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Physical Activity Improves Survival for Men With Localized Prostate Cancer63635512/19/2014 2:23:21 PM59http://www.aacr.org/Newsroom/Lists/News Releases/AllItems.aspx650False2014-12-19T05:05:00Z<div class="ExternalClassB8556EC4D81B44C1BA5DF3A29840CC7C"><p>PHILADELPHIA — Among a large group of men with localized prostate cancer, those who engaged in higher levels of physical activity had lower rates of overall mortality and lower rates of prostate cancer-specific mortality, according to a <a href="http&#58;//cebp.aacrjournals.org/content/early/2014/11/26/1055-9965.EPI-14-0707.abstract" target="_blank">study</a> published in <em>Cancer Epidemiology, Biomarkers &amp; Prevention</em>, a journal of the American Association for Cancer Research.<img alt="Stephanie Bonn, MSc" src="/PublishingImages/Bonn_Stephanie_150x200.jpg" style="margin&#58;10px;vertical-align&#58;auto;float&#58;right;" /></p><p>“Our results extend the known benefits of physical activity to include prostate cancer-specific survival,” said Stephanie Bonn, MSc, a doctoral candidate in the <a href="http&#58;//ki.se/en/meb/startpage" target="_blank">Department of Medical Epidemiology and Biostatistics</a> at the Karolinska Institutet in Stockholm. “However, it is important to remember that our results are on a group level. An individual’s survival depends on many factors, but physical activity is one factor that individuals can modify. Hopefully, our study can motivate men to be physically active even after a prostate cancer diagnosis.”</p><p>Men with localized prostate cancer who walked or cycled for 20 or more minutes a day had a 30 percent decreased risk of death from any cause (overall mortality) and a 39 percent decreased risk of death as a result of their disease (prostate cancer-specific mortality) compared with those who walked or cycled less. For those who engaged in one or more hours of exercise per week, overall and prostate cancer-specific mortality rates were decreased by 26 percent and 32 percent, respectively, compared with less active counterparts.</p><p>Bonn and colleagues generated these results after analyzing data from 4,623 men diagnosed with localized prostate cancer from 1997 to 2002 and followed until 2012. Participants in the study were all men in the National Prostate Cancer Register of Sweden Follow-up Study, a retrospective, nationwide cohort study of men with localized prostate cancer who were alive in 2007.</p><p>Data on physical activity were obtained through paper- and web-based questionnaires about lifestyle. Information about cause and date of death was obtained from the Swedish Cause-of-Death Registry.</p><p>“Nearly all men in Sweden who were diagnosed with localized prostate cancer from Jan. 1, 1997, to Dec. 31, 2002, were included in the National Prostate Cancer Register of Sweden Follow-up Study,” said Bonn. “This means our results are generalizable on the population level. However, our data came only from men who were still alive in 2007, which most likely excludes men with more aggressive disease. Our results are, therefore, most applicable to men with less aggressive disease.”</p><p>The study was supported by the Swedish Cancer Society and the Swedish Research Council for Health, Working Life, and Welfare. Bonn declares no conflicts of interest.</p></div>
Levels of Cancer-causing Chemicals in Smokeless Tobacco Products Influence Carcinogen Exposure63289512/18/2014 2:17:30 PM53http://www.aacr.org/Newsroom/Lists/News Releases/AllItems.aspx649False2014-12-18T05:05:00Z<div class="ExternalClassF2F7DF7693C8419A9F7391020C696338"><p>PHILADELPHIA — Higher levels of cancer-causing chemicals called tobacco-specific nitrosamines in smokeless tobacco products led to greater exposure to these carcinogens even after taking into account how much or how long the product was used, according to a <a href="http&#58;//cancerpreventionresearch.aacrjournals.org/content/early/2014/12/16/1940-6207.CAPR-14-0250.abstract" target="_blank">study</a> published in <em>Cancer Prevention Research</em>, a journal of the American Association for Cancer Research.</p><p>“Our results show that although the pattern of tobacco use—for example, amount of dip and number of dips—can influence the level of smokeless tobacco users’ exposure to tobacco-specific nitrosamines, the actual amount of these chemicals in the products also makes a significant difference,” said <a href="http&#58;//www.psychiatry.umn.edu/Faculty/hatsukami/home.html" target="_blank">Dorothy K. Hatsukami, PhD</a>, the Forster Family professor in cancer prevention in the <a href="http&#58;//www.psychiatry.umn.edu/home.html" target="_blank">Department of Psychiatry</a> at the University of Minnesota in Minneapolis.</p><p>“The majority of smokeless tobacco users in the United States are not aware of the levels of cancer-causing chemicals in their smokeless tobacco products or of the tremendous variability in the levels of these chemicals across brands sold in this country,” continued Hatsukami. “At a minimum, the FDA [U.S. Food and Drug Administration] should provide smokeless tobacco consumers information about the different levels of cancer-causing chemicals in different brands of smokeless tobacco and, ideally, require levels of tobacco-specific nitrosamines be substantially reduced, if not eliminated, in all products. Levels of these chemicals in smokeless tobacco products could be readily reduced by changing manufacturing practices.”