plus 3, Breast Cancer Screening: MRI Sensitive, No Added Value With ... - Science Daily |
- Breast Cancer Screening: MRI Sensitive, No Added Value With ... - Science Daily
- Genomic Health Announces Analysis Reinforcing Clinical Utility of ... - PR Inside
- Contralateral Prophylactic Mastectomy Associated With Survival In ... - Redorbit.com
- Genomic Health (GHDX) Announces Results of Oncotype DX Breast Cancer ... - StreetInsider.com
| Breast Cancer Screening: MRI Sensitive, No Added Value With ... - Science Daily Posted: 26 Feb 2010 08:59 AM PST Message from fivefilters.org: If you can, please donate to the full-text RSS service so we can continue developing it. ScienceDaily (Feb. 26, 2010) — Do we need a revision of current recommendations for breast cancer screening? According to a recent prospective multicenter cohort study published in the Journal of Clinical Oncology, this appears advisable at least for young women carrying an increased risk of breast cancer. The results of the EVA trial confirm once more that magnetic resonance imaging (MRI) is substantially more accurate for early diagnosis of breast cancer than digital mammography or breast ultrasound: MRI is three times more sensitive for breast cancer than digital mammography. For the EVA trial, almost 700 women were enrolled. Aim of the trial was to refine existing guidelines for surveillance of women at high and moderately increased risk of breast cancer. Findings suggest that in these women, MRI is essential for early diagnosis -- and that a mammogram or an ultrasound examination does not increase the "cancer yield" compared to what is achieved by MRI alone. Researchers conclude that annual MRI is not only necessary, but in fact sufficient for screening young women at elevated risk of breast cancer. In women undergoing screening MRI, mammograms will have no benefit and should be discontinued. Moreover, MRI screening is important not only for women at high risk, but also for those at moderately increased risk. Between 2002 and 2007, the EVA trial recruited 687 women who carried a moderately increased risk of breast cancer (lifetime risk of 20% and over). Women underwent 1679 screening rounds consisting of annual MRI, annual digital mammography and half-annual screening ultrasound examinations. During this time span, 27 women received a new diagnosis of invasive cancer or DCIS (Ductal Carcinoma In Situ). Of all imaging methods under investigation (digital mammography, ultrasound and MRI), MRI offered by far the highest sensitivity: MRI identified 93% of breast cancers. 37% of cancers were picked up by ultrasound. The lowest sensitivity was achieved by digital mammography, which identified only one-third of breast cancers (33%). These results confirm once more that MRI is essential for surveillance not only of women at high risk, but also for women at moderately increased risk of breast cancer. Moreover, the results contradict current guidelines according to which mammography is considered indispensable for breast cancer screening. One aim of the EVA trial was to question this concept and to ask whether it is still appropriate to require that MRI should only be used in addition to mammography. The results speak for themselves: If an MRI is available, then the added value of mammography is literally negligible. Researchers conclude that MRI is necessary as well as sufficient for screening young women at elevated risk of breast cancer. Since mammography appears to be unnecessary in women undergoing MRI, its use is no longer justifiable, and current guidelines should be revised to reflect this. Current guidelines questionable Current guidelines for women at high familial risk of breast cancer recommend annual MRI (with or without ultrasound) and annual MRI starting at age 25-30. "These guidelines were set up based on little or no scientific evidence, and mainly reflect expert opinion," summarizes Prof. Christiane Kuhl, radiologist at the University of Bonn and principal investigator of the EVA trial. "In the light of the results of the EVA trial, such recommendations should be revisited." This seems even more important because digital mammography uses x-rays (ionizing radiation) to detect breast cancer. "The radiation dose associated with regular mammographic screening is clearly acceptable and safe," underscores Kuhl. "However, regular mammographic screening usually starts at age 40-50." The situation is different if systematic annual mammographic screening is started at age 25-30. "Not only because these women will undergo more mammograms and therefore will experience a cumulative lifetime radiation dose that will be substantially higher, but also because the breast tissue of young women is more vulnerable to the mutagenic effects of radiation." This appears to be especially true for BRCA mutation carriers. "Accordingly, we impose more radiation on less radiation-tolerant breast tissue -- for a very limited, if any, diagnostic benefit." Therefore, Kuhl advocates a revision of existing guidelines: "It is no longer justifiable to insist on annual mammographic screening women in their thirties if they have access to screening MRI." MRI is a mature technology In the past, MRI was used strictly in addition to mammography only. The allegedly high rate of "false positive" diagnoses and the allegedly insufficient sensitivity for DCIS were the main reason to discourage its use as a stand-alone method for breast cancer screening. "In this multicenter trial, with basic quality assurance implemented not only for mammography, but also for MRI, we were able to prove that false positive diagnoses are avoidable if MRI studies are interpreted with adequate radiologist expertise." In the EVA cohort, the Positive Predictive Value achieved with MRI was already even higher than that of mammography or breast ultrasound. "Moreover, we found that MRI offered the highest sensitivity especially for DCIS," adds Dr. Kuhl. "It is simply wrong to state that we need a mammogram to detect intraductal cancer." Story Source: Adapted from materials provided by University of Bonn. Journal Reference:
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| Genomic Health Announces Analysis Reinforcing Clinical Utility of ... - PR Inside Posted: 26 Feb 2010 05:17 AM PST Message from fivefilters.org: If you can, please donate to the full-text RSS service so we can continue developing it. 2010-02-26 14:18:02 - REDWOOD CITY, CA and KYOTO, JAPAN -- (Marketwire) -- 02/26/10 -- Genomic Health :  , Inc.(NASDAQ: GHDX) today announced results from an analysis demonstrating that the Oncotype DX® breast cancer test : has similar clinical relevance in estrogen receptor-positive, early-stage breast cancer patients in Asia Pacific (AP) countries as it does in a comparable U.S.-based patient population. The analysis showed that this advanced diagnostic test consistently identified more than 50 percent of hormone receptor positive early-stage breast cancer patients in AP countries as having low Recurrence Scores, similar to what has been shown in U.S. and European clinical studies evaluating the Oncotype DX : breast cancer test. These results were presented in a poster presentation at the Organisation for Oncology and Translational Research (OOTR) 6th Annual Conference in Kyoto, Japan, on February 26.
