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Showing 7301 - 7350FDA Approves Atezolizumab for Extensive-Stage Small Cell Lung Cancer
On March 18, 2019, the U.S. Food and Drug Administration (FDA) approved atezolizumab (Tecentriq) in combination with carboplatin and etoposide for the first-line treatment of adult patients with extensive-stage small cell lung cancer. IMpower133 Approval was based on the IMpower133 study, a...
The Risks of Drug Approval Based on Shaky Evidence
Two recent publications in The New England Journal of Medicine (NEJM), and the resulting drug approval applications that have already been filed, lead to concern that the basis of medical practice on valid evidence may be corrupted. Each involves statistically shaky analysis leading to a striking...
CAR T-Cell Therapy for DLBCL: At the Crossroads of Hype and Reality
In the 20-plus years I have spent in hematologic oncology, I have been fortunate to have a ringside seat to watch “game-changing” advances come into our field—all-trans retinoic acid for acute promyelocytic leukemia, tyrosine kinase inhibitors starting with imatinib for chronic myeloid leukemia,...
Tisagenlecleucel Active in Adult Relapsed or Refractory Diffuse Large B-Cell Lymphoma
As reported in The New England Journal of Medicine by Stephen J. Schuster, MD, of Abramson Cancer Center, University of Pennsylvania, and colleagues, the international phase II JULIET trial has shown high response rates with the chimeric antigen receptor (CAR) T-cell therapy tisagenlecleucel in...
EAU 2019: Testosterone Replacement Therapy May Slow Recurrence in Low-Risk Prostate Cancer
Researchers have shown that testosterone replacement may slow the recurrence of prostate cancer in low-risk patients. Findings from the study were presented by Towe et al at the European Association of Urology (EAU) 2019 Congress (Abstract 646). Practitioners have long regarded testosterone as a...
American Skin Association Announces 18 New Grants for Skin Cancer and Disease Research
For more than 3 decades, the American Skin Association (ASA) and its affiliates have funded more than $50 million in grants to address the causes and treatments of melanoma, vitiligo, and psoriasis, as well as other skin diseases, and to search for cures. Recently, the American Skin Association...
Actively Recruiting Clinical Trials Focused on Treatments of Kidney Cancer
The information contained in this Clinical Trials Resource Guide includes actively recruiting clinical studies that are focused on several different kinds of treatments for kidney cancer. These trials are evaluating gene therapy, immunotherapy, chemotherapy, radiotherapy, and combinations thereof....
Assessing the Clinical Utility of ASCO’s and ESMO’s Value Frameworks
In 2015, ASCO and the European Society for Medical Oncology (ESMO) introduced value frameworks that utilize algorithmic scales to evaluate the clinical benefit of cancer therapies and provide an objective assessment of outcomes and treatment toxicities experienced by patients.1,2 Although the two...
Implementing Personalized Pathways for Cancer Follow-up Care in the United States
A new approach to cancer follow-up care is required to meet the needs of the growing population of cancer survivors in the United States, while also addressing provider shortages and rising costs, according to a new multiagency report. The report—published by Alfano et al in CA: A Cancer ...
Opioid Use Among Older Survivors of Colorectal, Lung, and Breast Cancers
In a linked Surveillance, Epidemiology, and End Results and Medicare study reported in the Journal of Clinical Oncology, Salz et al found that chronic opioid use varied by cancer among older cancer survivors. By 6 years after diagnosis, survivors were no more likely to be chronic opioid users...
FDA Pipeline: Assay Approval, Breakthrough Designations for AI Technology and CLL, and More
In the past week, the U.S. Food and Drug Administration (FDA) approved a companion diagnostic assay, granted Breakthrough Device and Breakthrough Therapy designations, and extended the review period of a proposed treatment. The agency also published four draft guidances and one final guidance...
Incidence of Nonmelanoma Skin Cancer in Recipients of Multiple Kidney Transplants
The incidence of nonmelanoma skin cancer may be more common in recipients of kidney transplants vs patients on maintenance dialysis. Researchers looked to determine if the risk of nonmelanoma skin cancer is lower during periods of graft loss with a return to dialysis vs during periods of...
Does Postoperative Conformal Radiotherapy Improve Survival in Pediatric Patients With Ependymoma?
Treatment with conformal radiation therapy immediately following surgery in children with ependymoma may greatly improve survival. The findings were published by Merchant et al in the Journal of Clinical Oncology. “Historically, children under the age of 3 with ependymoma have a worse...