</p><p>Levels of exposure to tobacco-specific nitrosamines are associated with disease risk, according to Hatsukami. Prior studies have shown that smokeless tobacco users in the United States experience about two to three times greater risks for oral cancer compared with those who do not use these products, she said. Pancreatic cancer has also been linked to smokeless tobacco use.</p><p>“Now that the FDA has the authority to establish product standards—that is, mandate the reduction of harmful and potentially harmful constituents in tobacco products—there has been greater interest in understanding how levels of tobacco-specific nitrosamines in products relate to exposure,” said Hatsukami.</p><p>To study this, Hatsukami; Stephen Hecht, PhD, the Wallin professor of cancer prevention in the Department of Laboratory Medicine and Pathology at the University of Minnesota; and their colleagues analyzed data from 391 adults from Minneapolis/St. Paul; Eugene, Oregon; and Morgantown, West Virginia, who used smokeless tobacco products daily. The smokeless tobacco brands used by different participants varied in nicotine and tobacco-specific nitrosamine content. Participants could not be current users of other tobacco or nicotine products.</p><p>At two assessment sessions, approximately one week apart, demographic information, smokeless tobacco-use history, and urine samples were collected from participants. Urine samples were analyzed for biomarkers of exposure to nicotine and the tobacco-specific nitrosamines N’-nitrosonornictoine (NNN) and 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanone (NNK).</p><p>Analysis showed that levels of biomarkers of NNN and NNK in users’ urine samples were independently positively correlated with the number of years of daily smokeless tobacco use, number of tins of smokeless tobacco used each week, mean daily dip duration, and levels of NNN and NNK in the smokeless tobacco products used. For every one unit (µg/g wet weight) increase of NNK and NNN in the smokeless tobacco product used, the estimated increase of the corresponding biomarkers was 32 percent and 12 percent, respectively.</p><p>The study was supported by the National Cancer Institute. Hatsukami declares no conflicts of interest. Hecht served as an expert witness in a smokeless tobacco trial 10 years ago.</p></div>
Fulvestrant Improves Survival Over Anastrozole for Patients With Advanced Breast Cancer60589712/12/2014 1:29:52 PM68http://www.aacr.org/Newsroom/Lists/News Releases/AllItems.aspx648False2014-12-12T13:30:00Z<div class="ExternalClass12E031FA3A6F464F861D365765B5C0D7"><p>SAN ANTONIO — Among patients with advanced, hormone receptor-positive breast cancer who had not been treated previously for advanced disease, those who took fulvestrant lived longer than those who took anastrozole, according to data from the phase II FIRST trial presented at the <a href="http&#58;//www.sabcs.org/" target="_blank">2014 San Antonio Breast Cancer Symposium</a>, held Dec. 9–13. <img alt="John Robertson, MD" src="/PublishingImages/Robertson_John_150x200.jpg" style="margin&#58;10px;vertical-align&#58;auto;float&#58;right;" /></p><p>“We found fulvestrant to be significantly better for women with advanced breast cancer than a third-generation aromatase inhibitor [anastrozole], which has been the most potent endocrine therapy thus far in the first-line setting for advanced disease,” said <a href="http&#58;//www.nottingham.ac.uk/medicine/about/medscigem/people/john.robertson" target="_blank">John Robertson, MD</a>, professor of surgery at <a href="http&#58;//www.nottingham.ac.uk/medicine/about/medscigem/index.aspx" target="_blank">Graduate Entry Medical School</a> at the University of Nottingham, Royal Derby Hospital, in the United Kingdom.</p><p>“Preliminary analysis from the <a href="http&#58;//clinicaltrials.gov/ct2/show/NCT00274469?term=NCT00274469&amp;rank=1" target="_blank">FIRST phase II trial</a>, which was reported previously, showed longer disease control with 500 mg fulvestrant during the treatment phase compared with anastrozole. The new data we report here translate our previous finding into improved overall survival,” Robertson added.</p><p>“Despite the improved disease control on treatment and improved overall survival seen in the FIRST study, we do not expect this to change the standard of care at this point since it was a phase II study,” Robertson explained. “A phase III [<a href="http&#58;//clinicaltrials.gov/show/NCT01602380" target="_blank">FALCON</a>] study has been initiated to support the regulatory approval for fulvestrant as a first-line agent in this setting, which would be practice-changing.”</p><p>The FIRST trial, initiated in 2006, was a randomized, open-label study, to which 205 women with advanced, hormone receptor-positive disease were enrolled from 62 centers in nine countries. Patients were assigned to either 500 mg fulvestrant (102 patients) or anastrozole (103 patients) as first-line therapy. As of July 2014, information on 170 patients was available&#58; 33 patients were alive and 137 have died.</p><p>Median overall survival, calculated when 67 percent of the study participants died, was 54.1 months for women who took fulvestrant, versus 48.4 months for those who took anastrozole. Patients who took fulvestrant were 30 percent less likely to die of their disease compared with those who took anastrozole. Adverse events were similar in both groups.</p><p>“This is an exciting and a promising finding given that CONFIRM, our earlier phase III trial to test 500 mg fulvestrant in a second-line setting, also showed a survival advantage over anastrozole,” Robertson said.</p><p>This study was funded by AstraZeneca. Robertson’s institution has received research grant funding from AstraZeneca for the work on fulvestrant. Robertson has received travel expenses and honoraria for speaking at AstraZeneca meetings or being a member of advisory boards for AstraZeneca, Pfizer, Novartis, Bayer, and Amgen.</p><p><a href="https&#58;//twitter.com/search?f=realtime&amp;q=%23SABCS14" target="_blank"><img alt="Twitter" src="/PublishingImages/Twitter-bird-blue-on-white_50x50.jpg" style="margin&#58;5px;" /></a><a href="https&#58;//twitter.com/search?f=realtime&amp;q=%23SABCS14" target="_blank">#SABCS14</a></p></div>
