CancerScope

In 2001, the Coalition of Cancer Cooperative Groups (CCCG) came to an important conclusion: with the vast number of clinical trials available, patients and physicians needed a simplified way to find trials. As a result, the CCCG developed TrialCheck, an Internet-based cancer clinical trial navigation and matching system of all federally registered cancer studies, both public and private. “We're trying to keep things simple and patient-accessible,” says Robert Comis, MD, president and chairman of the CCCG and group chair of the Eastern Cooperative Oncology Group. Increasing patient awareness and participation in clinical trials is 1 of the key missions of the CCCG, a nonprofit organization formed in 1997 to address the unmet needs in the clinical research community. Its core members are the 10 research cooperative groups of the National Cancer Institute (NCI)-sponsored Clinical Trials Cooperative Group Program. TrialCheck has been an important tool in the organization's mission. Unlike the Clinicaltrials.gov Web site, which Dr. Comis calls the “Dewey Decimal system of clinical trial information”, TrialCheck has a simple user interface. Without having to register or log in, patients are asked 7 basic questions, including their zip code, sex, age, disease type, stage, prior or current treatment, and their cancer's impact on their daily activities. Instantly, a tailored list of treatment trials is displayed according to distance from the provided zip code. The database is located on the CCCG's Web site (available at: www.CancerTrialsHelp.org) as well as the American Society of Clinical Oncology's patient Web site (available at: www.cancer.net), and on Web MD (available at: www.webmd.com). It also is used by the American Cancer Society (ACS), the Leukemia and Lymphoma Society, and the state of Georgia. “In the last couple of years, we've seen a tremendous increase in the number of Web site visitors to Trial Check,” Dr. Comis says. “We have about 250,000 to 300,000 visitors annually—and of those, about half are finding trials, and half of those have downloaded information.” The ACS has access to Trial Check in its call centers to help patients navigate the system, as does the Leukemia and Lymphoma Society. Employees at the latter's call-center have a script in which they proactively ask every patient if they have considered enrolling in a clinical trial. “We believe that clinical trials should be part of every treatment discussion,” Dr. Comis adds, noting that the CCCG is working to dispel the myth that clinical trials are only a last resort. “And we can't rely on physicians alone to do this, because they don't all participate in clinical research.” By using new methods to “mainstream” clinical trials, the CCCG hopes to increase public awareness. The state of Georgia, for example, used some of its tobacco tax settlement money to offer TrialCheck to many of its healthcare providers and organizations. Because many patients were leaving the state for their cancer treatment, state leaders believed it was important to let Georgia residents know about their options nearby. Now oncologists, primary care physicians, hospitals, and cancer advocacy organizations across the state are proactively disseminating the content of the Web site and increasing awareness. “We hope there will be more states going forward with this,” Dr. Comis notes, adding that the current economic downturn has slowed that process. The CCCG also is focused on helping providers by embedding clinical trial searches into electronic medical record (EMR) systems. IMPAC Medical systems, developer of integrated software for oncology, already offers TrialCheck, and the CCCG is in discussions with others. For the busy practitioner, access to clinical trial information through EMRs would greatly expedite the search process, Dr. Comis notes. “We're hoping we can push the provider side as more sites are required to be part of the EMR process,” he says. “We're also working with NCI to establish a nationwide EMR data capture program for clinical trials.” Next issue: The CCCG launches an effort to increase participation in breast cancer clinical trials. Noteworthy studies presented at the second Genitourinary Cancers Symposium, held February 26–28 in Orlando, Florida, included the following. Since the gene fusion is present in half the men who develop prostate cancer, it might become a therapeutic target as well. —Howard Sandler, MD The presentation titled “Feasibility and Clinical Utility of a TMPRSS2:ERG Gene Fusion UrineTest” focused on a novel molecular urine test that detects the fusion of 2 genes:TMPRSS2 and ERG. The test was found to be highly accurate for detecting prostate cancer and may be able to help identify cancers that are likely to grow and spread quickly. Because many cancers that are detected through prostate-specific antigen (PSA) tests and digital rectal examinations are low volume and low grade, and because biopsies miss approximately 15% of all prostate cancers, there is a need formore accurate tests that ideally can distinguish aggressive from indolent cancers, says principal author Jack Groskopf, PhD, of Gen-Probe Incorporated. The prospective study of 559 men scheduled to undergo biopsies at 3 different medical centers had a specificity of 84% for the detection of cancer compared with 27% for the PSA test. Preliminary data also indicated that TMPRSS2:ERG levels in the urine correlate with criteria for “indolent” and “significant” cancer.The researchers' next steps are to confirm the correlation results with significant cancer and to correlate their results with pathologic features, including tumor volume, stage, and grade in prostatectomy tissue. “Since