In the October Issue of the NCBC Newsletter, an important on-line September publication by Sparano JA et al, (New England Journal of Medicine, 2015) is reviewed by Don Steven Dizon, MD, FACP, Co-Director of Gynecologic Oncology at Massachusetts General Hospital. The article is the first prospective trial confirming the results of the Oncotype DX 21 Gene Assay.

Since Dr. Bonadonna's landmark research in the 1970s proved that adjuvant chemotherapy improved survival in early stage breast cancer, chemotherapy has been used in millions of women with the disease. However, it has been known that not all women derived a survival benefit. Until the advent of the Oncotype DX 21 Gene Assay, there was no accurate way to identify women who could be spared the potential toxicity of chemotherapy. The significance of the many studies cited in the Editorial and as well as others in the literature is that many women can be spared the toxicity of Chemotherapy. At ASCO 2014, it was reported that ~ 20% of women receiving chemotherapy for breast cancer are admitted to the hospital for chemotherapy-related complications. Mortality, however, has been reported in ~ 2%. Medicare approved coverage of the assay in 2006, and it was shortly thereafter incorporated into National Comprehensive Cancer Network (NCCN) Guidelines [Stage I/II, lymph node negative, ER+ tumors]. The American Society of Clinical Oncology (ASCO) also recommends use of the assay.

Despite this overwhelming clinical evidence, NCCN guideline pathway, and ASCO endorsement, the clinical use of the assay has not been widely utilized. Dinan M et al, reviewed 70,802 women in the SEER data base who met the Oncotype DX Test criterion between 2005 and 2009 (JAMA Oncol, 2015; 1[2] : 158). The authors reported that use of the assay increased from 1.1% in 2005 to only 10.1% in 2009. Medicare and CMS are currently evaluating using NCCN Guideline compliance for payment authorization. Hopefully, the recent publication by Sparano et al, will further improve application of Oncotype DX for women with a RS<11 as well as the previously documented studies of little benefit from scores of a RS<18 . We can aid in this effort by informing our clinical care team colleagues and patients. In so doing, chemotherapy can be tailored to women who are more likely to gain a survival benefit, while sparing others the toxicity, and reducing costs to our healthcare system. Breast Centers should document in their breast conference notes the rationale for not following the many guidelines and endorsements and now supported by the Sparano et al study. Read the Editorial included in this issue of The Bulletin which describes this important trial. Read More...

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