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Showing 1151 - 1200Emerging Global Leaders in Biosimilar Development: Regulatory Guidance and Cost Impact
BIOLOGICS PLAY A KEY ROLE in cancer treatment and are the principal components of many therapeutic regimens.1 However, they require complex manufacturing processes, resulting in high cost and occasional shortages in supply, limiting the accessibility of cancer treatment for many patients, more so ...
Adjuvant Temozolomide in 1p/19q Non-Codeleted Anaplastic Glioma
Interim results of the phase III CATNON trial (EORTC study 26053-22054) indicate a survival benefit of adjuvant temozolomide in 1p/19q non-codeleted anaplastic glioma. These findings were reported in The Lancet by van den Bent et al. Study Details In the open-label 2 x 2 factorial trial, 745...
Detection of Early-Stage Cancers With Circulating Tumor DNA
In a bid to detect cancers early and in a noninvasive way, scientists at the Johns Hopkins Kimmel Cancer Center, Baltimore, reported they have developed a test that spots tiny amounts of cancer-specific DNA in blood, and have used it to accurately identify more than half of 138 people with...
Updates of Key Trials in Metastatic Non–Small Cell Lung Cancer: KEYNOTE-024 and AvaALL
IMMUNOTHERAPY AND ANTIANGIOGENESIS were highlighted in a session on metastatic non–small cell lung cancer (NSCLC) at the Best of ASCO New Orleans meeting. Matthew Gubens, MD, MS, presented the selected abstracts from the ASCO Annual Meeting.1 Dr. Gubens is Associate Professor of Thoracic Medical...
Fighting Misinformation in HPV-Related Cancer Prevention
FAKE NEWS, junk science, and alternative facts seem pervasive in our current culture, to the detriment of important, verified scientific advancements. One area where this is quite evident is the vaccine against human papillomavirus (HPV). Although we have had a safe, effective vaccine since 2006...
Unraveling the Complexities of Cellular Immunotherapy and Its Potential to Cure Some Cancers
This past fall, the Fred Hutchinson Cancer Research Center in Seattle opened an all-encompassing 9,222-square foot outpatient cellular immunotherapy clinic, specifically designed to serve patients participating in the center’s novel immunotherapy clinical trials, which mainly focus on chimeric...
Increased Endometrial Cancer Rates Found in Women With Increased Levels of Cadmium
Through a 5-year observational study recently published by McElory et al in PLOS One, researchers at the University of Missouri (MU) found that women with increased levels of cadmium—a metal commonly found in foods such as kidney, liver, and shellfish, as well as tobacco—had an...
Are Thyroid Cancer Incidence and Mortality Rates Truly Increasing in the United States?
THYROID CANCER diagnoses are increasing at a rate faster than any other malignancy in the United States. In 2017, there will be 56,870 new cases, accounting for 3.4% of all cancers, and 2,010 people will die of thyroid cancer.1 This represents a more than 200% increase in incidence since the...
Challenges in Geriatric Oncology in Low- and Middle-Income Countries: Focus on Latin America
Virtually every region and country in the world are experiencing population aging. Although developed regions still have the largest proportion of older persons, the absolute number of older adults is higher in developing regions of the world. Globally, more than 60% of all persons aged 65 now...
How to Help Young Patients Preserve Their Fertility
GUEST EDITOR Adolescent and Young Adult Oncology explores the unique physical, psychosocial, social, emotional, sexual, and financial challenges adolescents and young adults with cancer face. The column is guest edited by Brandon Hayes-Lattin, MD, FACP, Professor of Medicine and Medical Director...
A New Triumvirate in Estrogen Receptor–Positive Metastatic Breast Cancer
THE BODY OF EVIDENCE supporting the use of cell-cycle inhibitors in combination with endocrine therapy for estrogen receptor–positive metastatic breast cancer now has another agent in the spotlight. The phase III MONARCH 2 trial—reported at the 2017 ASCO Annual Meeting and by Sledge et al in the...
