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Showing 6701 - 6750Expert Point of View: Susan F. Slovin, MD, PhD
Formal discussant for the presentation of SWOG S9921 results, Susan F. Slovin, MD, PhD, a medical oncologist at Memorial Sloan Kettering Cancer Center, New York, said there were some important points to understand about this “vintage” trial. “The trial was designed 20 years ago, and the view is...
No Benefit From Older Standard-of-Care Drug in Adjuvant Chemotherapy for High-Risk Prostate Cancer, but Newer Trials Feasible
An older trial designed to evaluate the benefits of adjuvant therapy following radical prostatectomy in patients with high-risk prostate cancer showed no difference in overall or disease-free survival between 2 years of androgen-deprivation therapy and 2 years of androgen-deprivation therapy plus...
Phase II Trial Evaluates New Gene Therapy for Non–Muscle Invasive Bladder Cancer After BCG
A novel approach using intravesical gene therapy showed promising activity in a phase II trial that enrolled patients with bacillus Calmette-Guérin (BCG)-refractory or -relapsed nonmuscle invasive bladder cancer.1 The rate of high-grade relapse-free survival at 12 months was 35% in patients treated ...
Financial Stress in Patients With Locally Advanced Head and Neck Cancer
In a single-institution study reported in the Journal of Oncology Practice, de Souza et al found that two-thirds of patients with locally advanced head and neck cancer had to use a financial coping strategy to help pay for care within the first 6 months of treatment. Study Details The study...
Barriers to Clinical Trial Accrual Include Trial Sponsorship and Time to Enrolling First Patient, Study Finds
A study by researchers from The University of Texas MD Anderson Cancer Center investigating factors associated with slow participant accrual into phase I to III cancer clinical trials at their institution has found trials initiated through national cooperative groups and the time taken from trial...
Adding Rituximab to Standard Therapy in Interim PET–Positive Advanced Hodgkin Lymphoma
As reported in The Lancet Oncology by Borchmann et al, a phase III German Hodgkin Study Group trial in advanced Hodgkin lymphoma showed no progression-free survival benefit of adding rituximab (Rituxan) in patients with positive positron-emission tomography (PET) findings after two courses (PET-2)...
Phase III APHINITY Study: Adjuvant Pertuzumab/Trastuzumab/Chemotherapy Increased Invasive Disease–Free Survival in HER2-Positive Breast Cancer
Genentech, the Breast International Group, the Breast European Adjuvant Study Team, and the Frontier Science Foundation have announced positive results from the phase III APHINITY study. The study met its primary endpoint and showed that adjuvant treatment with the...
Two Migration Proteins Boost Predictive Value of Pancreatic Cancer Biomarker
Adding two blood-borne proteins associated with cancer cell migration increases the predictive ability of the current biomarker for pancreatic cancer to detect early-stage disease, a research team from The University of Texas MD Anderson Cancer Center reported in a study by Balasenthil et al in the ...
11-Year Follow-up of Adjuvant Trastuzumab in the HERA Trial
In the 11-year follow-up of the HERA trial reported in The Lancet, Cameron et al found that 1 year of trastuzumab (Herceptin) following adjuvant therapy for HER2-positive breast cancer remained associated with improved disease-free and overall survival compared with observation. No additional...
Pembrolizumab vs Chemotherapy in Second-Line Treatment of Advanced Urothelial Carcinoma
In a phase III KEYNOTE-045 trial reported in The New England Journal of Medicine, Bellmunt et al found that pembrolizumab (Keytruda) significantly improved overall survival vs investigator choice of chemotherapy as second-line treatment in patients with advanced urothelial cancer whose disease...
FDA Approves Telotristat Ethyl for Carcinoid Syndrome Diarrhea
On February 28, the U.S. Food and Drug Administration (FDA) approved telotristat ethyl (Xermelo) tablets in combination with somatostatin analog therapy for the treatment of adults with carcinoid syndrome diarrhea that somatostatin analog therapy alone has inadequately controlled. About...
Effect of Adjuvant Chemoradiotherapy in Resected Locally Advanced Head and Neck Cancer
In a study of National Cancer Database data reported in the Journal of Clinical Oncology, Trifiletti et al found that adjuvant chemoradiotherapy was associated with a survival benefit in patients with resected locally advanced head and neck cancer with negative surgical margins and no extracapsular ...
Effect of Sorafenib and Hepatitis Status in Advanced Hepatocellular Carcinoma
In a meta-analysis reported in the Journal of Clinical Oncology, Jackson et al found that overall survival with sorafenib (Nexavar) in advanced hepatocellular carcinoma was significantly improved vs comparator treatments among patients who were both hepatitis B virus (HBV)-negative and hepatitis C...
