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Showing 26701 - 26750FDA Discourages Use of Laparoscopic Power Morcellation for Removal of Uterus or Uterine Fibroids
In a safety communication notice issued recently, the U.S. Food and Drug Administration (FDA) discouraged the use of laparoscopic power morcellation for the removal of the uterus (hysterectomy) or uterine fibroids (myomectomy) in women because, based on an analysis of currently available data, it...
Beyond the Cystoscope: Thinkers and Technicians
I have spent my career working with urologists. Over a long period of time, I have concluded that they are fine and interesting people who work hard, live well, support interesting hobbies, generally take good care of their families, and are very enjoyable company at parties. The recent discussion...
Continued Survival Benefits Seen With Radical Prostatectomy vs Watchful Waiting in Long-Term Follow-up of the SPCG-4 Trial
The long-term benefits of radical prostatectomy vs watchful waiting in men with localized prostate cancer has remained a debated issue. As reported in The New England Journal of Medicine by Anna Bill-Axelson, MD, of Uppsala University Hospital, and colleagues, additional long-term follow-up in the...
Demanding More From Clinical Trials
“The function of the formal controlled clinical trial is to separate the relative handful of discoveries that prove to be true advances in therapy from a legion of false leads and unverifiable clinical impressions, and to delineate in a scientific way the extent of and the limitations that attend...
Phase III Study Explores Addition of Nintedanib to Docetaxel in Second-Line Treatment of Non–Small Cell Lung Cancer
In a phase III trial (LUME-Lung 1) reported in The Lancet Oncology, Reck et al assessed the addition of nintedanib to docetaxel in second-line treatment of non–small cell lung cancer (NSCLC).1 The combination significantly improved progression-free survival in all patients and improved overall...
Cancer Chemotherapy Use During Pregnancy
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...
Volasertib Granted Orphan Drug Designation for Acute Myeloid Leukemia
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...
Supplemental New Drug Application Submitted for Ibrutinib in CLL
Pharmacyclics, Inc, and Janssen Biotech, Inc, have announced the submission of a supplemental New Drug Application to the U.S. Food and Drug Administration (FDA), based on data from the randomized, multicenter, open-label phase III RESONATE study, a head-to-head comparison of single-agent ibrutinib ...
FDA Approves Mercaptopurine Oral Suspension for Acute Lymphoblastic Leukemia
On April 28, 2014, the U.S. Food and Drug Administration approved a 20 mg/mL oral suspension of mercaptopurine (Purixan) indicated for the treatment of patients with acute lymphoblastic leukemia (ALL) as part of a combination regimen. Successive clinical trials have demonstrated that mercaptopurine ...
FDA Proposes to Extend Its Tobacco Authority to Additional Tobacco Products, Including E-Cigarettes
On April 24, 2014, as part of its implementation of the Family Smoking Prevention and Tobacco Control Act signed by the President in 2009, the U.S. Food and Drug Administration (FDA) proposed a new rule that would extend the agency’s tobacco authority to cover additional tobacco products. Products ...
FDA Approves First HPV Test for Primary Cervical Cancer Screening
The U.S. Food and Drug Administration (FDA) approved the first human papillomavirus (HPV) DNA test that can be used as a primary cervical cancer screening test for women aged 25 years and older. The test also can provide information about the patient’s risk for developing cervical cancer in the...
FDA Approves Siltuximab for Rare Castleman’s Disease
The U.S. Food and Drug Administration (FDA) has approved siltuximab (Sylvant injection) for the treatment of patients with multicentric Castleman’s disease who are human immunodeficiency virus (HIV)-negative and human herpes virus-8 (HHV-8)-negative. Multicentric Castleman’s disease is a rare...
FDA Approves Ceritinib for Late-Stage Lung Cancer
The U.S. Food and Drug Administration (FDA) has granted accelerated approval to ceritinib (Zykadia) for patients with a metastatic anaplastic lymphoma kinase (ALK)-positive non–small cell lung cancer (NSCLC) who were previously treated with crizotinib (Xalkori). Ceritinib is an ALK tyrosine kinase...
Ceritinib Highly Active in Patients With ALK-Rearranged Advanced NSCLC
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...
Personalized Cancer Fatigue Care: ASCO Clinical Practice Guideline Adaptation
The majority of cancer survivors report different levels of cancer-related fatigue that can last for many years after completion of therapy. The American Society of Clinical Oncology has made a valuable contribution to care of adult cancer survivors by providing a simple and effective clinical...
ASCO Releases Adapted Guideline on Screening, Assessment, and Management of Fatigue in Adult Survivors of Cancer
A majority of cancer patients experience some level of fatigue during the course of their treatment, and approximately 30% contend with persistent fatigue for years after treatment. Fatigue is among the most common and distressing long-term effects of cancer treatment and significantly affects...
