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Showing 9401 - 9450Reagan-Udall Foundation Announces Appointments of Ellen V. Sigal, PhD, and Richard L. Schilsky, MD
The Reagan-Udall Foundation for the U.S. Food and Drug Administration (FDA), an independent nonprofit organization that works to advance regulatory science to help support the scientific mission of the FDA, has elected Ellen V. Sigal, PhD, as its new Chairman, and Richard L. Schilsky, MD, as Vice ...
The FDA Ensures Quality and Safety of Generic Drugs in the United States
The U.S. Food and Drug Administration’s (FDA) generic drug program has substantially increased the availability of affordable, high-quality drugs in the United States. It is arguably the only really effective health-care cost–containment program. The more than 10,000 generic drugs currently...
Reducing the Risk of Oral Complications During and After Cancer Therapy
According to the National Institutes of Health,1 nearly all patients with head and neck malignancies receiving high-dose radiation therapy; approximately 80% of patients undergoing stem cell transplantation; and about 40% of patients receiving chemotherapy will experience oral complications that...
Concerns About Safety of Generic Oncology Drugs Made in Developing Countries
In an article in The Lancet Oncology, Y. Tony Yang, ScD, of George Mason University, Charles L. Bennett, MD, PhD, MPP, of the University of South Carolina and colleagues from the United States, Europe, and Japan examined clinical, policy, safety, and regulatory considerations for generic oncology...
SABCS 2016: Extended Letrozole Therapy Showed Limited Benefit in Postmenopausal Women With Early-Stage, Hormone Receptor–Positive Breast Cancer
Five additional years of hormone therapy with letrozole following an initial 5 years of aromatase inhibitor-based adjuvant hormone therapy did not demonstrate a statistical improvement in disease-free survival or overall survival in postmenopausal women with early-stage hormone...
SABCS 2016: Adding Everolimus to Fulvestrant Improved Outcomes for Postmenopausal Patients With Hormone Receptor–Positive Breast Cancer
Progression-free survival was more than doubled for patients with metastatic hormone receptor–positive, HER2-negative breast cancer resistant to aromatase inhibitor therapy by adding everolimus (Afinitor) to treatment with the endocrine therapeutic fulvestrant (Faslodex), according to data...
City of Hope’s Ravi Salgia, MD, PhD, Receives 2016 Asclepius Award From the Bonnie J. Addario Lung Cancer Foundation
City of Hope’s Ravi Salgia, MD, PhD, Chair of the Department of Medical Oncology and Therapeutics Research, has received an accolade that recognizes his decades-long dedication to treating patients with lung cancer and researching new therapies. Dr. Salgia received the 2016 Asclepius Award from...
Elizabeth M. Swisher, MD, Finds Juggling Research Projects and Clinical Care Improves Both
Elizabeth M. Swisher, MD, Medical Director of the Breast and Ovarian Cancer Prevention Program at the Seattle Cancer Care Alliance, enjoys developing long-term patient relationships and helping patients who are confronted with cancer and terminal issues. She is particularly interested in the...
Randi Kaplan, LMSW, Named Schwartz Center’s 2016 National Compassionate Caregiver of the Year
The Schwartz Center for Compassionate Healthcare, a national leader in providing compassionate care to patients and caregivers, has named Randi Kaplan, LMSW, Director of the Arthur D. Emil Caregiver Support Center at Montefiore, the National Compassionate Caregiver of the Year. The prestigious...
Center for Leukemia and Lymphoma Research at UNMC Renamed Dr. James O. Armitage Center for Leukemia and Lymphoma Research
The University of Nebraska Board of Regents voted to rename an area of the University of Nebraska Medical Center (UNMC) in honor of a longtime professor who has made extraordinary contributions to the institution. The Center for Leukemia and Lymphoma Research, established in 2003, was renamed by...
Daratumumab in Previously Treated Multiple Myeloma
On November 21, 2016, daratumumab (Darzalex) was approved for use in combination with lenalidomide (Revlimid) and dexamethasone or with bortezomib (Velcade) and dexamethasone for the treatment of patients with multiple myeloma who have received at least one prior therapy.1,2 The drug was initially ...
Disparities of Care: Navigation System Helps Connect Underserved Populations to Cancer Services
Although we’ve seen substantial progress in cancer treatment, screening, diagnosis, and prevention over the past decades, certain underserved populations have not reaped the benefits of many of these advances. Turning research into actionable programs in this area was highlighted by a presentation ...
