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Showing 6401 - 6450FDA Accepts sBLA, Grants Priority Review for Nivolumab in Previously Treated Patients With SCLC
On April 18, the U.S. Food and Drug Administration (FDA) accepted for Priority Review a supplemental biologics license application (sBLA) for nivolumab (Opdivo) to treat patients with small cell lung cancer (SCLC) whose disease has progressed after two or more prior lines of therapy. ...
ASCO Remembers Patient Advocate Karen Durham
ASCO AND THE ONCOLOGY COMMUNITY mourn the loss of Karen Durham, who passed away on March 26, 2018, in Tyler, Texas. Karen was a highly respected and beloved advocate for people living with cancer. Karen was diagnosed with stage II invasive breast cancer in 1989 and began volunteering with Susan...
Cooperative Group Trial Pioneer Dr. James F. Holland Dies at 92
ASCO AND THE ONCOLOGY COMMUNITY are deeply saddened by the loss of James F. Holland, MD, FASCO, who passed away on March 22, 2018. He was 92. Dr. Holland was a Distinguished Professor of Neoplastic Diseases in the Department of Medicine at the Tisch Cancer Institute, Icahn School of Medicine at...
CB-839 in Combination With Cabozantinib for Advanced RCC Granted FDA Fast Track Designation
On April 18, Calithera Biosciences, Inc, announced that the U.S. Food and Drug Administration (FDA) granted Fast Track designation to CB-839 in combination with cabozantinib (Cabometyx) for the treatment of patients with metastatic renal cell carcinoma (RCC) who have received one or two prior lines ...
FDA Grants Fast Track Designation for Balixafortide in Combination With Eribulin as Third-Line Therapy for Metastatic Breast Cancer
On April 19, Polyphor announced that the U.S. Food and Drug Administration (FDA) granted Fast Track designation for its novel immuno-oncology candidate balixafortide (POL6326) in combination with eribulin (Halaven) for the treatment of patients with HER2-negative metastatic breast cancer who...
Updated International Myeloma Working Group Criteria: Diagnostic Challenges
The ASCO Post is pleased to present Hematology Expert Review, an ongoing feature that quizzes readers on issues in hematology. In this installment, Drs. Abutalib and Landgren review the underlying data that shaped the updated International Myeloma Working Group (IMWG) diagnostic criteria for...
COA Practice Impact Report Details Consolidation, Shift of U.S. Cancer Care System Into More Expensive Hospital Setting
The Community Oncology Alliance (COA) has released the 2018 Community Oncology Practice Impact Report, which tracks data on the changing landscape of cancer care in the United States. It details a decade-long trend of closure and consolidation in the U.S. cancer system that has resulted in a...
Adjuvant FOLFOX or CAPOX for 3 or 6 Months in Stage II or III Colon Cancer
As reported in the Journal of Clinical Oncology by Sobrero et al, the Italian phase III TOSCA trial did not demonstrate noninferiority of 3 vs 6 months of adjuvant CAPOX (capecitabine plus oxaliplatin) or FOLFOX (fluorouracil, leucovorin, and oxaliplatin) in relapse-free survival in stage II or...
FDA Unveils Streamlined Path for Authorizing Tumor-Profiling Tests Alongside Its Latest Product Action
The U.S. Food and Drug Administration (FDA) recently finalized two guidances to drive the efficient development of next-generation sequencing, which scans a person’s DNA to diagnose genetic diseases, and guide medical treatments. The guidances provide recommendations for designing,...
Nut Consumption in Patients With Stage III Colon Cancer
People with stage III colon cancer who regularly eat tree nuts are at significantly lower risk of cancer recurrence and mortality than those who don’t, according to findings published by Fadelu et al in the Journal of Clinical Oncology.1 Study Findings The study followed 826 participants in the...
AACR 2018: New Liquid Biopsy–Based Cancer Model Reveals Data on Chemoresistance in SCLC
Small cell lung cancer (SCLC) accounts for 14% of all lung cancers and is often rapidly resistant to chemotherapy, resulting in poor clinical outcomes. Treatment has changed little for decades, but a study at The University of Texas MD Anderson Cancer Center offers a potential explanation for...
