Evidence map›Paper›PMID 27566443›Full record

Trial reportAnnals of oncology : official journal of the European Society for Medical Oncology2016

A phase II study of axitinib (AG-013736) in patients with incurable adenoid cystic carcinoma.

A L Ho, L Dunn, E J Sherman, M G Fury, S S Baxi, R Chandramohan, S Dogan, L G T Morris, G D Cullen, S Haque and 5 more

Open access · bronzeAbstract readClinical Trial, Phase II
In one paragraph

Trial report in Annals of oncology : official journal of the European Society for Medical Oncology, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 59 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
59citing papers in PubMed, 2 pooled it
5.6field-weighted citation impact, top 4% 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.

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

59 citing papers in PubMed, 2 syntheses or guidelines pooled it, 117 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Trial
  4. Trial
  5. TROP2 Expression in Salivary Gland Adenoid Cystic Carcinoma (ACC) According to Histologic Subtype: Therapeutic Implications.Journal of oral pathology & medicine : official publication of the International Association of Oral Pathologists and the American Academy of Oral Pathology · 2025
    Trial
  6. Phase 2 Trial of Regorafenib in Recurrent/Metastatic Adenoid Cystic Carcinoma.Clinical cancer research : an official journal of the American Association for Cancer Research · 2024
    Trial
  7. Trial
  8. A Phase II Trial of Rivoceranib, an Oral Vascular Endothelial Growth Factor Receptor 2 Inhibitor, for Recurrent or Metastatic Adenoid Cystic Carcinoma.Clinical cancer research : an official journal of the American Association for Cancer Research · 2023
    Trial
  9. Phase II Clinical Trial of Axitinib and Avelumab in Patients With Recurrent/Metastatic Adenoid Cystic Carcinoma.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2023
    Trial
  10. Phase II Study of Lenvatinib in Patients With Progressive, Recurrent or Metastatic Adenoid Cystic Carcinoma.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2019
    Trial
  11. Trial
  12. Article
  13. Single-cell sequencing reveals MCAMCancer cell international · 2025
    Article
  14. Article
  15. Article
  16. Article
  17. Article
  18. Article
  19. Review
  20. Article
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

15 authors at 2 institutions in 1 country.

A L HoDepartment of Medicine Department of Medicine hoa@mskcc.org.
L DunnDepartment of Medicine.
E J ShermanDepartment of Medicine Department of Medicine.
M G FuryDepartment of Medicine Department of Medicine.
S S BaxiDepartment of Medicine Department of Medicine.
R ChandramohanDepartment of Pathology.
S DoganDepartment of Pathology.
L G T MorrisHuman Oncology and Pathogenesis Program, Memorial Sloan Kettering Cancer Center, New York City, USA.
G D CullenDepartment of Medicine.
S HaqueDepartment of Radiology Department of Radiology, Weill Cornell Medical College, New York City.
C S SimaDepartment of Epidemiology-Biostatistics, Memorial Sloan Kettering Cancer Center, New York City, USA.
A NiDepartment of Epidemiology-Biostatistics, Memorial Sloan Kettering Cancer Center, New York City, USA.
C R AntonescuDepartment of Pathology.
N KatabiDepartment of Pathology.
D G PfisterDepartment of Medicine Department of Medicine.
Memorial Sloan Kettering Cancer Center · USCornell University · US

Funding

X-RAY CRYSTALLOGRAPHYP30CA008748 · NCI · SLOAN-KETTERING INSTITUTE FOR CANCER RES · PI Hongbiao Carl Lekaye · 1985 to 2026
$347.4M
Functionalizing recurrent FAT1 mutations and deletions in oral cancerK08DE024774 · NIDCR · SLOAN-KETTERING INST CAN RESEARCH · PI MORRIS, LUC GORDON TRANG · 2014 to 2018
$682k
NCI NIH HHS P30 CA008748NIDCR NIH HHS K08 DE024774
6 · The paper itself

Abstract

backgroundRecurrent/metastatic adenoid cystic carcinoma (ACC) is an incurable disease with no standard treatments. The majority of ACCs express the oncogenic transcription factor MYB (also c-myb), often in the context of a MYB gene rearrangement. This phase II trial of the tyrosine kinase inhibitor (TKI) axitinib (Pfizer) tested the hypothesis that targeting pathways activated by MYB can be therapeutically effective for ACC. PATIENTS AND

methodsThis is a minimax two-stage, phase II trial that enrolled patients with incurable ACC of any primary site. Progressive or symptomatic disease was required. Patients were treated with axitinib 5 mg oral twice daily; dose escalation was allowed. The primary end point was best overall response (BOR). An exploratory analysis correlating biomarkers to drug benefit was conducted, including next-generation sequencing (NGS) in 11 patients.

resultsThirty-three patients were registered and evaluable for response. Fifteen patients had the axitinib dose increased. Tumor shrinkage was achieved in 22 (66.7%); 3 (9.1%) had confirmed partial responses. Twenty-five (75.8%) patients had stable disease, 10 of whom had disease stability for >6 months. The median progression-free survival (PFS) was 5.7 months (range 0.92-21.8 months). Grade 3 axitinib-related toxicities included hypertension, oral pain and fatigue. A trend toward superior PFS was noted with the MYB/NFIB rearrangement, although this was not statistically significant. NGS revealed three tumors with 4q12 amplification, producing increased copies of axitinib-targeted genes PDGFR/KDR/KIT. Two 4q12 amplified patients achieved stable disease for >6 months, including one with significant tumor reduction and the longest PFS on study (21.8 months).

conclusionsAlthough the primary end point was not met, axitinib exhibited clinical activity with tumor shrinkage achieved in the majority of patients with progressive disease before trial enrollment. Analysis of MYB biomarkers and genomic profiling suggests the hypothesis that 4q12 amplified ACCs are a disease subset that benefit from TKI therapy.

Indexed as

AdultAgedAxitinibCarcinoma, Adenoid CysticChromosomes, Human, Pair 4Disease-Free SurvivalDose-Response Relationship, DrugDrug-Related Side Effects and Adverse ReactionsFemaleHigh-Throughput Nucleotide SequencingHumansImidazolesIndazolesMaleMiddle AgedNFI Transcription FactorsAxitinibImidazolesIndazolesNFIB protein, humanNFI Transcription FactorsOncogene Proteins, FusionProtein Kinase InhibitorsProto-Oncogene Proteins c-mybadenoid cystic carcinomaaxitinibMYB

Identifiers

PMID27566443
PMCPMC5035791
OpenAlexW2509315795

What OpenQuestion holds

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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.