Bad Year for Brain Tumors, but Still Reasons for Hope
Checkpoint inhibitors and targeted therapies are reshaping the landscape of cancer care across multiple tumor sites, but treatments for brain tumors remain decidedly unchanged. The standard of care for high-grade gliomas in the front-line setting—a combination of surgery and chemoradiation—is the...
Nivolumab in Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck
On November 10, 2016, nivolumab (Opdivo) was approved for treatment of recurrent or metastatic squamous cell carcinoma of the head and neck with disease progression on or after platinum-based therapy.1,2 Supporting Efficacy Data Approval was based on the finding of an overall survival advantage...
Mutanome-Directed Immunotherapy: Finding the Best Treatment Match
Oncologists may be accustomed to looking for commonalities in patients, but highly personalized therapies are now being developed based on mutational analysis of tumors. According to data presented at the Cedars-Sinai annual symposium on New Therapeutics in Oncology: The Road to Personalized...
Noteworthy Antitumor Activity Seen in Phase I Studies of PDGFRα and KIT Mutation Inhibitors
Two studies presented at the 28th EORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics in Munich focused on the inhibition of mutations in the KIT and PDGFRα oncogenes. These genes encode receptor tyrosine kinases, and when they are mutated, cell signaling malfunctions, leading to...
Genetic Link May Explain Outcomes Differences in Multiple Myeloma in African Americans
African Americans are more than twice as likely as their white counterparts to be diagnosed with multiple myeloma, and twice as likely to die from this form of cancer. Research presented at the 9th American Association for Cancer Research (AACR) Conference on the Science of Cancer Health...
City of Hope, Translational Genomics Research Institute Combine to Advance Precision Medicine and Speed Translational Research
City of Hope and Translational Genomics Research Institute (TGen) have announced an alliance to make precision medicine a reality for patients. This alliance enables both institutes to complement each other in their common areas of research and patient care, with City of Hope providing a...
Novel Immunotherapy Combinations May Be the Future of Melanoma Treatment
The future treatment of melanoma may rely on combinations of immunotherapy agents beyond the current checkpoint inhibitors, and they are entering clinical trials, according to Jeffrey Weber, MD, PhD, Deputy Director of the Laura and Isaac Perlmutter Cancer Center at New York University Langone...
MD Anderson Cancer Center Marks 75 Years of Research to End Cancer
In November, The University of Texas MD Anderson Cancer Center celebrated its 75th anniversary with a week-long series of events that raised nearly $15 million to support its efforts in patient care and in the investigation and treatment of cancer. Housed on 16 million square feet in the city of...
Experts Consider the New Immunotherapy Paradigm in Advanced Lung Cancer
One immune checkpoint inhibitor has now moved to the front of the line for treating advanced non–small cell lung cancer (NSCLC). Based on pivotal studies presented at the 2016 European Society for Medical Oncology (ESMO) Congress, pembrolizumab (Keytruda) became a first-line option, and it is...
Medicare Access and CHIP Reauthorization Act: The Final Rule
It is gratifying to see the Centers for Medicare & Medicaid Services (CMS) does listen to public comments regarding new proposals. Since CMS opened the comment period for its Quality Payment Program, which repeals the Sustainable Growth Rate Formula and was proposed to implement the Medicare...
ASH 2016: Additions to Standard Multiple Myeloma Therapy Do Not Appear to Yield Additional Benefit
Trial results presented by Stadtmauer during the 58th American Society of Hematology (ASH) Annual Meeting & Exposition in San Diego (Abstract LBA-1) suggest two therapies that are often added to standard therapy in patients with multiple myeloma do not improve rates of progression-free survival ...
ASH 2016: Ibrutinib and TGR-1202 Combination Yields Encouraging Results in Patients With Relapsed Forms of Leukemia or Lymphoma
A combination of two targeted agents has demonstrated safety as well as encouraging signs of effectiveness in a phase I clinical trial in patients with relapsed or hard-to-treat chronic lymphocytic leukemia (CLL) or mantle cell lymphoma (MCL). Davids et al reported the findings at the 58th American ...
ASH 2016: Ibrutinib Found Helpful in Treating Graft-vs-Host Disease After Stem Cell Transplant
A late-breaking abstract presented by Miklos et al during the 58th American Society of Hematology (ASH) Annual Meeting & Exposition in San Diego (Abstract LBA-3) showed patients who experience graft-vs-host disease (GVHD) after stem cell transplantation that is not resolved by corticosteroid...