Mirvetuximab Soravtansine in Platinum-Sensitive Ovarian Cancer
Kathleen N. Moore, MD, of Stephenson Cancer Center, The University of Oklahoma, and colleagues found that mirvetuximab soravtansine (also known as IMGN853)—an antibody-drug conjugate targeting folate receptor alpha (FRα)—is active in FRα-positive platinum-resistant ovarian cancer, according to a...
Results From MONALEESA-2: Are All CDK4/6 Inhibitors Equal?
Hormone receptor–positive breast cancer is the most common subtype of breast cancer, and while endocrine therapy has long been a mainstay of therapy for these patients, treatment resistance ultimately develops. Therefore, better therapeutic approaches are needed. There are some data to suggest...
First-Line Ribociclib Prolongs Progression-Free Survival in Hormone Receptor–Positive, HER2-Negative Breast Cancer
As reported by The ASCO Post from the recent European Society for Medical Oncology Conference, first-line treatment with ribociclib, a selective inhibitor of cyclin-dependent kinases 4 and 6 (CDK4/6), resulted in significantly longer progression-free survival vs placebo in women with hormone...
Clinical Trials Actively Recruiting Patients With Gynecologic Cancers
Phase I Study Title: Phase I Study to Determine the Effects of Mesenchymal Stem Cells Secreting Interferon Beta in Patients With Advanced Ovarian Cancer Study Type: Phase I/interventional/single-group assignment Study Sponsor and Collaborators: MD Anderson Cancer Center Purpose: To find the...
Are Most Patients With Metastatic Melanoma Eligible for Immunotherapy Clinical Trials?
A Danish study reported in the European Journal of Cancer by Donia et al indicates that more than half of patients with metastatic melanoma do not satisfy requirements for enrollment in phase III trials of immune checkpoint inhibitors. Study Details The study involved 276 unselected cases...
Regorafenib in Second-Line Setting for Hepatocellular Carcinoma: Balancing Benefit With Toxicity
During the past 40 years, hundreds of randomized trials testing treatments for advanced hepatocellular carcinoma have been published.1 Conventional systemic chemotherapy and radiotherapy lack survival advantages for these patients.1,2 In 2007, a phase III trial demonstrated survival benefits for...
Regorafenib Improves Survival in Patients With Hepatocellular Carcinoma Progressing on Sorafenib
In the phase III RESORCE trial reported in The Lancet, Jordi Bruix, MD, Head of the Barcelona Clinic Liver Cancer Group, University of Barcelona, and colleagues found that regorafenib (Stivarga) improved overall survival vs placebo in patients with hepatocellular carcinoma who had progressed on...
Bright Future for Osimertinib in EGFR T790M–Positive Lung Cancer
The AURA3 study—reported by Mok and colleagues and reviewed in this issue of The ASCO Post—confirms the dramatic activity of osimertinib (Tagrisso) in patients with advanced epidermal growth factor receptor (EGFR)-mutant non–small cell lung cancer (NSCLC) and acquired resistance to prior EGFR...
Osimertinib Improves Progression-Free Survival vs Platinum/Pemetrexed in EGFR T790M–Positive NSCLC
In the phase III AURA3 trial reported in The New England Journal of Medicine by Tony S. Mok, MD, of the Chinese University of Hong Kong, and colleagues, osimertinib (Tagrisso) significantly improved progression-free survival vs platinum/pemetrexed (Alimta) among patients with epidermal growth...
Radiotherapy vs Temozolomide in Low-Grade Glioma: The Importance of Molecular Classification
The optimal treatment strategy for low-grade glioma has yet to be established, and practice patterns vary in regard to the timing of treatment, as well as the chosen treatment modality. It was against this backdrop, at a time when the benefits of radiation and chemotherapy remained uncertain but ...
Tailoring Treatment for Older Adults With Colorectal Cancer
Nearly 60% of colorectal cancer cases are diagnosed in patients ≥ 65 years, with a median age at diagnosis of 68 years,1 but this population makes up only 34% of clinical trial participants.2 In addition, the older adults enrolled on clinical trials are traditionally the most-fit older adults....
Exploring the Opportunities and Challenges of Seamless Drug Development
The traditional three-phase clinical trial process for testing new drugs does not necessarily make sense when it comes to targeted therapies, according to many experts, including regulators, academic researchers, industry chief executive officers, and patient advocates alike. Instead of three...
