National Cancer Institute NCI Cancer Bulletin: A Trusted Source for Cancer Research News
September 20, 2011 • Volume 8 / Number 18

NEWS

HPV Vaccine Study in Costa Rica Yields Insights on Cancer Prevention

Diagram of an HPV virus-like particle and neutralizing antibodiesA flurry of new research findings on a vaccine that prevents persistent infections by cancer-causing types of the human papillomavirus (HPV) has confirmed the vaccine's efficacy and opened new avenues for research. The results, published in three separate reports, suggest that the vaccine could be simpler to administer and more affordable than researchers had thought previously—and the vaccine may also have unexpected benefits. Read more > >

COMMENTARY

A Conversation with Dr. Ted Trimble on NCI's Center for Global Health


Dr. Ted Trimble The director of NCI's new Center for Global Health explains why the center was formed and discusses the institute's global strategy for engaging the research community and other partners worldwide to ensure that cancer research has a global reach.  
  

IN DEPTH

UPDATES

  • FDA Update

    • Health Officials Issue Statement on Drug Shortages
    • Cancer Therapies Office Reorganized
  • Cancer.gov Update

    • NCI Recovery Act Website Highlights Training in Comparative Effectiveness Research
  • Notes

    • Appointments Announced for Two New NCI Centers, Division of Cancer Prevention
    • NCI's Norm Coleman Wins Service to America Medal
    • Director's Consumer Liaison Group Meets this Week
    • NCI, HHS Launch Mobile Services to Help Smokers Quit


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

HPV Vaccine Study in Costa Rica Yields Insights on Cancer Prevention

Diagram of an HPV virus-like particle and neutralizing antibodiesThe HPV vaccine contains virus-like particles (blue) that are noninfectious and stimulate the immune system to produce antibodies (red) that can prevent HPV infections.

A flurry of new research findings on a vaccine that prevents persistent infections by cancer-causing types of the human papillomavirus (HPV) has confirmed the vaccine's efficacy and opened new avenues for research. The results, published in three separate reports, suggest that the vaccine could be simpler to administer and more affordable than researchers had previously thought—and that the vaccine may also have unexpected benefits.

All three studies originate from an ongoing clinical trial of Cervarix in Costa Rica. The new findings could help inform efforts to develop vaccination programs to prevent cervical cancer in countries around the world, the researchers said.

"The results from our trial and from other trials are extremely promising for this vaccine," said Dr. Allan Hildesheim of NCI's Division of Cancer Epidemiology and Genetics (DCEG), a leader of the trial. "And they suggest that the impact of the vaccine may go beyond cervical disease."

HPV infections can lead to cancers of the anus, vagina, vulva, penis, and some oropharyngeal cancers, in addition to cervical cancer. Cervarix is one of two HPV vaccines currently approved by the Food and Drug Administration to prevent these infections; the other is Gardasil.

One of the studies found that fewer than the prescribed three doses of Cervarix may offer the same protection as the full course. If confirmed, this could make vaccination easier to administer and more affordable, factors that are especially important in developing countries that have high rates of cervical cancer.

A second study from the Costa Rica HPV Vaccine Trial found that the vaccine may protect against anal HPV infections that could eventually lead to anal cancer. (See "Clinical Trial Shows Potential Benefit of HPV Vaccine for Anal Cancer.")

Vaccine May Protect against Additional HPV Types

The third study confirmed that the vaccine is highly effective in preventing persistent infections with HPV types 16 and 18—the types targeted by Cervarix. The researchers also found evidence of "cross-protection" against other cancer-causing HPV types not targeted by the original formulation—HPV types 31, 33, and 45.

Testing an HPV Vaccine in the "Real World"

The safety and effectiveness of Cervarix and the other FDA-approved HPV vaccine, Gardasil, were established in clinical trials sponsored by the vaccine makers. Nonetheless, NCI researchers and their long-time collaborators in Costa Rica decided to conduct an independent study of a vaccine in a real-world setting.

A goal of the community-based trial was to collect data that could help with the implementation of cervical cancer prevention programs, said Dr. Herrero. "Our results could help the people who are planning vaccination programs to use this expensive vaccine in the most effective way possible."

Launched in 2004, the randomized trial includes 7,466 women between the ages of 18 and 25 from two Costa Rican communities (approximately one-third of the women in the region). Participants initially received Cervarix or a vaccine against hepatitis A. At the end of 4 years, the researchers offered the HPV vaccine to women in the control group.

The researchers will continue to follow the participants. "This community-based trial provides avenues to study not just the theoretical efficacy of the vaccine but the impact of vaccination on a well-defined population," said Dr. Hildesheim.

"This is a potential additional benefit from vaccination that we had not considered initially," said Dr. Hildesheim, noting that suggestive evidence for cross-protection has been reported previously.

The third study, published online September 9 in Cancer Discovery, also provided further evidence that the benefit of vaccination is greatest when the vaccine is given to young women before they have initiated sexual activity.

"Exposure to HPV occurs as soon as sexual activity begins, so if you start vaccination after that point, you will miss an opportunity to prevent infections," said the study's lead author, Dr. Rolando Herrero, formerly the study director in Costa Rica and now with the International Agency for Research on Cancer.

The findings on age are consistent with previous studies, noted Dr. Kevin Ault of Emory University's School of Medicine, who studies HPV but was not involved in the study. "As you age, you accumulate exposures to HPV, and, if the vaccine is given after you've been exposed to the virus, then it's not going to be effective."

Fewer Doses May Offer Protection

The discovery that two doses—and possibly even one—of Cervarix may protect against infection was possible because the study was done in a "real world" community setting. Many women in the trial (approximately 20 percent) received only one or two doses, often because of pregnancy or an unrelated health problem.

The researchers found, however, that all of the women who received the vaccine were protected equally—at least for the first 4 years after vaccination. Those results appeared online in the Journal of the National Cancer Institute on September 9.

"This study is terrific proof of concept," said Dr. Eduardo Franco of McGill University's Faculty of Medicine, who also studies HPV and was not involved in the research. "It suggests that countries could adopt the suboptimal dose regimens and still receive the same protection as the full course, assuming that the protection against lesions will also hold."

At the end of 4 years, the researchers offered the HPV vaccine to women in the control group. The researchers will follow the trial participants to determine how long the protection lasts. 

If the current results are confirmed, the costs of vaccination programs could drop. "Our results may have important implications for public health, although many questions remain unanswered," said the study's first author, Dr. Aimée Kreimer of DCEG.

