COBAS EGFR MUTATION TEST PDF

They can provide testing in people who are unable to, or do not wish to, have a tissue biopsy and whose disease otherwise would remain untested. Introducing plasma EGFR mutation testing may lead to quicker test results and treatment changes as it removes the need for a tissue biopsy in certain circumstances. Plasma EGFR mutation testing also avoids problems with tumour evolution and heterogeneity, when the presence of mutations may be missed in a biopsy of a single metastatic site or from using an existing sample. This method can detect resistance mutations — predominantly TM — which may need different treatment. This is still being researched and not in clinical use.

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This is the first FDA-approved, blood-based genetic test that can detect epidermal growth factor receptor EGFR gene mutations in non-small cell lung cancer patients. Lung cancer is the leading cause of cancer-related death among men and women in the U. According to the National Cancer Institute, an estimated , Americans will be diagnosed with lung cancer, and , will die from the disease this year.

NSCLC is the most common type of lung cancer. However, if such mutations are not detected in the blood, then a tumor biopsy should be performed to determine if the NSCLC mutations are present. Insofar as the test provides positive results, it may benefit patients who may be too ill or are otherwise unable to provide a tumor specimen for EGFR testing. The most common side effects of Tarceva are rash, diarrhea, anorexia, fatigue, difficulty breathing dyspnea , cough, nausea and vomiting.

Tarceva is not recommended for use in combination with platinum-based chemotherapy and the drug has not been evaluated as first-line treatment in patients with metastatic NSCLC whose tumors have EGFR mutations other than exon 19 deletions or LR substitution mutations. Tarceva is manufactured by Astellas Pharma Technologies, Inc. The FDA, an agency within the U. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines, and other biological products for human use, and medical devices.

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Epidermal Growth Factor Receptor (EGFR) Mutation, Cobas V2, Solid Tumor

In the study, treatment with Tarceva demonstrated that patients lived longer without their disease getting worse median progression-free survival; Tarceva is also approved for patients with advanced-stage NSCLC whose cancer has spread or grown after receiving at least one chemotherapy regimen second- or third-line treatment. Tarceva is not meant to be used at the same time as certain types of chemotherapy for advanced NSCLC. Tumour shrinkage response rate was observed in 65 percent of patients with Tarceva and in 16 percent of people treated with chemotherapy. The most frequent greater than or equal to 30 percent adverse events in Tarceva-treated patients were diarrhea, weakness, rash, cough, shortness of breath and decreased appetite. The most frequent Grade reactions in Tarceva-treated patients were rash and diarrhea. From February to January , patients mostly of European descent were randomly assigned to receive Tarceva or platinum-based chemotherapy.

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U.S. Food and Drug Administration

This is the first FDA-approved, blood-based genetic test that can detect epidermal growth factor receptor EGFR gene mutations in non-small cell lung cancer patients. Lung cancer is the leading cause of cancer-related death among men and women in the U. According to the National Cancer Institute, an estimated , Americans will be diagnosed with lung cancer, and , will die from the disease this year. NSCLC is the most common type of lung cancer. However, if such mutations are not detected in the blood, then a tumor biopsy should be performed to determine if the NSCLC mutations are present. Insofar as the test provides positive results, it may benefit patients who may be too ill or are otherwise unable to provide a tumor specimen for EGFR testing. The most common side effects of Tarceva are rash, diarrhea, anorexia, fatigue, difficulty breathing dyspnea , cough, nausea and vomiting.

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