Oncotype DX DCIS Score™ Data Presented at San Antonio Breast Cancer Symposium, New Cancer Coach Smartphone App, MMR Status for Stage II Colon Cancer
Dear friends and colleagues,
Happy Holidays! Wishing you a season a filled with happiness and warmth, surrounded by family and friends.
This issue of our newsletter for the advocacy community includes many exciting new developments from Genomic Health! We are thrilled to share the recently presented positive results from our study of the Onoctype DX® DCIS breast cancer test, as well as the launch of our unique new mobile app tool for cancer patients, Cancer Coach. The newsletter also contains highlights from some of the global studies presented at the San Antonio Breast Cancer Symposium, and an overview of the importance of understanding MMR status for Stage II colon cancer patients.
We hope that you will find these topics and resources helpful and relevant to the work you are doing on behalf of families affected by cancer. Looking forward to continuing our valuable work together in the New Year!
All the best,
Sara Chenault
Director, Patient Advocacy
Genomic Health, Inc.
schenault@genomichealth.com
New Oncotype DX DCIS Score™ Informs Treatment Decisions and Identifies Lower-Risk DCIS Breast Cancer Patients Who May Avoid Radiation
As many of you may have heard in the news recently, positive study results from a Genomic Health and Eastern Cooperative Oncology Group (ECOG) study demonstrated that the Oncotype DX DCIS Score can predict the likelihood of local recurrence for patients with DCIS. The study results were presented during the 2011 San Antonio Breast Cancer Symposium, and demonstrated that, for the first time, a multi-gene test (the Oncotype DX DCIS Score) can be used to identify approximately 75 percent of patients with low risk DCIS for whom withholding radiation therapy may be considered following tumor excision. Conversely women with high risk DCIS may have sufficient risk that adjuvant therapy including radiation be considered.
DCIS (Ductal Carcinoma In Situ) is an early or pre-invasive form of breast cancer that poses challenging decisions for patients and physicians in determining how to best treat the disease. Unlike invasive breast cancer, the tumor cells in DCIS are confined to the milk ducts within the breast. Breast-conserving surgery (usually lumpectomy), rather than mastectomy, has become the most common surgical procedure for DCIS. For DCIS patients after breast conserving surgery alone, local recurrences of DCIS or a new invasive breast cancer occur, on average, in 20-25 percent of patients at 10 years. However, the vast majority (65-70 percent) of DCIS patients go on to receive radiation. While the addition of radiation therapy for DCIS has been shown in clinical trials to reduce local recurrence risk, it has not been shown to prolong survival in DCIS patients (unlike invasive breast cancer, where the addition of radiation significantly reduces the rates of distant metastases and improves survival between treated and untreated patients).1 Similar to chemotherapy, radiation has significant side effects and to date, there have been no clinically validated molecular markers that clearly identify which patients might be low-risk and avoid radiation and which patients might be high-risk, for whom the side effects of radiation might be worth obtaining a reduction in local recurrence risk.
Because of the unique challenges presented by a DCIS diagnosis, with strong encouragement from breast cancer advocates (including many of you) and physicians, Genomic Health began research to better understand the biology of DCIS so we could develop a tool to help physicians and patients make more informed, individualized treatment decisions for DCIS based on each patient's individual cancer biology. The Oncotype DX breast cancer assay we developed for invasive breast cancer has been available since 2004, and is used to predict the likelihood of chemotherapy benefit as well as recurrence risk in estrogen receptor-positive HER2-negative early stage invasive breast cancer.
Applying our learnings from the validation of Oncotype DX in invasive breast cancer, we partnered with ECOG to conduct a large, prospectively designed clinical validation study to determine if the Oncotype DX DCIS test could predict local recurrence in patients with DCIS breast cancer. The study analyzed 327 DCIS tumor specimens from DCIS patients previously enrolled in the E5194 study of breast-conserving surgery alone. The Oncotype DX DCIS test was performed on each specimen, using a pre-specified DCIS algorithm to predict local recurrence regardless of whether adjuvant tamoxifen was given.
The study demonstrated that 75% of patients have a low DCIS Score as pre-specified in the study and may be able to forego radiation therapy. DCIS breast cancer patients with a low DCIS Score had a low 12% likelihood of a local recurrence, defined as either the development of a new invasive breast cancer or the recurrence of DCIS in the same breast, and an even lower 5% likelihood of developing a new invasive breast cancer. Conversely, the study demonstrated that patients with high DCIS Score had a 27% likelihood of local recurrence, of which approximately half was likely to develop a new invasive breast cancer.
