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Showing 6651 - 6700Gemtuzumab Ozogamicin in CD33-Positive Acute Myeloid Leukemia
On September 1, 2017, gemtuzumab ozogamicin (Mylotarg) was approved for treatment for newly diagnosed CD33-positive acute myeloid leukemia (AML) in adults and for treatment of relapsed or refractory CD33-positive AML in adults and pediatric patients aged ≥ 2 years.1,2 It may be used in combination...
FDA Helps Streamline Approval Process for Supplemental Drug Indications
As researchers learn more about the natural history of cancers, as more drugs are effective for more types of the disease, and as the number and complexity of combination therapies increase, the more important it is that new drugs and permutations of old ones be available to patients. The U.S. Food ...
Neratinib Is Approved: Should We Reject It Anyway?
The U.S. Food and Drug Administration (FDA) approved 1 year of extended adjuvant neratinib (Nerlynx) after chemotherapy and a year of trastuzumab (Herceptin) for HER2-positive breast cancer this summer on the basis of the ExteNET trial. Many were surprised at the approval, since the evidence of...
Mount Sinai Surgeons Remove Cancerous Lymph Nodes Using Novel Robot-Assisted Procedure
A team of surgeons at Mount Sinai Beth Israel, led by Hyunsuk Suh, MD, Assistant Professor in the Department of Surgery at the Icahn School of Medicine at Mount Sinai, has performed the first robot-assisted radical neck dissection in the United States using the bilateral axillo-breast approach, a...
St. John’s Wort
The ASCO Post’s Integrative Oncology series is intended to facilitate the availability of evidence-based information on integrative and complementary therapies commonly used by patients with cancer. In this installment, Jun J. Mao, MD, MSCE, and Jyothirmai Gubili, MS, explore the role of St....
Katherine E. Reeder-Hayes, MD, Sees Equity as Next Big Challenge in Breast Cancer Care
Breast cancer specialist Katherine E. Reeder-Hayes, MD, MBA, was born on a farm in Morgan County, Alabama. “My family grew soybeans and cotton and raised cattle. None of my family members were in the medical field, but I always felt comfortable around people who were sick or had emergencies and...
Fulvestrant Monotherapy for Postmenopausal Women With Advanced Breast Cancer
On August 28, 2017, fulvestrant (Faslodex) was approved at 500 mg as monotherapy for expanded use in postmenopausal women with hormone receptor–positive, HER2-negative advanced breast cancer who have not received previous endocrine therapy.1 Supporting Efficacy Data Approval was based on improved...
Another PI3K Inhibitor Welcome For Use in Indolent Lymphoma
PHOSPHATIDYLINOSITOL 3-KINASE (PI3K) signaling is important for the proliferation and survival of malignant B cells. Copanlisib (Aliqopa) is a novel pan-class PI3K inhibitor with predominant activity against PI3K-alpha and PI3K-delta isoforms. As reviewed in this issue of The ASCO Post, a phase II ...
Columbia and NewYork-Presbyterian Receive $700 Million Donation for Cancer Research and Care
Columbia University and NewYork-Presbyterian announced that Florence Irving and her late husband, Herbert Irving, have given $700 million to the two institutions to advance research and clinical programs for the treatment of cancer. The Irvings’ historic gift will have a profound impact on research ...
PI3K Inhibition With Copanlisib in Relapsed or Refractory Indolent Lymphoma
AS REPORTED in the Journal of Clinical Oncology by Martin Dreyling, MD, PhD, of University Hospital, Ludwig Maximilians University of Munich, and colleagues, the phase II CHRONOS-1 trial has shown a high response rate and durable responses with the phosphatidylinositol 3-kinase (PI3K) inhibitor...
ASCO Expands TAPUR Study Enrollment After Promising Initial Treatment Outcomes
ASCO’s Targeted Agent and Profiling Utilization Registry (TAPUR) Study has expanded four cohorts for enrollment of additional participants and continues to grow, with more than 500 participants and 16 therapies now available. The TAPUR Study is designed to identify signals of activity of...
Obinutuzumab in Previously Untreated Follicular Lymphoma
On November 16, 2017, obinutuzumab (Gazyva) was granted regular approval in combination with chemotherapy, followed by obinutuzumab monotherapy for patients achieving at least a partial remission, for the treatment of adult patients with previously untreated stage II bulky, III, or IV follicular...
ASCO Resolutions Approved by AMA House of Delegates
From November 11–14, ASCO delegates participated in the American Medical Association’s (AMA) Interim Meeting of the House of Delegates (HOD), the principal policy-making body of the AMA. During the meeting, several ASCO-backed resolutions were approved, including: Medicare Part B Drugs in QPP/MIPS...
