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April 6, 2010 • Volume 7 / Number 7

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NEWS

A dutasteride soft capsule and its packagingDutasteride Decreases Prostate Cancer Risk

Results from a large, randomized clinical trial indicate that men at an increased risk for prostate cancer reduced their risk with regular use of the drug dutasteride (Avodart). The results came from the REDUCE trial, which is the second large clinical trial to demonstrate a decreased risk of prostate cancer in men taking an agent from the class of drugs known as 5-α reductase inhibitors (5-αRIs). Previously, the Prostate Cancer Prevention Trial (PCPT) showed that the drug finasteride had a risk reduction similar to what has now been seen in REDUCE. Read more > >

COMMENTARY

Dr. James H. DoroshowGuest Director's Update: Improving the Efficiency of Clinical Trials— Decreasing Activation Times by Fifty Percent

by Dr. James H. Doroshow

NCI is dedicated to bringing new therapeutic and diagnostic options to patients with cancer as quickly as possible. On average, 25,000 to 30,000 patients per year are accrued to NCI-supported clinical trials through several networks of institutions and clinical trialists. However, the current process of activating new phase III clinical trials conducted by NCI’s cooperative groups averages more than 2 years; and the time to activate most phase I and II studies requires more than 500 days. A recent analysis of NCI’s clinical trials activation process demonstrated that many trials, especially those that took the longest to open, never reached their accrual goals and had to be closed, wasting precious time and resources. The analysis also showed that the complex path to trial activation was characterized by steps that did not ultimately add value to the clinical trial itself. Read more > >

Guest Commentary by Ambassador Nancy Brinker: Collaborating Globally to Address Breast Cancer in Latin America

The founder and CEO of Susan G. Komen for the Cure describes a partnership between her organization and NCI to address breast cancer issues in Latin American countries. Read more > >

A Conversation with Dr. Robert T. Croyle on Communicating Science

The Director of NCI’s Division of Cancer Control and Population Sciences talks about communicating health data clearly Read more > >

  

A MESSAGE TO READERS

Coverage of AACR Annual Meeting

AACR Annual Meeting banner The American Association for Cancer Research 101st Annual Meeting will take place April 17–21 in Washington, DC. Look for highlights from the meeting in the April 20 issue of the NCI Cancer Bulletin.

IN DEPTH

UPDATES

  • Legislative Update

    • House Committee Convenes Hearing on NCI Research
  • FDA Update

    • New Tobacco Products Advisory Committee Focuses on Menthol Cigarettes
    • Advisory Panel Recommends Restrictions on Tanning Bed Use by Minors
  • Notes

    • Take Part in SELECT Biorepository Symposium
    • Meet NCI Experts at AACR
    • Tutorial on Targeted Therapies for Multiple Myeloma Available Online
  • Correction

    An article in the March 9 issue of the NCI Cancer Bulletin on the potential cardiac side effects of some cancer therapies reported that a clinical trial involving the drug bevacizumab (Avastin) was temporarily halted by the FDA. The article should have stated that enrollment to the trial was temporarily halted, not the dosing of patients already enrolled in the trial. The original article has been corrected. More information on the trial is available here.

Selected articles from past issues of the NCI Cancer Bulletin are available in Spanish.

The NCI Cancer Bulletin is produced by the National Cancer Institute (NCI), which was established in 1937. Through basic, clinical, and population-based biomedical research and training, NCI conducts and supports research that will lead to a future in which we can identify the environmental and genetic causes of cancer, prevent cancer before it starts, identify cancers that do develop at the earliest stage, eliminate cancers through innovative treatment interventions, and biologically control those cancers that we cannot eliminate so they become manageable, chronic diseases.

For more information about cancer, call 1-800-4-CANCER or visit http://www.cancer.gov.

NCI Cancer Bulletin staff can be reached at ncicancerbulletin@mail.nih.gov.

Featured Article

Dutasteride Decreases Prostate Cancer Risk

A dutasteride soft capsule and its packaging The manufacturer of dutasteride has resubmitted an application with the FDA to market the drug for the prevention of prostate cancer.

Results from a large, randomized clinical trial indicate that men at an increased risk for prostate cancer reduced their risk with regular use of the drug dutasteride (Avodart). The results came from the REDUCE trial, which is the second largest clinical trial to demonstrate a decreased risk of prostate cancer in men taking an agent from the class of drugs known as 5-α reductase inhibitors (5-αRIs). Previously, the Prostate Cancer Prevention Trial (PCPT) showed that the drug finasteride had a risk reduction similar to what has now been seen in REDUCE.

Findings from this trial suggest “that the major effect of dutasteride is the shrinkage of prostate tumors or inhibition of their growth,” wrote the study’s lead investigator Dr. Gerald Andriole, of the Washington University School of Medicine in St. Louis, and his colleagues in the April 1 New England Journal of Medicine. GlaxoSmithKline, which funded the trial and manufactures dutasteride, has resubmitted an application with the FDA to market the drug for the prevention of prostate cancer in men at increased risk. Dutasteride is already approved to treat men with benign prostatic hyperplasia, or BPH.

The international trial involved more than 6,700 men between ages 50 and 75 who, at enrollment, had a prostate-specific antigen (PSA) test score between 2.5 and 10 and a negative biopsy in the prior 6 months. Participants, the large majority of who were white, also received biopsies 2 and 4 years after enrollment. After 4 years of follow up, there was a nearly 23 percent reduction in the relative risk of prostate cancer in men who took dutasteride compared with those who took a placebo (659 cancers versus 858 cancers).

Side effects, including erectile dysfunction and decreased libido, were similar to those typically seen with dutasteride use. The only exception was an increased risk of cardiac failure, although it was rare: 30 cases were reported in men taking dutasteride (0.7 percent of men taking the drug) compared with 16 (0.4 percent) of men in the placebo arm. Cardiac failure was more likely in men who were taking both dutasteride and drugs known as alpha blockers, which are commonly used to treat high blood pressure, as well as BPH.

The reduction in prostate cancer risk was found mostly for men diagnosed with Gleason score 6 (intermediate grade prostate cancer) on biopsy. As was the case with finasteride in the PCPT trial, more high-grade cancers (Gleason scores 8–10) were detected among men who received dutasteride than men who received a placebo. This was likely due in part, the authors explained, to the drug’s ability to reduce the volume of the prostate, which in turn improves the ability to identify high-grade tumors in biopsy samples. They did not exclude the possibility, though, that the drug could be responsible for some high-grade tumors.