The study met its primary endpoint by demonstrating that a pre-specified Oncotype DX DCIS Score goes beyond traditional clinical and pathologic measures, such as tumor size, tumor grade, and patient age, to predict the risk of local recurrence, defined as either the development of a new invasive breast cancer or the recurrence of DCIS in the same breast.
Based on these results, Genomic Health plans to make the Oncotype DX DCIS Score available to physicians and their DCIS patients on December 28, 2011. By revealing the underlying biology of DCIS, we can now help quantify the likelihood of local recurrence, which is key to devising an individualized treatment plan which will provide excellent outcomes for patients with the least treatment, toxicity, and disruption of daily life.
* For more information about Oncotype DX go to www.mybreastcancertreatment.org or call 1-866-662-6897.
1. Hughes et al, J Clin Oncol. 2009; 27:39
New Smartphone Mobile Application Tool Available for Cancer Patients - Cancer Coach!
In partnership with Breastcancer.org and Fight Colorectal Cancer, Genomic Health launched a smartphone application, Cancer Coach, designed to help newly diagnosed breast cancer or colon cancer patients, and their caregivers. The application allows patients to access information about personalized treatment options, and includes interactive functions to help manage the treatment journey. Cancer Coach was developed with Breastcancer.org and Fight Colorectal Cancer, creating a natural extension of the original My Breast Cancer Coach (www.mybreastcancercoach.org) and My Colon Cancer Coach (www.mycoloncancercoach.org) online tools which empower patients to make better informed decisions about their treatment based on accurate, accessible and personalized medical information about their cancer.
Cancer Coach features the narrated My Breast Cancer Coach and My Colon Cancer Coach tools, a calendar to mark medical appointments, important questions for the doctor, an audio notepad function that records additional questions and responses, a glossary, and a journal to keep track of key information shared during doctor visits throughout diagnosis and treatment.
"More and more women are seeking information about breast cancer, not just online, but using their mobile devices. The Cancer Coach app fulfills this need for reliable resources on-the-go as patients and their personal support networks navigate a new diagnosis," said Hope Wohl, CEO of Breastcancer.org. "Our partnership with Genomic Health on My Breast Cancer Coach and the Cancer Coach app supports our mission to help breast cancer patients and their loved ones make sense of complex medical information so they can make the most informed decisions."
The Cancer Coach app walks patients through a simple questionnaire with audio guidance for breast cancer by Lillie Shockney, RN, Administrative Director of the Johns Hopkins Avon Foundation Breast Center and for colon cancer by Richard M. Goldberg, MD, Professor and Physician-in-Chief of the James Cancer Hospital and Associate Director of the James Cancer Center at the Ohio State University. Based on a patient's responses, the Cancer Coach creates a customized treatment information guide that can be shared with their physician as they discuss treatment options. The Cancer Coach app is available on Apple iTunes and in the Android Market and features additional resources for breast and colon cancer, such as an RSS news feed unique to newly diagnosed breast cancer or colon cancer patients.
"We believe that as the biology of cancer becomes better defined it is critical that every patient begin to take a more informed and active role in their treatment plan," said Randy Scott, founder and executive chairman of the board, Genomic Health. "The Cancer Coach app allows patients to store and access high quality personalized information right at their fingertips so that it is readily available as they decide with their healthcare team how best to proceed with treatment."
Carlea Bauman, president of Fight Colorectal Cancer, believes colon cancer patients and their caretakers will find the Cancer Coach app to be extremely helpful as they are able to take the resources of My Colon Cancer Coach with them into the doctor's office, and use the key features of a smart phone to help manage all the information shared during health care visits, "The app is an effective tool for patients to have in hand, especially when they meet with their doctor. It gives them information unique to their diagnosis that can really make a difference in the discussion about treatment," she said.
The personalized treatment information guides provided by My Breast Cancer Coach and My Colon Cancer Coach online tools and the Cancer Coach app were developed in accordance with National Cancer Cooperative Network® (NCCN®) clinical treatment guidelines.2
The Cancer Coach app is available for iPhone® and for Android®. It can also be downloaded from My Breast Cancer Coach and My Colon Cancer Coach, or by visiting the Apple® store or Android Market on a mobile device and searching for "Cancer Coach."3
2. NCCN, National Cancer Comprehensive Network (NCCN), and NCCN guidelines are trademarks of NCCN. NCCN does not endorse any product or therapy.
