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Showing 15351 - 15400Priority Review Granted for Abemaciclib in the Treatment of Advanced Breast Cancer
On July 10, the U.S. Food and Drug Administration (FDA) accepted a new drug application (NDA) for abemaciclib, a cyclin-dependent kinase (CDK) 4/6 inhibitor, and gave the NDA a Priority Review designation. The NDA includes Eli Lilly and Company’s submission of abemaciclib for two indications: ...
FDA Accepts sNDA for Dasatinib in Pediatric Patients With Philadelphia Chromosome–Positive Chronic-Phase CML
On July 10, the U.S. Food and Drug Administration (FDA) accepted a supplemental new drug application (sNDA) to include an indication for dasatinib (Sprycel) to treat children with Philadelphia chromosome–positive chronic-phase chronic myeloid leukemia (CML), as well as a powder for oral...
Factors Associated With Near-Miss/Safety Incidents in Cancer Radiotherapy
In a single-institution case-control analysis reported in the Journal of Oncology Practice, Judy et al found that complexity of procedure or schedule was a significant factor in near-miss or safety incidents involving cancer patients undergoing radiotherapy. Study Details The study involved a...
Overall Survival With Nivolumab vs Chemotherapy in Ipilimumab-Refractory Advanced Melanoma
As reported in the Journal of Clinical Oncology by Larkin et al, the phase III CheckMate 037 trial has shown no difference in overall survival with nivolumab (Opdivo) vs investigator’s choice of chemotherapy in ipilimumab (Yervoy)-refractory advanced melanoma. More chemotherapy patients never ...
MammaPrint Test Addressed in ASCO Breast Cancer Guideline Update
New recommendations on the use of the MammaPrint genomic test issued on July 10 will help guide decisions on adjuvant systemic therapy for women with early breast cancer. The recommendations update the ASCO 2016 clinical practice guideline on the use of biomarkers in these patients. The...
Narrow Network Insurance Plans More Likely to Exclude Doctors at NCI-Designated and NCCN Member Cancer Centers
Patients with cancer in the United States may be unable to access care at the nation’s top hospitals due to narrow insurance plan coverage—leaving patients to choose between lower premiums or access to higher-quality cancer care. A new study from the Perelman School of Medicine at the...
Delaying Lymph Node Biopsy After Melanoma Diagnosis May Not Adversely Affect Survival Rates
Postponing lymph node biopsy more than 30 days after melanoma diagnosis does not adversely impact long-term clinical outcomes, according to findings published by Nelson et al in the Journal of the American College of Surgeons. Today, management of high-risk melanomas starts with surgical removal...
Effect of Patient-Reported Symptoms on Adherence to Preventive Treatment for Breast Cancer
In an analysis of the UK cohort of the International Breast Cancer Intervention Study (IBIS-I) reported in the Journal of Clinical Oncology, Smith et al found similar effects of predefined symptoms on nonadherence in both tamoxifen and placebo recipients. IBIS-I randomized women at high risk of...
Current Performance Measures for Cervical Cancer Screening
Health-care systems use performance measures for cervical cancer screening based on guidelines from such organizations as the American College of Obstetricians and Gynecologists to monitor the appropriateness of cervical cancer screening. According to the performance measure in the Healthcare...
FDA Grants 510(k) Clearance to Halcyon IMRT Treatment System
Varian Medical Systems has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its Halcyon system, a new device for cancer treatment. Halcyon simplifies and enhances image-guided volumetric-intensity modulated radiotherapy (IMRT). “We are proud that Halcyon has now...
FDA Places Clinical Hold on Three Studies Evaluating Pembrolizumab in Multiple Myeloma
On July 5, Merck announced that the U.S. Food and Drug Administration (FDA) has placed a clinical hold on KEYNOTE-183, KEYNOTE-185, and KEYNOTE-023, three combination studies of pembrolizumab (Keytruda), an anti–programmed cell death protein 1 (PD-1) therapy, in multiple myeloma. This...
Idarubicin vs High-Dose Daunorubicin Induction in Newly Diagnosed Acute Myeloid Leukemia
A Korean phase III trial has shown no difference in outcomes with high-dose daunorubicin vs idarubicin induction in newly diagnosed acute myeloid leukemia, although high-dose daunorubicin was associated with better outcomes in patients with FLT3–internal tandem duplication (ITD) mutation....