For instance, how long one or two doses of the vaccine protect against HPV infection is not known. In addition, the findings may not apply to other vaccines or to other populations, such as people who are malnourished or lack strong immune responses, the study authors cautioned.

More Affordable and Sustainable Cervical Cancer Prevention

Costa Rica HPV Vaccine Trial teamThe Costa Rica HPV Vaccine Trial team in Guanacaste, Costa Rica, at the start of the study in 2004.

"The importance of the current study is not so much for Costa Rica, which has cervical cancer screening programs, but for countries that have truly high incidences of cervical cancer and no screening," Dr. Franco said. More follow-up is needed to show that the suboptimal doses translate into fewer cervical precancerous lesions for vaccinated women, he added.

This study "represents an important step on the road to more affordable and sustainable cervical cancer prevention programs," wrote Dr. Cosette Marie Wheeler of the University of New Mexico in an accompanying editorial

Few, if any, developing countries where cervical cancer is common can afford vaccination programs, said Dr. Herrero. But if countries can afford to vaccinate only certain groups, they need to know which ones would benefit most, he noted. As the current study shows, this group would likely be young women who are not yet sexually active.

"When we started more than 25 years ago, we were just discovering that HPV was the cause of cervical cancer," said Dr. Herrero. "Today we have a tremendous amount of tools and knowledge, which make it possible to intervene in this disease."

Edward R. Winstead

Cancer Research Highlights

For Young Women, Breast Conserving Surgery May Be Acceptable Alternative to Mastectomy

Women under age 40 who had breast-conserving surgery (BCS) did not have higher rates of local recurrence or poorer overall survival compared with women who underwent mastectomy, according to results from two retrospective studies. Young age at diagnosis is thought to be a risk factor for disease recurrence, and many young women with breast cancer choose mastectomy for treatment.

The research was presented at the 2011 American Society of Clinical Oncology Breast Cancer Symposium in San Francisco. “These studies support [the idea] that breast conserving surgery with lumpectomy and radiation is an excellent option for young women, and may be the preferred approach,” commented Dr. Jo Anne Zujewski, head of Breast Cancer Therapeutics in NCI’s Division of Cancer Treatment and Diagnosis, who was not involved in the research.

In the first study, researchers led by Dr. Julliette Buckley of Massachusetts General Hospital reviewed the medical records of 628 young women with stage I to stage III breast cancer treated at their hospital between 1996 and 2008. The median follow-up time after treatment was 6 years. During the study period, 7.1 percent of women who had breast conserving therapy and 7.5 percent of women who underwent mastectomy had a local recurrence—a difference that was not statistically significant.

The local recurrence rates seen in this study are lower than in previous studies, stated the researchers. These new results suggest “that lumpectomy is indeed a safe option for young women,” said Dr. Buckley during a press briefing. “We believe that awareness of the genetic risk of breast cancer, advances in the screening for breast cancer, and improvements in systemic and radiation therapy have contributed to the longer overall survival for young women with breast cancer that we have demonstrated,” she explained.

In the second study, investigators led by Dr. Usama Mahmood of the University of Texas M. D. Anderson Cancer Center examined data from NCI’s Surveillance, Epidemiology, and End Results database for 14,760 women between the ages of 20 and 39 who were diagnosed with stage I or stage II breast cancer between 1990 and 2007. All patients who received BCS underwent radiation therapy. The 10-year overall survival rate was virtually identical between the two groups: 83.5 percent for women who had BCS and 83.6 percent for women who had mastectomy.

“We found similar survival with either breast conservation therapy or mastectomy in the treatment of young women with early-stage breast cancer,” said Dr. Mahmood. “This serves as a reminder that women should be counseled appropriately regarding their treatment options and should not choose mastectomy based on an assumption of improved survival.”

Dr. Andrew Seidman, of Memorial Sloan-Kettering Cancer Center, who moderated the press conference, added: “It’s very important that we periodically revisit conventional wisdom, and…this is an important revisitation of the conventional wisdom that young women who have breast cancer really need to have mastectomy.”

Fluorescent Probe Helps Surgeons Find Ovarian Cancer Cells

In a proof-of-concept study, a fluorescent probe designed to bind to epithelial ovarian cancer cells was used safely to visualize small deposits of cancer in the abdominal cavity during surgery, thus helping the surgeon remove the cells. The target of the probe, called folate receptor-alpha, is found in 90 to 95 percent of ovarian cancers but not in normal tissue. The study, the first in of its kind in humans, was led by Dr. Gooitzen M. van Dam of the University of Groningen in the Netherlands and published online September 18 in Nature Medicine.

Ovarian cancer often spreads widely throughout the abdominal cavity, and small deposits of cancer can be difficult to see with the naked eye or detect during surgery. To improve the visualization of tumor cells and allow surgeons to remove more tumor tissue, the researchers tested the imaging agent, which consists of folate linked to a compound (fluorescein isothiocyanate) that glows green under fluorescent light.

The researchers injected 10 women with the probe before surgery. During surgery, the surgeon performed a standard inspection of the abdominal cavity for tumor tissue; the researchers then captured and examined fluorescent images with a three-camera system that did not interfere with the surgical procedure. After the surgeon removed all suspected tumor tissue identified by eye and by the fluorescent probe, the researchers captured a second set of fluorescent images to look for remaining tumor cells. The surgeon then took biopsy specimens of remaining fluorescent tissue to make sure the probe did not give false-positive results (that is, did not mark normal tissue as tumor tissue).

Nine of the patients had tumors that expressed folate receptor-alpha, and the researchers detected fluorescence in tumor tissue in all of these patients during surgery. No fluorescence was seen in adjacent normal tissue. “Real-time image-guided excision of fluorescent tumor deposits [less than 1 mm in diameter] was feasible, and all fluorescent tissue was confirmed to be malignant,” wrote the authors. One woman’s tumor did not express folate receptor-alpha, and the camera system could not detect the tumor cells in her abdomen.

“The use of targeted fluorescent agents could provide a paradigm shift in surgical imaging,” stated the authors, potentially improving the outcomes for patients after surgery by allowing for more thorough removal of tumor tissue. Large studies are needed to confirm these results and determine whether use of the probe can improve diagnosis and surgical treatment, Dr. van Dam and his colleagues concluded.

Nurse Practitioners, Physician Assistants Could Alleviate Projected Oncology Workforce Shortage

The regular use of nurse practitioners and physician assistants in the care of patients with cancer may be a viable solution to the projected shortage of oncologists in the United States, a new study has found. Patients in practices that used this approach were "highly satisfied" with their care, and the oncologists, nurse practitioners, and physician assistants in these practices were also "highly satisfied" with the collaborative care arrangements, according to the study published September 15 in the Journal of Oncology Practice.