Broadening the Evidence Base for Older Patients: FDA-ASCO Workshop Explores Emerging Strategies
In the not-so-distant past, clinical trials were considered an option only for the young and fit. Enrolling older people “used to be thought unethical,” said Janet Woodcock, MD, Director of the U.S. Food and Drug Administration (FDA)’s Center for Drug Evaluation and Research (CDER), as she opened...
Disease Progression and Deterioration of Health-Related Quality of Life in Advanced Breast Cancer
IN PATIENTS WITH estrogen receptor–positive, HER2-negative advanced or metastatic breast cancer, better quality of life may be prolonged by delaying the progression of the disease, according to an ongoing quality-of-life assessment from the PALOMA-2 study, presented by Nadia Harbeck, MD, PhD, of...
NIH Grants $6.4 Million to Better Identify Breast Cancer Biomarkers
Researchers at Albert Einstein College of Medicine, part of Montefiore, and Hackensack Meridian Health John Theurer Cancer Center at Hackensack University Medical Center have secured a 5-year, $6.4 million grant from the National Institutes of Health (NIH) to identify biomarkers that may predict...
Lung Cancer in Never Smokers: A Complex Clinical Phenomenon
Despite advances in prevention, early detection, and treatments, lung cancer remains the leading cause of cancer-related death in the United States. Although cigarette smoking is the main cause of lung cancer, about 10% of these patients are lifelong never smokers for whom the molecular...
Bosutinib for First-Line Use in Chronic Myeloid Leukemia: Is Three a Crowd?
BOSUTINIB ( BOSULIF) is the latest tyrosine kinase inhibitor that has shown a superior molecular response profile when compared with imatinib.1,2 An orally available dual SRC/ABL1 inhibitor, the drug was shown in preclinical studies to have a potent inhibitory activity against BCR-ABL1 and minimal ...
Checkpoint Inhibition for Patients With Recurrent or Advanced Cervical Cancer: A Promising Strategy, but Which Patients Will Benefit the Most?
For nearly 20 years, chemoradiation using single-agent platinum therapy has been the standard of care for advanced or recurrent cervical cancer.1 More recently, the Gynecologic Oncology Group (GOG) 240 trial tested the addition of bevacizumab (Avastin) to platinum-based chemotherapy, which...
Pembrolizumab in PD-L1–Positive Advanced Cervical Cancer
As reported in the Journal of Clinical Oncology by Jean-Sebastien Frenel, MD, of the Institut de Cancerologie de l’Ouest, Centre Rene Gauducheau, Saint-Herblain, France, and colleagues, pembrolizumab (Keytruda) treatment was found to be active in patients with programmed cell death ligand 1...
Balancing Opioid Use to Relieve Cancer-Related Pain and Protecting Patients From Addiction and Death
According to the Centers for Disease Control and Prevention (CDC), from 1999 to 2015, more than 183,000 people have died in the United States from overdoses related to prescription opioids, including methadone, oxycodone, and hydrocodone.1 To stem the epidemic in prescription opioid–related use and ...
Extended Endocrine Therapy in Postmenopausal Women With Breast Cancer: 2 Years as Effective as 5 Years
An additional 5 years of aromatase inhibitor therapy after 5 years of adjuvant endocrine therapy failed to improve disease-free survival compared with an additional 2 years of aromatase inhibitor therapy in postmenopausal women with hormone receptor–positive breast cancer, according to the results ...
Ribociclib Doubles Progression-Free Survival in Premenopausal Breast Cancer
PREMENOPAUSAL WOMEN with hormone receptor–positive, HER2-negative advanced breast cancer benefited substantially from the addition of ribociclib (Kisqali) to first-line endocrine therapy plus medical ovarian suppression, according to results from the MONALEESA-7 study.1 At the 2017 San Antonio...
Front-Line Brentuximab Plus AVD vs Standard ABVD in Advanced Hodgkin Lymphoma
FRONT-LINE TREATMENT of advanced Hodgkin lymphoma with brentuximab vedotin (Adcetris) plus doxorubicin/ vinblastine/dacarbazine (A+AVD) achieved superior outcomes compared with the standard four-drug regimen of doxorubicin/bleomycin/vinblastine/dacarbazine (ABVD). The substitution of brentuximab...
Reports From the Journal of Clinical Oncology
Immunotherapy in PD-L1–Positive Advanced Cervical Cancer Pembrolizumab (Keytruda) treatment was active in patients with programmed cell death ligand 1 (PD-L1)–positive advanced cervical cancer enrolled in the phase Ib KEYNOTE-028 trial. The findings were reported by Jean-Sebastien Frenel, MD, of...
