Evidence map›Paper›PMID 29668860›Full record

Trial reportAnnals of oncology : official journal of the European Society for Medical Oncology2018

Alectinib versus chemotherapy in crizotinib-pretreated anaplastic lymphoma kinase (ALK)-positive non-small-cell lung cancer: results from the phase III ALUR study.

S Novello, J Mazières, I-J Oh, J de Castro, M R Migliorino, Å Helland, R Dziadziuszko, F Griesinger, A Kotb, A Zeaiter and 5 more

2 registry-linked trialsAbstract readClinical Trial, Phase IIIComparative StudyMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Annals of oncology : official journal of the European Society for Medical Oncology, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 175 papers, 16 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
175citing papers in PubMed, 16 pooled it
–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.

NCT02604342 phase3completednot on this map

Randomized, Multicenter, Phase III, Open-Label Study of Alectinib Versus Pemetrexed or Docetaxel in Anaplastic Lymphoma Kinase-Positive Advanced Non Small Cell Lung Cancer Patients Previously Treated With Platinum-Based Chemotherapy and Crizotinib

TypeinterventionalSponsorHoffmann-La RocheRan2015 to 2018Enrolled119ConditionsNon-small Cell Lung CancerArmsAlectinib, Docetaxel, Pemetrexed
NCT05015010 phase2active not recruitingnot on this mapstarted 2021, after this paper: background citation

Phase II, Open-label, Single-arm, Multicenter Study to Assess the Activity and Safety of ALectinib as NEO-adjuvant Therapy in Patients With Anaplastic Lymphoma Kinase-positive (ALK+) Locally Advanced Stage III Non-Small Cell Lung Cancer (NSCLC): ALNEO Trial

TypeinterventionalSponsorGruppo Oncologico Italiano di Ricerca ClinicaRan2021 to 2026Enrolled33ConditionsNon Small Cell Lung CancerArmsAlectinib
3 · Its place in the literature

Who cites it

175 citing papers in PubMed, 16 syntheses or guidelines pooled it.

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  12. SEOM-GEINO clinical guideline of systemic therapy and management of brain central nervous system metastases (2021).Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2022
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115 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

15 authors.

S NovelloDepartment of Oncology, University of Turin, Turin, Italy.
J MazièresDepartment of Pneumology, Toulouse University Hospital, Paul Sabatier University, Toulouse, France.
I-J OhDepartment of Internal Medicine, Chonnam National University Hwasun Hospital, Hwasun-gun Jeollanam-do, Republic of Korea.
J de CastroDepartment of Translational Oncology, La Paz University Hospital, Madrid, Spain.
M R MigliorinoAzienda Ospedaliera San Camillo Forlanini Hospital, Rome, Italy.
Å HellandDepartment of Cancer Genetics and Department of Oncology, Institute for Cancer Research, Oslo University Hospital, Oslo, Norway.
R DziadziuszkoDepartment of Oncology and Radiotherapy, Medical University of Gdańsk, Gdańsk, Poland.
F GriesingerDepartment of Hematology and Oncology, Pius Hospital, Medical Campus University of Oldenburg, Oldenburg, Germany.
A KotbF. Hoffmann-La Roche Ltd., Basel, Switzerland.
A ZeaiterF. Hoffmann-La Roche Ltd., Basel, Switzerland.
A CardonaF. Hoffmann-La Roche Ltd., Basel, Switzerland.
B BalasF. Hoffmann-La Roche Ltd., Basel, Switzerland.
H K JohannsdottirF. Hoffmann-La Roche Ltd., Basel, Switzerland.
A Das-GuptaF. Hoffmann-La Roche Ltd., Basel, Switzerland.
J WolfDepartment I of Internal Medicine, Center for Integrated Oncology, University Hospital Cologne, Cologne, Germany. Electronic address: juergen.wolf@uk-koeln.de.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background: This is the first trial to directly compare efficacy and safety of alectinib versus standard chemotherapy in advanced/metastatic anaplastic lymphoma kinase (ALK)-positive non-small-cell lung cancer (NSCLC) patients who have progressed on, or were intolerant to, crizotinib. Patients and methods: ALUR (MO29750; NCT02604342) was a randomized, multicenter, open-label, phase III trial of alectinib versus chemotherapy in advanced/metastatic ALK-positive NSCLC patients previously treated with platinum-based doublet chemotherapy and crizotinib. Patients were randomized 2 : 1 to receive alectinib 600 mg twice daily or chemotherapy (pemetrexed 500 mg/m2 or docetaxel 75 mg/m2, both every 3 weeks) until disease progression, death, or withdrawal. Primary end point was investigator-assessed progression-free survival (PFS). Results: Altogether, 107 patients were randomized (alectinib, n = 72; chemotherapy, n = 35) in 13 countries across Europe and Asia. Median investigator-assessed PFS was 9.6 months [95% confidence interval (CI): 6.9-12.2] with alectinib and 1.4 months (95% CI: 1.3-1.6) with chemotherapy [hazard ratio (HR) 0.15 (95% CI: 0.08-0.29); P < 0.001]. Independent Review Committee-assessed PFS was also significantly longer with alectinib [HR 0.32 (95% CI: 0.17-0.59); median PFS was 7.1 months (95% CI: 6.3-10.8) with alectinib and 1.6 months (95% CI: 1.3-4.1) with chemotherapy]. In patients with measurable baseline central nervous system (CNS) disease (alectinib, n = 24; chemotherapy, n = 16), CNS objective response rate was significantly higher with alectinib (54.2%) versus chemotherapy (0%; P < 0.001). Grade ≥3 adverse events were more common with chemotherapy (41.2%) than alectinib (27.1%). Incidence of AEs leading to study-drug discontinuation was lower with alectinib (5.7%) than chemotherapy (8.8%), despite alectinib treatment duration being longer (20.1 weeks versus 6.0 weeks). Conclusion: Alectinib significantly improved systemic and CNS efficacy versus chemotherapy for crizotinib-pretreated ALK-positive NSCLC patients, with a favorable safety profile. Trial registration: ClinicalTrials.gov NCT02604342; Roche study MO29750.

Indexed as

Salvage TherapyAdenocarcinomaAdultAgedAged, 80 and overAntineoplastic Combined Chemotherapy ProtocolsCarbazolesCarcinoma, Non-Small-Cell LungCentral Nervous System NeoplasmsCrizotinibDrug Resistance, NeoplasmFemaleFollow-Up StudiesHumansLung NeoplasmsLymphatic MetastasisalectinibCarbazolesCrizotinibPemetrexedPiperidines

Identifiers

PMID29668860
PMCPMC6005013

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.