The study “shows that coordinated and integrated cancer care provided by both oncologists and nonphysician providers is a very successful model,” said Dr. Dean Bajorin, who co-chairs the American Society of Clinical Oncology’s (ASCO) Workforce Advisory Group.

The study was conducted under the auspices of ASCO's Study of Collaborative Practice Arrangements initiative. ASCO launched this effort in March 2009 in response to the organization’s earlier report that forecast a major shortage of oncologists by 2020.

The first part of the study was a national survey of 226 oncology practices to identify those that commonly use nonphysician practitioners (NPPs). The researchers then analyzed a subset of 31 practices of different sizes and from varied geographic locations, of which only 27 provided complete data. As was the case with the overall survey group, most of the practices in the study group were physician-owned private practices. (Practices at academic centers were excluded from the study group.)

In both groups, NPPs most commonly performed duties such as assisting patients during treatment visits, managing pain and symptoms, educating and counseling patients, and providing follow-up care for patients in remission. Nearly all of the patients knew they were seeing an NPP, the study showed.

The most common approach to collaborative care was what study leader Elaine Towle of Oncology Metrics and her colleagues called the incident-to-practice model (ITPM). In this model, NPPs see patients independent of the oncologists in their practice (although they discuss patients’ care plans prior to the visit with an oncologist), but the oncologists are in the office and available for consultation.

In 60 percent of the practices in the study group, the NPPs work with all of the physicians in the practice. This arrangement appeared to be more efficient—increasing the number of patients seen by nearly 20 percent—than those in which the NPPs worked only with specific physicians in the practice.

The ITPM also offers some practical advantages, the authors explained. “In the private practice setting, the ITPM allows practices to bill Medicare for NPP services as though they were rendered by the physician and to receive reimbursement at the full physician fee schedule.” If these visits were billed under the NPP’s provider number, they noted, reimbursement would be 85 percent of the physician fee schedule.

Study Suggests How the BRCA1 Protein May Help Suppress Tumors

Mutations in the BRCA1 gene are known to increase a woman’s lifetime risk of developing breast and ovarian cancers, but researchers are still investigating how the protein encoded by this gene helps suppress the formation of tumors. A study by Dr. Inder Verma and his colleagues at the Salk Institute for Biological Studies in the September 8 Nature offers some clues.

Using mice and human breast cancer cells, the researchers identified a series of abnormalities in cells lacking the BRCA1 protein. Taken together, the findings suggest that BRCA1 helps to preserve the integrity of a cell’s genome by “silencing” stretches of repetitive DNA that might harm the cell if “awakened,” or transcribed.

When BRCA1 is missing, the researchers found, certain chromosome regions are no longer maintained in a condensed state. Normally, these regions (known as constitutive heterochromatin) are bound tightly; as a result, certain stretches of repetitive DNA are silent. In the absence of BRCA1, however, cells may produce relatively large amounts of RNA from the repetitive regions.

This activity, in turn, may make the genome less stable and set the stage for cancer. “When cells make a lot of this noncoding RNA, it can lead to DNA damage,” said co-author Dr. Quan Zhu. “This kind of damage is thought to cause cancer.”

The maintenance of distinct chromosomal regions in a condensed state may underlie the tumor-suppressive effect of the protein, wrote Dr. Ashok Venkitaraman of the Hutchison/Medical Research Council Research Centre, Cambridge, UK, in an accompanying editorial. The finding, he added, “might herald a breakthrough” for the field.

Over the past decade and a half, many studies have proposed potential functions for the normal BRCA1 protein, such as repairing damaged DNA or helping with transcription. Dr. Verma and his colleagues believe their findings could provide a framework for understanding the role this protein plays in a number of cellular functions.

By and large, the researchers note, their observations in mice and in human cells are consistent with previous studies of BRCA1. “We observed all of the cellular problems that people have reported over the years related to the loss of BRCA1,” said co-author Dr. Gerald Pao.

The activation of repetitive DNA observed in this study was seen in mouse and human tumors. “Whether, and how, this event promotes cancer development in carriers of germline BRCA1 mutations is not yet evident,” Dr. Venkitaraman wrote. Nonetheless, the study “reveals an intriguing new pathway for tumor suppression,” he added. 

Bacterium Associated with Stomach Cancer Directly Damages DNA

A new study helps explain how infection with the stomach bacterium Helicobacter pylori, the strongest known risk factor for gastric (stomach) cancer, may lead to cancer. Researchers have found that H. pylori infection triggers breaks in both strands of the DNA double helix in the nucleus of gastric epithelial cells. These DNA double-strand breaks activate the cells’ machinery for repairing DNA damage, but prolonged H. pylori infection overloads this machinery, which could lead to mutations involved in gastric cancer development.

Drs. Anne Müller and Massimo Lopes of the University of Zurich and their colleagues reported the findings online September 6 in Proceedings of the National Academy of Sciences.

“Human biopsies from infected individuals reveal higher mutation rates of gastric mucosal cells, and results from animal models suggested the same,” Dr. Müller wrote in an e-mail. “But very little is known regarding the mechanism” that causes these mutations.

Using techniques that analyze DNA integrity, the researchers showed that exposing laboratory-grown cells to H. pylori caused DNA double-strand breaks in human gastric cancer cells and in normal mouse gastric epithelial cells. The frequency of double-strand breaks—the most harmful lesions a cell can encounter, according to the authors—depended on the intensity and duration of exposure.

The researchers also showed that DNA damage depends on direct contact of live H. pylori bacteria with their host cells and is not caused by factors such as toxins that these bacteria secrete.

“Our study is one of the few suggesting direct DNA damage as the cause for mutations,” Dr. Müller noted. Other studies have suggested that chronic H. pylori infection and resulting inflammation lead indirectly to DNA damage by triggering the production of chemicals known as reactive oxygen species, which cause oxidation of DNA, but this study ruled out a role for oxidation.

Although most DNA breaks were repaired efficiently by the cell when H. pylori was eliminated by antibiotics, continuous exposure of human gastric cancer cells for 48 hours or longer appeared to flood the DNA-repair machinery. “DNA damage followed by potentially imprecise repair…may contribute to the genetic instability and frequent chromosomal aberrations that are a hallmark of gastric cancer,” the study authors wrote.

Dr. Richard Peek of Vanderbilt University Medical Center, whose research focuses on the role of H. pylori in gastric cancer, commented, “These findings suggest that therapies directed at reducing inflammation, without concomitant elimination of H. pylori, may not be effective in preventing DNA damage that develops in response to this pathogen.”