ASCO Endorses ASTRO Guideline on Radiation Therapy for Glioblastoma
As reported by Erik P. Sulman, MD, PhD, of MD Anderson Cancer Center, and colleagues in the Journal of Clinical Oncology, ASCO has endorsed the 2016 American Society for Radiation Oncology (ASTRO) evidence-based guideline on radiation therapy for glioblastoma. The endorsement was based on review of ...
ASH 2016: Interim Analysis Shows Adding Lenalidomide Maintenance Therapy to Chemoimmunotherapy Prolongs Progression-Free Survival in High-Risk CLL
The combined use of genetic markers and minimal residual disease assessment (MRD) has made it easier to identify chronic lymphocytic leukemia (CLL) patients likely to have a poor outcome after receiving frontline chemoimmunotherapy. Interim results from the phase III German CLL M1 study presented...
ASH 2016: Patients With CML and Stable Molecular Responses May Be Able to Safely Decrease the Dose of Their Tyrosine Kinase Inhibitor
A study led by researchers at the University of Liverpool presented by Clark et al at the 58th American Society of Hematology (ASH) Annual Meeting & Exposition (Abstract 938) suggests many patients with chronic myeloid leukemia (CML) may be able to safely reduce tyrosine kinase inhibitor side...
ASH 2016: Phase I Trial of Vadastuximab Talirine in Combination With 7+3 Induction Therapy for Patients With AML
In a clinical trial presented by Erba et al at the 58th American Society of Hematology (ASH) AnnualMeeting & Exposition (Abstract 211), vadastuximab talirine was found to be safe when used in combination with standard chemotherapy treatment for patients with acute myeloid leukemia (AML). The...
ASH 2016: Study Shows Patients Traditionally Ineligible for Studies May Benefit From Trial Participation
Patients who potentially could benefit most from participation in clinical trials due to poor prognoses often are not included based on eligibility criteria, such as existing medical illnesses. A novel study at The University of Texas MD Anderson Cancer Center revealed some patients with acute...
ASH 2016: Biomarker May Predict Which Patients Previously Treated for Cancer Will Develop Highly Fatal Form of Leukemia
Patients successfully treated for breast, colon, and other cancers can go on to develop an often-fatal form of leukemia, sometimes years after completion of treatment, due to a genetic mutation leading to secondary malignancies known as therapy-related myeloid neoplasms. A study conducted by...
ASH 2016: New CAR T-Cell Therapy Holds Promise for Children and Young Adults With Hard-to-Treat ALL in Phase I Trial
Children and young adults with relapsed or refractory acute lymphoblastic leukemia (ALL) who receive chimeric antigen receptor (CAR) T-cell therapy targeting CD22, a protein found on the surface of leukemic cells, appear to mount a clinical response and, in some cases, achieve remission....
ASH 2016: Preventative Antibiotics Could Prevent Clostridium difficile Among Stem Cell Transplant Recipients
It may be possible to safely prevent one of the most common—and costly to treat—infections contracted by hospitalized patients undergoing bone marrow transplantation for the treatment of blood cancers, according to a study from the Abramson Cancer Center at the University of...
EORTC-NCI-AACR 2016: ‘Remarkable Antitumor Activity’ in Phase I Studies of PDGFRα and KIT Mutation Inhibitors
Two studies at the 28th EORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics in Munich, Germany focused on the inhibition of mutations in the KIT and PDGFRα oncogenes. These genes provide instructions for making proteins that are part of a family of proteins called receptor...
FDA Grants Full Approval and Label Update for Ponatinib in CML and ALL
The U.S. Food and Drug Administration (FDA) has granted ponatinib (Iclusig) full approval for the treatment of adult patients with chronic-phase, accelerated-phase, or blast-phase chronic myeloid leukemia (CML) or Philadelphia chromosome–positive acute lymphoblastic leukemia (ALL) for whom no ...
ASCO Releases Criteria for High-Quality Clinical Pathways in Oncology
ASCO today released Criteria for High-Quality Clinical Pathways in Oncology, a set of 15 inter-related criteria that provide an overarching framework for assessing pathway programs in the United States. ASCO developed the criteria to guide stakeholders in assessing the quality, utility, and...
FDA Grants Priority Review to Pembrolizumab for New Indication in Microsatellite Instability–High Cancer
On November 28, the U.S. Food and Drug Administration (FDA) accepted for review the supplemental Biologics License Application (sBLA) for pembrolizumab (Keytruda) for the treatment of previously treated patients with advanced microsatellite instability–high (MSI-H) cancer. The FDA granted...