NCI-COG Pediatric MATCH Trial to Test Targeted Drugs in Childhood Cancers
Today, investigators at the National Cancer Institute (NCI) and the Children’s Oncology Group (COG) announced the opening of enrollment for a unique precision medicine clinical trial. NCI-COG Pediatric Molecular Analysis for Therapy Choice (Pediatric MATCH) is a nationwide trial to explore...
Pembrolizumab and Cetuximab-Treated Head and Neck Cancer: Activity Confirmed But No Surprises
WITH THE RECENT efficacy findings, improvements in survival, and resultant U.S. Food and Drug Administration (FDA) approvals of programmed cell death protein 1 (PD-1) immune checkpoint inhibitors across multiple solid tumor indications, the publication of yet another positive trial adds to the...
Pembrolizumab Is Active in Platinum- and Cetuximab-Refractory Head and Neck Cancer
IN THE PHASE II KEYNOTE-055 trial, pembrolizumab (Keytruda) was found to produce durable responses in patients with platinum- and cetuximab (Erbitux)-refractory head and neck squamous cell carcinoma.1 Results of the trial were reported by Joshua Bauml, MD, of the University of Pennsylvania,...
Avelumab in Refractory Metastatic Urothelial Carcinoma
The programmed cell death ligand 1 (PD-L1)–inhibitor avelumab (Bavencio) has shown activity in patients with refractory metastatic urothelial cancer, according to findings in a phase Ib study reported by Andrea B. Apolo, MD, of the Genitourinary Malignancies Branch, Center for Cancer Research,...
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...
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....
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/...
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...
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...
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...
Idelalisib in Resistant CLL: Benefit Shown, Questions Remain
As reported in The Lancet Oncology by Dr. Andrew Zelenetz and colleagues and reviewed in this issue of The ASCO Post, an international phase III trial in 416 patients with refractory or recurrent chronic lymphocytic leukemia (CLL) addressed the benefit of adding the first-in-class phosphoinositide...
FDA Unveils Plan to Eliminate Orphan Designation Backlog
Today, the U.S. Food and Drug Administration (FDA) unveiled a strategic plan to eliminate the agency’s existing Orphan Drug designation request backlog and ensure continued timely response to all new requests for designation with firm deadlines. The agency’s Orphan Drug Modernization...
Major Breakthrough in Development of Systemic Targeted Therapy for Midgut Neuroendocrine Tumors
This issue of The ASCO Post discusses a recent trial reported by Strosberg et al in The New England Journal of Medicine that is the first phase III randomized international multicenter clinical trial evaluating lutetium Lu-177 dotatate as a peptide receptor radionuclide therapy in midgut...
Abemaciclib Plus Fulvestrant Delays Breast Cancer Progression in MONARCH 2
In the treatment of metastatic estrogen receptor–positive breast cancer, a highly significant 45% reduction in progression was achieved with abemaciclib, combined with fulvestrant (Faslodex), in the global phase III MONARCH 2 trial, reported at the 2017 ASCO Annual Meeting by George W. Sledge, MD,...
Renowned Breast Cancer Researcher, Angela Hartley Brodie, PhD, Dies at 82
Angela Hartley Brodie, PhD, Professor Emeritus in the Department of Pharmacology at the University of Maryland School of Medicine, and an internationally recognized scientist whose groundbreaking cancer research is considered among the greatest advances in treating breast cancer, passed away on...
How Watson for Oncology Is Advancing Personalized Patient Care
After undergoing nearly 5 years of intensive medical training, IBM’s Watson for Oncology cognitive computing system is starting to make good on its promise to accelerate personalized care for patients with cancer. The system has been trained by oncologists at Memorial Sloan Kettering Cancer Center ...
SNMMI 2017: Personalized PRRT Improves Radiation Delivery to Neuroendocrine Tumors
Neuroendocrine tumors are difficult to manage and unlikely to be cured, but researchers intend to slow progression of these tumors and aid survival by personalizing patient doses of peptide receptor radionuclide therapy (PRRT), according to research presented at the 2017 Annual Meeting of the...
