Model-Based Evaluation of HangAmDan-B1 and Afatinib Combination Therapy in HCC827 Xenograft Mice with Resistance to Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor

<b>Objectives:</b> HangAmDan-B1 (HAD-B1), a blended herbal mixture, has been investigated as an adjuvant therapy with afatinib (AFT) to treat non-small lung cancer (NSCLC). Although preclinical studies demonstrated promising synergistic results, clinical trials have not yet confirmed the...

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Main Authors: Sung-yoon Yang, Lien Thi Ngo, Soyoung Lee, Hwi-yeol Yun, Tham Thi Bui, Dong-Hyeon Kim, Jung-woo Chae, Sojung Park
Format: Article
Language:English
Published: MDPI AG 2025-05-01
Series:Pharmaceuticals
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Online Access:https://www.mdpi.com/1424-8247/18/5/748
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author Sung-yoon Yang
Lien Thi Ngo
Soyoung Lee
Hwi-yeol Yun
Tham Thi Bui
Dong-Hyeon Kim
Jung-woo Chae
Sojung Park
author_facet Sung-yoon Yang
Lien Thi Ngo
Soyoung Lee
Hwi-yeol Yun
Tham Thi Bui
Dong-Hyeon Kim
Jung-woo Chae
Sojung Park
author_sort Sung-yoon Yang
collection DOAJ
description <b>Objectives:</b> HangAmDan-B1 (HAD-B1), a blended herbal mixture, has been investigated as an adjuvant therapy with afatinib (AFT) to treat non-small lung cancer (NSCLC). Although preclinical studies demonstrated promising synergistic results, clinical trials have not yet confirmed the expected benefits. This study aims to quantitatively examine the exposure–response relationship and synergistic interactions through pharmacokinetic/pharmacodynamic (PK/PD) modeling. <b>Methods:</b> A PK/PD model was established and validated based on tumor growth profiles from a xenograft mouse study of gefitinib-resistant HCC827. Model-based simulations were performed to predict and assess therapeutic effects across different treatment groups. <b>Results:</b> The PK/PD model confirmed HAD-B1 enhances the potency of AFT by 1.45-fold. Model-based simulations predicted that combination treatment maintains a lower tumor size compared to AFT monotherapy. <b>Conclusions:</b> This study quantitatively demonstrated the synergistic interaction between HAD-B1 and AFT. The developed PK/PD model provides insights into potential dosing strategies to treat NSCLC resistant to EGFR-TKIs. Further clinical trials are warranted to validate these findings and refine dosing strategies to improve therapeutic outcomes.
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spelling doaj-art-c0b6b81acb9e4a7587ef5eff8a937faa2025-08-20T03:47:58ZengMDPI AGPharmaceuticals1424-82472025-05-0118574810.3390/ph18050748Model-Based Evaluation of HangAmDan-B1 and Afatinib Combination Therapy in HCC827 Xenograft Mice with Resistance to Epidermal Growth Factor Receptor Tyrosine Kinase InhibitorSung-yoon Yang0Lien Thi Ngo1Soyoung Lee2Hwi-yeol Yun3Tham Thi Bui4Dong-Hyeon Kim5Jung-woo Chae6Sojung Park7College of Pharmacy, Chungnam National University, Daejeon 34134, Republic of KoreaFaculty of Pharmacy, PHENIKAA University, Yen Nghia, Ha Dong, Hanoi 12116, VietnamCollege of Pharmacy, Chungnam National University, Daejeon 34134, Republic of KoreaCollege of Pharmacy, Chungnam National University, Daejeon 34134, Republic of KoreaCollege of Pharmacy, Chungnam National University, Daejeon 34134, Republic of KoreaDepartment of Internal Medicine, Pusan National University, Korean Medicine Hospital, Yangsan 50612, Republic of KoreaCollege of Pharmacy, Chungnam National University, Daejeon 34134, Republic of KoreaDepartment of Internal Medicine, Pusan National University, Korean Medicine Hospital, Yangsan 50612, Republic of Korea<b>Objectives:</b> HangAmDan-B1 (HAD-B1), a blended herbal mixture, has been investigated as an adjuvant therapy with afatinib (AFT) to treat non-small lung cancer (NSCLC). Although preclinical studies demonstrated promising synergistic results, clinical trials have not yet confirmed the expected benefits. This study aims to quantitatively examine the exposure–response relationship and synergistic interactions through pharmacokinetic/pharmacodynamic (PK/PD) modeling. <b>Methods:</b> A PK/PD model was established and validated based on tumor growth profiles from a xenograft mouse study of gefitinib-resistant HCC827. Model-based simulations were performed to predict and assess therapeutic effects across different treatment groups. <b>Results:</b> The PK/PD model confirmed HAD-B1 enhances the potency of AFT by 1.45-fold. Model-based simulations predicted that combination treatment maintains a lower tumor size compared to AFT monotherapy. <b>Conclusions:</b> This study quantitatively demonstrated the synergistic interaction between HAD-B1 and AFT. The developed PK/PD model provides insights into potential dosing strategies to treat NSCLC resistant to EGFR-TKIs. Further clinical trials are warranted to validate these findings and refine dosing strategies to improve therapeutic outcomes.https://www.mdpi.com/1424-8247/18/5/748pharmacokinetic/pharmacodynamic modelingafatinibhangamdan-B1non-small cell lung cancerEGFR-TKI resistancedrug–drug interactions
spellingShingle Sung-yoon Yang
Lien Thi Ngo
Soyoung Lee
Hwi-yeol Yun
Tham Thi Bui
Dong-Hyeon Kim
Jung-woo Chae
Sojung Park
Model-Based Evaluation of HangAmDan-B1 and Afatinib Combination Therapy in HCC827 Xenograft Mice with Resistance to Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor
Pharmaceuticals
pharmacokinetic/pharmacodynamic modeling
afatinib
hangamdan-B1
non-small cell lung cancer
EGFR-TKI resistance
drug–drug interactions
title Model-Based Evaluation of HangAmDan-B1 and Afatinib Combination Therapy in HCC827 Xenograft Mice with Resistance to Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor
title_full Model-Based Evaluation of HangAmDan-B1 and Afatinib Combination Therapy in HCC827 Xenograft Mice with Resistance to Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor
title_fullStr Model-Based Evaluation of HangAmDan-B1 and Afatinib Combination Therapy in HCC827 Xenograft Mice with Resistance to Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor
title_full_unstemmed Model-Based Evaluation of HangAmDan-B1 and Afatinib Combination Therapy in HCC827 Xenograft Mice with Resistance to Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor
title_short Model-Based Evaluation of HangAmDan-B1 and Afatinib Combination Therapy in HCC827 Xenograft Mice with Resistance to Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor
title_sort model based evaluation of hangamdan b1 and afatinib combination therapy in hcc827 xenograft mice with resistance to epidermal growth factor receptor tyrosine kinase inhibitor
topic pharmacokinetic/pharmacodynamic modeling
afatinib
hangamdan-B1
non-small cell lung cancer
EGFR-TKI resistance
drug–drug interactions
url https://www.mdpi.com/1424-8247/18/5/748
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