Search Results
Your search for ,USE matches 11180 pages
Showing 6051 - 6100Brentuximab Vedotin for Adult Patients With Primary Cutaneous Anaplastic Large Cell Lymphoma
On November 9, 2017, brentuximab vedotin (Adcetris) received regular approval for the treatment of adult patients with primary cutaneous anaplastic large cell lymphoma or CD30-expressing mycosis fungoides who have received prior systemic therapy.1,2 Supporting Efficacy Data Approval was based on...
Giving Back After Cancer
My diagnosis of neuroblastoma when I was 14 happened rather accidentally. I was a competitive dancer and very active in sports my first year in high school and had no symptoms of cancer or any illness. It wasn’t until my mother, who is a nurse, came into my room one morning to wake me for school...
Gemtuzumab 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...
Data Must Be Generated to Support Cross-Labeling of Combination Therapies for Cancer
Combinations of targeted therapies (triple, quadruple, or even more) are part of the future of cancer treatment, which means that traditional clinical trials will have to be streamlined and updated to enable greater flexibility and to extract adequate safety and efficacy data. Problems inherent in...
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 ...
WHAT SHOULD PUMA DO?
Puma should invest in developing an escalating-dose schedule for neratinib (Nerlynx). If one plans on giving a drug for a year, and starts after finishing a year of effective adjuvant therapy, there is no hurry to begin at full, intolerable doses. Starting at a lower dose and escalating slowly as...
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....
FDA Grants Regular Approval to Pertuzumab for Adjuvant Treatment of HER2-Positive Breast Cancer
On December 20, 2017, the U.S. Food and Drug Administration (FDA) granted regular approval to pertuzumab (Perjeta) for use in combination with trastuzumab (Herceptin) and chemotherapy as adjuvant treatment of patients with HER2-positive early breast cancer at high risk of recurrence. Approval was...
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...
NIH Research Program Partners With National Library of Medicine to Advance Precision Medicine
THE NATIONAL INSTITUTES OF HEALTH’S All of Us Research Program and the National Library of Medicine (NLM) have teamed up to raise awareness about the program, a landmark effort to advance precision medicine. Through this 3-year pilot program, the National Network of Libraries of Medicine has...
ASCO Kicks Off Strategic Planning to Support Women in Oncology
Women in oncology aren’t ascending the leadership ladder at rates anywhere close to their male counterparts—and ASCO wants to fix that. The most recent report on “The State of Women in Academic Medicine” from the Association of American Medical Colleges (AAMC) said that although women make up...
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 ...
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...
European Union Expert Group Releases Position Statement on Lung Cancer Screening in Europe
AS REPORTED in The Lancet Oncology by Matthijs Oudkerk, MD, of the University of Groningen, the Netherlands, and colleagues, a European Union (EU) expert group has issued a position statement on low-dose computed tomography (CT) screening for lung cancer, proposing a near-term phased implementation ...
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...
National Cancer Institute Sponsors Training Program on Supportive Cancer Care
The National Cancer Institute has funded a training program for health-care professionals providing supportive cancer care. The training comprises foundational webinars by experts in the field, a 2-day skills-based workshop, ongoing monthly consultation, and a discussion board. Each workshop will...
Sunitinib Malate for Adjuvant Treatment of Renal Cell Carcinoma
On November 16, 2017, sunitinib malate (Sutent) was approved for the adjuvant treatment of adult patients at high risk of recurrent renal cell carcinoma following nephrectomy.1,2 Supporting Efficacy Data Approval was based on the findings of the double-blind phase III S-TRAC trial in which 615...
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...
Outcomes Associated With Higher Fiber Intake After Colorectal Cancer Diagnosis
IN A STUDY reported in JAMA Oncology, Mingyang Song, MD, ScD, of Massachusetts General Hospital and Harvard Medical School, and colleagues found that higher fiber intake after diagnosis of nonmetastatic colorectal cancer is associated with improved colorectal cancer–specific and overall survival.1 ...
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...
Medical Aid in Dying: When Legal Safeguards Become Burdensome Obstacles
In 2017, the District of Columbia (DC) became the seventh jurisdiction in the United States to legalize medical aid in dying,1 which gives terminally ill patients the option of how and when they die. The new DC statute is nearly identical to earlier enacted medical aid in dying statutes in...
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...
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 ...
Dose-Dense Chemotherapy in Early Breast Cancer: A ‘Win-Win’ Treatment Approach
INCREASING THE DOSE density of chemotherapy lowers the risk of recurrence and breast cancer death by about 15% in women with early breast cancer, according to a large, meticulously conducted meta-analysis by the Early Breast Cancer Trialists’ Collaborative Group (EBCTCG).1 The trials included in...
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...
