INSIDE THE BLACK BOX is an occasional column offering insight into the FDA and its policies and procedures. This installment addresses a changing paradigm in the treatment of lung cancer, exemplified by concurrent approval of a companion diagnostic with each of several new targeted agents or new...
The updated analysis of the Intergroupe Francophone du Myelome (IFM) 2005-02 trial in newly diagnosed multiple myeloma patients showed that lenalidomide (Revlimid) maintenance prolongs progression-free survival after stem cell transplantation, but does not improve overall survival, according to...
It has been posited that aspirin treatment may reduce risk for colorectal cancer through inhibition of WNT/cadherin-associated protein β1 (CTNNB1, or β-catenin) signaling. In a study reported recently in the Journal of the National Cancer Institute, Nan et al investigated the potential role of the...
In a study reported in the Journal of the National Cancer Institute, Pan et al assessed factors associated with noncompliance with recommended radiation therapy following breast-conserving surgery for breast cancer.1 A primary factor in underuse of radiation therapy was younger patients having...
From December 10 to 14, the American Association for Cancer Research, the Cancer Therapy & Research Center at The University of Texas Health Sciences Center at San Antonio, and Baylor College of Medicine once again hosted the San Antonio Breast Cancer Symposium (SABCS), presenting...
One of the key questions in geriatric oncology is: How can we use all of the work geriatricians have done over the years in general geriatrics and apply that to the field of oncology? One-quarter to one-third of us are going to develop cancer throughout our lifetime, and half of the time it is...
After the IBIS-II presentation at the San Antonio Breast Cancer Symposium, Carlos L. Arteaga, MD, of Vanderbilt Ingram Cancer Center, Nashville, noted that women at high risk are afraid of developing breast cancer and that pharmacologic intervention may allay their anxiety. “Dr. Cuzick’s study...
Based on age and risk, an estimated 10 million women in the United States may be eligible for an agent aimed at preventing breast cancer, but chemoprevention is underutilized. Fewer than 5% of women at high risk who are offered tamoxifen for chemoprevention agree to take the drug, partly due to...
Reports have been trickling in from centers conducting research on the use of chimeric antigen receptor–modified T cells (CAR-T) in hematologic cancer, and the news is encouraging. When directed against CD19, such personalized therapeutic T cells are known as CTL019, and small pilot trials of this...
Adjuvant use of bisphosphonates reduced the risk of bone recurrence by 34% and the risk of breast cancer death by 17% in postmenopausal women with early breast cancer in a large meta-analysis conducted by the Early Breast Cancer Trialists’ Collaborative Group (EBCTCG). The potentially...
Measuring certain hormone levels could help determine a woman’s risk for breast cancer and add a key factor to current risk-prediction models, according to investigators from Harvard Medical School. Their new study results were presented at the American Association for Cancer Research (AACR) Annual ...
I read with interest the article, “Breast Cancer Vaccines for Primary Prevention Move Toward Clinical Use,” which appeared in the December 15th issue of The ASCO Post (page 28). However, information presented regarding the National Breast Cancer Coalition’s (NBCC’s) Artemis Project for a breast...
“He gave his honours to the world again,his blessed part to heaven, and slept in peace.” —William Shakespeare, Henry VIII In 1971, John M. Goldman, DM, FRCP, FRCPath, FMedSci, began research in chronic myeloid leukemia (CML), a uniformly fatal disease at the time. Over the ensuing decades, Dr....
Champions Oncology, a company engaged in the development of advanced technology solutions and services to personalize the development and use of oncology drugs, has announced the appointment of Angela Davies, MD, as Chief Medical Officer. Dr. Davies has demonstrated experience in both academic...
As published in the Journal of Clinical Oncology by Batchelor and colleagues1 and reviewed in a recent issue of The ASCO Post (November 15, 2013, page 106), the REGAL trial was a randomized, phase III, placebo-controlled, partially blinded trial evaluating the efficacy of cediranib, an...
To help tell the story of progress against cancer, ASCO launched CancerProgress.Net in 2011. The site is intended as a resource for media, policymakers, oncologists, advocates, and the public. One central feature of the site is an interactive timeline of major milestones in cancer treatment,...