3. iPhone, Apple, and Android are registered trademarks of Apple, Inc., and Google, Inc., respectively.
Studies Shared During the San Antonio Breast Cancer Symposium Show the Oncotype DX Test Changes Treatment Decisions around the World
During the recent San Antonio Breast Cancer Symposium (SABCS), multiple studies were presented that reinforced the impact of the Oncotype DX breast cancer test on changing treatment decisions across multiple health care systems. Decision impact studies - studies that are designed to determine if using the Oncotype DX breast cancer test would change a doctor's decision about how to best treat a patient - were conducted in Australia, Germany and the UK. The results of these studies, which included a total of 658 invasive breast cancer patients, confirm data from previous similar studies that the Oncotype DX Recurrence Score® (RS) changes initial treatment decisions by approximately 30% in patients with ER+ early stage breast cancer.
"By providing prognostic and predictive information beyond traditional markers, Oncotype DX gives me and my patients greater confidence in selecting the most appropriate treatment option," said Simon Holt, MA, MB, BChir, FRCS, Lead Breast Surgeon, Hywel Dda NHS Trust Board, Wales, UK. "The results of this study reinforce that the use of Oncotype DX may result in better patient care by enabling physicians to tailor treatment recommendations and by providing added reassurance to patients that they have made the right decision about chemotherapy based on their individual tumor biology."
Additionally, data continues to reconfirm the accuracy, precision, reproducibility and consistency of the Recurrence Score results in patients with early-stage breast cancer. Presentations included ten international studies from the United Kingdom, Germany, France, Ireland, Australia, Venezuela, and a review including data from Israel, Canada, Hungary, Japan, and Singapore.
Christer Svedman, director, medical affairs in Europe, Genomic Health, said during the SABCS meeting, "We are committed to bringing these benefits into clinical practice worldwide."
For more information about the global studies presented at SABCS, click on the following link:
http://investor.genomichealth.com/releasedetail.cfm?ReleaseID=632392
Understanding the Significance of MMR Status for Stage II Colon Cancer Patients
The MMR status of a patient's tumor provides additional information about a patient's individualized prognosis. Studies have shown that Stage II colon cancer patients with MMR-deficient (MMR-D) tumors have a lower risk of recurrence compared to patients with MMR-proficient (MMR-P) tumors.4 Knowing their MMR status may help Stage II colon cancer patients and their doctors make more informed decisions about how to best treat their disease.
In MMR-P tumors, an intact MMR pathway corrects errors in DNA replication that occur routinely during cell division. In MMR-D tumors, the MMR pathway is compromised. Approximately 15% of stage II colon cancer patients have tumors that are MMR deficient. MMR deficiency is also observed in Lynch Syndrome, a hereditary form of colon cancer, though the majority of patients with MMR-D tumors do not have Lynch Syndrome. However, patients with MMR-D tumors should speak with their doctors about further testing.
Recent studies have also suggested that patients with MMR-D colon cancer may be resistant to 5-FU based chemotherapy, but this remains an ongoing question of study.5 Taken together, these findings have led to the consideration of MMR testing for assessment of recurrence risk in select stage II colon cancer patients in the NCCN Colon Cancer clinical practice guidelines, although its clinical application to adjuvant treatment decision-making continues to evolve.
Tumor MMR status can be ascertained in two different ways: immunohistochemistry (IHC) to identify protein expression of known proteins in the MMR pathway or DNA-based PCR analysis to assess the presence of microsatellite instability. Both methods have been shown to be highly concordant, with concordance rates of up to 97% reported in the literature.6 Based on recent data, Genomic Health will begin providing MMR testing for recurrence risk assessment as part of the Oncotype DX service in late 2011.
4. Kerr D, Gray R, Quirke P, et al; A quantitative multi-gene RT-PCR assay for prediction of recurrence in stage II colon cancer: selection of the genes in 4 large studies and results of the independent, prospectively-designed QUASAR validation study; American Society of Clinical Oncology (ASCO) Annual Meeting, 2009.
5. Sargent; Journal of Clinical Oncology, 2010
6. Bertagnolli; Journal of Clinical Oncology, 2010
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