A Conversation With

A Conversation with Dr. Ted Trimble on NCI's Center for Global Health

Dr. Ted TrimbleDr. Ted Trimble

Dr. Ted Trimble was recently named director of NCI's Center for Global Health, which was created earlier this year. Dr. Trimble was previously head of Gynecological Cancer Therapeutics in the Division of Cancer Treatment and Diagnosis (DCTD). NCI Director Dr. Harold Varmus cited Dr. Trimble's leadership role in the trans-NCI International Clinical Trials Collaboration Working Group and other global health experiences as important to developing the new center.

Why was the NCI Center for Global Health created?

The burden of cancer is felt worldwide and is expected to grow larger in the coming years. In 2008, approximately 7.6 million people died from cancer worldwide, and 64 percent of these deaths occurred in developing countries. These numbers are up from 2002, and by 2030 the number of cancer deaths may rise as high as 13.2 million, with 69 percent occurring in developing countries.

Global health issues have been a high priority for Dr. Varmus since he was NIH director, and the same is true for current NIH Director Dr. Francis Collins, who made global health one of his top five priorities at NIH. When Dr. Varmus returned to NIH in July 2010 to lead NCI, creating the Center for Global Health was on his short list of things to do. He has spent a lot of time talking to people inside and outside of NIH about how best to structure the center.

Directing the center is an exciting opportunity for me. The center can help NCI partner with our sister NIH institutes to build on the great work that's been done in terms of controlling infectious diseases and to expand the range of NCI's research globally in epidemiology and cancer genetics. We'll also be looking at how we can deliver cancer care, prevention, and screening interventions more effectively around the globe.

How does your background prepare you for this new leadership role?

Because of my responsibilities in DCTD, I became aware of the increasing need for international collaboration on clinical trials. In order to study these diseases as quickly as possible, we needed larger sample sizes and more patients, and we needed to build on the investments in research infrastructure that other countries are making, in addition to the clinical trials infrastructure we've built in the United States. This remains true for studying common and rare cancers.

You will need Adobe Flash Player 8 or later and JavaScript enabled to view this video.

A video of the director of NCI’s Center for Global Health, discussing how NCI is coordinating research and working with partners to address the burden of cancer worldwide.

At about the time that Dr. Collins arrived as NIH director, I discovered, in conversations with clinical trials staff at the National Heart, Lung, and Blood Institute (NHLBI) and the National Institute of Allergy and Infectious Diseases (NIAID), that staff at those institutes and NCI were encountering many of the same problems in our work. As a result, my NHLBI and NIAID colleagues and I put together an informal working group of the three institutes, the three largest NIH institutes with the largest international footprints. Our informal working group is now a subcommittee of Dr. Collins' Trans-NIH Global Health Research Working Group.

As part of these efforts, we've worked closely with the European Science Foundation and the European Medical Research Councils to help them identify some of the problems they've had with their Clinical Trials Directive in Europe, which have stymied academic research in Europe and trans-Atlantic collaboration.  We've also worked with the Organization for Economic Cooperation and Development. We hope our work will get national governments around the world to realize that they have to support the building of clinical trials infrastructure and undo some of the red tape that exists.

I have also traveled the world representing NCI over the past several years to try to figure out how we can implement widespread human papillomavirus vaccination and improve screening and treatment for cervical cancer. I've talked with people outside the United States, at the World Health Organization (WHO), WHO regional offices, the Union for International Cancer Control, and the International Agency for Research on Cancer (IARC). In the process, I've gained perspectives on where things stand with global control of cervical cancer, which is the second or third leading cause of cancer death for women in many developing countries.

How does the new center differ from NCI's previous approaches to international collaboration?

NCI has done a lot globally in the past, but these efforts have been spread across the institute. We haven't done as good a job as we might have done in coordinating those efforts. Nor have we learned, across NCI, about the best ways to work with other countries' ministries of health to, for example, transport biospecimens across borders, address intellectual property issues, or address informed consent issues. Each NCI division was forced to invent the wheel for itself when trying to set up international research collaborations.

NCI's Office of International Affairs and, more recently, the Office of Latin American Cancer Program Development have helped with these challenges. However, there wasn't a coordinating office for all of these activities so we could share information. 

Nor was NCI looking at what other NIH institutes were doing internationally that NCI could build upon. For example, in the developing world at least 20 percent of cancers are related to infectious disease, so there is a great opportunity for NCI to collaborate with our colleagues at NIAID. We really haven't had a coordinated effort to look for synergies like that until now.

Cancer Prevention and Control a Key Focus at United Nations Meeting

NCI and a number of other federal agencies are participating this week in a high-level meeting of the United Nations General Assembly on noncommunicable diseases. The goal of the meeting in New York is to address the prevention and control of noncommunicable diseases worldwide, including many cancers. Participants are focusing on developmental and other challenges, as well as social and economic impacts, particularly for developing countries.

More information about the meeting and this worldwide effort can be found online.

We're also excited about the opportunity to work with the Centers for Disease Control and Prevention (CDC). CDC Director Dr. Thomas Frieden has a new initiative to help promote control of noncommunicable diseases internationally. NCI can work well with CDC in this area, and Dr. Varmus and Dr. Frieden have spoken extensively about how our organizations can work together on control of infectious diseases linked to cancer, as well as other risk factors like obesity and tobacco use.

What are the goals of the Center for Global Health?

First, we want to coordinate NCI's international activities internally. The center will provide support to the other NCI divisions, offices, and centers (DOCs) as they conduct international projects. In addition, the center will work with the DOCs to help develop new scientific initiatives in global health.

Dr. Varmus and I also want the center to strengthen NCI's dialogue with other NIH institutes and centers, particularly the Fogarty International Center. We want to help develop a global cancer research strategy with the CDC, nongovernmental organizations, and universities and cancer centers that have strong global health programs. We also plan to work with the WHO and its regional offices and IARC to coordinate global health programs for cancer control.  As part of that effort, Dr. Varmus is attending the United Nations' High-Level Meeting on Noncommunicable Diseases, which is the first time that the UN General Assembly has focused on health issues other than HIV/AIDS. (See the sidebar for more about the meeting.)

In addition, the center will work with pharmaceutical and biotechnology companies to help develop new, inexpensive diagnostic tools and figure out how to make novel cancer therapeutics available in a cost-effective manner to people in low- and middle-income countries.  

What specific global initiatives will NCI and the new center launch in the next year or so?