The Oncotype DX breast cancer test :
"We believe these new findings, coupled with results from the multi-center Japanese validation study presented last April at the 2009 Kyoto Breast Cancer Consensus Conference, confirm the significant clinical benefit Oncotype DX :
For this analysis, researchers at Genomic Health's :
The table below illustrates the distribution of low, intermediate and high Recurrence Score (RS) risk groups in the Asia Pacific and the U.S.:
AP (n=546) US ( > 110,000) RS 0-17 51% 54% RS 18-30 33% 34% RS greater than or equal to 31 16% 13%
About Genomic Health Genomic Health :
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements relating to the applicability of clinical study results to actual outcomes, the belief the Oncotype DX breast cancer test provides a significant clinical benefit in treatment planning for early-stage breast cancer patients in Asia Pacific countries and the belief that the study supports the company's efforts to expand use of Oncotype DX into breast cancer treatment planning in the Asia Pacific region. Forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially, and reported results should not be considered as an indication of future performance. These risks and uncertainties include, but are not limited to: the risk that we may not be able to expand use of Oncotype DX in the Asia Pacific region; our ability to obtain or maintain sufficient levels of reimbursement for our tests; the risks and uncertainties associated with the regulation of our tests; the applicability of clinical study results to actual outcomes; and the other risks set forth in the company's filings with the Securities and Exchange Commission, including the risks set forth in the company's Quarterly Report on Form 10-Q for the quarter ended September 30, 2009. These forward-looking statements speak only as of the date hereof. Genomic Health disclaims any obligation to update these forward-looking statements.
NOTE: The Genomic Health logo, Oncotype, Oncotype DX and Recurrence Score are trademarks or registered trademarks of Genomic Health, Inc. All other trademarks and service marks are the property of their respective owners.
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| Contralateral Prophylactic Mastectomy Associated With Survival In ... - Redorbit.com Posted: 26 Feb 2010 06:35 AM PST Message from fivefilters.org: If you can, please donate to the full-text RSS service so we can continue developing it. Posted on: Friday, 26 February 2010, 08:40 CST First large, population-based study to find an association between procedure and survival; findings offer data for women making difficult, personal decision Contralateral prophylactic mastectomy (CPM), a preventive procedure to remove the unaffected breast in patients with disease in one breast, may only offer a survival benefit to breast cancer patients age 50 and younger, who have early-stage disease and are estrogen receptor (ER) negative, according to researchers at The University of Texas M. D. Anderson Cancer Center. Published online Feb. 25 in the Journal of the National Cancer Institute, it's the first population-based study to find an association between the procedure and survival in any group of breast cancer patients. The findings should offer evidence to both the women making this often agonizing decision and the physicians responsible for their care. According to Isabelle Bedrosian, M.D., assistant professor in M. D. Anderson's Department of Surgical Oncology, a growing number of breast cancer patients are opting for the procedure; recent statistics have shown that the rate of CPM in women with stage I-III breast cancer increased by 150 percent from 1998 to 2003 in the United States. "In our clinic, we've seen a dramatic increase in the number of women requesting CPM, and across the breast cancer community, studies have shown that the utilization of the procedure is skyrocketing," said Bedrosian, the study's co-corresponding author. "Until now, we've counseled these patients on a very important, personal decision in a vacuum. With our study, our goal was to understand the implications of the surgery and who may benefit." For the retrospective, population-based study, the researchers used the National Cancer Institute's Surveillance, Epidemiology and End Results (SEER) registry, the premier population-based cancer registry now representing 26 percent of the country's population, to identify 107,106 breast cancer patients who underwent a mastectomy for treatment, as well as a subset of 8,902 women who had CPM. All of the women were treated for stages I - III breast cancer between 1998 and 2003. Patients were stratified for ER status, stage of disease and age. Breast cancer-specific survival served as the study's primary endpoint. Rigorous analysis was paramount in the design of the study, said George J. Chang, M.D., assistant professor in M. D. Anderson's Department of Surgical Oncology. "It was important to take a critical eye and look at all the different ways the data could be misinterpreted to ensure that biases were not impacting our findings," said Chang, the study's co-corresponding author. "Using multi-variable analysis as well as risk stratification, we did our analysis in many different ways - through SEER, comparing the survival of these