In an accompanying editorial, Dr. Patrick Walsh of Johns Hopkins University called it “somewhat disappointing” that dutasteride “was ineffective in reducing these high-grade tumors.” Based on the evidence from the REDUCE and PCPT trials, he also argued that neither of the drugs prevents prostate cancer, but “merely temporarily shrink tumors that have a low potential for being lethal,” because their effect seems to be relegated to tumors with Gleason scores in the 5 to 6 range.

“The ‘prevention’ versus ‘delay’ argument is a distinction without a difference,” noted Dr. Howard Parnes of NCI’s Division of Cancer Prevention. “We now have two independent, randomized clinical trials showing that 5-αRIs decrease a man’s risk of being diagnosed with prostate cancer.” The benefit of reducing the incidence of Gleason score (GS) 6 prostate cancer should not be discounted, Dr. Parnes continued. “These are the most common prostate cancers and more than 90 percent of men with GS 6 prostate cancer are treated with radical surgery or radiation, both of which are associated with substantial morbidity.”

The higher incidence of cardiac failure associated with dutasteride is not of significant concern, said Dr. Brantley Thrasher, chair of the Department of Urology at the University of Kansas Medical Center. “We’ve been using this class of drugs for a long time and rarely see these types of problems,” he said.

In February 2009, the American Society of Clinical Oncology and the American Urological Association issued guidelines on 5-αRIs for prostate cancer prevention. The guidelines suggested that healthy older men who are already taking a 5-αRI for BPH or are being regularly screened for prostate cancer should discuss the possible long-term use of the treatment for prostate cancer prevention with their doctors.

Dr. Thrasher is already having those discussions with his patients, he said, and a number of them who are at an increased risk for prostate cancer because of factors such as family history or elevated PSA are taking finasteride or dutasteride. FDA approval of dutasteride for a prevention indication, he believes, would prompt many clinicians and patients to use it for that purpose. “I think the average clinician would have confidence to speak with their patients about using [5-αRIs] for prevention.”

—Carmen Phillips

Cancer Research Highlights

Phase III Lung and Pancreatic Cancer Trials Stopped

Two phase III clinical trials were suspended last week after it was determined that they were unlikely to meet their primary endpoints.

The ATTRACT-1 trial was testing the drug ASA404 in patients with previously untreated, advanced non-small cell lung cancer (NSCLC). ASA404, also called vadimezan, is a new type of angiogenesis inhibitor known as a vascular disrupting agent. The trial was halted after a planned interim analysis showed “that continuation of the trial would be futile, as there is little or no prospect of demonstrating a survival benefit,” the drug’s manufacturer, Antisoma, explained in a statement.

Termination of the trial comes approximately 2 months after encouraging results from a phase II trial of ASA404 as a first-line treatment for advanced NSCLC were reported at a lung cancer conference in San Francisco. In the phase II trial, the combination of ASA404 and chemotherapy nearly doubled median survival times compared with chemotherapy alone.

Also last week, GenVec announced the suspension of its phase III PACT trial, testing the drug TNFerade in patients with locally advanced pancreatic cancer. The trial was stopped after an interim data analysis showed that the trial “would not meet the goal of demonstrating persuasive evidence of clinical effectiveness that could form the basis for regulatory approval in the population chosen for study,” the company explained in a press statement.

TNFerade is a modified virus that carries the DNA for a protein known as tumor-necrosis factor. The drug is injected directly into tumors. In 2005, the company reported promising results from a phase I/II study of the drug in patients with pancreatic cancer. Late last year, the FDA granted TNFerade “orphan drug” status, which is used to promote the development of drugs for relatively rare diseases or conditions for which there are limited treatment options.

Use of Health Care Services May Contribute to Colorectal Cancer Disparities

Black Americans have a higher incidence of colorectal cancer and higher mortality from the disease than white Americans. A new study using data from the ongoing Prostate, Lung, Colorectal, and Ovarian Cancer Screening Trial (PLCO) suggested that use of health care services may play a larger role than biology in this disparity. The results were published online April 6 in the Journal of the National Cancer Institute.

Researchers led by Dr. Adeyinka Laiyemo from NCI’s Division of Cancer Prevention studied 57,561 non-Hispanic white and 3,011 non-Hispanic black PLCO participants who underwent sigmoidoscopy during baseline screening. According to PLCO protocol, patients with a colorectal polyp or mass detected during sigmoidoscopy would be referred to their regular physicians for diagnostic colonoscopy.

Although comparable numbers of black (25.5 percent) and white (23.9 percent) participants had an abnormal finding on their baseline screening tests, black participants were less likely than white participants to undergo a follow-up diagnostic colonoscopy (62.6 percent versus 72.4 percent, respectively). When analyzed by education level (a surrogate indicator for socioeconomic status) the difference was only statistically significant among participants with a high school education or less.

The researchers did not find a statistically significant difference in risk of colorectal cancer in blacks and whites at baseline screening. Overall, the results suggested “that the biology of colorectal cancer may not be materially different by race, at least in the early stages of carcinogenesis, but instead that health-care utilization differences among the races may play a more important role in the observed disparities in colorectal cancer,” stated the authors.

The study was not designed to identify factors responsible for lower use of health care by black participants, which may include procedural costs and cultural barriers, the authors concluded.

Complementary and Alternative Medicine Commonly Used by Pediatric Patients

Many pediatric cancer patients use complementary and alternative medicine (CAM), according to a systematic review published online March 22 in Pediatrics. The research team led by Dr. Felicity Bishop of the University of Southampton in the United Kingdom reviewed 28 studies that surveyed a total of 3,526 children from 14 countries between 1975 and 2005. Twenty-three of the studies were performed between 2000 and 2005, and 10 were performed in the United States.

The researchers found that 2 to 48 percent of surveyed children used herbal remedies (measured in 13 of the studies), 3 to 47 percent used dietary and nutritional interventions (measured in 13 of the studies), and 2 to 19 percent used megavitamins (measured in 7 of the studies). Other CAM modalities used included faith healing, mind-body therapies, and massage therapies.

Those surveyed cited various reasons for the child’s CAM use, including to help cure or fight the child’s cancer and to provide symptom relief (both from the cancer itself and from side effects of standard treatment). CAM use did not appear to be associated with the gender, age, ethnicity, or family income of the pediatric patients, indicating wide use across demographic groups.

Because some commonly used herbs and supplements can negatively interact with standard cancer treatments, the authors cautioned that “pediatric oncologists need to be aware that their patients (and their patients’ parents) will be seeking and integrating other therapeutic approaches while undergoing conventional treatments.”

Breast Cancer Study Tests Effects of Zoledronic Acid

Women with breast cancer who received the bone-preserving drug zoledronic acid (Zometa) along with chemotherapy were slightly less likely to have tumor cells detected in their bone marrow several months later than women who received chemotherapy alone. The results, published online in Lancet Oncology on April 1, are from a randomized phase II clinical trial.