Meta-Analysis Shows Survival Benefit of Preoperative Chemotherapy in NSCLC
In a systematic review and individual patient meta-analysis reported in The Lancet,1 the NSCLC Meta-analysis Collaborative Group found that neoadjuvant therapy for non–small cell lung cancer (NSCLC) was associated with a significant 13% reduction in risk of death. Significant benefits in...
Postmastectomy Radiotherapy Benefits Women With Breast Cancer That Has Spread to One to Three Lymph Nodes
In women with breast cancer who had between one and three positive lymph nodes, radiotherapy reduced the recurrence rate by 32% and the breast cancer death rate by 20%. Giving radiotherapy to these women led to nearly 12 fewer recurrences of breast cancer per 100 women after 10 years, and eight...
One Step Forward
ASCO has taken the field of psychosocial oncology a step forward in the right direction by providing guidelines for oncologists to direct care of the two most common emotional symptoms that patients experience: anxiety and depression.1 It is fair to say that all patients experience these...
ASCO Releases Adapted Guideline on Screening, Assessment, and Care of Anxiety and Depressive Symptoms in Adults With Cancer
Detection of depression is suboptimal, and its severity is underestimated in the general population, but it is known psychiatric disorders are more common in patients with cancer than in those with any other chronic illness. Although studies in cancer patients have yielded varying figures, it is...
Challenges in Creating and Promoting Clinical Practice Guidelines
With regard to clinical practice guidelines, clinicians want an authoritative resource that will clearly and concisely instruct them in most clinical scenarios. Guideline developers want to give them this, “but producing guidelines is not as straightforward as it might seem,” according to David...
The Affordable Care Act: NCCN Panelists Rate It ‘Average’
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,...
Andrew D. Zelenetz, MD, PhD, on Treating the Elderly Lymphoma Patient With Elevated Bilirubin
At the 19th Annual Conference of the National Comprehensive Cancer Network (NCCN), lymphoma expert and NCCN Panel Chair on Lymphoma, Andrew D. Zelenetz, MD, PhD, fielded questions from oncologists. The ASCO Post was there to capture his recommendations for a common clinical scenario—treating the...
Belinostat Moves Forward in Trials for Two Aggressive Cancers
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...
Workshops Train Community Cancer Center Nurses and Administrators to Implement Clinical Trials
A series of new workshops are teaching nurses and administrators from community hospital cancer programs how to promote, run, and improve their institutions’ clinical trials. The training focuses on specific skills and tasks, offers postcourse support and aims for long-term, measurable outcomes,...
Promoting Health Behaviors Among Cancer Survivors
Promoting healthy behaviors among cancer survivors is associated with improved quality of life according to many studies. But how to translate that evidence into community practice remains a huge question, and the need for answers is growing. It’s not only the lack of consensus on how to help...
Expert Point of View: Edith Perez, MD
Commenting on the I-SPY 2 neratinib results presented at the 2014 American Association for Cancer Research Annual Meeting, Edith Perez, MD, Deputy Director at Large, Mayo Clinic Comprehensive Cancer Center, Jacksonville, Florida, said that results were consistent with other data. “Testing for HER2...
I-SPY 2 Trial ‘Graduates’ Neratinib to Phase III Study in HER2-Positive, Hormone Receptor–Negative Breast Cancer
In the targeted-therapy era, it is important to identify subsets of patients who can benefit from novel agents and combinations as quickly as possible. The I-SPY 2 trial is designed to expedite this goal and to change the way that targeted agents are studied and approved. This innovative adaptive...
Expert Point of View: Paul K. Paik, MD
FGFR abnormalities have been reported in many cancers, including breast, lung, and bladder cancers. While the types of events that occur in these cancers are different, preclinical evidence supports a role for oncogenesis in each of these types,” said formal discussant of the FGFR inhibitor studies ...
FGFR Inhibitors of Interest in Bladder and Lung Cancer
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...
Expert Point of View: John C. Byrd, MD
Formal discussant of the AG-221 study presented at the 2014 American Association for Cancer Research meeting, John C. Byrd, MD, of The Ohio State University, Columbus, said, “Congratulations to Dr. Stein for bringing this drug forth.” He continued, “Acute myeloid leukemia (AML) is challenging to...
Early Data for AG-221 Show Unprecedented Activity in Acute Myeloid Leukemia and Myelodysplastic Syndrome
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...
Expert Point of View: Daniel Petrylak, MD
This is an extremely important study,” said Daniel Petrylak, MD, Professor of Medicine and Urology at the Yale School of Medicine in New Haven, Connecticut. “This work needs to be replicated prospectively in a larger group of patients. Right now we have no way to select appropriate first-line...
Blood Test Can Identify Prostate Cancer Patients Who Are Not Likely to Respond to Enzalutamide
A simple blood test may be able to identify men with castration-resistant prostate cancer who will not respond to enzalutamide (Xtandi). The presence of the splice variant androgen receptor (AR) V7 in circulating tumor cells identified men who were unlikely to respond to enzalutamide and whose...