Researchers to Present Progression-free Survival Results 60589812/12/2014 3:24:49 PM99http://www.aacr.org/Newsroom/Lists/News Releases/AllItems.aspx645False2014-12-12T13:30:00Z<div class="ExternalClass2A482827038742BB97451263B0FEF27E"><p>SAN ANTONIO — Results from the final analysis of progression-free survival, response rate, and safety for the randomized, phase III Breast Cancer Trials of Oral Everolimus-1 (BOLERO-1) are to be presented here at the <a href="http&#58;//www.sabcs.org/" target="_blank">2014 San Antonio Breast Cancer Symposium</a>, held Dec. 9–13.<img alt="Sara A. Hurvitz, MD" src="/PublishingImages/Hurvitz_Sara_150x200.jpg" style="margin&#58;10px;vertical-align&#58;auto;float&#58;right;" /></p><p>“BOLERO-1 is a randomized, double-blind, phase III clinical trial evaluating whether the addition of everolimus, an mTOR inhibitor, to trastuzumab and paclitaxel improves progression-free survival for patients with HER2-positive, advanced breast cancer who have received no prior treatments for advanced disease,” said <a href="http&#58;//www.cancer.ucla.edu/index.aspx?page=645&amp;recordid=370" target="_blank">Sara A. Hurvitz, MD</a>, an associate clinical professor of medicine and director of the Breast Oncology Program in the <a href="http&#58;//www.uclahealth.org/body.cfm?id=307&amp;action=detail&amp;limit_department=15&amp;limit_division=1037" target="_blank">University of California, Los Angeles, Division of Hematology/Oncology</a>.</p><p>“In San Antonio, we will be presenting data on progression-free survival for the overall patient population and in the subpopulation of patients with hormone receptor-negative disease,” continued Hurvitz. “We will also show our analysis of secondary endpoints of the study, including safety.”</p><p>Last year, results from the BOLERO-3 study showed that the addition of everolimus to trastuzumab and chemotherapy (vinorelbine) significantly improved progression-free survival for patients with trastuzumab-resistant, HER2-positive metastatic breast cancer who had previously been treated with a taxane-based chemotherapy.</p><p>“We are interested in evaluating whether inhibiting the mTOR pathway early in metastatic disease will help delay the development of resistance to HER2-targeted therapy,” said Hurvitz.</p><p>Hurvitz and colleagues enrolled in the BOLERO-1 study 719 women with advanced, HER2-positive breast cancer who had not received prior treatment with trastuzumab or chemotherapy after the advanced disease diagnosis. Among them, 480 patients were randomly assigned to everolimus in combination with weekly paclitaxel and trastuzumab, and 239 patients to placebo plus weekly paclitaxel and trastuzumab. The final analysis was performed after 425 patients in the full population were observed to have disease progression.</p><p>This study was supported by funds from Novartis. Hurvitz has contracted research with Novartis, Genentech, and Roche.<br><a href="https&#58;//twitter.com/search?f=realtime&amp;q=%23SABCS14" target="_blank"><img alt="Twitter" src="/PublishingImages/Twitter-bird-blue-on-white_50x50.jpg" /></a><a href="https&#58;//twitter.com/search?f=realtime&amp;q=%23SABCS14" target="_blank">#SABCS14</a></p></div>
Multigene Test Can Predict Risk of Disease Recurrence for Women With Ductal Carcinoma in Situ60589912/12/2014 3:11:33 PM39http://www.aacr.org/Newsroom/Lists/News Releases/AllItems.aspx646False2014-12-12T13:30:00Z<div class="ExternalClass529F8D7C0AC74C4CA81763F7922CD701"><p>SAN ANTONIO — A multigene test called <a href="http&#58;//breast-cancer.oncotypedx.com/en-US/Patient-DCIS/WhatIsTheOncotypeDXCancerTest.aspx" target="_blank">Oncotype DX DCIS Score </a>(DCIS Score) was validated as a predictor of risk of disease recurrence among women treated with breast-conserving surgery alone for ductal carcinoma in situ (DCIS), a noninvasive breast abnormality, according to data from a large, population-based study presented at the <a href="http&#58;//www.sabcs.org/" target="_blank">2014 San Antonio Breast Cancer Symposium</a>, held Dec. 9–13. The test could provide important individualized information on the risk of recurrence after treatment by breast-conserving surgery, which can help better inform physicians and patients on their future risks and the need for additional treatment.<img alt="San Antonio Breast Cancer Symposium" src="/PublishingImages/SABCS-Logo-2014_290x229.jpg" style="margin&#58;10px;vertical-align&#58;auto;float&#58;right;" /> </p><p>“We found that the DCIS Score was a good predictor of whether a patient with DCIS who was treated with breast-conserving surgery alone would experience recurrence of DCIS or invasive breast cancer in the same breast,” said <a href="http&#58;//sunnybrook.ca/research/team/member.asp?t=12&amp;page=172&amp;m=137" target="_blank">Eileen Rakovitch, MD</a>, an associate professor and radiation oncologist at Sunnybrook Health Sciences Centre and scientist at <a href="http&#58;//sunnybrook.ca/research/" target="_blank">Sunnybrook Research Institute</a> in Toronto, Ontario. “These data confirm the results of a study reported last year but in a more diverse population.