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Showing 17201 - 17250Investigational in Vitro Diagnostics in Oncology Trials: Streamlined Submission Process for Study Risk Determination
On April 16, 2018, the U.S. Food and Drug Administration (FDA) issued a draft guidance, “Investigational in Vitro Diagnostics in Oncology Trials: Streamlined Submission Process for Study Risk Determination,” to describe for sponsors of certain oncology trials an optional streamlined...
AACR 2018: Short-Acting Calcium Channel Blockers Associated With Increased Risk of Pancreatic Cancer in Postmenopausal Women
Calcium channel blockers (CCBs)—specifically the short-acting form of CCBs, which are prescribed to treat high blood pressure—were associated with an increased risk of pancreatic cancer in postmenopausal women, according to a study presented at the American Assocation for Cancer...
AACR 2018: Dual Inhibition of IDO1 and PD-L1 Safe in Patients With Advanced Solid Tumors
Treatment combining the IDO1 inhibitor epacadostat and the programmed cell death ligand 1 (PD-L1) inhibitor durvalumab (Imfinzi) was found to be safe in patients with advanced solid tumors, with safety data similar to treatment with durvalumab alone, according to data presented from the ongoing...
Efforts to Make Tobacco Cessation in Cancer Survivors Standard Practice
It is well established that smoking increases the risk for developing cancer, but when it comes to tobacco cessation in the cancer survivor population, should oncologists be stepping in, and what resources should they be using? Graham W. Warren, MD, PhD, posed these questions to the audience at the ...
AACR 2018: TLR9 Agonist CMP-001/Pembrolizumab Combination Shows Early Efficacy in Patients With Metastatic Melanoma Resistant to Anti–PD-1
A combination of CMP-001, an intratumoral Toll-like receptor 9 (TLR9) agonist, and pembrolizumab (Keytruda) was well tolerated and had clinical activity in patients with metastatic melanoma resistant to programmed cell death protein 1 (PD-1) checkpoint inhibition, according to preliminary data...
Expert Point of View: Timothy Gilligan, MD, MSc
“Knowing that exercise after surgery can help women with breast cancer quickly restore their full range of arm motion is an important step forward in their care,” said Timothy Gilligan, MD, MSc, Vice Chair for Education and Associate Professor of Medicine, Case Comprehensive Cancer...
AACR 2018: Prototype Assays Suggest Highly Specific Blood Test to Screen for Cancer Is Feasible
Initial findings from the Circulating Cell-Free Genome Atlas (CCGA) study showed that prototype sequencing assays tested in this analysis may facilitate the development of a highly specific blood test for early cancer detection, according to data presented at the American Association for Cancer...
Education Plus Exercise Improves Arm Mobility After Lymph Node Dissection in Women With Breast Cancer
In breast cancer survivors after lymph node dissection, a combined education and exercise intervention resulted in patients regaining full range of motion in both arms sooner than those who received education alone, according to follow-up from a phase III clinical trial reported by Electra D....
Expert Point of View: Christopher J. Recklitis, PhD, MPH
Christopher J. Recklitis, PhD, MPH, of Dana-Farber Cancer Institute and Harvard Medical School, called the results “instructive.” He said the study highlights the need for integrating mental health care into survivorship medical care. “We’re going to have to think about suicide prevention...
Elevated Suicide Risk Among Head and Neck Cancer Survivors Demands More Integrated Psychosocial Care
In general, the risk of suicide among cancer survivors is about 50% higher than in the general population, but this risk is especially elevated among survivors of head and neck cancer, according to research presented by Nosayaba Osazuwa-Peters, BDS, MPH, CHES, of the Department of...
Lower-Dose Radiation in HPV-Positive Head and Neck Cancers After Induction Chemotherapy
The results of a phase II clinical trial suggest that patients with head and neck cancers associated with the human papillomavirus (HPV) may receive significantly lower doses of radiation safely and effectively after response to induction chemotherapy.1 These findings from the OPTIMA study,...
Enormous Cost of Failure to Screen Heavy Smokers for Lung Nodules
In 2011 the American College of Radiology Imaging Network (ACRIN) group published its publicly funded study of three annual screening chest computed tomography (CT) scans among heavy smokers aged 55 to 74.1 The results remain the first and only screening study for any cancer demonstrating a...
Promise and Challenges of CAR T-Cell Therapy for Diffuse Large B-Cell Lymphoma: ZUMA-1 Trial Results
Advancing therapeutics and augmenting curability in diffuse large B-cell lymphoma (DLBCL) have been very challenging. Although many novel approaches have offered promise and continue to be developed, we have not yet identified a clearly superior approach to R-CHOP (rituximab [Rituxan],...