“When the first Surgeon General’s Report was released in 1964, more than half of American men and over a third of women smoked and lung cancer had gone from an obscure disease to a leading cause of death. In issuing this pioneering report summarizing the known health risks of smoking, our nation’s...
A new set of guides and interactive tools to help health-care providers more safely use electronic health information technology products, such as electronic health records (EHRs), are now available at www.HealthIT.gov. The Office of the National Coordinator for Health Information Technology (ONC)...
The U.S. Food and Drug Administration (FDA) has approved trametinib (Mekinist) for use in combination with dabrafenib (Tafinlar) for the treatment of patients with unresectable melanoma or metastatic melanoma with BRAF V600E or V600K mutations. These mutations must be detected by an FDA-approved...
Although many oncologists consider matched sibling donors as the best source of grafts for hematopoietic cell transplantation, two separate studies presented at the recent American Society of Hematology Annual Meeting support the use of alternative donor grafts for patients with lymphoma and acute...
In October, ASCO will cosponsor the inaugural Palliative Care in Oncology Symposium with the American Academy of Hospice and Palliative Medicine (AAHPM), the American Society for Radiation Oncology (ASTRO), and the Multinational Association of Supportive Care in Cancer (MASCC). The Symposium is...
The Conquer Cancer Foundation of the American Society of Clinical Oncology has announced the four recipients of the inaugural 2014 International Innovation Grant, which is a new program that underscores the Foundation’s continued commitment to improving the care of patients worldwide. The 1-year...
More than 1,000 scientists from 66 countries, including 32 of the 52 African countries, attended the African Organization for Research and Training in Cancer (AORTIC) 9th International Conference on Cancer in Africa, held this past November in Durban, South Africa. The theme of the 2013 meeting was ...
Editor’s note: The Centers for Disease Control and Prevention (CDC) recently issued a report on lung cancer incidence trends in the United States.1 According to the report, incidence rates for lung cancer have decreased between 2005 and 2009, the period evaluated. Lung cancer incidence has...
There is no doubt that this is a halcyon period in oncology. The unraveling of the genome has been tremendously important, and finally has helped us to move treatment selection from an era of rational empiricism to one of refined, molecular prognostication. In the care of breast cancer, the impact...
The achievement of a pathologic complete response in patients with triple-negative breast cancer was boosted by the addition of carboplatin to a standard neoadjuvant chemotherapy regimen, and by the addition of veliparib, an investigational oral PARP inhibitor, plus carboplatin to a standard...
“Tomorrow is the most important thing in life. Comes into us at midnight very clean. It’s perfect when it arrives and it puts itself in our hands. It hopes we’ve learned something from yesterday.” —John Wayne Donald L. Morton, MD, transformed the management of melanoma and breast cancer by...
Pomalidomide (Pomalyst) plus low-dose dexamethasone significantly improved progression-free survival compared to pomalidomide alone in patients with relapsed and refractory multiple myeloma enrolled in a multicenter, open-label study, the phase II part of the MM-002 trial. The study confirmed the...
Over the past several decades, outcomes data have traced the success stories in cancer research and therapeutics. However, during those decades of increasingly rapid scientific breakthroughs, certain psychosocial components in the continuum of cancer care were often overlooked. One such element is...
Kava Scientific Name: Piper methysticum Common Names: Kava-kava, kawa, kavain, rauschpfeffer, intoxicating long pepper, tonga, yagona, and yaqona. Overview Kava, a perennial shrub indigenous to the Hawaiian Islands and the Pacific Rim, is known for its relaxant effects and used for social and...
To help tell the story of progress against cancer, ASCO launched CancerProgress.Net in 2011. The site is intended as a resource for media, policymakers, oncologists, advocates, and the public. One central feature of the site is an interactive timeline of major milestones in cancer treatment,...
With the advent of Breakthrough Therapy designation, there are now four FDA programs to expedite the development of promising new agents: Fast Track, Breakthrough Therapy, Priority Review, and Accelerated Approval (Table 1). These programs complement one another and serve a common goal: to speed...
On January 9, 2014, the combination of trametinib (Mekinist) and dabrafenib (Tafinlar) was granted accelerated approval for the treatment of patients with unresectable or metastatic melanoma with BRAF V600E or V600K mutations as detected by a U.S. Food and Drug Administration (FDA)-approved...
