Biotechnology Healthcare - June 2008 - (Page 36) TUMOR MARKERS A NEW STANDARD OF BREAST CANCER CARE Diagnostic test creation often requires using many of the principles of drug development. Complex data analysis and evidence-based reviews are changing professional society guidelines and treatment options for breast cancer. BY BOB CARLSON, MHA Senior Contributing Editor I n November 2005, author and Harvard alumna Laurie Levin had her lumpectomy and was diagnosed with stage 2 invasive ductal carcinoma. Then came the bad news. The standard of care for this kind of breast cancer includes both radiation and chemotherapy, but Levin already had reached the recommended lifetime limits of certain chemotherapy agents during successful treatment for stage 3b histiocytic lymphoma in 1978. Levin’s oncologist recommended Oncotype DX, a new genetic expression test that would quantify the likelihood of distant breast cancer recurrence. A low Oncotype DX recurrence score also would correlate with a small likelihood of chemotherapy benefit. “Once I knew I had a low recurrence score, everything lifted,” Levin recalls. “Even before I finished the radiation treatments, I was already on the road to feeling okay about what had happened. No question in my mind, the Oncotype DX test was absolutely critical for my recovery.” Levin is now one of more than 40,000 women who have had their tumor tissue analyzed by Genomic Health in Redwood City, Calif. Chief medical officer Steven Shak, MD, is gratified that Oncotype DX allows breast cancer patients like Levin to make informed treatment decisions. “That’s why we do what we do,” says Shak with a smile. He’s smiling not only because of stories like Levin’s, but because the American Society of Clinical Oncology (ASCO) and the National Comprehensive Cancer Network (NCCN) have included Oncotype DX in their updated treatment guidelines. In effect, the ASCO and NCCN recommendations establish Oncotype DX as a new standard of care for a particular breast cancer patient population: Those whose disease is newly diagnosed, stage 1 or 2, nodenegative, estrogen receptor (ER)positive, and who will be treated with tamoxifen. This population accounts for about half of newly diagnosed breast cancer patients. Even though at least one similar test is commercially available, Oncotype DX is the only one recommended by ASCO and NCCN under the new category of multiparameter gene expression analysis for breast cancer. “The criteria being used by ASCO and other groups set an appropriately high bar for tests to be used during breast cancer treatment planning,” Shak adds. “DOING THE BEST THEY CAN” Clinical studies published in such peer-reviewed journals as the New England Journal of Medicine and The Lancet have long been taken as unalloyed scientific fact. So would it be considered shocking if not every study published in these prestigious journals is first-rate? “Alain Dupuy and I conducted a detailed review of about 45 papers in oncology research that were published in 2004, and related gene expression profiles to cancer outcomes for patients. We found that 50 percent of them had one or more of what we considered to be very se- 36 BIOTECHNOLOGY HEALTHCARE · MAY/JUNE 2008
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