FDA Approves Fostamatinib Disodium Hexahydrate for Chronic Immune Thrombocytopenia in Adult Patients
On April 17, the U.S. Food and Drug Administration (FDA) approved fostamatinib disodium hexahydrate (Tavalisse) for the treatment of thrombocytopenia in adult patients with chronic immune thrombocytopenia who have had an insufficient response to a previous treatment. Fostamatinib is an oral spleen ...
Fine-Tuning Treatment in Myeloma and Leukemia
It is a difficult task to include every notable presentation from the 2017 American Society of Hematology (ASH) Annual Meeting & Exposition. In addition to our more comprehensive coverage of the news from that meeting over the past several issues, below are summaries of additional key...
Talazoparib Reduces Risk of Disease Progression in BRCA-Mutated Breast Cancer
In patients with BRCA-positive advanced breast cancer, talazoparib reduced the risk of disease progression or death by 46% vs chemotherapy, according to the phase III EMBRACA trial presented at the 2017 San Antonio Breast Cancer Symposium.1 “We are very pleased that the EMBRACA trial—the largest...
Meeting the Challenges of Providing Long-Term Psychosocial Care for Cancer Survivors
Focusing on the first year after a cancer diagnosis is necessary, but not sufficient, for delivering care to cancer survivors, according to Deborah Mayer, PhD, RN, Director of Cancer Survivorship at the UNC Lineberger Comprehensive Cancer Center at the University of North Carolina at Chapel Hill....
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...
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....
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...
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...
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...
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 ...
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...
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 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...
ASCO Develops Professional Resources for Pain Management
When it comes to helping patients with cancer manage pain, education and communication are critical. ASCO University® has developed two resources for providers to help facilitate educated clinical decision-making skills for pain management and feedback from patients in the forms of the Pain...
How to Respond to a Patient’s Discriminatory Request for a Different Clinician
Some patients may make discriminatory requests for a different clinician for their health care.1-5 These individuals may want to avoid treatment with clinicians of a certain race, religion, gender, sexual orientation, or national origin. Oncologists are not exempt from this type of patient...
Future Looks Brighter for Treatment of Cholangiocarcinoma
THE INCIDENCE of cholangiocarcinoma is rising, and effective therapies are urgently needed. Several classes of experimental molecularly targeted agents might meet this challenge, according to Robin Kate Kelley, MD, Associate Professor of Medical Oncology and leader of the clinical trials program in ...
Greater Understanding of Family Dynamics May Help Cancer Teams Guide, Support Patients
WHETHER THEY are parents themselves or dealing with their own parents, patients with cancer often look to their health-care team to help guide these relationships, but data on how best to help are lacking, according to two poster presentations at the 2018 American Psychosocial Oncology Society...
EMA to Review Cemiplimab as a Potential Treatment for Advanced Cutaneous Squamous Cell Carcinoma
On April 3, the European Medicines Agency (EMA) accepted for review the Marketing Authorization Application (MAA) for cemiplimab for the treatment of patients with metastatic cutaneous squamous cell carcinoma (CSCC) or patients with locally advanced CSCC who are not candidates for surgery....
FDA Accepts BLA for Moxetumomab Pasudotox in Hairy Cell Leukemia
On April 3, the U.S. Food and Drug Administration (FDA) accepted a Biologics License Application (BLA) for moxetumomab pasudotox, an investigational anti-CD22 recombinant immunotoxin and a potential new medicine for the treatment of adult patients with hairy cell leukemia (HCL) who have received at ...
Anti–PD-1 Immunotherapy in Previously Treated Gastric Cancer
As reported in JAMA Oncology by Fuchs et al, pembrolizumab (Keytruda) showed activity in patients with previously treated advanced gastric and gastroesophageal junction cancer in the phase II KEYNOTE-059 trial. Study Details In the study, 259 patients from sites in 16 countries who had disease...
How Will ctDNA Assays Aid in Managing Breast Cancer?
CIRCULATING TUMOR DNA (ctDNA) assays are now commercially available for use in lung cancer and melanoma, where they can identify the presence of specific mutations that drive treatment selection. In breast cancer, ctDNA remains more of a research tool, but this is poised to change. At the 2018...
