Evidence map›Paper›PMID 39422602›Full record

Trial reportCancer2025

Phase 2 trial of avelumab in combination with gemcitabine in advanced leiomyosarcoma as a second-line treatment (EAGLES, Korean Cancer Study Group UN18-09).

Miso Kim, Yu Jung Kim, Koung Jin Suh, Se Hyun Kim, Jeong Eun Kim, Juhyeon Jeong, Jung Yong Hong, Jeeyun Lee, Su Jin Lee, Sung Yong Oh and 10 more

Erratum issuedAbstract readClinical Trial, Phase IIMulticenter Study
In one paragraph

Trial report in Cancer, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing 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

6 citing papers in PubMed.

  1. Trial
  2. Review
  3. Review
  4. A Review onPlants (Basel, Switzerland) · 2026
    Review
  5. Article
  6. Overview on biomarkers for immune oncology drugs.Exploration of targeted anti-tumor therapy · 2025
    Review
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

20 authors.

Miso KimDepartment of Internal Medicine, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, South Korea.
Yu Jung KimDepartment of Internal Medicine, Seoul National University Bundang Hospital, Seoul National University College of Medicine, Seongnam, South Korea.ORCID https://orcid.org/0000-0002-5037-0523
Koung Jin SuhDepartment of Internal Medicine, Seoul National University Bundang Hospital, Seoul National University College of Medicine, Seongnam, South Korea.ORCID https://orcid.org/0000-0002-1881-8738
Se Hyun KimDepartment of Internal Medicine, Seoul National University Bundang Hospital, Seoul National University College of Medicine, Seongnam, South Korea.ORCID https://orcid.org/0000-0002-2292-906X
Jeong Eun KimDepartment of Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea.
Juhyeon JeongDepartment of Pathology, Gil Medical Center, Gachon University College of Medicine, Incheon, South Korea.
Jung Yong HongDepartment of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea.
Jeeyun LeeDepartment of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea.
Su Jin LeeDepartment of Medicine, Ewha Womans University School of Medicine, Seoul, South Korea.
Sung Yong OhDepartment of Internal Medicine, Dong-A University Hospital, Dong-A University College of Medicine, Busan, South Korea.ORCID https://orcid.org/0000-0002-8321-4113
Jung Hoon KimDepartment of Internal Medicine, Pusan National University Yangsan Hospital, Yangsan, South Korea.ORCID https://orcid.org/0000-0002-1106-8030
Gyeong-Won LeeDivision of Hematology and Oncology, Department of Internal Medicine, Institute of Medical Science, Gyeongsang National University Hospital, Gyeongsang National University College of Medicine, Jinju, South Korea.
Mi Sun AhnDepartment of Hematology-Oncology, Ajou University School of Medicine, Suwon, South Korea.
Wonyoung ChoiCenter for Clinical Trials, National Cancer Center, Goyang, South Korea.
Yoon Ji ChoiDepartment of Internal Medicine, Korea University Anam Hospital, Korea University College of Medicine, Seoul, South Korea.
Taebum LeeLunit, Seoul, South Korea.ORCID https://orcid.org/0000-0002-9472-0644
Chiyoon OumLunit, Seoul, South Korea.
Jeongkyu KimBioinformatics, Geninus Inc., Seoul, South Korea.
Young Saing KimDepartment of Internal Medicine, Gil Medical Center, Gachon University College of Medicine, Incheon, South Korea.ORCID https://orcid.org/0000-0003-0207-2617
Jin-Hee AhnDepartment of Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea.

Funding

Merck KGaA 10.13039/100009945
6 · The paper itself

Abstract

backgroundIn this single-arm, multicenter, phase 2 trial, the authors evaluated the efficacy and safety of avelumab plus gemcitabine in patients with leiomyosarcoma (LMS) who failed on first-line chemotherapy.

methodsPatients with advanced LMS received avelumab 10 mg/kg on days 1 and 15 (for up to 24 months) plus gemcitabine 1000 mg/m

resultsIn total, 38 patients were enrolled. Of these, 35 patients were evaluable, and the ORR was 20% (95% confidence interval; [CI], 8%-37%). The disease control rate was 71%, and the median duration of response was 21.8 months (range, 7.6 to ≥43.3 months). The median progression free-survival was 5.6 months (95% CI, 4.5-6.8 months), and the median overall survival was 27.5 months (95% CI, 20.4-34.6 months). Grade 3-4 adverse events occurred in 70% of patients, of which neutropenia was the most common (54%). Immune-mediated adverse events occurred in five patients (14%; hypothyroidism, n = 3; hepatitis, n = 2). Patients who had a higher density of tumor-infiltrating lymphocytes (greater than the median) exhibited better ORR (35% vs. 8%; p = .104), progression-free survival (median, 7.3 vs. 3.3 months; p = .024), and overall survival (median, not reached vs. 21.5 months; p = .027).

conclusionsThe combination of avelumab and gemcitabine demonstrated promising efficacy and manageable safety in patients with advanced LMS who progressed on first-line therapy. Tumor-infiltrating lymphocyte density may be an important factor in predicting the response to combining immunotherapy with chemotherapy.

Indexed as

Antibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsDeoxycytidineGemcitabineLeiomyosarcomaAdultAgedFemaleHumansMaleMiddle AgedProgression-Free SurvivalAntibodies, Monoclonal, HumanizedavelumabDeoxycytidineGemcitabineavelumabgemcitabineleiomyosarcomasurvivaltumor‐infiltrating lymphocytes

Identifiers

PMID39422602
PMCPMC11694233

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.