Evidence map›Paper›PMID 30215676›Full record

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

Alectinib versus crizotinib in treatment-naive anaplastic lymphoma kinase-positive (ALK+) non-small-cell lung cancer: CNS efficacy results from the ALEX study.

S Gadgeel, S Peters, T Mok, A T Shaw, D W Kim, S I Ou, M Pérol, A Wrona, S Novello, R Rosell and 5 more

Registry-linked trialAbstract readClinical Trial, Phase IIIComparative StudyRandomized Controlled Trial
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 trial NCT02075840 (Randomized, Multicenter, Phase III, Open-Label Study of Alectinib Versus Crizotinib in Treatment-Naive Anaplastic Lymphoma Kinase-Positive Advanced Non-Small Cell Lung Cancer), which is not on this map. Cited by 183 papers, 8 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
183citing papers in PubMed, 8 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.

NCT02075840 phase3completednot on this map

Randomized, Multicenter, Phase III, Open-Label Study of Alectinib Versus Crizotinib in Treatment-Naive Anaplastic Lymphoma Kinase-Positive Advanced Non-Small Cell Lung Cancer

TypeinterventionalSponsorHoffmann-La RocheRan2014 to 2025Enrolled303ConditionsNon-Small Cell Lung CancerArmsAlectinib, Crizotinib
3 · Its place in the literature

Who cites it

183 citing papers in PubMed, 8 syntheses or guidelines pooled it.

  1. Pooled it
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  4. Guideline
  5. 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
    Guideline
  6. Pooled it
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  12. Post Hoc Analysis of Lorlatinib Intracranial Efficacy and Safety in Patients WithJournal of clinical oncology : official journal of the American Society of Clinical Oncology · 2022
    Trial
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  17. Article
  18. Article
  19. Adjuvant alectinib versus crizotinib in completely resectedTranslational lung cancer research · 2026
    Article
  20. Review

123 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 GadgeelDivision of Hematology & Oncology, Department of Internal Medicine, University of Michigan, Ann Arbor, USA. Electronic address: sgadgeel@med.umich.edu.
S PetersDepartment of Oncology, Lausanne University Hospital, Lausanne, Switzerland.
T MokDepartment of Clinical Oncology, State Key Laboratory of South China, Chinese University of Hong Kong, Shatin, Hong Kong.
A T ShawDepartment of Medicine, Massachusetts General Hospital, Boston, USA.
D W KimDepartment of Internal Medicine, Seoul National University Hospital, Seoul, South Korea.
S I OuIrvine School of Medicine, Chao Family Comprehensive Cancer Center, University of California, Orange, USA.
M PérolDepartment of Medical Oncology, Léon Bérard Cancer Center, Lyon, France.
A WronaDepartment of Oncology and Radiotherapy, Medical University of Gdansk, Gdansk, Poland.
S NovelloDepartment of Oncology, University of Turin, Turin, Italy.
R RosellCatalan Institute of Oncology, Barcelona, Spain.
A ZeaiterF. Hoffmann-La Roche Ltd, Basel, Switzerland.
T LiuF. Hoffmann-La Roche Ltd, Basel, Switzerland.
E NüeschF. Hoffmann-La Roche Ltd, Basel, Switzerland.
B BalasF. Hoffmann-La Roche Ltd, Basel, Switzerland.
D R CamidgeDivision of Medical Oncology, University of Colorado, Aurora, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background: The phase III ALEX study in patients with treatment-naive advanced anaplastic lymphoma kinase mutation-positive (ALK+) non-small-cell lung cancer (NSCLC) met its primary end point of improved progression-free survival (PFS) with alectinib versus crizotinib. Here, we present detailed central nervous system (CNS) efficacy data from ALEX. Patients and methods: Overall, 303 patients aged ≥18 years underwent 1:1 randomization to receive twice-daily doses of alectinib 600 mg or crizotinib 250 mg. Brain imaging was conducted in all patients at baseline and every subsequent 8 weeks. End points (analyzed by subgroup: patients with/without baseline CNS metastases; patients with/without prior radiotherapy) included PFS, CNS objective response rate (ORR), and time to CNS progression. Results: In total, 122 patients had Independent Review Committee-assessed baseline CNS metastases (alectinib, n = 64; crizotinib, n = 58), 43 had measurable lesions (alectinib, n = 21; crizotinib, n = 22), and 46 had received prior radiotherapy (alectinib, n = 25; crizotinib, n = 21). Investigator-assessed PFS with alectinib was consistent between patients with baseline CNS metastases [hazard ratio (HR) 0.40, 95% confidence interval (CI): 0.25-0.64] and those without (HR 0.51, 95% CI: 0.33-0.80, P interaction = 0.36). Similar results were seen in patients regardless of prior radiotherapy. Time to CNS progression was significantly longer with alectinib versus crizotinib and comparable between patients with and without baseline CNS metastases (P < 0.0001). CNS ORR was 85.7% with alectinib versus 71.4% with crizotinib in patients who received prior radiotherapy and 78.6% versus 40.0%, respectively, in those who had not. Conclusion: Alectinib demonstrated superior CNS activity and significantly delayed CNS progression versus crizotinib in patients with previously untreated, advanced ALK+ NSCLC, irrespective of prior CNS disease or radiotherapy. Clinical trial registration: ClinicalTrials.gov NCT02075840.

Indexed as

AdultAgedAged, 80 and overAnaplastic Lymphoma KinaseBrainBrain NeoplasmsCarbazolesCarcinoma, Non-Small-Cell LungChemoradiotherapyCrizotinibDisease ProgressionFemaleHumansLungLung NeoplasmsMagnetic Resonance ImagingalectinibALK protein, humanAnaplastic Lymphoma KinaseCarbazolesCrizotinibPiperidines

Identifiers

PMID30215676
PMCPMC6290889

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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.