Evidence map›Paper›PMID 34150658›Full record

ArticleFrontiers in oncology2021

Real-World Clinical Outcomes of Biosimilar Trastuzumab (CT-P6) in HER2-Positive Early-Stage and Metastatic Breast Cancer.

Soong June Bae, Jee Hung Kim, Sung Gwe Ahn, Hei-Cheul Jeung, Joohyuk Sohn, Gun Min Kim, Min Hwan Kim, Seung Il Kim, Seho Park, Hyung Seok Park and 2 more

Open access · goldAbstract read
In one paragraph

Article in Frontiers in oncology, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 17 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
17citing papers in PubMed, 1 pooled it
1.4field-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

17 citing papers in PubMed, 1 synthesis or guideline pooled it, 21 citations in OpenAlex.

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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

12 authors at 2 institutions in 1 country.

Soong June BaeDepartment of Surgery, Gangnam Severance Hospital, Yonsei University College of Medicine, Seoul, South Korea.
Jee Hung KimInstitute for Breast Cancer Precision Medicine, Yonsei University College of Medicine, Seoul, South Korea.
Sung Gwe AhnDepartment of Surgery, Gangnam Severance Hospital, Yonsei University College of Medicine, Seoul, South Korea.
Hei-Cheul JeungInstitute for Breast Cancer Precision Medicine, Yonsei University College of Medicine, Seoul, South Korea.
Joohyuk SohnDivision of Medical Oncology, Department of Internal Medicine, Yonsei Cancer Center, Yonsei University College of Medicine, Seoul, South Korea.
Gun Min KimDivision of Medical Oncology, Department of Internal Medicine, Yonsei Cancer Center, Yonsei University College of Medicine, Seoul, South Korea.
Min Hwan KimDivision of Medical Oncology, Department of Internal Medicine, Yonsei Cancer Center, Yonsei University College of Medicine, Seoul, South Korea.
Seung Il KimDepartment of Surgery, Yonsei Cancer Center, Yonsei University College of Medicine, Seoul, South Korea.
Seho ParkDepartment of Surgery, Yonsei Cancer Center, Yonsei University College of Medicine, Seoul, South Korea.
Hyung Seok ParkDepartment of Surgery, Yonsei Cancer Center, Yonsei University College of Medicine, Seoul, South Korea.
Ji Ye KimDepartment of Surgery, Yonsei Cancer Center, Yonsei University College of Medicine, Seoul, South Korea.
Joon JeongDepartment of Surgery, Gangnam Severance Hospital, Yonsei University College of Medicine, Seoul, South Korea.
Yonsei University · KRGangnam Severance Hospital · KR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe trastuzumab biosimilar CT-P6 has demonstrated equivalent efficacy and comparable safety to reference trastuzumab (RTZ) in clinical trials of human epidermal growth factor receptor 2 (HER2)-positive early breast cancer (EBC). Here, we present the first real-world comparison of CT-P6 versus RTZ with dual HER2-targeted therapy for the neoadjuvant and palliative first-line treatment with HER2-positive EBC and metastatic breast cancer (MBC) patients in two tertiary hospitals in Korea.

methodsWe retrospectively investigated medical records in the Severance Breast Cancer Registry in Korea. We identified patients with HER2-positive EBC (n=254) who had received neoadjuvant chemotherapy with RTZ or CT-P6, plus pertuzumab, carboplatin and docetaxel (TCHP) and untreated stage IV MBC (n=103) who had received palliative first-line treatment with RTZ or CT-P6, plus pertuzumab and docetaxel (THP) between May 2014 and December 2019. The primary endpoints were pathologic complete response (pCR) in the EBC and progression-free survival (PFS) in the MBC cohort. Overall survival (OS), overall response rate (ORR), disease control rate (DCR), and cardiac safety were secondary endpoints.

resultsA similar percentage of EBC patients achieved a pCR with CT-P6 versus RTZ (74.4% [93/125]) vs 69.8% [90/129],

conclusionsThese real-world data suggest that biosimilar trastuzumab CT-P6 has similar effectiveness and cardiac safety to RTZ in HER2-positive EBC and MBC patients, when administered as part of dual HER2-targeted therapy with pertuzumab plus chemotherapy in the neoadjuvant or palliative setting.

Indexed as

biosimilarCT-P6early breast cancer (EBC)HER2-positive breast cancermetastatic breast cancer (mbc)trastuzumab

Identifiers

PMID34150658
PMCPMC8213064
OpenAlexW3166492122

What OpenQuestion holds

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LicenceCC BY
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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.