Expert Point of View: Aaron Richard Hansen, BSc, MBBS (Hon), FRACP
“FOR THIS RARE tumor with a paucity of data, all we have are phase II trials to make treatment selection,” said invited discussant Aaron Richard Hansen, BSc, MBBS (Hon), FRACP, of the Princess Margaret Hospital, Toronto. “For patients with de novo metastatic disease or relapse after definitive...
Vinflunine May Benefit Selected Patients With Penile Cancer
PENILE CANCER is rare, outcomes remain poor, and there are few data from randomized trials to guide treatment decisions. However, in the small phase II VinCaP study, presented at the 2018 Genitourinary Cancers Symposium, 45.5% of patients with advanced or metastatic penile cancer had a clinical...
Expert Point of View: Young Jun Kim, MD, PhD
YOUNG JUN KIM, MD, PhD, Co-Leader of the Translational Research and Interventional Oncology Research Program at Vanderbilt-Ingram Cancer Center in Nashville, was more guarded in his interpretation of the data, particularly focusing on the lack of clinical improvement in the combination cohort that ...
Phase II Study Shows Durvalumab Active in Patients With Recurrent or Metastatic Head and Neck Cancer
IN A POPULATION of heavily pretreated patients with recurrent or metastatic head and neck cancer and low or negative programmed cell death ligand 1 (PD-L1) expression, durvalumab (Imfinzi) monotherapy demonstrated an overall response rate of 9.2%, consistent with that of single-agent programmed...
Potent Anti-HER2 Agents on the Horizon
THANKS TO the efficacy of five approved anti-HER2 agents, patients with HER2-positive breast cancer have overall survival numbers that are as good as, or better than, their HER2-negative counterparts. With the next generation of anti-HER2 therapies in clinical trials, these outcomes may become even ...
A Tribute to Two Amazing Scientists
Dr. Collins is Director of the National Institutes of Health. Originally posted on March 19, 2018, to the National Institutes of Health (NIH) Director’s Blog (https://directorsblog. nih.gov). OVER THE PAST couple of weeks, we’ve lost two legendary scientists who made major contributions to our...
MRI-Targeted vs Standard Biopsy in Prostate Cancer Diagnosis
In the international PRECISION trial reported in The New England Journal of Medicine, Kasivisvanathan et al found that magnetic resonance imaging (MRI)-targeted biopsy resulted in a significantly higher rate of diagnosis of clinically significant prostate cancer and a lower rate of diagnosis of...
In Remembrance of James F. Holland, MD
The ASCO Post mourns the loss of ASCO Past President James F. Holland, MD, FASCO, on March 22, 2018. Dr. Holland was the Distinguished Professor of Neoplastic Diseases in the Department of Medicine at the Icahn School of Medicine at Mount Sinai in New York. His wife of many years, Jimmie C....
Brentuximab Vedotin Plus Bendamustine in Relapsed or Refractory Hodgkin Lymphoma
A phase I/II trial has shown that the addition of brentuximab vedotin (Adcetris) to bendamustine is active in relapsed or refractory Hodgkin lymphoma. The study findings were reported in The Lancet Oncology by Owen A. O’Connor, MD, of the Center for Lymphoid Malignancies, Columbia University...
Cardiovascular Toxicity and Carfilzomib Treatment in Multiple Myeloma
The proteasome inhibitor carfilzomib (Kyprolis) has taken on an increasing role in the treatment of multiple myeloma, but new research from the Abramson Cancer Center of the University of Pennsylvania shows the therapy may come with the risk of cardiovascular problems in a higher-than-expected...
The Clinical Significance of Clinicaltrials.gov
“I think I found the trial that is going to save your life,” Stefanie Joho’s sister said after checking out the ClinicalTrials.gov website. “And sure enough, it did. That is not an exaggeration. That is exactly what happened,” Ms. Joho, a health advocate and consultant based in Philadelphia, told...
Physician-Patient Partnership Is Key to Recognizing and Managing Side Effects of Immune Checkpoint Inhibitors
“Immunotherapy has a completely different side-effect profile than chemotherapy, and that has caught physicians off guard,” noted Drew Pardoll, MD, PhD, in an article published earlier this year in The Washington Post.1 Since then, efforts have moved forward on several fronts to bring physicians,...
