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Data Must Be Generated to Support Cross-Labeling of Combination Therapies for Cancer

Combinations of targeted therapies (triple, quadruple, or even more) are part of the future of cancer treatment, which means that traditional clinical trials will have to be streamlined and updated to enable greater flexibility and to extract adequate safety and efficacy data. Problems inherent in...

issues in oncology

FDA Helps Streamline Approval Process for Supplemental Drug Indications

As researchers learn more about the natural history of cancers, as more drugs are effective for more types of the disease, and as the number and complexity of combination therapies increase, the more important it is that new drugs and permutations of old ones be available to patients. The U.S. Food ...

supportive care

Engaging Patients in Value-Based Care

Turning the Tide Against Cancer is an annual conference sponsored by the Personalized Medicine Coalition, American Association for Cancer Research (AACR), Feinstein Kean Healthcare, and CancerCare. Margaret Foti, PhD, MD (hc), AACR Chief Executive Officer, introduced the proceedings for the 2017...

issues in oncology
health-care policy

Accelerating Pediatric Drug Development: Master Protocols May Be a Way to Go

Development of pediatric cancer drugs has long lagged behind adult drug development for two major reasons: The process is more difficult, and childhood cancer is rarer by far than adult cancer. These and other phenomena in pediatric oncology were the subject of a workshop held by the Friends of...

issues in oncology

Friends of Cancer Research Rethinks Traditional Clinical Trials

Ellen V. Sigal, PhD, Chair and Founder of Friends of Cancer Research (Friends) began the annual meeting with a conversation with Douglas R. Lowy, MD, National Cancer Institute (NCI) Acting Director, and Robert M. Califf, MD, U.S. Food and Drug Administration (FDA) Commissioner. “Cancer research is ...

issues in oncology
cost of care

Understanding Biosimilars and Their Impending Role in Oncology Care

Biosimilars are among the newest threads in the fabric of cancer treatment in the United States, and they are spawning numerous questions for oncologists and patients with cancer. Many of these questions were taken up by participants in a recent Washington forum on “The Future of the U.S....

health-care policy
legislation

AACR Holds Congressional Briefing to Reiterate Moonshot Goals and Plans

“We are in an era of unprecedented scientific opportunities in cancer research,” said Margaret Foti, PhD, MD (hc), Executive Officer, American Association for Cancer Research (AACR), as she introduced the Congressional briefing, “Seizing Today’s Opportunities to Accelerate Cancer Research.” “Thanks ...

lung cancer

Lung Cancer Screening: Beneficial for Certain Populations but Not Without Controversy

The National Cancer Policy Forum of the National Academies of Sciences took up the issue of lung cancer screening at its mid-June workshop. Greta Massetti, PhD, Associate Director for Science, Division of Cancer Prevention and Control, Centers for Disease Control and Prevention (CDC), and chair of ...

issues in oncology
health-care policy

Road to Successful Use of Real-World Evidence for Drug Development Is Long and Rocky

Friends of Cancer Research (Friends) has been a leader in the push for better and faster cancer drug development. Now it is tackling the use of real-world evidence in clinical trials. This is the report of a meeting on the subject that took place on June 16 in Washington, DC.1 Real-world evidence...

issues in oncology

Breakthrough Therapy Efforts Result in Unprecedented Success

Friends of Cancer Research (Friends) and the U.S. Food and Drug Administration (FDA) have been working together for many years on an idea known as breakthrough therapy, and it has produced results beyond anyone’s hopes. Said Ellen Sigal, PhD, Friends Chair and Founder, “When we were first talking...

issues in oncology

Friends of Cancer Research Encourages FDA to Modernize and Consolidate

“In order to take advantage of today’s advancements in science, drug development, and patient treatment, the U.S. Food and Drug Administration’s (FDA’s) structure needs reorganization to focus its resources and ensure the best outcomes for patients. Friends of Cancer Research (Friends) proposes...

issues in oncology

Immunotherapy Could Be the Wave of the Future, but Problems and Challenges Cannot Be Ignored

Immunotherapy is on its way. A few agents have already been approved: ipilimumab (Yervoy) in 2011 for melanoma; nivolumab (Opdivo) in 2015 for non–small cell lung cancer (NSCLC) and then later that year for renal cell carcinoma; and pembrolizumab (Keytruda) for NSCLC. In addition, many clinical...

health-care policy

Providing Perspective on Pressing Economic Issues Facing Cancer Care—Now and in the Future