</p><p>“Currently, most patients diagnosed with DCIS undergo breast-conserving surgery,” continued Rakovitch, who is also an adjunct scientist in the Institute for Clinical Evaluative Sciences at the University of Toronto. “Decisions about further treatment, such as radiation therapy, are made based on clinical information like age at diagnosis and size and grade of the tumor. The DCIS Score can provide additional information on an individual’s risk of recurrence to help patients and their physicians make the personal decision about whether or not to undergo additional treatment.”</p><p>After a median follow-up of 9.4 years, among 571 patients with DCIS who were treated with breast-conserving surgery alone and had negative margins after surgery, those who were classified as having a low-risk DCIS Score had a significantly lower risk of developing a recurrence compared to individuals who had an intermediate or high-risk DCIS score. Every 50 point increase in the DCIS Score was associated with a two-fold increase in the risk of developing recurrence.</p><p>Rakovitch and colleagues identified 3,335 women diagnosed with DCIS from 1994 to 2003 in their study to test DCIS Score as a predictor of recurrence risk. Tumor samples were collected for 1,569 patients, 718 of whom were treated with breast-conserving surgery only and 846 who were treated with breast-conserving surgery followed by radiation therapy. Among the patients treated with breast-conserving surgery only, 571 had negative margins, and 100 of these patients had disease recur in the same breast. Forty-four had DCIS at recurrence and 56 had invasive breast cancer; one patient had both DCIS and invasive breast cancer.</p><p>“We are working on completing the analysis of the ability of DCIS Score to predict recurrence risk for those patients with DCIS who were treated with breast-conserving surgery followed by radiation therapy,” said Rakovitch. “We are also interested in developing a nomogram that will integrate DCIS Score with clinical features to further help inform patients and physicians as they decide on the patient’s optimal treatment course.”</p><p>The resarchers followed the <a href="http&#58;//jco.ascopubs.org/content/23/36/9067.full?ijkey=f85d2a334453c331f4f0605ef04ba974d4e50bf3&amp;keytype2=tf_ipsecsha" target="_blank">REMARK guidelines</a> for the reporting of tumor marker prognostic studies.</p><p>Funding for the study was provided by grants from the Canadian Cancer Society Research Institute and a research grant from Genomic Health. Rakovitch declares no conflicts of interest.</p><p><a href="https&#58;//twitter.com/search?f=realtime&amp;q=%23SABCS14" target="_blank"><img alt="Twitter" src="/PublishingImages/Twitter-bird-blue-on-white_50x50.jpg" /></a><a href="https&#58;//twitter.com/search?f=realtime&amp;q=%23SABCS14" target="_blank">#SABCS14</a></p></div>
Lowering Dietary Fat Intake Reduces Death Rates in Some Women With Breast Cancer60590012/12/2014 3:21:10 PM41http://www.aacr.org/Newsroom/Lists/News Releases/AllItems.aspx647False2014-12-12T13:30:00Z<div class="ExternalClass127C8AE98F6B497AB46E6FA67A83A898"><p>SAN ANTONIO — Among early-stage breast cancer patients who reduced their dietary fat intake for five years following a diagnosis, after over 15 years follow-up, death rates from all causes were significantly reduced in those who had hormone-unrelated breast cancer, according to data from the Women’s Intervention Nutrition Study (WINS) presented at the <a href="http&#58;//www.sabcs.org/" target="_blank">2014 San Antonio Breast Cancer Symposium</a>, held Dec. 9–13.<img alt="San Antonio Breast Cancer Symposium" src="/PublishingImages/SABCS-Logo-2014_290x229.jpg" style="margin&#58;10px;vertical-align&#58;auto;float&#58;right;" /></p><p>“The current findings with respect to long-term influence of dietary lifestyle intervention on overall survival are mixed, but of potential importance,” said <a href="http&#58;//www.cancer.ucla.edu/index.aspx?page=243&amp;recordid=45" target="_blank">Rowan Chlebowski, MD, PhD</a>, medical oncologist at the Los Angeles Biomedical Research Institute at the <a href="http&#58;//www.harbor-ucla.org/" target="_blank">Harbor-UCLA Medical Center</a>.</p><p>“In a <a href="http&#58;//jnci.oxfordjournals.org/content/98/24/1767.long" target="_blank">prior report</a> of WINS after five years follow-up, relapse events were 24 percent lower in the intervention group. In the current report, the intervention influence on long-term survival was examined,” Chlebowski continued. “Overall, while the death rate was somewhat lower in the intervention group compared with control group (13.6 percent versus 17 percent, respectively), the difference was not statistically significant. However, in exploratory subgroup analyses, in women with estrogen receptor [ER]-negative cancers, a 36 percent, statistically significant reduction in deaths was seen in women in the intervention group,” said Chlebowski.</p><p>The reduction was even more significant, at 56 percent, for women with cancers that were both ER- and progesterone receptor [PR]-negative, Chlebowski added.</p><p>“HER2 evaluation was not available when this study was conducted, but it is likely that a substantial number of ER/PR-negative breast cancers were also negative for HER2, making them&#160;triple-negative breast cancers, which generally have a poor prognosis,” Chlebowski said. “The signal that perhaps a lifestyle intervention targeting dietary fat intake associated with weight loss could substantially increase the chances of survival for a woman with triple-negative breast cancer could influence this group of patients.”