2018 Treatment Algorithm for Metastatic HER2-Positive Breast Cancer
How should clinicians position anti-HER2 agents and also incorporate endocrine therapies in the treatment of metastatic HER2-positive breast cancer? At the 2018 Miami Breast Cancer Conference, this question was explored by Sunil Verma, MD, Medical Director of the Tom Baker Cancer Center and...
FDA Approves Nivolumab/Ipilimumab Combination in Intermediate- or Poor-Risk Advanced RCC
On April 16, 2018, the U.S. Food and Drug Administration (FDA) granted approvals to nivolumab (Opdivo) and ipilimumab (Yervoy) in combination for the treatment of intermediate- or poor-risk previously untreated advanced renal cell carcinoma (RCC). CheckMate 214 The approvals were based on...
Low-Dose Abiraterone With Food vs Standard-Dose Abiraterone in Castration-Resistant Prostate Cancer
In a phase II trial reported in the Journal of Clinical Oncology, Szmulewitz et al found that low-dose abiraterone (Zytiga) given with a low-fat meal was noninferior to standard-dose abiraterone in the fasting state with regard to reduction in prostate-specific antigen (PSA) levels among patients...
Tivantinib in Second-Line Treatment of MET-High Advanced Hepatocellular Carcinoma
In the phase III METIV-HCC trial reported in The Lancet Oncology, Rimassa et al found no improvement in overall survival with the investigational MET inhibitor tivantinib vs placebo in patients with advanced hepatocellular carcinoma with high MET expression previously treated with sorafenib...
AACR 2018: Off-the-Shelf, Dual-Targeted CAR T-Cell Product Showed Promising Results in Preclinical Studies
FT819—an off-the-shelf, T-cell receptor–less CD19 chimeric antigen receptor (CAR) T-cell product that could potentially be made more accessible to patients with cancer than conventional CAR T-cell therapies—showed positive results in preclinical specificity, functionality, and...
AACR 2018: Selective Inhibitor Shows Early Promise in Patients With RET-Altered Cancers
BLU-667, a next-generation inhibitor that selectively targets the oncogenic receptor tyrosine kinase RET, was well tolerated and had broad clinical benefit in patients with advanced cancer that had progressed on previous therapies, including multikinase inhibitor therapy. Proof-of-concept data from ...
AACR 2018: Crizotinib Yielded a High Objective Response Rate for Adult Patients With ALK-Positive Inflammatory Myofibroblastic Tumor
Among patients with inoperable, advanced, or metastatic ALK-positive inflammatory myofibroblastic tumor, 50% were confirmed to have partial or complete tumor shrinkage after treatment with the ALK-targeted anticancer therapeutic agent crizotinib (Xalkori), according to data from the phase II EORTC...
AACR 2018: Children With Nonchromosomal Birth Defects May Face Higher Risk of Several Childhood Cancers
Children with nonchromosomal birth defects—such as congenital heart disease—had a significantly higher risk of developing childhood cancer than children who did not have birth defects, according to a study presented at the 2018 American Association for Cancer Research (AACR) Annual...
Racial/Ethnic Disparities in Liver Cancer Incidence in California
In a study among California residents reported in the Journal of the National Cancer Institute, Pham et al found that those designated as Asian/Pacific Islanders were at elevated risk of hepatocellular carcinoma (HCC) vs other racial/ethnic groups, with the highest risk observed among Southeast...
Minimal Residual Disease and Risk Stratification in Acute Myeloid Leukemia
In an analysis of the UK National Cancer Research Institute AML17 trial reported in the Journal of Clinical Oncology, Freeman et al found that detection of measureable/minimal residual disease (MRD) after first induction in acute myeloid leukemia (AML) may be prognostically equivalent to partial...
Wait for Diagnostic Testing and Effect on Outcomes in Patients With Cancer
The longer patients with a positive screening result wait for diagnostic testing, the worse their cancer outcomes may become, according to a literature review of breast, cervical, colorectal, and lung studies published by Doubeni et al in CA: A Cancer Journal for Clinicians led by researchers at...
Epacadostat Combined With Pembrolizumab in Patients With Unresectable or Metastatic Melanoma
On April 6, an external data monitoring committee commented on results from the phase III ECHO-301/KEYNOTE-252 trial of the investigational IDO1 inhibitor epacadostat plus pembrolizumab (Keytruda) in patients with unresectable or metastatic melanoma. The committee determined that the study did not...