Adding Evofosfamide to Doxorubicin in Advanced Soft-Tissue Sarcoma
A phase III trial (TH CR-406/SARC021) has shown no survival benefit of adding evofosfamide to doxorubicin in the first-line treatment of locally advanced unresectable or metastatic soft-tissue sarcoma. Trial results were reported in The Lancet Oncology by Tap et al. Evofosfamide is a...
Has a New Standard Really Been Established for the Adjuvant Treatment of Pancreatic Cancer?
THE PAST YEAR has undoubtedly been a disappointing one as far as clinical advances in pancreatic cancer go. No fewer than five high-profile randomized phase II or III trials in this setting reported negative results in 2016, ranging from next-generation cytotoxic agents1 to novel immunotherapeutic ...
Conquer Cancer Foundation Researcher Spotlight: Dr. Supriya Mohile
SUPRIYA MOHILE, MD, MS Associate Professor of Medicine, Director of the Geriatric Oncology Clinic University of Rochester Medical Center Rochester, New York Older adults are the population most affected by cancer: 60% of all cancer occurs in this group. Yet the field of oncology that focuses on...
Encouraging Results With Pembrolizumab in Relapsed/Refractory Classical Hodgkin Lymphoma
AN EFFECTIVE antitumor immune response relies on cytotoxic T cells that are activated and able to target the malignant clone. As T cells become activated, they upregulate suppressive receptors including programmed cell death protein 1 (PD-1). Upregulation of inhibitory signals is important to...
A Great IDEA: Celebrating 15 Years of the International Development and Education Award
In 2017, ASCO and the Conquer Cancer Foundation of ASCO are proud to celebrate the 15th anniversary of the International Development and Education Award (IDEA). The IDEA program supports the professional development of early-career oncologists in low- and middle-income countries around the world....
Pembrolizumab Is Highly Active in Relapsed/Refractory Classical Hodgkin Lymphoma
AS REPORTED in the Journal of Clinical Oncology by Robert Chen, MD, of City of Hope National Medical Center, and colleagues, the phase II KEYNOTE-087 trial has shown that the programmed cell death protein 1 (PD-1) inhibitor pembrolizumab (Keytruda) is highly active in patients with relapsed/...
Preparing for Future Challenges in Geriatric Surgical Oncology
In the past decade, advances in surgical oncology have been echoed in the field of geriatric oncology. The current literature regarding older people with cancer includes mainly retrospective cohort studies, focusing on alternatives to radical surgery in comorbid patients. More recently, work has...
ASCO’s New MACRA Decision Tree Tool Helps Determine Which QPP Reporting Requirements Apply to Your Practice
Believe it or not, we’re halfway through the 1st year of the Quality Payment Program (QPP). ASCO, the Centers for Medicare & Medicaid Services (CMS), and other stakeholders have released guidance on successfully complying with QPP, but tailored information addressing a practice’s specific...
ASCO’s TAPUR Study Continues Its Expansion of Sites, Participants, and Collaborators
ASCO’s Targeted Agent and Profiling Utilization Registry (TAPUR) Study continues to expand and now has more than 300 participants enrolled on study drugs, more than 100 sites in 20 states, new partnerships, and a -revised protocol to lower the age of eligibility. Recently, eight new centers in 36...
Neoadjuvant Studies of Endocrine Approaches in Breast Cancer Mandated Before Embarking on Large Adjuvant Studies
Largely based on studies demonstrating that letrozole can suppress plasma estradiol levels to a greater extent than anastrozole,1 the adjuvant activity of these endocrine agents were compared in 4,136 patients with node-positive breast cancer in the FACE trial. As reviewed in this issue of The ASCO ...
No Efficacy Difference Between Adjuvant Letrozole and Anastrozole in Postmenopausal Women With Early Breast Cancer
As reported in the Journal of Clinical Oncology by Ian E. Smith, MD, of The Royal Marsden Hospital and Institute of Cancer Research, and colleagues, final results of the phase III FACE trial showed no difference in disease-free or overall survival for adjuvant letrozole vs anastrozole in...
Autologous and Allogeneic Hematopoietic Cell Transplantation
HERE ARE SEVERAL ABSTRACTS selected from the proceedings of the 2016 American Society of Hematology (ASH) Annual Meeting & Exposition, highlighting clinical trials on autologous and allogeneic hematopoietic cell transplantation for various hematologic malignancies. Additional selected...
Update on NCI Projects Aimed at Advancing Precision Medicine
“PRECISION MEDICINE will lead to fundamental understanding of the complex interplay among genetics, epigenetics, nutrition, environment and clinical presentation, and direct effective, evidence-based prevention and treatment. We can’t measure all that all at once right now, but we are starting to...