</p><p>&#160;</p><p><strong>“Lifestyle Intervention Helps When It Is A Lifelong Change”</strong></p><p>“The dietary intervention was supported for a median of five years. Our findings suggest that if a lifestyle intervention is to have long-term influence on clinical outcome, it must be a lifelong change rather than be a short-term alteration,” Chlebowski said.</p><p>The WINS was a randomized trial, to which the investigators recruited 2,437 women ages 48 to 79 years with early-stage breast cancer receiving standard-of-care treatments at 39 centers in the United States. Of them, 1,597 had ER-positive breast cancer, 478 had ER-negative breast cancer, and 362 had ER/PR-negative breast cancer. Within six months from diagnosis, all women were randomly assigned either to a dietary intervention group (975 patients, of whom 205 had ER-negative cancer, and 147 had ER/PR-negative cancer) or to a control group (1,462 patients, of whom 273 had ER-negative cancer, and 215 had ER/PR-negative cancer).</p><p>The goal of dietary intervention was to lower fat intake for five years while maintaining nutritional adequacy. Women in the intervention group were given a fat gram goal by centrally trained, registered dieticians implementing a low-fat eating plan, explained Chlebowski. The women underwent eight biweekly individual counseling sessions with subsequent contacts every three months. The women self-monitored their fat/gram intake using a “keeping score” book. Fat intake was externally monitored by unannounced 24-hour telephone recalls performed annually.</p><p>After five years of dietary intervention, fat calories were lowered by 9.2 percent and body weight was lowered by nearly 6 pounds in the intervention group, compared with the control group.</p><p>This study was funded by the National Cancer Institute and the American Institute of Cancer Research. Chlebowski has received consulting support from Pfizer, Novartis, Amgen, Genomic Health, and Novo Nordisk, and honorarium from Novartis.</p><p>&#160;<a href="https&#58;//twitter.com/search?f=realtime&amp;q=%23SABCS14" target="_blank"><img alt="Twitter" src="/PublishingImages/Twitter-bird-blue-on-white_50x50.jpg" /></a><a href="https&#58;//twitter.com/search?f=realtime&amp;q=%23SABCS14" target="_blank">#SABCS14</a></p></div>
Capecitabine Monotherapy Does Not Improve Survival in Elderly Patients With Early-stage Breast Cancer59933512/11/2014 2:24:15 PM39http://www.aacr.org/Newsroom/Lists/News Releases/AllItems.aspx641False2014-12-11T13:30:00Z<div class="ExternalClass5DB256CABAFE4FC989C004826620845C"><p>​SAN ANTONIO — In elderly breast cancer patients with moderate- to high-risk early-stage disease for whom standard chemotherapy is too toxic, the chemotherapy capecitabine, which causes fewer side effects than the standard chemotherapy agents, did not improve outcomes when tested as monotherapy, according to data from the phase III ICE trial presented at the <a href="http&#58;//www.sabcs.org/" target="_blank">2014 San Antonio Breast Cancer Symposium</a>, held Dec. 9–13.</p><p><img src="/PublishingImages/Minckwitz_Gunter_150x200.jpg" alt="" style="margin&#58;5px 15px;vertical-align&#58;auto;float&#58;right;" />&quot;We tested capecitabine as single-agent chemotherapy in elderly women with early-stage breast cancer, who also took the bisphosphonate, ibandronate. After 61 months of follow-up, we found no difference in disease-free survival and overall survival between those who took capecitabine plus ibandronate and those who took ibandronate alone,&quot; said Gunter von Minckwitz, MD, chairman of the German Breast Group and a professor of gynecology at University of Frankfurt in Germany.</p><p>&quot;Combination chemotherapy should be tried with optimal supportive care even in elderly patients,&quot; von Minckwitz added.</p><p>&quot;We used ibandronate because many patients at this age have osteopenia/osteoporosis, especially after chemotherapy. Bisphosphonates are also potentially preventive for breast cancer metastasis,&quot; von Minckwitz said.</p><p>Although approximately 50 percent of newly diagnosed breast cancers arise in women older than 65, they are underrepresented in clinical trials, and frail elderly patients cannot be treated with conventional chemotherapy such as anthracyclines and/or taxanes, von Minckwitz explained. Subgroup analysis of an earlier trial, <a href="https&#58;//www.calgb.org/Public/results/results_docs/49907_results_08172010.pdf" target="_blank">CALGB 49907</a>, with metastatic breast cancer patients, showed capecitabine to be well tolerated in elderly patients, which served as a rationale for the study discussed here.</p><p>In the ICE study, of the 1,358 breast cancer patients ages 64 to 88 recruited between 2004 and 2008, 677 were randomly assigned to six cycles of capecitabine plus ibandronate, and 681 were randomly assigned to ibandronate only. About 80 percent of the patients in both groups had hormone receptor-positive disease and received a standard-of-care endocrine therapy.</p><p>The primary endpoint of the study was disease-free survival, and secondary endpoints included overall survival, and compliance and safety.&#160;</p><p>There was no difference in disease-free survival at the end of three years (85 percent in capecitabine group versus 84 percent in control group) and five years (79 percent in capecitabine group versus 75 percent in control group). There was no difference in overall survival at the end of three years (95 percent in capecitabine group versus 94 percent in control group) and five years (90 percent in capecitabine group versus 88 percent in control group).