- Study results presented at ASCO20 showed that the Recurrence Score® results on core biopsies predict the likelihood of response to neoadjuvant chemotherapy
- Results are particularly relevant in the context of the Covid-19 pandemic which is causing the delay of elective surgeries across health systems worldwide
MADISON, Wisconsin, May 29, 2020 /PRNewswire/ -- Exact Sciences Corp. today announced results from three studies of the Oncotype DX Breast Recurrence Score® test, presented at the virtual 2020 American Society of Clinical Oncology (ASCO) Annual Meeting. The findings highlight the value the Oncotype DX® test can provide by personalizing and improving neoadjuvant treatment decisions (i.e., prior to surgery) in women with hormone receptor positive, HER2-negative breast cancer.
"As health systems across the world respond to the Covid-19 pandemic, decisions are being made that are resulting in the postponement of both screening and diagnostic oncology services as well as elective surgery," said Dr Emilio Alba, Director of the Medical Oncology Units at the Hospital Universitario Virgen de la Victoria in Malaga, Spain. "This new evidence shows that the Oncotype DX test may be used to inform neoadjuvant therapy while awaiting surgery, therefore helping us to overcome some of the unique challenges we are currently facing in managing breast cancer patients."
One study1 presented at ASCO20 included 76 women treated with neoadjuvant chemotherapy from the Young Women's Breast Cancer Study, a multi-center prospective group of women diagnosed with breast cancer at age 40 or younger. The Oncotype DX test was performed on tumor specimens from core biopsies obtained from the patients prior to surgery. Results revealed that patients with a higher Recurrence Score result were more likely to achieve a pathologic complete response (pCR; no residual invasive tumor) with chemotherapy. Most pathologic complete responses were achieved in patients with a Recurrence Score result of 26 and above. In contrast, only two patients with a Recurrence Score of 0-25 achieved pCR, and both had results between 21-25. These findings are consistent with previously published neoadjuvant studies in older breast cancer patients.
A second study2 was conducted in Spain and prospectively analyzed a group of 63 patients who received neoadjuvant chemotherapy after the Oncotype DX test was performed on tumor specimens from core biopsies. The analysis also showed a strong correlation between pCR and Recurrence Score result. In particular, the Recurrence Score result was the most significant predictor of pCR when compared to other factors such as Ki67 (a classic prognostic factor), estrogen receptor status and initial tumor size. None of the patients with a Recurrence Score result of 0-25 achieved a pCR.
In the third study3, the Oncotype DX test was performed prior to surgery and patients with Recurrence Score results 0-30 received neoadjuvant endocrine therapy without chemotherapy. After four months of treatment, data from 142 patients showed that 97% of them had a clinical response or stable disease, suggesting that patients with a Recurrence Score result <31 can safely be offered neoadjuvant endocrine therapy alone with minimal risk of progression of disease.
The new data presented at ASCO20 add to existing evidence4,5,6 and reinforce the value of the Oncotype DX test in light of recent Covid-19 pandemic recommendations.7,8 Core biopsy specimens represent 14% of the overall Oncotype DX Breast Recurrence Score test volume, and they have a testing success rate of more than 98%.9
About early-stage breast cancer and the Oncotype DX test
Oncotype DX is the only genomic test validated for its ability to predict the likelihood of chemotherapy benefit as well as risk of recurrence in early-stage breast cancer. Breast cancer is the most common cancer in European women10 and affects many of them during their years dedicated to working and raising a family. While chemotherapy is routinely offered, research shows that only a minority of patients with early-stage breast cancer actually benefit from it.11,12 The Oncotype DX test is designed to facilitate personalized clinical decisions by providing information about the biology of an individual breast cancer, with the potential to deliver financial benefits for healthcare systems.
To learn more about the Oncotype DX test, visit: oncotypeiq.com/en
About Exact Sciences Corp.
A leading provider of cancer screening and diagnostic tests, Exact Sciences relentlessly pursues smarter solutions providing the clarity to take life-changing action, earlier. Building on the success of the Cologuard® and Oncotype DX tests, Exact Sciences is investing in its product pipeline to take on some of the deadliest cancers and improve patient care. Exact Sciences unites visionary collaborators to help advance the fight against cancer. For more information, please visit the company's website at www.exactsciences.com, follow Exact Sciences on Twitter @ExactSciences, or find Exact Sciences on Facebook.
NOTE: Oncotype, Oncotype DX, Breast Recurrence Score are trademarks or registered trademarks of Genomic Health, Inc. Exact Sciences is a trademark or registered trademark of Exact Sciences Corporation. All other trademarks and service marks are the property of their respective owners.
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1 Sella T. et al, Abstract #514, ASCO 2020
2 Morales S. et al, Abstract #e12630, ASCO 2020
3 Al-Saleh K. et al, Abstract #594, ASCO 2020.
4 Iwata H, et al. Breast Can Res Treat. 2019.
5 Pivot X, et al. Oncologist. 2015.
6 Kantor O, et al. Ann Surg Oncol. 2019.
7 Dietz JR, et al representing the COVID-19 Pandemic Breast Cancer Consortium. Breast Can Res Treat. 2020
9 Exact Sciences. Data on File.
10 Ferlay J et al, Global Cancer Observatory: Cancer Today. Lyon, France: International Agency for Research on Cancer. 2018 Available from: https://gco.iarc.fr/today/home
11 Paik et al. J Clin Oncol. 2006
12 Early Breast Cancer Trialists' Collaborative Group (EBCTCG) et al. Lancet. 2012
SOURCE EXACT SCIENCES CORP