Expert Point of View: Leisha A. Emens, MD, PhD
STUDY DISCUSSANT Leisha A. Emens, MD, PhD, of Bloomberg~Kimmel Institute for Cancer Immunotherapy at Johns Hopkins University, Baltimore, entitled her remarks, “Target Practice in Triple-Negative Breast Cancer,” referring to the fact that there is currently no validated target in this aggressive...
Retreatment With Checkpoint Inhibitors May Be Feasible for Some Patients With NSCLC
INCREASING NUMBERS of patients are being treated with checkpoint inhibitors, and about one-quarter to one-third will develop immune-related adverse events. One question on the minds of oncologists is can these patients be safely re-treated once their adverse events resolve? One of the first...
Expert Point of View: John Heymach, MD
"TO PUT THESE RESULTS into context, currently we have three approved epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors for EGFR-positive non–small cell lung cancer (NSCLC): gefitinib (Iressa), erlotinib (Tarceva), and afatinib (Gilotrif). Not many studies have compared these drugs ...
Dacomitinib Outperforms Gefitinib in EGFR-Positive NSCLC
DACOMITINIB, a second-generation epidermal growth factor receptor (EGFR)-targeted tyrosine kinase inhibitor, outperformed gefitinib (Iressa) as first-line treatment for EGFR-positive advanced non–small cell lung cancer (NSCLC) in the phase III ARCHER 1050 study.1 Dacomitinib improved...
Expert Point of View: Hans Hammers, MD, PhD
THE COMBINATION of checkpoint inhibitors and vascular endothelial growth factor (VEGF) inhibitors is attractive in renal cell carcinoma, said formal discussant of this trial, Hans Hammers, MD, PhD, of the University of Texas Southwestern Medical Center in Dallas. “Twenty-one percent of patients...
Cancer Survivor Publishes Book for Children About Cancer
A book aimed at helping young families understand cancer, Hair to the Queen! is now available on Amazon. Written by first-time author Tamara B. Rodriguez and illustrated by Carole A. Smith, the book empowers adults to discuss cancer with children in a simple and compassionate way. Hair to the...
Big Data and the Learning Machine
BOOKMARK Title: The Master Algorithm: How the Quest for the Ultimate Learning Machine Will Remake Our WorldAuthor: Pedro DomingosPublisher: Beacon PressPublication date: February 2017Price: $24.95, hardcover, 288 pages Technology is revolutionizing our understanding and treatment of diseases....
Atezolizumab/Bevacizumab Moves Forward in Metastatic Renal Cell Carcinoma
THE COMBINATION of atezolizumab (Tecentriq) plus bevacizumab (Avastin) showed promising results as first-line treatment of patients with metastatic renal cell carcinoma, according to a phase II trial called IMmotion 150. Based on these results, the phase III IMmotion 151 trial is comparing...
Fat Grafting and Patient-Reported Outcomes in Postmastectomy Breast Reconstruction
The use of fat grafting as a tool for breast reconstruction following a mastectomy may improve breast satisfaction, psychosocial well-being, and sexual well-being in patients, according to a study published by Bennett et al in JAMA Surgery. Fat grafting as an adjunct to breast reconstruction...
FDA Grants Marketing Approval to the Praxis Extended RAS Panel
On June 29, the U.S. Food and Drug Administration (FDA) granted marketing approval to the Praxis Extended RAS Panel, a next-generation sequencing test to detect certain genetic mutations in RAS genes in tumor samples of patients with metastatic colorectal cancer. The test is used to aid in the...
Annual Report to the Nation: Cancer Death Rates Continue to Decline
Overall cancer death rates continue to decrease in men, women, and children for all major racial and ethnic groups, according to the latest Annual Report to the Nation on the Status of Cancer, 1975–2014, published by Jemal et al in the Journal of the National Cancer Institute.1 The report finds...
Expert Point of View: Nitin Jain, MD, and Susan O'Brien, MD
Formal discussant of the GENUINE trial, Nitin Jain, MD, of The University of Texas MD Anderson Cancer Center, Houston, noted that the majority of responses to ibrutinib (Imbruvica) in high-risk patients are partial responses. “These patients [have disease progression] even in the context of...