Adding Abemaciclib to Fulvestrant in Hormone Receptor–Positive, HER2-Negative Breast Cancer
In the phase III MONARCH 2 trial reported at the recent ASCO Annual Meeting and in the Journal of Clinical Oncology by Sledge et al, the addition of the selective cyclin-dependent kinase 4 and 6 (CDK4/6) inhibitor abemaciclib to fulvestrant (Faslodex) improved progression-free survival in hormone...
Lenalidomide, Bortezomib, and Dexamethasone With or Without Transplantation in Younger Myeloma Patients
In the French phase III IFM 2009 trial reported in The New England Journal of Medicine by Michel Attal, MD, of the Institut Universitaire du Cancer de Toulouse-Oncopole, and colleagues, consolidation treatment with lenalidomide (Revlimid), bortezomib (Velcade), and dexamethasone (RVD) was...
Geriatric Oncology: A Multidisciplinary Approach in a Global Environment
Geriatrics for the Oncologist is guest edited by Stuart M. Lichtman, MD, FACP, FASCO, and developed in collaboration with the International Society of Geriatric Oncology (SIOG). Dr. Lichtman is an Attending Physician at Memorial Sloan Kettering Cancer Center, Commack, New York, and Professor of...
Combination Therapy With Pembrolizumab in Metastatic Nonsquamous NSCLC
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 May 10, 2017, pembrolizumab (Keytruda) was granted accelerated...
Selected Novel Agents in Development for Multiple Myeloma
Here are several abstracts selected from the proceedings of the 2016 America Society of Hematology (ASH) Annual Meeting & Exposition, highlighting newer therapeutics for the development for patients with relapsed or refractory multiple myeloma. For full details of these study abstracts, visit...
Venetoclax Achieves Durable and Deep Remissions in CLL
Preliminary study results suggest that venetoclax (Venclexta) plus rituximab (Rituxan) is a highly active combination in relapsed/refractory chronic lymphocytic leukemia (CLL), achieving durable responses and minimal residual disease negativity in previously treated patients. “The results of our...
FDA Approves Pembrolizumab for First Tissue/Site-Agnostic Indication
On May 23, 2017, the U.S. Food and Drug Administration (FDA) granted accelerated approval to pembrolizumab (Keytruda) for adult and pediatric patients with unresectable or metastatic, microsatellite instability–high (MSI-H) or mismatch repair deficient (dMMR) solid tumors that have progressed...
Eliezer Robinson, MD, Traveled a Long, Hard Road and Became an International Leader in Oncology
Eliezer Robinson, MD, was born in Vienna, Austria, on June 17, 1931. At that time, Vienna, a bustling and prosperous city, was an important center of Jewish culture and education. Jews made up a large portion of the city’s professional class of doctors, lawyers, bankers, and artists. Dr. Robinson...
Waun Ki Hong, MD, FACP, Helped Change the Standard of Care in Laryngeal Cancer, Now Focuses on Chemoprevention and Precision Medicine
Waun Ki Hong, MD, FACP, one of the nation’s leading experts in head and neck and lung cancers, was born in South Korea and grew up in a tiny village outside the nation’s capital of Seoul. Number six of seven siblings, Dr. Hong described his early life in the cozy village as blissful, until the...
Zoledronic Acid Every 12 Weeks Noninferior to Every 4 Weeks in Skeletal-Related Event Rate for Breast Cancer With Bone Metastases
In the phase III OPTIMIZE-2 trial reported in JAMA Oncology, Gabriel N. Hortobagyi, MD, of The University of Texas MD Anderson Cancer Center, and colleagues found that an every-12-week schedule of zoledronic acid was noninferior to an every-4-week schedule with regard to skeletal-related event...
Niraparib in Recurrent Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
On March 27, 2017, the oral poly ADP-ribose polymerase (PARP) inhibitor niraparib (Zejula) was approved for maintenance treatment of patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in complete or partial response to platinum-based chemotherapy.1,2...