Dr. Varmus has charged the center with sitting down with our colleagues in the DOCs to determine where there are gaps in NCI's global health research portfolio and come up with some initiatives. I don't anticipate that the center, on its own, will be sponsoring those projects. We would need to do it in partnership with the NCI DOCs or with Fogarty and other NIH institutes.


Spotlight

In Breast Cancer, Moving Toward More Personalized Hormone Therapies

After treatment for early-stage breast cancer, many postmenopausal women with estrogen-receptor positive tumors decide to take drugs, such as an aromatase inhibitor or tamoxifen, to prevent or delay a recurrence of their disease. Selecting which treatment strategy may be best for the individual patient is difficult, in part because there is conflicting scientific evidence.

Guidelines, such as those from the American Society of Clinical Oncology, suggest that all post-menopausal women should receive an aromatase inhibitor either alone or before or after tamoxifen, but they do not suggest an optimal approach.

As oncologists, we always focus on preventing cancer from recurring, but it is important to look at other causes of morbidity and mortality in our patients.

—Dr. Shannon Puhalla

Clear recommendations may eventually come from ongoing clinical trials. In the meantime, a new study suggests doctors should consider the potential side effects of the drugs as well as a patient's health history when making a selection.

The study, published in the September 7 Journal of the National Cancer Institute (JNCI), largely confirmed what is known about these drugs. Compared with tamoxifen, the longer use of aromatase inhibitors was associated with higher rates of heart disease and bone fractures but with lower rates of blood clots and endometrial cancer.

Aromatase inhibitors and tamoxifen, often referred to as adjuvant hormonal therapies, are designed to interfere with the body's production of estrogen and the promotion of breast tumor growth by estrogen, respectively. Estrogen is a naturally occurring hormone that can contribute to the growth of breast cancer.

The new findings highlight the need for physicians to select a therapy based on more than its ability to prevent a recurrence of breast cancer, the study authors said.

"Because the risks of these adjuvant therapies are relatively low, physicians don't spend a lot of time thinking about side effects," said lead investigator Dr. Eitan Amir of the Princess Margaret Hospital in Toronto. But there are clearly serious side effects associated with both approaches, he continued, noting that doctors should be able to identify patients at risk for some of these toxicities before selecting therapies.

"Don't Ditch the Switch"

Based on an analysis of seven clinical trials using these antihormonal therapies, the researchers concluded that switching from one type of therapy to another could offset the potential cumulative side effects of individual drugs and allow many women to experience the maximum benefits with lower side effects.

"We know that the one-size-fits-all approach does not work for every woman," said Dr. Shannon Puhalla of the University of Pittsburgh Cancer Institute, who co-authored an accompanying editorial entitled "Adjuvant Endocrine Therapy for Breast Cancer: Don't Ditch the Switch."

"As oncologists, we always focus on preventing cancer from recurring, but it is important to look at other causes of morbidity and mortality in our patients," Dr. Puhalla continued. As she and her co-authors wrote in the editorial, the field needs a risk model that can help clinicians select the most appropriate treatment for an individual.

This study provides further validation that both of these options are very good for patients.

—Dr. Tito Fojo

The current study, she added, "is a first step in trying to personalize hormonal therapies."

Serious side effects from adjuvant hormonal therapies are rare but may occur more frequently in patients with certain health conditions, such as a history of heart problems, the researchers said. 

"This study provides further validation that both of these options are very good for patients," said Dr. Tito Fojo of NCI's Center for Cancer Research, who was not involved in the research. "So it becomes incumbent on the doctor to think about toxicities and about which drug is best for an individual patient."

An Aromatase Inhibitor Puzzle

Clinical trials have shown that, compared with tamoxifen, aromatase inhibitors are better at delaying the time until disease recurs (disease-free survival or recurrence-free survival). But none of the trials has demonstrated improved overall survival for aromatase inhibitors.

The researchers hypothesized that the cumulative toxicity of aromatase inhibitors may lead to deaths from causes other than breast cancer. They tested their hypothesis by assessing the risks of six adverse events associated with therapies used by more than 30,000 women to interfere with cancer growth-promoting hormones.

The analysis suggested that the cumulative toxicity of aromatase inhibitors, when used as a first-line treatment, may explain the lack of an overall survival benefit despite improvements in disease-free survival.

Dr. Amir stressed that the findings should be considered preliminary and need to be validated. In the meantime, information about the potential risk of side effects should be clearly communicated to patients, he said.

"The key is to provide a more holistic assessment of the patient not just for preventing breast cancer, but also as it relates to the side effect profiles of drugs," Dr. Amir added.

Edward R. Winstead

A Closer Look

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This article is part of a series of stories related to cancer communications. You can read more articles in the series here.

Unpublished Phase III Cancer Trials: Eliminating the Negative?

Stack of peer-reviewed medical journalsMany phase III clinical trials with negative or inconclusive results are never published in peer-reviewed journals, contributing to publication bias.

Phase III clinical trials are the "gold standard" in oncology research, providing the highest level of evidence to support the effectiveness of cancer treatments. These trials usually involve hundreds of patients at multiple sites, cost millions of dollars, and take years to complete. Most important, the published results of a phase III trial can substantially change the standard of care for a particular tumor type or stage of disease.

The American Society of Clinical Oncology (ASCO) annual meeting, the largest meeting of its kind for oncologists, often provides a "first look" at potentially practice-changing clinical trial results, which are subsequently fleshed out in reports published in peer-reviewed journals.

A new study finds, however, that results of nearly one in ten phase III trials presented in abstract form at the ASCO annual meeting remained unpublished more than 6 years later. Most of these unpublished trials, involving more than 23,000 cancer patients, had negative or inconclusive results—that is, they failed to show that the experimental treatment under study was superior to the standard or control treatment.

Publication Bias

Previous studies have shown that clinical trials with positive results—trials that find the treatment being tested to be superior to the standard or control treatment—are more likely to be published than trials with negative or inconclusive results, said Dr. Monika Krzyzanowska of Princess Margaret Hospital in Toronto, senior author of the study published in the Journal of Clinical Oncology in August. Such selective publication of positive research findings is known as publication bias.

"When trials with negative results aren't published, the benefits of treatment may be overestimated and patients may be harmed because of inappropriate treatment decisions," said Dr. Krzyzanowska.

In a previous study, Dr. Krzyzanowska and her co-authors found that 26 percent of the 510 phase III trials presented as abstracts at the ASCO annual meeting between 1989 and 1998 were not published in full within 5 years after presentation. In the current study, the researchers expanded their analysis to include 709 phase III trials presented at the ASCO annual meeting between 1989 and 2003.

