Description
Erlotinib hydrochloride, the hydrochloride salt of the molecularly targeted drug erlotinib, has been approved by the U.S. Food and Drug Administration (FDA) in combination with erlotinib (Tarceva) in combination with gemcitabine as first-line treatment for locally advanced and metastatic pancreatic cancer . The small-molecule compound erlotinib is a receptor tyrosine kinase inhibitor that inhibits the phosphorylation reaction by competing with adenosine triphosphate to bind to the catalytic site of the intracellular domain of the receptor tyrosine kinase, thereby blocking the It has proliferation signal transduction, inhibits the activity of tumor cell ligand-dependent HER-1/EGFR, and achieves the effect of inhibiting tumor cell proliferation. Erlotinib is also another tyrosine kinase inhibitor used in the treatment of NSCLC. The results of the clinical phase I trial showed that its main toxicity and side effects were dose-dependent rash and diarrhea, and other rare side effects were headache, nausea and vomiting. Erlotinib was used as a second-line antitumor drug in a phase II clinical trial, and its efficacy was comparable to that of the second-line chemotherapy drug docetaxel. Phase III randomized controlled trial (BR21) [22], mainly for NSCLC patients (locally advanced and distant metastasis) after failure of first- or second-line chemotherapy. A total of 488 cases were treated with erlotinib 150mg per day in the study group. A total of 243 cases in the control group were treated with placebo. The results of Chemicalbook are: median overall survival rate: 6.7 months in the drug group, 4.7 months in the control group (P<0.001, mortality rate HR=0.73); 1-year survival rate: 31.2% in the drug group and 21.5% in the control group; median Progression-free time: 9.9 weeks in the medication group and 7.9 weeks in the control group. At the same time, the improvement of the patient's symptoms was more obvious in the erlotinib group. Based on the research results of BR21, several phase III clinical studies have been carried out successively. The TRIBUTE clinical trial study combined erlotinib with chemotherapy in an attempt to compare whether it was better with chemotherapy than with chemotherapy alone. The treatment group was chemotherapy (carboplatin plus paclitaxel) + erlotinib, and the control group was the same chemotherapy alone. A total of 1059 patients with advanced NSCLC were added for observation. The effective rate was 21.5% in the study group and 19.3% in the control group; median survival time: 10.8 months in the study group and 10.6 months in the control group; time to tumor progression (TTP): 5.1 months in the study group and 5.0 months in the control group . Another TALENT study also compared whether the combination of erlotinib and chemotherapy (Jianze + cisplatin) can improve the efficacy of chemotherapy, and entered a total of 1172 NSCLC patients. The results also did not show that erlotinib can significantly improve the efficacy of chemotherapy.
Complaint
