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Establishment and Characterization of Three Afatinib-resistant Lung Adenocarcinoma PC-9 Cell Lines Developed with Increasing Doses of Afatinib
Published on: June 26, 2019
A Randomized, Multi-Center, Open Label Study to Compare the Safety and Efficacy between Afatinib Monotherapy and
Eunbin Kwag1,2, Soo-Dam Kim1,3, Seong-Hoon Shin4
1East West Cancer Center, Daejeon Korean Medicine Hospital, Daejeon University, Daejeon 35235, Republic of Korea.
Background:
Lung 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.
Method:
A 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.
Results:
Among the 90 participants, no significant difference was found in initial dose maintenance (60.98% in the treatment group vs 52.50% in the control, P = .4414) or DCR (80.49% vs 90.00%, P = .2283). Secondary outcomes like PFS, TTP, and OS showed no notable differences. However, physical functioning significantly improved in the treatment group (P = .0475, PPS group). The control group experienced higher rates of adverse events of special interest and adverse drug reactions (P = .01), suggesting HAD-B1 with Afatinib might enhance physical function without increasing adverse effects.
Conclusion:
Combining 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 Registration:
Clinical Research Information Service (CRIS) of the Republic of Korea, https://cris.nih.go.kr/ (ID: KCT0005414).
Insights
This study found that combining HAD-B1 with Afatinib in advanced non-small cell lung cancer (NSCLC) patients did not improve disease control but did enhance physical functioning and reduce adverse events. Further research is needed to confirm long-term benefits.
Area of Science:
- Oncology
- Pharmacology
- Herbal Medicine
Background:
- Non-small cell lung cancer (NSCLC) presents a significant global health burden with high mortality rates.
- Afatinib, an epidermal growth factor receptor-tyrosine kinase inhibitor (EGFR-TKI), offers improved efficacy over chemotherapy but faces challenges with resistance and side effects.
- HAD-B1, a herbal medicine formulation, shows preclinical and clinical promise for lung cancer treatment, suggesting potential as an alternative or complementary therapy.
Purpose of the Study:
- To evaluate the efficacy and safety of combining HAD-B1 with Afatinib in advanced NSCLC patients.
- To assess the impact of this combination on Afatinib's initial dose maintenance and disease control rate (DCR).
- To explore the combination's effects on survival outcomes, quality of life, and adverse events.
Main Methods:
- A randomized, open-label trial involving 90 EGFR-mutation-positive NSCLC patients.
- Participants received Afatinib with or without HAD-B1.
- Primary endpoints included initial dose maintenance rate and DCR; secondary endpoints included survival rates and quality of life, with continuous safety monitoring.
Main Results:
- No significant differences were observed in initial dose maintenance or DCR between the treatment and control groups.
- While survival outcomes (PFS, TTP, OS) showed no notable differences, the treatment group experienced a significant improvement in physical functioning.
- The control group reported higher rates of adverse events, suggesting the combination may enhance physical function without increasing toxicity.
Conclusions:
- Combining HAD-B1 with Afatinib may improve quality of life and reduce adverse events in advanced NSCLC patients.
- The combination therapy demonstrated a positive impact on physical functioning.
- Further investigation is warranted to validate the long-term benefits and therapeutic potential of this combination approach in NSCLC treatment.
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