Study Shows Modestly Reduced Breast Cancer Recurrence Risk With Increased Protein Intake Independent of Tumor Insulin Receptor Status
In an analysis in the Nurses’ Health Study population reported in the Journal of Clinical Oncology, Holmes et al found modest reductions in the risk for distant recurrence of breast cancer with greater protein intake. No associations with intake of essential amino acids, branched-chain amino...
Gleevec Is Saving My Life but at a Cost
Like many patients in the chronic phase of chronic myeloid leukemia (CML), my cancer was discovered during a routine physical, when an off-the-chart white blood cell count signaled a serious problem that my primary care physician attributed to unspecified internal bleeding. Fortunately for me, my...
Long-Term Effects of Finasteride in Patients From the Prostate Cancer Prevention Trial
In the Prostate Cancer Prevention Trial finasteride was found to reduce the risk of low-grade prostate cancer but to have no effect on overall survival. Results of the trial, in which 18,880 men were randomized to receive finasteride or placebo for 7 years, were reported in 2003. In a recent study...
SU2C Launches $7.5 Million Initiative in Research Grants Focusing on Immuno-oncology
Stand Up To Cancer (SU2C) is making $7.5 million in research grants available to early-career scientists who are pursuing innovative cancer research projects focusing on immuno-oncology, the American Association for Cancer Research recently announced. Funded by a grant from SU2C Visionary...
Baylor Welcomes New McNair Scholar, Bing Zhang, PhD
Bing Zhang, PhD, a computational biologist with a focus on cancer bioinformatics, has been named the newest McNair Scholar at Baylor College of Medicine. The McNair Scholar program at Baylor identifies influential researchers in breast and pancreatic cancers, juvenile diabetes, and neuroscience....
Advanced Practitioners Convene at Fourth Annual JADPRO Live at APSHO
Launched in 2012 by Harborside Press, publisher of the Journal of the Advanced Practitioner in Oncology (JADPRO) and The ASCO Post, this year’s JADPRO Live at APSHO conference topped previous attendance records with nearly 1,100 attendees. APSHO, the Advanced Practitioner Society in Hematology and...
Drainage of Massive Ascites: Patient of Nicholas Senn, MD
Prior to the 20th century, there were very few specific therapies for disease. Many diseases, especially cancers and infections, resulted in accumulations of fluid or pus in body cavities. Physicians had to become masters of the trocar, needle, and catheter. They learned to artfully remove fluid...
Expect and Encourage Questions About Breast Reconstruction
An article in The New York Times about women who had chosen not to have reconstruction following breast cancer surgery might prompt questions from newly diagnosed patients considering their options.1 Deanna J. Attai, MD, FACS, told The ASCO Post that whenever an article on breast cancer appears in...
Helping Patients With Breast Cancer Decide Whether to Have Reconstruction
A “nascent movement to ‘go flat’” is how an article in The New York Times characterized the decisions by some women to opt out of reconstruction following surgery for breast cancer.1 The article examined the reasons several patients made that decision, which included avoiding multiple surgeries and ...
Elisabeth Heath, MD, FACP, Honored With 2016 Michigan Cancer Consortium Champion Award
Elisabeth Heath, MD, FACP, Leader of the Genitourinary Oncology Multidisciplinary Team and the Patricia C. and E. Jan Hartmann Endowed Chair for Prostate Cancer Research at the Barbara Ann Karmanos Cancer Institute, was recently honored with the Michigan Cancer Consortium’s inaugural Champion...
Dave, Dave, Dave
It was 1983, and I was in my third year as an attending physician at a major East Coast university medical center and just 5 years out of fellowship. As was common at the time, I saw and treated all malignancies except leukemia and gynecologic cancers. In the middle of a typically busy day at the ...
Center for Leukemia and Lymphoma Research at UNMC Renamed Dr. James O. Armitage Center for Leukemia and Lymphoma Research
The University of Nebraska Board of Regents voted to rename an area of the University of Nebraska Medical Center (UNMC) in honor of a longtime professor who has made extraordinary contributions to the institution. The Center for Leukemia and Lymphoma Research, established in 2003, was renamed by...
Bridge Medicines Launched to Advance Promising Early Technologies in Major Academic Institutions
Memorial Sloan Kettering Cancer Center, Rockefeller University, and Weill Cornell Medicine have announced that they have established a new drug discovery company called Bridge Medicines. Launched in partnership with Takeda Pharmaceutical Company Ltd and health-care investment firms Bay City Capital ...