Chinese Trial Adds Utidelone to Capecitabine in Heavily Pretreated Patients With Metastatic Breast Cancer
In a Chinese phase III trial reported in The Lancet Oncology, Zhang et al found that adding the epothilone analog utidelone to capecitabine prolonged progression-free survival in women with heavily pretreated metastatic breast cancer refractory to both anthracycline and taxane treatment. Study...
Myeloablative vs Reduced-Intensity HCT for Acute Myeloid Leukemia and Myelodysplastic Syndromes
In a phase III trial reported in the Journal of Clinical Oncology, Scott et al found that myeloablative conditioning for allogeneic hematopoietic cell transplantation was associated with a reduced risk of relapse and a nonsignificant overall survival advantage vs reduced-intensity conditioning in...
ASCO-SITC Clinical Immuno-Oncology Symposium: Utility of Biomarkers for Predicting Colorectal Cancer Survival Depends on Tumor Location
A large population-based study suggests that the utility of particular types of tumor-infiltrating lymphocytes (TILs) to predict colorectal cancer survival depends on where the tumor originates in the body. Although prior research has shown an association between high TIL density and longer...
Olaparib Meets Primary Endpoint in OlympiAD Trial in BRCA-Mutated Metastatic Breast Cancer
On February 17, positive results were announced from the phase III OlympiAD trial comparing olaparib (Lynparza) tablets to physician’s choice of a standard-of-care chemotherapy in the treatment of patients with HER2-negative metastatic breast cancer harboring germline BRCA1 or BRCA2...
2017 GU Cancers Symposium: Atezolizumab Plus Bevacizumab Shows Potential in Metastatic Renal Cell Carcinoma
Results from the phase II IMmotion150 study that compared atezolizumab (Tecentriq) plus bevacizumab (Avastin) and atezolizumab monotherapy to sunitinib (Sutent) alone in patients with previously untreated, locally advanced or metastatic renal cell carcinoma were presented at the 2017 Genitourinary...
2017 GU Cancers Symposium: Updated Efficacy and Tolerability of Durvalumab in Locally Advanced or Metastatic Urothelial Carcinoma
At the 2017 Genitourinary Cancers Symposium, Powles et al presented updated efficacy and safety data for durvalumab in patients with locally advanced or metastatic urothelial cancer (Abstract 286). Updated results from the phase I/II trial showed an objective response rate of 20.4% in all...
Exploring the Opportunities and Challenges of Seamless Drug Development
The traditional three-phase clinical trial process for testing new drugs does not necessarily make sense when it comes to targeted therapies, according to many experts, including regulators, academic researchers, industry chief executive officers, and patient advocates alike. Instead of three...
Combination Immunotherapy for Lung Cancer: The Wave of the Future
Increasing experience with immunotherapy for lung cancer in both the lab and the clinic is helping to refine treatment approaches and point the way forward, according to Naiyer Rizvi, MD, Director of both Thoracic Oncology and Immunotherapeutics at Columbia University Medical Center in New York....
Selected Abstracts From the 2016 ASH Annual Meeting
Here are several abstracts selected from the proceedings of this year’s American Society of Hematology (ASH) Annual Meeting & Exposition, highlighting newer therapeutics in high-grade, aggressive B-cell non-Hodgkin lymphomas (NHLs), including newly diagnosed as well as relapsed or refractory...
Ongoing Phase III Clinical Trials of Immunotherapy in Advanced Non–Small Cell Lung Cancer
The information contained in this Clinical Trials Resource Guide includes actively recruiting clinical studies focused on immunotherapy in lung cancer. All of the studies are listed on the National Institutes of Health website at ClinicalTrials.gov. Study Title: A Randomized, Double-Blind, Phase...
New Analysis of CheckMate 057: Search Continues for Predictors of Outcome With Nivolumab
Prognostic factors and tumor expression of programmed cell death ligand 1 (PD-L1) predict early mortality among patients with previously treated nonsquamous advanced non–small cell lung cancer (NSCLC) who receive nivolumab instead of docetaxel. But these features are not reliable for excluding...
KEYNOTE-010 Update Shows ‘Striking’ Durability of Second-Line Pembrolizumab in NSCLC
Pembrolizumab’s benefit in previously treated advanced non–small cell lung cancer (NSCLC) that expresses programmed cell death ligand 1 (PD-L1) is long lasting, persisting even after therapy ends, suggests an update of the KEYNOTE-010 trial.1 Initial results of the randomized phase II/III trial,...
Expert Point of View: Vincent J. Picozzi, MD
Vincent J. Picozzi, MD, a pancreatic cancer specialist at Virginia Mason Hospital in Seattle, commented on the findings by Chan et al presented at the 2017 Gastrointestinal Cancers Symposium. Dr. Picozzi first acknowledged that there is a strong biologic rationale for evaluating cabozantinib...
