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Showing 5651 - 5700Pegfilgrastim-jmdb as Biosimilar to Pegfilgrastim to Decrease Risk of Infection During Cancer Treatment
On June 4, 2018, pegfilgrastim-jmdb (Fulphila) was approved as a biosimilar to pegfilgrastim (Neulasta) to decrease infection risk in patients with nonmyeloid cancer receiving myelosuppressive chemotherapy associated with a significant incidence of febrile neutropenia.1,2 Approval Basis Approval...
Opportunities, Issues, and Challenges for Biosimilars in Oncology
In an article published recently in TheNew England Journal of Medicine, Gary H. Lyman, MD, MPH, FACP, FRCP (Edin), FASCO, of Fred Hutchinson Cancer Research Center in Seattle, and colleagues reviewed opportunities, issues, and challenges posed by the advent of biosimilar medications, focusing on...
When Can Patients With Gleason 6 Prostate Cancer Safely Undergo Active Surveillance?
Prior to ASCO’s 2016 endorsement of the Cancer Care Ontario (CCO) guideline on active surveillance in the management of localized prostate cancer,1 most men—over 90%—diagnosed with low-risk localized disease were treated with active therapy.2 Today, about 50% of American men with low-risk disease...
Cost Differences in Chemotherapy Administration by Site
Critics of health-care consolidation have cited higher costs of chemotherapy administration as an example of how mergers drive up costs. A new study by Kalidindi et al in The American Journal of Managed Care found that although drug administration costs in hospitals are higher,...
Pediatric CT Scans and Subsequent Malignancy Risk
A new study by Meulepas et al in the Journal of the National Cancer Institute suggests that computed tomography (CT) scans may increase the risk of brain tumors. The use of CT scans has increased dramatically over the past 2 decades. CT scans greatly improve diagnostic capabilities,...
Less Toxicity With Pelvic IMRT vs Standard RT in Cervical and Endometrial Cancers
In the phase III NRG Oncology-RTOG 1203 study, patient-reported gastrointestinal (GI) and urinary toxicities were reduced with intensity-modulated radiation therapy (IMRT) vs standard radiotherapy (RT) in women with cervical or endometrial cancer. The findings were reported by Klopp et al in the...
Olaparib for Germline BRCA-Mutated Metastatic Breast Cancer
EARLY IN 2018, olaparib tablets (Lynparza) were granted regular approval for treatment of patients with deleterious or suspected deleterious germline BRCA-mutated, HER2-negative metastatic breast cancer who have been treated with chemotherapy in the neoadjuvant, adjuvant, or metastatic setting.1,2...
Abiraterone Plus Prednisone in High-Risk Metastatic Castration-Sensitive Prostate Cancer
EARLY IN 2018, abiraterone acetate tablets (Zytiga) in combination with prednisone were approved for the treatment of metastatic high-risk castration-sensitive prostate cancer.1,2 Supporting Efficacy Data APPROVAL WAS based on the findings of the phase III LATITUDE trial, in which 1,199 patients...
Risk of Cancer After Treatment of Testicular Germ Cell Cancer
In a Dutch study reported in the Journal of Clinical Oncology, Groot et al found that the risk of subsequent malignant neoplasms was increased in the long-term follow up of patients receiving cisplatin or radiotherapy for testicular germ cell cancer. Risk vs General Population The study involved...
FDA Approves Ivosidenib for IDH1-Mutated AML
Today, the U.S. Food and Drug Administration (FDA) approved ivosidenib (Tibsovo) tablets for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) who have a specific genetic mutation. This is the first drug in its class (isocitrate dehydrogenase-1 [IDH1]...
Phase III TOURMALINE-MM3 Trial of Ixazomib as Maintenance Therapy in Patients With Multiple Myeloma Posttransplant
The randomized, phase III TOURMALINE-MM3 study met its primary endpoint, demonstrating single-agent oral ixazomib (Ninlaro) as a maintenance therapy resulted in a statistically significant improvement in progression-free survival (PFS) vs placebo. The trial evaluated the effect of ixazomib as a...
Study Finds Gender Disparities in Head and Neck Cancer Treatment and Outcomes
An analysis of cancer registry data from a California hospital system showed that women with head and neck cancer were less likely to receive intensive chemotherapy (35% vs 46%) and radiation (60% vs 70%) compared to men. Controlling for factors such as age and serious medical conditions, a...
In Case You Missed It: Update on Breast Cancer Research
The ASCO Post presents these brief summaries of important studies in breast cancer, presented at the 2018 ASCO Annual Meeting. Ribociclib Plus Fulvestrant in Metastatic Breast Cancer The benefit of an inhibitor of cyclin-dependent kinase 4/6 (CDK4/6) added to fulvestrant has now been proven to...
