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Testing Targeted Therapies in Cancer using Structural DNA Alteration Analysis and Patient-Derived Xenografts
Published on: July 25, 2020
OncoVee™-MiniPDX-guided anticancer treatment for HER2-negative intermediate-advanced gastric cancer patients: a
Baonan Zhang1, Yuzhen Li1, Xiaodan Zhu1
1Department of Oncology, Wuxi Hospital Affiliated to Nanjing University of Chinese Medicine, 8 West Zhongnan Road, Wuxi, 214071, China.
Background:
Chemotherapy is the main treatment strategy for patients with advanced HER2-negative gastric cancer (GC); yet, many patients do not respond well to treatment. This study evaluated the sensitivity of a mini patient-derived xenograft (MiniPDX) animal model in patients with HER2-negative intermediate-advanced GC.
Methods:
In this single-arm, open-label clinical study, we consecutively recruited patients with HER2-negative advanced or recurrent GC from September 2018 to July 2021. Tumor tissues were subjected to MiniPDX drug sensitivity tests for screening individualized anti-tumor drugs; appropriate drug types or combinations were selected based on drug screening results. The primary endpoints were progression-free survival (PFS) and safety, and the secondary endpoints were overall survival (OS) and objective response rate (ORR).
Results:
A total of 17 patients were screened, and 14 eligible patients were included.The median follow-up time was 9 (2-34) months. The median PFS time was 14.1 (2-34) months, the median OS time was 16.9 (2-34) months, ORR was 42.9% (6/14), and DCR was 92.9% (13/14). The most common treatment-related adverse events (TRAE) were fatigue (14 (100%)), anorexia (13 (93%)) and insomnia (12 (86%)), and the most common grade 3 or worse TRAE was fatigue (6 (43%)), and anorexia (6 (43%)). The occurrence rate of myelosuppression, nausea and vomiting, abnormal liver enzymes, and other grade 3-4 chemotherapy adverse reactions were relatively low, and no grade 5 treatment-related adverse events occurred.
Conclusion:
Screening HER2-negative medium-advanced GC/GJC chemotherapy regimens and targeted drugs based on MiniPDX animal models showed good tumor activity and safety.
Insights
Mini patient-derived xenograft (MiniPDX) models show promise for predicting chemotherapy effectiveness in HER2-negative advanced gastric cancer (GC). This approach improves treatment selection, demonstrating good tumor activity and safety in patients.
Area of Science:
- Oncology
- Gastroenterology
- Translational Medicine
Background:
- Chemotherapy is standard for advanced HER2-negative gastric cancer (GC), but response rates vary.
- Many patients with HER2-negative GC do not respond optimally to current chemotherapy regimens.
- This study investigates the utility of a mini patient-derived xenograft (MiniPDX) model for predicting treatment response.
Purpose of the Study:
- To evaluate the drug sensitivity screening capability of the MiniPDX model for HER2-negative advanced or recurrent gastric cancer.
- To assess the clinical efficacy and safety of individualized anti-tumor drugs selected via MiniPDX testing.
- To determine if MiniPDX models can improve treatment outcomes for patients with difficult-to-treat GC.
Main Methods:
- A single-arm, open-label study included 14 eligible patients with HER2-negative advanced/recurrent GC.
- Tumor tissues underwent MiniPDX drug sensitivity testing to identify effective anti-tumor drugs or combinations.
- Treatment selection was based on MiniPDX screening results, with progression-free survival (PFS) and safety as primary endpoints.
Main Results:
- The median PFS was 14.1 months, and the median overall survival (OS) was 16.9 months.
- Objective response rate (ORR) was 42.9%, and disease control rate (DCR) was 92.9%.
- Common treatment-related adverse events (TRAE) included fatigue (100%), anorexia (93%), and insomnia (86%); grade 3/4 TRAEs were manageable, with no grade 5 events.
Conclusions:
- MiniPDX model-based drug screening is effective for selecting chemotherapy regimens and targeted drugs in HER2-negative advanced GC.
- The MiniPDX approach demonstrated good tumor activity and a favorable safety profile in this patient cohort.
- This preclinical model offers a promising strategy for personalized medicine in advanced gastric cancer.
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