The goal of the study was to see whether zoledronic acid, a type of bisphosphonate, could reduce the presence of disseminated tumor cells—or DTCs—in the bone marrow when given along with chemotherapy prior to surgery. The trial, led by Dr. Rebecca Aft of the Washington University School of Medicine in St. Louis, included 109 women with newly diagnosed stage II or stage III breast cancer who were randomly assigned to receive the combination therapy or chemotherapy alone.

After 3 months, 17 of 56 women treated with zoledronic acid had DTCs in their bone marrow compared with 25 of 53 patients who received chemotherapy only. This difference was not statistically significant, the researchers noted. At 12 months, the number of patients with detectable DTCs was essentially the same in both groups.

The study, which was funded by Novartis Pharmaceuticals and Pfizer Inc., also found that giving women zoledronic acid at the start of chemotherapy prevented a loss of bone density, measured 1 year later. This is consistent with other studies of bisphosphonates in breast cancer, the researchers noted.

“Zoledronic acid administered with chemotherapy resulted in a decreased proportion of patients with DTCs detected in the bone marrow at the time of surgery,” the researchers concluded. Results from this study and others suggest that zoledronic acid has anti-metastatic properties within the bone marrow and systemically, they noted.

Guest Director's Update

Improving the Efficiency of Clinical Trials: Decreasing Activation Times by Fifty Percent

Dr. James H. Doroshow Dr. James H. Doroshow

NCI is dedicated to bringing new therapeutic and diagnostic options to patients with cancer as quickly as possible. On average, 25,000 to 30,000 patients per year are accrued to NCI-supported clinical trials through several networks of institutions and clinical trialists.

However, the current process of activating new phase III clinical trials conducted by NCI’s cooperative groups averages more than 2 years; and the time to activate most phase I and II studies requires more than 500 days. A recent analysis of NCI’s clinical trials activation process demonstrated that many trials, especially those that took the longest to open, never reached their accrual goals and had to be closed, wasting precious time and resources. The analysis also showed that the complex path to trial activation was characterized by steps that did not ultimately add value to the clinical trial itself.

To dramatically improve the current situation, NCI’s Clinical and Translational Research Advisory Committee (CTAC) initiated a review of the clinical trial activation process. On March 23, CTAC’s Operational Efficiency Working Group (OEWG) presented its final report, outlining a series of recommended changes to NCI’s current clinical trials activation procedures. These changes aim to decrease by half the time it takes to initiate new clinical studies.

The OEWG, whose 63 members were drawn from cancer research in academia, clinical practice, industry, and government, as well as the advocacy community, began its deliberations in December 2008; the report from this broadly representative group outlines 14 initiatives and implementation plans that describe both target dates and hard deadlines for the initiation of new clinical trials.

These initiatives are targeted at improving activation processes within the cooperative groups, the cancer centers, and institutions conducting early-phase trials. The OEWG set a target of 300 days for the time between submitting a phase III concept to the NCI Cancer Therapy Evaluation Program (CTEP) and the time of trial activation. Phase III trials will be terminated if they are not activated in 24 months. For phase I and II studies, the target for submission to opening is 210 days, with a drop-dead date for activation of 18 months.

To achieve these timelines, the report recommends:

  • Dedicated clinical trial development managers for protocol activation duties
  • Real-time project tracking systems that monitor where a concept or protocol is in the review process and who the responsible party is for that stage of the process
  • More support for protocol development, including dedicated medical writers who may be able to reduce the number of protocol revisions
  • Policies and procedures that coordinate interactions between group members, phase I/II trialists, and CTEP

Because of the consensus development that occurred during the writing of the report, many of the recommended initiatives are already being implemented. Administrative supplements are being awarded to all of the cooperative groups to help them develop action plans, hire appropriate staff, and acquire and begin using appropriate project tracking tools. Supplement requests for 48 of the NCI-designated cancer centers are currently under review. CTEP has also developed its own action plan to improve efficiency and speed protocol activation through more coordinated, real-time interactions with the clinical trials community. These changes were initiated as of April 1, 2010. The new timeliness deadlines for trial termination will become effective on January 1, 2011.

The OEWG report calls for all those involved in clinical trials, both inside and outside of NCI, to interact more effectively and to coordinate all of the tasks in the clinical trial development process in the most efficient manner possible. We owe our patients nothing less.

I was very fortunate to co-chair the OEWG with Dr. Gabriel Hortobagyi of the University of Texas M. D. Anderson Cancer Center. I would like to take this opportunity to express my appreciation to him for his extraordinary commitment to this effort. We both consider the implementation of the OEWG recommendations to be of the utmost importance for cancer patients everywhere.

James H. Doroshow
Director, NCI Division of Cancer Treatment and Diagnosis

Guest Commentary by Ambassador Nancy Brinker

Collaborating Globally to Address Breast Cancer in Latin America

Ambassador Nancy Brinker Ambassador Nancy Brinker

It’s increasingly apparent that the most successful global health efforts require not just the best minds, but the best minds working collaboratively, to make a difference on the world stage. This approach is the driving force behind a unique NCI partnership funded in part by Susan G. Komen for the Cure®, the world’s largest breast cancer organization, to address breast cancer issues in Latin American countries.

As Susan G. Komen for the Cure’s founder and CEO, and in my capacity as a global Goodwill Ambassador for Cancer Control with the World Health Organization, I’ve seen firsthand the devastation that cancer creates around the world. As much progress as we’re making in the United States in education, screening, and access, the best of what we have to offer is still not reaching women who desperately need it, particularly in low-resource regions of the world, where the lion’s share of cancer cases are expected to develop over the next 20 years.

In an age where breast cancer information is available 24/7 on thousands of Web sites, I visited with a woman in India last year who was anxious to know whether her breast cancer was contagious.

We’ve talked with women in the deserts of Africa, dying in unimaginable pain without palliative care. We’ve addressed women in the Middle East who have lost everything—husbands, families, and security—because they were diagnosed with breast cancer. And we’ve seen firsthand the need in Latin America, where women are often diagnosed at advanced stages of the disease.

Susan G. Komen for the Cure has been funding or partnering with organizations globally for more than 15 of our 28 years, investing $40 million to date with nongovernmental organizations, research institutions, and governments to build breast cancer advocacy, research, and health programs in about 50 countries. In all that time, our focus has been on creating partnerships, sharing what we know, and empowering organizations and individuals to make a difference in their home countries.

Collaboration isn’t always easy, and I applaud NCI’s for successfully bringing together the varying interests of several organizations and six governments, including our own, to launch the Latin American initiative. Komen is investing $1 million into this partnership to support the development of programs for cancer research, clinical trials, training, technology, and capacity building.