In Case You Missed It: Short Takes on Current Cancer Research
It would be impossible to cover all of the important presentations from the 5,000-plus abstracts accepted for the 2018 ASCO Annual Meeting. In addition to our regular meeting coverage of the top news stories, the following highlights focus on novel investigational approaches to therapy for various...
Geographic Differences in End-of-Life Cancer Care
When it comes to how much end-of-life care a patient with cancer receives, geography may, indeed, be destiny, according to new research led by Harvard Medical School that found differences in this type of cancer care across different parts of the country. The findings, published by Keating et al...
FDA Expands Ribociclib Indication in Hormone Receptor–Positive, HER2-Negative Advanced or Metastatic Breast Cancer
Today, the U.S. Food and Drug Administration (FDA) expanded the indication for ribociclib (Kisqali) in combination with an aromatase inhibitor for premenopausal or perimenopausal women with hormone receptor–positive, HER2-negative advanced or metastatic breast cancer as initial...
Progression-Free Survival as Surrogate for Overall Survival in First-Line Treatment of DLBCL
In an individual patient-level analysis reported in the Journal of Clinical Oncology, Shi et al found that progression-free survival could serve as a surrogate endpoint for overall survival in the first-line treatment of diffuse large B-cell lymphoma (DLBCL). The study involved data from 7,507...
Individual Training to Improve Provider Efficiency and Confidence in EMR Use
In a study reported in the Journal of Oncology Practice, Kadish et al found that individually tailored training improved provider confidence in electronic medical record (EMR) use and offers promise of improving efficiency in use. The study was undertaken at Dana-Farber Cancer Institute after...
Expert Point of View: David Graham, MD, FASCO and Richard Schilsky, MD, FACP, FASCO, FSCT
ASCO expert David Graham, MD, FASCO, of the Levine Cancer Institute in Charlotte, North Carolina, was encouraged by the IMpower131 findings. “This is one more example of how immunotherapy is making steady gains against a number of cancers. Immunotherapy has been shown to be effective in other...
Atezolizumab Plus Chemotherapy Extends Survival in Squamous NSCLC Regardless of PD-L1 Level
Patients with advanced squamous non–small cell lung cancer (NSCLC) had a greater benefit from first-line treatment with the combination of atezolizumab (Tecentriq) plus chemotherapy vs chemotherapy alone in the randomized, phase III, IMpower131 clinical trial.1 At the landmark of 12-month...
8-Year Update of SOFT and TEXT Trials: Positive but Not Definitive
At the 2017 San Antonio Breast Cancer Symposium (SABCS), the International Breast Cancer Study Group (IBCSG) and its collaborators presented the 8-year updates of the key modern trials of ovarian function suppression after local treatment for young women with resected breast cancer.1 These updates...
Immunotherapy in Merkel Cell Carcinoma: ‘Field Has Been Thrown on Its Head’
At the 2018 ASCO Annual Meeting, investigators presented long-term follow-up data for immunotherapy in patients with Merkel cell carcinoma and new data for its use in the neoadjuvant setting. The results drew high interest from attendees and a number of questions were raised following the...
Expert Point of View: Colin D. Weekes, MD, PhD and Manish A. Shah, MD, FASCO
Two pancreatic cancer specialists commented on the PREOPANC-1 study for The ASCO Post: Colin D. Weekes, MD, PhD, of Massachusetts General Hospital and Harvard Medical School, Boston, who had discussed the abstract at the ASCO Annual Meeting, and Manish A. Shah, MD, FASCO, Chief of the Solid Tumor...
Early Study Shows Elasticity of Cancer Cells May Determine Where Pancreatic Cancer Metastases Form
Pancreatic cancer often metastasizes to the liver or lungs. The prognosis is better for patients with metastases in the lungs. However, the organ that is more likely to be affected depends on the cancer cells’ ability to alter their characteristics and shape—as a research team at the...
Addition of Systemic Therapy to Involved-Field Radiotherapy in Early-Stage Follicular Lymphoma
Results of the phase III Trans-Tasman Radiation Oncology Group 99.03 trial reported in the Journal of Clinical Oncology by MacManus et al indicate that use of systemic therapy following involved-field radiotherapy (IFRT) increased progression-free survival in patients with stage I or II low-grade...
