Evidence map›Paper›PMID 42546251›Full record

Trial reportJournal of clinical oncology : official journal of the American Society of Clinical Oncology2026

Darolutamide Alone and in Combination With Goserelin in Androgen Receptor-Positive Salivary Gland Carcinoma: Results From the Phase II DISCOVARY Trial.

Susumu Okano, Makoto Tahara, Kiyoaki Tsukahara, Tomoyuki Otsuka, Satoshi Kano, Masato Nagaoka, Hideoki Uryu, Daisuke Sano, Naoki Nishio, Kazuchika Ono and 6 more

Abstract readClinical Trial, Phase IIMulticenter Study
In one paragraph

Trial report in Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

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

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

0 citing papers in PubMed.

No citing paper in PubMed yet.

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

16 authors.

Susumu OkanoDepartment of Head and Neck Medical Oncology, National Cancer Center Hospital East, Chiba, Japan.ORCID 0000-0001-6639-9753
Makoto TaharaDepartment of Head and Neck Medical Oncology, National Cancer Center Hospital East, Chiba, Japan.ORCID 0000-0001-9035-3106
Kiyoaki TsukaharaDepartment of Otorhinolaryngology-Head and Neck Surgery, Tokyo Medical University, Tokyo, Japan.
Tomoyuki OtsukaDepartment of Medical Oncology, Osaka International Cancer Institute, Osaka, Japan.ORCID 0000-0003-3394-0720
Satoshi KanoDepartment of Otolaryngology-Head and Neck Surgery, Faculty of Medicine and Graduate School of Medicine, Hokkaido University, Hokkaido, Japan.ORCID 0000-0003-4750-5332
Masato NagaokaDepartment of Otorhinolaryngology-Head and Neck Surgery, Jikei University School of Medicine, Tokyo, Japan.ORCID 0000-0001-6350-5186
Hideoki UryuDepartment of Otolaryngology-Head and Neck Surgery, National Hospital Organization Kyushu Medical Center, Fukuoka, Japan.ORCID 0009-0002-3502-817X
Daisuke SanoDepartment of Otorhinolaryngology-Head and Neck Surgery, Yokohama City University Graduate School of Medicine, Kanagawa, Japan.ORCID 0000-0002-7686-4724
Naoki NishioDepartment of Otorhinolaryngology, Nagoya University Graduate School of Medicine, Aichi, Japan.ORCID 0000-0003-1495-0376
Kazuchika OnoDepartment of Head and Neck Surgery, Institute of Science Tokyo, Tokyo, Japan.ORCID 0000-0001-6826-799X
Akira OhkoshiDepartment of Otolaryngology-Head and Neck Surgery, Tohoku University Graduate School of Medicine, Miyagi, Japan.ORCID 0000-0003-0652-7041
Toyoyuki HanazawaDepartment of Otorhinolaryngology-Head and Neck Surgery, Graduate School of Medicine, Chiba University, Chiba, Japan.
Satoru ShinodaYCU Center for Novel and Exploratory Clinical Trials (Y-NEXT), Yokohama City University, Kanagawa, Japan.ORCID 0000-0003-0651-438X
Yuriko TakedaYCU Center for Novel and Exploratory Clinical Trials (Y-NEXT), Yokohama City University, Kanagawa, Japan.
Kouji YamamotoYCU Center for Novel and Exploratory Clinical Trials (Y-NEXT), Yokohama City University, Kanagawa, Japan.ORCID 0000-0003-0696-9659
Naomi KiyotaDepartment of Medical Oncology and Hematology, Cancer Center, Kobe University Hospital, Hyogo, Japan.ORCID 0000-0001-8021-6116

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeSalivary gland carcinoma (SGC), particularly salivary duct carcinoma (SDC), is a rare and aggressive malignancy with no standard systemic treatment. Androgen receptor (AR) expression is frequently detected in SDC, which suggests inhibition of the AR pathway as a therapeutic strategy. We conducted a prospective phase II trial of the efficacy and safety of darolutamide, a second-generation AR signaling inhibitor, as monotherapy or in combination with goserelin, in patients with AR-positive unresectable locally advanced (LA) or recurrent/metastatic (R/M) SGC.

methodsDISCOVARY was a multicenter, single-arm, phase II trial conducted in Japan. Patients with unresectable LA or R/M AR-positive SGC were enrolled into two sequential cohorts, a monotherapy cohort (darolutamide 600 mg orally twice daily) and a combination cohort (darolutamide plus goserelin 3.6 mg subcutaneously once every 28 days). The primary end point was objective response rate (ORR). Secondary end points included progression-free survival (PFS), overall survival (OS), safety, and health-related quality of life.

resultsFifty-seven patients were enrolled (monotherapy, n = 24; combination, n = 33). In the monotherapy cohort, the confirmed ORR was 8.3% (90% CI, 1.5 to 24.0) and the median PFS was 5.7 months. In the combination cohort, ORR was 45.2% (90% CI, 29.7 to 61.3) and the median PFS was 13.1 months. Twelve-month OS rates were 91.3% and 87.0%, respectively. Most adverse events were grade 1 or 2 in severity, with no treatment-related deaths. Quality of life was preserved. No clear association between AR expression level or Ki-67 index and treatment response was evident in exploratory analysis.

conclusionDarolutamide demonstrated antitumor activity in AR-positive SGC, with numerically more favorable outcomes with goserelin. Darolutamide plus goserelin may represent a chemotherapy-sparing option in this rare malignancy.

Indexed as

Antineoplastic Combined Chemotherapy ProtocolsCarcinomaGoserelinReceptors, AndrogenSalivary Gland NeoplasmsAdultAgedFemaleHumansMaleMiddle AgedProgression-Free SurvivalProspective StudiesSalivary DuctsAR protein, humanGoserelinReceptors, Androgen

Identifiers

PMID42546251
PMCPMC13581294

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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.