The participating Latin American countries—Argentina, Brazil, Chile, Mexico, and Uruguay—and the United States will link their research efforts through the cancer Biomedical Informatics Grid (caBIG), an information network that allows researchers to share data and knowledge. They will also develop pilot projects to enhance research and improve delivery of cancer treatments to patients in the United States and Latin America.

This is the first major multicountry research effort specifically aimed at women in Latin American countries. Over time, we hope to get answers about the roles that genetics, the environment, and social issues play in breast cancer incidence and mortality in Latin American women.

This work has important implications right here in the United States, where 14,000 cases of breast cancer were diagnosed and 2,200 deaths among U.S. Hispanic women occurred in 2009, making breast cancer the leading cause of cancer death among Latin American women in the United States. These numbers, unfortunately, are just part of more frightening global figures, with an estimated 7 million cancer deaths worldwide this year alone—more than 1.3 million due to breast cancer.

We’ve been fortunate in the United States that we’ve been able to transform the culture around breast cancer, and we’re eager to continue to apply what we’ve learned on a global scale. What we learn in these Latin American countries through this collaboration may very well give us the roadmap to successful treatment and social strategies for Latin American women, as well as for women worldwide.

Ambassador Nancy G. Brinker
Founder and CEO, Susan G. Komen for the Cure®

A Conversation With

A Conversation with Dr. Robert T. Croyle on Communicating Science

Dr. Robert Croyle Dr. Robert Croyle

Dr. Robert T. Croyle is the director of NCI’s Division of Cancer Control and Population Sciences (DCCPS) and co-author with Drs. David E. Nelson and Bradford W. Hesse of the book Making Data Talk: Communicating Public Health Data to the Public, Policy Makers, and the Press, published by Oxford University Press in 2009. The book analyzes research on the presentation of public health data and provides practical solutions for how scientists can better communicate data to the public. Drs. Nelson and Hesse discussed the book at a recent cyber-seminar.

Where did you get the idea for the book Making Data Talk?

Over the years that I’ve been at NCI, I’ve observed that our Institute, and NIH as a whole, doesn’t always do the best job in terms of explaining evidence. There are a lot of people who study how to communicate numbers effectively, but a lot of what they learn never gets used in practice. The idea behind the book was to pull that information together in one place. DCCPS is also expanding NCI’s support for research on communication itself, and the Centers of Excellence in Cancer Communications Research (CECCRs) are a big component of that. The CECCRs are an ongoing effort to bridge the gap between scientists and practitioners, but also an effort to get various scientists to work collaboratively so that people in medicine, behavioral science, and public health will generate evidence-based models to inform communication strategies.

What are some of the more significant missteps members of the media make in communicating science?

One challenge is the way the press allocates coverage of cancer issues, which ultimately has an impact at the policy level and among the public in terms of what issues receive attention. For example, we know that breast cancer gets more media coverage than lung cancer, even though lung cancer is a much greater cause of cancer death in the United States. A few years ago, we did a national survey of science and medical journalists, and we asked them how they decide what to cover. We found that they often rely on a local practitioner to interpret new scientific evidence, which can be a concern if the source has limited experience.

What is the best way to filter the surge of health information?

Information alone is not what people want. It’s only the first step toward getting access to a service or an answer to a specific question. By itself, disseminating information to increase awareness doesn’t do a lot of good, unless that effort is coupled with action steps, connecting people to the service providers, hospitals, health educators, and cancer programs that provide care.

In cancer prevention, the greatest opportunity is where we have good evidence that leads to actionable strategies for reducing risk or improving prevention and treatment. By growing the field of communication science, we can increase the impact of scientific discoveries on public health.

There has also been an explosion of information about peoples’ genetic susceptibility for certain diseases. How do you foresee people using this information?

As more genetic information becomes less expensive and widely available, what people are going to be most interested in are the things that they can do something about. There will always be some people who say, “Tell me everything you know about me.” These people, like scientists, have a great need for information, and they have a great tolerance for ambiguous information. They’re curious. But I think there is a larger group of people who are going to be less curious about genetic information unless there is something they think they can do with it.

What is the specific role that government agencies such as NCI have in communicating health information?

I think there has been steady but slow progress in the government about making both information resources and strategies more user-centered, whether through Web usability testing or surveying the public to identify needs and wants in terms of information.

Cancer is a word that sparks fear, and our survey data continue to show that many people associate cancer with death. So the people who are communicating with the public about cancer need to be sure that the information they provide addresses both the need for facts and also the need to reduce fear. We should make a clear distinction between trying to persuade people and trying to inform them.

Particularly for the government, transparency in this process is key. I think it’s important to clearly define information that is provided to be useful versus information that is part of a public relations campaign. If the priority is institutional self-promotion, as opposed to health promotion, this can undermine trust. NCI’s most precious and fragile asset is our credibility. Effective communication about new discoveries can mobilize our scientists and empower patients. But we also need to be honest about how much remains to be learned.

—K.M. Crane

Special Report

Scientists Restore DNA Repair in Mice with Brca1 Gene Mutations

The gene BRCA1 plays an important role in repairing DNA damage that inevitably occurs as cells replicate. Through a pathway known as homologous recombination (HR), the gene helps cells make repairs and prevent further genetic changes that could set the stage for cancer.

But as a new study in mice suggests, multiple pathways may actually compete with one another to repair DNA damage within cells. The study further suggests that it may be possible to restore the HR pathway and promote faithful DNA repair in cells with BRCA1 mutations.

As a demonstration, researchers identified and then shut down an alternative DNA-repair pathway called nonhomologous end joining (NHEJ) that is associated with the protein 53BP1. This had the effect of restoring the HR pathway in a mouse model of breast cancer. These mice have targeted mutations in the Brca1 gene and normally develop mammary tumors, but deletion of the gene encoding 53BP1 prevented the formation of tumors, according to results published online in Cell on April 1.

An enzyme called DNA ligase repairing a broken strand of DNA An enzyme called DNA ligase repairs a broken strand of DNA. (Image courtesy of Dr. Tom Ellenberger, Washington University School of Medicine in St. Louis.)

“Our findings show that you can take cells with a deficient DNA-repair pathway and make them normal again,” said the study’s senior author, Dr. Andre Nussenzweig, who heads the Molecular Recombination Section of NCI’s Experimental Immunology Branch.

Some repair pathways, he noted, do more harm than good. While the HR pathway is essentially free of errors, the 53BP1-associated pathway produces genetic mutations that increase the risk of cancer when the BRCA1 protein is absent.