"Negative results can be just as important as positive results," said Dr. Jeff Abrams, director of NCI's Cancer Therapy Evaluation Program. "When negative findings don't become part of the scientific literature, other researchers may go down the wrong path, spending time on duplicative studies because they don't realize that approach was tried and was unsuccessful."

Important Questions

Most of the unpublished trials were of therapies for breast, gastrointestinal, hematologic, or lung cancer. A majority addressed an important clinical question and might have affected clinical practice had they been published in a timely fashion, according to oncologists specializing in those cancers, whom the investigators asked to evaluate the trial abstracts.

It's a disservice to science not to publish studies that are inconclusive or negative.

—Dr. Jeff Abrams

The specialists' opinions are subjective, acknowledged Dr. Krzyzanowska. "It is challenging to retroactively assess the potential clinical impact of trials that in some cases were performed 15 or more years ago," she said.

Investigators involved in the unpublished trials most frequently cited a lack of time, funds, or other resources as the reason for not publishing the results. Some said a report of the trial had been submitted for publication but rejected.

Nonpublication of clinical trial results "breaks an implicit contract" between investigators and patients, who are motivated to enroll in a trial at least in part by the belief that their participation will advance scientific knowledge. It also breaches trust between investigators and funding agencies, which may adversely affect funding for future clinical trials, Dr. Krzyzanowska and her colleagues wrote.

"The term 'negative' is a psychological barrier to getting results published," said Dr. Bjorn R. Olsen of Harvard Medical School, who is editor-in-chief of the Journal of Negative Results in Biomedicine, an open-access, peer-reviewed online journal. "Journal editors and reviewers are looking for results that they believe will move the field forward." Papers reporting negative findings may be rejected for publication because reviewers or editors attribute the findings to weaknesses in the study design or execution, he added.

Trial Registration

Since 2007, all clinical trials initiated at one or more sites in the United States (except for phase I trials) by law must be registered in ClinicalTrials.gov, a publicly available database. Since 2008, trial sponsors must submit a summary of the trial's results to ClinicalTrials.gov within a year of the trial's completion.

These requirements will help ensure that, even if a trial's results are not published in a peer-reviewed journal, a summary of the findings will be available to researchers, patients, and the public, explained Dr. Abrams.

A journal dedicated to publishing negative results specifically in oncology might also be part of the solution, according to Dr. Krzyzanowska. Dr. Abrams, however, questioned whether a journal focused on negative results would attract readers. A better approach, he suggested, might be to encourage medical journals to publish brief reports of negative trials. This would offer an incentive to investigators who would likely not be motivated to spend time writing full-length reports of negative trials that they believe are unlikely to be published. These brief reports would provide more information about the trials than is available in an abstract.

"It's a disservice to science not to publish studies that are inconclusive or negative," said Dr. Abrams.

Eleanor Mayfield

Delayed Publication: How Long is Too Long?

In addition to trials that remained unpublished 6 years after being presented as abstracts at the ASCO annual meeting, Dr. Krzyzanowska and her colleagues found another 13 percent of trials were published after a delay of 5 years or more from the time of their presentation.

The impact trial results have on practice depends on their being published in a timely fashion, she explained.

"A 250-word abstract touches only briefly on a trial's key results—and those results may evolve between presentation of the abstract and publication of the final manuscript," said Dr. Krzyzanowska. "Many clinicians and funding agencies wait to see the published paper, which not only provides more detailed information about the study but also has been rigorously peer-reviewed."

When an abstract presents interim study results, delayed publication is understandable because time is needed for the data to mature, Dr. Krzyzanowska commented. "For mature studies, most people would agree that, if your goal is to influence practice, a delay of 5 years or more from presentation of an abstract to publication of the full results is too long."

Featured Clinical Trial

Studying the Natural Course of Precursor Conditions to Multiple Myeloma

Name of the Trial
Natural History Study of Monoclonal Gammopathy of Undetermined Significance (MGUS) and Smoldering Myeloma (SMM) (NCI-10-C-0096). See the protocol summary.

Dr. Ola Landgren Dr. Ola Landgren

Principal Investigator
Dr. Ola Landgren, NCI Center for Cancer Research

Why This Trial Is Important
Multiple myeloma is a rare type of cancer in which abnormal plasma, or myeloma, cells collect in the bone marrow and other soft tissue. These abnormal cells can form tumors that damage bone directly. They also produce large amounts of antibodies, known as M proteins, that may collect in and impair the function of the bone marrow and other organs of the body, causing problems such as hypercalcemia, anemia, and organ damage. This disease is currently incurable, and most patients succumb within 3 to 4 years of diagnosis.

Multiple myeloma is preceded by one of two precursor conditions called monoclonal gammopathy of undetermined significance (MGUS) and smoldering multiple myeloma. Both of these conditions are characterized by varying levels of M protein in the blood and/or urine and of plasma cells in the bone marrow. They are distinguished from multiple myeloma by the absence of symptoms. MGUS and smoldering myeloma are usually diagnosed via blood or urine tests for unrelated conditions or as part of a routine physical exam.

MGUS is found in about 3 percent of Caucasian Americans over the age of 50 and is even more prevalent in African Americans, but the vast majority of people with MGUS will never develop multiple myeloma. The risk of progressing to symptomatic multiple myeloma is much greater for those diagnosed with smoldering myeloma: about 10 percent per year progress in the first 5 years following diagnosis. Most of what is known about the progression of these precursor conditions comes from retrospective studies, which may not accurately reflect their true nature. To more accurately characterize the risk and clinical course of these conditions, including defining which patients are more likely to progress and why, prospective studies are needed.

In the current study, doctors at NCI will examine people previously diagnosed with MGUS or smoldering myeloma when they enroll in the study, after 6 months, and every 12 months for up to 5 years. At the beginning and at the end of the study, a bone marrow aspiration and biopsy will be done to characterize the molecular status of the bone marrow. The doctors may collect blood and urine samples and conduct various imaging studies, possibly including a skeletal survey of the head, torso, and upper arms and legs. The researchers hope to determine whether any risk factors or molecular markers can be identified that reliably predict which people will progress to full-blown multiple myeloma.

"All patients who develop multiple myeloma go through a precursor phase of asymptomatic disease, so if we can catch the disease at that point, there may be a possibility of curing it," said Dr. Landgren. "Therefore, it's very important to identify the molecular profiles of those people who progress from MGUS or smoldering myeloma and those who don't.

