INSIDE THE BLACK BOX is an occasional column providing insight into the FDA and its policies and procedures. In this installment, National Toxicology Program scientists Kembra L. Howdeshell, PhD, and Michael D. Shelby, PhD, discuss a recently completed monograph that reviews the published data on...
The U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to volasertib for acute myeloid leukemia. Volasertib is currently being evaluated in a phase III clinical trial for the treatment of patients aged 65 or older, with previously untreated AML, who are ineligible for...
Non-small cell lung cancer (NSCLC) harboring ALK rearrangement is sensitive to the ALK inhibitor crizotinib (Xalkori), but resistance ultimately occurs. In a phase I study reported in The New England Journal of Medicine, Alice T. Shaw, MD, PhD, of Dana-Farber/Harvard Cancer Center, Boston, and...
Oncologists and third-party payers are already experiencing changes as a result of the Affordable Care Act, which earned an “average” rating by a panel of providers, payers, and patients assembled at the 19th Annual Conference of the National Comprehensive Cancer Network (NCCN) in Hollywood,...
In February, the U.S. Food and Drug Administration (FDA) granted belinostat (Beleodaq), a targeted histone deacetylase (HDAC) inhibitor, priority review status based on a pivotal phase II trial in peripheral T-cell lymphoma. Just 1 month later, researchers at the National Cancer Institute (NCI) in...
Fibroblast growth factor receptor (FGFR) inhibitors are an emerging area of interest in cancer therapeutics. Studies presented at the 2014 American Association for Cancer Research (AACR) Annual Meeting in San Diego provided early encouraging data for two investigational pan-FGFR inhibitors for the...
Although the data are preliminary, experts were impressed with responses to a novel IDH2 inhibitor called AG-221 in patients with hematologic malignancies. In the first clinical trial of AG-221, there were three complete remissions, two complete remissions with incomplete platelet count recovery...
At the 19th Annual Conference of the National Comprehensive Cancer Network (NCCN), held recently in Hollywood, Florida, NCCN Panel members presented updates for several tumor types, briefly summarized here. For a more complete description of all updates, visit www.nccn.org. Breast Cancer Guidelines ...
It is a tribute to the advances in supportive care that peripheral neuropathy, along with fatigue, has become the most vexing management challenge in cancer patients receiving chemotherapy. The successes of modern antiemetic regimens and white blood cell growth factor support have radically altered ...
ASCO has released a clinical practice guideline on prevention and treatment of chemotherapy-induced peripheral neuropathy in adult cancer patients, published in the Journal of Clinical Oncology.1 The guidelines resulted from the efforts of an expert panel, with representation from the fields of...
In 2005, Richard Pazdur, MD, was named the FDA’s Director of the Office of Hematology and Oncology Products. By any measure, being arbiter of the nation’s oncology drug pipeline is a daunting prospect, but Dr. Pazdur sees it as an opportunity to encourage his talented staff to work for the greater ...
Nationally regarded radiation oncologist and lymphoma expert Richard Hoppe, MD, was reared in Seaford, a small town hugging the South Shore of Long Island, New York. “I grew up in the early part of Long Island’s suburban sprawl, and my childhood was a fairly typical experience for that time,”...
Physicians have a duty to speak up against high cancer drug prices,” Hagop M. Kantarjian, MD, resolutely stated in an interview with The ASCO Post. “We should speak up because high drug prices are harming patients.” A leader in the effort to drive down the cost of drugs needed to treat patients...
I’ve been plagued with various ailments all my life. Physically and emotionally abused by my stepfather as a child, over the years I’ve developed severe psychological issues including depression and anxiety disorder. I am also in constant physical pain from cervical degenerative disc disease,...
The Clinical Trials and Translational Research Advisory Committee (CTAC) of the National Cancer Institute (NCI) met for the 22nd time on March 12, 2014, in their ongoing effort to improve efficiency and effectiveness of cancer clinical trials. A significant portion of the meeting addressed lagging...
The use of dietary supplements by patients with cancer has increased significantly over the past 2 decades despite insufficient evidence of safety and effectiveness. Finding reliable sources of information about dietary supplements can be daunting. Patients typically rely on family, friends, and...