Women who inherit a defective copy of the BRCA1 gene have an approximately 80 percent chance of developing breast or ovarian cancer during their lifetimes. The researchers suggested that multiple repair pathways may coexist in cells from these women until a mutation inactivates the remaining normal copy of BRCA1. When this happens, the 53BP1 pathway takes a greater role in the response to DNA damage, leading to genetic changes and instability that are associated with cancer.

“This study shows that by controlling the types of pathways used to repair DNA in cells, we can select for error-free repair or for a more mutagenic repair pathway,” said Dr. Samuel Bunting of NCI’s Center for Cancer Research and the study’s lead author.

“We want to know whether we can prevent the genomic instability that leads to cancer in women who lose the remaining normal copy of the BRCA1 gene,” he continued. “We would like to be able to manipulate the types of pathways that cells use to repair DNA damage.”

The research team included Dr. Toren Finkel of the National Heart, Lung and Blood Institute. His group recently discovered that mice that were deficient in both the Brca1 and 53BP1 proteins were not prone to cancer, and the new results help explain why the mice did not develop tumors.

“This is a very elegant study that reveals a highly unexpected relationship between 53BP1 and BRCA1,” wrote Dr. Titia de Lange, who heads the Laboratory of Cell Biology and Genetics at Rockefeller University’s Anderson Center for Cancer Research, in an e-mail message. She was not involved in the research.

The study may also have implications for understanding mechanisms of resistance to a class of drugs called PARP inhibitors. In phase II clinical trials, these drugs have demonstrated the ability to selectively kill cells with BRCA1 mutations while largely sparing other cells. Based on the mouse study, it appears that tumors could become resistant to PARP inhibitors by inactivating 53BP1.

“Our work strongly suggests that, through the inactivation of mutagenic repair pathways, tumors could become resistant to PARP inhibitors,” noted Dr. Bunting.

The researchers are investigating whether inhibiting 53BP1 can restore the HR pathway in cells with mutations in the BRCA2 gene, which also plays a role in DNA repair.

Edward R. Winstead

Spotlight

Oncology Nursing
This is the fourth article in a series of stories related to oncology nursing. Look for the symbol on the left in an upcoming issue for the next article in the series.

Focusing on Older Cancer Patients: A Clinical Need and a Research Necessity

People age 65 and older represent approximately 60 percent of cancer patients and account for 70 percent of annual cancer deaths. As the U.S. population continues to age, these percentages will only continue to grow in the coming decades.

A nurse administers chemotherapy to an elderly patient

And yet there is a dearth of evidence on how to best treat older patients. The evidence deficit includes not just which therapies are most effective, but also how to approach the unique needs of patients who, because of their age, metabolize drugs differently, are more likely to have other illnesses, and are more prone to problems such as depression, dementia, falling, and poor nutrition—all of which can influence treatment efficacy.

“We really need to ask ourselves, if the majority of cancer patients are 65 and older, why have we structured oncology science and care to be a set of systems that is focused on younger patients and views the majority as a minority?” asked Dr. Sarah Kagan, a clinical nurse specialist and geriatric oncology researcher at the University of Pennsylvania Abramson Cancer Center. For instance, she continued, cancer clinical trials typically include few older patients and mostly those without other significant illnesses. “That’s not real life in an aging society,” Dr. Kagan said.

Recognition of these issues has improved greatly, said Dr. Harvey J. Cohen, director of the Center for the Study of Aging and Human Development at Duke University Medical Center. “But there is still a long way to go to have the broader [oncology] community understand and generate more specific evidence of what to do about them,” he said.

Clinical Trials and Older Patients

Making clinical trial participants more representative of the types of patients seen in everyday practice, particularly older patients, has been a significant challenge, said Dr. Ted Trimble of NCI’s Division of Cancer Treatment and Diagnosis (DCTD). Comorbidities and clinician and patient reluctance are among the factors that limit older patient participation. In addition, Dr. Trimble explained, older patients are less likely to be referred for treatment to NCI-designated cancer centers, and they are more likely to be treated at sites that don’t offer clinical trials.

NCI is working at multiple levels to improve the situation, he said. “We’re working with the clinical trials cooperative groups to develop more trials that target older patients, particularly those with comorbidities,” he explained. “We want to be able to figure out if the results coming out of trials with healthier patients can safely be used in older patients and those with comorbidities.” The available evidence, Dr. Trimble added, indicates that older patients are often undertreated because of a lack of such information.

DCTD also has a program to test newly identified chemotherapy agents in patients with issues such as organ dysfunction. “As new agents come to be used in clinical trials or become standard therapy, we’ll have information on how to dose patients with comorbidities,” said Dr. Trimble.

The “Older” Patient

How to most effectively treat and manage older patients is one of the greatest challenges in contemporary cancer care, said Deborah Boyle, an oncology nurse from Banner Good Samaritan Medical Center in Phoenix, and an advocate for geriatric cancer patients for more than 2 decades. In 2008, Ms. Boyle led a Geriatrics Task Force assembled by the Oncology Nursing Society to focus greater attention on the needs of older patients and the role of nurses in their care.

The challenge, Ms. Boyle said, begins with defining just what constitutes an older patient. “Chronologic age is not a good marker of appropriateness for therapy,” she explained. “Rather, what we should address is a patient’s physiologic age.”

For example, an oncologist may see two 70-year-old women diagnosed with breast cancer. The first could be quite fit with good mobility, strong mental acuity, and no other significant medical conditions. The other patient could be a widow with little in the way of a support system at home, suffering from osteoporosis and heart disease, taking six or seven different medications, and have early signs of dementia. The needs and treatment approaches of these two patients are likely quite different.

And that’s the problem, argued Dr. Kagan. “Oncology has yet to find effective, comprehensive ways to understand the integration not just of biological aging, but also the psychological and sociological implications of what it means to be old in our society.”

The Nurses’ Role

When seeing older patients, oncologists may be aware of issues apart from the cancer itself, such as the patients’ mental state and the kind of care assistance they have at home, said Dr. Cohen, who works with NCI-funded clinical trials cooperative groups. “But they don’t necessarily call it to mind when occupied with a patient,” he said. “They’re preoccupied with how to best treat the tumor itself, which is understandable.”

That’s why oncology nurses can play such an important role in helping to manage older patients, said Mary Kate Eanniello, an oncology nurse educator from Hartford Hospital, a large community hospital in Hartford, CT.

“We are knowledgeable about the diversity of patients, that elderly patients are different from the average younger patient,” she said. Nurses can be more focused, she continued, on “the idea of age competency; that different patients at different times in their lives will need to be handled differently.”