CANCERSCAPE, the 2016 Annual Meeting of the Association of Community Cancer Centers (ACCC), provided a forum for about 300 attendees to gain insight into the complexities of oncology treatment, where “clinical advances, policy mandates, and value-based payment reform intersect.” Of particular...

issues in oncology

Research in Combining Targeted Agents Faces Numerous Challenges

If the clinical trials endeavor in oncology is falling short of its goals and if targeted agents have not kept their promise, can a new approach to drug development provide a solution? Very possibly, said John Hohneker, MD, Chair of the Workshop Planning Committee for the conference, “Facilitating...

issues in oncology
health-care policy

Congressional Hearing Highlights Oncology Drug Shortages

Some oncology drugs are in such short supply that the situation is now critical, with almost 200 drugs affected—triple that of 2003. This was the background described by speakers at a July 2011 congressional briefing sponsored by the Association of Community Cancer Centers (ACCC), ASCO, and other...

issues in oncology
health-care policy

Developing Targeted-agent Combinations: Business and Regulatory Issues, and Legal Obstacles

The Institute of Medicine’s National Cancer Policy Forum recently convened a public workshop, “Facilitating Collaborations to Develop Combination Investigational Cancer Therapies,” to address the promises and challenges involved in the development of combination oncologic drug therapies. In the...

health-care policy

AACR Urges Congress to Maintain, Preferably Increase, Cancer Research Funding

December 23, 2011, marked the 40th anniversary of the National Cancer Act. To mark that occasion, on February 2, the American Association for Cancer Research (AACR) held a Congressional briefing, attended by about 100 legislative aides, to remind Congress that the war on cancer is far from over....

issues in oncology

Cancer Informatics: A Future Necessity, but Challenges Abound

The National Cancer Policy Forum of the Institute of Medicine (IOM) recently convened a workshop on cancer informatics to examine and discuss needs and challenges facing biomedical researchers, which will in turn affect the way oncology is practiced in the future. “This is a time of huge scientific ...

health-care policy

ACCC Meeting Focuses on Affordable Care Act: Its Future, and What It Might Accomplish

The Association of Community Cancer Centers (ACCC) mid-March Annual Meeting devoted several sessions to the Patient Protection and Affordable Care Act: Will it still be here after the Supreme Court decides its fate? If so, how much of it will survive, and how will it affect oncology practice? In...

lung cancer
issues in oncology

After a Decade of Decline in Smoking Rates, Progress Has Stalled

Approximately 20% of all Americans smoke, and 443,000 of them will die each year as a result. Tobacco use is the leading cause of preventable death in the United States and the greatest behavioral determinant of morbidity and mortality (6%–10% of U.S. health-care costs). Nearly 30% of all cancer...

health-care policy

Expert Point of View: Frank McCormick, PhD

The ASCO Post asked AACR President Frank McCormick, PhD, Director, UCSF Helen Diller Family Comprehensive Cancer Center, about the ongoing problem of health-care disparities among minorities and other subpopulations. First, can the Patient Protection and Affordable Care Act lessen these...

AACR’s Cancer Progress Report 2012 Highlights Advances, Challenges, Opportunities

The American Association for Cancer Research (AACR) recently released its Cancer Progress Report for 2012,1 providing a snapshot of the major advances in cancer research, and highlighting the great need for continued funding for the field. “It is a new day for cancer research and cancer patients,” ...

Delivering Affordable Cancer Care: Is It Possible and What Will It Entail?

Many experts agree that at 18% of gross domestic product, health care (to paraphrase Shakespeare) is eating the country out of house and home. “The average cost of treating the most common cancers has increased, and as more expensive targeted therapies and other new technologies become the...

health-care policy
legislation

AACR Briefs Congressional Staffers on Importance of Continued Funding for Research 

As we all now know, the start of the sequestration prescribed by the Budget Control Act of 2011 was delayed until March 1, 2013, by the American Taxpayer Relief Act of 2012. With Congress unable to strike a deal, the mandatory reductions in Federal spending were triggered on March 1. Those...

health-care policy

Highlights of ACCC Annual Meeting Include Discussion of Trends Shaping the Future of Health Care 

The 39th Annual National Meeting of the Association of Community Cancer Centers (ACCC) was held in Washington, DC, in March. With a focus on business, economics, and policy, the program included the inauguration of a new ACCC President (see page 102), a keynote speech on the future of health care,...

health-care policy

Implementing a National Cancer Clinical Trials System for the 21st Century 

In March 2011, the National Cancer Policy Forum of the Institute of Medicine (IOM), in conjunction with ASCO, held a workshop to discuss a collaborative approach to making the National Cancer Institute (NCI)-funded clinical trials system more viable and productive. That workshop included...