Phase II Data for Venetoclax/Ibrutinib Combination in Relapsed or Refractory Chronic Lymphocytic Leukemia
THE COMBINATION of ibrutinib (Imbruvica) plus venetoclax (Venclexta) achieved favorable responses in patients with relapsed or refractory chronic lymphocytic leukemia (CLL), according to initial results of the phase II CLARITY trial presented at the 2017 American Society of Hematology (ASH) Annual ...
Daratumumab Improves Progression-Free Survival in Front-Line Myeloma Setting
FOR NEWLY DIAGNOSED multiple myeloma patients not eligible for transplant, the addition of the anti-CD38 monoclonal antibody daratumumab (Darzalex) to subcutaneous bortezomib (Velcade), melphalan, and prednisone (VMP) reduced the risk of disease progression or death by 50%, the phase III ALCYONE...
Updated Follow-up of ZUMA-1 Confirms Benefit of CAR T-Cell Therapy in Aggressive B-Cell Lymphoma
POSITIVE DATA about chimeric antigen receptor (CAR) T-cell therapy in lymphoma continue to accrue. Long-term follow-up of the pivotal ZUMA-1 trial shows that patients with refractory diffuse large B-cell lymphoma (DLBCL) continue to have durable responses to the CD19-directed CAR T-cell therapy...
Alexander Fleming Would Have Loved Our Success With Cancer Immunotherapy
THE UNIVERSITY of Edinburgh Medical School was established in 1726 during the Scottish Enlightenment. As one of the oldest medical schools in the English-speaking world, it is interesting to reflect on the seminal contributions made centuries ago by several alumni that are still relevant to the...
Howard A. ‘Skip’ Burris III, MD, FACP, FASCO, Elected ASCO President for 2019–2020 Term
Howard A. “Skip” Burris III, MD, FACP, FASCO, a long-time member and volunteer, has been elected to serve as the President of ASCO for the term beginning in June 2019. He will take office as President-Elect during the ASCO Annual Meeting in Chicago in June 2018. Additionally, five...
Study Finds Racial Disparities in Treatment of Clinically Significant Prostate Cancer
In a study reported in the Journal of Oncology Practice, Bickell et al found underuse of treatment for clinically significant prostate cancer was infrequent among white and black patients at two New York City hospitals, but black men accounted for nearly all such underuse of treatment. As noted by...
CAR T-Cell Therapy in Refractory B-Cell Lymphomas
As reported at the recent American Society of Hematology Annual Meeting & Exposition and in The New England Journal of Medicine, Schuster et al found that chimeric antigen receptor (CAR) T-cell therapy produced responses in a high proportion of patients with B-cell lymphomas refractory to or...
Updated Data in KEYNOTE-061: Pembrolizumab in Previously Treated Gastric or Gastroesophageal Junction Adenocarcinoma
The phase III KEYNOTE-061 trial investigating pembrolizumab (Keytruda) as a second-line treatment for patients with advanced gastric or gastroesophageal junction (GEJ) adenocarcinoma did not meet its primary endpoint of overall survival (OS) (hazard ratio [HR] = 0.82, 95% confidence interval [CI] = ...
FDA Accepts sNDA for Rucaparib in Recurrent Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
On December 5, Clovis Oncology announced that the U.S. Food and Drug Administration (FDA) has accepted a supplemental New Drug Application (sNDA) for rucaparib (Rubraca) and granted Priority Review status to the application, with a Prescription Drug User Fee Act (PDUFA) date of April 6, 2018. In...
ASH 2017: Dasatinib Plus Standard Chemotherapy Demonstrates 3-Year Survival Benefit in Pediatric Patients With Philadelphia Chromosome–Positive ALL
At the 59th American Society of Hematology (ASH) Annual Meeting & Exposition, Hunger et al presented data from the phase II CA180-372 study in pediatric patients with newly diagnosed Philadelphia chromosome–positive acute lymphoblastic leukemia (ALL) treated with dasatinib (Sprycel) added ...
Anti–PD-L1 Antibody in Advanced Urothelial Carcinoma After Platinum Failure
As reported in The Lancet Oncology by Patel et al, the anti–programmed cell death ligand 1 (PD-L1) antibody avelumab (Bavencio) produced durable responses in patients with locally advanced or metastatic urothelial carcinoma after failure of platinum-based therapy in two expansion cohorts of...
ASH 2017: Low–Molecular-Weight Heparin/Edoxaban vs Dalteparin for VTE Associated With Cancer
People with cancer face an increased risk for venous thromboembolism (VTE). Under current guidelines, cancer patients who develop VTE are prescribed low–molecular-weight heparin, an anticoagulant that must be injected under the skin daily for several months. While effective, this regimen can...
ASH 2017: Abatacept Nearly Eliminates Severe Acute GVHD After Hematopoietic Stem Cell Transplant
Results from a phase II clinical trial presented by Kean et al at the 59th American Society of Hematology (ASH) Annual Meeting (Abstract 212) show that the drug abatacept (Orencia) nearly eliminated life-threatening severe acute graft-versus-host disease (GVHD) in patients receiving hematopoietic...