"Study participants will receive a very extensive clinical work up when they first arrive at NIH, more than would normally be done at a community clinic, and they will undergo thorough testing every year thereafter," Dr. Landgren added. "If a patient progresses during the course of the study, he or she can either go back to their local doctor for treatment or we can offer therapy at the NIH through clinical trials. Additionally, patients with smoldering myeloma may be eligible to participate in both this natural history study and an ongoing clinical trial testing a novel therapy for smoldering myeloma."

Dr. Landgren's team has also developed advanced molecular imaging studies for MGUS and smoldering myeloma patients. "Patients with either MGUS or smoldering myeloma enrolled in the natural history study may be eligible to also participate in an imaging clinical trial designed to rule out evidence of previously undetected early bone disease."

For More Information
See the lists of entry 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/featured.

Community Update

Researchers Discuss State of the Science on Myelodysplastic Syndromes

Abnormal platelet-producing bone marrow cells in a patient with myelodysplastic syndrome. (Image courtesy of the Armed Forces Institute of Pathology) Abnormal platelet-producing bone marrow cells in a patient with myelodysplastic syndrome. (Image courtesy of the Armed Forces Institute of Pathology)

The National Heart, Lung, and Blood Institute (NHLBI) and NCI recently held a state-of-the-science symposium on myelodysplastic syndromes (MDS) to identify areas of research where investment would improve understanding of these diseases and accelerate the development of better treatments.

MDS is a set of rare diseases in which a patient's bone marrow does not make enough healthy red or white blood cells, leading to severe anemia and infections. In about 30 percent of patients with MDS, the condition eventually progresses to acute myelogenous leukemia (AML), but the genetic changes driving this transformation—as well as those leading to the inevitable worsening of MDS in patients whose disease does not progress to AML—are not well understood.

Dr. Susan Shurin, acting director of NHLBI, described the symposium as a "call to action" to better understand the biology and environmental factors that cause MDS in order to develop new therapies. Participants came from many countries, reflecting "how global a research endeavor the whole area of MDS and bone marrow failure is," said Dr. Shurin. A common theme of the meeting was that international collaboration is vital for MDS research because the diseases are relatively rare.

Speakers at the symposium described what is and what isn't understood in the field of MDS, including how best to treat patients given the limitations of available therapies, the biology and pathophysiology of MDS, and the complex genetic and epigenetic factors driving this set of diseases.

A Complex Disease

Researchers recognized long ago that MDS is genetically complex—patients whose bone marrow cells have identical chromosomal abnormalities can have very different clinical outcomes. But until 3 or 4 years ago, said Dr. Pierre Fenaux of the Hôpital Avicenne University in France, perhaps only three genes were known to play a role in driving MDS.

In the past few years, he continued, the availability of microarrays and high-throughput genetic sequencing has helped experts identify more of the genes found within the most common chromosomal abnormalities in MDS, including those that affect the epigenetic state of cells.

Researchers speaking at the conference expressed hope that having a more complete genetic and epigenetic profile of MDS will help them design new treatments to target specific abnormalities, as well as improve upon current systems for determining prognoses.

Speakers also highlighted areas of current uncertainty: whether MDS is driven by "MDS stem cells," similar to the cancer stem cells postulated to drive leukemia; whether, in some cases, the bone marrow microenvironment or immune system might promote MDS; the role of microRNAs in MDS initiation and progression; and the difference between idiopathic MDS and MDS caused by chemical exposures, such as some chemotherapy drugs (secondary MDS or treatment-induced MDS).

International collaboration is vital for MDS research because the diseases are relatively rare.

The cellular events that cause disease initiation and progression—and that are, therefore, targets for treatment—may be different for MDS that progresses to AML and MDS that is characterized by worsening blood cell counts (cytopenias), said Dr. Sten Eirik W. Jacobsen of the University of Oxford. The conference participants advocated the importance of studying MDS as a set of distinct diseases.

Funding Priorities

Several areas that would likely benefit from focused funding emerged from the many discussion sessions. One of these, outlined by University of New Mexico Cancer Center Director, Dr. Cheryl Willman, is an urgent need for high-quality tissue banks containing biospecimens and the appropriate control specimens for genetic and epigenetic studies that are well-annotated and compiled with proper patient consent. Dr. Willman's research group at the University of New Mexico has helped to assemble such a tissue bank for NCI's Therapeutically Applicable Research to Generate Effective Treatments (TARGET) initiative.

Such a resource is necessary to build a complete biological profile of MDS, including genetic mutations, epigenetic alterations, bone marrow microenvironments, and fates of healthy blood-forming stem cells as disease progression occurs, the speakers said. Better MDS cell lines and more mouse models would also help researchers working to understand the basic mechanisms of these diseases.

The clinical significance of any genetic mutations or epigenetic alterations discovered in MDS will need to be validated in large prospective populations, which will require funding and collaboration. Clinical trials testing new treatments for MDS based on genetic information may need to be restricted to include only patients with the genetic profiles thought to potentially benefit from a new treatment, suggested Dr. Guillermo Garcia-Manero of the University of Texas M. D. Anderson Cancer Center.

And the focus of any research must be to move closer to new treatments, stressed many participants, as few currently exist. The available drugs only slow progression for several months to years, and the only potentially curative treatment—allogeneic stem cell transplantation (SCT)—is a high-risk procedure. Most patients with MDS are older than 70 and have other medical problems, stressed Dr. Garcia-Manero, making SCT an option for relatively few.

"With the great tools [we now have for research], if we had the right resources and the right infrastructure, I think we could really make a huge difference," summarized Dr. Steven D. Gore of Johns Hopkins University.

Sharon Reynolds

FDA Update

Health Officials Issue Statement on Drug Shortages

Following a September 9 meeting of stakeholders to discuss solutions to the national drug shortages, Food and Drug Administration (FDA) Commissioner Dr. Margaret Hamburg and Assistant Secretary for Health Dr. Howard Koh issued a statement expressing their commitment to minimize drug shortages, protect patients, and identify solutions to “this serious problem.”

The FDA is analyzing the problem and will release a report with recommendations. One suggestion is a mechanism for manufacturers to report impending supply disruptions and discontinuation of drugs, which could help to curb drug shortages and improve the continuity of the drug supply.

The FDA is working with drug manufacturers to counteract the shortages. For example, the agency is expediting requests to qualify new manufacturing sites, new production lines, and new raw material suppliers to avert shortages.

“There is no quick solution that solves this critical public health issue; addressing it will require a multifaceted approach,” wrote Drs. Hamburg and Koh. “All parties involved in the supply of drugs to Americans have a responsibility to make sure patients have access to the drugs they need.”

