Evidence map›Paper›PMID 40561362›Full record

Trial reportJapanese journal of clinical oncology2025

Multicenter phase II trial of trastuzumab and docetaxel for HER2-positive salivary gland cancer.

Satoshi Kano, Naomi Kiyota, Ichiro Kinoshita, Yuichiro Tada, Kei Ijichi, Tomoko Yamazaki, Yasushi Shimizu, Yutaka Hatanaka, Hitoshi Tsuda, Shojiroh Morinaga and 8 more

Abstract readClinical Trial, Phase IIMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Japanese journal of clinical oncology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing 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

5 citing papers in PubMed.

  1. Article
  2. Article
  3. Article
  4. Article
  5. 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

18 authors.

Satoshi KanoDepartment of Otolaryngology-Head and Neck Surgery, Faculty of Medicine and Graduate School of Medicine, Hokkaido University, N15, W7, Kita-ku, Sapporo, 060-8638, Japan.
Naomi KiyotaDepartment of Medical Oncology and Hematology, Kobe University Hospital, 7-5-2 Kusunoki-ku, Kobe, 650-0017, Japan.
Ichiro KinoshitaDepartment of Medical Oncology, Hokkaido University Hospital, N14, W5, Kita-ku, Sapporo, 060-8648, Japan.
Yuichiro TadaDepartment of Head and Neck Oncology and Surgery, International University of Health and Welfare, Mita Hospital, 1-4-3 Mita, Minato-ku, Tokyo, 108-8329, Japan.
Kei IjichiDepartment of Otolaryngology- Head and Neck Surgery, Nagoya City University Graduate School of Medicine, 1 Kawasumi, Mizuhomachi, Mizuho-ku, Nagoya, 467-8601, Japan.
Tomoko YamazakiDivision of Head and Neck Cancer Oncology, Miyagi Cancer Center, 47-1 Nodayama, Aza-Shiote, Aijima, Natori, 981-1293, Japan.
Yasushi ShimizuDepartment of Medical Oncology, Hokkaido University Hospital, N14, W5, Kita-ku, Sapporo, 060-8648, Japan.
Yutaka HatanakaCenter for Development of Advanced Diagnostics, Hokkaido University Hospital, N14, W5, Kita-ku, Sapporo, 060-8648, Japan.
Hitoshi TsudaDepartment of Basic Pathology, National Defense Medical College, 3-2 Namiki, Tokorozawa, 359-8513, Japan.
Shojiroh MorinagaDepartment of Diagnostic Pathology, Hino Municipal Hospital, 3-1, 4-chome, Tamadaira, Hino, 191-0062, Japan.
Yoshihiro MatsunoDepartment of Surgical Pathology, Hokkaido University Hospital, N14, W5, Kita-ku, Sapporo, 060-8648, Japan.
Yoichi M ItoData Science Center, Promotion Unit, Institute of Health Science Innovation for Medical Care, Hokkaido University Hospital, N14, W5, Kita-ku, Sapporo, 060-8648, Japan.
Naoki NishimotoClinical Research and Medical Innovation Center, Hokkaido University Hospital, N14, W5, Kita-ku, Sapporo, 060-8648, Japan.
Keiko KobayashiClinical Research and Medical Innovation Center, Hokkaido University Hospital, N14, W5, Kita-ku, Sapporo, 060-8648, Japan.
Toshiyuki IsoeClinical Research and Medical Innovation Center, Hokkaido University Hospital, N14, W5, Kita-ku, Sapporo, 060-8648, Japan.
Takuro NoguchiDepartment of Medical Oncology, Hokkaido University Hospital, N14, W5, Kita-ku, Sapporo, 060-8648, Japan.
Akihiro HommaDepartment of Otolaryngology-Head and Neck Surgery, Faculty of Medicine and Graduate School of Medicine, Hokkaido University, N15, W7, Kita-ku, Sapporo, 060-8638, Japan.
Hirotoshi Dosaka-AkitaDepartment of Medical Oncology, Hokkaido University Hospital, N14, W5, Kita-ku, Sapporo, 060-8648, Japan.

Funding

Japan Agency for Medical Research and Development 19lk0201074h0003Ministry of Health, Labour and Welfare 16lk0103005h0005
6 · The paper itself

Abstract

backgroundsStandard systemic chemotherapy remains unestablished for recurrent or metastatic (RM) salivary gland cancer (SGC) due to its rarity. A single institute phase II trial of trastuzumab and docetaxel previously showed efficacy with human epidermal growth factor receptor 2 (HER2)-positive SGC.

methodsWe conducted a multicenter, single-arm, open-label phase II trial of trastuzumab and docetaxel for HER2-positive RM SGC. Patients received trastuzumab 6 mg/kg (loading dose 8 mg/kg) and docetaxel 70 mg/m2 every 3 weeks up to eight cycles. The primary endpoint was the objective response rate (ORR) by a blinded independent review committee. Secondary endpoints included progression-free survival (PFS), overall survival (OS), disease control rate (DCR), and safety. Forty-eight patients were screened for HER2 status; 23 were HER2-positive.

resultsEighteen patients were enrolled, with 16 receiving the protocol treatment. Fourteen patients were diagnosed with salivary duct carcinoma. The ORR was 60.0% (95% confidence interval [CI], 32.3 to 83.7). The median PFS was 8.5 months (95% CI, 6.0 to 12.7), the median OS, 33.8 months (95% CI, 16.9 to not estimable), and the DCR, 93.3% (95% CI, 68.1 to 99.8). The most frequent grade ≥3 treatment-emerged adverse events were neutropenia (100%), leukopenia (93.8%), lymphopenia (18.8%), and febrile neutropenia (12.5%). One treatment-related death occurred (6.3%) due to hypoalbuminemia.

conclusionsThese results demonstrate the significant efficacy and predictable toxicities of trastuzumab and docetaxel in patients with HER2-positive RM SGC, leading to the simultaneous approval of trastuzumab and HER2 companion diagnostics assay for this setting in Japan.

Indexed as

Antineoplastic Combined Chemotherapy ProtocolsErb-b2 Receptor Tyrosine KinasesSalivary Gland NeoplasmsAdultAgedDocetaxelFemaleHumansMaleMiddle AgedTrastuzumabDocetaxelERBB2 protein, humanErb-b2 Receptor Tyrosine KinasesTrastuzumabdocetaxelHER2phase II trialsalivary gland cancertrastuzumab

Identifiers

PMID40561362
PMCPMC12501972

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

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.