the gene fusion is present in half the men who develop prostate cancer, it might become a therapeutic target as well,” notes Howard Sandler, MD, moderator of the symposium press briefing and chair of radiation oncology at Cedars-Sinai Medical Center in Los Angeles, California. “The TMPRSS2:ERG gene fusion has been shown to be a key genetic event in the development of prostate cancer,” said Badrinath Konety, MD, of the University of California at San Francisco, and editor of the genitourinary section for Cancer. “These new data suggesting that this gene fusion can be detected in the urine is particularly exciting as it provides a means for physicians to assess the ‘aggressiveness’ of the disease. It is well acknowledged that not all patients with prostate cancer need curative therapy. Many of these men may die of other causes. Using tests such as the TMPRSS2:ERG, physicians could better select patients who would definitely benefit from treatment while avoiding needless overtreatment in those who do not have an aggressive form of prostate cancer.” Another presentation at the symposium focused on the value of PSA and other risk factors in determining future risk of prostate cancer and was presented by Monique Roobol, PhD, of the Erasmus Medical Centre in Rotterdam, the Netherlands.The data presented were from the Rotterdam section of the European Randomized Study of Screening for Prostate Cancer, which is a large, population-based screening study of more than 5000 men ages 55 to 70 years. PSA was determined to be the most significant predictor of developing the disease. The risk of developing cancer over 4 years was 5.1% with an average PSA level of 1.5 ng/mL. Men with PSA levels measuring 1.5 ng/mL or higher were 7 times more likely to develop prostate cancer than those with a PSA below that amount. PSA assessment, combined with other common predictive factors such as family history, may offer a personalized assessment of a man's future risk of developing the disease, researchers note. Men above a certain risk threshold may benefit from more frequent screening or active risk reduction strategies, if available, Dr. Roobol adds. “This study provides a tool that can be used to determine an individual's risk of developing prostate cancer,” Dr. Konety says. “This tool could serve as a guide to facilitate decisions regarding screening for the disease, and this issue is particularly important given the recent contradictory reports on the benefits of prostate cancer screening. Tools like this one may further aid the dialogue between physician and patient in making these decisions.” Experts predict drastic reductions in the number of mammography professionals per women aged 40 years and older over the next 15 to 30 years. A study by the Center for Health and Workforce Studies of the Albany School of Public Health in Rensselaer, New York, forecasted that in the year 2010, there will be approximately 19.4 radiologists per 100,000 women aged 40 years and older and 32.4 technologists per 100,000 women. However, in 2025, that figure will decline to 17.5 radiologists per 100,000 women aged 40 years and older and 22.4 technologists. These rates compare with 20.6 radiologists and 37.1 technologists reported per 100,000 women aged 40 years and older in 2005. The forecasting model is based on data provided by the American College of Radiology and the American Society of Radiologic Technologists. The study appeared in the American Journal of Roentgenology.1 “The data clearly show that the number of women 40 years and older is going to grow dramatically over the next 20 years,” say Margaret Langelier and Paul Wing, lead authors of the study. “Mammography, unlike other care that can be provided through telecommunication, requires hands-on participation of workers.” 1. Wing P, Langelier MH. Workforce shortages in breast imaging: impact on mammography utilization. AJR Am J Roentgenol. 2009;192:370–378. A new test may help physicians determine which breast cancer patients will benefit from chemotherapy after lumpectomy. “In women whose tumors have spread, we can predict with very high accuracy which ones are going to respond to chemotherapy and which type of chemotherapy will work,” says Phillip Bernard, MD, an investigator at the University of Utah's Huntsman Cancer Institute in Salt Lake City and 1 of the senior authors of a multicenter study published in the Journal of Clinical Oncology.1 Researchers examined 50 genes that play an important role in identifying subtypes of breast cancer. By measuring the expression level of these genes in the tumors, they were able to determine how each individual will respond to standard therapies.The research translates into a simple test that will be available in prospective clinical trials nationwide this summer at the Huntsman Cancer Institute and collaborating institutions. The test, which researchers refer to as the Breast Bioclassifier, has been validated on thousands of women. “This will give women peace of mind knowing that we're diagnosing cancer more accurately than before,” Dr. Bernard says. “We can tell them if they're likely to benefit from chemotherapy. If chemo isn't going to be beneficial, we shouldn't be giving it.” The research took 10 years to complete and involved collaboration among Huntsman; the University of North Carolina's Lineberger Comprehensive Cancer Center at Chapel Hill; the University of British Columbia in Vancouver; and Washington University Siteman Cancer Center in St. Louis,Missouri. 1. Parker JS, Mullins M, Cheang MC, et al. Supervised risk predictor of breast cancer based on intrinsic subtypes. J Clin Oncol. 2009;27:1160–1167.

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