</p><p>About 8 percent of patients discontinued capecitabine treatment due to adverse events, and another 8 percent discontinued due to other reasons.</p><p>Thirty-one percent of patients in the capecitabine plus ibandronate group had grade 3 or 4 adverse events, compared with 8.7 percent in the ibandronate group.</p><p>This study was funded by Roche and AstraZeneca. The institution of von Minckwitz received research funding and medication for this study.</p><p> <a href="https&#58;//twitter.com/search?f=realtime&amp;q=%23SABCS14" target="_blank"><img src="/PublishingImages/Twitter-bird-blue-on-white_50x50.jpg" alt="" style="margin&#58;5px;" /></a><a href="https&#58;//twitter.com/search?f=realtime&amp;q=%23SABCS14" target="_blank">#SABCS14</a></p> </div>
Impact of Adding Bevacizumab to Presurgery Chemo for Triple-negative Breast Cancer Varies With Subtype59940812/11/2014 2:28:32 PM78http://www.aacr.org/Newsroom/Lists/News Releases/AllItems.aspx644False2014-12-11T13:30:00Z<div class="ExternalClass1955BDCE8BB642AFAEA4AD235AA0BA46"><p>​SAN ANTONIO — Among women with triple-negative breast cancer, the benefit of adding bevacizumab to standard presurgery chemotherapy was greater for those whose cancers were classified as basal-like by gene expression assay compared with those whose cancers were nonbasal-like, according to data presented at the <a href="http&#58;//www.sabcs.org/" target="_blank">2014 San Antonio Breast Cancer Symposium</a>, held Dec. 9–13. In contrast, the benefit of adding carboplatin was equivalent across subtypes.&#160;</p><p><img src="/PublishingImages/Sikov_William_150x200.jpg" alt="" style="margin&#58;5px;vertical-align&#58;auto;float&#58;right;" />&quot;We found that adding bevacizumab to standard preoperative, or neoadjuvant, chemotherapy increased pathologic complete response rates for women with basal-like cancers—that is, it increased the proportion of women who had no residual cancer detected at surgery—but decreased pathologic complete response rates for women with nonbasal-like cancers,&quot; said <a href="http&#58;//www.womenandinfants.org/physicians/William-Sikov.cfm" target="_blank">William M. Sikov, MD</a>, associate director of clinical research for the <a href="http&#58;//www.surgonc.org/training-education/breast-oncology/program-list/the-breast-health-center-program-in-women-s-oncology-women-and-infants-hospital" target="_blank">Program in Women's Oncology at Women and Infants Hospital</a> and associate professor of medicine at the <a href="http&#58;//brown.edu/academics/medical/" target="_blank">Alpert Medical School of Brown University</a> in Providence, Rhode Island.</p><p>Among patients with basal-like disease, adding bevacizumab to standard neoadjuvant chemotherapy increased the pathologic complete response rate from 45 percent to 64 percent. Among those with nonbasal-like disease it decreased the rate from 60 percent to 43 percent.</p><p>&quot;In contrast, adding the chemotherapy drug carboplatin to standard neoadjuvant chemotherapy increased pathologic complete response rates equally for women with basal-like and nonbasal-like cancers,&quot; said Sikov.</p><p>&quot;While these are interesting observations, I don't think that our data will change clinical practice, for two reasons,&quot; continued Sikov. &quot;First, we observed a much lower percentage of nonbasal-like triple-negative cancers [13 percent] than we had anticipated based on prior reports. Second, while subtype [basal-like vs. other] may be predictive of response with the addition of bevacizumab, interest in the use of this agent in early-stage triple-negative breast cancer has diminished following disappointing results from a number of phase III studies.</p><p>&quot;On the other hand, subtype was not predictive of response with the addition of carboplatin, for which long-term outcomes are not known,&quot; added Sikov. &quot;Thus, identification of the relatively small proportion of triple-negative breast cancer patients whose cancers are not basal-like by gene expression array would not appear to be helpful in deciding on the appropriate neoadjuvant treatment regimen.</p><p>&quot;We don't understand the reasons for the difference in benefit from bevacizumab experienced by patients with basal-like and nonbasal-like disease,&quot; continued Sikov. &quot;With low numbers of triple-negative breast cancer patients with nonbasal-like disease it will be hard to study this.&quot;</p><p>Sikov and colleagues reported last year that, in a randomized, phase II clinical trial called CALGB/Alliance 40603, adding either bevacizumab or carboplatin to standard neoadjuvant chemotherapy increased pathologic complete response rates for women with triple-negative breast cancer. These latest results are further analysis of data from this clinical trial, in which 443 patients with operable, stage 2 or 3 triple-negative breast cancer were enrolled.</p><p>Pretreatment tumor samples from 360 patients for whom pathologic complete response information was available were classified as basal-like or nonbasal-like following mRNA sequencing analysis and comparison of gene expression patterns to a standard panel from The Cancer Genome Atlas. Three hundred and thirteen were classified as basal-like; the other 47 were a mix of subtypes&#58; 25 were normal-like, 14 were HER2-enriched, seven were claudin-low, and one was luminal A.