Palliative care is essential to good cancer care, but it is a topic that can raise red flags because of the common misperception that it is reserved for those in the terminal stage of the disease. In truth, palliative care is highly necessary for all patients with cancer, and when it is integrated...
The Early Breast Cancer Trialists’ Collaborative Group (EBCTCG) continues to provide valuable clinically relevant and practice-influencing information garnered from individual patient-level data from numerous randomized trials in breast cancer. The large numbers of patients and long-term follow-up...
ASCO recently convened an update committee of experts in medical oncology, pathology, radiation oncology, surgical oncology, guideline implementation, and advocacy to develop evidence-based recommendations that update the ASCO 2005 clinical practice guideline on use of sentinel node biopsy in...
It’s the dawn of a new era in the treatment of chronic lymphocytic leukemia (CLL), largely due to the development of agents targeting the BCR signaling pathway, according to John C. Byrd, MD, of The Ohio State University Comprehensive Cancer Center, Columbus. At the 19th Annual Conference of the...
Attendees at this year’s annual conference of the National Comprehensive Cancer Network (NCCN) not only got up to date on the Guidelines but left with a better understanding of how children deal with a parent’s cancer, and how oncology providers can best help. Panelists for the NCCN roundtable...
In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs. On April 28, 2014, an oral suspension of mercaptopurine (Purixan) ...
In men with prostate cancer and a prostate-specific antigen (PSA)-only recurrence after curative surgery or radiation, delaying androgen deprivation therapy for at least 2 years or until clinical progression (ie, new symptoms, metastasis by imaging techniques or short PSA doubling time) did not...
Preliminary evidence suggests that AZD9291, a novel mutant-selective epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor, may become a treatment option for patients with advanced, EGFR-mutant, non–small cell lung cancer (NSCLC) that has progressed on standard EGFR inhibitors....
The highly anticipated results from the phase III ALTTO trial show no additional benefit for adding lapatinib (Tykerb) to trastuzumab (Herceptin) in the adjuvant treatment of HER2-positive breast cancer.1 The results were presented at the 2014 ASCO Annual Meeting’s Plenary Session by Martine J....
Adding docetaxel to standard androgen ablation therapy (ie, testosterone suppression) extended survival by more than 1 year in men with newly diagnosed metastatic hormone-sensitive prostate cancer in the phase III E3805 trial, funded by the National Institutes of Health. As reported at the ASCO...
The problematic rollout of the Affordable Care Act’s website, HealthCare.gov, made good political theater, but while much of the heated discussion centered on the plan’s need to enroll “young invincibles,” America’s cancer care system and the older patients it serves were also affected by parts of...
For the past 40 years the story of breast cancer surgery in general, and for the past 20 years the management of the axilla in particular, has been one of increasing conservatism. To give our readers insight into the current and future direction of axillary management, The ASCO Post spoke with...
INSIDE THE BLACK BOX is an occasional column providing insight into the FDA and its policies and procedures. In this installment, FDA hematologist/oncologist Albert Deisseroth, MD, PhD, discusses the recent approval of siltuximab for patients with multicentric Castleman’s disease who are human...
New screening modalities and the customization of the screening population could soon change the way that screening for colorectal cancer is done. At Digestive Disease Week 2014, the largest gathering of gastrointestinal disease specialists in the world, researchers presented data suggesting that...
The good news for younger women with hormone receptor–negative early breast cancer is that adding goserelin (Zoladex), a luteinizing hormone–releasing hormone (LHRH) agonist, to chemotherapy can prevent sudden menopause, better preserve ovarian function and fertility, and lead to successful...
Separate studies in early-stage non–small cell lung cancer (NSCLC) found that the addition of consolidation chemotherapy to concurrent chemoradiotherapy did not improve survival and that adjuvant erlotinib (Tarceva) did not improve survival. There was a suggestion of benefit for adjuvant erlotinib...
Three separate studies of treatments for prostate cancer reported at the 2014 ASCO Annual Meeting in Chicago showed excellent, intermediate, and disappointing results. An update of the previously reported PREVAIL trial (see March 1 issue of The ASCO Post, page 1) was overwhelmingly positive for the ...