Ms. Eanniello’s hospital is one of more than 300 across the country that have implemented the Nurses Improving Care for Healthsystem Elders (NICHE) program. Developed by the Hartford Institute for Geriatric Nursing at the New York University College of Nursing, the NICHE program provides programs and tools nurses can use to improve the care of elderly patients.

At Hartford Hospital (which is not affiliated with the Hartford Institute), Ms. Eanniello is the primary NICHE educator for the facility’s oncology nurses. The training that nurses receive through the NICHE program, she said, allows them to anticipate whether patients are likely to tolerate certain treatments or if they require more vigilant post-treatment monitoring. According to Chris Waszynski, a nurse who oversees the NICHE program for the entire hospital, the results of the training speak for themselves: a significant decrease in patient falls, increased detection of delirium, and decreased length of hospital stays.

“I tell our staff on the inpatient unit that you can’t not like geriatrics and be an oncology nurse,” Ms. Eanniello said. “The opportunities we have to make an impact on the quality of life for older patients are only limited by the time we can stay awake.”

Oncology nurses play a central role in the Senior Adult Oncology Program at the H. Lee Moffitt Cancer Center in Tampa, FL, said Dr. Lodovico Balducci, the program’s chief. “The nurses are in the best position to identify age-related problems, because the nurses, by both training and vocation, are better attuned to the kinds of issues older patients face,” he said.

Getting Cancer Specific

Currently, few hospitals, academic cancer centers, and community oncology practices have specialized or standardized methods for managing older patients, Dr. Cohen noted. One potentially valuable tool is the comprehensive geriatric assessment (CGA), which provides an in-depth analysis of medical, psychological, or social issues that can affect patient treatment and overall management. The assessments can be clinically important, added Dr. Ted Trimble of NCI’s Division of Cancer Treatment and Diagnosis. “We’ve learned that those initial assessments can be more predictive of how a patient will do with their cancer than their [Eastern Oncology Cooperative Group] performance status.”

In addition to a lack of training on how to conduct such assessments, there is also a shortage of evidence on their use in an oncology setting, Dr. Cohen noted, including whether they measurably improve outcomes and overall care. But that may soon change.

At Moffitt, for instance, patients who are age 70 or older routinely undergo a two-part screening process, Dr. Balducci explained. The initial screening, performed by a nurse, identifies patients who may need a more in-depth geriatric assessment because of signs of depression or lack of an adequate caregiver. Patients will also undergo an assessment by one of the program’s oncologists with a tool called CRASH, developed by Dr. Balducci’s colleague Dr. Martine Extermann, which identifies older patients at increased risk of severe chemotherapy complications. Results from a study done at Moffitt involving the CRASH assessment will be presented at the American Society of Clinical Oncology annual meeting in June.

The NCI cooperative clinical trials group Cancer and Leukemia Group B, meanwhile, is incorporating a CGA into several clinical trials for use with older participants. The CGA that will be used, Dr. Cohen explained, is less extensive than similar tools used at other elder care facilities, and can be completed by patients in the waiting room. The trials will determine whether the assessment results correlate with outcomes such as survival and toxicities, which “could allow oncology staff to make better decisions about which drug regimens to use and the intensity of those regimens,” he said.

Such assessments, Ms. Boyle said, address a critical need for older patients. “We need to identify issues that could influence their outcomes before treatment begins, not during the course of therapy,” she stressed.

The cancer patient population is changing, Dr. Balducci said, and oncology professionals must not only acknowledge that shift, but begin to alter how they approach older patients. “It’s a general principle that physicians and nurses need to become experienced in the assessment of the older person,” he said, “because that is going to be the medicine of the future.”

Carmen Phillips

ONS to Launch New Geriatric Training for Nurses

The Oncology Nursing Society is developing a new training program on older patients for oncology nurses, according to the society’s director of education, Michelle Galioto. The training program is being developed by a team of gero-oncology and geriatric nursing specialists from across the country, Ms. Galioto explained, and will be reviewed by other specialists and enhanced as needed.

The program is expected to be launched later this year on a regional level and will cover:

  • Normal and pathologic changes in the older adult
  • The different side effects of cancer and cancer treatment in older adults
  • Strategies for managing symptoms and treatment side effects
  • Psychosocial considerations
  • Patient and family education

Featured Clinical Trial

New Chemotherapy Drug for Advanced Cervical Cancer

Name of the Trial
Phase II Clinical Trial of Ixabepilone (Ixempra, BMS-247550, NSC 710428), an Epothilone B Analog, in Cervical Cancer (NCI-09-C-0037). See the protocol summary.

Dr. Antonio Tito Fojo Dr. Antonio Tito Fojo

Principal Investigator
Dr. Antonio Tito Fojo, NCI Center for Cancer Research

Why This Trial Is Important
Women with advanced cervical cancer that cannot be treated surgically may benefit from chemotherapy given with or without radiation therapy. Several chemotherapy drugs, including taxanes and platinum-based drugs, have shown some activity in patients with advanced disease. Unfortunately, response rates to these drugs tend to be low and the response durations brief. Doctors are eager to develop better chemotherapy treatments for these patients.

In preliminary studies, a new drug called ixabepilone (Ixempra) has shown promise in treating women with advanced cervical cancer. Ixabepilone belongs to a class of drugs called epothilones. Like taxanes, epothilones stabilize cellular structures called microtubules, which are involved in many important processes, including cell division. Depending on the needs of the cell, microtubules either increase or decrease in size, and, when they are prevented from changing (e.g., by microtubule-stabilizing drugs), they cannot function normally. As a result, cell division is inhibited. The epothilones are thought to be more potent than the taxanes, and mechanisms that make cancer cells resistant to taxanes and other drugs do not appear to confer resistance to epothilones.

In this clinical trial, women with cervical cancer that has recurred or demonstrated resistance to previous chemotherapy and that cannot be treated surgically will receive ixabepilone as a 1-hour intravenous infusion on the first 5 days of a 3-week cycle. The number of cycles a woman receives will depend on how her cancer responds to the drug. Doctors will assess whether tumors shrink or disappear (response rate), as well as the drug’s effects on cell division and cell death.

“Drugs that target the microtubules are among the most widely used in oncology,” said Dr. Fojo. “They are effective in a broad range of cancers, and our goal with this study, as well as a similar study in kidney cancer, is to see if a type of drug we believe is an improvement on the taxanes will actually improve outcomes for patients with these diseases.

“Ixabepilone is already approved by the FDA for second-line treatment of advanced breast cancer, and the regimen that we are using has been demonstrated to be very tolerable in an earlier study,” he added.

For More Information
See the lists of eligibility criteria and trial contact information or call the NCI Clinical Trials Referral Office at 1-888-NCI-1937. The call is toll free and confidential.