FDA Accepts New Drug Application, Grants Priority Review for Duvelisib in CLL/SLL and Follicular Lymphoma
On April 9, the U.S. Food and Drug Administration (FDA) accepted for filing with Priority Review a new drug application (NDA) for the oral agent duvelisib, a first-in-class, dual inhibitor of phosphoinositide 3-kinase (PI3K)-delta and PI3K-gamma. The NDA is seeking full approval for duvelisib in...
ELCC 2018: Canadian Study Shows Coordinating Nurses Can Improve Patients’ Quality of Life and Satisfaction During Lung Cancer Treatment
Investing in the continuity of care for lung cancer patients can bring tremendous benefits in terms of patient satisfaction and quality of life. In Quebec, this investment has taken the form of a dedicated role on the medical team: The Pivot Nurse in Oncology (PNO). A study presented by Kassouf et...
ELCC 2018: Alectinib Provides Longer Symptom Improvement Than Crizotinib in ALK-Positive Lung Cancer
Alectinib provides longer symptom improvement than crizotinib in <em>ALK</em>-positive non–small cell lung cancer (NSCLC), according to results from the ALEX trial presented by Pérol et al at the European Lung Cancer Congress (ELCC) in Geneva, Switzerland (Abstract...
ELCC 2018: Immunotherapy Provides Long-Term Survival Benefit for Patients With Lung Cancer
Further evidence that immunotherapy provides long-term survival benefit for patients with lung cancer was presented by Mazières et al at the European Lung Cancer Congress (ELCC) in Geneva, Switzerland (Abstract 136PD_PR). Researchers presented the 3-year survival results of the randomized...
ASCO Clinical Practice Guideline: Optimizing Anticancer Therapy in Metastatic Noncastrate Prostate Cancer
As reported in the Journal of Clinical Oncology by Michael J. Morris, MD, of Memorial Sloan Kettering Cancer Center and Weill Cornell Medicine, and colleagues, ASCO has released a clinical practice guideline on optimizing anticancer therapy in men with metastatic noncastrate prostate cancer. To...
Larotrectinib in Pediatric Solid Tumors With TRK Gene Fusions
As reported in The Lancet Oncology by Laetsch et al, phase I results from an ongoing phase I/II trial have shown activity of the TRK kinase inhibitor larotrectinib in pediatric patients with solid tumors harboring TRK fusions. Study Details In the study, 24 patients in a dose-escalation cohort...
ESMO Releases Comments on Findings From the Pan-Cancer Atlas
The European Society for Medical Oncology (ESMO) welcomes the latest reports from The Cancer Genome Atlas (TCGA) as a major resource for researchers across the world and calls for increased across-the-board commitment to translate these efforts into medical advances for the benefit of patients with ...
NIH Completes In-Depth Genomic Analysis of 33 Cancer Types
Researchers funded by the National Institutes of Health (NIH) have completed a detailed genomic analysis, known as the Pan-Cancer Atlas, on a data set of molecular and clinical information from over 10,000 tumors representing 33 types of cancer. “This project is the culmination of more than...
Updated ASTRO Guideline for Palliative Radiotherapy in Lung Cancer
The American Society for Radiation Oncology (ASTRO) has issued an update to its clinical guideline for the use of palliative-intent radiation therapy for patients with incurable non–small cell lung cancer (NSCLC). Reflecting new evidence from randomized clinical trials, the guideline now...
Selinexor Receives Fast Track Designation From the FDA in Pentarefractory Multiple Myeloma
On April 10, the U.S. Food and Drug Administration (FDA) granted Fast Track designation to the oral selective inhibitor of nuclear export (SINE) compound selinexor for the treatment of patients with multiple myeloma who have received at least three prior lines of therapy. The FDA’s...
Nivolumab/Ipilimumab or Nivolumab Alone in Melanoma Brain Metastases
In an Australian phase II trial reported in The Lancet Oncology, Long et al found that the combination of nivolumab (Opdivo) and ipilimumab (Yervoy) and nivolumab alone showed intracranial activity in patients with melanoma brain metastases. Study Details In the open-label trial, 76 evaluable...
Targeted Sequencing Detection of Molecular Minimal Residual Disease and Prognosis in AML
In a study reported in The New England Journal of Medicine, Jongen-Lavrencic et al found that molecular minimal residual disease identified by next-generation sequencing during complete remission was associated with increased risk of relapse and mortality over 4 years of follow-up in patients with...