Ublituximab/Ibrutinib Beneficial in Patients With Chronic Lymphocytic Leukemia
The addition of ublituximab (a glycoengineered anti-CD20 antibody) to ibrutinib (Imbruvica) improved response rates, depth of response, and led to quicker resolution of ibrutinib-associated lymphocytosis in patients with high-risk chronic lymphocytic leukemia (CLL) in the phase III GENUINE trial,...
Expert Point of View: Michael S. Sabel, MD; Marcela Maus, MD, PhD; and Carl June, MD
"We are now seeing the merger of immunotherapy with precision medicine. This is the epitome of personalized medicine,” said ASCO-invited expert Michael S. Sabel, MD, Chief of the Division of Surgical Oncology at University of Michigan Health Systems, Ann Arbor. He called the effort to target...
Pediatric Cancer Pain May Be Misunderstood and Largely Undertreated
Cancer pain in children poses certain unique challenges. Over the past decade, insightful research into pediatric cancer pain has focused on pain management that incorporates nonopioid therapies into standard care. To shed light on this important issue, The ASCO Post spoke with Christine T....
CAR T-Cell Therapy in Multiple Myeloma Yields 100% Response Rate
Chinese investigators reported that 100% of patients with relapsed or refractory multiple myeloma responded to autologous chimeric antigen receptor (CAR) T-cell therapy, and 14 of 19 (74%) who were followed for a median of 4 months achieved a stringent complete response and have not recurred.1...
Overcoming Sexism in Academic Medicine
The troubling results from a survey1 investigating the sexual harassment and discrimination experiences of academic medical faculty show that such incidents continue to happen with unexpected frequency despite increasing awareness of the problem. The study by Reshma Jagsi, MD, DPhil, and...
The Emperor’s New Clothes: Biosimilars and Cost in Oncology
Biosimilars are biologic products similar to the parent (branded) molecule in structure and function—such as erythropoietin and filgrastim (Neupogen).1 To truly bend the cost curve, we want to see a dramatic economic savings achieved as oncology biosimilars for rituximab (Rituxan), trastuzumab...
High-Risk Mutations Predict Poor Outcomes for Patients With Myelodysplastic Syndromes Undergoing Transplantation
Although several treatment options are available for patients with myelodysplastic syndromes (MDS), hematopoietic stem cell transplantation (HSCT) remains the only curative therapy.1 The risks of complications and death from transplantation can be substantial. Determining which patients may...
Pembrolizumab Moving Forward in Triple-Negative Breast Cancer
In the treatment of triple-negative breast cancer, checkpoint inhibition is making inroads in both early- and late-stage disease, and the line of treatment and expression of the programmed cell death ligand 1 (PD-L1) could be important in determining outcomes, according to studies reported at the...
Mutations in Myelodysplastic Syndrome Associated With Poorer Outcome After Stem Cell Transplantation
In a study reported in The New England Journal of Medicine, R. Coleman Lindsley, MD, PhD, of Dana-Farber Cancer Institute, and colleagues found that a number of mutations present in patients with myelodysplastic syndromes (MDS) were associated with poorer clinical outcome after allogeneic...
World Health Assembly’s New Cancer Resolution Reflects New Realities
The World Health Assembly (WHA)—the decision-making body of the World Health Organization (WHO)—adopted a long-expected cancer resolution at its 2017 meeting, the body’s first resolution on cancer in 12 years and the first to emphasize, among other issues, the accessibility and affordability of...
First Comprehensive Pediatric Hematology/Oncology Initiative Launched in Africa
Through public-private partnerships with the governments of Botswana, Uganda, and Malawi, His Excellency the President Lieutenant General Dr. Seretse Khama Ian Khama, of the Republic of Botswana; the Honorable Minister Dorcas Makgato, of the Ministry of Health and Wellness; the Bristol-Myers Squibb ...
FDA Approves Panitumumab for Use in Wild-Type RAS Metastatic Colorectal Cancer
On June 30, 2017, the U.S. Food and Drug Administration (FDA) approved the supplemental Biologics License Application (sBLA) for panitumumab (Vectibix) for patients with wild-type RAS (defined as wild-type in both KRAS and NRAS as determined by an FDA-approved test for this use) metastatic...
Scalp Cooling to Prevent Chemotherapy-Induced Alopecia: Is It Now Ready for Prime Time?
In oncology, sometimes we forget about the small, everyday things that can significantly impact a patient’s life. When patients are explained the side effects of chemotherapy and chemotherapy-induced alopecia, most women will cry or become visibly upset. When a woman loses her hair, it represents...