Cabozantinib Elicits Responses in Neuroendocrine and Carcinoid Tumors
In a phase II study reported at the 2017 Gastrointestinal Cancers Symposium, the tyrosine kinase inhibitor cabozantinib (Cometriq) was evaluated in advanced carcinoid and pancreatic neuroendocrine tumors. Radiographic responses to therapy were observed in both tumor subtypes, and compared to other ...
Health-Related Quality of Life in Pivotal Trial of Adjuvant Ipilimumab in Stage III Melanoma
As reported in The Lancet Oncology by Coens et al, there was little difference between adjuvant ipilimumab (Yervoy) vs placebo in health-related quality of life in patients with high-risk stage III melanoma in the phase III EORTC 18071 trial supporting the 2014 approval of ipilimumab in this...
Study Finds Suboptimal Use of Adjuvant Endocrine Therapy in Breast Cancer
In a retrospective cohort study reported in JAMA Oncology, Daly et al found that recommended use of adjuvant endocrine therapy for breast cancer improved in the United States between 2004 and 2013 but remains suboptimal. The study included data on 981,729 women with stage I to III breast cancer...
Durvalumab Shows Activity in Heavily Pretreated Patients With Non–Small Cell Lung Cancer
The immune checkpoint inhibitor durvalumab (also known as MEDI4736) is active and achieves durable responses in patients with heavily pretreated advanced non–small cell lung cancer (NSCLC) that does not have any epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK)...
Atezolizumab Benefits Survival vs Docetaxel Across Multiple Subtypes of Non–Small Cell Lung Cancer
A wide range of patients with advanced non–small cell lung cancer (NSCLC) see a survival advantage from second- or third-line atezolizumab (Tecentriq) as compared with docetaxel, according to new data from the OAK trial.1 The main results of the randomized phase III trial, previously reported,...
Quality-of-Life Data From KEYNOTE-024: First-Line Pembrolizumab vs Chemotherapy in Advanced NSCLC
When used as first-line therapy for advanced non–small cell lung cancer (NSCLC), pembrolizumab (Keytruda) yields better health-related quality of life than platinum-based chemotherapy, suggest new data from the randomized phase III KEYNOTE-024 trial.1 After 15 weeks of treatment, changes in scores...
Clinical Trials Study the Role of Immunotherapy in the First-Line Setting of Non–Small Cell Lung Cancer
In 2016, the KEYNOTE-024 trial set the bar for first-line immunotherapy in non–small cell lung cancer (NSCLC). Trial results showed that pembrolizumab (Keytruda), an antibody to programmed cell death protein 1 (PD-1), reduced the risk of disease progression or death by 50% and the risk of death by...
Adding Bevacizumab to Perioperative Chemotherapy in Esophagogastric Adenocarcinoma
In the UK Medical Research Council ST03 phase II/III trial reported in The Lancet Oncology, Cunningham et al found that adding bevacizumab (Avastin) to perioperative chemotherapy did not improve survival in patients with operable esophagogastric cancer and may have been associated with impaired...
Patients With Breast Cancer With Dense Breast Tissue More Likely to Develop Contralateral Disease
Patients with breast cancer with dense breast tissue have almost a twofold increased risk of developing disease in the contralateral breast, according to new research from The University of Texas MD Anderson Cancer Center. The study, published by Brewster et al in the journal Cancer, is among the...
Zoledronic Acid Every 12 Weeks vs Every 4 Weeks in Women With Breast Cancer and Bone Metastases
In the phase III OPTIMIZE-2 trial reported in JAMA Oncology, Hortobagyi et al found that an every-12-week schedule of zoledronic acid was noninferior to an every-4-week schedule in terms of skeletal-related event rate in women with bone metastases from breast cancer who were currently receiving...
Residual Cancer Burden, Breast Cancer Phenotype, and Long-Term Prognosis After Neoadjuvant Chemotherapy
In a study reported in the Journal of Clinical Oncology, Symmans et al found that residual cancer burden (RCB) after neoadjuvant chemotherapy was significantly prognostic for long-term outcome across breast cancer subtypes. Study Details The study included 5 patient cohorts from The University of ...
Italian Trial Adds Bevacizumab to Cisplatin/Etoposide in Extensive-Disease Small Cell Lung Cancer
In an Italian phase III trial reported in the Journal of Clinical Oncology, Tiseo et al found that adding first-line bevacizumab (Avastin) to cisplatin/etoposide did not prolong overall survival in patients with extensive-disease small cell lung cancer. Study Details In the open-label trial, 204...
