"If you negate the effects of those mutations in lab experiments, the cancer dies." In the study, 97 percent of the driver mutations were the primary driver of the cancer, making them useful for selecting specific drugs, he said. Kris said many centers do not routinely test patients to see which type of mutation is driving their lung cancer, partially because of cost. He said having this information can help doctors make treatment decisions and may even serve as a model for treating lung and other cancers. [1] In the lung cancer study, researchers from a consortium of U.S. cancer centers set out to collect 1,000 tumor samples from patients with a type of lung cancer known as adenocarcinoma. [1]
The study, a large-scale retrospective analysis using blinded data to create a pooled dataset of 841 patients from cancer centers around the world, found that CTC count at or above the threshold of five was reliably associated with disease progression. [3]
"The study is important because it suggests that the sipuleucel-T therapy may have extended survival for a longer time than estimated in the clinical trials due to the beneficial effects of the frozen product on some men who initially received the placebo," said Leonard Gomella, Chair of Urology at Jefferson's Kimmel Cancer Center in Philadelphia. [7] The Zytiga trial found that measuring the circulating cells predicted a better prognosis and improved survival as early as four weeks after taking the drug. [6]
The measurement of the cells in relation to patient survival was part of a formal collaboration with the FDA. The cells represent about one cell in a billion in the blood stream, according Dr. Scher. [6] Veridex's IVD products may significantly benefit patients by helping physicians make more informed decisions that enable better patient care. Veridex's Clinical Research Solutions provide tools and services that may be used for the selection, identification and enumeration of targeted rare cells in peripheral blood for the identification of biomarkers, aiding scientists in their search for new, targeted therapies. [3] The test can be administered at any time during the course of therapy as a routine blood test. It is used in combination with other tests and a clinician's assessment, to provide a more complete picture of a patient's prognosis. [3]
Scher said the study will be used to develop tests to predict whether prostate cancer drugs are working. [1] The drug received Food and Drug Administration approval in April in combination with prednisone for patients with a certain type of late-stage prostate cancer previously treated with chemotherapy. The drug was given a shorten review and the decision came ahead of its June 20 regulatory goal date. [6] APC8015F is made from immune system cells taken from a patient with prostate cancer. [7]
Provenge was approved based on studies showing it prolonged survival but the novel immunotherapy, which costs $93,000 for a course of treatment, doesn't shrink prostate cancer tumors in ways that can be easily detected by oncologists or urologists. [5] Additional studies are underway to further validate CTCs as a surrogate endpoint in metastatic prostate cancer studies. [3]
To establish a surrogate for survival is a multistep process that requires consistent results in multiple Phase III studies and which have the CTC biomarker question embedded. [4] The data suggest that changes in CTC counts can predict overall survival during treatment. [3] While the data are encouraging, Dr. Scher said the finding will be tested in subsequent studies that may eventually determine if the measure could help guide treatment decisions for individual patients. [6] In the study, the median overall survival of patient on Zytiga rose to 4.6 months, compared to the previously reported benefit of 3.9 months. [6] Tests of the first 830 patients found that 54 percent had a mutation that drives tumor growth. [1] The predictive value of CTCs was not affected by treatment type (chemotherapy, endocrine therapy, biologic therapy), tumor type (hormone receptor positive/negative, HER2 positive/negative), or sites of disease involvement. [3]
American Society of Clinical Oncology (ASCO)
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