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Therapy Selection Assay for Ductal Carcinoma in Situ (Breast Cancer)
TDI's Isonostics™ assay development program in breast cancer is targeted to select the 20-30% of ductal carcinoma in situ (DCIS) patients who would receive net benefit from adjuvant chemotherapy treatment following surgery, from the 80% of DCIS patients who currently receive such treatment and experience the significant impact of chemotherapy upon quality of life.1, 2, 3, 4
Virtually all patients undergo surgical removal of the tumor whether by a breast conserving procedure or complete mastectomy, at an average cost of $15,000 per patient.5 Some also undergo radiation therapy, averaging an additional $10,000 per patient.6 If the tumor has elevated levels of the estrogen receptor (ER+), then the patient is often placed on a 5 year-course of tamoxifen treatment at an average cost of $4500/year, despite the significant negative side-effect rates for promotion of thrombosis, increased risk of endometrial cancer, and cataracts.7
The specific question to be addressed by this assay is whether or not the patient should also undergo a course of chemotherapy, with costs averaging $16,000 ($15-$20,000).8, 9, 10, 11 Chemotherapy for non-metastatic breast cancer usually involves taking combinations of different classes of drugs, all of which have side effects ranging from mild to life-threatening. The specific combination a patient is prescribed depends on the characteristics of the tumor, lymph node involvement, previous chemotherapies received, and oncologist preference. All chemotherapeutic regimens cause the most common side effects: nausea, vomiting, diarrhea, hair loss, fatigue, anemia, and increased susceptibility to infections. Some have gravely serious side effects, such as: bone loss, peripheral neuropathy, cardiotoxicity, and even treatment-induced leukemia. These side effects are significant enough to make some women forego the treatment who might otherwise have benefited from it. The potentially avoidable aggressive treatments of early stage DCIS could offset up to $0.5-2.0B in annual expenditures for the US heathcare system.
Breast is one of the top diagnosed cancers in the US with 235,000 diagnosed cases in 2005.12 Through increased awareness, routine population screening, and the development of new chemotherapies and hormonal treatments, more than 70% of breast cancers are caught pre-metastatic and are effectively treated, resulting in an overall mortality rate of less than 20% (40,000).13 Ductal carcinoma, cancer of the epithelial cells in the milk duct, accounts for 80-85% of all cancers of the breast.14
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1Mamounas et al., “Association between the 21-gene recurrance score assay (RS) and risk of loco-regional failure in node-negative, ER-positive breast cancer: Results from NSABP B-14 and NSABP B-20,” presented paper, 28th Ann. San Antonio Breast Cancer Symp (2005).
2Paik et al., N. Engl. J. Med., 351:2817-2826 (2004).
3Paik et al., N. Engl. J. Med., 351:2817-2826 (2004).
4Hornberger et al., Am. J. Managed Care, 11:313-324 (2005).
5Fireman et al., Health Care Fin. Rev. 18:51 (1997).
6Suh et al., Int. J. Radiation Oncol. Biol. Phys., 62:790-796 (2005).
7Nolvadex package insert (2005).
8Hornberger et al., Am. J. Managed Care, 11:313-324 (2005).
9Fireman et al., Health Care Fin. Rev. 18:51 (1997).
10Ostreicher et al., Cancer, 104:2054-2062 (2005).
11Neyt et al., Ann. Oncol., advance access publication (Nov. 30, 2005).
12 Ho Cheng, Olivia, "A new look at cancer detection", article, The Boston Globe, Healthcare Section, October 23, 2005.
13American Cancer Society, “Cancer Facts and Figures,” (2005).
14http://www.breastcancer.org/idc_invasive_ductal_carcinoma.html (111 Forrest Ave., Narberth, PA, 19072).
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