</p><p>&quot;We have also looked at expression of various gene signatures in the pretreatment tissue samples to determine if these are predictive of response and increased benefit from the addition of bevacizumab or carboplatin,&quot; said Sikov. &quot;Of particular interest is the observation that gene signatures indicating high proliferation rates and low estrogen-receptor signaling, which are both considered characteristics of more aggressive disease, were associated with higher pathologic complete response rates overall and with increased benefit from adding bevacizumab. Many additional correlative studies are now being performed using tissue and blood samples obtained from the patients treated on this study.&quot;</p><p>Funding for the study was provided by the National Cancer Institute, Roche-Genentech, and the Breast Cancer Research Foundation. Sikov declares no conflicts of interest.</p><p> <a href="https&#58;//twitter.com/search?f=realtime&amp;q=%23SABCS14" target="_blank"><img src="/PublishingImages/Twitter-bird-blue-on-white_50x50.jpg" alt="" style="margin&#58;5px;" /></a><a href="https&#58;//twitter.com/search?f=realtime&amp;q=%23SABCS14" target="_blank">#SABCS14</a></p> </div>
Adding Ovarian Suppression to Tamoxifen Reduced Recurrence for Some Women With Premenopausal Breast Cancer59941112/11/2014 2:27:21 PM42http://www.aacr.org/Newsroom/Lists/News Releases/AllItems.aspx643False2014-12-11T13:30:00Z<div class="ExternalClass674B422787834258BB2C778080C225E9"><p>​SAN ANTONIO — Among premenopausal women with early-stage, hormone receptor-positive breast cancer, adding ovarian suppression to tamoxifen reduced breast cancer recurrence for those who had previously received chemotherapy and remained premenopausal, according to data from the randomized, phase III suppression of ovarian function trial (SOFT) presented at the <a href="http&#58;//www.sabcs.org/" target="_blank">2014 San Antonio Breast Cancer Symposium</a>, held Dec. 9–13.</p><p><img src="/PublishingImages/Francis_Prudence_150x200.jpg" alt="" style="margin&#58;5px 15px;vertical-align&#58;auto;float&#58;right;" />&quot;We found that that adding ovarian suppression to tamoxifen was somewhat beneficial for those women with early-stage, hormone receptor-positive breast cancer who remained premenopausal after chemotherapy,&quot; said <a href="http&#58;//www.petermac.org/search/expert?search=prue+francis" target="_blank">Prudence Francis, MD</a>, head of breast medical oncology at the <a href="http&#58;//www.petermac.org/" target="_blank">Peter MacCallum Cancer Centre</a> in Melbourne, Australia. &quot;However, we found a greater reduction in recurrence in this same patient group with the use of ovarian suppression plus the aromatase inhibitor exemestane.</p><p>&quot;I believe that these results will result in changes in clinical practice,&quot; continued Francis. &quot;For women who have not reached menopause and have hormone receptor-positive breast cancer that carries sufficient risk of recurrence that they receive chemotherapy, physicians are likely to discuss the option of treatment with ovarian suppression plus an aromatase inhibitor.&quot;</p><p>Analysis of data from all patients assigned tamoxifen or tamoxifen with ovarian suppression showed that there was not a statistically significant improvement in disease-free survival with the addition of ovarian suppression overall. Just over half of the patients had received chemotherapy prior to enrollment in SOFT, and there was a 22 percent decrease in risk of breast cancer recurrence for those patients assigned tamoxifen with ovarian suppression who had received prior chemotherapy compared with their counterparts assigned tamoxifen; the decrease was a trend and not statistically significant.</p><p>A 35 percent decrease in risk of breast cancer recurrence was observed for premenopausal women who received chemotherapy for early-stage, hormone receptor-positive breast cancer and were assigned exemestane with ovarian suppression compared with those assigned tamoxifen. This comparison was a secondary question of the trial, but the results of the statistical analysis were conclusive.</p><p>&quot;We found that with the addition of ovarian suppression to tamoxifen, four or five fewer patients out of 100 experienced a breast cancer recurrence within five years in the group of patients who remained premenopausal after chemotherapy,&quot; said Francis. &quot;However, we found an even greater reduction in recurrence in this same patient group with the use of ovarian suppression plus the aromatase inhibitor exemestane, which resulted in seven or eight fewer patients out of 100 experiencing a breast cancer recurrence within five years.&quot;</p><p>Francis and colleagues enrolled 3066 women with early-stage, hormone receptor-positive breast cancer in SOFT, led by the International Breast Cancer Study Group (IBCSG). Patients were randomized to five years of tamoxifen (1021 patients), tamoxifen and ovarian suppression (1024 patients), or exemestane and ovarian suppression (1021 patients). In most patients, ovarian suppression was achieved by monthly triptorelin injections. The data reported were obtained after a median follow-up of 67 months.</p><p>&quot;We are continuing to follow the patients enrolled in SOFT and plan to provide future updates on cancer recurrence rates, later side effects, as well as the overall survival for the different patient groups in the trial,&quot; said Francis.