapy has become a routine treatment for advanced non-small-cell lung cancer (NSCLC). The post-authorization, non-interventional study 'AVAiLABLE' assessed the effectiveness and safety of bevacizumab combined with chemotherapy as first-line treatment.

methodsNine hundred and eighty-seven adult patients (mean age 61.5 years, 59.8% male) with non-resectable advanced, metastatic or recurrent, predominantly non-squamous NSCLC were evaluated at 185 sites across Germany. 72.8% of the patients had stage IV disease at start of observation, 90.1% had histologically confirmed adenocarcinoma and 80.8% met the bevacizumab label 'NSCLC other than predominantly squamous cell histology'. According to bevacizumab label, chemotherapy plus bevacizumab was recommended, followed by bevacizumab maintenance therapy. Effectiveness endpoints included response rates and progression-free survival (PFS); safety endpoints comprised adverse drug reactions (ADRs). Patients were followed until progression or intolerable toxicity. Data were evaluated by descriptive statistical methods.

resultsMedian PFS was 7.4 months (95% CI: 7.1; 8.4), overall response rate (ORR) 45.6% and disease control rate (DCR) 75%. The majority of patients (72.7%) achieved partial response or stable disease. Complete response was reached by 2.3%. 33.6% of patients experienced an ADR of grade ≥ 3. Bevacizumab-related ADRs of grade ≥ 3 occurred in 5.7% of patients, with the highest incidence for leukopenia, neutropenia, and hypertension.

conclusionsResults of the non-interventional study 'AVAiLABLE' confirmed the effectiveness and safety of bevacizumab in combination with platinum-based chemotherapy as first-line treatment for advanced NSCLC in accordance with previous studies. No new safety signals were identified. Maintenance therapy with bevacizumab was well tolerated and safe even over extended periods (> 20 cycles).

trial registrationClinicalTrials.gov Identifier: NCT02596958; registered on 4 November 2015.

Indexed as

AgedAntineoplastic Agents, ImmunologicalBevacizumabCarcinoma, Non-Small-Cell LungFemaleGermanyHumansLung NeoplasmsMaintenance ChemotherapyMaleMiddle AgedNeoplasm StagingPlatinumStandard of CareSurvival AnalysisTreatment OutcomeAntineoplastic Agents, ImmunologicalBevacizumabPlatinumAdenocarcinomaAdvanced non-small-cell lung cancerBevacizumab (Avastin®) plus chemotherapyPost-authorization study

Identifiers

PMID31077164
PMCPMC6511164

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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.