patients to that of the general population, as well as examining non-cancer related versus cancer-specific survival. All alternative analyses resulted in the same conclusion; we found one group for whom this surgery offers a true survival benefit." The researchers found a clear survival benefit for a select group of women that represents less than 10 percent of the breast cancer population. Those younger than age 50 with stage I or II cancer with ER negative disease had a survival benefit of 4.8 percent at five years. However, both Bedrosian and Chang expect that future research will show increased survival benefit with longer follow-up in the population, as a patient's likelihood of getting a second breast cancer increases with time. While the findings should serve as a guideline for breast cancer patients and their physicians to have an informed, medically-based discussion about CPM, they do not determine that CPM is medically inappropriate for all others with the disease, said the researchers. "Our research found that breast cancer patients over the age of 60 can be reassured that they will not benefit from CPM," said Bedrosian. "However, there are other populations - such as women between the age of 50 and 60 - where the findings about the procedure remain less clear. In addition, for young women with early stage, estrogen receptive positive breast cancer who receive Tamoxifen for only five years, we really do not know whether they would derive a life-long protective effective from a second breast cancer event. Therefore, for some additional breast cancer patients, CPM may very well be a medically-appropriate option." In addition, the researchers note, the study captured neither family history nor BRCA status; it also did not include DCIS, or stage 0 breast cancer patients. In addition to Bedrosian and Chang, Chung Yuan Hu in the Department of Surgical Oncology, also authored the all-M. D. Anderson study. --- On the Net: Five Filters featured article: Chilcot Inquiry. Available tools: PDF Newspaper, Full Text RSS, Term Extraction. This posting includes an audio/video/photo media file: Download Now |
| Genomic Health (GHDX) Announces Results of Oncotype DX Breast Cancer ... - StreetInsider.com Posted: 26 Feb 2010 05:31 AM PST Message from fivefilters.org: If you can, please donate to the full-text RSS service so we can continue developing it. Genomic Health, Inc. (NASDAQ: GHDX) today announced results from an analysis demonstrating that the Oncotype DX breast cancer test has similar clinical relevance in estrogen receptor-positive, early-stage breast cancer patients in Asia Pacific (AP) countries as it does in a comparable U.S.-based patient population. The analysis showed that this advanced diagnostic test consistently identified more than 50 percent of hormone receptor positive early-stage breast cancer patients in AP countries as having low Recurrence Scores, similar to what has been shown in U.S. and European clinical studies evaluating the Oncotype DX breast cancer test. These results were presented in a poster presentation at the Organisation for Oncology and Translational Research (OOTR) 6th Annual Conference in Kyoto, Japan, on February 26. The Oncotype DX breast cancer test measures the expression of 21 genes of an individual breast cancer tumor to generate a Recurrence Score that quantifies the magnitude of chemotherapy benefit and the likelihood of recurrence for early-stage patients. As of February 2010, more than 8,000 physicians have used the Oncotype DX test for more than 135,000 breast cancer patients in more than 50 countries. The test was launched in the United States in 2004 where it has since been widely adopted for treating early-stage breast cancer, and is available worldwide. "We believe these new findings, coupled with results from the multi-center Japanese validation study presented last April at the 2009 Kyoto Breast Cancer Consensus Conference, confirm the significant clinical benefit Oncotype DX provides in breast cancer treatment planning for early-stage breast cancer patients in Asia Pacific countries," said Calvin Chao, M.D., Medical Director, Genomic Health. "We believe these data support our efforts to expand the use of Oncotype DX throughout this important region of the world." For this analysis, researchers at Genomic Health's CLIA (Clinical Laboratory Improvement Amendments) certified, CAP (College of American Pathologists) accredited laboratory analyzed tumor samples from 546 AP patients located in Japan, Taiwan, Hong Kong, Singapore, Thailand, India, Australia, and New Zealand. The tumor samples were submitted by physicians between 2006 and 2009. The AP Recurrence Score results, when compared to U.S. scores, showed a similar distribution of Recurrence Scores -- low Recurrence Score group (51 percent AP, versus 54 percent U.S.), intermediate Recurrence Score group (33 percent AP, versus 34 percent U.S.) and high Recurrence Score group (16 percent AP, versus 13 percent U.S.). These findings were consistent with results from numerous U.S. and international validation and confirmatory studies evaluating Oncotype DX, despite observed differences in practice pattern management of early-stage breast cancer. Related CategoriesCorporate NewsFDA
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