Evidence map›Paper›PMID 37327700›Full record

Trial reportESMO open2023

Safety and efficacy of trastuzumab biosimilar plus irinotecan or gemcitabine in patients with previously treated HER2 (ERBB2)-positive non-breast/non-gastric solid tumors: a phase II basket trial with circulating tumor DNA analysis.

J Hyung, J Y Lee, J E Kim, S Yoon, C Yoo, Y S Hong, J H Jeong, T W Kim, S Jeon, H R Jun and 5 more

Open access · goldAbstract readClinical Trial, Phase II
PubMed Full text at PMC Publisher
In one paragraph

Trial report in ESMO open, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
1.7field-weighted citation impact, top 15% 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

4 citing papers in PubMed, 7 citations in OpenAlex.

  1. Review
  2. Review
  3. Article
  4. Review
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 1 institution in 1 country.

J HyungDepartment of Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul.
J Y LeeDepartment of Medical Science, Asan Medical Institute of Convergence Science and Technology, Asan Medical Center, University of Ulsan College of Medicine, Seoul; Asan Center for Cancer Genome Discovery, Asan Institute for Life Science, Asan Medical Center, Seoul.
J E KimDepartment of Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul.
S YoonDepartment of Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul.
C YooDepartment of Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul.
Y S HongDepartment of Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul.
J H JeongDepartment of Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul.
T W KimDepartment of Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul.
S JeonDepartment of Medical Science, Asan Medical Institute of Convergence Science and Technology, Asan Medical Center, University of Ulsan College of Medicine, Seoul; Asan Center for Cancer Genome Discovery, Asan Institute for Life Science, Asan Medical Center, Seoul.
H R JunDepartment of Medical Science, Asan Medical Institute of Convergence Science and Technology, Asan Medical Center, University of Ulsan College of Medicine, Seoul; Asan Center for Cancer Genome Discovery, Asan Institute for Life Science, Asan Medical Center, Seoul.
C K JungGenopeaks Co., Ltd., Seoul.
J P JangGenopeaks Co., Ltd., Seoul.
J KimDepartment of Pathology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea.
S M ChunAsan Center for Cancer Genome Discovery, Asan Institute for Life Science, Asan Medical Center, Seoul; Department of Pathology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea. Electronic address: smchun@amc.seoul.kr.
J H AhnDepartment of Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul. Electronic address: drjiny@amc.seoul.kr.
Ulsan College · KR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundHuman epidermal growth factor receptor 2 (HER2) (ERBB2)-directed agents are standard treatments for patients with HER2-positive breast and gastric cancer. Herein, we report the results of an open-label, single-center, phase II basket trial to investigate the efficacy and safety of trastuzumab biosimilar (Samfenet®) plus treatment of physician's choice for patients with previously treated HER2-positive advanced solid tumors, along with biomarker analysis employing circulating tumor DNA (ctDNA) sequencing.

methodsPatients with HER2-positive unresectable or metastatic non-breast, non-gastric solid tumors who failed at least one prior treatment were included in this study conducted at Asan Medical Center, Seoul, Korea. Patients received trastuzumab combined with irinotecan or gemcitabine at the treating physicians' discretion. The primary endpoint was the objective response rate as per RECIST version 1.1. Plasma samples were collected at baseline and at the time of disease progression for ctDNA analysis.

resultsTwenty-three patients were screened from 31 December 2019 to 17 September 2021, and 20 were enrolled in this study. Their median age was 64 years (30-84 years), and 13 patients (65.0%) were male. The most common primary tumor was hepatobiliary cancer (seven patients, 35.0%), followed by colorectal cancer (six patients, 30.0%). Among 18 patients with an available response evaluation, the objective response rate was 11.1% (95% confidence interval 3.1% to 32.8%). ERBB2 amplification was detected from ctDNA analysis of baseline plasma samples in 85% of patients (n = 17), and the ERBB2 copy number from ctDNA analysis showed a significant correlation with the results from tissue sequencing. Among 16 patients with post-progression ctDNA analysis, 7 (43.8%) developed new alterations. None of the patients discontinued the study due to adverse events.

conclusionsTrastuzumab plus irinotecan or gemcitabine was safe and feasible for patients with previously treated HER2-positive advanced solid tumors with modest efficacy outcomes, and ctDNA analysis was useful for detecting HER2 amplification.

Indexed as

Biosimilar PharmaceuticalsCirculating Tumor DNAStomach NeoplasmsAdultAgedAged, 80 and overErb-b2 Receptor Tyrosine KinasesFemaleGemcitabineHumansIrinotecanMaleMiddle AgedTrastuzumabBiosimilar PharmaceuticalsCirculating Tumor DNAERBB2 protein, humanErb-b2 Receptor Tyrosine KinasesGemcitabineIrinotecanTrastuzumabbasket trialbiosimilarcirculating tumor DNAHER2-directed agents

Identifiers

PMID37327700
PMCPMC10334451
OpenAlexW4380854133

What OpenQuestion holds

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LicenceCC BY-NC-ND
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.