Viral Vector–Based Immunotherapy in Metastatic Castration-Resistant Prostate Cancer
In a phase III trial reported in the Journal of Clinical Oncology, Gulley et al found that PROSTVAC, a viral vector-based immunotherapy, did not improve overall survival or 6-month event-free survival vs placebo in patients with asymptomatic or minimally symptomatic metastatic castration-resistant...
Activity of Cabozantinib in Advanced Non–Clear Cell Renal Cell Carcinoma
In a retrospective cohort study reported in The Lancet Oncology, Chanzá et al found evidence of activity of cabozantinib in advanced non–clear cell renal carcinoma. Cabozantinib is approved in metastatic renal cell carcinoma on the basis of studies in clear cell histology. As noted by ...
Addition of Pegylated Recombinant Human Hyaluronidase to FOLFIRINOX in Metastatic Pancreatic Adenocarcinoma
In the phase I/II SWOG S1313 trial, which was reported in the Journal of Clinical Oncology by Ramanathan et al, researchers found that the addition of pegylated recombinant human hyaluronidase (PEGPH20) to modified (m) FOLFIRINOX (fluorouracil, leucovorin, irinotecan, and oxaliplatin) worsened...
2019 Thoracic Cancers Symposium: Trends in Use of Prophylactic Cranial Irradiation for Extensive-Stage SCLC
A new survey of radiation oncologists points to a sharp decline in the use of prophylactic cranial irradiation for patients with extensive-stage small cell lung cancer (SCLC), indicating a rapid change in standard practice for the disease following the 2017 publication of a major clinical trial by...
Nivolumab Plus Ipilimumab in Advanced NSCLC: Outcomes by PD-L1 and Tumor Mutational Burden Status
As reported in the Journal of Clinical Oncology by Ready et al, the phase II CheckMate 568 trial has shown that higher tumor mutational burden is associated with response, irrespective of programmed cell death ligand 1 (PD-L1) expression in first-line nivolumab plus low-dose ipilimumab treatment of ...
Global Incidence of Undiagnosed Pediatric Cancers
Nearly half of all childhood cancers are not being diagnosed globally, according to a new modeling study published by Ward et al in The Lancet Oncology. “Our model suggests that nearly one in two children with cancer are never diagnosed and may die untreated,” said lead...
Intense Neoadjuvant Androgen Deprivation Before Prostatectomy in Locally Advanced Prostate Cancer
In a phase II trial reported in the Journal of Clinical Oncology, McKay et al found a trend toward improved pathologic response or minimal residual disease with the addition of neoadjuvant abiraterone and prednisone to enzalutamide and leuprolide prior to radical prostatectomy in patients with...
Safety Comparison of Two Dosing Regimens for Nivolumab Plus Ipilimumab in Advanced Melanoma
In the phase IIIb/IV CheckMate 511 study reported by Lebbé et al in the Journal of Clinical Oncology, a regimen of nivolumab at 3 mg/kg plus ipilimumab at 1 mg/kg (NIVO3+IPI1) was found to significantly reduce the incidence of treatment-related grade 3 to 5 adverse events compared with...
Conservatively Managing Ovarian Tumors
In an interim analysis of a prospective cohort study (IOTA5) reported in The Lancet Oncology, Wouter Froyman, MD, and colleagues found that the risk of malignancy and acute complications is low when adnexal masses with benign ultrasound findings are managed conservatively. In the study, patients...
Factors Influencing Conversion to Mastectomy in Ductal Carcinoma in Situ
In a prospective cohort clinical trial reported in JAMA Oncology, Constance D. Lehman, MD, PhD, and colleagues found that multiple factors, including magnetic resonance imaging (MRI) findings, played a role in conversion to mastectomy among women with ductal carcinoma in situ (DCIS) who were...
Outcomes With Dose-Intense Adjuvant Chemotherapy in Early Breast Cancer
In a patient-level meta-analysis reported in The Lancet, the Early Breast Cancer Trialists’ Collaborative Group found that an increased dose intensity of adjuvant taxane and anthracycline chemotherapy in early breast cancer was associated with a decreased risk of recurrence and death from breast...
We Need Better Screening Methods for Detecting Breast Cancer
MY BREAST CANCER was probably a decade in the making, although I only became aware that there might be a problem in 2014, when I noticed some slight pain in my left breast. A routine mammogram and ultrasound found benign cysts in my dense breasts, which most likely explained the pain, I was told,...