hematologic malignancies
leukemia
multiple myeloma
issues in oncology

ACCC Institutes Network to Provide Assistance in Treating Uncommon Cancers 

Among the more than 200 types of cancer are those called “forgotten” or “orphan” cancers, with fewer than 40,000 new cases each year. They present treatment challenges in community cancer centers. Because of the low incidence of these diseases, such as chronic myeloid leukemia, acute promyelocytic ...

issues in oncology

Adolescents, Young Adults with Cancer Often Challenged By Unmet Needs Following Treatment 

About 70,000 adolescents and young adults (AYAs) between the ages of 15 and 39 are diagnosed with cancer each year, and in the past 30 years, there has been little or no improvement in survival in this population. In addition to the disease itself, they face many other challenges: reentry into...

health-care policy

National Cancer Policy Summit: Setting Priorities for the Next 3 Years

Welcome to the meeting we hold every 3 years to choose our next projects,” said John Mendelsohn, MD, Chair of the National Cancer Policy Forum and Director of the Khalifa Institute for Personalized Cancer Therapy at The University of Texas M.D. Anderson Cancer Center, Houston. “We have here a...

issues in oncology

Oncology Drug Dosing: Can an Optimal Dose Be Fine-Tuned for Each Patient?

ASCO Chief Medical Officer Richard L. Schilsky, MD, and other oncology drug experts presented a panel on drug dosing at a recent meeting, cosponsored by the Friends of Cancer Research and the Brookings Institution, in Washington, DC.1 The presentations made it clear that issues surrounding drug...

issues in oncology

Developing Intermediate Endpoints in Immunotherapy

“The immune system holds tremendous potential for long-term sustained antitumor activity,” said James P. Allison, PhD, Immunology Chair, The University of Texas MD Anderson Cancer Center, Houston, as he opened a panel discussion at a meeting cosponsored by the Friends of Cancer Research and the...

lung cancer

Activation of Innovative Lung Cancer Master Protocol Officially Announced, Enrollment to Begin in March

At a recent meeting in Washington, DC, Friends of Cancer Research and the Engelberg Center for Health Care Reform at the Brookings Institution officially announced activation of the Lung Cancer Master Protocol, a new research strategy that has the potential to hurdle or bypass known clinical trial...

issues in oncology

Informed Consent: Not Just About Blood Tests and Procedures Anymore

On February 24, the Institute of Medicine National Cancer Policy Forum convened a workshop, “Contemporary Issues in Human Subjects Protection in Cancer Research,” in Washington, DC. In his introduction to the workshop, Steven Piantadosi, MD, PhD, Director, Samuel Oschin Cancer Institute,...

pain management

Individualized Care Key to Cancer Pain Management at Sidney Kimmel Comprehensive Cancer Center

Learning about the particulars of each cancer patient’s pain and treating each case uniquely is the key to keeping pain manageable. That is the goal of the Duffey Pain and Palliative Care Program at The Sidney Kimmel Comprehensive Cancer Center in Baltimore. The team consists of physicians, nurse...

issues in oncology

Cancer Research Funding Still Tight—and Getting Tighter

Margaret Foti, PhD, MD (hc), CEO of the American Association for Cancer Research (AACR), welcomed about 150 congressional staffers to a March briefing in Washington, DC, with a plea for increased federal funding. “Extraordinary progress is being made in cancer research today, as evidenced by the...

issues in oncology

Project Data Sphere: Megadata in the Cloud Could Speed Clinical Trials Here on Earth

Project Data Sphere, which launched on April 8, is a “giant digital laboratory, an enormous library containing data about tens of thousands of patients and hundreds of clinical trials, all of which will be in the public domain,” said Martin J. Murphy, Jr, DMedSc, PhD, FASCO, Chief Executive Officer ...

issues in oncology

Expert Panels Offer Five Proposals to Address Challenges in Regulating, Implementing Next-Generation Sequencing

At the third annual Blueprint for Drug/Diagnostic Co-Development forum, cohosted by Friends of Cancer Research in Washington, DC, and the Alexandria Center for Life Science in New York, two panels tackled considerations in simultaneous development of drugs and companion diagnostics. Friends of...

issues in oncology

The Ohio State and Moffitt Collaborate on ORIEN: Using Big Data to Accelerate Trials With a Cancer Research ‘Expressway’