Discussion of the drug shortages will continue at the FDA’s public meeting on September 26. 

Additional information on this topic can be found on the FDA drug shortage website.

Further reading: “Continued Shortage of Chemotherapy Drugs Causing Concern

Cancer Therapies Office Reorganized

The Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) announced the reorganization of its Office of Oncology Drug Products last week. The reorganized and renamed Office of Hematology and Oncology Products (OHOP) now consists of four divisions organized primarily by disease site.

The Division of Oncology Products 1 is responsible for reviewing therapies for breast, gynecologic, and genitourinary cancers, as well as supportive care for nonhematologic cancers.

The Division of Oncology Products 2 is responsible for reviewing therapies related to gastrointestinal, lung, head and neck, neurologic, and rare cancers, as well as pediatric solid tumors, melanoma, and sarcoma.

The Division of Hematology Products is responsible for adult and pediatric blood cancers, and the Division of Hematology Oncology Toxicology will review nonclinical pharmacology and toxicology issues related to cancer therapies.

OHOP will be directed by Dr. Richard Pazdur, who headed the Office of Oncology Drug Products. The reorganization “aligns FDA with the organizational structure of leading cancer treatment centers, academic programs, and the National Cancer Institute,” Dr. Pazdur said in a news release. The reorganization is expected to lead to “greater efficiencies” in the review process of cancer therapies, added CDER Director Dr. Janet Woodcock.

Cancer.gov Update

NCI Recovery Act Website Highlights Training in Comparative Effectiveness Research

Screenshot of a story on NCI's American Recovery and Reinvestment Act at NCI website

NCI's American Recovery and Reinvestment Act (ARRA) website features a new article highlighting how ARRA funding is creating opportunities for academic research institutions to train and build interdisciplinary teams of scholars to pursue comparative effectiveness research (CER). This area of research is of growing importance to public health, particularly oncology.

Although there have been remarkable advances in cancer detection and treatment, it is important to understand which screening, treatment, and management options may be most effective in specific patient populations. CER provides a relevant framework to assess the impact these options have in real-world settings.

The Recovery Act-funded KM1 CER Mentored Career Development Awards provide health care professionals pursuing CER with the tools and training necessary to improve the care and treatment of cancer patients.

Notes

Appointments Announced for Two New NCI Centers, Division of Cancer Prevention

This fall, three leaders in cancer research will begin their tenures at NCI's new Center for Cancer Genomics, the new Center for Global Health, and the Division of Cancer Prevention.

 

Dr. Barbara Wold Dr. Barbara Wold
Dr. Barbara Wold, a renowned geneticist, director of the Beckman Institute and professor of Molecular Biology at the California Institute of Technology (Caltech), began leading the Center for Cancer Genomics on September 1. During her year of leave from Caltech, Dr. Wold will help build the new center, whose flagship program is The Cancer Genome Atlas (TCGA), and incorporate many other NCI-sponsored genomics initiatives.

 

Dr. Ted Trimble Dr. Ted Trimble
Dr. Ted Trimble has spent several months organizing the Center for Global Health and will be its first permanent director. Dr. Trimble is well known to NCI from his long tenure in the Division of Cancer Treatment and Diagnosis, and he will work with parties within and outside of NIH to integrate cancer into the field of global health.

 

Dr. Barry Kramer Dr. Barry Kramer
Beginning in October, Dr. Barry Kramer will become the new director of NCI's Division of Cancer Prevention (DCP). Dr. Kramer is a leading expert in cancer prevention, serves as editor-in-chief of the Journal of the National Cancer Institute and NCI's Physician Data Query (PDQ) Screening and Prevention Editorial Board. He is a member of NCI's PDQ Adult Treatment Editorial Board and formerly headed the NIH Office of Disease Prevention.

 


NCI's Norm Coleman Wins Service to America Medal

Dr. Norm Coleman Dr. Norm Coleman (Photo by Sam Kittner)
Dr. Norm Coleman, associate director of NCI's Radiation Research Program, received the 2011 Samuel J. Heyman Service to America Medal for Homeland Security at a ceremony in Washington, DC, last week. Dr. Coleman was awarded the medal for developing a plan to deal with the health consequences of a radiological or nuclear incident in the United States and for helping the Japanese government respond to radiation from the Fukushima power plants damaged by the March 2011 earthquake and tsunami.

The emergency response plans that Dr. Coleman and his team use are built from the best available science. The team works with NCI and the Centers for Medical Countermeasures Against Radiation in the National Institute of Allergy and Infectious Diseases. They rely on advanced development support from the Department of Health and Human Services' Office of the Assistant Secretary for Preparedness and Response. This builds on the concept of "dual-utility" so that investments in cancer research and emergency response benefit one another.

The Partnership for Public Service, a nonprofit, nonpartisan organization, awards Service to America Medals annually to outstanding federal employees who have made a significant contribution to the United States. The Homeland Security Medal is given to a federal employee who has met a critical national need in areas including emergency preparedness and response, border enforcement, transportation security, intelligence, and law enforcement.

To see a video of Dr. Coleman discussing his work, click here.

Director's Consumer Liaison Group Meets this Week

The NCI Director's Consumer Liaison Group (DCLG) will meet September 21–23 in Washington, DC. The agenda includes presentations on how scientific advances are changing clinical cancer research, clinical trial design, and the co-development of diagnostic and therapeutic interventions.

The DCLG provides advice to the NCI director on promoting research outcomes that are in the best interest of cancer patients. DCLG activities focus on identifying new approaches, promoting innovation, recognizing unforeseen risks or barriers, and identifying unintended consequences that could result from NCI decisions or actions. DCLG also provides insight into enhancing input, optimizing outreach, and promoting strong collaborations, all with respect to nonscientist stakeholders.

NCI, HHS Launch Mobile Services to Help Smokers Quit

As part of a series of new e-health initiatives guided by the Department of Health and Human Services (HHS) Text4Health Task Force, NCI is launching the SmokefreeTXT program, a mobile service designed to help teens and adults quit smoking. Teens and adults can enroll in this program online.

NCI is also launching QuitNowTXT, a library of interactive text messages to help U.S. adult smokers quit. The QuitNowTXT text messages offer tips, motivation, encouragement, and fact-based information.

These tobacco control message libraries, along with other libraries (smoking cessation for pregnant women, early childhood health, emergency response, etc.) will be available to the public on healthdata.gov in the future.

HHS announced the SmokefreeTXT text messaging service and the availability of the QuitNowTXT library at the United Nations Meeting on Noncommunicable Diseases on September 19.