Evidence map›Paper›PMID 39103991›Full record

Trial reportIntegrative cancer therapies

A Randomized, Multi-Center, Open Label Study to Compare the Safety and Efficacy between Afatinib Monotherapy and Combination Therapy with HAD-B1 for the Locally Advanced or Metastatic NSCLC Patients with EGFR Mutations.

Eunbin Kwag, Soo-Dam Kim, Seong-Hoon Shin, Chulho Oak, So-Jung Park, Jun-Yong Choi, Seong Hoon Yoon, In-Cheol Kang, Mi-Kyung Jeong, Hyun Woo Lee and 5 more

Abstract readRandomized Controlled TrialMulticenter Study
In one paragraph

Trial report in Integrative cancer therapies. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed, 1 pooled it
–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

4 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Review
  3. Review
  4. 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

15 authors.

Eunbin KwagEast West Cancer Center, Daejeon Korean Medicine Hospital, Daejeon University, Daejeon 35235, Republic of Korea.
Soo-Dam KimEast West Cancer Center, Daejeon Korean Medicine Hospital, Daejeon University, Daejeon 35235, Republic of Korea.ORCID 0000-0002-4872-2462
Seong-Hoon ShinKosin University College of Medicine, Busan 49267, Republic of Korea.ORCID 0000-0002-5745-560X
Chulho OakKosin University College of Medicine, Busan 49267, Republic of Korea.
So-Jung ParkSchool of Korean Medicine and Korean Medicine Hospital, Pusan National University, Yangsan 50612, Republic of Korea.
Jun-Yong ChoiSchool of Korean Medicine and Korean Medicine Hospital, Pusan National University, Yangsan 50612, Republic of Korea.
Seong Hoon YoonSchool of Medicine, Pusan National University Yangsan Hospital, Pusan National University, Yangsan 50612, Republic of Korea.
In-Cheol KangCollege of Life and Health Sciences and BioChip Research Center, Hoseo University, Asan‑si, Chungcheongnam‑do 336‑795, Republic of Korea.
Mi-Kyung JeongKorea Institute of Oriental Medicine, Daejeon 34054, Republic of Korea.ORCID 0000-0002-0239-0159
Hyun Woo LeeAjou University School of Medicine, Suwon 16499, Republic of Korea.
Sun-Hwi BangHwirim Korean Medicine Hospital, Busan 48942, Republic of Korea.
Ji Woong SonKonyang University Hospital, Daejeon 35365, Republic of Korea.
Sanghun LeeDankook University, Gyeonggi-do 16890, Republic of Korea.ORCID 0000-0002-0573-9555
Seung Joon KimSeoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul 06591, Republic of Korea.
Hwa-Seung YooEast West Cancer Center, Daejeon Korean Medicine Hospital, Daejeon University, Daejeon 35235, Republic of Korea.ORCID 0000-0003-3738-3239

Funding

X-RAY CRYSTALLOGRAPHYP30CA008748 · NCI · SLOAN-KETTERING INSTITUTE FOR CANCER RES · PI SELWYN M VICKERS · 1985 to 2026
$347.4M
NCI NIH HHS P30 CA008748
6 · The paper itself

Abstract

backgroundLung cancer, especially non-small cell lung cancer (NSCLC), poses a significant health challenge globally due to its high mortality. Afatinib, a second-generation epidermal growth factor receptor-tyrosine kinase inhibitor (EGFR-TKI), has shown superior efficacy over traditional chemotherapy in NSCLC treatment. However, issues like secondary resistance and adverse effects call for alternative therapies. HAD-B1, comprising 4 herbal medicines, has shown promise in lung cancer treatment in both preclinical and clinical settings. This study assesses the combination of HAD-B1 and Afatinib in advanced NSCLC patients to potentially improve outcomes by addressing the limitations of current EGFR-TKI therapies.

methodA randomized, open-label trial evaluated the efficacy and safety of HAD-B1 with Afatinib in 90 EGFR-mutation-positive NSCLC patients. Participants were divided into treatment and control groups, receiving Afatinib with or without HAD-B1. The study focused on the initial dose maintenance rate and disease control rate (DCR) of Afatinib, alongside secondary outcomes like survival rates and quality of life, under continuous safety monitoring.

resultsAmong the 90 participants, no significant difference was found in initial dose maintenance (60.98% in the treatment group vs 52.50% in the control,

conclusionCombining HAD-B1 with Afatinib potentially improves quality of life and reduces adverse events in advanced NSCLC patients. Further research is necessary to confirm the long-term benefits of this combination therapy, aiming to advance NSCLC treatment outcomes.

trial registrationClinical Research Information Service (CRIS) of the Republic of Korea, https://cris.nih.go.kr/ (ID: KCT0005414).

Indexed as

AfatinibCarcinoma, Non-Small-Cell LungErbB ReceptorsLung NeoplasmsAdultAgedAntineoplastic Combined Chemotherapy ProtocolsFemaleHumansMaleMiddle AgedMutationProtein Kinase InhibitorsQuality of LifeAfatinibEGFR protein, humanErbB ReceptorsProtein Kinase InhibitorsAfatinibEGFR-TKIHAD-B1non-small cell lung cancerrandomized controlled trial

Identifiers

PMID39103991
PMCPMC11301725

What Socratic holds

Textmetadata
LicenceCC BY-NC
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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 Socratic graph.