AR-V7 as Marker for Taxane vs Androgen Receptor Inhibitor Treatment in Castration-Resistant Prostate Cancer
In a study reported in JAMA Oncology, Scher and colleagues found that the presence of nuclear-localized androgen receptor splice variant 7 (AR-V7) protein in circulating tumor cells (CTCs) may predict better survival with taxane therapy vs androgen receptor signaling (ARS) inhibitor treatment in...
ASCO Clinical Practice Guideline Update: Systemic Therapy for Patients With Advanced HER2-Positive Breast Cancer
As reported in the Journal of Clinical Oncology by Sharon H. Giordano, MD, of The University of Texas MD Anderson Cancer Center, and colleagues, ASCO has released a clinical practice guideline update on systemic therapy for patients with advanced HER2-positive breast cancer. The guideline update...
Statement by FDA Commissioner on Opioid Access for Patients With Chronic and End-of-Life Pain
U.S. Food and Drug Administration (FDA) Commissioner Scott Gottlieb, MD, recently issued the following statement. The opioid epidemic continues to take an emotional, physical, and financial toll on Americans. The FDA is committed to taking every possible step to address the many facets of this...
ESHRE 2018: Large Population Study Does Not Find Causal Link Between Assisted Reproduction and Ovarian Cancer Risk
Following concerns over many years that hormonal stimulation of the ovaries necessary for in vitro fertilization (IVF) may increase the risk of ovarian cancer, a nationwide cohort study from Denmark has now concluded that any perceived increase in risk is actually a statistical bias resulting from...
ESHRE 2018: Early-Stage Research Shows Potential of Artificial Ovary for Fertility Preservation Without the Risk of Reintroducing Malignancy
Important steps in the development of an artificial ovary have been successfully completed. Researchers from the Rigshospitalet in Copenhagen, Denmark, reported that they have—for the first time—isolated and grown human follicles to a point of biofunctionality on a bioengineered ovarian ...
PROSPER: Enzalutamide Prolongs Metastasis-Free Survival in Nonmetastatic Castration-Resistant Prostate Cancer
As reported in The New England Journal of Medicine by Hussain et al, the phase III PROSPER trial has shown a 71% reduction in risk of metastasis or death with enzalutamide (Xtandi) vs placebo in men with nonmetastatic castration-resistant prostate cancer. Study Details In the double-blind trial,...
ASCO Supports NCI-Designated Cancer Centers’ Goal of Eliminating HPV-Related Cancers
ASCO HAS officially endorsed a statement by the 70 National Cancer Institute (NCI)-designated cancer centers calling for increased human papillomavirus (HPV) vaccination and screening to eliminate HPV-related cancers. The full uptake of the vaccine and screening could prevent 12,000 cervical...
Excerpt From the 2018 ASCO Presidential Address: ‘Delivering Discoveries: Expanding the Reach of Precision Medicine’
In my area of research, lung cancer, precision medicine is indeed transforming the treatment of this disease and has important implications for other cancers and for the future of our patients with cancer. Today’s achievement of being able to systematically identify genomic changes that can be...
Treatment Beyond Disease Progression in Melanoma: Challenge Centers on Knowing Who May Benefit
Dr. Weiss is Assistant Professor (Medical Oncology), Developmental Therapeutics, Melanoma Program, Yale Cancer Center. Dr. Sznol is Professor of Medicine (Medical Oncology); Co-Director, Cancer Immunology Program, Yale Cancer Center Co-Director, Yale SPORE in Skin Cancer, New Haven, Connecticut. ...
Expert Point of View: David Rimm, MD, PhD
“TUMOR MUTATIONAL burden is an emerging biomarker independent of programmed cell death ligand 1 (PD-L1) level. There are a few reasons for enthusiasm. Tumor mutational burden is a compelling biomarker for response and progression-free survival. Six-month progression-free survival is 50% with a...
Early Data Suggest TLR9 Agonist May Combat PD-1 Resistance in Advanced Melanoma
COMBINING CMP-001, a Toll-like receptor 9 (TLR9) agonist, plus pembrolizumab (Keytruda) appears to overcome resistance to anti–programmed cell death protein 1 (anti–PD-1) therapy, according to a preliminary phase Ib study.1 Adding CMP-001 to pembrolizumab was well tolerated, with antitumor efficacy ...
Expert Point of View: Harold Burstein, MD, PhD
HAROLD BURSTEIN, MD, PhD, of Dana-Farber Cancer Institute and Harvard Medical School, where he is Associate Professor of Medicine, commented on the SANDPIPER trial during a press briefing at the 2018 ASCO Annual Meeting. PIK3 mutations are probably the most common mutation in breast cancer, and...