Update on Newer Treatments in Non-Hodgkin Lymphomas
AS PART of The ASCO Post’s continued coverage of the 2018 American Society of Hematology (ASH) Annual Meeting & Exposition, here is an update on several different studies on new therapeutics in non-Hodgkin lymphomas (NHLs), including follicular lymphoma, diffuse large B-cell lymphoma (DLBCL), ...
FDA Grants Accelerated Approval to Atezolizumab/Nab-Paclitaxel; Regular Approval Contingent on Confirmatory Trials
Today, the U.S. Food and Drug Administration (FDA) granted accelerated approval to atezolizumab (Tecentriq) plus nanoparticle albumin-bound (nab)-paclitaxel (Abraxane) for the treatment of adults with unresectable, locally advanced or metastatic, programmed cell death ligand 1 (PD-L1)-positive ...
Omega-3 Fatty Acids
The ASCO Post’s Integrative Oncology series is intended to facilitate the availability of evidence-based information on integrative and complementary therapies sometimes used by patients with cancer. Gary Deng, MD, PhD, and Jyothirmai Gubili, MS, explore the use of omega-3 fatty acids, which have...
A Peaceful Transformation: The Origin of the Frederick National Laboratory
JUST 2 MONTHS before Congress passed what to this day is America’s most sweeping anticancer legislation, President Richard Nixon came to Fort Detrick in Frederick, Maryland, to declare his administration’s historic commitment to the fight. “I have come here today for the purpose of making an...
Health-Care Fraud Prosecutions Are on the Rise
Prosecuting health-care fraud is a top priority for the U.S. Department of Justice (DOJ) and other federal government agencies.1,2 After all, the government earns a $6 return for every $1 that it spends on enforcement. In December 2018, the DOJ announced that it had obtained more than $2.5 billion...
Cabozantinib for Hepatocellular Carcinoma Previously Treated With Sorafenib
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. On January 14, 2019, cabozantinib was approved for the...
Reshaping the Treatment Landscape in Refractory Multiple Myeloma
THE TREATMENT approaches for multiple myeloma, both newly diagnosed and relapsed disease, continue to undergo major transformation as new agents and combinations are being introduced.1 This change has been driven by the introduction of novel drug classes such as monoclonal antibodies, as well as...
Addition of Elotuzumab to Pomalidomide and Dexamethasone in Previously Treated Patients With Multiple Myeloma
AS REPORTED in The New England Journal of Medicine by Meletios A. Dimopoulos, MD, of the National and Kapodistrian University of Athens, and colleagues, the phase II ELOQUENT-3 trial has shown that the addition of elotuzumab to pomalidomide and dexamethasone significantly prolonged...
A Single Dose of a PD-1 Inhibitor Before Surgery May Predict Outcomes in Patients With Melanoma
A single dose of a programmed cell death protein 1 (PD-1) inhibitor before resection for melanoma may predict clinical outcomes for patients. Researchers from the Abramson Cancer Center at the University of Pennsylvania—who documented this finding in the largest cohort of patients to be...
Effect of Adjuvant Treatment for Early Testicular Cancer on Reproductive Potential
Men with early-stage testicular cancer can safely receive one course of adjuvant chemotherapy or radiotherapy without it having a long-term effect on their reproductive potential, according to a study published by Weibring et al in Annals of Oncology. Although it is known already that several...
FDA Pipeline: Updates on Treatments for Cervical Cancer, Myelofibrosis, Chemotherapy-Induced Nausea and Vomiting, and More
The FDA recently issued announcements on a Fast Track designation, a Priority Review, two supplemental new drug applications, an investigational new drug application, and a marketing clearance. The agency also released a safety communication on cancer-related surgery. Fast Track Designation for...
Late Morbidity and Mortality in Survivors of Medulloblastoma
In a report from the Childhood Cancer Survivor Study published in the Journal of Clinical Oncology, Salloum et al found that changes in medulloblastoma therapy over 3 decades that have improved survival have also increased risk for subsequent neoplasms and debilitating health conditions. As noted...
Addition of Lomustine to Temozolomide and Radiotherapy in Newly Diagnosed Glioblastoma With Methylated MGMT Promoter
In a German phase III trial (CeTeG/NOA–09) reported in The Lancet, Herrlinger et al found that the addition of adjuvant lomustine to temozolomide and radiotherapy improved overall survival in newly diagnosed glioblastoma with methylated MGMT promoter. The researchers noted that findings...