A campaign “Palliative Care: Conversations Matter” recently launched by the National Institute of Nursing Research (NINR) aims to increase the use of palliative care for children with serious illness. Palliative care can reduce a child’s pain, help manage other distressing symptoms, and provide...
As 2014 rolls in, ASCO is calling for a renewed commitment to federal funding of cancer research. In a letter sent to House and Senate Appropriations leaders, ASCO urged Congress to use spending levels in the recently passed budget to set the highest possible funding level for the National...
In November of 2013, the Conquer Cancer Foundation partnered with the Stelter Company—one of the leaders of planned giving resources in the nonprofit community—to launch a new planned giving portal on the Foundation’s website. The planned giving portal focuses on the variety of ways individuals can ...
The implementation of clinical trials and quality research programs by community-based investigators and research staff is one of the most effective weapons available in the fight against cancer. The ASCO Community Research Forum was designed in support of this mission and to aid these...
The National Institutes of Health (NIH) has awarded a 5-year grant of more than $1.5 million to Herbert J. Zeh III, MD, and Michael T. Lotze, MD, at the University of Pittsburgh Cancer Institute (UPCI), partner with UPMC CancerCenter, to study a novel treatment for pancreatic ductal ...
Late last year, the American Society of Clinical Oncology and College of American Pathologists published a comprehensive update of guidelines for HER2 testing,1 the first such update since their initial landmark publication in 2007.2 This new report, summarized in this issue of The ASCO Post,...
The American Society of Clinical Oncology (ASCO) and College of American Pathologists (CAP) recently convened an Update Committee to conduct a systematic literature review and update recommendations for optimal HER2 testing. In particular, the Committee identified criteria and areas requiring...
Multiple myeloma researchers moved the field forward at the 2013 American Society of Hematology (ASH) Annual Meeting, presenting evaluations of treatment schedules and reports of encouraging activity with compounds in development. Alternating vs Sequential Regimens In 231 newly diagnosed elderly...
The U.S. Food and Drug Administration (FDA) has approved the Miltenyi Biotec’s CliniMACS CD34 Reagent System as a Humanitarian Use Device for the prevention of graft-vs-host disease in patients with acute myeloid leukemia (AML) in first complete remission undergoing allogeneic stem cell...
Last September, Jamie H. Von Roenn, MD, left her position as Professor of Medicine at the Northwestern University Feinberg School of Medicine in Chicago to join ASCO as its Senior Director of Education, Science and Professional Development. In her new position, Dr. Von Roenn will provide strategic...
The connection between smoking and lung cancer is universally accepted as scientific fact, and those who choose to smoke are painfully aware of the risk it poses for addiction and subsequent cancer. However, to fully appreciate the significance of the Surgeon General’s report, one must turn back to ...
The tobacco industry has always been a major player in congressional races, especially in Southern tobacco-growing states. Moreover, the industry is notoriously bipartisan in their political donations, and members of both parties have returned the favor by voting for tobacco interests. “The 2014...
A state-by-state update on the progress of antismoking initiatives. States are graded on four metrics: tobacco prevention, smoke-free air, cigarette tax, and cessation coverage. For example, Kentucky received 4 F’s, while New York received grades of, F, A, A, and F, respectively. Major parts of the ...
On January 11, 2014, the nation commemorated the 50th anniversary of a document that transformed our public health landscape and has saved millions of lives: Smoking and Health: Report of the Advisory Committee to the Surgeon General of the Public Health Service. This groundbreaking report, which...
Overall survival was improved in metastatic pancreatic cancer patients through an innovative immunotherapy strategy in a multicenter study reported at the 2014 Gastrointestinal Cancers Symposium.1 “This is the first time a randomized study has shown that immunotherapy is effective in pancreatic...
The Ovarian Cancer Research Foundation has awarded researchers at Dana-Farber Cancer Institute a $900,000 grant to test new combinations of targeted drugs against the disease. Ursula Matulonis, MD, Director of the Gynecological Cancer Treatment Center in the Susan F. Smith Center for Women’s...
As a medical oncologist and palliative care physician, I’ve had the privilege of caring for cancer patients and delivering primary palliative care and symptom control, as well as the chance to care for patients especially referred for complex pain and symptom problems (in secondary and even...