This study provides key insights into the longstanding and vexing debate about optimal systemic therapy for these young women. We wonder about the role of tamoxifen, aromatase inhibitors, chemotherapy, and ancillary therapies like bisphosphonates,” said Nancy E. Davidson, MD, Director of the...
Public awareness of head and neck cancer is limited, with the lack of awareness including the term head and neck cancer and common symptoms and risk factors, such as tobacco use and human papillomavirus (HPV), according to results of a cross-sectional online survey reported in JAMA...
Discontinuing statins for patients near the end of life is safe, saves money, spares patients from swallowing yet another pill and from the symptoms associated with statins, and is generally welcomed by patients. That last bit might come as a surprise to some physicians who worry that discontinuing ...
In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs. On April 23, 2014, the anti–interleukin (IL)-6 monoclonal antibody...
Several times during his lecture at the 2014 ASCO Annual Meeting, Stuart M. Lichtman, MD, FACP, FASCO, the recipient of the B.J. Kennedy Award for Scientific Excellence in Geriatric Oncology, emphasized, “Physician education is the key” to continued advances in geriatric oncology. He specified that ...
Brain metastases are a devastating complication of cancer, and occur in up to 50% of patients with advanced human epidermal growth factor 2 (HER2)-positive breast cancer. Management of brain metastases requires individualized coordination between the traditional treatment modalities for...
TH3RESA is a randomized phase III open-label study, reported in The Lancet Oncology and summarized in this issue of The ASCO Post, which examined the activity of ado-trastuzumab emtansine (Kadcyla) in heavily pretreated HER2-positive metastatic breast cancer.1 Formerly known as T-DM1,...
There are few treatment options for breast cancer patients with progressive disease after two or more HER2-directed regimens for recurrent or metastatic disease. In the open-label phase III TH3RESA trial reported in The Lancet Oncology by Ian E. Krop, MD, PhD, of the Dana-Farber Cancer Institute,...
In advanced melanoma, two immune checkpoint inhibitors may be better than one, according to the promising outcomes of a study reported at the 2014 ASCO Annual Meeting. Concurrent treatment with the anti–CTLA-4 antibody ipilimumab (Yervoy) and nivolumab, an antibody targeting the programmed death...
Monoclonal antibodies targeting the programmed death receptor-1 (PD-1) pathway are expected to answer an unmet need in non–small cell lung cancer (NSCLC). With first-line platinum-doublets, 1-year overall survival is 30% to 50%, and while treatments targeting sensitizing mutations are more...
Ipilimumab (Yervoy) has transformed the treatment of metastatic melanoma, producing long-term responses in about 20% of patients. A phase III study has now evaluated its impact in the adjuvant setting, and the results are a bit less striking. Primary Endpoint The European Organisation for Research...
Cancer patients’ out-of-pocket costs are rising dramatically, and insurance premiums, cost sharing, and ancillary expenses can be devastating. Many people go bankrupt as a result of the high costs of health care. Drugs are among the most serious economic culprits. They grow more expensive every...
The latest bit of good news for the programmed death receptor-1 (PD-1)–targeting antibodies in advanced melanoma comes for pembrolizumab (MK-3475). While the results came from only a phase I study, they were among those chosen for presentation at an ASCO press briefing during the Annual Meeting....
His life was gentle, and the elements So mixed in him that Nature might stand up And say to all the world, “This was a man!” —William Shakespeare I have too many positive memories of John to regale you with here,” said Roger Kirby, MD, in a tribute to his close friend and colleague, John Michael...
Prostate cancer will be diagnosed in 233,000 American men in 2014. It is one of the leading causes of death by a cancer (killing ~29,500 men annually).1 Hundreds of thousands of men undergo prostate biopsies each year, most for either benign disease or for a cancer that will never lead to their...
Patrick G. Johnston, MD, PhD, FMedSci, Professor of Oncology and President and Vice-Chancellor of Queen’s University Belfast, grew up in Derry, a city in Northern Ireland. Derry is distinct in being Ireland’s only remaining fully intact walled city, considered one of the finest examples of a walled ...
The Ohio Hematology Oncology Society (OHOS) was formed 2 decades ago to advocate for and provide educational seminars and networking opportunities to hematologists and medical oncologists throughout the states of Ohio and West Virginia. Today, the society is focused on the needs of its nearly 200...