The Ohio State University Comprehensive Cancer Center and Moffitt Cancer Center have joined forces to create the Oncology Research Information Exchange Network (ORIEN), the largest collaboration of its kind designed to accelerate discoveries in cancer research. Members of this alliance of cancer...

issues in oncology
cost of care

Tackling the Complexity of Cancer: Finding Common Ground on Value and Progress

To kick off the second national Turning the Tide Against Cancer conference, sponsored by the American Association for Cancer Research, Personalized Medicine Coalition (PMC), and Feinstein Kean Healthcare, Edward Abrahams, PhD, President of PMC, noted that U.S. health-care costs are unsustainable...

health-care policy

Policy Issues in Molecularly Targeted Therapy: The Science, the Money, the Applications

In the past decade, much new knowledge about the molecular underpinnings of cancer has accumulated, and the array of molecular aberrations in each individual tumor can be assessed through genomic sequencing and other tests. The rationale for and feasibility of developing molecularly targeted...

supportive care

Childhood Cancers: Significant Medical Success but Many Psychosocial Needs Still Unmet

Treatment of childhood cancer is remarkably successful, but still, 2,000 children die of it each year, and for some forms of the disease, no progress has been made at all, said Otis Brawley, MD, Chief Medical Officer, American Cancer Society (ACS). “At least half of all pediatric cancer survivors...

Breast Imaging Reporting and Data System (BI-RADS)

The Breast Imaging Reporting and Data System (BI-RADS) is a standardized system to describe mammogram findings and results. Developed by the American College of Radiology (ACR), results of mammograms are sorted into categories numbered 0 through 6 with interpretation as follows: Category 0:...

breast cancer
issues in oncology

Assessing and Improving Imaging Interpretation in Breast Cancer Screening

The quality of mammography images has markedly improved over the past few decades. However, the quality of the interpretation of mammograms remains variable. That said, more than 38 million mammograms are performed annually in the United States. So said Diana Buist, PhD, Senior Scientific...

issues in oncology

Translational Research: Dogs and Humans Nearly Interchangeable in the Laboratory

“Between animal and human medicine there is no dividing line—nor should there be. The object is different but the experience obtained constitutes the basis of all medicine.” — Rudolf Virchow (1821–1902)   Everyone has seen photographs of people who look like their dogs: the young woman with long...

issues in oncology

New Techniques in Oncologic Surgery and Radiology: Some Worth the Expense, Some Not So Much

In recent years, patients with cancer have had the benefit of much high technology: proton-beam radiotherapy, intensity-modulated radiation therapy, various minimally invasive surgery techniques, and robots in the operating room. They all receive hype in the professional and public press, and...

geriatric oncology

Coping With Aging and Cancer: Psychosocial Factors and Geriatric-Specific Interventions

You can’t control the wind, but you can adjust your sails,” said Mindy Greenstein, PhD, consulting psychologist and author, to begin her talk at the 2015 World Congress of Psycho-Oncology, held in July in Washington, DC. The sense of this proverb pervaded the entire session on cancer and aging....

supportive care

Suicide After Cancer: Understanding the Challenges Across the Treatment Trajectory

Suicidal thoughts and impulses are among the most challenging symptoms in patients with cancer, and they may occur both during and after treatment. It has long been known that a cancer diagnosis carries an increased risk for suicide, but the problem is not widely addressed. Suicide is one of the...

International Psycho-Oncology Society and American Psychosocial Oncology Society Meet to Foster Psychosocial Oncology Worldwide

The International Psycho-Oncology Society (IPOS) has partnered with the American Psychosocial Oncology Society (APOS) for the 17th World Congress of Psycho-Oncology, held in late July 2015 in Washington, DC. Its theme, “From National to Global: Implementing the Standard of Psychosocial Care in...

issues in oncology

A Blueprint for Drug/Diagnostic Development: Expansion and Use of Curated Genetic Databases

In a continuation of a 2014 conference that explored regulatory considerations and strategies for next-generation sequencing, the Friends of Cancer Research, with support from Alexandria Real Estate Equities, Inc, Pasadena, California, met to discuss the issues and problems of coordinating drug and ...

issues in oncology
health-care policy

Cancer Care in Low-Resource Areas: Some Improvements Over the Years, but Serious Problems Remain

Low- and middle-income countries bear a larger share of the global cancer burden than does the developed world,” said Greta ­Massetti, PhD, Associate Director for Science, Centers for Disease Control and Prevention (CDC) Division of Cancer Prevention and Control and Co-Chair of the National Cancer...

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