Expert Point of View: David Graham, MD, FASCO
ASCO EXPERT David Graham, MD, FASCO, Medical Director at the Levine Cancer Institute in Charlotte, North Carolina, was enthusiastic about this new technology. “This is an important first step showing there is an easier way to detect lung cancer at earlier stages. If the promise of this report...
Expert Point of View: Marina Chiara Garassino, MD, and Justin Gainor, MD
“TODAY WE HAVE good news, because IMpower 150 is another clear positive trial on the combination of chemotherapy with immunotherapy. This is true in terms of progression-free and overall survival, which are both statistically significant [for atezolizumab (Tecentriq) plus bevacizumab (Avastin)...
More Evidence of Benefit With Immunotherapy and Chemotherapy in Nonsquamous Non–Small Cell Lung Cancer
ATEZOLIZUMAB (TECENTRIQ) plus bevacizumab (Avastin) plus a platinum doublet (ABCP) improved overall survival by 22% compared with bevacizumab plus a platinum doublet (BCP) in patients with advanced wild-type (without an identified mutation) nonsquamous non–small cell lung cancer (NSCLC), according...
Expert Point of View: Bruce D. Cheson, MD
BRUCE D. CHESON, MD, Director of the Division of Hematology/Oncology at the Lombardi Comprehensive Cancer Center, Washington, DC, agreed that rituximab (Rituxan) plus lenalidomide (Revlimid; R2) is a reasonable first-line option, considering the findings of the RELEVANCE trial. “Dr. Fowler showed ...
Chemotherapy-Free Regimen Comparable to Rituximab-Chemotherapy as Front-Line Therapy for Follicular Lymphoma
IN PATIENTS with previously untreated advanced follicular lymphoma, the chemotherapy-free combination of rituximab (Rituxan) plus lenalidomide (Revlimid), the so-called R-squared (R2) regimen, yielded outcomes as good as those in patients who received standard rituximab-chemotherapy, in the interim ...
With European Protocol, Maintenance Therapy Improved 5-Year Survival in Rhabdomyosarcoma
THE ADDITION OF 6 months of maintenance chemotherapy in the treatment of rhabdomyosarcoma improved 5-year survival by 13%, in the European RMS2005 Maintenance study reported at the 2018 ASCO Annual Meeting.1 “At the end of this long, not-easy study, we concluded that maintenance is an effective and ...
Pooled Study Analysis Explores the Use of CDK4/6 Inhibitors in Metastatic Breast Cancer
RESEARCH TO DATE has not been able to identify a subgroup of patients with estrogen receptor–positive HER2-negative metastatic breast cancer who do not derive benefit from the addition of inhibitors of cyclin-dependent kinases 4/6 (CDK4/6) to endocrine therapy, according to a study by the U.S. Food ...
With Compassion Toward None, With Technology for All?
Imagine health care in the not too distant future… JOHN IS GOING about his usual Saturday at home, when his health-care–enabled smart watch alerts him to a sudden rise in his heart rate. As he is wondering about the reason, he feels a sharp pain in his left lower quadrant. The tachycardia...
Many Childhood Cancer Survivors Not Concerned About Their Future Health
A research team led by a St. Jude Children’s Research Hospital epidemiologist has conducted the largest analysis to date of how adult survivors of childhood cancer view their health risk. The scientists found that a surprisingly high number of survivors showed a lack of concern for their...
Analgesic Use and Risk of Ovarian Cancer
In a study of Ovarian Cancer Cohort Consortium data reported in the Journal of the National Cancer Institute, Trabert et al found that daily aspirin use was associated with a modest reduction in the risk of ovarian cancer. The study included prospective individual-level data from 13 studies in the ...
Apalutamide in Nonmetastatic Castration-Resistant Prostate Cancer
In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms of action, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs. Earlier this year, apalutamide (Erleada) was approved for ...
Socioeconomic and Racial Disparities in Management of Brain Metastases
Increasing use of a potentially life-saving treatment for metastatic cancer is leaving many vulnerable patients behind, according to a new study from Yale Cancer Center/Smilow Cancer Hospital published by Benjamin H. Kann, MD, of Yale University School of Medicine, and colleagues in the Journal of ...
Oxybutynin for Androgen Deprivation–Associated Hot Flashes in Prostate Cancer
In a letter to the editor of The New England Journal of Medicine, Thomas J. Smith, MD, of Johns Hopkins Sidney Kimmel Comprehensive Cancer Center, Baltimore, and colleagues described the successful use of oxybutynin to treat hot flashes in a patient receiving androgen-deprivation therapy (ADT) for ...