An archive of "Featured Clinical Trial" columns is available at http://www.cancer.gov/clinicaltrials/ft-all-featured-trials.

Cancer Center Profile

Indiana University Melvin and Bren Simon Cancer Center

Director: Dr. Patrick J. Loehrer, Sr. • 535 Barnhill Drive, Indianapolis, IN 46202
Phone: 888-600-4822 • Web site: www.cancer.iu.edu

Background

Indiana University Simon Cancer Center Indiana University Melvin and Bren Simon Cancer Center

The Indiana University (IU) Melvin and Bren Simon Cancer Center began as the Indiana University Cancer Center, receiving its NCI cancer center designation in 1999 under the leadership of the late Dr. Stephen Williams. Today, it involves a partnership between Clarian Health and the IU School of Medicine, which is the nation’s third largest medical school. The IU Simon Cancer Center has significantly grown its extramural research funding base in the last decade, attracting world-class physicians and researchers and opening new patient care and translational research facilities.

IU has become an incubator for national and international leadership. Examples of IU faculty and staff who have gone on to accept important roles in the cancer community include Dr. George Sledge, who is president-elect of the American Society of Clinical Oncology and will take office this June; Dr. Peter Johnstone, who is president-elect of the American Radium Society and will take office in May; Dr. Hal Broxmeyer, current president of the American Society of Hematology; and Dr. Victoria Champion, who serves on the National Cancer Advisory Board.

Research

Research expertise at the IU Simon Cancer Center is known around the world, offering renewed hope for patients and families and new options in cancer care. Among the list of these accomplishments and the faculty who continue to pioneer cancer treatments are the following:

  • Dr. Lawrence Einhorn developed the curative chemotherapy regimen for testicular cancer. Trials conducted at IU were instrumental in the FDA’s approval of cisplatin, etoposide, and ifosfamide to treat this indication.
  • Dr. Hal Broxmeyer is a scientific pioneer in the field of umbilical cord blood stem cell transplantation. As one of the first scientists to recognize the value of harvesting stem cells from cord blood, Dr. Broxmeyer was a member of the international team that performed the first transplant of this kind in France in 1988.
  • In a phase III trial led by Dr. Kathy Miller, bevacizumab improved progression-free survival when it was given with chemotherapy to patients with metastatic breast cancer. This study, conducted by the Eastern Cooperative Oncology Group, was the first to show a benefit of antiangiogenic therapy in patients with breast cancer and provided the pivotal data for FDA approval of the drug in this disease.
  • Dr. David Flockhart demonstrated that women taking tamoxifen with certain antidepressants double their chances of the disease returning. The FDA revised the tamoxifen label to include this information.

Patient Care

Nearly 40,000 outpatients and 4,000 inpatients turn to the IU Simon Cancer Center for care each year, seeking the multidisciplinary team approach that combines treatment, research, and supportive care in a manner that is individualized for each patient.

Located in downtown Indianapolis, the IU Simon Cancer Center opened a $150 million, 405,000 square-foot patient care building in late 2008 that brings these various aspects of cancer care together in one location. And through its affiliation with the Midwest Proton Radiotherapy Institute at Indiana University-Bloomington, the center offers proton radiotherapy as a treatment option for certain cancers.

Other Notable Programs

Researchers with the Susan G. Komen for the Cure Tissue Bank at the IU Simon Cancer Center collect and share healthy breast tissue samples with researchers around the world to help further understanding of how breast cells turn cancerous. This tissue bank, which is the first and only healthy breast tissue bank in the world, currently has samples from more than 6,700 women.

The Hoosier Oncology Group (HOG), one of the most successful networks of community and academic partners that work together to conduct clinical cancer research at the local level, will celebrate its 25th anniversary later this month. Founded by faculty members at the IU Simon Cancer Center and others, it has grown to a network of more than 400 physicians and has enrolled more than 3,000 people in more than 150 clinical trials.

Legislative Update

House Committee Convenes Hearing on NCI Research

The House of Representatives Committee on Energy and Commerce, Subcommittee on Health, held a hearing on March 23, “NCI Cancer Research: Today’s Progress, Tomorrow’s Challenges,” to discuss advances in cancer research and NCI’s research plans, with a focus on high mortality cancers with 5-year survival rates below 50 percent. NCI Deputy Director Dr. Anna Barker testified before the committee, and an additional panel of witnesses included advocates and an NCI-designated cancer center director.

Dr. Barker shared updates on a number of NCI strategic initiatives that are helping the cancer research community to better understand the biology of cancer and make progress toward targeted treatments. Her testimony focused on progress in molecular biology and advanced technologies, and she provided an overview of The Cancer Genome Atlas (TCGA). TCGA is a collaboration between NCI and the National Human Genome Research Institute, and a program that was of particular interest to members of the subcommittee. Dr. Barker emphasized that the biggest challenge to expanding TCGA is obtaining high-quality biospecimens, and she stressed that advocates can play an important role in this effort, particularly for rare and lethal cancers.

TCGA aims to map the relevant genomic alterations in approximately 20 types of cancer over the next 5 years and has catalogued the genomes of three cancer types to date—lung, brain (glioblastoma), and ovarian cancers. These three cancer types are considered high mortality cancers, which were the focus of much of the testimony from the second panel at the hearing. While panelists recognized NCI’s commitment to high mortality cancers through TCGA, some also called upon NCI to make a larger investment in developing targeted treatments for these cancers.

The hearing was not called to address specific legislation, but members of the subcommittee and panelists referenced the possible introduction of a House companion bill to the Access to Life-Saving Early detection, Research and Treatment (ALERT) Act (S.717), originally introduced in the Senate by the late Sen. Edward Kennedy (D-MA). The subcommittee expressed interest in having further conversations about next steps in cancer research as this process moves forward.

More information on the hearing, including a full list of witnesses and their statements, can be found on the committee Web site.

For more information about this and other NCI congressional activity, visit the NCI Office of Government and Congressional Relations Web site.

FDA Update

New Tobacco Products Advisory Committee Focuses on Menthol Cigarettes

The FDA’s new Tobacco Products Scientific Advisory Committee (TPSAC) held its inaugural meeting in Washington, DC, last week. The main focus of the meeting was on menthol in cigarettes, and presentations focused on the demographics of menthol cigarette users, preferential use of menthol cigarettes by persons initiating tobacco use, the health effects of menthol in cigarettes, the effects of menthol on addiction and cessation, marketing and consumer perceptions about menthol cigarettes, the sensory qualities of menthol cigarettes, and the effects of menthol on how cigarettes are smoked.