Lymphedema Lingers Long After Sentinel Lymph Node Dissection for Early Breast Cancer
Patients with early-stage breast cancer who underwent sentinel lymph node dissection experienced lymphedema with increasing incidence over time, according to a presentation at the 2014 Society of Surgical Oncology (SSO) Cancer Symposium in Phoenix.1 In women who took part in the American College of ...
FDA Approves Ramucirumab for Stomach Cancer
The U.S. Food and Drug Administration (FDA) has approved ramucirumab (Cyramza) to treat patients with advanced or metastatic gastric cancer or gastroesophageal junction adenocarcinoma with disease progression on or after prior treatment with fluoropyrimidine- or platinum-containing chemotherapy....
Survival Analysis of Contralateral Prophylactic Mastectomy Sparks Discussion
Contralateral prophylactic mastectomy improved breast cancer patients’ odds of overall survival by 23% compared with single mastectomy alone, according to a retrospective analysis of nearly 170,000 patients in a U.S. database, but surgical breast cancer specialists warned that the data needed to be ...
NCCN Clinical Practice Guidelines in Oncology: 2014 Updates
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 ...
Reflecting on the Past Year and Looking Ahead to the Next
On assuming the Presidency of ASCO a year ago, I recognized that one of our greatest challenges as a professional society is helping the American public understand the value of cancer research, especially now, when scientific advances are accelerating but resources are contracting. This is partly...
ASCO Develops New Strategy to Increase Value in Cancer Care
Last January, ASCO held a leadership summit in Washington, DC, with representatives from the pharmaceutical industry, insurance payers, patient advocates, and physicians to address the skyrocketing costs of new drugs and technologies used in the diagnosis and treatment of cancer. Although costs are ...
Guidelines for Chemotherapy-Induced Neuropathy: The Known Unknowns
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 Releases Guideline on Prevention and Management of Chemotherapy-Induced Peripheral Neuropathy in Survivors of Adult Cancers
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...
About the Writer
Ronald Piana is an independent writer and reporter with more than 15 years of experience in oncology communications and publishing. In addition to the profiles published in this special anniversary issue of The ASCO Post, Ron has written more than 100 articles, interviews, and profiles for leading...
Ernest Louis Mazzaferri, Sr, MD: September 27, 1936–May 14, 2013
Ernest Louis Mazzaferri, Sr, MD, MACP, of Henderson, Nevada, passed away peacefully at home on May 14, 2013 after a short illness, surrounded by his family. He was born September 27, 1936 in Cleveland, Ohio. Dr. Mazzaferri spent most of his medical career at The Ohio State University, serving as...
Jane Weeks, MD, MSc: August 12, 1952–September 10, 2013
On September 10, 2013, Jane Carrie Weeks, MD, MSc, a prominent researcher at Dana-Farber Cancer Center, died of cancer in her Boston home. She was 61. At the time of her death, Dr. Weeks was Professor of Medicine at Harvard Medical School, Professor of Health Policy and Management at the Harvard...
Janet L. Rowley, MD: April 5, 1925–December 17, 2013
Dr. Janet L. Rowley’s groundbreaking research in the translocation of genetic material bucked scientific convention and heralded a new understanding that cancer is indeed a genetic disease. Her research was largely responsible for the discoveries that led to the development of the targeted cancer...
Donald L. Morton, MD: September 12, 1934–January 10, 2014
Donald L. Morton, MD, transformed the management of melanoma and breast cancer by introducing the sentinel node biopsy, giving surgeons an accurate roadmap for treatment, and sparing generations of cancer patients from the morbidity associated with unnecessary surgery. Throughout his distinguished...
Peter Jacobs, MD, PhD: 1934–2013
Peter Jacobs, MD, PhD, regarded as the father of hematology in his native country of South Africa, began each day at 3 AM in the gym. During his workout, Dr. Jacobs would routinely call the nursing staff for updates on patients in his ward. Before sunup, Dr. Jacobs was on his way to the hospital....
ASCO’s Visionary Founders
On April 9, 1964, seven physicians—Jane Cooke Wright, MD, FASCO; Arnoldus Goudsmit, MD, PhD; Fred J. Ansfield, MD, FASCO; Harry F. Bisel, MD, FASCO; Herman H. Freckman, MD, FASCO; Robert W. Talley, MD, FASCO; and William Wilson, MD, FASCO—met for lunch at the Edgewater Beach Hotel in Chicago. They...
David A. Karnofsky: The Man Behind the Karnofsky Memorial Award and Lecture
David A. Karnofsky, MD, dedicated himself to the pursuit of scientific excellence and the investigation of more effective therapies for cancer for nearly 30 years, from the time he was a young resident at the Collis P. Huntington Memorial Hospital for Cancer Research of Harvard University, until...