ASH 2017: ALCYONE Trial: Adding Daratumumab to Bortezomib, Melphalan, and Prednisone in Multiple Myeloma
The first randomized trial to evaluate the use of a monoclonal antibody for treating newly diagnosed multiple myeloma showed that adding the drug daratumumab (Darzalex) to one of the standard treatment regimens reduced the likelihood of disease progression or death by 50%. The regimen also induced...
ASH 2017: Clinical Activity Seen With Anti-BCMA CAR T-Cell Therapy in Heavily Pretreated Multiple Myeloma
A one-time infusion of an investigational chimeric antigen receptor (CAR) T-cell therapy that targets a protein found on most multiple myeloma cells elicited an 86% overall response rate in 21 patients whose disease had come back or had not responded after a median of seven prior treatments,...
ASH 2017: JULIET Trial: 6-Month Analysis of Tisagenlecleucel in Relapsed/Refractory DLBCL Shows Sustained Responses
Six months after receiving a single dose of tisagenlecleucel, a chimeric antigen receptor (CAR) T-cell therapy that targets CD-19, high response rates persist among adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), according to findings reported by Schuster et al at...
ASH 2017: ZUMA-1: Responses to CAR T-Cell Therapy Still Strong After 1 Year in Patients With Refractory NHL
Among 108 patients with fast-growing and refractory aggressive non-Hodgkin lymphoma (NHL), more than half were still alive at least a year after receiving a single infusion of a CAR T-cell therapy called axicabtagene ciloleucel that targets the CD-19 protein frequently found on cancerous lymphoma...
ASH 2017: CLARITY Trial: Combination Treatment With Two Targeted Agents Shows Promise in Previously Treated CLL
One-third of patients with previously treated chronic lymphocytic leukemia (CLL) had no detectable disease after 6 months of combination therapy with the targeted agents ibrutinib (Imbruvica) and venetoclax (Venclexta), with no increase in the occurrence of tumor-lysis syndrome, a serious treatment ...
FDA Announces Approval, CMS Proposes Coverage of Diagnostic Test for Cancer Biomarkers
On November 30, the U.S. Food and Drug Administration (FDA) approved CDx (F1CDx), a breakthrough-designated, next-generation sequencing–based in vitro diagnostic test that can detect genetic mutations in 324 genes and 2 genomic signatures in any solid tumor type. The Centers for Medicare &...
Partial-Breast and Reduced-Dose Radiotherapy After Breast-Conserving Surgery
The UK IMPORT LOW phase III trial has shown noninferiority in local relapse for partial-breast and reduced-dose vs standard whole-breast radiotherapy after breast-conserving surgery in early breast cancer. These study results were reported by Charlotte E. Coles, PhD, of the University of...
Asparaginase-Associated Pancreatitis in Childhood Acute Lymphoblastic Leukemia
An observational study reported in The Lancet Oncology by -Wolthers et al in the Ponte di Legno Toxicity Working Group identified characteristics and the course of asparaginase-associated pancreatitis in childhood acute lymphoblastic leukemia. Kjeld Schmiegelow, MD, of The University Hospital...
Living a Full Life With Stage IV Non–Small Cell Lung Cancer
The discovery of my non–small cell lung cancer (NCSLC) in 2005 was serendipitous and completely unexpected. A never smoker and physically active my whole life, the only hint something might be amiss was a slight tickle in my throat, which I’m not even sure was related to my cancer diagnosis. In...
Untangling the Controversies of Hematopoietic Cell Transplantation
BOOKMARK Title: Hematopoietic Cell Transplants: Concepts, Controversies, and Future DirectionsEditors: Hillard M. Lazarus, MD; Robert Peter Gale, MD, PhD, DSc (hon), FACP; Armand Keating, MD, FRCP(C); Andrea Bacigalupo, MD; Reinhold Munker, MD; Kerry Atkinson, MBBS, MD, DTM&H, FRCP, FRACP; and...
Clinical Trials Actively Recruiting Patients With Pediatric Leukemia
The information contained in this Clinical Trials Resource Guide includes actively recruiting clinical studies focused on pediatric leukemia. These studies highlight quality-of-life reporting; neutropenia management; combination chemotherapy; chimeric antigen receptor (CAR) T-cell therapy and some...
Liposome-Encapsulated Daunorubicin and Cytarabine for AML Subtypes
On August 3, 2017, a liposome-encapsulated combination of daunorubicin and cytarabine (Vyxeos) was approved for treatment of adults with newly diagnosed therapy-related acute myeloid leukemia (AML) or AML with myelodysplasia-related changes.1,2 This is the first U.S. Food and Drug...