The Family Smoking Prevention and Tobacco Control Act, enacted last year, granted the FDA regulatory authority over tobacco products and required the formation of the TPSAC. Under the new law, the committee is required to submit a report by March 23, 2011 to the Secretary of Health and Human Services on the public health impact of using menthol in cigarettes.

The 2-day TPSAC meeting can be viewed in its entirety on the FDA’s tobacco products Web site. A second meeting, focusing on tobacco industry research and documents related to menthol and cigarettes, is planned for summer 2010.

Advisory Panel Recommends Restrictions on Tanning Bed Use by Minors

On March 25, the General and Plastic Surgery Devices Panel of the FDA’s Medical Devices Advisory Committee recommended that the agency consider restricting minors’ access to indoor tanning beds by requiring parental consent or outright banning their use by those under the age of 18. The panel also recommended that the FDA reclassify indoor tanning beds from Class I to Class II or Class III medical devices, which would allow for greater regulatory oversight. An increase in tanning bed use is one factor blamed for the rising incidence of melanoma in the United States, and a 10 percent tax on indoor tanning was included in the health reform bill signed by President Obama on March 23.

Notes

Take Part in SELECT Biorepository Symposium

As the largest prostate cancer prevention trial ever undertaken, the Selenium and Vitamin E Cancer Prevention Trial, or SELECT, has assembled a substantial biorepository of specimens. To help make SELECT resources available to a wider research community, NCI and the Southwest Oncology Group (SWOG) will host a symposium May 4 in Dallas, TX, to develop an RFP for projects using the trial’s biorepository. The symposium will bring together leaders in prostate cancer biology and nutritional science and micronutrients to discuss the current state of the science and outline potential future directions. Investigators interested in participating in the symposium should complete the online application form.

SELECT logo

SELECT is an NCI-funded phase III study of the effects of selenium and vitamin E, both separately and together, on the incidence of prostate cancer. The study opened in 2001 and quickly accrued 35,533 men. In the fall of 2008, the trial’s Data Safety and Monitoring Committee recommended that participants discontinue taking the study supplements based on an interim finding of no preventive benefit. The almost 31,000 patients remaining on SELECT are now being transitioned to a centralized follow-up system to track their health.

The trial’s growing biorepository includes toenail clippings, baseline and post-baseline blood samples, linked nutritional data, adherence cohort data, and a vast clinical database from semiannual visits with each participant. The biorepository also holds prostate biopsies and surgical specimens collected from a subset of the more than 2,100 men who have been diagnosed with prostate cancer during the course of the trial. DNA has been extracted from the serum of these prostate cancer patients and from an age- and race-matched cohort of control subjects.

Meet NCI Experts at AACR

Learn about NCI’s programs and Web sites by visiting booth #1121 in the exhibit hall during the American Association for Cancer Research Annual Meeting. NCI experts will be available to talk about a wide range of topics. See the schedule below.

Sunday, April 18 
1:00 PMTranslational Research Program (SPOREs) 
 Ivan Ding, Division of Cancer Treatment and Diagnosis
2:00 PMNCI-funded Research Portfolio
 Michele Vos, Division of Extramural Activities
3:00 PMCancer.gov Evolution
 Jonathan Cho, Office of Communications and Education
  
Monday, April 19 
9:00 AMSmall Business Innovation Research Development Center
 Natalia Kruchinin and Patti Weber, Small Business Innovation Research Program 
10:00 AMFellowships in the Division of Cancer Epidemiology and Genetics
 Jackie Lavigne, Division of Cancer Epidemiology and Genetics
11:00 AMEpidemiology and Genetics Research Program 
 Mukesh Verma, Division of Cancer Control and Population Sciences 
12:00 PMFunding for Biomarker, Imaging, and QOL Studies Associated with NCI’s Clinical Trials
 Geoffrey Seidel, Office of the Director 
1:00 PMNCI caHUB: How Will a National Biobank Serve the Cancer Researcher?
 Carolyn Compton, Office of Biorepositories and Biospecimen Research
2:00 PMNCI-funded Research Portfolio
 Lisa Krueger, Division of Extramural Activities
3:00 PMValidation of Emerging Technologies for Cancer Epidemiology
 Rao Divi, Division of Cancer Control and Population Sciences
4:00 PMNanotechnology: Presenting a Pipeline of New Tools for Cancer Diagnosis and Treatment 
 Piotr Grodzinski, Center for Strategic Scientific Initiatives
  
Tuesday, April 20 
9:00 AMIMAT - Supporting the Early-stage Development of Innovative Technologies
 Mark Lim, Center for Strategic Scientific Initiatives  
10:00 AMCancer Prevention Fellowship Program
 David E. Nelson, Office of the Director
11:00 AMFunding for Biomarker, Imaging, and QOL Studies Associated with NCI’s Clinical Trials
 Geoffrey Seidel, Office of the Director 
12:00 PMUnlocking the Potential of Proteomics Medicine: Answering the What, Why, and How
 Henry Rodriguez, Center for Strategic Scientific Initiatives
1:00 PMTCGA Data Portal Tools and Support
 Carl Schaefer, Center for Biomedical Informatics and Information Technology
2:00 PMNCI-funded Research Portfolio
 Michele Vos, Division of Extramural Activities 
3:00 PMNutritional Epidemiology 
 Joseph Su, Division of Cancer Control and Population Sciences  
4:00 PMSmall Business Innovation Research Development Center
 Deepa Narayanan, Small Business Innovation Research Program
  
Wednesday, April 21 
9:00 AMNCI-funded Research Portfolio
 Lisa Krueger, Division of Extramural Activities  
10:00 AMCenter for Cancer Research  
 Terry Moody, Office of the Director 
11:00 AMCancer Training Branch
 Dorkina Myrick and Susan Lim, Office of the Director

Tutorial on Targeted Therapies for Multiple Myeloma Available Online

NCI recently added a new tutorial to its Understanding Cancer Series, a collection of education tutorials for life science teachers, health professionals, and the interested public. Targeted Therapies for Multiple Myeloma is part of the Targeted Therapies Tutorials. In multiple myeloma, abnormal plasma cells accumulate in the bone marrow, which may eventually interfere with the production and function of normal blood cells. The tutorial focuses on the variety of targeted therapies that have been and are being developed to treat multiple myeloma. The tutorial explains the molecules and pathways in multiple myeloma cells that are being targeted, as well as the agents that are being developed to target these molecules and pathways. Individuals will learn which targeted therapies are currently approved by the FDA and how to find clinical trials of targeted therapies for multiple myeloma.

View or download Targeted Therapies for Multiple Myeloma at
/cancertopics/understandingcancer/targetedtherapies or contact Donna Kerrigan at kerrigad@mail.nih.gov or Kimberly Martin at martinkim@mail.nih.gov to request a DVD.