Notch Signaling and Treatment With Vismodegib in Basal Cell Carcinoma
A study by Eberl et al in Cancer Cell has pinpointed a mechanism that controls how basal cell cancers respond to treatment and offers new ideas for controlling this disease. Basal cell carcinomas are incredibly common—somewhere between 1 million to 3 million diagnosed each year—and...
FDA and EMA Accept Regulatory Submissions for Dacomitinib in Metastatic NSCLC With EGFR-Activating Mutations
On April 4, Pfizer Inc announced that the U.S. Food and Drug Administration (FDA) accepted the company’s new drug application and granted Priority Review for dacomitinib, a pan-human epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor, for the first-line treatment of...
mTOR Inhibitor Plus Endocrine Therapy in Postmenopausal Women With Advanced ER-Positive, HER2-Negative Breast Cancer
In the phase II BOLERO-4 trial reported in JAMA Oncology, Royce et al found that the combination of the mTOR inhibitor everolimus (Afinitor) and endocrine therapy was active in first-line treatment of postmenopausal women with advanced estrogen receptor (ER)-positive, human epidermal growth factor...
Adjuvant Chemotherapy Duration in Stage III Colon Cancer
In a preplanned pooled analysis of phase III trials reported in The New England Journal of Medicine, Grothey et al did not establish noninferiority of 3 vs 6 months of adjuvant FOLFOX (fluorouracil, leucovorin, and oxaliplatin) or CAPOX (capecitabine and oxaliplatin) in disease-free survival in...
Updated Analysis of Obinutuzumab in Rituximab-Refractory Indolent Non-Hodgkin Lymphoma
As reported in the Journal of Clinical Oncology by Cheson et al, an updated analysis of the phase III GADOLIN trial showed an overall survival advantage with obinutuzumab (Gazyva) plus bendamustine induction followed by obinutuzumab maintenance vs bendamustine alone in patients with rituximab...
FDA Expands Rucaparib Approval to Include Maintenance Treatment of Recurrent Ovarian Cancer
Today, the U.S. Food and Drug Administration (FDA) approved rucaparib (Rubraca) tablets for the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who have a complete or partial response to platinum-based chemotherapy. The FDA...
Phase III REACH-2 Study in Hepatocellular Carcinoma Meets Overall Survival Endpoint
Topline results from the phase III REACH-2 study of ramucirumab (Cyramza) as a single agent in the second-line treatment of patients with hepatocellular carcinoma (HCC) were recently announced. The trial met its primary endpoint of overall survival as well as the secondary endpoint of...
FDA Grants Fast Track Designation for TAR-200 in Muscle-Invasive Bladder Cancer
On April 3, the U.S. Food and Drug Administration (FDA) granted Fast Track designation for TAR-200, a gemcitabine-releasing intravesical system (GemRIS), for the treatment of patients with organ-confined or locally advanced muscle-invasive bladder cancer who are unfit for curative-intent therapy....
Nivolumab Plus Ipilimumab vs Sunitinib in Previously Untreated Advanced RCC
As reported in The New England Journal of Medicine by Motzer et al, the phase III CheckMate 214 trial has shown an overall survival advantage with nivolumab plus ipilimumab vs sunitinib in patients with previously untreated advanced renal cell carcinoma (RCC). Study Details In the open-label...
Total Neoadjuvant Therapy in Locally Advanced Rectal Cancer
In a retrospective cohort study reported in JAMA Oncology, Cercek et al found evidence supporting the use of total neoadjuvant therapy as an effective option in locally advanced rectal cancer. Study Details The study involved data on 811 patients presenting with locally advanced rectal cancer (T3 ...
Inaugural Content Collection in JCO Clinical Cancer Informatics Highlights the Benefits of Data Sharing in Oncology
ON FEBRUARY 16 , JCO Clinical Cancer Informatics (JCO CCI) published its first special collection of articles. This collection highlights ways in which sharing cancer research data is now possible through individual networks, including ASCO’s CancerLinQ®. In his introduction to the collection,...
ASCO Launches New Website Focused on the Business of Oncology
ASCO RECENTLY launched ASCO Practice Central, a new website that serves as an online information hub to help oncology professionals navigate a complicated and ever-changing practice environment— while providing high-quality patient care. The first ASCO website dedicated to the business of oncology, ...
Conqueror in Action: Dr. Kurtz Takes on Lymphoma
WHAT IF people with blood cancer—and their doctors—could learn whether a treatment is working in real time? Typically, it takes months to confirm whether cancer treatment is effective. For patients, this means months filled with worry and doubt: Am I getting better? What if the treatment isn’t...