</p><p>SOFT receives financial support for trial conduct from Pfizer, the IBCSG, and the National Cancer Institute (NCI). Pfizer and Ipsen provide drug supply. Support for the coordinating group, IBCSG&#58; Frontier Science and Technology Research Foundation, Swiss Group for Clinical Cancer Research (SAKK), NCI (CA75362), Swiss Cancer Research/Oncosuisse, and the Foundation for Clinical Cancer Research of Eastern Switzerland (OSKK). The pharmaceutical companies have no role in the reporting or interpretation of the trials, other than a minority representation on the Steering Committee. Grant support of cooperative groups&#58; Australia and New Zealand Breast Cancer Trials Group (NHMRC 351161 and 510788); SWOG (US NIH CA32102); Alliance/CALGB (US NIH CA31946); ECOG-ACRIN (US NIH CA21115 and CA16116); NSABP/NRG (US NIH U10-CA-12027, U10-CA-69651, U10-CA-37377, U10-CA-69974); NCIC (US NIH CA077202 and CCSRI 015469 and 021039); ICR-CTSU on behalf of the National Cancer Research Institute (NCRI). Breast Clinical Studies Group United Kingdom (NCRI-BCSG – ICR-CTSU Partnership) was supported by CRUK, CRUKE/03/022, CRUKE/03/023, A15955, NIHR RM/ICR Biomedical Research Centre and by NIHR Cambridge Biomedical Research Centre.&#160;</p><p>Francis declares no conflicts of interest.</p><p> <a href="https&#58;//twitter.com/search?f=realtime&amp;q=%23SABCS14" target="_blank"><img src="/PublishingImages/Twitter-bird-blue-on-white_50x50.jpg" alt="" style="margin&#58;5px;" /></a><a href="https&#58;//twitter.com/search?f=realtime&amp;q=%23SABCS14" target="_blank">#SABCS14</a></p> </div>
IBIS-I Trial Finds Tamoxifen Lowered Breast Cancer Rates Among High-risk Women59944712/11/2014 2:27:37 PM46http://www.aacr.org/Newsroom/Lists/News Releases/AllItems.aspx642False2014-12-11T13:30:00Z<div class="ExternalClassCE0720A7EB74465892126D5B3A81B277"><p>SAN ANTONIO — After a median of 16 years of following women at high risk for breast cancer, the International Breast Cancer Intervention Study-I (IBIS-I) trial found that tamoxifen significantly decreased the incidence of all breast cancers, according to data presented at the <a href="http&#58;//www.sabcs.org/" target="_blank"> 2014 San Antonio Breast Cancer Symposium</a>, held Dec. 9–13.</p><p><img src="/PublishingImages/Cuzick_Jack_150x200.jpg" alt="" style="margin&#58;5px 15px;vertical-align&#58;auto;float&#58;right;" />&quot;The International Breast Cancer Intervention Study-I was designed to investigate the long-term risks and benefits of taking tamoxifen to prevent breast cancer in women at high risk for developing the disease,&quot; said <a href="http&#58;//www.wolfson.qmul.ac.uk/a-z-staff-profiles/jack-cuzick" target="_blank"> Jack Cuzick, PhD</a>, John Snow professor of epidemiology at Wolfson Institute of Preventive Medicine at <a href="http&#58;//www.qmul.ac.uk/" target="_blank"> Queen Mary University of London</a>.</p><p>&quot;We found that the reduction in breast cancer incidence remains strong and unabated for 20 years,&quot; added Cuzick. &quot;There are concerns related to endometrial cancer mortality and development of estrogen receptor [ER]-negative cancers but they are statistically nonsignificant, and could be chance observations.</p><p>&quot;For postmenopausal women, the aromatase inhibitors anastrozole or exemestane are probably better alternatives, both in terms of greater effectiveness and better side-effect profiles, but for premenopausal women, tamoxifen remains the only choice and it is a good one,&quot; said Cuzick.</p><p>Of the 7,154 pre- and postmenopausal women recruited to the IBIS-I trial, 3,579 were randomly assigned to receive daily 20 mg tamoxifen for five years, and 3,575 were randomly assigned to receive a matching placebo for five years. Women were aged 35 to 70 years with an increased risk for breast cancer, primarily due to a family history of the disease.</p><p>The primary endpoint of this study was the occurrence of noninvasive or invasive breast cancer, and the secondary endpoints included overall mortality, other cancers, and breast cancer-specific mortality.</p><p>During a median of 16 years of follow-up, 246 women from the tamoxifen group and 343 from the placebo group developed breast cancers. There was a 29 percent reduction in breast cancer rates among women from the tamoxifen group. The rates of ER-positive breast cancer were reduced by 35 percent, but no effect was seen for ER-negative breast cancers.&#160;</p><p>Larger benefits were seen for women who did not take hormone replacement therapy (HRT) during the trial&#58; 45 percent reduction for ER-positive breast cancer and 38 percent reduction for all breast cancers in noncurrent HRT users.</p><p>No differences were seen in breast cancer-related mortality rates between the two groups. However, among women who took tamoxifen, there was a nonsignificant increase in all-cause mortality, but this was smaller than seen in the 96-month follow up report, according to Cuzick. There was a nonsignificant increase in other cancers overall, with increases in endometrial cancer and nonmelanoma skin cancer, and decreases in colorectal cancer.</p><p>&quot;While the durability of the breast cancer incidence reduction is an important finding, some uncertainties still remain about mortality effects,&quot; said Cuzick.</p><p>This study was funded by Cancer Research U.K. and AstraZeneca. Cuzick is an ad hoc speaker for AstraZeneca.</p><p> <a href="https&#58;//twitter.com/search?f=realtime&amp;q=%23SABCS14" target="_blank"><img src="/PublishingImages/Twitter-bird-blue-on-white_50x50.jpg" alt="" style="margin&#58;5px;" /></a><a href="https&#58;//twitter.com/search?f=realtime&amp;q=%23SABCS14" target="_blank">#SABCS14</a></p> </div>