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Showing 1 - 50Next-Generation Sequencing: New Technology That Requires Further Thought
Next-generation sequencing is used with increasing frequency to provide essential information about a patient’s diagnosis and treatment. In recent months, the U.S. Food and Drug Administration (FDA) has approved several new next-generation sequencing diagnostic tools, and the Centers for Medicare...
Real-World Evidence Gaining Credibility and Practicality in Treatment Evaluation
In a Friends of Cancer Research (Friends) meeting devoted to real-world evidence, members of the cancer community generally agreed that its use has an increasingly important role to play in gathering the data necessary to test, evaluate, and bring new therapeutic agents to market. This Friends...
Up-to-Date Labels for Older Drugs Essential for Appropriate Use
Oncology drug labels, especially those that have been on the market for more than 15 years, may not always be up-to-date. Critical data about safety, efficacy, or prescribing information may be missing. Modernizing the labeling process can correct inaccurate information, add data for indications ...
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...
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 ...
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...
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...
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 ...
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....
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 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 ...
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...
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...
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...
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...
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...
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...
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...
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...
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....
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 ...
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...
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...
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...
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...
SIDEBAR: Achievement Award
Jimmie C. Holland, MD, Wayne E. Chapman Chair in Psychiatric Oncology, Memorial Sloan-Kettering Cancer Center, received ACCC’s Annual Achievement Award for excellence in advocacy, dedication, and commitment to the care and treatment of patients with cancer. In her acceptance speech, Dr. Holland...
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,...
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...
The ASCO Post Up Close: Our Reporters and Contributors
About the Writers Charlotte Bath has been writing about cancer and related fields of medicine since serving as Public Information Director of the American Cancer Society, Long Island Division, from 1975 to 1979. She subsequently worked as a writer for Memorial Sloan-Kettering Cancer Center and...
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...
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...
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...
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...
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...
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...
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,...
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...
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...
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 ...
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...
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...
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...
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...
Friends of Cancer Research Holds Annual Conference on Clinical Cancer Research
Friends of Cancer Research, in conjunction with the Engelberg Center for Health Care Reform at Brookings, recently held the seventh annual Conference on Clinical Cancer Research in Washington, DC. The panels that comprised the daylong meeting discussed a future that has already begun. The most...
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:...
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...
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...
