Thymidylate Synthase Biomarker Selection for Renal Cell Carcinoma Chemotherapy
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Solution Overview
Problem
Current therapies for renal cell carcinoma, including molecular target drugs like sorafenib and sunitinib, have shown limited effectiveness and safety concerns, with no established standard therapy in Japan, leaving patients with few treatment options and unsatisfactory therapeutic outcomes.
Innovation Solution
A method for predicting the therapeutic effect of chemotherapy with a combination drug of tegafur/gimeracil/oteracil potassium in renal cell carcinoma patients by measuring the expression level of the thymidylate synthase gene, using real-time PCR to determine if the expression level is equal to or less than a predetermined cut-off point, thereby selecting patients likely to respond effectively to the treatment.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If molecular target drugs (sorafenib, sunitinib) are used as standard therapy for renal cell carcinoma, then the therapeutic effect is improved compared to cytokine therapies, but the response rate remains low (10-36.5%) and progression-free survival is limited (5.5-8.7 months)
Solution Approach 1:
The patent changes the parameter of drug selection by introducing a biomarker-based classification system. Patients are stratified based on thymidylate synthase expression levels, and different chemotherapy regimens are prescribed accordingly. This parameter change transforms the treatment approach from uniform molecular target therapy to personalized chemotherapy based on gene expression profiles, thereby improving response rates while maintaining therapeutic effectiveness.
2Adaptability or versatility
If chemotherapy with tegafur/gimeracil/oteracil potassium is administered to all renal cell carcinoma patients, then more treatment options are provided, but unnecessary treatments increase and medical expenses rise
Solution Approach 1:
The patent applies local quality by making treatment personalized based on local characteristics of each patient's tumor. Through measuring thymidylate synthase expression levels in individual patients, the therapy is tailored to match the specific biological characteristics of their cancer. This localized approach ensures that chemotherapy is administered only to patients whose tumors exhibit the appropriate molecular profile, thereby avoiding unnecessary treatments and reducing overall medical expenses while maintaining diverse treatment options for different patient subgroups.
3Measurement precision
If thymidylate synthase gene expression level is measured to select patients for chemotherapy, then treatment effectiveness is improved, but diagnostic complexity and measurement requirements increase
Solution Approach 1:
The patent replaces complex clinical judgment and trial-and-error treatment selection with a molecular biology-based diagnostic system. By using in vitro measurement of thymidylate synthase gene expression levels, the system objectively identifies suitable candidates for chemotherapy. This substitution of mechanical/cellular measurement for clinical assessment simplifies the decision-making process while improving selection accuracy, as the diagnostic method relies on standardized laboratory techniques rather than subjective evaluation.
Data Source
AI summary
The present invention developed a novel antitumor agent for renal cell carcinoma that cannot be fully treated by the existing therapies. The present invention provides an antitumor agent comprising a combination drug of tegafur/gimeracil/oteracil potassium that ensures an excellent therapeutic effect in renal cell carcinoma patients that is superior to that of the existing therapies, by way of selecting the patients based on thymidylate synthase.