QOPI Round 1 Now Open for Data Abstraction
As of January 9, ASCO’s Quality Oncology Practice Initiative (QOPI®) Round 1 of reporting is open for data abstraction. Round 1 will close on June 3, and final reports will be available approximately 2 weeks after the round closes. To get started, go to the registration portal and log in. A...
Advances in Haploidentical Transplantation and Cellular Therapies
With advances in the field, the number of haploidentical stem cell transplants being performed (ie, using human leukocyte antigen [HLA] half-matched donor stem cells) has been increasing. In recognition of evolving strategies to improve outcomes, a group of transplant physicians started the...
National Consensus Project Releases 4th Edition of Clinical Practice Guidelines for Quality Palliative Care
As reported by Betty R. Ferrell, PhD, MA, FAAN, FPCN, of the Division of Nursing Research and Education, City of Hope Medical Center, Duarte, California, and colleagues in the Journal of Palliative Medicine, the National Consensus Project (NCP) of the National Coalition for Hospice and Palliative ...
Innovative Research to Improve the Supportive Care Needs of Cancer Survivors
First launched in 2014, the Palliative Care in Oncology Symposium introduced a nascent interdisciplinary approach to the treatment of both the physical and psychological symptoms of cancer to improve disease outcome and quality of life for patients. Today, it has evolved into a leading forum for...
Neoadjuvant Palbociclib Plus Letrozole Reduces Ki67 Levels
In the neoadjuvant setting, adding palbociclib to letrozole significantly enhanced the suppression of malignant cell proliferation, as measured by Ki67 levels, in patients with primary estrogen receptor–positive breast cancer but did not increase the clinical response rate over 14 weeks, according ...
2019 ASCO-SITC: Efficacy and Safety of Less Frequent Dosing of Second-Line Nivolumab for Non–Small Cell Lung Cancer
Researchers reported similar efficacy and safety with an every-4-week regimen of nivolumab in the second-line setting compared to an every-2-week schedule in patients with non–small cell lung cancer (NSCLC). Edward B. Garon, MD, and colleagues presented the results of an interim analysis of...
Long-Term Study Finds Axillary Radiotherapy Safe and Effective After Positive Sentinel Node Biopsy
Following identification of a positive sentinel lymph node, surgical axillary lymph node dissection and axillary radiation therapy provide comparable locoregional control and survival, according to a 10-year follow-up of the large European Organisation for Research and Treatment of Cancer AMAROS...
Expert Point of View: Eleftherios (Terry) P. Mamounas, MD, William Sikov, MD, and Laura Esserman, MD
Several breast cancer experts said the findings of the Early Breast Cancer Trialists’ Collaborative Group (EBCTCG) meta-analysis and the AERAS study are in line with data emerging from other studies of extended treatment with aromatase inhibitors. All of these studies suggest that extended...
More Data Show Small Benefit From Extended Endocrine Therapy
Two studies presented at the 2018 San Antonio Breast Cancer Symposium validated a small benefit of extending adjuvant aromatase inhibitor therapy beyond thestandard 5 years for postmenopausal women with hormone receptor–positive breast cancer. In a meta-analysis of 24,912 patients from 12...
Does Adjuvant Denosumab Improve DFS in Postmenopausal Women With Hormone Receptor–Positive Breast Cancer Receiving Aromatase Inhibitors?
As reported by Gnant et al in The Lancet Oncology, disease-free survival (DFS) was improved with adjuvant denosumab vs placebo in postmenopausal women with hormone receptor–positive, early-stage breast cancer receiving aromatase inhibitor treatment. A primary analysis of the phase III...
Study Shows Limited Antitumor Activity of Pembrolizumab in Neuroendocrine Tumors
Neuroendocrine tumors appear resistant to single-agent immunotherapy, according to the results of the KEYNOTE-028 trial of pembrolizumab. “Pembrolizumab monotherapy showed limited antitumor activity but a manageable safety profile in patients with previously treated, advanced neuroendocrine...
ARAMIS Trial Reports Darolutamide Improves Outcomes in High-Risk Nonmetastatic Prostate Cancer
Darolutamide—an investigational androgen receptor inhibitor—significantly improved metastasis-free survival in men with high-risk nonmetastatic castration-resistant prostate cancer vs placebo in the large phase III ARAMIS trial.1 Men treated with darolutamide had a median metastasis-free survival...
