Oncotype 2018 update – pro

The published literature for Oncotype primarily consists of validation studies to identify the optimal set of cancer-related genes.
Oncotype is now widely accepted. The American Society of Clinical Oncology (ASCO) has included Oncotype DX™ into its 2007 updated clinical guidelines for the use of tumor markers in breast cancer. Most recently, NCCN has decided to include Oncotype in its 2008 guidelines and BCBS issued a supportive TEC assessment. All of these, however, was in node negative patients, but NCCN changed that as well..

Oncotype DX Breast Recurrence Score® test has been categorized as the only “preferred” test for chemotherapy treatment decision-making for patients with node-negative early-stage breast cancer by the National Comprehensive Cancer Network (NCCN) in its 2018 guidelinesfor invasive breast cancer chemotherapy treatment. The only test elevated to “strongly consider” guideline inclusion with level 1 evidence, Oncotype DX continues to be distinguished as the only genomic test predictive of chemotherapy benefit.

NCCN’s guidelines update follows the recent publication of results of Trial Assigning IndividuaLized Options for Treatment (Rx), or TAILORx, led by ECOG-ACRIN Research Group. The largest adjuvant treatment breast cancer trial to date, TAILORx involved 10,273 women across 1,100 trial sites in six participating countries. The study results, published in The New England Journal of Medicine,  demonstrated that the Oncotype DX Breast Recurrence Score test definitively identifies the vast majority of women with early-stage breast cancer who receive no benefit from chemotherapy, and the important minority of women for whom chemotherapy benefit can be life-saving.

Additionally, the NCCN guidelines elevated Oncotype DX into the algorithm for chemotherapy treatment of patients with micrometastases and one to three positive lymph nodes.

HER positivity is an independent poor risk factor that indicates adjuvant chemotherapy irrespective of Oncotype status. Oncotype has a much lower predictive value in such patients.

I. Baker J et al. Tumor gene expression predicts distant disease-free survival (DDFS) in breast cancer patients with 10 or more positive nodes: High throughput RT-PCR assay of paraffin-embedded tumor tissues. Proc Am Soc Clin Oncol 2003;22:850 (abstract 3415)

Paik S, Shak S, Tang G et al. Multi-gene RT-PCR assay for predicting recurrence in node-negative breast cancer patients – National Surgical Adjuvant Breast and Bowel Project (NSABP) studies B-20 and B-14. San Antonio Breast Cancer Symposium. San Antonio, TX, December 2003. www.abstracts2view.com/bcs03/view.php?nu=BCS3L_701 (Verified 1/10/06)
Paik S, Shak S, Tang G, et al. A multigene assay to predict recurrence of tamoxifen-treated, node-negative breast cancer. NEJM 2004;351(27):2817-26

However, there is much less acceptance for using it for DCIS.  A validation study was presented in the 2014 SABSS (Abstract 2014).  This population-based study was undertaken to validate the score in women diagnosed with pure DCIS and treated with breast-conserving surgery alone in Ontario, Canada. Of 1,658 cases that met these criteria, tissue blocks were available for 858 and 257 were excluded, leaving a study cohort of 571 individuals. At a median follow-up of 9.6 years, 100 cases of local recurrence were identified (57 invasive and 44 DCIS).

This finding needs t o e confirmed and that using Oncotype makes a clinical difference needs to be proven still.

Rakovitch E, Nofech-Mozes S, Hanna W, Baehner FL, Saskin R, Butler SM, Tuck A, Sengupta S, Elavathil L, Jani PA, Bonin M, Chang MC, Slodkowska E, Anderson JM, Jamshidian F, Cherbavaz DB, Shak S, Paszat L. Sunnybrook Health Sciences Centre, Toronto, ON, Canada; Institute for Clinical and Evaluative Sciences, Toronto, ON, Canada; University of Toronto, Toronto, ON, Canada; Genomic Health Inc, Redwood City, CA; University of California, San Francisco, CA; London Health Sciences Centre, London, ON, Canada; Kingston General Hospital, Kingston, ON, Canada; Henderson General Hospital, Hamilton, ON, Canada; Thunder Bay Regional Health Sciences Centre, Thunder Bay, ON, Canada; Northern Ontario School of Medicine, Thunder Bay, ON, Canada; Health Sciences North Sudbury, Sudbury, ON, Canada; Mount Sinai Hospital, Toronto, ON, Canada. S5-04] A large prospectively-designed study of the DCIS score: Predicting recurrence risk after local excision for ductal carcinoma in situ patients with and without irradiation

National Comprehensive Cancer Network Clinical Practice Guidelines in Oncology. Breast Cancer. http://nccn.org/professionals/physician_gls/PDF/breast.pdf
Lisa Flaum, William J. Gradishar, Refining Treatment Decisions in Older Patients With Breast Cancer. JAMA Oncol.  2015;1(2):166-167

2007 TEC Assessment: Gene expression profiling for managing breast cancer treatment. www.bcbs.com/tec/vol20/20_03.html
National Comprehensive Cancer Network Clinical Practice Guidelines in Oncology. Breast Cancer. http://nccn.org/professionals/physician_gls/PDF/breast.pdf
The American Society of Breast SurgeonsJuhi Asad et al Does oncotype DX recurrence score affect the management of patients with early-stage breast cancer? The American Journal of Surgery (2008) 196, 527–529

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