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Use of Gefitinib in EGFR-Amplified Refractory Solid Tumors: An Open-Label, Single-Arm, Single-Center Prospective
Seonggyu Byeon1, Jung Yong Hong1, Jeeyun Lee1
1Division of Hematology-Oncology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, 81 Irwon-ro, Gangnam-gu, Seoul, 06351, South Korea.
Background:
Treatment options for patients with chemotherapy-refractory solid tumors are limited.
Objective:
We conducted an open-label, single-arm, single-center phase II trial to evaluate the efficacy and safety of gefitinib in patients with chemotherapy-refractory solid tumors and EGFR amplification or sensitivity to an EGFR inhibitor identified through a drug-screening platform with patient-derived tumor cells (PDCs).
Patients And Methods:
EGFR amplification was detected by targeted sequencing. Sensitivity to an EGFR inhibitor was established in chemical screening using PDCs. Gefitinib (250 mg daily) was administered continuously in 28-day cycles until the occurrence of disease progression, unacceptable toxicity, or death due to any cause. The primary endpoint was the objective response rate (ORR).
Results:
In total, 15 patients were assigned to the present study. The most common tumor type was glioblastoma multiforme (n = 9, 60%), followed by gastric cancer (n = 3, 20%), anal squamous cancer, rectal cancer, and sarcoma (each n = 1, 6.7%). Among 13 evaluable patients, one patient had a partial response and five had stable disease, with an ORR of 7.7% and a disease control rate of 46.1%. The median progression-free survival was 2.1 months (95% confidence interval [CI] 0.77-3.43). The most common adverse events were diarrhea (26.7%) and skin rash (26.7%).
Conclusion:
Gefitinib demonstrated modest anti-tumor activity and a manageable safety profile in chemotherapy-refractory solid tumors with EGFR amplification or sensitivity to an EGFR inhibitor identified through a drug-screening platform with PDCs. CLINICALTRIALS.
Gov Identifier:
NCT02447419.
Insights
Gefitinib showed modest efficacy in patients with advanced solid tumors that were resistant to chemotherapy. This study highlights potential treatment avenues for tumors with EGFR amplification or specific drug sensitivities.
Area of Science:
- Oncology
- Molecular Biology
- Clinical Trials
Background:
- Limited treatment options exist for patients with chemotherapy-refractory solid tumors.
- Targeting Epidermal Growth Factor Receptor (EGFR) is a strategy for certain cancers.
Purpose of the Study:
- To evaluate the efficacy and safety of gefitinib in patients with chemotherapy-refractory solid tumors.
- To assess gefitinib's activity in tumors with EGFR amplification or sensitivity identified via patient-derived tumor cells (PDCs).
Main Methods:
- An open-label, single-arm, phase II clinical trial was conducted.
- Patients received gefitinib (250 mg daily) until disease progression or unacceptable toxicity.
- EGFR amplification was assessed by targeted sequencing, and drug sensitivity by PDCs screening.
Main Results:
- Fifteen patients were enrolled, with glioblastoma multiforme being the most common diagnosis.
- The objective response rate (ORR) was 7.7% and the disease control rate was 46.1% among evaluable patients.
- The median progression-free survival was 2.1 months; common adverse events included diarrhea and skin rash.
Conclusions:
- Gefitinib demonstrated modest anti-tumor activity in this patient cohort.
- The safety profile of gefitinib was manageable in patients with chemotherapy-refractory solid tumors.
- This study supports gefitinib as a potential therapeutic option for selected solid tumors based on genetic markers and drug sensitivity screening.
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