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Mountainer Study: Effectiveness of Tucatinib and Herceptin Combination Therapy in Patients With HER2-Positive Metastatic Colorectal

2024.02.07 15:22

In breast and gastric cancer, therapeutic drugs that block various HER2 genes are already approved and used in patients with HER2 gene amplification, and amplification of HER2 gene is also observed in 3% of metastatic colorectal cancer patients. In March 2022, Japan's Ministry of Food and Drug Safety authorized the use of Perjeta and Herceptin combination therapy in patients with HER2-positive metastatic colorectal cancer (with gene amplification), but no other drug has been approved for use in patients with HER2-positive metastatic colorectal cancer yet. Recently, the effects of the combination therapy of tucatinib and herceptin in patients with HER2-positive metastatic colorectal cancer were presented at the 2022 European Society of Oncology and Gastrointestinal Cancer.
 

Of a total of 86 patients who received combination therapy with tucatinib and herceptin, 38.1% had a partial response, the average duration of maintaining a response was 12.4 months, and the average duration of disease progression suppression was reported as 8.2 months. In the second year of the study, more than half of the patients -- 51.3% -- were alive. In this study, 31 patients who used tucatinib alone had a response rate of only 3.3% at 3 months, and patients who did not respond to tucatinib monotherapy until 3 months or had a disease were converted to tucatinib and herceptin combination therapy for treatment.
 

Diarrhea, the most notable side effect of the combination therapy of the two drugs, was observed less than 6 times a day in 60% of patients, and level 3 (more than 7 times) was about 3%, but no patients stopped treatment, and symptoms could be controlled with antidiarrheal drugs. In addition, fatigue and nausea have been reported. The most common occurrence of Grade 3 or higher toxicity was hypertension (7%), hepatotoxicity reduced or discontinued in 6% of patients, and left ventricular function reduced or discontinued in 4% of patients. There were no treatment-related deaths.
 

Based on these findings, a phase 3 clinical study is underway in which HER2-positive metastatic colorectal cancer is diagnosed and tucatinib is combined with standard treatment (FOLFOX +/- Avastin) as the first treatment.


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