EGFR inhibitors like erlotinib (Tarceva) can greatly benefit non-small cell lung cancer (NSCLC) patients with mutations in the EGFR gene, but their effectiveness in patients without such mutations is less clear. VeriStrat is a blood test meant to predict how well patients would respond to EGFR-inhibitor treatment. A study designed to evaluate VeriStrat examined patients with advanced NSCLC without EGFR mutations in whom platinum-based chemotherapy had stopped working and who received either different chemotherapy or Tarceva as their second-line treatment. Patients with a VeriStrat result of ‘poor’ survived longer when treated with chemotherapy than with Tarceva. In contrast, chemotherapy and Tarceva worked equally well for those with a ‘good’ test result. Good VeriStrat results also predicted longer survival in general.
“VeriStrat, a serum-based protein assay, can help select which patients with non–small cell lung cancer (NSCLC) who are not known to have epidermal growth factor receptor (EGFR) mutations might benefit from an EGFR-targeted agent, according to a study described at the 2013 Best of ASCO Los Angeles meeting by Heather A. Wakelee, MD, Associate Professor of Medicine, Stanford University, Palo Alto, California.”
On July 12, the FDA announced that it had approved the targeted therapy afatinib (Gilotrif) for the treatment of metastatic non-small cell lung cancer (NSCLC) with mutations in the epidermal growth factor receptor (EGFR) gene.
EGFR mutations occur in about 10 to 15 percent of all NSCLC patients. The overexpression of the EGFR protein caused by the mutation leads to rapid cell division in tumors. Prior to the approval of afatinib, patients in the United States could only take erlotinib (Tarceva) to combat the EGFR mutation. The third major drug available to treat EGFR-mutated tumors, gefitinib (Iressa) has not yet been approved by the United States but is readily available in many other countries. Erlotinib has consistently outperformed gefitinib, so its lack of availability in the U.S. is no huge loss. Continue reading…
Results from the FASTACT clinical trial suggest that interspersing erlotinib (Tarceva) among rounds of chemotherapy improves outcomes in non-small cell lung cancer (NSCLC). Patients with advanced NSCLC received six cycles of gemcitabine (Gemzar) plus carboplatin (Paraplatin) or cisplatin (Platinol), with Tarceva added during the second half of each chemotherapy cycle. This regimen prolonged time without cancer worsening and increased survival compared to patients who had received chemotherapy and placebo, though the benefit was only seen in patients with mutations in the EGFR gene. This approach may be most useful for patients whose EGFR status is unknown, as patients with known EGFR mutations may be even better served by first-line treatment with Tarceva alone.
Colorado’s Medicare provider has announced that it will cover VeriStrat, a test designed to guide decisions about second-line therapies for advanced non-small cell lung cancer (NSCLC). The main second-line therapy options in NSCLC include chemotherapy or the drug erlotinib (Tarceva). While Tarceva can significantly improve outcomes in patients with mutations in the EGFR gene, it also benefits some patients without these mutations. VeriStrat, a rapid blood test, helps predict which of these patients would be more likely to respond to Tarceva and which would be better served by other treatments. Medicare coverage will allow many more patients in Colorado to access this useful tool.
Update: We are deeply saddened to report that Neil passed away on July 29, 2015. It is a privilege to share his story and keep his memory alive.
Neil Schiffman has lived as healthy a life as one can live. An avid cycler and triathlon participant well into his 60s, Neil was visiting Arizona in April 2011 when he began to cough. The cough mimicked the symptoms of exercise-induced asthma, so at first he thought nothing of it. When the cough failed to disappear, he visited his pulmonologist, who suspected bacterial pneumonia. Meanwhile, Neil’s legs and feet began to swell–he went from wearing a size 10 shoe to a size 14. Alarmed, he had an X-ray and a CT scan, which revealed a mass identified as a neoplasm. He was referred to an oncologist, who delivered the bad news in June: Neil had stage IV non-small cell lung cancer (NSCLC). Continue reading…
A recent phase III clinical trial confirmed that the VeriStrat test can predict which lung cancer patients are likely to fare better when treated with EGFR inhibitors like erlotinib (Tarceva). Patients with advanced non-small cell lung cancer (NSCLC) were tested using VeriStrat before beginning Tarceva treatment. Those who had a VeriStrat result of “Good” experienced longer times without cancer growth and longer overall survival on Tarceva compared to those with a “Bad” result. VeriStrat results may help doctors distinguish patients who should be given EGFR inhibitors from those for whom the benefits would not outweigh the side effects, and who would be better served by other treatments. VeriStrat does not test for mutations in the EGFR gene. Instead, the test assesses the pattern of several proteins in the blood to pinpoint patients likely to respond to EGFR inhibitors, including patients who may not have an EGFR mutation.
Patients with non-small cell lung cancer (NSCLC) who have mutations in the EGFR gene often improve significantly when treated with EGFR inhibitors like erlotinib (Tarceva) or gefitinib (Iressa). However, in virtually all cases, patients eventually develop resistance to these drugs. Resistance to EGFR inhibitors is frequently associated with patients developing an additional mutation in the EGFR gene called T790M. Hope for these patients may come from a new EGFR inhibitor designed to target the T790M mutation, called CO-1686. Preliminary results from an ongoing early clinical trial of CO-1686 show that the drug shrank tumors in at least a subset of patients with EGFR-mutant advanced NSCLC who were resistant to EGFR inhibitors and carried the T790M mutation.
The FDA has approved the use of erlotinib (Tarceva) as a first-line treatment for patients with advanced non-small cell lung cancer (NSCLC) who have a mutation in the EGFR gene. Tarceva, a tyrosine kinase inhibitor (TKI) that inhibits EGFR, had already been approved for patients with advanced NSCLC as a second- or later-line treatment if at least one chemotherapy regimen had failed, or as maintenance treatment if their disease had not progressed after four cycles of chemotherapy. At the same time, the FDA approved, for the first time, a test for EGFR mutations, the cobas EGFR Mutation test. The test enables doctors to identify which patients have EGFR mutations and are therefore candidates for first-line treatment with Tarceva, making it a so-called ‘companion diagnostic’ for Tarceva.