FDA Grants Priority Review to sBLA for Pembrolizumab in Recurrent or Advanced Gastric or GEJ Adenocarcinoma
The U.S. Food and Drug Administration (FDA) has accepted for review a supplemental Biologics License Application (sBLA) for pembrolizumab (Keytruda) seeking approval for treatment of patients with recurrent or advanced gastric or gastroesophageal junction (GEJ) adenocarcinoma who have already...
The Ongoing Challenges of Lung Cancer Screening
Lung cancer persistently remains the leading cause of cancer death among men and women in the United States. Only about 15% of lung cancers are diagnosed at the localized stage, when clinical intervention could markedly improve patient outcomes. For decades, lung cancer specialists and advocacy...
FDA Grants Accelerated Approval to Pembrolizumab for First Tissue/Site-Agnostic Indication
On May 23, 2017, the U.S. Food and Drug Administration (FDA) granted accelerated approval to pembrolizumab (Keytruda) for adult and pediatric patients with unresectable or metastatic, microsatellite instability–high (MSI-H) or mismatch repair deficient (dMMR) solid tumors that have progressed ...
Neratinib in Combination With Ado‑trastuzumab Emtansine in HER2-Positive Metastatic Breast Cancer
Puma Biotechnology presented interim results from the phase Ib/II FB-10 clinical trial of the oral pan-HER family irreversible tyrosine kinase inhibitor neratinib given in combination with the antibody-drug conjugate ado-trastuzumab emtansine (also known as T-DM1, Kadcyla) at the 2017 American...
Optimizing Treatment for Elderly Patients With Glioblastoma
In 2005, Stupp and colleagues published their landmark paper demonstrating in a randomized phase III trial that the addition of temozolomide to radiation increased overall survival in patients with newly diagnosed glioblastoma. Notably, patients over age 70 years were excluded from this study.1...
Short-Course Radiotherapy Plus Temozolomide Improves Survival in Older Patients With Glioblastoma
In a phase III trial reported in The New England Journal of Medicine, James R. Perry, MD, of Sunnybrook Health Sciences Centre, Toronto, and colleagues found that adding temozolomide to short-course radiotherapy improved overall survival in patients aged at least 65 years with newly diagnosed...
Intratumoral Plasmid Interleukin-12 Boosts Response to Pembrolizumab
In patients with stage III/IV melanoma, immunologically “cold” tumors were rendered immunologically active through intratumoral injections of plasmid interleukin-12 (IL-12) combined with pembrolizumab (Keytruda).1 Describing the approach at the 2017 ASCO-SITC Clinical Immuno-Oncology Symposium,...
FDA Approves Pembrolizumab for Advanced or Metastatic Urothelial Carcinoma
Today, the U.S. Food and Drug Administration (FDA) granted regular approval to pembrolizumab (Keytruda) for patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or...
Durvalumab With Olaparib or Cediranib in Women’s Cancers
As reported in the Journal of Clinical Oncology by Lee et al, a phase I study has shown activity of the combination of the programmed cell death ligand 1 (PD-L1) inhibitor durvalumab with either the poly (ADP-ribose) polymerase (PARP) inhibitor olaparib (Lynparza) or vascular endothelial growth...
Impact of Expert Pathologic Review on Lymphoma Diagnoses
As reported in the Journal of Clinical Oncology by Laurent et al, expert review of lymphoma diagnoses in French patients resulted in a change in diagnosis in 19.4% of cases of noncutaneous disease. Study Details In the study, 42,145 samples from patients with newly diagnosed or suspected...
FDA Approves Ribociclib/Letrozole Co‑Pack for Postmenopausal Patients With Advanced or Metastatic Breast Cancer
On May 8, the U.S. Food and Drug Administration (FDA) approved the copackaging of ribociclib (Kisqali) and letrozole (Femara) tablets for the treatment of hormone receptor–positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer in postmenopausal ...