Expert Point of View: Keith Stewart, MB, ChB
COMMENTING ON the ALCYONE trial for The ASCO Post, Keith Stewart, MB, ChB, the Carlson and Nelson Endowed Director of the Center for Individualized Medicine at the Mayo Clinic, Rochester, Minnesota, said, “Daratumumab added to a combination of drugs that we don’t use much anymore in the United...
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...
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...
FDA Grants Regular Approval to Pertuzumab for Adjuvant Treatment of HER2-Positive Breast Cancer
On December 20, 2017, the U.S. Food and Drug Administration (FDA) granted regular approval to pertuzumab (Perjeta) for use in combination with trastuzumab (Herceptin) and chemotherapy as adjuvant treatment of patients with HER2-positive early breast cancer at high risk of recurrence. APHINITY...
FDA Accepts sNDA for Osimertinib in First-Line Treatment of EGFR-Mutated NSCLC
On December 18, the U.S. Food and Drug Administration (FDA) accepted a supplemental New Drug Application (sNDA) for the use of osimertinib (Tagrisso)—a third-generation, irreversible epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor with clinical activity against central...
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...
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...
Does Warfarin Have Anticancer Potential in Persons Older Than Age 50?
A Norwegian population–based cohort study indicated that the use of warfarin was associated with a reduced risk of cancer overall and site-specific cancers among patients aged > 50 years. The findings were reported in JAMA Internal Medicine by Haaland et al. As noted by the investigators,...
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...
Hormonal Contraception and Breast Cancer Risk
As reported in The New England Journal of Medicine by Mørch et al, a Danish study has shown that the risk of breast cancer is increased in hormonal contraception users vs nonusers, with the absolute increase in risk being small. Study Details The study assessed the association between the...
ASH 2017: MURANO Trial: Venetoclax Found Superior to Standard Chemotherapy When Combined With Rituximab in CLL
In the phase III MURANO trial, treatment with the targeted cancer drug venetoclax (Venclexta) in combination with rituximab (Rituxan) more than doubled the likelihood that patients with chronic lymphocytic leukemia (CLL) would survive for 2 years without cancer progression, compared to treatment...
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: People Aged 75 Years and Older Are Underrepresented in Blood Cancer Clinical Trials
In the first comprehensive analysis of clinical trial enrollment among older adults with blood cancers, researchers from the U.S. Food and Drug Administration (FDA) found significant gaps in participation among those aged 75 and older when considered against the incidence of these malignancies in...
Novel Clinical-Genomic Risk Group Classification for Localized Prostate Cancer
As reported in the Journal of Clinical Oncology, Spratt et al have developed an integrated clinical-genomic risk classifier for predicting distant metastasis in patients with localized prostate cancer. The classifier uses National Comprehensive Cancer Network® (NCCN) risk categories and risk...
BELLE-3 Trial: Combination Therapy in Resistant Advanced Breast Cancer
The phase III BELLE-3 trial has shown prolonged progression-free survival but a worse safety profile with the addition of the pan-phosphoinositide 3-kinase inhibitor buparlisib to fulvestrant (Faslodex) in postmenopausal women with hormone receptor–positive, HER2-negative advanced breast...
ASH 2017: Addition of Brentuximab Vedotin to Multidrug Regimen Reduces Risk of First-Line Treatment Failure in Advanced Hodgkin Lymphoma
Patients with advanced Hodgkin lymphoma (HL) who were treated with a multidrug regimen that included the targeted agent brentuximab vedotin (Adcetris) had a 23% reduction in the risk of disease progression, death, or the need for additional therapy, compared with patients who received the standard...
ASH 2017: Sustained Benefit With Ibrutinib in Relapsed or Refractory Mantle Cell Lymphoma
The results of a pooled analysis of patients with relapsed or refractory mantle cell lymphoma (MCL) treated with ibrutinib (Imbruvica) were presented at the 2017 American Society of Hematology (ASH) Annual Meeting & Exposition (Abstract 151). The extended follow-up data demonstrated that...
ASH 2017: RESONATE-2 Trial: Patient-Reported Outcomes on Ibrutinib Treatment in Patients With CLL
At the 2017 American Society of Hematology (ASH) Annual Meeting & Exposition, the 3-year follow-up data from the RESONATE-2 study (PCYC-1115/1116) were presented. The investigators found that patients with previously untreated chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL)...
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 &...
FDA Approves First Biosimilar for the Treatment of Certain Breast and Stomach Cancers
On December 1, 2017, the U.S. Food and Drug Administration (FDA) approved trastuzumab-dkst (Ogivri) as a biosimilar to trastuzumab (Herceptin) for the treatment of patients with breast or metastatic gastric or gastroesophageal junction adenocarcinoma whose tumors overexpress the HER2 gene. The...
