Evidence map›Paper›PMID 29211833›Full record

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

A prospective phase II study of combined androgen blockade in patients with androgen receptor-positive metastatic or locally advanced unresectable salivary gland carcinoma.

C Fushimi, Y Tada, H Takahashi, T Nagao, H Ojiri, T Masubuchi, T Matsuki, K Miura, D Kawakita, H Hirai and 3 more

Abstract readClinical Trial, Phase II
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. Cited by 101 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
101citing papers in PubMed, 1 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.

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

101 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Guideline
  2. Trial
  3. Trial
  4. Phase II Study of Enzalutamide for Patients With Androgen Receptor-Positive Salivary Gland Cancers (Alliance A091404).Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2022
    Trial
  5. Abiraterone Acetate in Patients With Castration-Resistant, Androgen Receptor-Expressing Salivary Gland Cancer: A Phase II Trial.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2021
    Trial
  6. Trial
  7. Trial
  8. Theranostics · 2020
    Trial
  9. Article
  10. Article
  11. Review
  12. Article
  13. Article
  14. Contemporary Management of Malignancies of the Parotid Gland: A State-of-the-Art Review.Otolaryngology--head and neck surgery : official journal of American Academy of Otolaryngology-Head and Neck Surgery · 2026
    Review
  15. Article
  16. Review
  17. Review
  18. Article
  19. Article
  20. Article

41 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

13 authors.

C FushimiDepartment of Head and Neck Oncology and Surgery, International University of Health and Welfare Mita Hospital, Tokyo, Japan.
Y TadaDepartment of Head and Neck Oncology and Surgery, International University of Health and Welfare Mita Hospital, Tokyo, Japan. Electronic address: ytada@iuhw.ac.jp.
H TakahashiDepartment of Head and Neck Oncology and Surgery, International University of Health and Welfare Mita Hospital, Tokyo, Japan.
T NagaoDepartment of Anatomic Pathology, Tokyo Medical University School of Medicine, Tokyo, Japan.
H OjiriDepartment of Radiology, The Jikei University School of Medicine, Tokyo, Japan.
T MasubuchiDepartment of Head and Neck Oncology and Surgery, International University of Health and Welfare Mita Hospital, Tokyo, Japan.
T MatsukiDepartment of Head and Neck Oncology and Surgery, International University of Health and Welfare Mita Hospital, Tokyo, Japan.
K MiuraDepartment of Head and Neck Oncology and Surgery, International University of Health and Welfare Mita Hospital, Tokyo, Japan.
D KawakitaDepartment of Otorhinolaryngology, Head and Neck Surgery, Nagoya City University Graduate School of Medical Sciences, Nagoya, Japan.
H HiraiDepartment of Anatomic Pathology, Tokyo Medical University School of Medicine, Tokyo, Japan.
E HoshinoSupport Unit for Conducting Clinically Essential Studies, Graduate School of Public Health, St Luke's International University, Tokyo, Japan.
S KamataDepartment of Head and Neck Oncology and Surgery, International University of Health and Welfare Mita Hospital, Tokyo, Japan.
T SaotomeDivision of Medical Oncology, Matsudo City Hospital, Chiba, Japan.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background: There is no standard first-line chemotherapy for recurrent/metastatic (RM) or unresectable locally advanced (LA) salivary gland carcinoma (SGC). Patients and methods: We conducted a single institution, open-label, single arm, phase II trial of combined androgen blockade (CAB) for androgen receptor (AR)-positive SGC. Leuprorelin acetate was administered subcutaneously at a dose of 3.75 mg every 4 weeks. Bicalutamide was administered orally at a daily dose of 80 mg. Patients were treated until progressive disease or unacceptable toxicities. Results: Thirty-six eligible patients were enrolled. Thirty-three patients had RM disease and three patients had LA disease. The pathological diagnoses were salivary duct carcinoma (34 patients, 94%) and adenocarcinoma, NOS (two patients, 6%). The best overall response rate was 41.7% [n = 15, 95% confidence interval (CI), 25.5%-59.2%], the clinical benefit rate was 75.0% (n = 27, 95% CI, 57.8%-87.9%). The median progression-free survival was 8.8 months (95% CI, 6.3-12.3 months) and the median overall survival was 30.5 months (95% CI, 16.8 months to not reached). Additional analyses between treatment outcomes and clinicopathological factors or biomarkers including AR positivity, human epidermal growth factor receptor 2 status, and its complex downstream signaling pathway gene mutations showed no statistically significant differences. Elevated grade 3 liver transaminases and increased serum creatinine were reported in two patients, respectively. Discontinuation of leuprorelin acetate or bicalutamide due to adverse event occurred in one patient. Conclusion: This study suggests that CAB has equivalent efficacy and less toxicity for patients with AR-positive RM or unresectable LA SGC compared with conventional chemotherapy, which warrants further study. Clinical Trial Registration: UMIN-CTR (http://www.umin.ac.jp/ctr/index-j.htm), identification number: UMIN000005703.

Indexed as

Neoplasm MetastasisAgedAged, 80 and overAndrogen AntagonistsAnilidesDisease-Free SurvivalFemaleHumansLeuprolideMaleMiddle AgedNitrilesProspective StudiesReceptors, AndrogenSalivary Gland NeoplasmsTosyl CompoundsAndrogen AntagonistsAnilidesbicalutamideLeuprolideNitrilesReceptors, AndrogenTosyl Compounds

Identifiers

PMID29211833
PMCPMC5913639

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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.